Health Technology Assessment
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.
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.
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.
European pricing and reimbursement processes, including in the UK, are on hold for now.
Standing “shoulder to shoulder” can help alleviate difficult global market conditions, according to the Joint Nordic HTA Body.
Joint scientific consultations are an important opportunity for companies to seek advice on how to optimize their clinical research for joint clinical assessments under the Health Technology Assessment Regulation, although the number of slots available remains too low.
Immedica’s Loargys is set to become the first disease modifying treatment for arginase 1 deficiency to be reimbursed in England. Meanwhile, the US regulator is reviewing a resubmitted marketing application for the product and has set a target action date of Feb. 23.
Revelations about a big underspend on England’s Innovative Medicines Fund for promising new non-oncology medicines have prompted calls for more transparency about how the money is allocated and how the fund is administered.
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.
The Pink Sheet’s investigation into England’s Innovative Medicines Fund has prompted calls for change from patients and industry representatives.
Challenges with identifying eligible patients within the England’s National Health Service care pathway meant there was insufficient evidence to support a full reimbursement application for Rozlytrek to treat NTRK fusion-positive solid tumors, Roche has said.
The trade association Medicines Australia has set out key priorities for the government’s upcoming budget announcement in light of worsening access to innovative medicines for Australian patients.
External reference pricing is one of several drug pricing control measures used by a number of countries to contain drugs prices.
The UK-US trade deal offers the “the most encouraging signs the industry has seen for many years,” but UK companies had little influence over it and details are still scarce, according to one industry expert.
England’s health technology assessment institute, NICE, is soon to increase the thresholds used to evaluate the cost-effectiveness of new medicines – a lawyer cautions that even with the uplift, some new drugs may still struggle to secure reimbursement in the region.
Products likely to be subject to evidence generation agreements under England’s Innovative Medicines Fund are those that are costly and which serve a low number of patients. Orphan drugs appear most likely to receive interim funding through the IMF.