{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T15:11:37Z","timestamp":1771081897370,"version":"3.50.1"},"reference-count":26,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Intern Med"],"published-print":{"date-parts":[[2023,6,1]]},"abstract":"<jats:sec id=\"ab-ioi230018-4\"><jats:title>Importance<\/jats:title><jats:p>Allowing the US Centers for Medicare &amp;amp;amp; Medicaid Services to negotiate prescription drug prices for Medicare may improve drug affordability.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ioi230018-5\"><jats:title>Objective<\/jats:title><jats:p>To estimate savings from Medicare price negotiation under the Inflation Reduction Act (IRA) and examine opportunities to increase savings.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ioi230018-6\"><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>This cross-sectional, population-based study used data from 2020 Medicare prescription drug claims. The study was conducted and data were analyzed in 2022.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ioi230018-7\"><jats:title>Exposures<\/jats:title><jats:p>Eligibility for Medicare price negotiation under the IRA and alternative criteria.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ioi230018-8\"><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>Minimum savings under the IRA\u2019s eligibility criteria were estimated and compared with savings within alternative scenarios, including (1) selecting drugs for negotiation based on net spending after rebates rather than gross spending; (2) extending eligibility to drugs with biosimilar or generic competitors; (3) reducing the minimum years since US Food and Drug Administration approval for eligibility; and (4) changing 2 or 3 of these factors. Estimated savings were calculated at different levels of scale-up of price negotiation under the IRA, from 10 Part D drugs in 2026 to 60 Part B and D drugs in 2029. Gross spending was calculated using the US Centers for Medicare &amp;amp;amp; Medicaid Services 2020 Medicare drug spending dashboard. Rebates were estimated using SSR Health data. Information on FDA approvals, generics, and biosimilars was obtained from FDA websites.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ioi230018-9\"><jats:title>Results<\/jats:title><jats:p>Under IRA rules, estimated minimum savings from price negotiation in 2026 for 10 Part D drugs would be $3.2 billion. For 2029 for 60 Part D and B drugs, estimated savings were $16.0 billion. Selecting drugs for negotiation based on net rather than gross spending would be associated with estimated savings of $4.6 billion (a 45% increase) in 2026 and $18.9 billion (an 18% increase) in 2029. Including drugs with generic competitors or biosimilars would be associated with an estimated savings of $6.6 billion (a 109% increase) in 2026 and $24.9 billion (a 56% increase) in 2029. Making both changes would be associated with savings of $9.5 billion (a 200% increase) in 2026 and $28.3 billion (a 77% increase) in 2029. A sensitivity analysis suggested that reducing the required number of years since marketing approval by 2 years would be associated with increased estimated savings of 4% when 10 Part D drugs are negotiated and 12% when 60 Part D and B drugs are negotiated. Changing all 3 criteria would be associated with the greatest increase in estimated savings in 2029 (119% increase when 10 Part D drugs are negotiated and 93% increase for 60 Part D and B drugs).<\/jats:p><\/jats:sec><jats:sec id=\"ab-ioi230018-10\"><jats:title>Conclusions and Relevance<\/jats:title><jats:p>The results of this cross-sectional study suggest that adjusting the eligibility criteria for Medicare prescription drug price negotiation to permit inclusion of drugs with biosimilar or generic competitors and selecting drugs based on net rather than gross spending may be a promising approach to substantially increase estimated savings.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamainternmed.2023.0763","type":"journal-article","created":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T15:01:18Z","timestamp":1681743678000},"page":"581","source":"Crossref","is-referenced-by-count":11,"title":["Examining Opportunities to Increase Savings From Medicare Price Negotiations"],"prefix":"10.1001","volume":"183","author":[{"given":"Marissa B.","family":"Reitsma","sequence":"first","affiliation":[{"name":"Department of Health Policy and Freeman Spogli Institute for International Studies, Stanford University School of Medicine, Stanford, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stacie B.","family":"Dusetzina","sequence":"additional","affiliation":[{"name":"Department of Health Policy, Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeromie M.","family":"Ballreich","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio J.","family":"Trujillo","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle M.","family":"Mello","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Freeman Spogli Institute for International Studies, Stanford University School of