Biktarvy is among the 15 drugs facing Medicare price negotiations

Biktarvy, the commonly prescribed single-tablet regimen for treating HIV, is among the 15 drugs that will face Medicare price negotiations this year aimed at significantly reducing program expenditures and out-of-pocket costs for Medicare beneficiaries.

Release of the January 27 list kicks off a process that will unfold throughout most of 2026 and involve participation by drug companies and the public.

The Centers for Medicare & Medicaid Services (CMS) announced the 15 drugs covered by Medicare Part B and Part D as the third annual cycle of the Medicare Drug Price Negotiation Program, part of the Biden-era Inflation Reduction Act. Under the federally mandated program, CMS directly negotiates the prices of some high-cost drugs, focusing on single-source drugs that have no generic version or direct competitor.

This is the first time an HIV medication has been selected for the Medicare Drug Price Negotiation Program.

CMS looked at Part B and Part D drug expenses between November 1, 2024 and October 31, 2025, to determine which drugs to choose. The selected drugs accounted for $27 billion in total expenses to Parts B and D, for about 1,777,000 beneficiaries who were given the medications for conditions that included cancer, psoriatic arthritis and HIV. Biktarvy cost Medicare about $3.9 billion for 101,000 beneficiaries during that period, according to a CMS fact sheet.

Makers of the 15 drugs had until February 28 to decide if they would participate in price negotiations with CMS. 

March 1 was the deadline for drug companies and the public to submit data. By then, drug companies will need to have submitted manufacturer-specific data to CMS to make their case for what the Maximum Fair Price (MFP) should be for their drug. Also by then, the public must have submitted data on the selected drugs and their therapeutic alternatives, if any, as well as data on unmet medical needs, impacts to specific populations and other considerations.

CMS planned to host a series of patient-focused and clinical-focused public engagement sessions in April, including patient-focused combined roundtables on all 15 drugs. Patients, patient advocacy organizations and caregivers were invited to offer patient-focused input.

Early summer will see CMS negotiating with participating drug makers over the MFP, with CMS submitting an initial price offer on June 1; manufacturers are expected to accept CMS’ initial offer or submit a counteroffer by July 1. A final MFP offer from CMS is expected by September 30; drug companies will have until October 31 to accept or reject the final offer. Negotiations are set to end November 1. CMS is expected to publish any agreed-upon MFPs by November 30. MFPs will go into effect January 1, 2028.

Gilead is expected to be most impacted by any new negotiated Medicare drug pricing, say healthcare industry analysts. According to a report by CNBC, one analyst estimated that Medicare revenue from Biktarvy could represent about 8% of Gilead’s total projected worldwide sales for 2027.

For 2024, the latest year for which figures are available, Gilead reported global sales of Biktarvy at $13.4 billion, about a 13% increase over 2023. The company reached an agreement with generic drug manufacturers, delaying Biktarvy’s entry into the U.S. generic market until April 1, 2036; the CMS negotiations could challenge that.