Beginning July 1, 2022, according to a final rule released by the U.S. Centers for Medicare and Medicaid Services (CMS), drug manufacturers will be able to report varying “best price” points (that is, multiple best prices) for a covered drug to the Medicaid Drug Rebate Program, provided they’re pursuing a value-based purchasing (VBP) arrangement that aligns pricing with outcomes-based clinical and economic measures, such as positive clinical benefits, improved quality of life, fewer physician visits, and reduced hospitalizations. 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 VBPs.

Since 1990, the statutory Medicaid rebate has ensured that states obtain lower net prices for pharmaceuticals. For brand name drugs, the rebate is 23.1% of Average Manufacturer Price (AMP) or the difference between AMP and “best price,” whichever is greater. Here, best price is defined as the lowest available price to any wholesaler, retailer, or provider, excluding certain government programs, such as the Department of Veteran Affairs program. The AMP is the average price paid to drug manufacturers by wholesalers and retail pharmacies. It is proprietary and therefore not publicly available.

The best price stipulation can, however, hamper manufacturers and payers who wish to experiment with value-based arrangements. Suppose a drug manufacturer offers a payer a 100% money-back guarantee for a treatment it is launching. Then, in case the treatment being sold is ineffective, this would imply the possibility of a Medicaid best price of zero dollars. In turn, this would require that the drug be given away free of charge to every state Medicaid program.

The new rule allows manufacturers to report multiple “best prices” for a single dosage form and strength of a therapeutic, provided the prices are tied to one or more VBPs. Further bolstering the rule is proposed bipartisan legislation – Medicaid VBPs for Patients Act – which, if passed, would codify the best price rule. Importantly, the reporting of multiple best prices under different VBPs does not impact the best price for sales outside of the VBPs.

Drug manufacturers and health insurers have long considered linking reimbursement of certain treatments, particularly cell and gene therapies, to health outcomes. Here, VBPs tie reimbursement to the actual benefits that patients receive. Accordingly, VBPs alleviate the significant risk payers take on when they reimburse the high upfront costs of cell and gene therapies; treatments which still need to demonstrate durability over time. However, drug makers and insurers have been stymied by the Medicaid best price rules. The CMS rule change aims to encourage insurers to negotiate value-based outcome deals with drug makers.

For the sake of illustration, suppose a manufacturer has a $2,000,000 gene therapy to treat a rare disease, and is willing to sign a contract which stipulates that the treatment will have its intended therapeutic effect in 80% of the patients who take it. In the VBP, the manufacturer agrees to provide a payer with an 80% rebate if a patient or subgroup of patients does not respond positively to the therapy.

In the event of treatment failure, as a signatory to the Medicaid Drug Rebate Program subject to the best price requirement, the manufacturer would be forced to extend the 80% discount – the best price of the therapy in this case is $400,000 - to the entire Medicaid program, nationwide, because it represents the best price offered to all relevant U.S. purchasers.

Under the new approach in which multiple best prices can be used, as the manufacturer of a $2,000,000 gene therapy, it can structure a VBP with a payer that promises an 80% rebate in the event a patient or subgroup of patients fails to meet pre-specified clinical outcomes. But, for the drug maker the good news is that the 80% discount will not trigger an 80% best price across all Medicaid programs.

It’s hoped that beginning in July 2022 manufacturers in the U.S. will be more willing to negotiate VBPs with payers, including Medicaid. When the rule goes into effect this summer, Lyfegen will be ready to assist companies establish successful VBPs.

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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.

For cell and gene therapy companies to (re)enter the European market, value-based contracting will be imperative

Bluebird Bio – a biotechnology company that develops gene therapies for severe genetic disorders and cancer - has exited the European market. Evidently, this is because the company couldn’t strike deals with payers for its EMA-approved gene therapies, Zynteglo (betibeglogene autotemcel) and Skysona (elivaldogene autotemcel). Payer reluctance to reimburse cell and gene therapies should send shock waves throughout the cell and gene therapy industry. Partnering with Lyfegen may be the solution for pharma and payers alike, as its platform can put users on the right track towards successful implementation of value-based arrangements.

The high price tag of cell and gene therapies has been a topic of discussion for several years and remains an unresolved challenge. Practically all approved cell and gene therapies are priced at more than $350,000 per dose. Zolgensma (onasemnogene abeparvovec-xioi) is currently the most expensive therapy ever launched, with a $2.1 million price tag.

