The program has demonstrated savings but legal challenges threaten its future.
Medicare Part D saved nearly $15 billion over six years with the use of "skinny label" generics, a new report says.
However, the program is imperiled by a lawsuit claiming patent infringement, researchers at Brigham and Women's Hospital and Harvard Medical School said in a research letter published on Monday in Annals of Internal Medicine.
The researchers are urging Congress to "reinforce the skinny-label pathway by creating a safe harbor that protects manufacturers engaged in skinny labeling from induced patent infringement laws."
Skinny labels permit the use of generics for conditions that are not specified by brand-name drug makers and allow the cheaper generics to enter the market before the patent of the brand-name drug expires.
The Brigham and Women's / Harvard Med School researchers analyzed 15 name-brand drugs and their "skinny label" counterparts, compared actual spending on each brand-name drug and its skinny-label generics, and projected spending had the generics been unavailable.
The researchers determined that Medicare Part D spending on these 15 drugs and their skinny-label generics was $16.8 billion, while projected spending without generics was $31.5 billion, saving Medicare $14.6 billion from 2015-2021.
The savings were the greatest for rosuvastatin (Crestor, AstraZeneca; $6.5 billion), pregabalin (Lyrica, Pfizer; $4.2 billion), and imatinib (Gleevec, Novartis; $3.1 billion).
Legal Landmines
A Delaware jury in 2017 awarded $235 million to GlaxoSmithKline for patent infringement by Teva Pharmaceutical Industries Ltd.'s generic version of GSK's beta-blocker Coreg.
A federal appeals court in 2021 upheld the award and rejected Teva's claim that it had followed Food and Drug Administration mandates to "carve out" a patented use for the drug to treat heart failure.
The appeals court affirmed GSK's complaint that Teva's labeling and marketing encouraged physicians to prescribe the generic for patent-protected conditions.
"This court's decision may discourage the marketing of skinny label generics," the brief notes.
The U.S. Supreme Court last year declined to hear the case, despite the urging of the Biden administration.
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.
KEY TAKEAWAYS
Researchers analyzed 15 name-brand drugs and their 'skinny label' counterparts, compared actual spending on each brand-name drug and its skinny-label generics, and projected spending had the generics been unavailable.
The researchers determined that Medicare Part D spending on these 15 drugs and their skinny-label generics was $16.8 billion, while projected spending without generics was $31.5 billion, saving Medicare $14.6 billion from 2015-2021.
The savings were the greatest for rosuvastatin (Crestor, AstraZeneca; $6.5 billion), pregabalin (Lyrica, Pfizer; $4.2 billion), and imatinib (Gleevec, Novartis; $3.1 billion).
Researchers want Congress to 'reinforce the skinny-label pathway by creating a safe harbor that protects manufacturers engaged in skinny labeling from induced patent infringement laws.'