Leveraging clinical- and cost-effectiveness data to inform drug pricing and reimbursement
READ MORE
READ MORE
How the U.S. Institute for Clinical and Economic Review is reshaping market access
In the U.S., comparative clinical effectiveness analyses are gaining traction as ways to inform coverage, pricing, and reimbursement of pharmaceuticals by both public and commercial payers. And, while use of cost-effectiveness data to inform coverage decisions is prohibited in the public sector (Medicare and Medicaid) it can be used in the commercial sector.
A recently released Xcenda analysis shows that 70% of U.S. commercial payers identified comparative clinical- and cost-effectiveness evidence in the Institute for Clinical and Economic Review’s (ICER) published reviews as the most important items in the reports with respect to informing coverage and reimbursement decisions.
Additionally, 50% of payers said that long-term cost-effectiveness – for example, cost-per-Quality-Adjusted-Life-Year – is “very impactful” in informing the decision-making process. And, as the figure below shows, 52% used results from an ICER assessment in pricing negotiations while 38% implemented a prior authorization protocol based on an ICER evaluation.
Source: Xcenda, International Society for Health Economics and Outcomes Research (ISPOR) annual meeting presentation, May 2022
Further bolstering the Xcenda analysis, an Evidera study from late 2019 suggested that ICER can influence value-based benchmark prices. The use of value-based pricing is increasing in the U.S. And, where appropriate, ICER favors the use of value-based contracting to align price and value. In fact, in certain instances such as gene therapies, ICER believes that such treatments can only be viewed as being cost-effective if value-based contracting is applied. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based pricing arrangements.
To illustrate the impact ICER assessments can have with respect to pricing and reimbursement decisions, let’s consider ICER’s evaluation of PCSK9 inhibitors – indicated for individuals with inadequately treated levels of LDL-cholesterol. In 2016, two PCSK9 inhibitors were approved by the Food and Drug Administration: Alirocumab (Praluent) and evolocumab (Repatha). ICER reviewed the drugs’ clinical- and cost-effectiveness and suggested the list prices needed to be substantially reduced to make the treatments cost-effective.
What ensued was the establishment of several ICER-payer partnerships that led to formulary exclusions of these therapies and subsequent “price wars” as manufacturers of Praluent and Repatha drastically lowered their list prices to remain competitive.
Broadly, cardiovascular disease represents a competitive market with an established standard of care that includes numerous therapeutic options for most patients. Here, payers were able to leverage ICER’s assessment of the PCSK9 inhibitors in negotiations with drug manufacturers. In turn, this led, for example, to one manufacturer lowering the wholesale acquisition cost of Praluent to $5,850, down from $14,600.
In other therapeutic categories with much less competition, ICER’s impact is less clear-cut. For example, in a therapeutic area such as spinal muscular atrophy, characterized by low prevalence, high mortality rates, and lack of effective treatments, ICER’s cost-effectiveness analysis either did not influence payer coverage - as with the drug Spinraza (nusinersen) - or may have been leveraged by the manufacturer to push for wider acceptance among payers -as with Zolgensma (onasemnogene abeparvovec).
In 2019, ICER published its final recommendations on spinal muscular atrophy therapies. To meet an ICER-imposed cost-effectiveness threshold of up to $150,000 per life year gained, Spinraza would need to be priced at a maximum of $145,000 for the first year of treatment and $72,000 annually for subsequent years. This was considerably lower than Spinraza’s list price of $750,000 for the first year and $375,000 annually for subsequent years. ICER also recommended that Zolgensma could be priced at up to $2.1 million per treatment to be considered cost-effective, which turned out to be in line with its list price of $2.125 million at launch.
Interestingly, although ICER’s analysis found that Zolgensma was cost-effective while Spinraza was not, payer coverage for both drugs followed a similar trend over time, with payers restricting access in the initial periods immediately after launch and later relaxing these criteria.
The shift in coverage criteria could be due to an initial reflex response that payers have to restrict access to extremely expensive medications, followed by a loosening of criteria. Historically, this has been the case. Subsequently, after acknowledging the dramatic clinical benefits that Spinraza and Zolgensma have demonstrated in clinical trials for treating a disease with no other therapeutic options, payers relent, if you will. Also, in the case of Zolgensma, ICER’s evaluation may have led to a further easing of payer restrictions.
Of course, cost-effectiveness analyses, such as the ones published by ICER, must invariably be adapted for local use. Context matters, nationally, but also intra-nationally, in different jurisdictions and sub-markets. Further challenges include local or federal (national) regulations which may prevent the use of cost-effectiveness analyses under certain circumstances; stakeholders’ resistance to adopting such analyses or be bound by their findings; and the general lack of available (and appropriate) cost-effectiveness data.
Nevertheless, there is a consistent trend which points to the growing influence of ICER evaluations on payer decision making, specifically with respect to drug pricing and reimbursement. Clinical- and cost-effectiveness data can be used to determine whether to cover a technology, inform the use of prior authorization or other conditions of reimbursement, and serve as a benchmark for price negotiations with manufacturers.
About the author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst n a variety of research, teaching, speaking, editing, and writing projects.
READ MORE
Signs point to a greater role for indication-specific pricing in Medicare and Medicaid
Indication-specific pricing is a differential pricing method used by payers. Conceptually, it’s based on the idea that certain drugs with multiple indications have differential relative clinical benefit for each indication, or for each distinct patient subpopulation. The rationale behind indication-specific pricing is that the comparative clinical value of a drug can vary widely across indications, accordingly, so should the price if price and value are to align.
The figure below shows the difference between a uniform price – in this case, the price for indication A; green line – applied to all indications versus indication-based pricing.
Figure: Indication-specific pricing
The standard pricing model for pharmaceuticals constitutes a single price across all indications; in this instance, the price for indication A. It’s straightforward, as there is only one price. Besides, it’s the model stakeholders in the healthcare system have been accustomed to for decades. Moving to indication-specific pricing implies different prices for the four indications A, B, C, and D.
The most straightforward approach to indication-specific pricing by payers for a drug approved for, say, two different indications is to simply treat it as two different drugs. This would require two types of packaging, unique sets of National Drug Codes, for instance, for each of the packages, and for injectable drugs, two different Healthcare Common Procedure Coding System (HCPCS) J codes.
Indication-specific pricing is appealing because it supports value-based healthcare by aligning price and value. But it’s not an easy task for both drug manufacturers and payers to set indication-specific prices, as this requires patient stratification, and ultimately anchoring of prices to certain measures of cost-effectiveness, such as the cost per Quality-Adjusted-Life-Year (QALY).
Thus far, the use of indication-specific pricing has been limited in the U.S. to several pilot programs. Specifically, the pharmacy benefit manager (PBM) Express Scripts employs indication-specific pricing in number of different classes of cancer drugs, and the PBM CVS Caremark does this for several auto-immune diseases.
According to the PBMs, indication-specific pricing can provide a justification for higher prices for secondary indications that provide greater clinical benefits. In the context of value being assessed, this may help address payer resistance to expanding coverage to include supplemental indications.
Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of indication-specific pricing arrangements. The Lyfegen platform identifies and operationalizes value-based indication-specific models in a cost-effective manner.
Indication specific pricing could alter prices for the biologic Avastin (bevacizumab), for example, when used for cervical cancer and colon cancer, respectively, depending on the willingness to pay threshold, which in turn may be based on different cost per QALY estimates.
Also, there are differences in the comparative value of the cancer drug Herceptin (trastuzumab) when used in different indications (metastatic versus adjuvant HER-2 positive breast cancer). A possible solution to this problem is for Herceptin to have two prices, one for its metastatic indication, and another for its adjuvant indication.
When Novartis won its groundbreaking CAR-T approval, Kymriah (tisagenlecleucel) in 2018, both the drugmaker and U.S. policymakers at Centers for Medicare and Medicaid Services (CMS) touted performance-based and indication-specific pricing as ways to help finance the $475,000 therapy. Unfortunately, the CMS backed away from a plan to implement a value-based contract for Kymriah. This decision may be revisited, as the pipeline is filled with cell and gene therapies that have large upfront costs for CMS, which must somehow be managed.
