The Centers for Medicare & Medicaid Services (CMS) continues to advance the implementation of the Medicare Drug Price Negotiation Program, a landmark policy designed to address high prescription drug expenditures within the Medicare program. Established under federal law, the program authorizes CMS to directly negotiate prices—referred to in statute as Maximum Fair Prices (MFPs) for certain high-expenditure, single-source drugs without generic or biosimilar competition.
Following two prior cycles of negotiations affecting Medicare Part D drugs with prices effective in 2026 and 2027, CMS announced on January 27, 2026, the selection of 15 additional drugs payable under Medicare Part B and/or covered under Medicare Part D for the third cycle of negotiations. The negotiated prices for these drugs will take effect on January 1, 2028. Notably, this cycle includes several high-cost oncology therapies, underscoring the growing intersection between federal drug pricing reform and cancer care.
Legislative and Regulatory Framework
Under the statute governing the program, CMS must identify “qualifying single source drugs.” These include small-molecule drugs approved for at least seven years and biologics licensed for at least eleven years, provided there is no generic or biosimilar competition under specified conditions. Certain categories are excluded, including select orphan drugs, low-expenditure Medicare drugs, plasma-derived products, and drugs qualifying for the Small Biotech Exception.
For the third negotiation cycle, CMS used total Medicare Part B and Part D expenditures from November 1, 2024, through October 31, 2025, to determine eligibility. From the pool of negotiation-eligible drugs, CMS ranked products by total expenditures and selected the 15 highest-spend drugs, excluding biologics with a high likelihood of imminent biosimilar entry under the statutory Biosimilar Delay provision.
During the relevant expenditure period, approximately 1.78 million Medicare beneficiaries used the selected drugs, accounting for $27.0 billion in total Medicare Part B and Part D spending—approximately six percent of total program expenditures for those benefits.
Oncology Drugs Selected for Initial Price Applicability Year 2028
Among the 15 selected drugs for the third negotiation cycle, several are central to contemporary oncology practice. These include:
Erleada, indicated for prostate cancer, with Medicare expenditures of approximately $1.95 billion and 19,000 Medicare users during the relevant period.
Kisqali, a CDK4/6 inhibitor used in hormone receptor positive breast cancer, with expenditures of $1.58 billion and 17,000 Medicare users.
Verzenio, another CDK4/6 inhibitor for breast cancer, accounting for $1.43 billion in expenditures and 15,000 Medicare users.
Lenvima, indicated for multiple malignancies including thyroid, endometrial, liver, and kidney cancers, with expenditures of $1.09 billion and 10,000 Medicare users.
Collectively, these oncology therapies represent a substantial share of Medicare oncology drug spending and are widely utilized in advanced and metastatic disease settings. Their inclusion in the third negotiation cycle signals a pivotal moment for oncology stakeholders, as negotiated Maximum Fair Prices will directly affect reimbursement, patient cost-sharing, and potentially prescribing dynamics beginning in 2028.
Renegotiation and Ongoing Oversight
In addition to new drug selections, CMS announced one drug for renegotiation in the third cycle: Tradjenta, originally negotiated for initial price applicability in 2027. Under the statute, drugs may be eligible for renegotiation if monopoly status changes, new indications are added, or a material change in statutory negotiation factors occurs. Renegotiation reflects the program’s adaptive structure, particularly relevant in oncology, where label expansions and evolving standards of care are common.
Public and Clinical Engagement in the Negotiation Process
CMS has established formal opportunities for stakeholder engagement during the negotiation and renegotiation process. These include patient-focused roundtable events and a clinical town hall meeting, anticipated in April 2026. Patient advocacy organizations, caregivers, practicing clinicians, and researchers are encouraged to provide input.
In addition, CMS invited public data submissions by March 1, 2026, on patient experiences, comparative effectiveness data, therapeutic alternatives, prescribing information, and unmet medical need. For oncology drugs, such input may be especially influential, given the complexity of cancer care, heterogeneity of treatment pathways, and high burden of disease.
CMS has emphasized balancing transparency and confidentiality. While narrative explanations of agreed-upon MFPs will be published, proprietary commercial or financial information submitted by manufacturers will be redacted.
Timeline and Implementation Milestones
The third negotiation cycle follows a structured timeline beginning with draft guidance issued in May 2025 and final guidance in September 2025. After publication of the selected drug list in January 2026, participating manufacturers must sign negotiation agreements by February 28, 2026.
CMS will issue initial MFP offers by June 1, 2026, followed by optional negotiation meetings and written exchanges throughout summer 2026. Final MFP offers, if needed, will be issued by September 30, 2026, with the negotiation period concluding November 1, 2026. Agreed-upon Maximum Fair Prices will be published by November 30, 2026, with explanatory documentation released by March 1, 2027.
All negotiated prices for the third cycle will become effective January 1, 2028.
Implications for Oncology Care
The inclusion of high-expenditure oncology drugs in the Medicare Drug Price Negotiation Program represents a significant development in U.S. cancer policy. Cancer therapies are among the most costly categories within Medicare Part B and Part D, often characterized by prolonged treatment durations, combination regimens, and expanding indications.
Potential implications include reduced beneficiary cost-sharing, altered revenue streams for manufacturers, and evolving considerations for oncology practice management. For patients with advanced prostate, breast, thyroid, endometrial, liver, and kidney cancers, the introduction of Maximum Fair Prices in 2028 may improve affordability and access, particularly for individuals with high out-of-pocket exposure under Part D.
At the same time, stakeholders continue to monitor how negotiated pricing may affect innovation incentives, market competition, and future oncology drug development.
As CMS proceeds with the third cycle of negotiations, oncology professionals, patient advocates, and industry participants will play a critical role in shaping the evidence base and policy discourse surrounding these high-impact therapies. The 2028 implementation year will mark the first time several major oncology agents are subject to federally negotiated prices—an inflection point in the evolving relationship between cancer therapeutics and public payer policy.
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Written by Nare Hovhannisyan, MD