IRA Medicare drug negotiation third cycle: 15 drugs selected for 2028

On January 27, 2026, the Centers for Medicare & Medicaid Services (CMS) announced the selection of 15 high-cost prescription drugs for the third cycle of the Medicare Drug Price Negotiation Program, established under the Inflation Reduction Act (IRA) of 2022. This cycle is the first to include drugs payable under Medicare Part B (physician-administered drugs), in addition to drugs covered under Medicare Part D (outpatient prescription drugs). CMS also selected one drug — Tradjenta (linagliptin) — for renegotiation. On March 13, 2026, CMS confirmed that all manufacturers of the selected drugs have chosen to participate in the negotiation process. Negotiations will occur throughout 2026, and any negotiated Maximum Fair Prices (MFPs) will become effective January 1, 2028.

This guide is for market-access professionals, payer strategists, formulary managers, and commercial teams who need to understand the third-cycle drug list, the negotiation timeline, manufacturer participation status, and the market access implications for each therapeutic category.

Short answer

The 15 selected drugs

Complete drug list

Drug selected for renegotiation

Key differences from prior cycles

Market access implications by therapeutic category

GLP-1 and diabetes: Trulicity

Trulicity (dulaglutide) is the third GLP-1 receptor agonist selected for IRA negotiation, following Ozempic/Wegovy/Rybelsus (semaglutide) in Cycle 2. Key implications:

• Formulary impact: The MFP for Trulicity will reduce its net cost in Medicare Part D, potentially making it more competitive against Ozempic (which will also have a negotiated MFP starting in 2027).
• Generic timeline: Trulicity has no approved biosimilar or generic competitor yet, though Lilly's patent position is being monitored. If a biosimilar launches before 2028, Trulicity could be removed from the negotiation list.
• BALANCE Model interaction: Trulicity is not among the drugs included in CMS's BALANCE Model for GLP-1 access (which covers semaglutide, tirzepatide, and orforglipron products). However, as a GLP-1 receptor agonist with an IRA-negotiated MFP, Trulicity's pricing will still be benchmarked against BALANCE Model GLP-1 products that have a $245/month net price.
• Commercial spillover: The IRA MFP does not directly apply to commercial plans, but PBMs may use the MFP as a benchmark in rebate negotiations with Lilly.

Oncology: Erleada, Kisqali, Verzenio, Lenvima

Four oncology drugs were selected — the highest oncology representation across all cycles:

Key implication: CMS is now negotiating prices across multiple drugs within the same therapeutic class (CDK4/6 inhibitors: Kisqali, Verzenio, Ibrance; and AR inhibitors: Erleada, Xtandi). Manufacturers will need to differentiate on clinical evidence and pricing to maintain formulary position.

Immunology: Cimzia, Cosentyx, Entyvio, Orencia, Xeljanz, Xolair

Six immunology/autoimmune drugs were selected — the largest single category:

• Cimzia, Orencia: Part B physician-administered biologics for rheumatoid arthritis and related conditions. Dr. Reddy's filed an interchangeable biosimilar aBLA for Orencia (DRL_AB) in December 2025, accepted for FDA review in February 2026 with a decision expected Q4 2026.
• Cosentyx: IL-17 inhibitor for psoriasis and spondyloarthritis. A major revenue drug for Novartis.
• Entyvio: Gut-selective integrin inhibitor for IBD (Crohn's, UC). Competes with Stelara biosimilars entering the market.
• Xeljanz: JAK inhibitor with generic tofacitinib approved (August 2025). CMS selected Xeljanz/Xeljanz XR — but note that generic tofacitinib exists. The MFP may primarily affect remaining brand utilization.
• Xolair: Anti-IgE biologic for asthma, nasal polyps, and food allergy. An approved interchangeable biosimilar (Omlyclo, omalizumab-igec, Celltrion) was approved in March 2025. Additional biosimilar candidates are in clinical development (Teva, Amneal/Kashiv, Aurobindo/CureTeQ) but no additional aBLAs have been publicly filed. Xolair could face expanded biosimilar competition before 2028, potentially affecting its negotiation status.

CNS: Rexulti

Rexulti (brexpiprazole) was selected for its use in major depressive disorder (adjunctive), schizophrenia, and agitation associated with Alzheimer's dementia. This is the first CNS drug selected across all three cycles. Implications:

• Part D coverage, significant Medicare utilization in elderly psychiatric populations
• No direct generic competition yet
• May face step therapy competition from older atypical antipsychotics on formulary

HIV: Biktarvy

Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is the first HIV drug selected for IRA negotiation and the only antiretroviral on the list. Implications:

• Biktarvy is Gilead's top-selling product and one of the most widely prescribed HIV regimens in the U.S.
• Generic entry is not expected until the early 2030s due to patent protections
• An MFP could significantly reduce HIV treatment costs for Medicare beneficiaries (Medicare covers a growing population of older adults living with HIV)
• Community advocacy groups are watching closely; lower costs could improve adherence and viral suppression rates

COPD: Anoro Ellipta

Anoro Ellipta (umeclidinium/vilanterol) is a long-acting muscarinic antagonist/long-acting beta-agonist (LAMA/LABA) inhaler for COPD. This is the first COPD drug selected for negotiation.

