Health Technology Assessment
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.
The health technology assessment institute said its recommendation for the multiple sclerosis drugs, Tysabri and Tyruko, highlighted its continued efforts to drive the adoption of biosimilars across the National Health Service.
Deputy chief Jonathan Benger moves up to become NICE’s fourth-ever CEO. While the face may be familiar, the challenges are anything but as the HTA body has launched a new joint scientific advice process with the MHRA and will implement new cost-effectiveness thresholds driven by a US trade deal.
A new value set to be used by UK health technology appraisal body NICE is expected to impact the cost-effectiveness of some medicines and make room for higher drug prices.
New UK Cost-Effectiveness Thresholds Will Not Mean A Reprieve For Drugs Already Denied Reimbursement
Some companies in the UK undergoing a health technology appraisal by the HTA body, NICE, will see reimbursement recommendations for their products paused in the run up to the implementation of higher cost-effectiveness thresholds.
Under the newly-announced UK-US trade deal, the UK will increase the thresholds used to evaluate the cost-effectiveness of new medicines, which should allow higher prices for innovative therapies.
While there is a general shift towards alignment and collaboration in health technology assessments in the EU under the new HTA Regulation, member states still have “their own recipe” when it comes to making reimbursement decisions.
While the volume of questions that companies have received from the EU member states under the Health Technology Assessment Regulation has been lower than expected, some firms are struggling with the comparator analysis required to answer some questions, an expert says.
England is set to become the first market outside of the US where Autolus’ CAR-T therapy Aucatzyl is reimbursed for acute lymphoblastic leukemia, after the country’s health technology assessment institution, NICE, recommended its use for certain patients.
As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.
Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”
Rare disease drugs with limited evidence are most likely to be awarded a negative reimbursement recommendation in Denmark following a QALY-based health technology assessment, finds an analysis from industry group LIF.
An early negotiation process for certain cancer drugs could cut pricing negotiation times by up to six months, while a targeted process for non-complex drug negotiations could lead to timelines that are 30–45% faster than standard negotiations.
Making use of regulatory pathways such as fast-track designation, accelerated approval and conditional marketing approval can “really appeal to investors” and can help secure funding for clinical trials, says the CEO of rare disease biotech SynaptixBio Dan Williams.
A French spending bill that would tax drug company turnover would create a “catastrophic competitiveness gap” between France and its European neighbors, warns Leem, the French pharmaceutical industry group.
Economic woes in France mean that tough and unpopular choices impacting the biopharmaceutical industry are inevitable, according to industry expert Alexandre Regniault.
More light has been shed on how a new parallel health technology assessment and regulatory decision-making pathway in England will work in practice, and what requirements companies will need to meet to benefit from the scheme.
The trade body, Medicines Australia, has flagged a downturn in new drug launches, attributing it to the effects of President Trump’s trade policies. It has called for “urgent action.”