Market Access & Reimbursement

Psychedelic drug developers are focusing on the US market, and there are no approvals in sight in the EU. The European Medicines Agency wants to change that.

The talks are still tough, with the Pathogen Access and Benefit Sharing proposal proving the most difficult aspect of the treaty, but there is cautious optimism that some form of agreement may be reached this week.

After several rejections by NICE and an appeal by Pfizer, the company has reduced the price for its first-in-class sickle cell disease drug to a level that the health technology assessment institute deems acceptable.

The mechanics of implementing the new prices is the most significant update in the draft. The few revisions to key elements of the negotiation process in the guidance include alternative approaches to forums for collecting patient input on the selected drugs. 

The schedule for the second round of negotiations is different from the first cycle, in part because the Inflation Reduction Act allowed for extra time initially as the program launched. The first- and second-year timelines also overlap: The second negotiation cycle will begin before the first cycle prices are implemented. 

Developing drugs for some rare diseases is “just not commercially feasible,” meaning that alternative approaches, such as funding through venture philanthropy and not-for-profit models, need to be explored, a gene therapy professor has said.

Novo Nordisk is expecting a relatively modest uptake in Medicare Part D for the cardiovascular claim, but plans still will worry about stemming demand in obesity.

Shionogi’s UK general manager praised NHS England’s novel subscription model for antibiotics, but warned the country would be “wasting money” unless other global regulators introduced similar incentives for antimicrobial development.

At issue is a narrow jurisdictional ruling, not the constitutionality of the Medicare price negotiation program, US attorney reminds the judges.

The US Medicare Payment Advisory Commission is analyzing two of the lower-cost segments of the US medicine marketplace: generic drugs and the 340B brand discount program. In both cases, there is a picture of complexity and unintended consequences to rival higher cost segments.

The fourth court loss for pharma in industry's attempts to kill Medicare’s drug price negotiation program adds to the list of reasons courts have rejected legal challenges to the Inflation Reduction Act.

The authorized generic also could mitigate the impact of eliminating the cap on Medicaid price inflation rebates, which went into effect in January.

The UK’s drug regulator, the MHRA, has taken a hit in terms of capacity and funding post-Brexit, and could benefit from government backing to rebuild its regulatory capacity, a leading venture capitalist has said.

Real-world evidence and patient involvement can help developers shore up evidence from single arm trials for EU-wide joint clinical assessments.

The statement, which is part of a final rule on the 340B administrative dispute resolution process, could facilitate manufacturer efforts to seek repayments from hospitals in such cases.

The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.