Blood glucose monitor and insulin.

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Intellectual Property, Pharmaceuticals, PORTAL Round-Up, Reimbursement

By Ameet Sarpatwari, Alexander Egilman, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of June. The selections feature topics ranging from a review of modifications to blood glucose monitoring systems and related patent protections, an examination of insulin price changes from 2012-2019, and a discussion of why a proposed federal bill that would ban government health care programs from using the quality-adjusted life-year is misguided. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Cliff ERS, Kesselheim AS, Feldman WB. Ensuring Ethical Postprogression Therapy for Patients in Randomized Trial Control Arms. J Clin Oncol. 2023 Jun 21:JCO2202675. Epub ahead of print.
  2. Darrow JJ, Van de Wiele V, Beran D, Kesselheim AS. An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. J Diabetes Sci Technol. 2023 Jun 5:19322968231178016. Epub ahead of print.
  3. Dhodapkar MM, Ross JS, Ramachandran R. US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Netw Open. 2023 Jun 1;6(6):e2318889.
  4. Dickson SR, Gabriel N, Gellad WF, Hernandez I. Assessment of Commercial and Mandatory Discounts in the Gross-to-Net Bubble for the Top Insulin Products From 2012 to 2019. JAMA Netw Open. 2023 Jun 1;6(6):e2318145.
  5. Dickson S, Gabriel N, Gellad WF, Hernandez I. Estimated Changes in Insulin Prices and Discounts After Entry of New Insulin Products, 2012-2019. JAMA Health Forum. 2023 Jun 2;4(6):e231430.
  6. Feldman WB, Rome BN. The Rise and Fall of the Insulin Pricing Bubble. JAMA Netw Open. 2023 Jun 1;6(6):e2318074.
  7. Jenei K, Raymakers AJN, Bayle A, Berger-Thürmel K, Cherla A, Honda K, et al. Health Technology Assessment for Cancer Medicines across the G7 Countries and Oceania: An International, Cross-Sectional Study. Lancet Oncol. 2023 Jun;24(6):624-635.
  8. Rand LZ, Raymakers A, Rome BN. Congress’ Misguided Plan to Ban QALYs. JAMA. 2023 Jun 27;329(24):2125-2126.
  9. Rome BN, Patel AN, Kesselheim AS. Inflationary Rebates For Generic Drugs Sold Through Medicaid Saved Billions During 2017-20. Health Aff (Millwood). 2023 Jun;42(6):770-778.

Ameet Sarpatwari

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

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