With passage of the Inflation Reduction Act, the Medicare Part D (outpatient drug benefit) will be undergoing a comprehensive redesign, which will be implemented in 2025. There will be a dramatic shift towards payer responsibility of costs, particularly in the catastrophic phase of the Medicare Part D benefit.

Currently, during the calendar year there are four phases a Medicare beneficiary goes through when obtaining coverage of outpatient drugs: Deductible, initial coverage, coverage gap, and catastrophic. Here, catastrophic refers to the point when a beneficiary’s total prescription drug costs for a calendar year have reached a set maximum level. At present, the catastrophic threshold is set at $7,100. In a given year, once beneficiaries hit the threshold they will have spent $3,250 out of pocket, at which point they begin paying 5% co-insurance in the catastrophic phase.

Over a five-year period from 2016 to 2021, nearly three million enrollees in Medicare Part D spent above the catastrophic threshold at least once. And, currently more than 1.5 million beneficiaries are in the catastrophic phase. That number is expected to grow steadily in the coming years. Moreover, at present, spending in the catastrophic phase now accounts for about 45% of total Medicare Part D expenditures.

The redesigned Medicare Part D benefit features a $2,000 hard cap on beneficiary out-of-pocket spending. At the same time, there will be a massive shift in cost management liability in the catastrophic phase. Currently, Medicare picks up the tab for 80% of costs in the catastrophic phase (the government is essentially the reinsurer in the catastrophic phase); plans, 15%; and beneficiaries, 5%. In the restructured Part D benefit, starting in 2025, the drug manufacturer will be responsible for 20% of catastrophic costs; plans, 60%; Medicare, 20%; and Medicare beneficiaries, 0%.

This $2,000 cap will obviously reduce Medicare beneficiaries’ financial burden considerably, especially those who are prescribed high-priced specialty cancer drugs, many of which put them in the catastrophic phase by the end of January in a given year, with no limit on out-of-pocket expenditures. In all probability, the $2,000 cap will lead to more utilization of specialty drugs and better patient adherence.

The Part D overhaul will also force payers and drug makers to rethink their strategies vis-à-vis cancer drug pricing and reimbursement. Payers will have to strike a harder bargain with drug makers when purchasing specialty pharmaceuticals. As payers won’t be able to fully offset their higher burden of cost management by raising premiums – there will be a 6% annual cap on premium increases. There will very likely be increased use of utilization management tools. And, perhaps most importantly, a more competitive market with more use of utilization management tools, such as prior authorization, step edits, and quantity limits. Also more use of outcomes-based pricing models. 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.

Historically, as new checkpoint inhibitors, anti-PD-1 and PD-L1 agents, have gained approval – such as Jemperli (dostarlimab) in April of 2021 - price competition has not been a factor. This is extraordinarily unusual, given how relatively crowded the various oncology indications targeted by checkpoint inhibitors have become; from breast, renal, and colorectal cancer, to melanoma and non-small cell lung cancer. Several companies, including traditional ones like Lilly but also new entrants such as EQRx, are seeking to disrupt this space by offering lower-priced alternatives.

Outside the U.S., oncology drug pricing is generally heavily regulated. And, we observe that certain drugs may not be reimbursed by government (monopsonist) purchasers if there isn’t sufficient clinical benefit to justify the price. Moreover, in international markets, outcome- or value-based pricing strategies for cancer drugs are commonplace, which they aren’t yet in the U.S.

However, Medicare Part D restructuring alters the competitive landscape considerably. For high-priced specialty pharmaceuticals, in particular, it will become increasingly important for payers to contain costs by way of utilization management, promote the use of generics and biosimilars, and negotiate value-based prices. The Lyfegen Platform enables more efficient and transparent management of value-based drug pricing contracts by using intelligent algorithms to capture and analyze patient-level drug cost data.

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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 on a variety of research, teaching, speaking, editing, and writing projects.

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When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare their budgets and formularies to launch value-based drug pricing arrangements as soon as a new treatment receives FDA approval. Pre-approval data sharing between manufacturers and payers gives patients quicker access to newly approved treatments.

