GSK’s Arexvy and Pfizer’s Abrysvo are FDA-approved for individuals younger than 60 years old, but CDC’s Advisory Committee on Immunization Practices wants more data on Guillain-Barré syndrome cases in older adults and efficacy in severely immune-compromised persons before making a recommendation.
Plan sponsors continue working to offset the risk from major policy shifts.
Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.
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.
An appeals court panel seemed skeptical of whether AstraZeneca has standing in its Administrative Procedure Act challenges against the IRA’s drug price negotiation program, but suggested a company with standing might be successful in their court.
PBM reform likely will remain a priority no matter which party controls Congress, but experts differ on the party that likely would be harder on the industry.
Two of three appeals court judges hearing Bristol Myers Squibb and Janssen’s appeal questioned whether Medicare’s drug price negotiation program was truly structured in a way that gives manufacturers a choice not to participate.
Medicines Australia has expressed skepticism over the Pharmaceutical Benefits Advisory Committee’s claim that in March 2025 it will only be able to assess 32 submissions from companies that want to get their drugs subsidized under the Pharmaceutical Benefits Scheme.
The move towards greater regulatory collaboration is a positive step for gene therapy developers, Astellas’ gene therapy strategy lead Richard Wilson says – adding, however, that pharma still needed to understand the Asian markets better.
Judges on the Third Circuit panel in the BMS and JNJ IRA cases seemed sympathetic to industry’s concerns about the government using the term “maximum fair price” in the IRA’s Medicare drug price negotiation program.
Along with the much heralded guidance requiring coverage of OTC birth control, the Biden Administration also required insurers to cover pre-exposure prophylaxis (PrEP) for prevention of HIV.
Some of the industry’s biggest challenges, and potential solutions, were hot topics at the BioFuture conference in New York.
The European Commission has now adopted the third implementing act for the Health Technology Assessment Regulation. This sets out rules for managing conflicts of interest of anyone involved in joint clinical assessments or joint scientific consultations under the regulation.
A proposed rule requiring US insurers to cover non-prescription birth control would also broaden the existing mandate to cover prescription contraceptives at no cost for beneficiaries.
European cross-country HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.
The leading supplier of repackaged off-label Avastin for ophthalmic uses is discontinuing the product. Is this the beginning of the end for a relatively cheap wet AMD treatment?
Generics of the schizophrenia treatment Latuda generated more than $4bn in savings a year after their 2022 approval, according to an FDA study.
Drug discount program reform would have the best chance of enactment if Republicans gain control of both the House and Senate and former president Trump is re-elected.
The landmark drug pricing reforms from the Inflation Reduction Act are starting to take full effect – and it turns out that the impact may not be as dramatic as originally projected based on updated analyses from the US Congressional Budget Office.
The UK’s drug regulator has approved Eli Lilly’s early Alzheimer’s drug Kisunla, but England’s health technology assessment agency NICE said that the product “does not currently demonstrate value” for the National Health Service.