Moreover, given the many value-based experiments state Medicaid agencies are currently involved in – from value-based formularies to subscription models for the purchase of hepatitis C medications – this could spur more use of indication-specific pricing in Medicaid.
New “best price” rules in Medicaid went into effect July 1, 2022. The reason for changes in best price rules is to induce more use of value-based contract arrangements, including indication-specific pricing. Newly established protocols allow for the reporting of multiple best prices.
Specifically, to facilitate the broad adoption of these types of contracts, the novel best price rule allows drug manufacturers to report a range of best prices to the extent they may be determined by varying discounts under value-based pricing arrangements, along with the regular best price under any non-value-based pricing arrangements.
Here, value-based pricing arrangements are outcomes-based contracts which vary rebates based on patient outcomes. This can be stratified by indication. In this context, lower discounts may be offered for patients with better-than-expected outcomes in certain indications, and higher discounts for poorer outcomes and lower-than-expected clinical effectiveness of a drug in one or more indications.
About the author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.
READ MORE
Medicaid’s launched its multiple best price program in July 2022 to address a major regulatory barrier to value-based drug pricing arrangements. Policy makers hope with this potential contracting risk and liability gone, manufacturers and healthcare payers will increase their participation in value-based drug pricing agreements.
In 1990, the Medicaid Prescription Drug Rebate Program (MDRP) was created to help slow the expenditures of outpatient prescription drugs to Medicaid patients. Under the MDRP, drug manufacturers who want their drugs covered by state-run Medicaid programs must sign a National Drug Rebate Agreement (NDRA) with the Department of Health and Human Services (HHS).
The NDRA requires participating manufacturers to reveal the lowest available price of their products and pay rebates on their products. According to the Centers for Medicare and Medicaid (CMS), there are around 780 drug manufacturers with NDRAs currently in effect.
The rebates of the Medicaid Best Price Policy
Under the MDRP, manufacturers must inform CMS of the “best price” available for its products. Excluding the price negotiated with some government programs, manufacturers are required to report the lowest price it offers to any drug wholesaler, retail outlet, or healthcare provider. This best price is then used to calculate rebates. Manufacturers pay rebates quarterly to states for the drugs covered under state Medicaid programs.
The rebate for most brand name drugs (excluding certain clotting drugs and pediatric drugs) is 23.1% of the average manufacturer price (AMP) paid by wholesalers and retail pharmacies. If the difference between the AMP and the best price on the market is more than the AMP, then this percentage would become the rebate. The rebate amount for generic drugs does not include a best price provision and stands at 13%.
Outcome-based drug pricing can affect rebates
Despite the industry-wide push from stakeholders and policy makers towards value-based drug pricing arrangements, manufacturers have been wary of signing on to these agreements. They argue these outcomes-based pricing agreements could have unintended consequences that affect the AMP and best price. This, in turn, can skew the calculations for a manufacturer’s rebate liability.
In value-based drug pricing, a drug’s purchase price is linked to the effectiveness of the drug; if the drug underperforms, the manufacturer must pay a rebate, or other form of reimbursement, to the purchaser. Depending on the terms of the value-based pricing arrangement, this could be a substantial reimbursement to a payer for poor patient outcomes. The reduced price after the rebate–even if it’s paid on behalf of only one patient’s poor outcome–could become the new, lower best price.
The new Multiple Best Price policy
Before the multiple best price policy went into effect, manufacturers feared that, in theory, if the terms of a pricing agreement resulted in a 100% reimbursement to a payer for a drug proven to be ineffective, the manufacturer could find themselves in a situation where they had to give away their drug for free to every state Medicaid program.
In response to this interpretation of the best price policy–which became a regulatory barrier to value-based drug pricing arrangements–CMS revised the best price policy with the Final Rule. Under the Final Rule, as of July 2022, manufacturers can now report multiple best prices: the single best price for traditional sales and the prices negotiated under value-based pricing arrangements.
This option to report multiple best prices to CMS is only available for manufacturers who offer states the same terms negotiated in the value-based drug pricing arrangements with commercial insurances. State Medicaid programs can choose to take part in the value-based arrangements or continue to make purchases using the traditional best price.
Critique of the Multiple Best Price policy
Although CMS’ goal with the multiple best price policy was to reduce a significant regulatory barrier, this change still draws critics. And CMS has acknowledged that there will be implementation challenges. Here are some examples of criticisms of the new multiple best price policy.
· Critics find the Final Rule’s updated definition of a value-based drug pricing agreement to be too narrow or too broad. Before the Final Rule went into effect, organizations such as the Coalition for Affordable Prescription Drugs (CAPD) and the Pharmaceutical Research and Manufacturers of America (PhRMA) were concerned the CMS definition of value-based contracting is too narrow and will exclude some value-based pricing arrangements that are already in effect or in negotiations.
y contrast, AARP worried there is a lack of clarity on the definition of value in the Final Rule that could lead to the designation of almost any drug purchasing agreement as a value-based agreement and open the door to fewer rebates for Medicaid programs and more revenue for manufacturers. Time will tell which is the real problem.
· There may not be a non-value-based price for a drug. If a manufacturer is not offering its product outside of a value-based pricing arrangement, there may not be a single, traditional best price to report. When there are no non-value-based sales to look at, CMS advises manufacturers to use reasonable assumptions to set a non-value-based price. Critics, of course, question the loose guidance of a “reasonable assumption” and see this as an opportunity for manufacturers to game the system.
Some stakeholders are also concerned manufacturers will shift most traditional sales contracts to value-based pricing arrangements with the goal of eliminating less profitable, non-value-based best prices. AARP and the National Association of Medicaid Directors (NAMD) have warned that the new rule could undermine the MDRP best price policy that has been so successful in reducing Medicaid drug expenditures.
· There may be technological and operational barriers for State Medicaid programs who want to take part in value-based drug pricing agreements. Like NAMD and AARP, the National Organization for Rare Disorders (NORD) worries manufacturers could be working to erode the MDRP’s best price policy by providing better rebates to commercial insurance companies under value-based pricing arrangements.
Manufacturers and CMS know that some state Medicaid programs will not have the infrastructure needed to implement value-based pricing agreements with more favorable terms. In its Technical Guidance for using multiple best prices, CMS makes suggestions for creating alternative, innovative agreements when intensive data collection and analysis are not feasible.
The Lyfegen Solution
A lack of resources and staff prevents some state Medicaid programs from operationalizing value-based drug pricing arrangements. Lyfgen assesses an organization’s current data gathering capacity, then offers customized solutions using its contracting software platform to support the execution of value-based drug pricing arrangements.
Lyfegen’s Platform helps healthcare insurances, pharma, and medtech companies implement and scale value-based drug pricing contracts with greater efficiency and transparency. By collecting real-world data and using intelligent algorithms, the Lyfegen solution can provide valuable insights into drug performance and cost in value-based contracts.
Lyfegen helps increase affordability and access to healthcare treatments by enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare.
Contact us to learn more about Lyfegen’s software solutions and to book a demo.
READ MORE
Biosimilars are launching soon in several categories, including auto-immune disorders and ophthalmology
2023 will likely be a pivotal year for biosimilars, as Humira-referenced adalimumab products launch in the U.S. Worldwide, Humira has been a massive blockbuster for AbbVie, but also a drain on payer budgets. Once Humira-referenced biosimilars were marketed in Europe, they took off in many countries, as payers sought to reduce financial exposure with heavily discounted products. Steep discounts and tender offers, in which the best bid gets the lion’s share of the market, have helped boost uptake of biosimilars. Additionally, European payers have bought into the value proposition that biosimilars are cost-effective.
Besides auto-immune disorders, biosimilars are entering new therapeutic areas such as ophthalmology. Together with Samsung Bioepis, Biogen is launching Byooviz (ranibizumab) this month. Byooviz is a biosimilar referencing Lucentis. Approved by the FDA in September of last year, the drug will soon become the first ophthalmology biosimilar in the U.S. Byooviz’s approved indications include wet age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Byooviz is being offered at a list price of $1,130 per single-use vial, which is a 40% discount off the wholesale acquisition cost of Roche’s originator, Lucentis. It’s expected that the price of Lucentis will also drop.
