Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies DOI Creative Commons
Gregory Vaughan,

Roger Du,

Fred D. Ledley

et al.

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

A Global Comparison of Liver Transplant Drug Pricing: US Versus Other G7 Countries and Australia DOI Creative Commons

Leah Yao,

Xiaohan Ying, Arun Jesudian

et al.

Transplantation Direct, Journal Year: 2025, Volume and Issue: 11(6), P. e1805 - e1805

Published: May 12, 2025

Background. A major contributor to increased healthcare spending in the United States is drug pricing, as US prices are nearly 3× higher than those other countries. This cross-sectional study aimed investigate current global price differences liver transplant medications and provide potential cost savings for Medicare Part D if international reference pricing was adopted. Methods. Publicly available formularies Canada, Kingdom, Japan, France, Germany, Italy, Australia were used collect 2024 8 commonly (mycophenolate mofetil, mycophenolate sodium, sirolimus, tacrolimus, Advagraf, Envarsus, everolimus, cyclosporine). obtained from UptoDate’s listed representative average wholesale D’s 2022. Results. The spend originator 4.1× 6.8×, respectively, G7 countries Australia. Adopting per dose may lead an estimated $26 141 463 year Medicare. generic 2.76× 3.75×, prices. $363 538 474 Conclusions. demonstrates significantly greater financial burden that patients face compared with 7 industrial Future adoption of help bridge this disparity.

Language: Английский

Citations

0

Drug pricing and transparency in Europe and the United States: what is it and how does it work? DOI
Steven Simoens, Mondher Toumi

Expert Review of Pharmacoeconomics & Outcomes Research, Journal Year: 2024, Volume and Issue: 24(4), P. 477 - 486

Published: Jan. 26, 2024

Introduction As drug prices are viewed to be opaque, there have been increasing societal demands on policy and decision makers implement initiatives that promote price transparency.

Language: Английский

Citations

3

Considering Returns on Federal Investment in the Negotiated “Maximum Fair Price” of Drugs Under the Inflation Reduction Act: an Analysis DOI Open Access
Edward Zhou,

Paula G. Chaves da Silva,

Debbie Quijada

et al.

Published: Feb. 28, 2024

The Inflation Reduction Act (IRA) of 2022 contained landmark provisions authorizing government to negotiate a “maximum fair price” for selected Medicare Part D drugs considering the manufacturer’s research and development costs, federal support discovery development, extent which address unmet medical needs, other factors. This working paper describes investment in ten price negotiation first year IRA as well health value created through spending on these drugs. We identified $11.7 billion NIH funding basic or applied leading approval with median costs $895.4 million/drug. early public provided cost savings industry $1,485 million/drug, comparable reported levels by industry. From 2017-2021, spent $126.4 (median $10.7 billion) products before rebates. Excluding two diabetes, was $97.4 total 650,940 QALYs $67.7 (WTP/QALY=$104K) representing negative residual -$29.7 (before rebates). argue that negotiated should provide returns both private investments commensurate scale risk investments, principal return sector being (net price) accruing those using product. These empirical data basis negotiating rewards innovation provides social public.

Language: Английский

Citations

3

JAMA Health Forum—The Year in Review, 2023 DOI Creative Commons

John Z. Ayanian

JAMA Health Forum, Journal Year: 2024, Volume and Issue: 5(3), P. e240265 - e240265

Published: March 22, 2024

3][4][5] The JAMA Network recently announced the call for candidates to serve as next Editor in Chief of Health Forum. 6I strongly encourage colleagues with relevant experience who are passionate about advancing health policy and services research apply.Compared 2022, 7 total number manuscript submissions journal increased by 25% 1255 2023, submitted manuscripts (Original Investigations, Brief Reports, Research Letters) also rose 894 (Table 8 -15 ).With robust growth submissions, journal's acceptance rate has dropped from 26%

Language: Английский

Citations

3

Examining Opportunities to Increase Savings From Medicare Price Negotiations DOI
Marissa B Reitsma, Stacie B. Dusetzina, Jeromie Ballreich

et al.

JAMA Internal Medicine, Journal Year: 2023, Volume and Issue: 183(6), P. 581 - 581

Published: April 17, 2023

Importance Allowing the US Centers for Medicare & Medicaid Services to negotiate prescription drug prices may improve affordability. Objective To estimate savings from price negotiation under Inflation Reduction Act (IRA) and examine opportunities increase savings. Design, Setting, Participants This cross-sectional, population-based study used data 2020 claims. The was conducted were analyzed in 2022. Exposures Eligibility IRA alternative criteria. Main Outcomes Measures Minimum IRA’s eligibility criteria estimated compared with within scenarios, including (1) selecting drugs based on net spending after rebates rather than gross spending; (2) extending biosimilar or generic competitors; (3) reducing minimum years since Food Drug Administration approval eligibility; (4) changing 2 3 of these factors. Estimated calculated at different levels scale-up IRA, 10 Part D 2026 60 B 2029. Gross using dashboard. Rebates SSR Health data. Information FDA approvals, generics, biosimilars obtained websites. Results Under rules, would be $3.2 billion. For 2029 drugs, $16.0 Selecting associated $4.6 billion (a 45% increase) $18.9 (an 18% Including competitors an $6.6 109% $24.9 56% Making both changes $9.5 200% $28.3 77% A sensitivity analysis suggested that required number marketing by increased 4% when are negotiated 12% negotiated. Changing all greatest (119% 93% drugs). Conclusions Relevance results this cross-sectional suggest adjusting permit inclusion a promising approach substantially