As the healthcare system in the U.S. continues its transition from fee-for-service to value-based care, the sharing of healthcare economic information (HCEI) is becoming increasingly important to pharmaceutical manufacturers and healthcare payers seeking to enter value-based drug pricing arrangements.

In the past, drug manufacturers were hesitant to share HCEI and other pre-approval information with payers because regulations were unclear about the legal limits of this type of communication. But payers want HCEI from drug manufacturers for planning, formulary design, budgeting, and purchasing decisions. And lawmakers want to eliminate legislative barriers that inhibit the sharing of HCEI and the increased adoption of value-based healthcare.

The history of legislation surrounding manufacturer/payer communications

Policymakers and regulators, like the Food and Drug Administration (FDA), recognize the importance of big data and the sharing of HCEI for promoting value-based payment arrangements. Their first attempts to remove the legislative barriers to the exchange of HCEI between drug and device manufacturers and population healthcare managers did not produce the desired effects.

The first U.S. federal consumer protection law, the Food and Drugs Act, was enacted in 1906. This law’s consumer protections and law enforcement capabilities were strengthened by the 1938 Food, Drug, and Cosmetic Act (FD&C). Section 502(a) of the FD&C introduced and defined HCEI, giving the pharmaceutical industry their first instructions about what kind of economic data promotion could be communicated and with whom. But manufacturers refused to share information, fearing the penalties of accidentally disseminating off-label information.

Section 114 of the FDA Modernization Act (FDAMA) of 1997, amended FD&C Section 502(a) and provided a safe harbor for HCEI sharing. But manufacturers continued to resist sharing economic data because they felt the guidelines were still too vague about some topics, such as the definition of reliable scientific evidence and who was authorized to receive HCEI. The FDA failed to issue guidance on how to interpret the law.

The industry-wide push towards value-based care after the Affordable Care Act passed made clarification of Section 114 a priority again. In 2016, policymakers issued clarifying guidance about communications and transparency of HCEI, both pre- and post- FDA approval. The 21st Century Cures Act, Section 3037 further defined what types of HCEI and analyses could be used for drug promotion and to whom the HCEI should be communicated. The FDA published a draft payer guidance document in 2017 and then final guidance documents in 2018 suggesting ways to operationalize communications between pharmaceutical manufacturers and payers.

Current FDA guidance

An FDA press statement from June 2018 emphasizes that the 2018 guidance documents are meant to help pharmaceutical manufacturers provide payers with truthful, non-misleading background and contextual information about their products. Furthermore, manufacturers are encouraged to share both clinical data and HCEI payers need to make informed decisions about formulary management, cost effectiveness and reimbursement; this may be more and different data than the safety and efficacy data submitted by the manufacturer to the FDA for drug approval decisions.

The guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities–Questions and Answers, expands upon the sources of scientific evidence for HCEI as defined under Section 502(a). And the guidance clarifies who can receive HCEI, including public and private sector payers, formulary committees, technology assessment panels, third-party administrators, and other multidisciplinary parties.

This first guidance also addresses manufacturers’ communications with payers regarding unapproved uses of FDA-approved products. The FDA does not object to the sharing of this type of information as long as the manufacturer makes it abundantly clear in its communications what uses the product is not approved for.

The second guidance introduced in the FDA press statement is titled Medical Product Communications That Are Consistent With FDA-Required Labeling–Questions and Answers. It pertains to information not included in a drug’s labeling but information that a manufacturer may want to share with payers. Examples can include data from pre- and post-market studies or surveillance of patient compliance that can affect the measurement of a drug’s benefits to health outcomes in value-based contracts. (The first guidance offers safe harbor for communications related to the negotiations or implementation of value-based drug pricing agreements.)

Timing of information exchanges

Payers prefer to receive information regularly from manufacturers during the latter part of the FDA drug approval process. Annual budgets and formulary planning are more difficult to forecast if payers don’t have data in advance to prepare for the coverage of a new drug. Payers are more likely to make a newly approved treatment available to patients without delay when manufacturers share the clinical data and HCEI needed to make formulary and pricing decisions during pre-approval.

