Medicaid

If successful, the new CMS cell and gene therapy access model eventually could expand to oncology or hemophilia products, an Avalere Health expert said.

A Catalyst fix, a pediatric rare disease voucher reauthorization that should prevent future workload imbalances for FDA, and a boost for out-of-state coverage in Medicaid are among Congress’s year end commitments to pediatric and rare disease patients that now seem in doubt.

Scant evidence has emerged proving that carving out retail pharmacy benefit management from Medicaid managed care organization contracts helps limit costs.

The proposal states that Part D plans could define "obesity" for coverage determination, but CMS said overly restrictive criteria would be inconsistent with formulary review requirements and step-therapy would not be allowed.

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.

But the expected nominee brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.

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.

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

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 move is positive for manufacturers and follows the agency’s decision to drop another contentious proposal that would have ‘stacked’ drug discounts when calculating Medicaid best prices.

Congressional Budget Office responses to questions from US lawmakers on pharmacy benefit managers could add to the momentum for PBM reforms to go further than the current leading proposals.

Vertex’s fertility preservation assistance program would provide up to $70,000 in financial support for in vitro fertilization and other services to patients prescribed Casgevy.

The agency says it will collect additional information from manufacturers on methods for adding up price concessions from the supply chain before moving ahead.

The authorized generic also could mitigate the impact of eliminating the cap on Medicaid price inflation rebates, which went into effect in January.

Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.

Various government and private payer initiatives are good steps forward, but lack coordination. Payers continue to face perverse incentives to use high-cost drugs because of rebates in 340B, while providers don’t have enough incentives to use cost-saving clinical decision tools.

Changes to inhaler pricing may be more ‘business as usual’ for the drug industry than the Vermont senator wants to let on. FTC, meanwhile, is keeping the patent pressure on Teva, the only inhaler manufacturer to not act following Sanders’ investigation.

The manufacturer requirement, which invokes CMMI’s safe harbor authority, could help overcome some barriers to access that the companies are facing in Medicaid outside of the demonstration. 

The well-known businessman and TV personality told the White House that the US needs to ‘stop doing business with the big three PBMs,’ helping to fight the drug industry’s battle against the middlemen with a friendlier face not associated directly with the brand industry.

As further details emerge, questions continue about whether the CMMI model could delay access to Lyfgenia and Casgevy; states will be added on ‘rolling basis.’ A new administration could change or cancel the model, but a CMS official predicts that is unlikely.