After months of speculation and litigation, the Centers for Medicare & Medicaid Services has unveiled the initial 10 medications designated for Medicare price negotiations in accordance with the Inflation Reduction Act (IRA).
Broadly, the legislative measure was designed to tackle inflation, reduce the federal fiscal deficit, promote investments in domestic clean energy production and cut down on prescription expenses— but much of the pharma industry has noted flaws in the government’s approach to drug pricing, with some companies even taking grievances to court.
The medications identified for negotiation belong to a group of “high-cost, exclusive-source drugs with no generic or biosimilar alternatives available.” Medicare, which provides coverage to 66 million people, will now work with drugmakers to obtain better pricing for these drugs.
1. Eliquis — BMS, Pfizer
Approved in 2012, the anticoagulant, prescribed to prevent strokes and blood clots in individuals with conditions like atrial fibrillation, generated $18.2 billion in sales last year for its co-marketers, making it one of the top-selling drugs in the world. The FDA approved the first generic apixaban applications from Mylan (now Viatris) and India’s Micro Labs in late 2019, but extensive litigation has staved off the generics’ arrival until 2028.
2. Jardiance — Boehringer Ingelheim, Eli Lilly
First approved in 2014, Jardiance is an SGLT2 inhibitor for the management of type 2 diabetes. Currently, the drugmakers are looking to expand the drug’s indication to include chronic kidney disease. The list price of a 30-day supply of Jardiance oral tablets can vary, but typically is around $600. India-based Alembic got the nod for a generic version in 2020 but with patent disputes pending, the generic likely won’t hit the market until 2029.
3. Xarelto — Bayer, J&J
Xarelto, approved in 2011, is an anticoagulant used to lower the risk of blood clots, strokes and deep vein thrombosis. The drug, which has a list price of over $600 for a 30-day supply, brought in $7.5 billion in sales last year. The earliest date for generic versions to enter the market is projected to be December 2024.
4. Januvia — Merck & Co.
Januvia, first approved in 2006, is utilized for the treatment of type 2 diabetes, aiding in the regulation of blood sugar levels. Merck has now reached settlement agreements with more than 20 generic drugmakers, deferring launch plans for generics until 2026.
5. Farxiga — AstraZeneca
Farxiga’s original approval in 2014 for adults with type 2 diabetes was later expanded to cover heart failure and more recently, chronic kidney disease. The expanded approvals ballooned sales to $4.4 billion in 2022. The drug’s list price is around $550 for a onemonth supply. In 2018, Farxiga became eligible for patent litigation, and although there are 16 protecting the drug, U.S. patents are set to expire in 2024. Beating out over a dozen ANDA hopefuls, Zydus Cadila was the first to score FDA approval for a generic version last year.
6. Entresto — Novartis
Initially approved in 2015, Entresto is a heart failure medication that enhances heart function in individuals with certain heart conditions. Last year the drug brought in $4.64 billion in sales. An approval in HFpEF in 2021 extended its exclusivity period and there are currently no approved generic versions.
7. Enbrel — Amgen
Enbrel was first approved for rheumatoid arthritis back in 1998 and over the years has picked up approvals in five additional indications. Without insurance, the drug can cost as much as $8,000 per month. In 2016, the FDA approved Sandoz’ biosimilar version of the TNF inhibitor, but following a federal court decision, it won’t be available until 2029.
8. Imbruvica — AbbVie, J&J
Imbruvica was first approved in 2013 for a rare form of non-Hodgkin lymphoma. The kinase inhibitor now has approvals for various forms of lymphoma and leukemia. AbbVie is no stranger to patent walls, and following a similarly aggressive tactic, has 88 patents for Imbruvica. With the granting of pediatric exclusivity in 2022, the company fended off generic competition until 2032.
9. Stelara — J&J
After some initial obstacles, Stelara was approved in 2009 to treat psoriasis and since then has accumulated approvals in ulcerative colitis, arthritis and Crohn’s disease. The drug saw a price hike in 2019, which sent its out-of-pocket costs surging to close to $25,500 for an 8-week treatment. J&J recently struck a deal with Amgen, delaying the launch of a proposed biosimilar until 2025.
10. Insulin — Novo Nordisk
The largest insulin maker in the world, Novo has built its business on diabetes care. Under fire for high prices, the drugmaker, along with its competitors, has sought its own ways of lowering list prices in the U.S. Earlier this year, the company said it would be discounting its insulin by 75%, effective on January 1, 2024.