Health Technology Assessment
The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.
EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.
If all goes to plan, improvements the national health technology assessment agency wants to make to its drug review procedures – including the tailored, complex and accelerated access reviews – could become effective for applications received in the first half of 2025.
As application of the Health Technology Assessment Regulation nears, the European Commission has launched two new websites to help developers kick start the joint clinical assessment process and request a joint scientific consultation.
The HTA Co-ordination Group will explain how developers can request joint scientific consultations.
Pharmaceutical trade associations warn that demand for joint scientific consultations under the incoming EU Health Technology Assessment Regulation will outstrip supply, which could delay market access decisions for innovative therapies.
The incoming EU Health Technology Assessment Regulation will see historical data move “more center stage” for advanced therapies, because directly comparing highly individualized therapies is often unfeasible, an advanced therapies expert says.
A new methods guide from Canada’s health technology assessment agency should help drug sponsors generate and report appropriate clinical evidence.
Greater transparency around EU health technology assessment processes “can only be a good thing” for innovative rare disease therapies, Virginie Bros-Facer, the new CEO of the EU network of rare disease patient organizations, EURORDIS, tells the Pink Sheet.
NICE, England’s health technology assessment institute, says it was unable to reach a price agreement for AstraZeneca/Daiichi Sankyo’s HER2-low breast cancer drug Enhertu, breaking a line of 21 positive recommendations for breast cancer therapies.
A new, international group of health technology assessment agencies will work together on topics related to health economic methods that could include dynamic pricing and non-traditional ways of evaluating value in cost-effectiveness analyses.
The health technology assessment institute said its “unique insights” could help companies effectively prepare for their appraisals, potentially streamlining their path through the process, and helping to get innovative technologies to patients faster.
While many companies demonstrated an interest in the UK’s licensing and access pathway for innovative medicines, few made use of the various benefits the scheme had to offer, the MHRA said.
The government’s decision for the Pharmaceutical Benefits Advisory Committee to hold an extra meeting in 2025 has been welcomed by Medicines Australia, which says that Australians already wait on average 466 days from the time a medicine is approved to when it is subsidized.
Up to 40,000 people could be set to access Outlook Therapeutics’ Lytenava in England, according to health technology assessment institute NICE, which found the drug for wet age-related macular degeneration had similar health benefits to aflibercept and ranibizumab, and similar costs to aflibercept.
Medicines Australia has expressed skepticism over the Pharmaceutical Benefits Advisory Committee’s claim that in March 2025 it will only be able to assess 32 submissions from companies that want to get their drugs subsidized under the Pharmaceutical Benefits Scheme.
The European Commission has now adopted the third implementing act for the Health Technology Assessment Regulation. This sets out rules for managing conflicts of interest of anyone involved in joint clinical assessments or joint scientific consultations under the regulation.
European cross-country HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.
The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.
The UK’s drug regulator has approved Eli Lilly’s early Alzheimer’s drug Kisunla, but England’s health technology assessment agency NICE said that the product “does not currently demonstrate value” for the National Health Service.