A new survey of French healthcare professionals reveals concerns that France is increasingly being excluded from major international clinical studies.
Japan's regulatory authorities recommend approval of products including a cell therapy, while setting reimbursement prices of newly approved drugs and cutting some others following cost-effectiveness assessment.
Although the legislation has little chance of passing, it offers some clues about the administration's goals for MFN agreements, which differ from the voluntary deals struck with large pharma companies.
The expansion of the US Medicare drug price negotiation to include Part B products for the first time should be a very big deal, but the impact is not going to be significant in the first year and maybe future years.
Norway’s pharmaceutical industry association says it is waiting to hear from the ministry of health about how it will address the country’s low willingness to pay for innovation.
CMS also outlined eligibility criteria for patients with a body mass index of 27, 30 and 35 or more for the demonstration project planned in Medicare and Medicaid.
CMS is proposing enhanced payments for hospitals that commit to purchasing essential medicines from domestic sources, but wants ideas for defining a “domestic” medicine.
The agency may be prepared to discuss broader voluntary Most Favored Nation agreements with small and mid-size firms during April meetings about the GENEROUS model.
At BIO’s Investor and Growth Summit, panelists said Most Favored Nation pricing in the US is forcing biopharma companies to scrap plans to to out-license ex-US rights to their drugs, a previously common practice.
The CMS proposal to assign liability to manufacturers despite licensing arrangements reflects the agency’s concern that companies will try to game the models.
Trump touted his "big achievement" on drug pricing during his State of the Union address and did not imply other reforms are coming.
The move is aligned with a growing industry shift toward lowering list prices to current net pricing levels and eliminating rebates.
The first round of price caps imposed via Medicare negotiation have taken effect, but if the leading target is any indication, industry appears able to handle the consequences.
SGLT-2 inhibitors should be used to treat patients with type 2 diabetes much earlier in their treatment, the English health technology assessment institute said, adding that using generic dapagliflozin would save the National Health Service £560m.
CMS’ explanation of the process for arriving at the maximum fair prices for 15 Medicare Part D drugs scheduled to be implemented in 2027 still was general and opaque with significantly redacted documents.
The Trump administration has launched TrumpRx, a website the White House says could help save Americans billions in pharmaceutical spending, although it does not itself sell or dispense drugs.
The sales opportunity in Medicare Part D and Medicaid arrives as Lilly and Novo Nordisk face a new competitive threat from compounded semaglutide for obesity.
The US Labor Department also added a proposed rule requiring PBMs to disclose additional compensation information to certain employer-plan sponsors.
The HHS OIG advisory pertains to manufacturer sales to patients. OIG will seek stakeholder input regarding possible additional guidance on manufacturer arrangements with pharmacies, pharmacy benefit managers, telemedicine vendors and marketers.
The process will pit breast cancer treatment competitors Kisqali and Verzenio against each other as CMS develops pricing offers.