Ideally, gene therapies address the root causes of disease with a single curative dose. If they can replace a lifetime of expensive maintenance treatments this may lead to cost savings in the long run. Yet, the high upfront costs and uncertainty surrounding long-term efficacy and adverse events have caused payer push-back.

Payer concerns are further exacerbated due to there being hundreds of cell and gene therapies in the pipeline, across a wide range of therapeutic categories, from sickle cell anemia to HIV. Should many of these therapies be approved in the coming decade the budgetary impact on payers could become overwhelming.

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Related Post: A Promising Sickle Cell Cure Is Almost Here. What About the Money to Pay for It?

Payers are trying to find alternative reimbursement approaches. Examples of innovative reimbursement models include installment plans, which spread out payments, analogous to a mortgage; and value-based payments. Here, the manufacturer is paid the total cost of the therapy upfront, or in installments. Then, if the patient experiences disease progression, manufacturers must provide a partial or full refund.

One publicly known example of such an arrangement involves the gene therapy Luxturna (voretigene neparvovec). This treatment holds the promise to restore “functional vision” to certain patients with inherited blindness. After the product was approved by the FDA in 2017, the sponsor, Spark Therapeutics, set the price at $425,000 per eye. The insurer Harvard Pilgrim signed a value-based contract with Spark Therapeutics. In the deal, Harvard Pilgrim pays for Luxturna, but is refunded certain undisclosed amounts if the treatment wears off over time.

In 2019, Bluebird Bio told investors that in preparation for the possible approval of LentiGlobin - which is named Zynteglo in Europe - it was seeking what it called “installment plan contracts.” Bluebird Bio proposed that insurers would pay installments over a period of up to five years. Furthermore, after an initial charge, Bluebird Bio would only get reimbursed if the one-time infusion benefits patients.

There are, however, significant challenges in implementing these kinds of frameworks. For example, in many countries, healthcare budgets have one-to-five-year terms, which don’t suit longer payment cycles spanning a patient’s lifetime. In addition, in the U.S. there is substantial churn at insurers, as beneficiaries frequently switch plans, which lowers the potential return on investment for payers. They’re saddled with very high upfront costs without necessarily experiencing the downstream long-term benefits and cost offsets.

Looking to the future, it’s not as if drug companies appear to want to lower their price points. If its gene therapy for patients with hemophilia A is approved by the FDA this year, BioMarin is considering pricing Valrox (valoctocogene roxaparvovec) between $2 and $3 million, which would make it the most expensive treatment in the world. CEO Jean-Jacques Bienaimé asserts that insurers have indicated in preliminary discussions that they are “comfortable” with the proposed price range. Well certainly if Valrox proves durable and cures hemophilia A, the $2 to $3 million price per unit would compare favorably to the lifetime cost of treatment for hemophilia A using existing therapies, which is around $25 million.

But, in my experience talking to payers, they are still wary about high upfront costs, particularly given the uncertainties surrounding efficacy and safety, and possible durability issues. Indeed, European payer reluctance to engage with Bluebird Bio with respect to its two products indicates the need for price concessions coupled with evidence generation to establish proof of efficacy, safety, and durability.

Moving forward, a dynamic pricing structure will likely be required, using a combination of installment plans and value-based arrangements. Moreover, in the U.S. context a solution to the churn problem must be found; perhaps through enhanced portability, so that when patients change insurers there’s mutual recognition of value-based contracts across payers.

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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 4 years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.

In a year marked by landmark legislative changes in support of value-based drug pricing, Medicare has recently received authorization to negotiate directly with drug manufacturers under the health provisions of the Inflation Reduction Act of 2022. Proponents of the law are hoping value-based pricing negotiations and inflation-based rate hike rebates for the country’s largest public healthcare payers will lower national drug costs and save U.S. taxpayers hundreds of billions over the next decade. Of course, pharmaceutical companies disagree.

In 2022, the pharmaceutical industry spent $187 million in lobbying funds fighting–unsuccessfully–to stop passage of a law that would grant Medicare negotiating authority for drug prices. The Inflation Reduction Act (IRA) of 2022 brought to life a legislative fix patient advocates, physician groups, and Democratic legislators have been trying to enact for decades as a tool to help lower prescription drug costs.

When the Medicare Part D retail prescription drug program was created in 2003, Republican legislators added the “noninterference clause” to the law to prevent Medicare from negotiating drug prices. Private health plans run the Medicare Part D drug program, but they set formularies and conduct drug price negotiations without Medicare’s input. The IRA establishes Medicare’s voice in drug price negotiations with drug manufacturers under the Drug Price Negotiation Program set to begin in 2023.