But, selling biosimilars like Byooviz to payers and clinics isn’t as simple as discounting the price. As with any new biosimilar, detailing Byooviz’s launch – demonstrating its value - will be an elaborate endeavor, which involves engaging doctors, payers, and patient advocacy groups to facilitate access and appropriate physician and patient support. Biogen, for instance, has said it will be educating ophthalmologists about the science and value of biosimilars, as well as the regulatory framework for its approval.
In the U.S., policymakers firmly believe that safe, effective, and lower-cost biosimilars must be made available to all who need them. However, biosimilars have sometimes been excluded from formularies owing to rebate schemes. In this context, higher-priced originator medications are sometimes preferred by some U.S. payers as rebates are larger for those products. Indeed, perverse financial incentives in the U.S. have been a limiting factor with respect to increasing adoption of biosimilars.
Nevertheless, with employers and patients demanding more pass-through of rebates and the role of cost-effectiveness and value-based pricing gradually becoming more important to payers, it’s expected that biosimilars will ascend in market share across all therapeutic categories where they are available.
Indeed, after a painfully slow start from 2015 to 2019, the U.S. has finally been experiencing a sustained uptick in the uptake of biosimilars in the past few years. Robust biosimilar penetration is now apparent across several therapeutic classes. In addition to the filgrastims and pegfilgrastims, there’s been erosion of the originator biologic market share in the trastuzumab, rituximab, and bevacizumab classes.
Biosimilar usage can be bolstered by value-based contracts in which financial incentives of key stakeholders – payers, drug manufacturers, and healthcare providers - are aligned. For example, payers can institute capitated contracts with healthcare providers which hold those who prescribe originator biologics and biosimilars accountable in part for the total cost of care. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based purchasing agreements. The Lyfegen platform identifies and operationalizes value-based payment models in a cost-effective manner.
Undoubtedly, payers who are less reliant on rebate arrangements and therefore more cost- and value-conscious will be able to achieve a decrease in overall costs, as lower-priced biosimilars introduce market competition within therapeutic classes. In turn, this sparks steeper discounts across all drugs, including originator products.
What may further ameliorate the adoption of biosimilars Is the granting of therapeutic interchangeability designation to certain products. To illustrate, on July 28th, 2021, the FDA approved the first interchangeable biosimilar product, Semglee (long-acting insulin glargine), which implies that it can be automatically substituted at the pharmacy counter. This has ushered in more competition, specifically in the insulin glargine class. Furthermore, one of the six biosimilars referencing Humira (adalimumab), Cyltezo, is now approved as therapeutically interchangeable and may be automatically substituted for its reference product Humira. All six approved biosimilars, including Cyltezo, are slated to enter the U.S. market at different points in 2023.
When determining the cost-effectiveness and budgetary impact of biosimilars, payers must consider dynamics, such as the distinguishing between the initiation of treatment-naïve patients on a biosimilar and therapeutic switching practices, as well as price competition with alternative therapies, and the effect of originator companies who can introduce biobetters, or improvements – often in terms of formulation and dosing – on their original product. Lyfegen can assist with evaluation of the cost-effectiveness of biosimilars and biobetters.
Armed with information about biosimilar and originator biologic clinical efficacy, patient preference, and treatment costs - which Lyfegen can provide - payers will be positioned to make appropriate coverage decisions.
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.
READ MORE
The transition to value-based care is happening at a slower pace than policymakers and healthcare industry leaders had hoped. Stakeholders are struggling to negotiate and then operationalize these complex agreements.
The adoption of value-based drug pricing agreements is not widespread in the U.S., despite the stated strong interest from policymakers and the healthcare industry in tying the price of drugs to their benefit to patient outcomes and value to the health system. Outside of the government Medicare and Medicaid programs, the fee-for-service, volume-based payment model still accounted for almost 56% of commercial health payer contracts as of 2018.
Many value-based pharmaceutical arrangements are not disclosed publicly, making it difficult to know how many are implemented in the U.S. each year. According to the trade group Pharmaceutical Research and Manufacturers of America (PhRMA), there were 73 publicly disclosed value-based drug contracts at the end of 2019. A study published the same year in the American Journal of Managed Care (AJMC) suggested that, because of the confidentiality surrounding most agreements, analysts are underestimating the number of value-based pricing arrangements in effect and their impact on the U.S. pharmaceutical market.
In this article, we will highlight some concerns a payer and manufacturer considering a value-based drug pricing arrangement may each face, and give some insight into why these agreements aren't more widely accepted.
Payers modeling risk
A 2019 survey by the National Pharmaceutical Council (NPC) and the Duke-Margolis Center for Health policy showed that for payers, top deal-breakers in negotiations for value-based pricing arrangements were disagreements over incentive mechanisms for participation and financial terms.
From the payer’s standpoint, a new, high-cost drug–especially one that addresses unmet needs or rare and orphan diseases–is worth the risk if it brings innovative, effective treatment for patients who may have no other options. But payers want to share that risk with the manufacturer when there’s the potential for a substantial impact on the payer’s budget.
Based on publicly available information, oncology, hematology, cardiology, and endocrinology drug treatments are common subjects of value-based pricing arrangements. These treatments have well-defined patient populations, easy-to-see impact measures, endpoints, and cures that make them more appealing to payers. It’s much more difficult to objectively measure the patient health outcomes for treatments covering pain management or mental health.
Payers also prefer treatments that show clinical results in a few months, not years. Tracking a patient’s health to confirm a drug’s value becomes more difficult when a drug takes years to show evidence of long-term benefits. For example, a longer-term benefit of treatment may be the avoidance of hospitalization. In the U.S., patients may leave a payer’s plan at any time, so this future cost may not be captured in the data collection under a current agreement.
Manufacturers sharing risk
When considering coverage of a new drug, payers might question the results of clinical trials, especially if there is limited real-world data because of an expedited FDA approval. So manufacturers must continue to create opportunities to generate real-world evidence that convinces payers of their drug’s value. And they must be ready and willing to share in the risk that a drug may not meet expectations in phase 4 confirmatory trials.
When a new drug has strong competition in the market, manufacturers need real-world evidence to differentiate their product and show their treatment brings better clinical outcomes and value than other options available. Value-based drug pricing agreements are an opportunity to fill that knowledge gap. Pharmaceutical companies not willing to do them to get that real-world evidence may lose out to those who are ready to take on innovative pharmaceutical agreements.
Related Post: Indication-specific pricing to make inroads in the U.S.
Contract partners building data-gathering and analytics capacity
In the 2019 NPC survey, manufacturers cited data collection challenges and disagreements on outcome measures among their top deal breakers.
Choosing the right contract model to fit the product and the capabilities of the contract partners is the first step. This means researching publicly available value-based drug pricing arrangements to learn the rewards and pitfalls of various contract models. All the contract partners must agree on the key metrics to be measured and how the data will be used to determine a drug’s value to patient health outcomes.
For the data-sharing component of value-based pricing arrangements, contract partners must develop a relationship that includes trust, cooperation, and an unusual level of transparency. Sometimes this relationship is best fostered and protected by the support services of a neutral third party, especially when one or both of the contract partners doesn’t have the technical capacity or administrative staff to operationalize a value-based drug pricing agreement.
The Lyfegen Solution
Value-based drug pricing arrangements are hard, but Lyfegen can make them easier. If your organization is considering a value-based pricing agreement, start by researching real-world examples of drug pricing arrangements in Lyfegen’s Models and Agreements Library. With a collection of more than 20 drug pricing models and over 1000 value-based agreements in use worldwide, the Lyfegen Library can help you discern what pricing arrangement is appropriate for your goals, your current operational capabilities, and your contract partners.
Lyfegen’s value-based contracting software can then operationalize the contract model you choose. We help healthcare insurances, pharma, and medtech companies implement and scale value-based drug pricing contracts with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable insights on drug performance and cost.
By enabling the shift away from volume-based, fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.
To learn more about Lyfegen’s software solutions, contact us to book a demo.
