Gene Therapies: Negotiating the Priceless-Insights from the Lyfegen 2024 Drug Contracting Trends Report
READ MORE
Insights & Articles
4 min
The next wave of biosimilars, including Humira-, Eylea-, and Stelara-referenced products, is upon us.
In the U.S., 10 Humira-referenced biosimilars are on the market, nine of which launched in 2023. Until now the biosimilars have gained minimal traction. But that is changing, as the number of new prescriptions written for biosimilar versions of Humira soared to 36% from just 5% during the first week of April, after CVS Caremark altered its formulary.
CVS Caremark—the largest pharmacy benefit manager in the U.S.— removed Humira from its national commercial “template” lists of reimbursable drugs starting April 1. In its place, the PBM included the Humira-referenced biosimilars Hyrimoz, Hadlima and adalimumab-fkjp (a Biocon-produced unbranded product). Hyrimoz appears to be the most favored biosimilar. Similar moves have been signaled by the PBM Express Scripts and its parent company Cigna to be enacted this month, but this time Simlandi will be the most preferred biosimilar.
The FDA also recently approved two interchangeable biosimilars to Eylea, which will produce additional competition for the pharma’s blockbuster as key patent protections are set to expire.
And the biologic Stelara, which was selected as one of the first 10 drugs for Medicare price negotiations, will have its net price disclosed in September of this year in addition to facing biosimilar competition in 2025. The downward pressure on Stelara's price, but also Stelara-referenced biosimilars, will likely be significant.
For their large populations of covered lives who take products in the Humira, Eylea and Stelara-related therapeutic classes, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.
Improved access to biosimilars will offer patients expanded, less costly treatment options. For uptake to happen, payers must educate healthcare providers and patients on the value of biosimilars so that they are on board, whether they are designated by the Food and Drug Administration as therapeutically interchangeable or not.
Hyrimoz and Simlandi are therapeutically interchangeable and favored due to the formulary moves by CVS Caremark and Express Scripts, respectively.
The therapeutic interchangeability designation still plays a role in the U.S., because for biosimilars to be automatically substitutable at the pharmacy they must have proven interchangeability in addition to biosimilarity. As a result, physicians have expressed a preference for biosimilars that have the designation.
But for the many biosimilars that don’t have the therapeutic interchangeability designation, to boost their adoption manufacturers and payers must overcome this de facto regulatory barrier by informing healthcare providers and patients that proof of biosimilarity is sufficient.
Lyfegen can assist in the design of formularies tailored to clients' objectives. It can also accommodate information requests concerning which value-based arrangements are the most appropriate, given the scope of its library database as well as other client services.
If you wish to improve your negotiating leverage you can do so with real-world simulations for effective prescription drug contracts.
.svg)
.svg)
.svg)
READ MORE
With price tags in the millions, gene therapies are redefining medicine—and reshaping how we negotiate access to it. For both payers and pharmaceutical companies, these breakthrough treatments present a shared challenge: how do you fund what feels priceless?
From Zolgensma to Hemgenix, gene therapies promise one-time cures for rare and life-threatening diseases. But the financial model behind them can’t follow the traditional playbook. These treatments call for a smarter, more collaborative approach to pricing—and that’s exactly what’s taking root.
Why Payers and Pharma Need a New Playbook
Unlike conventional drugs, gene therapies frontload their cost while delivering benefits over time. That disconnect forces a fundamental rethink of how pricing, reimbursement, and risk-sharing are handled.
According to the Lyfegen 2024 Drug Contracting Trends Report, health systems worldwide are moving toward innovative agreements: outcome guarantees, installment plans, and subscription-based models. These aren’t just experiments—they’re becoming essential tools to balance patient access with financial responsibility.
For payers, it’s about managing risk while maintaining equity. For pharma, it’s about demonstrating value in a way that aligns with clinical reality. Either way, the direction is clear: shared risk, shared benefit.
Global Shifts That Are Shaping the Market
The trends are global and accelerating. In the United States, payers like Blue Cross Blue Shield and Medicaid are embracing outcome-based models for sickle cell gene therapies like Casgevy and Lyfgenia. Brazil’s Ministry of Health uses installment payments for Zolgensma, spreading risk over five years while tying reimbursement to real-world outcomes.
In Europe, countries like Spain and Italy combine restricted coverage with annual reassessments, ensuring that high-cost therapies are only reimbursed if they continue to deliver results.
The message? Pricing innovation is no longer a nice-to-have—it’s the only way forward.
How Lyfegen Bridges the Gap
At Lyfegen, we help payers and pharma move beyond the negotiation table—and into action.
• Our Agreements Library, the world’s largest digital repository of value-based contracts, helps you understand what others are doing and where the benchmarks lie.
• Our pricing simulation engine lets both sides explore scenarios before committing—making deals smarter from day one.
• And our automated platform handles everything from contract setup to rebate tracking, saving time, reducing risk, and driving transparency.
A Smarter Way to Fund the Future of Medicine
Gene therapies will continue to challenge the limits of what we think healthcare can afford. But with the right models and tools, both payers and pharma can find common ground—ensuring that innovation reaches the patients who need it most.
Curious about what’s next in drug contracting?
Download the 2024 Drug Contracting Trends Report for exclusive insights, real-world examples, and global benchmarks.
READ MORE
The UK government is taking a bold step toward modernizing public services by cutting red tape, integrating AI into operations, and bringing NHS England back under direct ministerial control. This reform signals a shift toward efficiency, innovation, and better patient care—one where AI-driven solutions like Lyfegen can play a pivotal role.
NHS England was originally established in 2012 as an arm’s-length organization to insulate the health service from political interference. Over time, however, bureaucracy accumulated, slowing decision-making and increasing costs. With Starmer’s decision to fold NHS England’s functions back into the Department of Health and Social Care (DHSC), the system is poised for a fresh start. This restructuring aims to eliminate redundant roles, reduce administrative waste, and reallocate resources to frontline care—ushering in a new era of efficient and accountable healthcare management.
A key takeaway from Starmer’s announcement is his strong push for automation. The government is aiming to cut administrative costs by 25%, ensuring that resources are directed where they matter most: patient care.
Some of the expected changes include:
By integrating NHS England’s functions into the DHSC, the government is positioned to strengthen and streamline negotiations with pharmaceutical companies. This shift could lead to:
One of the most promising aspects of this reform is the government’s commitment to leveraging AI to transform operations. For an AI-powered platform like Lyfegen, this presents a significant opportunity to deliver real-world benefits in healthcare management. Here’s how Lyfegen can help:
While AI promises to revolutionize healthcare efficiency, successful implementation will require overcoming hurdles such as:
Transforming the NHS is no small task. Beyond balancing innovation and cost, the government must manage vast amounts of healthcare data and navigate the complexities of implementing change at scale. However, Starmer’s announcement represents more than just another cycle of NHS reforms—it’s a meaningful step toward a future where efficiency and technology-driven innovation deliver real, lasting benefits to patients.
At Lyfegen, we’re ready to support this transformation by delivering AI-powered solutions that drive real savings and faster patient access. Let’s build a smarter, more efficient NHS together.
Want to see how our AI-powered solutions can support smarter drug pricing and better healthcare access? Let’s schedule a demo today.
Sign up & be the first to know about INNOVATIONS
* By sending this message, you agree to our privacy policy.
