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CMS Drug Price Negotiation: A Guide - News Directory 3

CMS Drug Price Negotiation: A Guide

June 18, 2025 Health
News Context
At a glance
  • Drug⁢ price negotiations by the Centers for ⁢Medicare &⁢ Medicaid Services (CMS) are moving forward, but new drug indications and market exclusivity ⁢regulations⁣ could create challenges for future...
  • After its passage, several drug manufacturers filed lawsuits against the negotiation provision.
  • Future negotiations face uncertainties,particularly regarding new prices for already ‍negotiated drugs if there are key ⁣changes,such as⁤ a new indication or⁤ a shift in market exclusivity.
Original source: beckershospitalreview.com

Key Points

  • CMS drug price negotiations are advancing under the Inflation Reduction Act.
  • New drug indications⁢ adn exclusivity rules could ‍complicate future pricing.
  • Lawsuits ⁣challenging the negotiation provision have largely failed.
  • Uncertainties remain regarding price adjustments for drugs with key changes.
  • negotiated prices for some drugs are set too take effect Jan. 1, 2026.

CMS Drug Price Negotiations Face Uncertainties

‍ Updated June 18, 2025

Drug⁢ price negotiations by the Centers for ⁢Medicare &⁢ Medicaid Services (CMS) are moving forward, but new drug indications and market exclusivity ⁢regulations⁣ could create challenges for future pricing cycles. The CMS gained authority to⁣ negotiate drug prices following the Inflation Reduction Act in 2022, which ended a long-standing ban on direct government negotiation for Medicare Part D drugs.

The pharmaceutical industry had actively opposed the bill. After its passage, several drug manufacturers filed lawsuits against the negotiation provision. Many of these lawsuits have been⁢ unsuccessful. CMS Administrator Dr. Mehmet ⁣Oz said the ⁣agency would defend its⁢ drug pricing negotiation power in court.

Future negotiations face uncertainties,particularly regarding new prices for already ‍negotiated drugs if there are key ⁣changes,such as⁤ a new indication or⁤ a shift in market exclusivity. CMS proposed this idea in draft guidance⁣ published May 12.

To be eligible for negotiation, medications must lack generic or biosimilar competition and have been on the market for more than ⁣10 years. CMS⁣ has announced the drugs negotiated under Medicare Parts D for‍ 2026 and 2027, with prices taking effect Jan.1, 2026. Negotiations are underway for the 15 drugs in the second cycle.

The first⁤ negotiation cycle to include Medicare Part B drugs will be in 2028, with CMS able to select up to 20 drugs for the 2029 cycle. The ⁣agency⁤ can currently select medications under Part D,typically distributed in outpatient pharmacy settings. Part B drugs are ofen injections or infusions given in a physician’s office or hospital⁢ outpatient⁣ setting, such⁤ as chemotherapy or anesthesia.

Negotiated Prices for ⁢2026

Here are the 10 drugs with negotiated prices for 2026:

  1. Januvia (Merck): For Type 2 ‍diabetes. List price in 2023: ⁢$527. Negotiated price: $113.
  2. Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, and NovoLog PenFill‍ (Novo Nordisk): For Type 2 diabetes. ‍List price in 2023: $495. Negotiated price: $119.
  3. Farxiga (AstraZeneca): For Type 2 diabetes, heart ⁤failure, and chronic kidney disease. List price in 2023: $556. Negotiated price: $178.
  4. Enbrel (Immunex): For rheumatoid arthritis, psoriasis, and psoriatic arthritis. List price in 2023: $7,106. Negotiated price: $2,355.
  5. Jardiance (Boehringer Ingelheim): For Type 2 diabetes and heart failure. List price in ‍2023: $573.Negotiated price: $197.
  6. Stelara (Janssen): For psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. List price in⁢ 2023: $13,836. Negotiated price: $4,695.
  7. Xarelto (Janssen): For blood ‍clot prevention and treatment. list‍ price in⁣ 2023: $517. Negotiated price: $197.
  8. Eliquis (Bristol ⁢Myers Squibb): For ⁤blood clot prevention and treatment. List price in 2023: $521. Negotiated price: $231.
  9. Entresto (Novartis): For heart⁢ failure. list price in 2023: $628.⁢ Negotiated price: $295.
  10. Imbruvica (Abbvie/Janssen): ⁣For blood cancers.List price in 2023: $14,934. ⁣Negotiated price: $9,319.

Drugs Selected ⁣for 2027

The 15 ‍drugs selected for negotiation in 2027 include:

  1. Ozempic, Rybelsus, Wegovy (Novo Nordisk)
  2. Trelegy Ellipta (GSK)
  3. Xtandi (Astellas / Pfizer)
  4. Pomalyst (Bristol Myers Squibb)
  5. Ibrance (Pfizer)
  6. Ofev (Boehringer Ingelheim)
  7. Linzess (AbbVie/Ironwood)
  8. Calquence (AstraZeneca)
  9. Austedo, Austedo Extended-Release (Teva)
  10. BREA ELLIPTA (GSK)
  11. Tradjenta ⁣(Boehringer Ingelheim)
  12. Xifaxan (Bausch/Salix)
  13. Vraylar (AbbVie)
  14. Janumet, Janumet XR (Merck)
  15. Otezla (Ambigence)

What’s ⁢next

As the CMS moves forward with drug price ⁣negotiations, stakeholders will be closely watching how new indications and exclusivity rules impact the process and the resulting prices for medications.

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