• Competes with Trelegy Ellipta (already negotiated in Cycle 2)
• Both products are GSK/innovator inhalers; the MFP for Anoro may track relative to the Trelegy MFP

Negotiation timeline and process

Manufacturer participation and legal landscape

All 15 manufacturers of selected drugs chose to participate in the negotiation program, consistent with prior cycles where no manufacturer has opted out. Under the IRA, manufacturers that refuse to negotiate face an escalating excise tax of up to 95% of U.S. sales — making non-participation financially prohibitive for companies with significant Medicare market share.

Supreme Court developments

In May 2026, the U.S. Supreme Court declined to hear challenges to the IRA's drug price negotiation program brought by AstraZeneca, Novo Nordisk, Johnson & Johnson, and other pharmaceutical companies. The denial lets stand lower court rulings that the program is constitutional. The companies had argued that the negotiation program amounts to a forced taking of property (patent rights) without just compensation.

Implication: With the Supreme Court declining review, the legal path is clearer for continued implementation of the negotiation program through future cycles. However, additional lawsuits challenging specific aspects of the program's implementation may continue.

What access teams should do now

1. Model MFP impact for Cycle 3 drugs: For each of the 15 drugs that your organization covers, models the potential MFP discount range (38–79% off list price based on prior cycles). Evaluate how MFPs interact with existing rebate agreements.

2. Assess Part B implications: This is the first cycle with Part B drugs (Botox, Cimzia, Entyvio, Orencia, Xolair). Understand how MFPs will affect buy-and-bill reimbursement, ASP pricing, and physician-administered drug pathways.

3. Monitor biosimilar pipeline: Several selected drugs have biosimilars in development (Orencia, Xolair). If a biosimilar launches before January 1, 2028, the reference product could be removed from the negotiation list or the MFP could affect biosimilar pricing dynamics.

4. Evaluate therapeutic class overlap: With multiple drugs from the same class selected (CDK4/6 inhibitors, AR inhibitors, immunology biologics), assess whether MFPs will shift formulary preference within these classes.

5. Prepare for Tradjenta renegotiation: Tradjenta was selected for Cycle 2 (IPAY 2027) and is now being renegotiated. The new MFP could be lower or adjusted. Monitor for changes that could affect DPP-4 inhibitor class positioning.

6. Track CMS guidance updates: CMS may issue additional guidance or updates during the 2026 negotiation period. Watch for the top-50 negotiation-eligible drug list, which signals which drugs may be selected in future cycles.

What to monitor next

1. MFP announcement (expected November 2026): CMS will publish the negotiated Maximum Fair Prices for all 15 drugs. The discounts will establish new pricing benchmarks across multiple therapeutic categories.

2. Biosimilar launches before 2028: Orencia and Xolair have biosimilar applications pending at FDA. A biosimilar launch could change the negotiation status or create pricing complexity.

3. Cycle 4 drug selection (early 2027): The fourth cycle will select 20 drugs for IPAY 2029. The top-50 list published alongside the Cycle 3 selections provides early signals.

4. Most Favored Nation (MFN) policy interaction: The Trump administration's MFN drug pricing models (GLOBE, GUARD) run alongside the IRA negotiation program. How these interact for drugs that are in both programs will be important.

5. Part D redesign implications: The IRA's Manufacturer Discount Program (MDP) interacts with the negotiation program — drugs selected for negotiation are exempt from the MDP during the price applicability period. Understand the net financial impact on plan sponsors and manufacturers.

6. Congressional action: Changes to the orphan drug exclusion (already expanded under H.R. 1) and other legislative modifications could affect which drugs are eligible for future cycles.

Sources

• CMS. CMS Announces Selection of Drugs for Third Cycle of Medicare Drug Price Negotiation Program (January 27, 2026). cms.gov/newsroom
• CMS. Selected Drugs and Negotiated Prices — Medicare Drug Price Negotiation Program. cms.gov/initiatives/medicare-prescription-drug-affordability
• CMS. Fact Sheet: Medicare Drug Price Negotiation Program Selected Drug List for IPAY 2028 (January 2026). cms.gov/files/document/factsheet-medicare-negotiation-selected-drug-list-ipay-2028.pdf
• CMS. Fact Sheet: CMS Announces Manufacturer Participation in Third Cycle of Medicare Drug Price Negotiation (March 13, 2026). cms.gov
• Fox Business. Medicare Selects Botox, Trulicity for Third Round of Price Negotiations (January 2026). foxbusiness.com
• HCPLive. CMS Selects 15 Drugs for Third Cycle of Medicare Drug Price Negotiation Program (January 2026). hcplive.com
• KFF. Key Facts About Medicare Drug Price Negotiation (2026). kff.org/medicare
• Milliman. 4 Key Takeaways from the Third Round of Drugs Selected for Medicare Drug Price Negotiation (2026). milliman.com
• AARP. US Prescription Drug Prices Rise While Falling Abroad (2026). aarp.org
• Fierce Pharma. Supreme Court Declines to Hear IRA Challenges from 6 Pharmas (May 2026). fiercepharma.com