Medicare will be authorized to negotiate directly with manufacturers to find Maximum Fair Prices (MFPs) for a limited number of drugs that have no generic or biosimilar competition. The law also limits price increases year-over-year for Medicare Part D and Part B units sold (not for commercial units sold). Outside of a few product exceptions, drug makers who increase their prices more than the rate of inflation will have to pay rebates to Medicare.

Which drug prices can Medicare negotiate?

According to the new law, each year the Secretary of the Department of Health and Human Services (HHS) will select from a list of qualified single-source drugs with the highest total Medicare spending. The list of negotiation-eligible drugs will consist of the 50 costliest drugs from Medicare’s Part D program and (after 2028) the 50 costliest drugs from Medicare Part B (for drugs physician-administered on an outpatient basis).

A timeline for the changes enacted by the new legislation gives pharmaceutical manufacturers and health insurers time to adjust. The first step of the Drug Price Negotiation Program gives Medicare the authority to negotiate the 10 most expensive Part D drugs, with the negotiated price starting in 2026. The program expands to 15 eligible Part D drugs by 2027. Beginning in 2028, some Part B drugs may also be included in the list of 15 products that can be negotiated. From 2029 forward, Medicare can negotiate pricing for up to 20 Part D and Part B drugs. In total, Medicare will be able to negotiate prices on up to 60 eligible drugs by 2029.

The drugs for price negotiations under the IRA must meet certain standards, including the following:

• The drug may not have a generic substitute.

• For small-molecule drugs, it must be at least 7 years since FDA approval was granted.

• For biologics, it must be at least 11 years since FDA approval was granted.

• New drug formulations or treatments for rare diseases are excluded.

• Treatments extracted or developed from human blood or plasma are not eligible for price negotiations.

• A drug is excluded if Medicare’s total expenditures for the drug are no more than 1% of total Part D expenditures.

• Most drugs developed by small biotechnology companies are excluded.

Not surprisingly, pharmaceutical companies see the passage of the IRA as an unfavorable development and view the Medicare negotiation process as price setting, not negotiations. The HHS and manufacturers are required to negotiate and agree on MFPs for negotiation-eligible drugs; negotiations are not optional. The drug manufacturer has 30 days to accept or counter the price offer Medicare makes. If a manufacturer refuses to cooperate with HHS or fails to negotiate in good faith, HHS can impose civil monetary penalties and an excise tax for non-compliance. It’s likely the pharma industry will challenge the law in court.

What analysts predict about industry impact and cost savings

In July 2022, the Congressional Budget Office (CBO) published the latest estimate of the budgetary effects of the health provisions in the IRA. The CBO expects Medicare’s ability to negotiate drug prices will save $102 billion in public sector healthcare costs over 10 years. During the same period, the CBO estimates an additional $62 billion in savings will result from the cap on drug price hikes at the rate of inflation.

The CBO expects manufacturers will increase launch prices for their new products to counteract the IRA’s inflation-rebate provision which slows the growth of prices over time. The analysts predict this will lead to an increase in Medicaid spending because Medicaid’s rebate program, triggered by the higher launch prices, would not fully offset the price increases. The CBO says Medicare Part B may also be affected by higher launch prices since that program uses the market’s average sales price of a drug to determine its reimbursement rate.

Analysts from Moody’s Investors Service expect there will be both price reductions for some drugs and limited price growth for other drugs. Moody’s analysts warn manufacturers that show high Medicare spending–due to their high prices, not patient consumption–will feel the impact of these regulatory changes the most.

Using the data from value-based drug purchasing arrangements

Proponents of Medicare’s authorization to negotiate drug prices believe the prescription drug provisions in the IRA are a suitable compromise that allows drug manufacturers to realize a reasonable profit while increasing the health benefits, accessibility, and affordability of prescription drugs for Medicare patients. Value-based purchasing arrangements will be an important tool at the core of this compromise.

Part of the criteria the HHS Secretary will consider when negotiating an MFP is the drug’s value to health outcomes and its cost-effectiveness compared with alternative treatments. Industry experts recognize that one of the best ways to gather insights into a drug’s performance is from the data collected in the implementation of value-based drug agreements. The data can either provide real-world evidence of a drug’s cost-effectiveness and benefit to patient health outcomes or reinforce the terms of a rebate for a drug’s underperformance.

Since negotiation-eligible drugs include those approved by the FDA at least 7 years ago, performance data may already be available from past value-based drug agreements for the first round of Medicare price negotiations. Manufacturers can prepare for future negotiations with Medicare by seeking value-based purchasing arrangements for their newer products as soon as possible after FDA approval.

