Health Technology Assessment
The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.
France’s health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures.
Manufacturers should make use of joint scientific consultations under the EU Health Technology Assessment Regulation, but they must pay close attention to the selection criteria as consultation slots are limited, experts say.
HAS, the French health technology assessment body, has issued positive recommendations for several orphan drugs, including for Vyloy, which was provisionally rejected for reimbursement in the UK last year.
The European Commission has released three exercises to help pharma companies prepare for joint clinical assessments under the new EU Health Technology Assessment Regulation. Experts explain how manufacturers should interpret these and what their limitations are.
Company dossiers submitted for EU-level joint clinical assessments under the Health Technology Assessment Regulation will be made public. This could conflict with other strategic business decisions and should be planned for in advance, experts say.
The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.
Competition to win a coveted joint scientific advice slot will be fierce due to the limited number available.
Companies that are admitted to the UK’s revised innovative licensing and access scheme will be mandated to work with the regulator on developing a target development profile for their product.
The Belgian health technology assessment agency will also lead on joint scientific consultations, which will be instrumental in helping companies submit appropriate dossiers for joint clinical assessments.
Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.
The strategy includes a committee made up of pharmaceutical industry representatives and ministers to discuss the impact of regulatory proposals.
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.