READ MORE
The news are out: we are immensely proud to be partnering with Johnson & Johnson to advance value-based healthcare and help patients around the world. We dived into a conversation with our CEO Girisha Fernando on why this partnership holds so much value for Lyfegen.
Girisha, why was the partnership with Johnson & Johnson such an important milestone for Lyfegen?
Girisha Fernando: Johnson & Johnson and Lyfegen share the same vision of sustainable & a value-based healthcare environment. Our goal is to help patients to receive the healthcare treatments they need and with this partnership, Lyfegen is proud to have been a key enabler for Johnson & Johnson and hospitals to deliver better health outcomes for patients.
How can this partnership be a blueprint for future collaborations?
Girisha Fernando: The increasing demand for healthcare measured against the limited financial resources is forcing the healthcare system to deliver innovative technologies to patients at sustainable costs. This can be done with value-based healthcare approaches and value-based agreements. The partnership between hospitals, Johnson & Johnson and Lyfegen shows how healthcare providers, manufacturers and an innovative tech company can deliver more value to patients whilst making efficient use of limited resources.
What would you suggest healthcare payers and hospitals to do if they are considering to implement value-based healthcare agreements with manufacturers?
Girisha Fernando: I believe it is important to focus on how to deliver better patient outcomes at lower cost. Value-based healthcare agreements can be used as a value-maximising method. It allows payers and hospitals to measure health outcomes and the adjacent cost to achieve these outcomes. Thus, hospitals can pivot on focusing their resources on value-adding healthcare treatments whilst addressing financial risk and uncertainty. It will take initial & minimal investment, but the return on investing in value-based healthcare and technology will be in the form of more value for money and better quality and patient health outcomes.
Why is Lyfegen the right platform for this?
Girisha Fernando: With over 120 value-based healthcare agreements running on the Lyfegen platform, we provide the necessary expertise, knowledge and technical competence to our customers. With these capabilities, we break down the complexity of implementing and managing value-based healthcare agreements. And lastly, we ensure that our customers can improve patient health outcomes by using value-based agreements at scale, efficiently.
Learn more about our platform by booking a demo today:
The news are out: we are immensely proud to be partnering with Johnson & Johnson to advance value-based healthcare and help...
Read MoreREAD MORE
Basel, Switzerland | April 17th, 2019 – Lyfegen HealthTech AG successfully closes its seed financing round, raising a total of CHF 750‘000. The funding was led by Swiss private investors. The funds will be used to further build Lyfegen’s value-based payments platform Lyfevalue and conduct further pilots with partners in the US, Africa, and the EU, including the UK.
Lyfegen is a healthcare technology company that has developed a ground-breaking solution to accelerate value-based healthcare, entering a market set to grow to USD 390.7 billion by 2024 according to latest market research. Its platform, Lyfevalue, collects, analyses & reconciles disparate healthcare data for the purpose of automating value-based healthcare contracting. The platform enables life sciences companies, national and private healthcare payers and healthcare providers to operationalise value-based healthcare strategies whilst benefiting from a single holistic solution for their value-based healthcare operations, visit checklistmaids.com. In addition, the platform allows for personalised healthcare by enabling patient level pricing, fostering accelerated and facilitated access to innovative treatments for patients.
“Enabling the shift to sustainable healthcare is a huge challenge, giving us at Lyfegen great purpose and we are honoured to work with individuals that truly care about making a difference for patients around the world,” said Girisha Fernando, Lyfegen’s CEO & Founder.
READ MORE
The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment.
Official Communication by KPMG on 26.10.2020
KPMG addresses the most pressing challenges the healthcare sector is facing today and in the future. Society’s desire to obtain value from the wider healthcare system is not new, however recent experience shows that there is a need to rethink and move healthcare into a new age.
Two current megatrends are: 1) the redesign of pricing for health solutions, and 2) the value of data and the importance of patient access. It is important to address both elements within the Life Sciences ecosystem, including how to innovate, how to develop successful digitalization strategies, and how to get the most out of data.
How outcome-based contracts benefit healthcare
The pricing of services and products based on outcomes or value created is another intrinsic element of the future of healthcare. Rising healthcare costs impact patient budgets and hinder access to treatments. Incentivizing positive outcomes can only benefit patients, while payers gain confidence that they are only reimbursing effective treatments. Manufacturers and providers that buy into the outcome-based model are taking an important step towards making their business more sustainable while contributing to the wider interest of the healthcare ecosystem.
One of the key issues has always been defining the factors that represent value and deciding how to measure them. To give an example, how do you measure if a patient is symptom-free and how long should the observation period last? How is the impact on those caring for an individual considered and how is the societal or economic impact assessed, e.g., can the individual go back to pursuing a career? These questions are key in any reimbursement of pricing arrangements.
Helping the healthcare community
Teaming up with Lyfegen, a healthtech company facilitating access to innovative therapies, KPMG recently published a joint whitepaper (see link below) on the application of outcome-based contracting. Girisha Fernando (CEO and Founder of Lyfegen HealthTech AG) and Martin Rohrbach (Head of Life Sciences for KPMG Switzerland) discuss how this approach can deliver value for healthcare payers, providers and patients.
The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment. The combination of knowledge, reach, and technology specific to value-based healthcare, together with proven practical experience, brings unique insights into value and data-driven pricing agreements for healthcare stakeholders. The whitepaper focuses on why outcome-based contracting can address drug access and reimbursement challenges, and how such contracts can be enabled by innovative technology. There are some clear takeaways, serving as building blocks and opportunities to engage in outcome-based contracting for the benefit of healthcare systems.
READ MORE
Lyfegen’s value-based contracting software is used by healthcare payers and leading pharma companies, including Novartis, Roche, MSD, Bristol Myers Squibb (BMS) and Johnson & Johnson
New York, NY - September 20, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, today announced an oversubscribed $8 million Series A financing round led by aMoon, with additional participation from APEX Ventures and others.
Currently, less than 2% of the health insurance population requiring specialty drugs is responsible for 51% of drug spending. The cost of specialty drugs in the US is spiraling out of control, increasing 12% from 2020 to 2021 alone, with no sign of slowing down due to the increase of cell and gene therapies expected to come to market. As a result, value-based contracting is becoming a more viable alternative for healthcare payers to only pay for drugs that actually work.
By 2025, total net spending on medicine in the US is expected to reach up to $400B. Additionally, new drugs regularly enter the market, but when pharmaceutical companies fail to agree on commercial terms with payers, patients are at risk of being denied access to life saving therapies. Lyfegen’s platform helps regulators, pharma companies and payers more easily adopt value-based payment models by digitizing the end-to-end process of data collection, anonymization and contract negotiations for all parties to agree upon drug pricing and reimbursement.
“We are excited to be announcing this funding round and to have this vote of confidence from aMoon, APEX and our other investors who understand the shift in healthcare that we are experiencing, and are supporting our efforts to expand the Lyfegen platform,” said Girisha Fernando, CEO and founder of Lyfegen. “We currently work with leading government payers, health insurance companies in Europe, the US and the Middle East, and some of the world’s largest pharma companies. Our plan now is to further expand our presence in the US, partnering with both private and public healthcare insurance companies. The move away from volume-based healthcare has never been more needed, and we are happy to play an important role in the shift to value-based contracting.”
“Lyfegen is addressing a significant market need in an industry that is changing dramatically and rapidly, and we are thrilled to help validate their efforts through our investment,” said Moshic Mor, General Partner at aMoon, and former Partner at Greylock and Greylock Israel. “During a time of healthcare budget pressures and recessions, the world needs Lyfegen’s solution now more than ever. We look forward to seeing the company, led by an incredible executive team, continue to enhance access to new drugs as they drive value-based healthcare to become increasingly mainstream.”
About Lyfegen
Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for health insurances, pharma, medtech & hospitals around the globe. The secure platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, health insurances & hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.
Lyfegen is based in the USA & Switzerland, and was founded by individuals with decades of experience in healthcare, pharma and technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.
