112 Medicare Part B drug codes topped $100 million in 2024. October's international pricing rule expects to reach four manufacturers

Sources

11 primary releases.

1. Centers for Medicare & Medicaid Services, Federal Register, Global Benchmark for Efficient Drug Pricing (GLOBE) Model, final rule CMS-5545-F, 91 FR 62936 (2 October 2026)
   Effective 30 November 2026. Performance years 1 April 2027 to 31 March 2032; payment period through 31 March 2034. "The GLOBE Model will test whether a payment model that uses an alternative method for calculating Medicare Part B drug inflation rebate amounts" lowers spending. Estimated Medicare Part B net savings $440 million over the payment period; 19 reference countries; cohort of about 25 percent of Original Medicare Part B enrollees in randomly selected ZIP code areas. "overall total OM Part B drug spending was $81.90 billion according to 2025 claims data." "Certain product categories are excluded from the definition of a Part B rebatable drug," including qualifying biosimilar biological products, skin substitutes and "certain vaccines and other products"; the model also excludes drugs with a negotiated maximum fair price in effect, orphan-only drugs, products on FDA's approved cellular and gene therapy list and plasma-derived products. The proposed rule (published 23 December 2025) "would impose approximately $11.9 billion in new rebates."
   federalregister.gov
2. Covington & Burling, CMS Finalizes MFN Pricing in Medicare Part B Through GLOBE Model (2 October 2026)
   Model drugs are those in seven USP categories "with Part B spending in excess of $100 million over a specified 12-month period": antigout agents, antineoplastics, blood products and modifiers, central nervous system agents, immunological agents, metabolic bone disease agents, ophthalmic agents. The final rule estimates GENEROUS exemptions cut participating manufacturers from 19 to 4 on an illustrative set of model drugs. Proposed rule estimated $11.9 billion in savings; final rule "overall savings of $440 million in Medicare Part B net spending." Exclusions: orphan drugs, approved cell and gene therapies, plasma-derived products, generics, biosimilars, drugs with an MFP in effect, drugs under the threshold. Start delayed from 1 October 2026 to 1 January 2027.
   cov.com
3. Sidley Austin, GLOBE MFN Drug Pricing for Medicare Part B Significantly Narrowed in Final Rule (5 October 2026)
   CMS expects "the number of remaining manufacturers of GLOBE Model drugs would be four," with an "expected consolidation of two" of them. Annualized savings estimate fell from approximately $2.3 billion (proposed) to approximately $80 million (final). Lookback: "the consecutive 12-month period ending six months prior to the start of the applicable calendar quarter," with quarterly inflation adjustment. CMS intends to waive mandatory participation for any quarter in which a manufacturer participates in GENEROUS; "manufacturers that have signed GENEROUS participation agreements as of August 17, 2026 will receive the waiver." Sidley attributes the four-manufacturer figure to the final rule's changes as a whole and notes CMS does not name the four.
   sidley.com
4. Health Affairs Forefront (Rachel Sachs and Kristi Martin), Administration Finalizes Medicare Part B International Reference Pricing Model (22 October 2026)
   Final rule released Wednesday 30 September 2026. The final model covers an estimated 3 percent of eligible Part B drug spending, down from about 54 percent of non-dual, non-340B Part B FFS drug spending under the proposed rule, and "as few as four manufacturers." Federal savings estimate $440 million against $11.9 billion proposed. The orphan drug exclusion first appears in the final rule.
