Weight loss drugs have likely proven to be the most challenging medicines to introduce to the National Health Service in England, and lessons should be learned in preparation for other game changing products.
Canada’s Drug Agency is also looking to consider the impact on productivity outcomes for both patients and informal caregivers when assessing the value of a drug.
According to the health technology assessment institute, NICE, new cost-effectiveness thresholds – which are higher than those that applied when the original decisions were made – will apply when its committee reconsiders the appraisals for Eisai and Eli Lilly’s Alzheimer’s disease drugs.
The EU remains a major global player in biopharma but needs to act quickly or risk falling further behind its rivals, according to EFPIA.
A US lawmaker described program reform goals as returning the program to its original focus on supporting federally qualified health centers and rural hospitals.
Smaller biotech companies without the regulatory resources of big pharma should approach the UK medicines regulator and health technology appraisal body for early, informal discussions on how to generate the right evidence.
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.
England’s health technology institute, NICE, said that Astellas’ non-hormonal drug for menopausal hot flushes, Veoza, should be funded for use via the National Health Service and that the drug addresses a “real and important” need for people who cannot take hormone replacement therapy.
Leem, the French industry association, is reaching out to patients, carers and the general public with the aim of building better policies to improve access to medicines and ensure the pharmaceutical industry is competitive.
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.
Japan's regulatory authorities are implementing a number of updates and revisions to the national drug law in measures designed to address shortages of high-demand products and clarify guidance in areas including conditional approvals.
The program could increase the momentum for establishing a new model for employer-sponsored insurance coverage.
European pricing and reimbursement processes, including in the UK, are on hold for now.
A regulatory sandbox and greater global harmonization will not only improve pathways for Indian cell and gene and other advanced therapies to reach the UK’s National Health Service but also speed up approvals in India
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.