Media Contact
Yael Hart
GK for Lyfegen
Read the Exclusive article with AXIOS
Read the Press Release on PR Newswire
READ MORE
EGK uses the Lyfegen Platform to handle complex pricing models of on and off-label usage of more than 80 drugs
Basel, Switzerland - November 29, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced today that EGK-Gesundheitskasse is joining its portfolio of insurer partners to execute all of their value-based pricing contracts for high-cost drugs efficiently, securely, and transparently.
Switzerland, with the fourth-highest pharmaceutical spending per capita, spent CHF 8 Billion (8.1 billion euro) on drugs prescribed for specific diseases in the first nine months of 2022. In an effort to combat the high drug spending, Switzerland has implemented an increasing number of discount models for on and off-label drug usage over the last five years. While intending to ensure accessibility to patients at sustainable prices, the complexity of the price models leads to millions spent by insurers to monitor and adjudicate the price models, resulting in an estimated CHF two- to three-digit million range of missed rebates.
Lyfegen's software enables EGK to identify and claim rebates from 141 drug price models with 32 manufacturers, with minimal effort and maximum transparency. This includes cases of rare or chronic illnesses, promising therapies that may be used outside the approved indication, or new drugs not yet available or approved in Switzerland. Lyfegen's platform addresses the needs of Swiss health insurers for cost efficiency and digitalization, helps solve existing complexities in the system, and does its utmost to counteract high insurance premiums.
"We are delighted to support EGK and take an active role in addressing the growing complexity of drug pricing models to support sustainable access to innovative drugs and therapies in Switzerland,” said Nico Mros, CXO and Co-Founder of Lyfegen. “By focusing on making the implementation of the platform as easy as possible and being responsive to EGK, we were able to quickly present results and kickoff the collaboration to a successful start!"
“With the Lyfegen Platform, EGK is further expanding its focus on sustainability and efficiency for the benefit of our policyholders”, said Carolina Pirelli, Head of Benefits and Deputy CEO at EGK. “The ever-increasing number of pricing models for medications poses challenges for insurance companies in terms of resources and processes. With the automated processing of pricing models through the Lyfegen Platform, we are able to perfectly meet our current needs and with Lyfegen's flexibility, focus and understanding, we see ourselves in good hands.”
About Lyfegen
Lyfegen is a global healthtech SaaS analytics company providing a value-based agreement platform for drugs, therapies and devices. Health insurances, pharma, medtech companies & hospitals use the secure platform for thousands of payment models throughout Switzerland, Europe, the Middle East and North America. The Lyfegen Platform supports the negotiation and automated execution of value-based payment models cost-effectively and at scale using real-world data and machine learning. Globally renowned health insurances, hospitals, pharma & medtech companies have already implemented Lyfegen’s patent-pending platform to scale value-based payment models for drugs, therapies and devices, improving access to treatments and patient outcomes.
Lyfegen was founded by individuals with decades of experience in healthcare, pharma and technology, pioneering the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.
About EGK-Gesundheitskasse
EGK-Gesundheitskasse is an SME health insurer based in Laufen (BL), Switzerland. The EGK Group comprises EGK Grundversicherungen AG (basic insurance in accordance with KVG), EGK Privatversicherungen AG (supplementary insurance in accordance with VVG) and EGK Services AG (administration). It insures around 100,000 people in basic insurance throughout Switzerland, 80% of them also have EGK supplementary insurance.
Naturalness and sustainability are part of EGK's values. It is considered a pioneer in providing unrestricted access to excellent complementary medicine. It launches and supports activities throughout Switzerland to strengthen health in a natural way.
Read on PR newswire in English
READ MORE
We are thrilled to welcome Ina Hasani to our team at Lyfegen as Director of Sales & Business Development for Canada. Ina brings nearly a decade of experience in the life sciences sector, specializing in healthcare strategy, market access, and health economics. We sat down with Ina to learn more about her background, her vision for transforming healthcare in Canada, and what excites her most about joining Lyfegen.
Can you tell us a bit about your background and what led you to your role as Director, Sales &Business Development for Canada at Lyfegen?
I have spent close to a decade in the life sciences sector, working with companies like Novartis and Pfizer, where I gained deep expertise in healthcare strategy, market access, and health economics. My passion has always been focused on improving patient outcomes and the healthcare system. This led me to Lyfegen, a company at the forefront of transforming healthcare through innovative solutions. The opportunity to work with payers and drug manufacturers to ensure better and sustainable access to innovative treatments for patients was a natural fit for me, both professionally and personally.
What are the biggest challenges facing the healthcare market in Canada, particularly in terms of drug pricing and access?
The Canadian healthcare system is highly complex! The biggest challenge that we are facing is how to accelerate access to innovative therapies without compromising the sustainability of the healthcare system. Payors, including both public and private insurers, are struggling to balance their budgets with the rising costs of therapies, particularly for specialty drugs. Outcome based agreements are a potential solution to enable timely access to breakthrough therapies. However, payors and pharmaceuticals don’t have the infrastructure in place to efficiently implement and operationalize such agreements.
What opportunities do you see for growth in Lyfegen’s sales efforts in Canada? How can we better support health insurers and government bodies?
There is tremendous potential for growth. Currently, payors and pharmaceuticals adjudicate their product listing agreements (PLAs) manually through Excel spreadsheets. It is resource intensive, leaves room for errors and is a barrier to potential innovative contracting. In addition, as Canada increasingly looks towards value-based healthcare models, Lyfegen is an enabler by providing the digital infrastructure for payor and manufacturers.
From your perspective, what key actions need to be taken in the next 12 months to drive success for Lyfegen in the Canadian market?
In the next 12 months, we need to focus on deepening our relationships with key stakeholders and demonstrate the value of our digital solutions for payors, manufacturers, healthcare system and, ultimately, the patients.
How do you see your role influencing the implementation of value-based solutions in Canada, and what impact do you hope to have?
Lyfegen has extensive experience in OBA implementation and operationalization in many countries. In my role, I hope to bridge the gap from theory to practice in the implementation of value-based healthcare in Canada.
In your opinion, what’s the most important aspect of building strong client relationships in the healthcare industry? How do you approach this in your role?
Trust and communication are at the core of any strong client relationship in healthcare. Given the complexity and sensitivity of the industry, clients need to know that you understand their unique challenges and are committed to solving them. In my role, I prioritize open and ongoing communication, ensuring that clients feel heard and that their feedback is integrated into our solutions. I also work hard to build trust by delivering results and being transparent about what we can achieve together.
Looking ahead, what excites you most about the future of sales and business development at Lyfegen in Canada?
I’m excited about the potential to be a catalyst for significant change in the Canadian healthcare landscape. Lyfegen is in a unique position to lead this transformation. The combination of increasing demand for cost-effective healthcare solutions and our innovative approach makes this an incredibly exciting time to be in sales and business development.
Outside of work, what are some of your favorite things to do in your free time?
Outside of work, I enjoy spending quality time with my family and friends. I also prioritize my health by being active on a daily basis. I also enjoy learning. Now that I have completed my MBA, I’m on a mission to learn Spanish.
We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!
READ MORE
Once upon a time, In a whimsical forest, there lived a smart and creative blue bird. This bird, known for its brilliance in the world of tiny forest biotech, had concocted a magical potion.
This potion was a wonder, a gene therapy to cure the forest creatures of a troublesome disease called sickle cell. Perched thoughtfully on a branch, the blue bird faced a whimsical yet vital challenge. The potion, potent in its healing, needed to be more than just a marvel of science – it had to be reachable and affordable for all in the forest. Additionally, this magical creation was still unnamed, a name that should echo its life-affirming qualities and the journey from a mere idea to a beacon of hope in the forest.
Amidst this puzzlement, the blue bird heard tales of the wise owls of Lyfegen, far beyond the forest. These owls were not just wise; they were masters of a different kind of magic – the magic of numbers and agreements that made health solutions reachable to all. Intrigued, the blue bird fluttered over to learn more.
As it learned about Lyfegen's remarkable ability to navigate the complex world of potion pricing and access, inspiration struck. "Ah-ha!" chirped blue bird, "If Lyfegen can make health solutions accessible, why not name my potion in honor of their work? Lyfgenia – a name that sings of life, hope, and the ingenuity of Lyfegen!"
