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Deutetrabenazine Among Notable Drugs Selected by Medicare to Lower Prescription Costs for Seniors
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Key Takeaways
- CMS has selected 15 additional drugs for Medicare Part D price negotiations, aiming to reduce costs for seniors and people with disabilities.
- Deutetrabenazine, a VMAT2 inhibitor, is included for its use in treating tardive dyskinesia and Huntington's disease chorea.
The U.S. HHS announced 15 drugs, including deutetrabenazine, will undergo Medicare Part D price negotiations to lower costs for seniors by 2027.
Xavier Becerra, HHS Secretary
Recently, the U.S Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced the selection of 15 additional drugs to be covered under Medicare Part D for price negotiations. Among them was deutetrabenazine (Austedo; Austedo XR; Teva Pharmaceuticals), a medication for tardive dyskinesia and chorea associated with Huntington disease (HD).1
The list of drugs included: semaglutide (Ozempic; Rybelsus; Wegovy), fluticasone furoate, umeclidinium, and vilanterol inhalation powder (Trelegy Ellipta), enzalutamide (Xtandi), pomalidomide (Pomalyst), palbociclib (Ibrance), nintedanib (Ofev), Linactolide (Linzess), acalabrutinib (Calquence), deutetrabenazine, fluticasone furoate/vilanterol (Breo Ellipta), linagliptin (Tradjenta), rifaximin (Xifaxan), cariprazine (Vraylar), sitagliptin/metformin (Janumet; Janumet XR), and apremilast (Otezla).
Under the Inflation Reduction Act, negotiations for the 15 added drugs will occur in 2025, with prices effective in 2027. Between November 2023 and October 2024, these drugs were used by 5.3 million Medicare Part D enrollees for conditions like cancer, diabetes, and asthma, accounting for $41 billion (14%) of Part D prescription costs. Combined with the first cycle of negotiated drugs, this totals over a third of Medicare Part D's prescription costs.
"Last year we proved that negotiating for lower drug prices works. Now we plan to build on that record by negotiating for lower prices for 15 additional important drugs for seniors," Xavier Becerra, HHS Secretary, said in a statement.1 "Today’s announcement is pivotal – the Inflation Reduction Act is lowering prices for people on Medicare. HHS will continue negotiating in the best interest of people with Medicare to have access to innovative, life-saving treatments at lower costs."
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Deutetrabenazine, the only drug on the list with neurologic implications, was originally approved as a twice-daily treatment for chorea associated with HD in April 2017 and later had its label expanded in August 2017 to include the treatment of tardive dyskinesia.2 Years later, in 2023, the FDA approved a once-daily, extended-release formulation of the agent, further allowing for more administration flexibility and improved adherence.3 Deutetrabenazine, both in its original formulation and extended-release option, was the first VMAT2 inhibitor approved by the FDA for the treatment of tardive dyskinesia and chorea associated with HD.
The 2023 approval was supported by data from a phase 3 open-label, single-arm, 2-cohort, multicenter ARC-HD extension study (NCT01897896) which showed that deutetrabenazine was safe and enhanced and maintained chorea in patients with HD over a 3-year period. In the study, treatment with deutetrabenazine resulted in a mean Total Maximal Chorea (TMC) score decrease of –4.5 points (SD, 3.1; 95% CI, –5.2 to –3.7) for those who completed the double-blind First-HD trial (NCT01795859), termed the rollover cohort (n = 82), and a decrease of –2.1 points (SD, 3.3; 95% CI, –3.1 to –1.0) for those who converted overnight from a stable tetrabenazine dose (switch arm, n = 37) from baseline to week 8.4
Under the Drug Price Negotiation Program, drug companies must decide by February 28, 2025, if they will participate in latest negotiations. CMS will evaluate each drug's clinical benefits, unmet medical needs, and impact on Medicare populations, along with research, production, and distribution costs. Thanks to the Inflation Reduction Act, Medicare can now negotiate drug prices, making medications more affordable for seniors and people with disabilities. In August 2023, HHS announced the first 10 drugs selected for negotiation under Medicare Part D.
"The Biden-Harris Administration continues to make history by announcing the latest round of drugs selected for the Medicare Drug Price Negotiation Program, with the goal of improving access to some of the costliest drugs while saving the American people billions of dollars," Chiquita Brooks-LaSure, CMS Administrator, said in a statement.1 "Improving prescription drug affordability for Medicare enrollees is the core of the Inflation Reduction Act, and the next cycle of negotiations will continue to strengthen Medicare for generations to come."
Deutetrabenazine’s approval in February 2023 allowed for 3 tablet strengths: 6 mg, 12 mg, and 24 mg, all of which could be administered with or without food. More than a year later, the FDA approved a new one-pill, once-daily tablet with 4 new dosing strengths (30, 36, 42, and 48 mg), adding from its original dosing options.5 The therapy remains contraindicated for patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.
REFERENCES
1. HHS Announces 15 Additional Drugs Selected for Medicare Drug Price Negotiations in Continued Effort to Lower Prescription Drug Costs for Seniors. News release. Centers for Medicare & Medicaid Services. January 17, 2025. Accesed January 21, 2025. https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower
2. Teva Announces FDA Approval of AUSTEDO™ (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington’s Disease. News release. Teva Pharmaceuticals. April 3, 2017. Accessed January 21, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2017/Teva-Announces-FDA-Approval-of-AUSTEDO-deutetrabenazine-Tablets-for-the-Treatment-of-Chorea-Associated-with-Huntingtons-Disease/default.aspx
3. Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of AUSTEDO® (deutetrabenazine) Tablets. News release. Teva. February 17, 2023. Accessed January 21, 2025. https://www.businesswire.com/news/home/20230217005357/en/Teva-Announces-FDA-Approval-of-AUSTEDO%C2%AE-XR-deutetrabenazine-Extended-Release-Tablets-a-New-Once-Daily-Formulation-of-AUSTEDO%C2%AE-deutetrabenazine-Tablets
4. Teva announces results from 3-year study assessing the safety and tolerability of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease. News release. October 18, 2022. Accessed January 21, 2025. https://www.businesswire.com/news/home/20221018005197/en/Teva-Announces-Results-from-3-Year-Study-Assessing-the-Safety-and-Tolerability-of-AUSTEDO%C2%AE-deutetrabenazine-Tablets-for-the-Treatment-of-Chorea-Associated-with-Huntington%E2%80%99s-Disease
5. Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option for Clinically Therapeutic Doses (24–48 mg/day). News release. Teva Pharmaceuticals. May 29, 2024. Accessed January 21, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-austedo-xr-deutetrabenazine-extended-release-tablets-now-u.s.-fda-approved-as-a-one-pil/
