Pricing Debate
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.
Although the FTC’s administrative complaint focuses only on insulins, the commission hopes it will have a broader impact by driving reforms of rebate and contracting practices for other drugs as well.
The Pharmacy Benefit Management sector remains nearly universally unpopular with both Democratic and Republican lawmakers in the US. But a September 11 hearing stands out as an event where at least the witnesses suggested that there is value in the PBM business model.
The new US Medicare drug price negotiation authority got a brief mention during the 10 September presidential debate, not that anyone is likely to be talking about it afterwards.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Industry says it is ready to work with the government on the recommendations from a major review of Australia’s health technology assessment system that covers areas such as discount rate reductions and setting up a separate budgetary allocation to temporarily subsidize access to certain drugs.
CBER Director Peter Marks said recent leaps in gene therapy science have not been matched by more affordable manufacturing technology and that the field needs to set a cost-effectiveness target.
The World Health Organization says its new 98-page guidance dealing with wastewater and solid waste management for antibiotic manufacturing is a first of its kind and addresses an important but neglected issue.