Language: Английский

Citations

8

Cost-effectiveness of neoadjuvant pembrolizumab plus chemotherapy with adjuvant pembrolizumab for early-stage non-small cell lung cancer in the United States DOI Creative Commons
Wentao Tian, Lishui Niu, Ziqi Wang

et al.

Frontiers in Immunology, Journal Year: 2023, Volume and Issue: 14

Published: Sept. 26, 2023

Perioperative (neoadjuvant and adjuvant) pembrolizumab has shown favorable efficacy in patients with early-stage non-small cell lung cancer (NSCLC). This study aims to evaluate the cost-effectiveness of this treatment from perspective United States healthcare payers.We established a Markov model compare perioperative that neoadjuvant chemotherapy 21-day cycles, utilizing data phase 3 KEYNOTE-671 trial. Additional were extracted other publications or online sources. Sensitivity analyses conducted robustness findings. A willingness-to-pay threshold $150,000 per quality-adjusted life-years (QALYs) gained was established. The main outcomes measurement QALYs, overall costs, incremental ratio (ICER), net monetary benefit (NMB).During 10-year time horizon, total costs control $224,779.1 $110,026.3, respectively. QALYs 4.19 2.97 for two treatments, respectively, which led an ICER $94,222.29 QALY gained. NMB at WTP $67,931.3. One-way sensitivity analysis identified cost as primary factor influencing cost-effectiveness. Probabilistic indicated 97.7% probability being cost-effective threshold.From payers, is NSCLC.

Language: Английский

Citations

7

A critical review of clinician-directed nudges DOI
Briana S. Last, Rinad S. Beidas, Katelin Hoskins

et al.

Current Opinion in Psychology, Journal Year: 2024, Volume and Issue: 59, P. 101856 - 101856

Published: Aug. 2, 2024

Language: Английский

Citations

2

Drug Pricing Stewardship from Mark Cuban’s Cost Plus Generic Drug Program DOI
Snigdha Gulati, Mohak Gupta,

TingTing Yan

et al.

PharmacoEconomics, Journal Year: 2024, Volume and Issue: 42(11), P. 1279 - 1286

Published: Aug. 21, 2024

Language: Английский

Citations

2

The Imperative to Enhance Cost-Effectiveness for Cardiovascular Therapeutic Development DOI Creative Commons
Michael H. Davidson, Andrew Hsieh,

Mary R. Dicklin

et al.

JACC Basic to Translational Science, Journal Year: 2024, Volume and Issue: 9(8), P. 1029 - 1040

Published: Feb. 21, 2024

Cardiovascular disease (CVD) is the leading cause of mortality worldwide. Therapeutic agents, such as those that lower low-density lipoprotein cholesterol, have been a critical factor in mitigating CVD event risk and demonstrate important role drug discovery plays reducing morbidity mortality. However, rapidly rising development costs, diminishing returns, an increasingly challenging regulatory environment all contributed to declining number cardiovascular (CV) therapeutic agents entering health care marketplace. For pharmaceutical companies, traditional outcomes trial (CVOT) can be major financial burden impediment CV agent development. They take long decade conduct, delaying potential investment return while carrying failure. patients, lengthy CVOTs delay accessibility. Without cost-effective CVOTs, innovation may compromised, with patients bearing consequences. This paper reviews approaches for making more cost-effective.

Language: Английский

Citations

2

Stakeholder Perspectives of the Inflation Reduction Act’s (2022) Impact on Prescription Drugs: A Narrative Review DOI Creative Commons
Cristian Lieneck, Matthew McLauchlan,

Valerie Adachi

et al.

Pharmacy, Journal Year: 2023, Volume and Issue: 11(6), P. 187 - 187

Published: Dec. 17, 2023

In this review, we examine the impact of Inflation Reduction Act (IRA) 2022 on pharmaceutical drugs in United States, drawing a diverse range sources to understand perceptions multiple stakeholders and professionals. Findings suggest that Act, while aiming control price inflation, has had multifaceted sector. Stakeholders, including companies, healthcare providers, patient advocacy groups, policymakers, offered varied perspectives: some laud for its potential controlling runaway drug prices making more accessible, others raise concerns about possible reductions innovation, disruptions supply chains, sustainability smaller companies. The review identified four underlying constructs (themes) literature surrounding stakeholders' IRA's upon prescription drugs: pricing and/or dictation issues, topics related patent law pharmaceuticals, processes (2022) rules regulations, threats industry concerning research development future medications. complex interplay Act's implications underscores importance ongoing assessment iterative policy refinements as implementation endures.

Language: Английский

Citations

5