Coinsurance for Part B drugs may reflect rebates by April, and sponsors are already liable for them, but payments will be delayed several years as CMS develops its systems. Agency seeks comment on how to account for 340B discounts and make allowances for drug shortages, among other issues.
The Centers for Medicare and Medicaid Services will not begin sending out invoices for price inflation rebates owed by manufacturers on Parts B and D drugs until 2025 even though rebate liability has already begun, according to the agency.
The delay in releasing invoices is allowed by the Inflation Reduction Act, which established the rebate program, and will give...
The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.
A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
