TABLE 1.
Drugs Anticipated to be Selected for Medicare Price Negotiation in 2025
| Rank | Brand name | Generic name | Manufacturer | Therapeutic area | Gross Part D spending in 2022 | Projected gross Part D spendinga | Time since approval as of 2/2025b |
|---|---|---|---|---|---|---|---|
| 1 | Ozempic, Rybelsus & Wegovyc | Semaglutide | Novo Nordisk | T2DM | $5,603,055,114 | $7,476,655,091 | 7 yrs 1 mo |
| 2 | Trelegy Ellipta | Fluticasone/umeclidinium/vilanterol | GlaxoSmithKline | COPD | $3,340,110,326 | $4,259,329,331 | 7 yrs 4 mos |
| 3 | Xtandi | Enzalutamide | Astellas Pharma Inc. | Prostate cancer | $2,436,795,703 | $2,740,436,348 | 12 yrs 5 mos |
| 4 | Ofev | Nintedanib | Boehringer Ingelheim | Lung diseases | $1,762,963,783 | $2,077,308,575 | 10 yrs 3 mos |
| 5 | Pomalyst | Pomalidomide | Bristol Myers Squibb | Blood cancers | $1,743,892,720 | $1,887,642,864 | 11 yrs 11 mos |
| 6 | Ibrance | Palbociclib | Pfizer Inc. | Breast cancer | $1,948,323,854 | $1,822,279,057 | 9 yrs 11 mos |
| 7 | Linzess | Linaclotide | AbbVie Inc. | Gastrointestinal disorders | $1,581,669,987 | $1,804,032,885 | 12 yrs 5 mos |
| 8 | Calquence | Acalabrutinb | AstraZeneca | Blood cancers | $1,192,914,435 | $1,615,471,380 | 7 yrs 3 mos |
| 9 | Creon | Pancrelipase | AbbVie Inc. | Pancreatic insufficiency | $1,310,801,528 | $1,478,112,273 | 15 yrs 9 mos |
| 10 | Breo Ellipta | Fluticasone / vilanterol | GlaxoSmithKline | COPD | $1,427,824,950 | $1,408,763,895 | 11 yrs 8 mos |
| 11 | Tradjenta | Linagliptin | Boehringer Ingelheim | T2DM | $1,326,573,079 | $1,349,012,342 | 13 yrs 8 mos |
| 12 | Janumet | Metformin/sitagliptin | Merck and Co., Inc. | T2DM | $1,212,934,060 | $1,246,237,036 | 17 yrs 10 mos |
| 13 | Austedo | Deutetrabenazine | Teva Pharmaceuticals | Neurological diseases | $890,369,750 | $1,055,519,879 | 7 yrs 9 mos |
| Drugs with uncertain negotiation status | |||||||
| Victozad | Liraglutide | Novo Nordisk | T2DM | $ 1,557,800,382 | $1,399,269,640 | 15 yrs 0 mos | |
| Tagrissoe | Osimertinib | AstraZeneca | NSCLC | $1,081,280,466 | $1,217,143,163 | 9 yrs 2 mos | |
| Xifaxanf,g | Rifaximin | Salix Pharmaceuticals | Antibacterial | $969,541,694 | $1,026,447,056 | 20 yrs 8 mos | |
| Humalogf,h | Insulin lispro | Eli Lilly and Co | DM | $2,067,729,284 | $954,335,188 | 28 yrs 7 mos | |
| Epclusaf | Sofosbuvir/velpatasvir | Gilead Sciences | Hepatitis c | $899,944,724 | $934,777,002 | 8 yrs 7 mos | |
| Xeljanzf | Tofacitinib | Pfizer Inc. | Immunological diseases | $886,548,263 | $901,642,064 | 12 yrs 2 mos | |
| Venclextaf | Venetoclax | AbbVie Inc. | Blood cancers | $767,860,286 | $876,884,918 | 8 yrs 9 mos | |
aWe projected 2023 gross spending for all products except for Humalog using a linear regression and 2020 to 2022 Part D gross spending data. Estimates for Humalog represent projected November 2023-October 2024 spending based on the list price reduction effective January 1, 2024.
bCalculated as the time between drug approval and February 1, 2025.
cWe expect that Ozempic, Rybelsus, and Wegovy will be considered a single product for negotiation, as they contain the same active moiety, semaglutide, and are manufactured by the same firm. Spending estimates listed include the combination of Ozempic and Rybelsus, as Wegovy was not covered by Medicare Part D in 2022 (this is because weight-loss drugs are excluded from Part D coverage by statute). It is likely, however, that some Part D plans will cover Wegovy after its approval for cardiovascular risk reduction.
dSelection for negotiation will depend on the potential launch of independent generics before February 2025.
eTagrisso may be eligible for the orphan drug exclusion, as discussed in the text.
fThe projected gross Part D spending estimates for Xifaxan, Humalog, Epclusa, Xeljanz, and Venclexta are within a close range. The selection of the final product for negotiation will depend on spending trends in 2022-2024 as well as whether Victoza and Tagrisso are eligible for negotiation. As a result, we identify these products as candidates to complete the list of 15 eligible for selection. Final selection will be based on actual spending trends in November 2023-October 2024, which we are not able to observe as recent data are not publicly available.
gThe manufacturer of Xifaxan is Salix Pharmaceuticals, and Xifaxan represents more than 90% of Part D spending for Salix Pharmaceuticals in 2022. For this reason, Xifaxan could qualify for the small biotech exception. However, Salix Pharmaceuticals is a subsidiary of Bausch Health Companies. According to the Inflation Reduction Act, manufacturers with subsidiaries will be treated as a single company as long as they are a single employer under the Internal Revenue Code, which we are not capable of evaluating.
hHumalog experienced list price decreases on January 1, 2024, of around 70%. We accounted for them in projecting gross spending in November 2023-October 2024, the months of data that will be used by CMS for drug selection. We assumed constant utilization as observed in 2022 and applied the list price reduction effective January 1, 2024, to units representing 10/12s of utilization. The remaining 2/12 of units were not adjusted by price, as list prices in 2023 were the same as those of 2022. List price adjustments were performed at the formulation level (70% list price reduction for all formulations except for Humalog Kwikpen U-200, which kept constant price, and Humalog vial, which had a list price decrease of 76% in comparison with 2022).
CMS = Centers for Medicare and Medicaid Services; COPD = chronic obstructive pulmonary disease; DM = diabetes mellitus; mos = months; NSCLC = nonsmall cell lung cancer; T2DM = type 2 diabetes mellitus; yrs = years.