Drug Pricing
The US election result brought stock market volatility especially to pharma and biotech companies but the poster children for approved GLP-1 agonists and vaccines were initially the hardest hit.
Eli Lilly’s India chief, at a recent summit, talked about India moving up the “priority list” when it came to boardroom discussions, while the founding CEO, Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, outlined the implications for pharma as the massive publicly funded health assurance scheme widens coverage in the country.
The proposal states that Part D plans could define "obesity" for coverage determination, but CMS said overly restrictive criteria would be inconsistent with formulary review requirements and step-therapy would not be allowed.
But the expected nominee brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.
While election results are not complete, prospects improve under new regime for 340B program reforms, PBM legislation, and Inflation Reduction Act drug pricing revisions. But immediate priorities for Congress and the new president will be elsewhere.
Some of the industry’s biggest challenges – and potential solutions to those problems – were hot topics at the BioFuture conference in New York.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.
Arexvy has become the first RSV vaccine to show it can provide protection over three years – but that might mean lower market uptake than originally expected.
Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.
A high-profile panel that included a senior executive from F-Prime Capital, Novo Nordisk's India chief and a leading endocrinologist discussed, at a recent event, some of the big opportunities, challenges and transformational trends underway as obesity drugs take the world by storm.
Miplyffa (arimoclomol) was approved for Niemann-Pick disease type C when administered with another high-priced drug used off label as standard of care for about 80% of NPC patients.
The company stands a strong chance of winning approval for lenacapavir as a twice-yearly injectable drug for preventing HIV infection, though market challenges remain.
The drug maker could end up doubling the addressable patient population for Filspari thanks to the new label removing the proteinuria threshold, plus a draft treatment guideline from a kidney disease group.
The company’s VAX-31 against 31 pneumococcal serotypes outperformed Pfizer’s market-leading Prevnar 20 and could provide the broadest coverage of any vaccine in its class.
The company is offering Zepbound in single-dose 2.5mg and 5mg vials, both to expand supply and access, especially for patients without coverage for the obesity drug.
Merck & Co. won European Commission approval for Winrevair on top of other medicines for pulmonary arterial hypertension and expects an initial EU launch in Germany.
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.
Cost watchdog NICE has blocked Leqembi’s use, but a pricing deal could unlock access to the beta-amyloid targeting drug
The first round of US government drug price negotiations resulted in prices for 10 drugs that will lower aggregate net spending by 22%