And so, the potion was christened Lyfgenia, a nod to the owls of Lyfegen whose wisdom ensured that such medical marvels reached every nook and cranny of the forest without burdening its inhabitants.
With its new name, Lyfgenia became more than just a potion; it symbolized a harmonious blend of medical genius and financial savvy. The blue bird turned Lyfgenia into a symbol of hope and healing in the whimsical world of the forest.
Disclaimer: "A Fable of the Blue Bird and Lyfegen's Wise Owls" is a work of fiction, created solely for entertainment and illustrative purposes. This fable does not represent any real-life strategies, decisions, or actions of these entities, nor should it be interpreted as an endorsement or representation of their values, capabilities, or business practices.
Using Lyfegen's solutions can streamline the financial management of advanced therapies like Lyfgenia, leading to more effective pricing strategies and improved access for patients. Learn more about how our solutions enable value-based contracting for gene therapies: lyfegen.com
READ MORE
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh perspective to our mission.
Quick introduction – tell us a bit about yourself!
I'm based out of the UK. I studied Law at University but soon realized that a career as a Solicitor wasn’t my calling. Post-university, I ventured into Software Sales, initially focusing on Cloud Solutions and then transitioning into the Life Sciences realm. Most of my career has been dedicated to building startups and introducing new ideas and products to the market.
What excites you about your job?
What really thrills me about joining Lyfegen is the potential impact I can have on those needing life-saving treatments. The core goal of the pharma industry is to enhance the health and wellbeing of society, and at Lyfegen, we're crafting solutions that make medications more accessible, allowing us to treat more people. It's also incredibly rewarding to collaborate with some of the world's leading pharma companies, supporting them as they launch new assets.
Why did you decide to join Lyfegen?
It was the founders' vision that drew me to Lyfegen. Their passion was evident right from our initial conversations. Joining Lyfegen is an incredible opportunity for me to contribute my experience to another startup, and together, we can continue to thrive on this exciting journey.
What is something you want to learn or improve in the next 12 months?
Over the next year, I aim to deepen my understanding of the market access space within the pharma industry. Launching assets is intricate, with many layers involved, and there's a wealth of knowledge I'm eager to absorb. It's fascinating to learn about the different approaches of various companies and how they navigate the market.
How will your know-how help improve our customers’ experience of Lyfegen solutions?
With my background in launching new solutions for startups, I'm well-acquainted with the challenges that can arise. We can be proactive in addressing these before they occur. As Lyfegen is growing rapidly, it’s crucial that we adapt while maintaining our high standards and always remembering that our customers are our biggest priority. My experience with Global enterprises has also given me insight into the ongoing support they need and the importance of fostering great relationships based on trust and understanding.
Let’s get personal: What are your favorite things to do in your free time?
In my free time, I love to travel as much as I can, exploring different cultures and places, with my next plans to delve into more of Asia. When I'm in the UK, I spend time with my German Shepherd, Max, or playing water polo.
Is there anything else you are looking forward to outside of work in the next few months?
As we near the end of Q4, it's a busy period, but I'm looking forward to a well-deserved break over Christmas with friends and family, indulging in good food. It's the perfect time to recharge and gear up for a significant 2024 for Lyfegen, where we'll continue to serve our customers, engage with new ones, and grow as a company.
Our conversation with Simon ends on a high note, filled with anticipation for the contributions he will bring to Lyfegen. In the words of Girisha Fernando, our CEO, "we are very excited about Simon joining us. His experience is a valuable addition to our team, and we are confident he'll make a significant contribution to our mission. It's a pleasure to welcome him to Lyfegen."
Here’s to new beginnings and transformative journeys!
Welcome to our crew, Simon.
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...
Read MoreREAD MORE
At this years World Evidence, Pricing and Access event, Girisha Fernando, the CEO of Lyfegen, expressed excitement as he spoke about the company’s latest launched offering - the Lyfegen Model & Agreement Library. This unique learning resource is a true game-changer that builds upon the company’s existing product. It expands our horizons by allowing payers and market access & pricing professionals to explore over 2’500 real-life public agreements, and 18 drug pricing models from around the world. The library provides an unparalleled understanding of drug reimbursement models that help users make better informed choices like never before.
Selecting a drug reimbursement model is very complex, as manufacturers want quick market access, while payers may have many concerns, such as a drug’s efficacy and affordability. Fernando emphasized that the library bridges the gap by assisting payers and market access professionals in finding specific models that address each stakeholder’s concerns, and key real-life agreement examples, resulting in better-informed decision-making, and ultimately more efficient reimbursement processes.
“Because of rising healthcare costs and the increase of medical innovations, the thirst for knowledge and need for value-based healthcare capabilities has surged among healthcare payers and pharma companies across the world”, said Fernando, “That is why we are excited about launching the world’s largest database of real-world value-based agreements. It gives payers and pharma a unique insight into how to structure value-based agreements.”
But that’s not all – Fernando explained that the database is constantly evolving, being updated weekly with new public agreements, allowing stakeholders to be up to date on public agreements.
Overall, it is clear that the Lyfegen Model & Agreement Library is an invaluable groundbreaking tool, that is becoming indispensable in increasing the knowledge on drug and Cell & Gene Therapy reimbursement.
READ MORE
He’s analytical, a techie and has a fantastic gift for music! Yes, we are talking about the latest addition to our team, our very own “Technical Business Analyst” and Ukrainian superstar: Pavlo Lupandin!
Just last month we announced the arrival of our Lead Developer, Daniel, and now more great news follows as Lyfegen continues to lay focus on the technical team: we have our very own Technical Business Analyst, Pavlo!
“Pavlo’s sharpness and problem-solving skills just made it clear that we needed him in our team! His drive and commitment will bring great value to our patients, our customers and Lyfegen as we continue to sharpen our platform” says Lyfegen’s CEO, Girisha Fernando.
We are proud to have him as part of the team and sat down with him to give you a little more insight behind the musical talent and witty “Technical Business Analyst”:
Hi Pavlo! Tell us a little about yourself: where are you from and what is your work experience background?
Hello! I was born in the east of Ukraine, got the Master’s Degree in Economics in Kyiv, worked at one of the Big 4 companies for 3 years as an Auditor, following one year in the role of Business Analyst. After this experience, I found myself being a fresh ACCA Member, who wanted to dive into something not that accounting related. Business analysis has proven to be an interesting area where I can develop further capitalizing on my previous experience.
It’s interesting, that back in my audit days I’ve had some big healthcare-related projects. Who knew that it was only the beginning of working in this promising domain…
This is your first experience in the Health Tech industry – what triggered this move?
Pace of development. The Healthcare & IT industries are developing in overwhelming waves, and to ride the peak of those waves is a challenge – formidable, but a tempting one. As soon as this opportunity presented itself, I decided to chase it. We’ll see, where this decision will bring me in a couple of years.
You are joining Lyfegen as Technical Business Analyst. In simple terms: what will you be working on?
I would be occupied mainly with gathering, documenting and communicating the requirements of our customers. Ever heard of different communication barriers? Those I would try to eliminate, trying to grasp the very core of what has to be done for the maximum customer satisfaction and making sure the development team implements requirements as close as possible to the ideal.
What are your next personal goals with Lyfegen?
There are several of them. First, I strive for development as a professional, and I think Lyfegen will provide me with opportunities to do that. Second, I want to embrace that spirit of a high-growth startup – after working for a massive and complex company, the flexibility and freedom of Lyfegen is a breath of fresh air. And finally, I want to know new talented people. I already know, that the Lyfegen team has a great diversity, and I can’t wait to learn some interesting things from people of other countries and cultures.
What motivated you to join?
Purpose and value. As simple as that. I can see the purpose and value of what I’m doing. Obviously, we are at the beginning of this journey, and it’s a bit early to speak about “value-based pricing for everybody” or “pay only for what is really working” but…the concept is huge, and it will become the question of life and death for some patients. And I’ll do my best to make it as close to life as possible.
