Medicare

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.

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.

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?

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 US Congressional Budget Office acknowledged that weight loss drug coverage could drive long term savings from ancillary health issues, but not enough to offset the cost of the drugs. Expanding Medicare coverage would cost the US Treasury $35 billion over 10 years.

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.

Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations, legal wrangling related to compounding GLP-1 drugs for obesity and diabetes, and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable.

The US Medicaid agency will not require diagnostic codes on prescriptions any time soon after hearing “overwhelming” opposition from stakeholders.

Pharmacy benefit managers are not the only ones in the supply chain that may not feel incentivized to encourage patient access to Medicare negotiated drugs.

The US Centers for Medicare and Medicaid Services is counting on “good faith” between manufacturers and covered entities to ensure appropriate 340B pricing is offered on drugs subject to the new negotiation authority.

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.

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.

Prior authorization reforms could emerge as an important under-the-radar area of drug policy next year. An upcoming Medicare proposed rule, the extraordinary uptake of weight loss therapies, and the launch of the overhauled Part D benefit design will all drive attention to the issue.

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.’

Instead of $5bn in 2025, the redesign could cost the federal government two to four times that amount, the Congressional Budget Office told Republican lawmakers. And the Part D premium stabilization demonstration will cost an additional $7bn, the office projected.