Health Technology Assessment

Gene Editing Therapy Casgevy Now Funded In 8 Countries But French Access Withdrawn

 

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.

EU HTA: Submission Period For Joint Scientific Consultations Goes Live

 

Competition to win a coveted joint scientific advice slot will be fierce due to the limited number available.

UK’s MHRA Revamps Innovative Pathway And Tightens Entry Criteria

 

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.

Belgian Agency To Lead EU Joint Clinical Assessments Under HTA Regulation

 

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.


England’s NICE Leads Global Effort On Surrogate Endpoints For Cost-Effectiveness

 

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.

Spain Bets On New Pharmaceutical Strategy To Boost Access And Innovation

 

The strategy includes a committee made up of pharmaceutical industry representatives and ministers to discuss the impact of regulatory proposals.

UK’s MHRA To Offer Private Meetings For Innovative RWE Strategies

 

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.

Game-Changing EU-Level HTA Regs Must Allow For Lessons To Be Learned

 

EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.


Revamped Drug Reimbursement Reviews Expected In Canada Soon

 

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.

EU Adopts New Procedural Rules To Guide Joint Scientific Consultations For HTA

 

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.

EU HTA-Coordination Group Prepares For New Wave Of Joint Clinical Assessments In 2025

 

The HTA Co-ordination Group will explain how developers can request joint scientific consultations.

EU HTA Regulation: Lack Of Scientific Consultation Capacity ‘Concerning’

 

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.


Why Historical Data Will Be Important Under The New EU HTA Regulation

 

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.

Canadian HTA Agency Consults On First Methods Guideline

 

A new methods guide from Canada’s health technology assessment agency should help drug sponsors generate and report appropriate clinical evidence.

EU HTA Regulation A Positive Move For Rare Disease Therapies, says EURORDIS Chief

 

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.

England’s Funding Rejection For Enhertu At Odds With 19 European Countries

 

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.


HTA Bodies In England, US and Canada Collaborate On Developing Health Economic Methods

 
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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.

England: NICE Finds Its Advice Can Cut Drug Appraisal Times By Three Months

 

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.

UK MHRA’s ILAP: High Interest But Low Uptake Of Benefits

 

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 Right Call:’ Australia’s PBAC Addresses ‘Unprecedented’ Backlog With Extra Meeting

 

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.