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HHS Secretary Alex Azar on Monday plugged the Trump administration’s efforts to bring some daylight to prescription drug rebates through proposed “transparent and upfront discounts” that go directly to the patients. Read More
Any amendments must be submitted electronically even if the original submission was submitted prior to implementation of the electronic submission requirements, the agency said. Read More
The group called for an update to the “outmoded” Part D requirement that plans cover two drugs per class, claiming that the requirement has created an incentive for drugmakers to drive up Part D costs. Read More
Approximately 65,000 residents of the state live with chronic hepatitis C virus, and about 30,000 are covered by state-purchased health care insurance. Read More
While the FDA shot down Keryx Biopharmaceuticals’ request for five-year new chemical entity (NCE) exclusivity for its Auryxia (ferric citrate) oral tablets, it OK’d the drugmaker’s petition for three-year exclusivity. Read More
PhRMA said it “strongly opposes” the proposed changes to the protected-classes policy, claiming it would be unlikely to result in significant savings and would be inconsistent with Medicare Part D’s non-discrimination protections. Read More
Spread pricing has previously been targeted by states such as Ohio, which forced PBMs contracted by its Medicaid program to scrap spread pricing models. Read More
Cancer drug sponsors should consider informing the public about pricing and reimbursement decisions, including the rationale behind them, as well as reporting R&D and any public funding sources, WHO suggests. Read More
“It is vital that Government makes minimizing disruption to the medicines supply the highest priority as it prepares for a potential hard or disorderly… Read More
Insurers and hospitals will be allowed to pay drugmakers based on the effectiveness of their products, if a bipartisan Senate bill that amends the Social Security Act is passed. Read More
The European Medicines Agency began a six-month public consultation Thursday for draft principles on a common EU standard for human drug electronic product information. Read More
HHS released a proposed rule on Thursday that would target “backdoor” rebates between drugmakers and pharmacy benefit managers (PBMs), restructuring the rebate system to pass the discounts directly on to consumers. Read More