Enough about work! What passions do you have outside of Lyfegen?
Oh, you don’t want to hear a full list, I assure you. Let me try to sum it up quickly…Music, videogames and tabletop games – I play them all. A small collection of musical instruments – some of them are quite exotic, especially for my home country (banjo and djembe, for example). A bigger collection of tabletop games in different genres – the Lyfegen team can definitely expect a session or two in the nearest future. And a vast collection of videogames on different platforms…without much details let’s just agree there are a lot.
There are some other hobbies of mine, but I’d prefer to keep a couple of surprises up my sleeve!
We are proud to have the Lyfegen team continue to grow with such fantastic team-members!
READ MORE
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh perspective to our mission.
Quick introduction – tell us a bit about yourself!
I'm based out of the UK. I studied Law at University but soon realized that a career as a Solicitor wasn’t my calling. Post-university, I ventured into Software Sales, initially focusing on Cloud Solutions and then transitioning into the Life Sciences realm. Most of my career has been dedicated to building startups and introducing new ideas and products to the market.
What excites you about your job?
What really thrills me about joining Lyfegen is the potential impact I can have on those needing life-saving treatments. The core goal of the pharma industry is to enhance the health and wellbeing of society, and at Lyfegen, we're crafting solutions that make medications more accessible, allowing us to treat more people. It's also incredibly rewarding to collaborate with some of the world's leading pharma companies, supporting them as they launch new assets.
Why did you decide to join Lyfegen?
It was the founders' vision that drew me to Lyfegen. Their passion was evident right from our initial conversations. Joining Lyfegen is an incredible opportunity for me to contribute my experience to another startup, and together, we can continue to thrive on this exciting journey.
What is something you want to learn or improve in the next 12 months?
Over the next year, I aim to deepen my understanding of the market access space within the pharma industry. Launching assets is intricate, with many layers involved, and there's a wealth of knowledge I'm eager to absorb. It's fascinating to learn about the different approaches of various companies and how they navigate the market.
How will your know-how help improve our customers’ experience of Lyfegen solutions?
With my background in launching new solutions for startups, I'm well-acquainted with the challenges that can arise. We can be proactive in addressing these before they occur. As Lyfegen is growing rapidly, it’s crucial that we adapt while maintaining our high standards and always remembering that our customers are our biggest priority. My experience with Global enterprises has also given me insight into the ongoing support they need and the importance of fostering great relationships based on trust and understanding.
Let’s get personal: What are your favorite things to do in your free time?
In my free time, I love to travel as much as I can, exploring different cultures and places, with my next plans to delve into more of Asia. When I'm in the UK, I spend time with my German Shepherd, Max, or playing water polo.
Is there anything else you are looking forward to outside of work in the next few months?
As we near the end of Q4, it's a busy period, but I'm looking forward to a well-deserved break over Christmas with friends and family, indulging in good food. It's the perfect time to recharge and gear up for a significant 2024 for Lyfegen, where we'll continue to serve our customers, engage with new ones, and grow as a company.
Our conversation with Simon ends on a high note, filled with anticipation for the contributions he will bring to Lyfegen. In the words of Girisha Fernando, our CEO, "we are very excited about Simon joining us. His experience is a valuable addition to our team, and we are confident he'll make a significant contribution to our mission. It's a pleasure to welcome him to Lyfegen."
Here’s to new beginnings and transformative journeys!
Welcome to our crew, Simon.
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...
Read MoreREAD MORE
The Centers for Medicare and Medicaid Services is leveraging third-party health technology assessments to inform its offer price in February 2024 for the 10 drugs it has selected for price negotiations. To illustrate, the drug cost watchdog the Institute for Clinical and Economic Review published a report on the blockbuster blood thinners Xarelto and Eliquis and submitted it to CMS. Xarelto and Eliquis are two of the 10 drugs set to face the first round of Medicare price negotiations under the Inflation Reduction Act.
The ICER report modeled the comparative effectiveness of these products over generic warfarin in stroke prevention, myocardial infarction prevention and major bleeding episodes. This includes an assessment of the justifiable price premiums for the two branded products given several different cost-effectiveness thresholds. The table below shows ICER’s calculations of price premiums for Eliquis relative to the generic comparator warfarin and the branded comparator Pradaxa (dabigatran).
Drug manufacturers and payers impacted by the IRA will need to gather and evaluate this kind of information, as well as evidence from peer-reviewed articles and other sources. In turn, they must use the data to inform the price negotiation process for selected drugs but also competing products in the same therapeutic classes.
Launching soon, the Lyfegen Drug Pricing Simulator is a dynamic tool that gathers data inputs and runs real-time simulations that help users understand potential rebate, revenue, cash flow, and budget impacts for the different types and combinations of drug pricing models.
READ MORE
The Inflation Reduction Act authorizes Medicare for the first time to negotiate prices at the national level for a limited subset of single-source drugs. Recently, the Centers for Medicare and Medicaid Services selected the first 10 drugs to be negotiated. The 10 high-cost drugs in the table below represent 20% of total outpatient spend in the Medicare program from June 2022 through May 2023.
Prices will be negotiated over a one-year period with an offer and counteroffer process between CMS and drug manufacturers in which maximum fair prices will be established and posted in the fall of 2024 and implemented in January 2026.
Makers of drugs selected for negotiation should consider how payers in the Medicaid and commercial markets will leverage the published MFP information when negotiating rebates. Also, manufacturers of drugs competing with those selected for negotiation should consider how payers will leverage the published MFP information when making pricing, rebating and reimbursement decisions in the Medicid and commercial markets.
At the time a drug’s negotiated MFP price is posted, competitors may react to the published price by trying to undercut it, perhaps by offering even higher rebates, which in turn may cause the manufacturer of the selected drug to lower the net price of a drug a year prior to the MFP being implemented. Also, once MFPs are posted, payers will have publicly available information on the negotiated prices for the selected drugs as well as evidence used to inform the offer and counteroffers. This may then be utilized as leverage in negotiations for competing products in the same therapeutic classes.
The Lyfegen Rebate Analytics Platform is a cloud-based software that can manage all the complexities of drug rebate administration for payers and pharmaceutical companies affected by the IRA. The data-driven platform automates identifying, calculating, and tracking rebates in a timely manner, all of which help to ensure agreement compliance and reduce revenue leakage.
Learn more: lyfegen.com/products/ara
READ MORE
Prices for drugs in the U.S. continue to rise – faster than the rate of inflation – according to a Harvard study that shows nearly half of new drugs marketed now cost $150,000 or more annually. Insurers, along with consumers and regulators, are anxiously seeking ways to lower costs and to make sure patients get the treatments they need. One solution that is gaining interest is value-based pharmaceutical contracting, where costs are tied to results; the more effective a drug, the more a payer will allocate for that drug.
This model isn’t new and it has proven to be successful in Europe, where many value-based pharma contracting are showing positive results for payers, patients, and pharmaceutical companies. As a result, some companies that cater to the U.S. market are moving towards this model, although there are challenges.
Value-based contracting is especially applicable for the growing number of cell and gene therapies and other new ultra-expensive treatments. By allowing insurers and other payers to pay in installments that are dependent on patient outcomes, or even to receive refunds if the drug does not perform as expected, pharma companies are sharing the risk with payers. And there is great value in that shared risk. Payers, for example, are able to realize better patient outcomes when drugs proving to be ineffective can be replaced with more effective ones. At the same time, pharmaceutical firms are incentivized to ensure that the treatments they offer payers are truly effective ones, spurring better and more effective research.
In addition to making sure that prices reflect patient outcome, value-based contracting helps expand the amount of data associated with a treatment. With more data on the effectiveness of treatments recorded – and more tracking of patients over time – researchers will have more data to draw on when developing new treatments. That data can include details on all aspects of a patient's care and even factor in the patient's adherence to medication schedules. This data can also help pharma companies advance their research.Finally, healthcare providers benefit from value-based contracting because they will be able to get a more accurate picture of their patients' overall health situations, which will allow them to provide higher-quality care. Despite all of the advantages for all parties involved, value-based contracting has not yet been widely embraced by payers or pharma companies. A survey of 180 large employers, insurers, and unions with health benefit programs shows just 12% use value-based contracting for specialty drugs, which are usually the most expensive treatments, and fewer than 1% of organizations are using them for more common drugs.