The Lyfegen solution

Lyfegen, an independent global software analytics company, offers a contracting platform solution that helps health insurances, pharma, medtech, and hospitals implement value-based payment models with efficiency and transparency. Lyfegen’s Platform performs real-time, end-to-end, data collection and analysis through intelligent algorithms that can operationalize any value-based pharmaceutical purchasing arrangement and provide deep insights into a drug’s performance.

By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

To learn more about our services and the Lyfegen Platform, book a demo.

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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.

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.

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Pharmaceutical regulating authorities in the U.S. and Europe are under increasing pressure to approve new treatments as quickly as possible. Expedited approval programs were created to speed up patients’ access to innovative treatments that meet unmet health needs or treat life-threatening diseases. But concerns about post-approval follow-up persist. Value-based drug pricing arrangements are a solution that generates real-world data and evidence of a drug’s safety and benefit to health outcomes.

Global health authorities must consider the risks of bringing a new drug to market quickly with limited data about a product’s safety and effectiveness–these risks versus the potential benefits of a new drug that addresses an unmet medical need, alleviates a public health emergency, or saves a patient’s life. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the ones weighing those risks and benefits and guarding the safety of pharmaceutical products and medical devices.

The usual approval process for pharmaceutical products is similar for both agencies. It includes pre-clinical testing, three clinical trials, and a final approval before manufacturers can sell their drugs to patients. Drugs that show potential and meet certain criteria may qualify for an expedited approval process.

Expedited drug approval programs

Both the European and U.S. agencies have developed expedited approval programs to speed up the process of drug development and approval when a treatment shows the potential to meet an unmet medical need or treat a life-threatening condition. A new drug may qualify for consideration under more than one expedited approval program.

FDA programs:

• Priority-review designation (PR) – started in 1992, ensures the submission application will be reviewed within 6 months instead of the usual 12 months

• Accelerated approval (AA) – started in 1992, allows drugs to be approved using a surrogate endpoint instead of the outcomes of a clinical trial

• Fast-track designation (FTD) – started in 1997, a process to expedite the development and review of drugs designed to treat unmet medical needs and serious, life-threatening conditions

• Breakthrough-therapy designation (BTD) – started in 2012, speeds the development and review of drugs with the potential for better health outcomes compared to the results of current treatments on the market

EMA programs:

• Accelerated assessment – started in 2004, a review of the application to be completed in 150 days instead of 210 days if there are no major objections from the authorizing agency

• Exceptional circumstances authorization – started in 2005, eligible for drugs that treat extremely rare diseases and where it is not possible to conduct large clinical trials

• Conditional marketing authorization (CMA) – started in 2006, accelerates approval of drugs designed to meet an unmet medical need or serious, life-threatening disease

• Priority medicines scheme (PRIME) – started in 2016, reviewers are appointed earlier than usual in the development process, mostly used for orphan medicines

Comparing FDA and EMA use of expedited approvals

A study published in 2020 in The BMJ (British Medical Journal) compares the use of expedited approval programs by the FDA and the EMA. The focus of the study included approvals of new medicines from 2007 to 2017. During that time, the FDA approved 320 new drugs, and the EMA approved 268.

The study shows that, as of April 2020, there was an overlap of 75% (239) of new drugs which were approved by both the FDA and the EMA. Most of the drugs approved by both agencies were developed to treat cancer, digestive and metabolic disorders, or blood and cardiovascular disorders.

Out of the 320 drugs the FDA approved, 57% (181) of the new drugs qualified for at least one of the FDA’s accelerated approval programs. Out of the 268 drugs approved by the EMA, only 15% (39) qualified for one of the EMA’s expedited approvals.

A different study of global drug approval programs, covering January 2007 to May 2020, focused on expedited approvals for 128 new cancer drugs. The EMA approved 73% (94) out of the 128 new drugs and qualified 46% of them through expedited approval. The FDA expedited 91% (117) of the new cancer drugs through at least one accelerated approval program. (In 2019, all the cancer drugs the FDA approved during the year qualified for expedited approval.)

Of the six jurisdictions in the study, the FDA was the first to approve 80% (102) of the new cancer drugs. In Europe, delays in submissions of regulatory applications slowed many of the approvals. The EMA’s approvals of the same 102 drugs took an additional median time of 9.7 months.

