Drug Pricing and PBM Scrutiny: Medicare Rulemaking Gains Detail
Companies added proposed Medicare rulemaking and voluntary Medicaid rebates to their pricing disclosures, alongside continuing warnings about revenue and reimbursement.
The therapeutics company Edgewise Therapeutics, Inc. (EWTX) added a June CMS proposal to formalize Medicare drug-price negotiation policies to its August disclosure, expanding its May discussion of negotiation schedules and legal challenges. The proposed rule would “codify policies established in guidance documents” for initial price applicability year 2029 and beyond. Edgewise also said CMS plans guidance on implementing negotiated prices for 2028.
Enliven Therapeutics, Inc. (ELVN), another therapeutics company, added the same proposed rule and planned 2028 implementation guidance in August to the negotiation framework it had described in May. The pharmaceutical company SpyGlass Pharma, Inc. (SGP) also added the June proposal to its August discussion. Both companies continued to identify legal challenges to the negotiation program, preserving that qualification alongside the added rulemaking detail.
Corcept Therapeutics Inc. (CORT), whose products treat hypercortisolism, described more concrete litigation outcomes in July: HHS had generally won substantive disputes and continued to win on appeal, and the Supreme Court had denied review, leaving those appellate decisions intact. The company also described CMS's proposed transition from guidance documents to formal rulemaking. Corcept warned that revenue from its products may be significantly reduced if they become eligible for Medicare negotiation.
Corcept identified its hypercortisolism products as orphan drugs covered by the negotiation exemption for medicines indicated for one rare disease or condition. Its inflation-rebate warning reaches medications sold to Medicare recipients regardless of negotiation eligibility: the company anticipates that the provision “will limit the revenue we receive from Medicare patients” and may materially reduce revenue and profits in 2026 and beyond. The therapeutics company Dyne Therapeutics, Inc. (DYN) retained its May and July descriptions of legislation extending the negotiation exemption to drugs and biologics with multiple orphan designations. Dyne also retained its conditional warning about achieving expected returns and the full value of its patents if products become subject to negotiated prices.
The drugmaker Gilead Sciences, Inc. (GILD) maintained a product-specific warning in May and August, anticipating that its negotiated Medicare price would be “substantially lower” than its current Medicare price. In August, Gilead identified Biktarvy as selected for Medicare maximum fair price determination, effective in 2028. The company said the negotiated price may also increase rebates to Medicaid agencies and potentially other segments, and reduce ceiling prices charged to entities covered by the Section 340B program.
Other companies retained explicit uncertainty about the IRA's overall impact. Vera Therapeutics, Inc. (VERA), which discussed its lead product and product candidates, said in both May and August that the impact cannot yet be fully determined but is likely to be significant. The pharmaceutical company Rhythm Pharmaceuticals, Inc. (RYTM) retained the same qualification across those months, together with its discussion of inquiries and initiatives addressing pricing transparency, manufacturer patient programs and reimbursement methods.
Edgewise also expanded its August discussion of most-favored-nation pricing to include the voluntary GENEROUS Medicaid model, announced in November 2025; its May excerpt had described executive orders addressing direct manufacturer purchases and foreign pricing practices. ImmunityBio, Inc. (IBRX), which has an approved product and other product candidates, had already described that model in May and warned that measures using most-favored-nation pricing targets can adversely affect its ability to price new drugs adequately to recover research and development costs. Under the model, manufacturers may voluntarily offer supplemental rebates to participating state Medicaid programs for covered outpatient drugs.