Under the FDA’s accelerated approval process, therapies sometimes become available to patients even before the publication of clinical trial data is complete. Payers say, ideally, they would like clinical and HCEI data about new products 12 to 18 months before the projected FDA approval date.

Many manufacturers wait to begin communications with payers until just 6 to 12 months before their product’s expected approval date. Recognizing the importance of HCEI in negotiating value-based drug pricing arrangements, some manufacturers have included HCEI in their FDA product dossier and promotional materials for payers.

The FDA guidance recommends increased transparency about cost data, including price range, price parity with competitors, price premiums, discounts, and inflation adjustments. Some manufacturers and payers prefer to wait for final clinical trial data before discussing pricing. Post-approval data-sharing of real-world evidence must continue between manufacturers and payers to implement value-based drug pricing agreements.

The Lyfegen solution

With most regulatory barriers removed and value-based contract communications exempted from FDA reporting, policymakers hope to see an increase in value-based drug pricing arrangements. Manufacturers and payers can partner with third-party vendors like Lyfegen to employ technology that facilitates easy, continued data-sharing for innovative pricing agreements.

Lyfegen is an independent, global analytics company that offers a value-based contracting platform for healthcare insurances, pharma, and medtech companies wanting to implement value-based drug pricing arrangements with greater efficiency and transparency. 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.

In June, the U.S. Federal Trade Commission (FTC) voted unanimously (5-0) to examine rising list prices of insulin, but also to probe possible anti-competitive practices by pharmacy benefit managers (PBMs) with respect to the use of rebate arrangements. Rebates are payments from drug manufacturers to PBMs in exchange for moving market share towards so-called preferred products on the formulary.

The FTC has specifically cited instances in which cheaper generics and biosimilars are excluded from PBM formularies, as this may violate competition and consumer protection laws.

The FTC inquiry into pharmacy benefit manager (PBM) practices could lead to legal action prohibiting certain rebate practices. In turn, this could induce major changes in the U.S. rebate system. Formulary management could become increasingly value- or outcomes-based, rather than simply a function of a financial power play between drug makers and PBMs. Or, rebates could fall by the wayside altogether, to be replaced by a combination of upfront discounts in lieu of rebates and value-based pricing arrangements. 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.

The FTC has warned of legal action against PBMs if its inquiries find proof of anti-competitive practices. Here, the agency raised the stakes when it included terms like “commercial bribery” in its statements to describe what it perceives as anti-competitive rebates in the insulin market.

The latest FTC inquiries follow a recent investigation by Senators Grassley (R-Iowa) and Wyden (D-Oregon), which blamed rebate schemes for much of what ails the prescription drug market. Furthermore, nearly two years ago, Senator Klobuchar (D-Minnesota) and colleagues commissioned the General Accounting Office (GAO) to examine rebates. The GAO report is due out this fall.

PBMs receive rebates from drug manufacturers in exchange for preferred positioning on the formulary, which in turn drives market share. Experts have criticized rebates for the fact that payers often don’t base their decisions to include a drug on comparative clinical- and cost-effectiveness. Rather, decisions are strictly based on financial terms, namely which manufacturer offers a higher rebate payment to the PBM; a financial power play in which PBMs may threaten not to cover certain drugs if they don’t get the rebate they want. This applies to insulin as well as numerous other therapeutic categories.

What’s worse is when rebate traps or walls are involved. Branded manufacturers leverage their position as market leaders by offering financial incentives to PBMs and health insurers in the form of “all or nothing” conditional volume-based rebates, in exchange for (virtually) exclusive positioning on the formulary. This can mean keeping competitors off the formulary entirely, or severely limiting formulary access to a competing drug with drug utilization management tools like step edits. Here, a patient must use a preferred drug and fail on it (a so-called “fail-first” policy) before “stepping up” to a non-preferred drug.

