Comment on CMS-2026-2080-0001

Comment of the Consumer Choice Center Docket No. CMS-2026-2080 – Medicare Drug Price Negotiation Program, IPAY 2029 and subsequent years; treatment of fixed-combination drugs The Consumer Choice Center (CCC) is an independent, nonpartisan consumer advocacy group championing freedom of choice, innovation and affordability for consumers in more than 100 countries. We write regarding one provision of the proposed rule: the plan to aggregate certain fixed-combination drugs with earlier products that share an active ingredient, where an added ingredient primarily enables a different route of administration. We urge CMS to withdraw this provision. 1. The proposal treats distinct, separately approved medicines as the same product. Under current policy, a fixed-combination drug with a distinct combination of active ingredients is its own qualifying single source drug (QSSD). The proposed rule would fold a newer combination product into the QSSD of the original and subject it to the same maximum fair price. The practical effect is illustrated by Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), approved by FDA on December 27, 2024. This subcutaneous formulation required its own Biologics License Application, its own Phase 3 trial (CheckMate-67T, 495 patients in 17 countries) and roughly a decade of development. FDA, the agency Congress charged with determining what constitutes a distinct drug product, concluded it is one. We do not believe the Inflation Reduction Act grants CMS authority to redefine drug product identity by assessing the pharmacological role of individual ingredients. That is FDA's expertise and FDA's statutory role. A pricing agency should not override it for pricing purposes. 2. The proposal penalizes the post-approval innovation that benefits patients and the program. Much of the improvement in medicine occurs after first approval. Roughly half of new indications and about three quarters of industry-funded clinical trials stem from post-approval R&D. The product at issue is not a repackaging exercise: it reduces hypersensitivity and infusion reactions about sevenfold, improves maintained dose intensity (89.5% vs. 79.6%) and is preferred by 71% of patients. It also saves money, with modeled savings of roughly $637,000 over three years per U.S. health plan in a 50% switch scenario, driven by a 64% reduction in preparation and administration time and an 18% reduction in direct provider cost per episode. Sweeping such products into a predecessor's price cap signals that patient-centered improvements will not be rewarded. Over time that means fewer improved options for Medicare beneficiaries, not lower costs. 3. The proposal is likely to reduce, not increase, long-term savings. Aggregation would weaken CMS's ability to independently capture the value of distinct innovations in future negotiation cycles and would discourage subcutaneous biosimilar development. CMS has published no economic analysis of these effects. Calling the change a "narrow modification" does not substitute for one. 4. If affordability is the goal, better tools exist. Three pharmacy benefit managers control roughly 80% of the U.S. prescription market; the FTC and the House Oversight Committee have documented how these intermediaries profit from rebates tied to higher list prices. The USC Schaeffer Center estimates that delinking intermediary compensation from list prices could cut U.S. net drug spending by roughly $95 billion per year without touching innovation incentives. Rebate transparency and continued trade efforts to end foreign free-riding on American pharmaceutical investment would likewise deliver savings without discouraging improved medicines. Recommendations. CCC respectfully urges CMS to: (1) withdraw the proposed fixed-combination modification and preserve the framework treating products with separate BLAs and distinct active-ingredient combinations as distinct QSSDs; (2) defer to FDA as the definitive arbiter of drug product identity; (3) conduct and publish a thorough economic analysis of aggregation's effects on long-term Medicare savings, biosimilar competition and provider costs before finalizing any change; and (4) engage patients, clinicians and health systems that rely on subcutaneous therapies before reshaping this framework. Thank you for the opportunity to comment. We would welcome further discussion with agency staff. Fred Roeder Health Economist and Managing Director Consumer Choice Center