Pricing Debate
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.
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.
A manufacturer information campaign is increasing awareness about the Inflation Reduction Act provisions easing cost sharing obligations for high-cost drugs in Part D, the insurer said.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to cause a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the companies that have been part of pricing discussions.
A growing number of future Part B candidates for Medicare price negotiation may avoid price controls in the program with injectable versions.
But the prospects for attaching the legislation to a federal spending package in December will be dependent on the outcome of the upcoming elections.
Big corporations fought to scuttle a California PBM reform bill, despite favoring federal efforts, in part from a desire to be held to one national standard.
Pink Sheet reporter and editors discuss experts’ experience helping drug sponsors negotiate prices with CMS and the FDA’s proposal for a new pathway to update vaccines before a pandemic is declared.
The proposed CMS innovation center's $2 drug list model will not address the barriers to newer generics getting on Part D formularies and plans may have little incentive to participate in the demo, an industry group said.
Policy experts and consultants recount their experiences shepherding manufacturers through the first round of Medicare price negotiations during a recent webinar.
Issues raised in the first six months of the new VPAG include potential adverse impacts on both older and newer innovative drugs, as well as uncertainties over the “exceptional circumstances” clause that allows requests for price increases or cuts in repayment rates.
HRSA threatens nuclear option and Johnson & Johnson suspends its 340B rebate model. But the company also ‘reserves all of its legal rights with respect to this matter.’
The final Medicare price negotiation guidance for the next cycle includes improvements from last year’s patient listening sessions.
An agreement to extend government funding until 20 December means no shutdown for the US FDA or other agencies, but also that a busy December awaits for biopharma lobbyists.
The UK government should remove a cost-neutrality restriction on England’s health technology assessment institute, NICE, that limits the value it places on medicines for severe conditions, says industry body the ABPI.
Senate HELP Committee chair Sanders is trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices for Ozempic and Wegovy. Prominent Republican raises international reference pricing.
Alternatives to the top pharmacy benefits managers argue health plan-PBM integration is leading to anti-competitive tactics that make it impossible for some employers to switch PBMs.