Month-to-month Spherical-Up of What to Learn on Pharma Regulation and Coverage

By Ameet Sarpatwari,  Liam Bendicksen, and Aaron S. Kesselheim

Every month, members of the Program On Regulation, Therapeutics, And Regulation (PORTAL) evaluation the peer-reviewed medical literature to determine attention-grabbing empirical research, coverage analyses, and editorials on well being legislation and coverage points related to present or potential future work within the Division.

Beneath are the abstracts/summaries for papers recognized from the month of January. The picks characteristic subjects starting from a examine of inhaler producers’ revenues after the expiration of major patents, to an evaluation of the medical worth of medication that corporations closely market to shoppers on tv, to an exploration of how the general public sector and tutorial establishments have contributed to gene remedy innovation. A full posting of abstracts/summaries of those articles could also be discovered on our web site.

1. Clemans-Cope L, Epstein M, Banthin J, Kesselheim AS, Hwang TJ. Estimates of Medicaid and Non-Medicaid Internet Costs of Prime-Promoting Model-name Medicine Incorporating Finest Value Rebates, 2015 to 2019. JAMA Well being Discussion board. 2023 Jan 6;4(1):e225012.
2. Egilman AC, Kesselheim AS, Rome BN. Estimated Medicare Half B Financial savings From Inflationary Rebates. JAMA. 2023 Jan 3;329(1):89-92.
3. Everhart AO, Sen S, Stern AD, Zhu Y, Karaca-Mandic P. Affiliation Between Regulatory Submission Traits and Recollects of Medical Units Receiving 510(ok) Clearance. JAMA. 2023 Jan 10;329(2):144-156.
4. Feldman WB, Tu SS, Alhiary R, Kesselheim AS, Wouters OJ. Producer Income on Inhalers After Expiration of Major Patents, 2000-2021. JAMA. 2023 Jan 3;329(1):87-89.
5. Jenei Ok, Meyers D, Gyawali B. Evaluation of Value and Scientific Advantage of Most cancers Medicine in Canada, 2011-2020. JAMA Netw Open. 2023 Jan 3;6(1):e2253438.
6. Kadakia KT, Dhruva SS, Caraballo C, Ross JS, Krumholz HM. Use of Recalled Units in New System Authorizations Below the US Meals and Drug Administration’s 510(ok) Pathway and Threat of Subsequent Recollects. JAMA. 2023 Jan 10;329(2):136-143.
7. Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Worth of Medicine Regularly Marketed Utilizing Direct-to-Client Tv Promoting, 2015 to 2021. JAMA Netw Open. 2023 Jan 3;6(1):e2250991.
8. Roberts TJ, Kesselheim AS, Avorn J. Variation in Use of Lung Most cancers Focused Therapies Throughout State Medicaid Applications, 2020-2021. JAMA Netw Open. 2023 Jan 3;6(1):e2252562.
9. Rome BN, Nagar S, Egilman AC, Wang J, Feldman WB, Kesselheim AS. Simulated Medicare Drug Value Negotiation Below the Inflation Discount Act of 2022. JAMA Well being Discussion board. 2023 Jan 6;4(1):e225218.
10. Tu SS, Nagar S, Kesselheim AS. Current Patent Reform Payments and Their Implications for Prescription Medicine. JAMA. 2023 Jan 13. Epub forward of print.
11. Vokinger KN, Avorn J, Kesselheim AS. Sources of Innovation in Gene Therapies – Approaches to Attaining Reasonably priced Costs. N Engl J Med. 2023 Jan 26;388(4):292-295. 
12. Wang J, Lee CC, Kesselheim AS, Rome BN. Estimated Medicaid Spending on Unique and Citrate-Free Adalimumab From 2014 By means of 2021. JAMA Intern Med. 2023 Jan 30. Epub forward of print.

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