Clinical Trials, Journal Year: 2024, Volume and Issue: unknown
Published: July 24, 2024
Provisions of the Inflation Reduction Act mandating drug price negotiation by Centers for Medicare & Medicaid Services have been criticized as a threat to pharmaceutical innovation. This study models potential impacts on approvals based differential contributions large companies and smaller biotechnology firms clinical trials availability capital.
Language: Английский
American Society of Clinical Oncology Educational Book, Journal Year: 2023, Volume and Issue: 43
Published: June 1, 2023
Chimeric antigen receptor (CAR) T-cells are a cellular immunotherapy with remarkable efficacy in treating multiple hematologic malignancies but they associated extremely high prices that are, for many countries, prohibitively expensive. As their use increases both and other indications, large numbers of new therapies developed, novel approaches will be needed to reduce the cost therapy, pay them. We review factors lead CAR offer proposals reform.
Language: Английский
Citations
56
Nature Biotechnology, Journal Year: 2024, Volume and Issue: unknown
Published: Jan. 31, 2024
Language: Английский
Citations
16
JAMA Dermatology, Journal Year: 2024, Volume and Issue: 160(4), P. 409 - 409
Published: Feb. 21, 2024
The US lacks a systematic approach for aligning drug prices with clinical benefit, and traditional cost-effectiveness analysis (CEA) faces political obstacles. efficiency frontier (EF) method offers policymakers an alternative approach.
Language: Английский
Citations
9
Journal of the American College of Cardiology, Journal Year: 2023, Volume and Issue: 81(21), P. 2103 - 2111
Published: May 1, 2023
Language: Английский
Citations
21
JAMA, Journal Year: 2023, Volume and Issue: 329(15), P. 1283 - 1283
Published: April 18, 2023
Importance The Inflation Reduction Act of 2022 authorizes Medicare to negotiate prices top-selling drugs based on several factors, including therapeutic benefit compared with existing treatment options. Objective To determine the added 50 brand-name in 2020, as assessed by health technology assessment (HTA) organizations Canada, France, and Germany. Design, Setting, Participants In this cross-sectional study, publicly available ratings, US Food Drug Administration documents, Part B D prescription drug spending dashboards were used single-source 2020 assess their ratings through 2021. Main Outcomes Measures Ratings from HTA bodies Germany categorized high (moderate or greater) low (minor no) benefit. Each was rated its most favorable rating across countries, indications, subpopulations, dosage forms. We use prerebate postrebate (ie, net) between vs Results Forty-nine (98%) received an at least 1 country; 22 36 (61%) a 34 47 France (72%), 17 29 (59%). Across 27 (55%) had rating, accounting for $19.3 billion annual estimated net spending, 35% 11% total 2020. Compared those benefit, more beneficiaries (median 387 149 44 869) lower per beneficiary $992 $32 287). Conclusions Relevance Many national When negotiating these drugs, should ensure they are not priced higher than reasonable alternatives.
Language: Английский
Citations
15
Diabetes Care, Journal Year: 2024, Volume and Issue: 47(8), P. 1246 - 1256
Published: March 27, 2024
Escalating insulin prices have prompted public scrutiny of the practices drug manufacturers, pharmacy benefit managers, health insurers, and pharmacies involved in production distribution medications. As a result, series policies been proposed or enacted to improve affordability foster greater equity access. These implications for other diabetes obesity therapeutics. Recent legislation, at both state federal level, has capped out-of-pocket payments some patients. Other legislation targeted manufacturers directly requiring rebates on drugs with price increases beyond inflation rates, an approach that may restrain hikes existing In addition, government negotiation pricing, contentious issue, gained traction, Inflation Reduction Act 2022 permitting limited certain high expenditure without generic biosimilar competition, including products However, concerns persist this inadvertently encourage higher launch new Addressing barriers competition also priority such as through increased enforcement against anticompetitive (e.g., “product hopping”) reduced regulatory requirements development market entry. A novel involves production, exemplified by California’s CalRx program, which aims provide insulins significantly prices. Achieving affordable equitable access medications requires multifaceted approach, involving intervention, ongoing policy evaluation refinement, critical examination corporate influences care.
Language: Английский
Citations
4
Journal of Managed Care & Specialty Pharmacy, Journal Year: 2023, Volume and Issue: 29(8), P. 868 - 872
Published: July 31, 2023
BACKGROUND: Starting in 2026, Medicare will be able to negotiate drug prices. Although recent reports have identified the drugs that likely face negotiation, no study has estimated maximum negotiated price according guidance from Centers for and Medicaid Services. OBJECTIVE: To identify 10 expected by 2026. METHODS: We apply peer-reviewed methodology estimate 2020 rebates anticipated compare statutory minimum discounts 2026 savings. RESULTS: The discount stipulated Inflation Reduction Act exceeds 4 of including etanercept, which is subject a 60%, compared with an rebate 39.1%, cancer ibrutinib, palbociclib, enzalutamide, all 25%, 9%, 5.7% 15.0%, respectively. Based on gross spending, required these would generate savings $1.8 billion. CONCLUSIONS: In only negotiation. For most drugs, net prices establish ceiling price. achieve projected Congressional Budget Office ($3.7 billion), fall below established statute. DISCLOSURES: This work was funded West Health Policy Center. Dr Hernandez consulting fees Pfizer Bristol Meyers Squibb, outside submitted work. Following submission this manuscript, Mr Dickson became employee American's Insurance Plans. Plans had role reviewing manuscript. statements, findings, conclusions, views, opinions contained expressed herein are not necessarily those IQVIA Inc. or any its affiliated subsidiary entities.
Language: Английский
Citations
10
Journal of the American Heart Association, Journal Year: 2025, Volume and Issue: unknown
Published: Jan. 23, 2025
Language: Английский
Citations
0
Journal of Managed Care & Specialty Pharmacy, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 8
Published: April 23, 2025
In 2021, a large pharmacy benefit management organization (PBM) changed preferred agents on its national formulary from one branded interleukin (IL)-17 inhibitor (TxA) to another (TxB), prompting nonmedical switch (NMS) for patients using TxA. To evaluate the impact of this change treatment patterns among with psoriasis, psoriatic arthritis, or ankylosing spondylitis. Patients receiving TxA at least 84 days and no other biologic July 2020 December were identified PBM-specific data Symphony Health Analytics database. Two comparator groups established: affected (PBM-1) not (PBM-2) by change. Outcomes (1) changes in monthly fills TxA/TxB (July June 2021; PBM-1 group only), (2) proportion TxA-treated experiencing any medication discontinuation switching (PBM-1 PBM-2 groups), (3) medication-taking behaviors (adherence, discontinuation, switching) continuing vs those that NMS TxB only). Demographics similar (N = 1,703) 462). After (January 2021 2021), prescription decreased 7% while increased 8% group. Compared (PBM-2 group), significantly more completely discontinued (27% 14%). The had higher (P < 0.001) rates (19% 1%) (8% 2%). Following TxB, 0.05) lower adherence (46% 63%) subsequent (14% 6%) absolute (20% 14%) than change, 25% exposed experienced nearly double rate exposed. This unfavorable finding, along nonadherence switching, warrants careful monitoring policy changes.
Language: Английский
Citations
0
Published: Jan. 1, 2025
Language: Английский
Citations
0