Pricing Debate
Outcomes-based and price-volume agreements are the alternative pricing deals most frequently suggested by industry to AMGROS, Danish procurement body.
A shifting political power balance in Japan is leading to renewed debate on the pace of regular drug reimbursement price cuts.
The collapse of the French government brings more uncertainty for the pharmaceutical industry.
The manufacturer dispute with hospitals and US agency tasked with overseeing the outpatient drug discount program is entering a new phase.
While Japan awarded relatively high premiums to several products newly listed for reimbursement, others were the subject of prolonged debate or are facing imminent cost-effectiveness assessment.
Proposed rule on GLP-1s sets up an expensive benefit that would need to be implemented (or rejected) by the incoming Trump administration. Move suggests the next round of drugs subject to Medicare price-setting will include Novo’s semaglutide – and could be announced by the Biden team before they leave.
Japan has granted an initial reimbursement price for Kisunla slightly above that for Alzheimer's rival Leqembi, but is holding out the prospect of future price revisions.
The FDA’s Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing.
Company’s move against the US agency tasked with overseeing the 340B drug discount program is the latest in a series of manufacturer attempts to rein in ballooning 340B price concessions.
Plan sponsors continue working to offset the risk from major policy shifts.
The government’s decision for the Pharmaceutical Benefits Advisory Committee to hold an extra meeting in 2025 has been welcomed by Medicines Australia, which says that Australians already wait on average 466 days from the time a medicine is approved to when it is subsidized.
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.
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.
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.
Some of the industry’s biggest challenges, and potential solutions, were hot topics at the BioFuture conference in New York.
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.
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.