Health Technology Assessment
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.”
The proportion of AMNOG benefit assessments leading to a positive rating, which has a direct impact on drug pricing, has decreased in recent years, according to analysis from the VFA, the association representing the German pharmaceutical industry.
The National Health Service said the roll out of ViiV Healthcare’s Apretude would bring England closer to its aim of becoming the first country in the world to end HIV transmissions by 2030.
The UK’s commercial environment is “incredibly strained,” meaning that there is little money left to pay for innovative medicines. The ABPI’s chief executive says a “fundamental transformation” will be required to drive necessary changes.
A new US-UK partnership could mean companies benefit from higher UK drug prices.
Revision of the EU’s pharmaceutical legislation will include a new definition of unmet need, but getting it wrong could have unintended consequences for pricing and reimbursement.
European regulators could investigate alternative ways of offering early advice to companies in relation to the Health Technology Assessment Regulation, given that official scientific advice slots are limited, a senior figure at EUCOPE says.
More than half of drug marketing authorization applicants whose products fell within the scope of the Health Technology Assessment Regulation this year failed to communicate with the HTA Secretariat as required, a senior figure at the European Medicines Agency says.