Because the portion of the rebate retained by PBMs is often calculated as a percentage of a drug’s list price, PBMs can have incentives to establish formularies that favor branded drugs with higher list prices and larger rebates over lower priced biosimilars, specialty generics, or even branded competitors. Rival drugs entering the market lack sufficient sales volume to be able to offer the same level of rebates to PBMs that originator firms can provide.

Proof of the establishment of anti-competitive practices could lead to legal action being taken against PBMs. The question then becomes what would replace rebates? Payers may establish an entirely different formulary management system that is more value-based. Surely, it would be a system that’s less contingent on the role of the financial power play between drug makers and PBMs.

In areas such as immunotherapy targeting certain cancers, cell and gene therapy, and rheumatology, there are already a growing number of value-based agreements.

Girisha Fernando, CEO and Founder of Lyfegen, which offers a platform to track value-based agreements with real-world data, said that many outcomes-based deals are kept secret and therefore under the radar, so to speak. Commercial payers generally don’t share publicly what types of value-based deals they have with drug companies to maintain their competitive advantage. Yet, in an interview with Endpoints News Fernando stated that he’s observed at least a 300% increase in value-based agreements over the last five years. The Lyfegen Platform enables more efficient and transparent management of value-based drug pricing contracts by using intelligent algorithms to capture and analyze patient-level drug cost data.

Fallout from the FTC inquiry – should rebates be identified as anti-competitive - may entail further increases in value-based dealmaking.

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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 n a variety of research, teaching, speaking, editing, and writing projects.

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.

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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

Related Post: Value-based pricing vs best price? Medicaid's best price problem

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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

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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.

Related Post: Indication-specific pricing to make inroads in the U.S.

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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.

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

The high-costs of newer drug treatments make the adoption of non-traditional, value-based drug purchasing arrangements a necessity for healthcare payers and administrators trying to manage their budgets, provide patients with quicker access to the most effective treatments, and reduce wasteful spending on treatments that don’t work. Recent regulatory changes and advanced AI contracting software options are making value-based drug pricing arrangements easier.

Even before the onset of the pandemic, annual budgets for public and private healthcare insurers were strained by the high and increasing costs of prescription drugs. Meanwhile, pharmaceutical manufacturers are bringing new and even more expensive drug treatments to market each year. According to Bloomberg, the median list price for a year’s supply of a new drug introduced to the U.S. market in 2021 was $180,007.

Thanks to COVID-19 vaccines and COVID-related treatments, pharmaceutical sales reached record levels in 2021. Sales in North America account for close to half of the total $7.3 billion global market revenue for that year. And since prescription drug prices are higher in the U.S. than anywhere else in the world, the increasing costs of drugs are a top concern for policy makers, healthcare payers, and consumers.

New, more expensive drug therapies are in development

A growing niche and focus for pharmaceutical companies is high-cost cell and gene therapy products. Market analysis by Grand View Research forecasts the global cell and gene therapy clinical trials market to reach a compound annual growth rate of close to 15% and an estimated market revenue of USD 24.5 billion by 2030.

While the U.S. Food and Drug Administration (FDA) has approved only a limited number of cell and gene therapies so far, expedited approvals of new drugs and favorable designations of new therapies as orphan drug or breakthrough therapies support increasing consumption of these new drug therapies in the U.S. market. The FDA predicts that by 2025, it will approve up to 20 cell and gene therapy products a year.

Healthcare payers and consumers feel the pain of higher drug prices

Even though payers are getting rebates and not paying drug manufacturers’ full list prices, they still have cause for concern as drug prices increase annually. Payers need to protect their annual budgets from outsized expenditures, especially for specialty drugs.

Both payers and patients suffer the effects of high and increasing drug prices. A study of 14.4 million pharmacy claims made from 2010 to 2016 revealed the median healthcare insurer payments for specialty medications rose by 116%; the median patient out-of-pocket costs increased by 85%. Drug list prices during the same 7-year period more than doubled, rising faster than inflation.