Post-approval confirmatory trials

The expedited approval process in both Europe and the U.S. relies on post-market, real-world clinical data to confirm the safety and effectiveness of a drug. After the FDA or EMA grants expedited approval and the drug is on the market, the manufacturer is required to conduct confirmatory trials to gather enough real-world evidence to transition the drug from an expedited approval to a regular approval. Both the FDA and the EMA carry a backlog of confirmatory trials that were not completed on time.

An NPR (National Public Radio) analysis of FDA and National Institutes of Health data showed there are around 200 drugs with expedited approvals currently on the U.S. market. Many drugs, especially cancer treatments, have more than one accelerated approval to cover expanded uses. Close to half of these drugs transitioned to standard approvals after confirmatory trials, and another 9% were withdrawn.

The 30 years of data NPR reviewed also revealed that 42% of confirmatory trials didn’t start within the first year after the drug was made available to patients. Some confirmatory trials were delayed by three or more years, and even up to ten years.

The EMA also appears to have a substantial percentage of manufacturers who are slow to transition expedited approvals to standard approvals. In 2016, only about half of the drugs that received expedited approvals from the EMA had converted to standard approvals. Manufacturers who switched to standard approvals took an average of 4 years to complete the conversion process.

Gathering real-world evidence through value-based drug pricing arrangements

Both healthcare payers and drug manufacturers benefit from value-based drug purchasing arrangements for drug treatments that come to market under expedited approval programs.

For manufacturers, the real-world evidence generated by a value-based agreement may be quite helpful for a few reasons. First, the data could satisfy the requirements for post-approval confirmatory trials. Second, manufacturers can show with real-world evidence that their treatment offers better benefits to patient outcomes as compared to competitors’ products. Third, manufacturers can use the data supporting the real-world effectiveness of their product to negotiate and justify their drug’s list price and preferential position on a payer’s formulary.

While payers want the expedited approval process to bring treatments for unmet needs to patients as quickly as possible, they may still have unanswered questions post-approval about a new drug’s benefits. Under a value-based arrangement, payers can collect and analyze real-world evidence to address their uncertainty and concerns about a drug’s safety, benefit to patient health outcomes, and cost-effectiveness.

Value-based pricing agreements between payers and manufacturers allow both parties to share the financial risk of a drug not performing as expected. And if a drug underperforms, real-world data from the value-based agreement can reinforce the terms of a manufacturer’s rebate. Therefore, manufacturers willing to share risk and enter value-based drug purchasing arrangements with payers have a competitive advantage.

The Lyfegen Solution

Lyfegen is an independent, global analytics company that offers a value-based contracting platform for healthcare insurances, pharma, and medtech companies wanting to participate in value-based drug pricing agreements. Lyfegen’s software platform includes three-fold functionality to implement value-based, data-driven agreements with greater efficiency and transparency: data ingestion, agreement execution, and insights generation. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable information about drug performance and cost.

By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

To learn more about our services and the Lyfegen Platform, book a demo.

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Basel, Switzerland, August 3rd, 2021

Lyfegen announces that its value-based healthcare contracting platform has been implemented together with Johnson & Johnson Medical Devices Companies Switzerland (Johnson & Johnson) and a leading Swiss Hospital.  

Through this new value-based healthcare approach, Lyfegen and its partners drive the shift towards what matters most to patients: improved patient health outcomes and more efficient use of financial and human resources, enabling a sustainable post-COVID-19 healthcare environment.  

The shift towards a value-based healthcare in Switzerland and globally can only be achieved through the support of innovative technologies. Lyfegen’s platform is a key enabler for this transition. The platform digitalises and automates the execution of value-based healthcare agreements, paving the way for the resource-efficient scaling of such novel agreements.   

“COVID-19 has shown us the urgent need for a more sustainable healthcare system. With the implementation of value-based healthcare agreements on the Lyfegen platform, we are extremely proud to help Johnson & Johnson and hospitals to accelerate the transition to value-based healthcare and improve patient health outcomes at reduced cost.” says Lyfegen’s CEO, Girisha Fernando.

Lyfegen's compliant, secure and patent-protected value-based healthcare contracting platform automates the collection and analysis of patient-level data. Users receive transparency on actionable health outcomes and agreement performance. Lyfegen’s contribution to this partnership is a blueprint for the scaling of value-based healthcare models across hospitals, health insurances, medical device & pharma companies globally. The partnership marks another important milestone for Lyfegen, as the company continues to grow and has recently opened its next investment round.  

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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.

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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.

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 THE WHITEPAPER

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

yael@gkpr.com

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Read the Press Release on PR Newswire

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.

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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.

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We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!

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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.

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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.

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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.

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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

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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.

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.

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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!

MEET THE LYFEGEN TEAM