In one of its familiar U-turns, the U.K. National Institute for Health and Care Excellence (NICE) has recommended NHS England should fund a rare disease gene therapy from Orchard Therapeutics plc, considered to be the world’s most expensive drug. The list price for Libmeldy (atidarsagene autotemcel) in England and Wales is £2,875,000 (US$3.9 million), making it the most expensive drug that NICE has ever evaluated.
While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
Cardiologist Robert Califf has been nominated a second time to lead the FDA, and drug pricing was again high on the agenda at the Dec. 14 Senate hearing for his nomination.
Two reports, one from Democrats and one from Republicans, point fingers at the reasons prescription drug prices have risen so dramatically. Both came at a time when President Joe Biden wants to change the way drug prices are determined.
The push for legislation that would lower prescription drug prices in the U.S. has mounted in recent months, but support for Medicare pricing negotiations has faltered in the past few weeks. Sen. Bob Menendez (D-N.J.) is the latest Senate Democrat to signal his aversion to giving the government the authority to negotiate prices with drugmakers, breathing new life into hopes that the pharmaceutical industry will yet again escape a mechanism that critics say would suppress innovation at the expense of patients in desperate need of state-of-the-art therapies.
Boehringer Ingelheim International GmbH is the latest drug company to come into the crosshairs of the U.S. Health Resources and Services Administration over its restrictions on giving 340B drug discounts to contract pharmacies.
South Korea’s Ministry of Health and Welfare (MHW) is currently discussing the implementation of a preferential drug pricing system and plans to initiate an expert survey in 2022. The preferential drug pricing system is part of a three-prong strategy that South Korea plans to adopt to promote the growth of eight leading companies in the pharmaceutical, medical device and cosmetic industries by 2030.
As the U.S. House of Representatives resumes work Aug. 23 on a budget reconciliation proposal to get a $3.5 trillion fiscal 2022 budget across the finish line, many lawmakers are looking to provisions to reduce prescription drug prices as a way to pay for increased spending in other health care sectors.
Instead of waiting for Congress to come up with a solution to reduce drug prices, a trio of U.S. lawmakers told the U.S. Department of Health and Human Services (HHS) it needs to tackle drug prices with the tools it already has – compulsory licensing and march-in rights.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
