Emerging Solutions to Address Financial, Reimbursement Challenges Associated With Gene and Cell Therapies

Several solutions are emerging that can help health plans, especially smaller plans, address the financing and reimbursement challenges associated with gene and cell therapies, according to a panel of experts during a presentation at Academy of Managed Care Pharmacy’s 2021 Nexus meeting.

The panel offered insight into the similarities and differences between emerging product solutions, as well as the implications of the solutions and actionable next steps to implement and expand them as more gene and cell therapies receive FDA approval.

Multiple gene and cell therapies have been approved since 2017, and between 54 and 74 additional therapies are expected to be approved for the US market by 2030, said Jane F Barlow, MD, MPH, MBA, senior advisor at MIT Center for Biomedical Innovation and the chief clinical officer at Real Endpoints. Barlow explained the 4 main financial challenges that are associated with these therapies:

• Payment timing risk, where cost is front-loaded or benefits accrue over time
• Actuarial risk
• Product performance risk, which involved whether the product works over time and retains durability
• Mobility, which involved challenges presented as patients move in and out of plans

Barlow explored some precision financing solutions to overcome these financial challenges, including using orphan reinsurer and benefit manager and risk pools, short-term milestone-based contracts, multiyear performance-based annuities, warranty models, and a Netflix subscription model, which involved defining a population and purchasing the payments in bulk for the number of agreed upon patients over a period of time at a set cost.

Barlow also explained that it’s important to consider the needs of all stakeholders, including patients, providers, administrators, to ensure that benefits impact everyone. Additionally, the market is evolving to meet emerging needs to address how smaller commercial payers, self-insured employers, and Medicare Advantage and Medicaid plans may not be able to manage gene therapies on their own.

Michelle Harika, PharmD, senior advisor at MIT Center for Biomedical Innovation and chief clinical officer at Equity Healthcare, talked about a project she worked on that set out to conduct a survey to gather and assemble relevant information on emerging programs to overcome the challenges outlined by Barlow. The results were published as a white paper.

“The goal of the project was to really identify the existing and emerging products and find out more about them, so that we would have that knowledge available to the participants of focus, but also to anyone else,” said Harika.

The digital survey included 45 questions, was disseminated to 12 organizations, and identified 16 new products or services . The products were categorized into 4 groups and related to the precision financing solutions that Barlow mentioned:

• Reinsurance/stop loss/risk carve out
• Contract negotiation and data management
• Provider contract negotiations that included Centers of Excellence for a treated condition
• Financial and warranty services

Harika stated that the products were similar to each other in that they all were relatively new to the market and sought to overcome financial barriers, whether that involved addressing reinsurance, payment timing, or support for performance-based contracts. A good portion of the products also included provisions to expand overtime as more gene and cell therapies are approved.

However, there were several differences, including that some focused more on traditional insurance instead of offering a service, target customers varied greatly, and some products included therapies that weren’t classified as gene or cell therapies.

Barlow provided some of the key takeaways from their findings, saying that the market is responding to the challenges of cell and gene therapies by developing new products and solution, that products take different avenues to address various stakeholder needs, and that one solution is likely not going to address all stakeholder concerns and needs.

“I would still put all the risk-based contracts and value-based contracts as something that will continue to grow and get momentum, but they're still somewhat of a cutting edge approach. And there's learnings to be had by all,” said Barlow.