This apparent reluctance to adopt value-based contracting is surprising because payers who have leveraged this approach are finding that their pharma costs are falling.
But challenges do remain for both payers and insurance companies in adopting value-based contracting. In order to speed up the adoption of value-based contracting, there needs to be a willingness to change business culture and long-entrenched processes; an acknowledgement that value-based contracting can expand insights and opportunities for pharma companies, but more clear incentives are necessary; and more dialogue around industry standards and regulatory flexibility that take this contracting model into account.
Industries like insurance and pharma often have institutional, or legacy, systems and processes that no longer best serve the organization and market opportunity. Innovative new opportunities like value-based contracting likely requires change–changes to systems, to processes, and to people’s day-to-day operations. Some organizations find the implementation of value-based contracting models complicated because they require analyzing patient outcomes, negotiating prices based on those outcomes, and determining which drugs should be included in the program. All of these steps require access to–and analysis of–a great deal of data, which can be a significant investment. However, there are digital platforms that are designed to implement value-based contracting without overcomplicating the process–and the investment can yield operational efficiency, recovery of missed revenues, and, most importantly, provide critical access for patients to life-saving drug therapies.
Within the industry, there is an assumption among pharma companies that there is a limited return on their investment with value-based contracting, or even the possibility of lower revenues due to lower prices. But with the transparency that value-based contracting can bring to pharma companies through real-world data from patients taking their drugs, there comes expanded opportunities to understand drug performance and patient outcomes, both of which are valuable for future drug development and marketing. A KPMG report notes another important benefit of value-based contracting–for example, such agreements can enable pharma companies access to currently highly-regulated markets that they were unable to sell in before, thus serving as a competitive advantage. In order to keep pushing pharma companies in this direction, there need to be more clear incentives that can help them with access challenges.
As value-based contracting continues to be more commonplace, it is likely that there will be more standardization within the industry and regulatory parties. However, these changes should be happening now. For example, standards are needed regarding what factors should be included when evaluating the effectiveness or value of a drug. Furthermore, value is a dynamic concept and the definition changes depending upon the viewpoint–value for a payer is different from value for pharma is different from value for a patient. The industry also needs to sort out what happens in outcome-based contracts when patients switch insurers.
Regulations can also stand in the way. While Medicaid has adopted a value-based contracting model for a small selection of drugs, most others are not covered by that arrangement. Most drugs are subject to Medicaid's Best Price policy where prices aren't connected to effectiveness or results, thus perpetuating the disconnect between price and value. The good news is that CMS, the government agency responsible for Medicaid and Medicare services, plans to extend and expand the value-based contracting model already in effect as they continue working towards the goals of improving health outcomes and lowering costs.
Change can be challenging. But as drug prices rapidly rise, the need for change has never been greater. Value-based contracting is the innovative solution that leverages the right data, at the right time, and with the right level of transparency to reduce costs, recover lost revenues, ensure more effective outcomes, help patients get healthier, and provide valuable data insights for future drugs and treatments. It's time to start implementing them.
READ MORE
Advanced gene therapies that could “practically cure” patients suffering from sickle-cell disease (SCD) are just over the horizon. But they may not reach the people who need them most, many of whom are minorities with fewer financial resources and are reliant on Medicaid for their health coverage. Figuring out how to pay for their treatment looms as one of the biggest questions – both economic and ethical - facing US public health policymakers in the coming years.
Amid Medicaid’s efforts to cut spending, the dilemma of how to cover these drugs could end up increasing rancor and anger in the country – or it could spur budgetary creativity. While programs like Medicaid have traditionally filled the gap between availability and lack of affordability in treatment, the cost of SCD therapies developed by Vertex and CRISPR – estimated at nearly $2 million a dose – could quickly overwhelm even Medicaid's robust resources, especially in states that have higher rates of the disease. And this is just the beginning. As more ultra-expensive drug and cell therapies are developed for numerous conditions in the coming years, the question of how to pay for them looms large.
The American healthcare system has been long accused of discriminating against the poor and minorities – and that discrimination is likely to come into far greater focus when millions of the poorest Americans who could benefit from new therapies are unable to take advantage of them. Altogether, there are over 40,000 SCD patients on Medicare in any given year - about 60% of the estimated 100,000 victims of the disease in the US. Of the 74,817 hospitalized for sickle cell disease in 2023, 69,889 (93.4%) were African-American; on average, one of every 13 Black babies are born with sickle-cell trait (SCT), a forerunner of the disease. Even for SCD patients who can afford private insurance, the out-of-pocket cost for therapy is very burdensome. But for the poor and others who lack private health coverage, Medicaid is a singular life raft – the difference between life and a possibly very abrupt death.
Given the situation, it's likely that patient advocacy groups will make a strong bid for increased government funding. And given the issues of social justice and racism surrounding the historic lack of interest in SCD by the medical establishment, there's a good chance that funding will be forthcoming. But budgets are still budgets; if Medicaid is going to spend more on SCD therapies, it is going to have to cut other payments, especially given the strong pressure to cut Medicaid spending – both on the federal and state level, even in states where the incidence of SCD is high.
This could be the time for Medicaid to follow in the footsteps of Medicare, and implement changes in the way it pays for treatments, specifically implementing models where payment is based on patient outcome. Indeed, Medicaid has proposed doing this, but it must move much faster if it wants to help those with SCD benefit from treatments expected to be approved by the end of the year.
Medicare recently adopted a limited form of results-based drug pricing for some of its most expensive drugs. The legislation initially covers ten high-priced drugs, with the list expanded to 20 by the end of the decade. Under the program, the government will pay a price closer to that demanded by the drug’s maker if a drug does in fact significantly reduce the costs of lifetime treatment. But if a drug does not have the desired result, the cost would be significantly lower. Experts are predicting significant savings for the government.
Medicaid, through CMS/CMMI, plans to do something similar - negotiate results--based contracts for gene-based therapies on behalf of all 50 state Medicaid programs. According to government data, the lifetime cost for treating SCD patients through 64 years of age is also close to $2 million. So Medicaid would be spending roughly the same amount on each patient receiving gene-based therapies, while reducing or eliminating costs for treatment of those over 64. These outcome-based contracts, also called value-based contracts, would allow drug-makers to be paid full price only if the treatment does end up working. These contracts could also allow Medicaid to pay in installments, rather than upfront. In addition, if treatment works faster or better than expected in some patients, there could be room in these contracts for drugmakers to be paid more, or paid earlier. Drug companies and science would also benefit from the extended real-world data involved in these contracts, which track the progress of treated patients for years.
But this model is likely to come too late for many with SCD: CMS/CMMI will only be running a pilot negotiation program in 2026 at the earliest. This means that it's very possible that Medicaid will have to, at least temporarily, ignore very promising gene-based therapies that could help hundreds of thousands of people because it can't pay for them.
Meanwhile, the public pressure and demand for widespread implementation of SCD gene therapies is likely to be very high. Lives are at stake; as is correcting a historic injustice. So how will officials deal with an increase in public pressure to pay for therapies? One possibility is to appeal to the private sector for help. Infact, the NIH will be partnering with the Bill & Melinda Gates Foundation to provide some $200 million to increase the development of affordable gene therapies for SCD and HIV by providing funding to researchers to develop lower-cost therapies, and assistance to those who need treatment. Another option could be transferring unused state Medicaid allocations for SCD from states with very low incidence rates, like Idaho, to states with higher incidence rates, like Mississippi.
Regardless of the solution Medicaid adopts, there's no question that a storm has been raging for years over who gets what in the American healthcare system – and that storm is likely to strengthen as gene-based therapies for SCD become available. Given the history of how the establishment has dealt with that disease – and the people who are its biggest victims – it's likely that changes to how Medicaid pays for expensive therapies will come sooner rather than later. These changes must happen, or inequality in the American health system will only become worse as the pipeline of life-changing gene and cell therapies grows.