Enhancing Adoption of Infused Biosimilars for a Sustainable Future

A recent IQVIA Institute report on the long-term sustainability of infused biosimilars in the US highlighted challenges in uptake and sustainability, providing background on issues and potential policy solutions.

The report summarized an expert roundtable discussion from May 2024, including representatives from Pfizer, the Biosimilars Forum, Moffit Cancer Center, and more. The document began by outlining some of the biggest issues to biosimilar uptake and market sustainability, including rebate walls and high concessions that limit biosimilar uptake and future competition. This primarily impacts biosimilar manufacturers by slowing uptake and reducing health care savings.

Additionally, declining average sales price (ASP), influenced by rebates, can leave providers under-reimbursed, impacting their cost recovery for biosimilars and discouraging their use. This limits biosimilar adoption and affects both providers and manufacturers. Continuous ASP declines from competition threaten manufacturer profitability, risking market exits and reduced competition, which could reverse savings and lead to shortages. Low out-of-pocket costs for both biosimilars and originators mean patients have little incentive to switch to cost-saving biosimilars, limiting potential health care savings.

“Patients are the ones that benefit the least from biosimilars, and we should try to come up with a solution that weaves in financial benefit to patients as well, not just the health care system,” remarked panelist Ken Komorny, PharmD, BCPS, vice president and chief pharmacy officer at Moffitt Cancer Center.

The report cautioned that any policy changes should optimize long-term savings and incentives for all stakeholders, ensure transparent CMS policies, provide fair reimbursement for providers, incentivize biosimilar use by manufacturers, and minimize patient out-of-pocket costs. The reimbursement system has long been categorized as a major barrier to biosimilars, focusing on the ASP of a product and often favors reference biologics.²

“It’s time to think about a floor for reimbursement for biosimilars and generics. We’ve demonstrated that there is a competitive market driving prices down, but if we don’t do something with regards to a floor for reimbursement, then we will continue to see products drop off the market and crash,” commented Robert Popovian, one of the panelists and chief science policy officer at the Global Healthy Living Foundation.

Following a multi-stakeholder roundtable discussion, 5 key policy proposals emerged:

1. Evolve the ASP-based reimbursement system beyond the “ASP plus 8%” policy laid out in the Inflation Reduction Act.³
2. Track biosimilar use with utilization metrics, offering incentives for high-performing providers.
3. Use shared savings models, giving providers a share of Medicare savings from biosimilar use.
4. Set a minimum reimbursement rate to ensure provider stability and prevent unsustainable ASP trends.
5. Limit the impact of payer rebates on ASP calculations to keep reimbursements above acquisition costs.

Setting a minimum reimbursement would decouple from each biosimilar’s reported ASP and instead relate to the originator’s costs to CMS, providing predictability for providers and locking in savings for CMS. Once the floor is established, manufacturers could offer further discounts or rebates, encouraging competition among them. From the stakeholders' perspective, implementing a reimbursement floor would mitigate the downward pressure on ASPs, thereby helping to maintain economic incentives for all parties involved.

However, payers might experience reduced short-term savings due to slower declines in ASPs. Long-term concerns persist regarding potential decreases in investment for future biosimilars, with reports indicating a decline in the number of biosimilars in development.

Overall, the introduction of a provider reimbursement floor is anticipated to facilitate predictable and consistent savings over time, preventing a reversal of savings in existing markets and ensuring a stable biosimilar market. This approach could ultimately support the sustainability of biosimilars, benefitting providers, patients, and the health care system at large.

The authors concluded, “Currently, most patients do not directly benefit from savings through biosimilars. There is a need to evaluate how the benefits can be passed on to the patients. At this stage, policy considerations did not take this aspect into account; however, all stakeholders noted the importance of addressing this issue. Future policy discussions should carry this consideration forward and ensure that benefits for the patient are a part of policy discussions.”

References

1. Policy proposals to achieve long-term sustainability of infused biosimilars in the U.S. IQVIA Institute for Human Data Science. October 17, 2024. Accessed October 29, 2024. https://www.iqvia.com/library/insight-brief/policy-proposals-to-achieve-long-term-sustainability-of-infused-biosimilars-in-the-us?utm_campaign=2024_2024_PolicyPropBiosims_INSTITUTE_TC&utm_medium=email&utm_source=Eloqua

2. Jeremias S. Sandoz report: a unified approach to overcoming drug shortages. The Center for Biosimilars^®. October 10, 2024. Accessed October 30, 2024. https://www.centerforbiosimilars.com/view/sandoz-report-a-unified-approach-to-overcoming-drug-shortages

3. Inserro A. Biosimilar Medicare Part B payment boost begins. The Center for Biosimilars. October 3, 2022. Accessed October 30, 2024. https://www.centerforbiosimilars.com/view/biosimilar-medicare-part-b-payment-boost-begins