Drug manufacturers recognize the need for non-traditional, value-based payment arrangements

A new cell or gene therapy’s price tag may generate as much attention as the drug’s ability to treat disease. For example, one of the most expensive drug therapies in the world is Zolgensma, approved by the FDA in 2019. Novartis Gene Therapies (formerly AveXis) developed the drug to be a cure for around 500 infants born each year in the U.S. with spinal muscular atrophy (SMA). A full course of treatment is priced at $2.125 million.

Soon after Zolgensma received FDA approval, some of the top U.S. insurers quickly set up tight restrictions limiting coverage of the treatment. To help payers manage the impact of the cost and ensure patient access to Zolgensma, Novartis offers insurers the option of either a 5-year, pay-over-time contract or an outcome-based agreement.

The list price of Zyntelgo, the latest gene therapy to be approved by the FDA, surpassed Zolgensma as the world’s most expensive one-time drug therapy. Zyntelgo was developed by bluebird bio as a single-use treatment for an inherited blood disorder, beta thalassemia. According to bluebird, Zyntelgo’s price of $2.8 million is a good value when compared to the estimated $6.4 million worth of lifetime care costs for a patient living with beta thalassemia.

Estimates suggest that only around 850 patients in the U.S. will meet the criteria for treatment with Zyntelgo, and not all of those who are eligible will want the drug. Predictions of Zyntelgo’s annual sales revenue range from $64 million to $200 million.

The majority of patients eligible for Zyntelgo are covered by commercial health insurance, with most of the rest using Medicaid. Bluebird is offering payers a sizeable refund if the treatment underperforms or fails. If patients still need blood transfusions within two years after receiving Zyntelgo, bluebird will refund the payer up to 80% of the treatment’s costs.

Payers recognize the benefits of using value-based drug pricing agreements

Outcome-based agreements help payers address any uncertainty about the effectiveness of a new treatment, gain insight into a drug’s value to patient health outcomes, and reduce the risk of overpaying for a low-value treatment. The real-world evidence collected while managing value-based drug arrangements helps manufacturers justify their list price and reinforces refunds and rebates to the payer if the treatment doesn’t deliver results as expected. So why has there not been greater use of value-based drug agreements?

Regulatory barriers to value-based drug purchasing arrangements eliminated

This year, U.S. legislators have addressed most of the legislative hurdles that, in the past, hindered value-based drug purchasing arrangements. Policymakers updated two pieces of legislation to support increased adoption of value-based drug pricing agreements.

The Medicaid Best Price rule was changed in July, allowing pharmaceutical manufacturers taking part in Medicaid to report multiple best prices. This was followed by the passage of the Inflation Reduction Act in August, which allows Medicare to negotiate directly with drug manufacturers over the prices of some of the most expensive drugs covered by the Medicare program.

Overcoming technological challenges to implementing value-based drug agreements

Another significant obstacle to increased adoption of value-based drug pricing arrangements has been the difficulty in operationalizing complex, data-driven, outcome-based contracts. These non-traditional agreements require a powerful, interoperable contracting software platform with extensive data collection and analysis capabilities to make real-world evidence both accessible and insightful.

To take on an outcome-based contract, an organization has two options. The first is to develop the IT framework in-house and devote management resources to monitor compliance and data security. This option is expensive, time-consuming, and beyond the current capabilities of many organizations.

The second option is to outsource the administrative burden of an outcome-based contract. In recent years, third-party vendors have developed comprehensive contracting software to bridge the gap and help manufacturers, payers, and providers transition from fee-for-service into value-based agreements.

The Lyfegen Solution

Lyfegen is an independent, global analytics company that offers a software-as-a-service platform for healthcare insurances, pharma, and medtech companies wanting to participate in value-based drug pricing agreements without making large investments in software upgrades. With extensive industry expertise and a vast library of resources, we can assess your current capabilities and advise and guide you through pre-implementation. Deployment of our customizable and scalable contracting platform is quick and integrates seamlessly into your existing workflow without compromising data security or compliance.

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.

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:

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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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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.

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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