Closed-Door Policy Change Exempted Blockbuster AbbVie Drug from Negotiations
An unnoticed CMS policy change delayed Medicare price negotiation for AbbVie’s blockbuster drug Creon for an additional seven years — despite Creon, a pancreatic enzyme replacement therapy, accounting for higher Medicare spending than six other drugs chosen in the third round of negotiations. Brought to light by a new Public Citizen analysis, the revised CMS guidance pertains to drugs that were initially designated as small molecule drugs, but later reclassified as biologics. The switch effectively restarted their eligibility timeline for negotiation, although the interpretation of the policy was not publicly debated and runs counter to the intent of the Medicare negotiation program, allowing drugs to effectively bypass negotiation despite having profits far higher than other drugs selected instead. As Public Citizen noted, 185,000 Medicare beneficiaries used Creon in 2024, while the drug selected for negotiation instead, Amgen’s Otezla, accounted for $1.05 billion over the same period and was used by only 31,000 beneficiaries. — [Public Citizen, STAT News]
Most-Favored-Nation Pricing Could Save Medicare Nearly $200 Billion
AARP’s new report found that applying most-favored-nation pricing to 10 high cost drugs could reduce Medicare spending by nearly $200 billion between 2029 and 2033. These 10 drugs have not yet been selected for Medicare negotiation, and only one will be eligible in 2027 — despite accounting for nearly $50 billion in annual Medicare spending in 2025 and being used by more than 3 million people on Medicare. AARP’s analysis suggests that a well-designed MFN-style policy could serve as an additional tool to strengthen Medicare drug price negotiation and lower costs for patients. — [AARP]
New Analysis Confirms: ORPHAN Cures is an Unnecessary Pharma Giveaway
A new analysis finds that orphan drugs recover their clinical trial costs at a comparable rate to other drugs — undercutting industry arguments for the ORPHAN Cures Act. That provision created a carveout in the Medicare Negotiation Program, shielding some blockbuster orphan drugs like the top-selling cancer medicine Keytruda from negotiation at an estimated cost to Medicare of $8.8 billion. The policy also postponed negotiation for orphan disease treatments that receive an approval for a non-rare condition. P4AD has long argued that this exemption is unnecessary since Medicare negotiation already exempted single-indication orphan drugs from negotiation. Congress should be strengthening Medicare negotiation, and resisting industry pressure for similar unnecessary carveouts via policies like GLOBE and GUARD. Patients continue to urge lawmakers to repeal ORPHAN Cures and block further industry-backed carveouts to negotiation like EPIC and MINI that would keep prices high for longer. — [Health Affairs, STAT News, CBO, Congress, BioSpace, Endpoints, STAT News]
Patient Advocate Spotlight: Susan Vigen
Condition: Severe overactive bladder and interstitial cystitis
Drugs: Myrbetriq (Listed at $1,677 / 90 day supply, with a monthly copay that increased from $120 to $365 in 2024)
Background: Patient advocate from South Carolina
In Her Words: “Myrbetriq has a monthly copay responsibility for me that increased from $120 to $365 every 90 days starting in the fall of 2024. This is simply too expensive for me and while there is a generic version of the drug called Mirabegron, my insurance will not cover it. Thus, I am left constantly looking for cheaper pharmacies and ways to save.”
“As someone who used to work in the pharmaceutical industry for about 17 years on the data management side, I understand the cost of bringing a drug to market and the need for some profit making to be made, however, I am now the patient feeling the financial frustration.”