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.
The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.
Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.
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.
It is time for a much greater focus on pull incentives to ensure viable market conditions for medicines for neglected diseases that are traditionally regarded as unprofitable.
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.
Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.
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.’
NHS England says it is proposing a “realistic but challenging uptake trajectory” that will make “this clinically and cost-effective drug” available to as many patients as possible without overwhelming health care providers.
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.
Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.
Hemgenix has now secured reimbursement in several European markets, with more talks ongoing. While the path to reimbursement has not always been easy, innovative access deals have helped to smooth the way.
The final Medicare price negotiation guidance for the next cycle includes improvements from last year’s patient listening sessions.
Manufacturers ‘strongly object’ to the possibility floated by the Centers for Medicare and Medicaid Services that it could extend price inflation rebates to Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.
A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.