Medicine, Stanford, California"},{"name":"Stanford Law School, Stanford, California"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"10","reference":[{"issue":"1","key":"ioi230018r6","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2022.5218","article-title":"Simulated Medicare drug price negotiation under the Inflation Reduction Act of 2022.","volume":"4","author":"Rome","year":"2023","journal-title":"JAMA Health Forum"},{"issue":"1","key":"ioi230018r19","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1007\/s11151-018-9627-y","article-title":"Estimating the causal effect of entry on generic drug prices using Hatch-Waxman exclusivity.","volume":"53","author":"Olson","year":"2018","journal-title":"Rev Ind Organ"},{"issue":"1","key":"ioi230018r20","doi-asserted-by":"publisher","first-page":"76","DOI":"10.1377\/hlthaff.2018.05147","article-title":"The contribution of new product entry versus existing product inflation in the rising costs of drugs.","volume":"38","author":"Hernandez","year":"2019","journal-title":"Health Aff (Millwood)"},{"issue":"6","key":"ioi230018r21","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2021.0626","article-title":"Estimating rebates and other discounts received by Medicare Part D.","volume":"2","author":"Feldman","year":"2021","journal-title":"JAMA Health Forum"},{"issue":"3","key":"ioi230018r25","doi-asserted-by":"publisher","first-page":"537","DOI":"10.1111\/hesr.v57.3","article-title":"Prescribing of low- versus high-cost part B drugs in Medicare Advantage and traditional Medicare.","volume":"57","author":"Anderson","year":"2022","journal-title":"Health Serv Res"},{"key":"ioi230018r2","volume-title":"Making Medicines Affordable: A National Imperative","author":"National Academies of Sciences, Engineering and Medicine","year":"2018"},{"key":"ioi230018r1","unstructured":"US Congress. H.R.5376: Inflation Reduction Act of 2022. Accessed March 17, 2023. https:\/\/www.congress.gov\/bill\/117th-congress\/house-bill\/5376\/text"},{"key":"ioi230018r3","unstructured":"Kirzinger? A, Kearney? A, Quasem? M, Stokes? M, Hamel? L, Brodie? M. KFF health tracking poll. Accessed March 17, 2023. https:\/\/www.kff.org\/health-costs\/poll-finding\/kff-health-tracking-poll-march-2022\/"},{"key":"ioi230018r4","unstructured":"Cubanski? J, Neuman? T, Freed? M. Explaining the prescription drug provisions in the Build Back Better Act. Accessed March 17, 2023. https:\/\/www.kff.org\/medicare\/issue-brief\/explaining-the-prescription-drug-provisions-in-the-build-back-better-act\/#_Allow_the_Federal"},{"key":"ioi230018r5","unstructured":"Congressional Budget Office. Estimated budgetary effects of Public Law 117-169, to provide for reconciliation pursuant to title II of S. Con. Res. 14. 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Search orphan drug designations and approvals. Accessed March 17, 2023. https:\/\/www.accessdata.fda.gov\/scripts\/opdlisting\/oopd\/"},{"key":"ioi230018r14","unstructured":"US Food and Drug Administration. Purple Book database of licensed biological products. Accessed March 17, 2023. https:\/\/purplebooksearch.fda.gov\/"},{"key":"ioi230018r15","unstructured":"US Food and Drug Administration. Biosimilar product information. Accessed March 17, 2023. https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilar-product-information"},{"key":"ioi230018r16","unstructured":"Ippolito? B, Levy? J. Best practices using SSR Health net drug pricing data. Accessed March 17, 2023. https:\/\/www.healthaffairs.org\/do\/10.1377\/forefront.20220308.712815\/"},{"key":"ioi230018r17","unstructured":"Cardinal Health. 2022 Biosimilars report: the U.S. journey and path ahead. Accessed March 17, 2023. https:\/\/www.cardinalhealth.com\/content\/dam\/corp\/web\/documents\/Report\/cardinal-health-2022-biosimilars-report.pdf"},{"key":"ioi230018r18","unstructured":"Mulcahy? A. Medicare drug price negotiation: key decisions to reach a \u201cfair price.\u201d Accessed March 17, 2023. https:\/\/www.healthaffairs.org\/content\/forefront\/medicare-drug-price-negotiation-key-decisions-reach-fair-price"},{"key":"ioi230018r22","unstructured":"Biden? J. Joe Biden: my plan to extend Medicare for another generation. Accessed March 7, 2023. https:\/\/www.nytimes.com\/2023\/03\/07\/opinion\/joe-biden-medicare.html"},{"key":"ioi230018r23","unstructured":"Philipson? TJ, Durie? T. The evidence base on the impact of price controls on medical innovation. Accessed March 17, 2023. https:\/\/bfi.uchicago.edu\/working-paper\/the-evidence-base-on-the-impact-of-price-controls-on-medical-innovation\/"},{"key":"ioi230018r24","unstructured":"Seshmani? M. Medicare Drug Price Negotiation Program: initial memorandum, implementation of sections 1191-1198 of the Social Security Act for Initial Price Applicability year 2026, and solicitation of comments. Accessed March 15, 2023. https:\/\/www.cms.gov\/files\/document\/medicare-drug-price-negotiation-program-initial-guidance.pdf"},{"key":"ioi230018r26","unstructured":"Ollendorf? DA, Voehler? D. Options for CMS price negotiations. 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