   healthaffairs.org
5. Centers for Medicare & Medicaid Services, data.cms.gov, Medicare Part B Spending by Drug, record J9271 Keytruda (pembrolizumab) (Data year 2024; dataset modified 25 June 2026)
   Brnd_Name Keytruda; Gnrc_Name Pembrolizumab; Tot_Spndng_2024 5988521233; Tot_Benes_2024 75361; Tot_Clms_2024 455858; Tot_Spndng_2020 3501098225. The API's stats endpoint reports "found_rows":799,"total_rows":799.
   data.cms.gov
6. Centers for Medicare & Medicaid Services, data.cms.gov, Medicare Part B Spending by Drug, record J0897 Prolia* (denosumab) (Data year 2024; dataset modified 25 June 2026)
   Brnd_Name Prolia*; Gnrc_Name Denosumab*; HCPCS_Desc "Injection, denosumab, 1 mg"; Tot_Spndng_2024 2430935308; Tot_Benes_2024 700724; Tot_Clms_2024 1339338; Tot_Spndng_2020 1627019055.
   data.cms.gov
7. Centers for Medicare & Medicaid Services, data.cms.gov, Medicare Part B Spending by Drug, record J0129 Orencia* (abatacept) (Data year 2024; dataset modified 25 June 2026)
   Brnd_Name Orencia*; Gnrc_Name Abatacept*; Tot_Spndng_2024 930380810.7; Tot_Benes_2024 33154; Tot_Clms_2024 291579; Tot_Spndng_2020 1023005572.
   data.cms.gov
8. Centers for Medicare & Medicaid Services, data.cms.gov, Medicare Part B Spending by Drug, record Q4205 Membrane graft or membrane wrap, per square centimeter (Data year 2024; dataset modified 25 June 2026)
   Brnd_Name "Membrane graft or membrane wrap, per square centimeter"; Tot_Spndng_2024 1442222387; Tot_Benes_2024 10459; Tot_Clms_2024 59317; Tot_Spndng_2020 2348892.04.
   data.cms.gov
9. Centers for Medicare & Medicaid Services, data.cms.gov, Medicare Quarterly Part B Spending by Drug Methodology (v260716) (July 2026)
   Covers "Medicare fee-for-service Part B claims"; Medicare Advantage excluded. Excludes Not Otherwise Classified codes (J3490, J3590, J9999), claims where Medicare was not primary payer, critical access and Maryland hospital claims, zero-spending claims, and drugs with fewer than 11 Part B claims. Total spending is Medicare payment plus deductible and coinsurance and "represents the full value of the product." The 2025 data dictionary: an asterisk "Indicates multiple brand and/or generic names for a specific HCPCS code."
   data.cms.gov
10. Centers for Medicare & Medicaid Services, CMS Announces Selection of Drugs for Third Cycle of Medicare Drug Price Negotiation Program, Including First Part B Drugs (27 January 2026)
    15 drugs selected with prices applicable in 2028: Anoro Ellipta, Biktarvy, Botox; Botox Cosmetic, Cimzia, Cosentyx, Entyvio, Erleada, Kisqali, Lenvima, Orencia, Rexulti, Trulicity, Verzenio, Xeljanz; Xeljanz XR, Xolair. The selection includes "for the first time, drugs payable under Medicare Part B." About $27 billion in Part B and Part D spending, November 2024 through October 2025.
    cms.gov
11. Svatantra.ai, Signal database (23 October 2026)
    Counted: rows of the CMS Medicare Part B Spending by Drug dataset held in the database, one per HCPCS code per data year 2020 to 2024 (799 codes in 2024), using total spending as printed: 112 codes above $100,000,000 in 2024 summing to $52,726,168,496 of $60,838,164,403; 8 above $1,000,000,000 summing to $19,777,715,253; 80, 86, 83, 94 and 112 codes above $100 million in 2020 to 2024. The 112 by code prefix: 82 J, 18 Q4, 5 CPT 9xxxx, 5 Q5, 2 Q2. Rows of the CMS selected drug list and maximum fair price file (dated 21 September 2026) matched by HCPCS code: 5 of the 82 J codes (Orencia, Entyvio, Botox, Xolair, Cimzia; prices effective 1 January 2028). The GLOBE final rule held as a Federal Register signal published 2 October 2026. Counts at 23 October 2026.
    svatantra.ai