Health Technology Assessment
Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.
Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
The Member State Coordination Group on HTA has also resolved to improve information sharing with drug developers to improve resource planning for EU-level joint clinical assessments.
Pharming has convinced NICE to reverse its rejection of its treatment for APDS by providing the health technology assessment institute with more data. It has also dropped the price it was asking for the drug, which has a list price of £352,000 per year per patient.
The UK drug regulator has made a number of improvements to its innovative licensing and access pathway, including a more “core” role for National Health Service partners, which is expected to facilitate flexible commercial discussions around drug reimbursement.
Cost and evidence gaps remain barriers for Kisunla and Leqembi as NICE rejects the drugs again but opens further consultations on the reimbursement of the Alzheimer's disease-modifying treatments.
Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.
The EU, US and other countries with similar health care systems must “take responsibility” for the financial and health risks involved in getting innovative drugs, such as gene therapies, to market, says an academic expert who has worked in the advanced therapy field.
The health technology assessment institute, NICE, has reversed its rejection of Sobi’s once-weekly drug for preventing and treating severe hemophilia A, meaning that the treatment has now secured reimbursement in three European countries.
Health technology assessment agencies are willing to pay more than usual for advanced therapies that treat rare or severe diseases, but an advanced therapy for a common condition would not qualify for such a modifier, a former senior figure at England’s NICE says.