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Health Technology Assessment

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

‘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.

Transnational Collaborative Health Tech Assessments Have Much To Offer

Transnational Collaborative Health Tech Assessments Have Much To Offer

European cross-border HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, say Nordic health technology assessment experts. Talks on HTA collaborations outside Europe are also underway.

Australian Industry Strikes Deal On Deferred PBS Submissions, Challenges Govt's Capacity Claim

Australian Industry Strikes Deal On Deferred PBS Submissions, Challenges Govt's Capacity Claim

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.

Nordic HTA Body Tells Pharma Users: ‘Feel the Fear And Do It Anyway’

Nordic HTA Body Tells Pharma Users: ‘Feel the Fear And Do It Anyway’

It is time for companies to take part in cross-country health technology assessments and stop only asking “what’s in it for me?”

Has Competition Reassurance Helped Counter Combination Woes In The UK?

Has Competition Reassurance Helped Counter Combination Woes In The UK?

The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.

EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group

EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group

Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.

Spain Consults On HTA Regulations

Spain Consults On HTA Regulations

New rules on health technology assessments in Spain make room for real-world evidence and early dialog.  

EU HTA Regulation: Views Wanted On Draft Rules On Joint Scientific Consultations

EU HTA Regulation: Views Wanted On Draft Rules On Joint Scientific Consultations

A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.

England’s NICE Says Severity Modifier Working, But Industry Wants Cost Restrictions Lifted

England’s NICE Says Severity Modifier Working, But Industry Wants Cost Restrictions Lifted

The UK government should remove a cost-neutrality restriction on England’s health technology assessment institute, NICE, that limits the value it places on medicines for severe conditions, says industry body the ABPI.

EUCOPE: EU Pharma Reform Positive, But Industry Needs Clearer Definitions

EUCOPE: EU Pharma Reform Positive, But Industry Needs Clearer Definitions

High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.