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Pricing Debate

Australia Considers New 'Bridging Fund' Among 50 Recommendations For HTA Reform

Industry says it is ready to work with the government on the recommendations from a major review of Australia’s health technology assessment system that covers areas such as discount rate reductions and setting up a separate budgetary allocation to temporarily subsidize access to certain drugs.

Health Technology Assessment Australia

US FDA’s Marks Issues ‘Provocative’ Call For Target Gene Therapy Profile That Includes Costs

CBER Director Peter Marks said recent leaps in gene therapy science have not been matched by more affordable manufacturing technology and that the field needs to set a cost-effectiveness target. 

Gene Therapy Cost Effectiveness

Market Prices Or Political Expediency? Amgen’s US Lawsuit Seen As Litmus Test

As the US struggles to contain the cost of prescription medicines, a growing number of state governments are trying to take matters into their own hands and believe prescription drug affordability boards could be the answer.

Market Access Government Payers

Landmark Guidance For Curbing Antibiotic Pollution Considers Impact On Pricing & Supply

The World Health Organization says its new 98-page guidance dealing with wastewater and solid waste management for antibiotic manufacturing is a first of its kind and addresses an important but neglected issue.

International Manufacturing

HRSA-J&J Dispute Over 340B Rebate Plan Again Underscores Need For Program Reform

Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.

Pricing Debate Legal Issues

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: CMS’s price reveal better than expected?; new diabetes risk data for Zepbound; can J&J’s lung cancer combo stand up to Tagrisso?; new recruits for BioMarin leadership; and Glenmark’s shifting revenues.

Pricing Debate Sales & Earnings

US Presidential Elections: Are Prescription Drug Pricing Reforms Losing Political Luster?

Neither Kamala Harris nor Donald Trump mentioned drug pricing reforms in their presidential convention speeches.

Pricing Debate Policy

PBMs and Vertical Integration: CBO Adds To Growing Concerns About Negative Impacts

Congressional Budget Office responses to questions from US lawmakers on pharmacy benefit managers could add to the momentum for PBM reforms to go further than the current leading proposals.

Reimbursement Pricing Debate

CMS’s Big Drug Price Reveal Turns Out Better For Pharma Than Feared

The first round of US government drug price negotiations resulted in prices for 10 drugs that will lower aggregate net spending by 22%

Medicare Pricing Debate

Japan Recommends Donanemab, Sets Raft Of New And Reduced Prices

A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.

Japan Approvals

UK Firms Given More Time To Submit Sales Data Under New Price Scheme

It appears that the complexity of dealing with older products under the VPAG is the main cause of delays at the health department in sharing reference prices with pharma companies.

Europe United Kingdom

Sanofi: England Needs ‘Flexible’ Pricing For Multi-Indication Drugs

Sanofi, Alexion and Eli Lilly argue for changes in England’s health technology assessment and medicine pricing processes that could help patients to access more medicines.

BioPharmaceutical Europe

US PBM Reform: ‘Bust Them Up’ A Theme For 2025?

Another House hearing again showcases the bipartisan desire to enact reforms to the US pharmacy benefit management sector. Legislators also sound ready to push for more significant actions than “transparency” measures would promise, but that means waiting until 2025.

Legislation Reimbursement

One In Five English HTAs Terminated Due To Company Non-Submissions And Withdrawals

Since 2019, 91 health technology assessments have been terminated by England’s NICE because companies withdrew their applications or did not submit evidence. In the first of this three-part article series, pharma firms share their reasons for opting out of the process.

Europe United Kingdom

AstraZeneca’s Enhertu Expansion Blocked By NICE Over Price

The cost effectiveness watchdog claims AstraZeneca and Daiichi-Sankyo have not offered a fair price for use in the larger HER2-low setting.

Commercial Market Access

Pink Sheet Podcast: US FDA Device Director Retires, PBM Execs On Capitol Hill, Voucher Program Renewal Push

Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after another Capitol Hill appearance, and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed.

Leadership Pricing Debate
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