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European HTA Round-Up: NICE Focuses On Cost Effectiveness, IQWiG On Clinical Benefit, But Convergence May Come

 
• By Faraz Kermani

It is becoming increasingly clear that NICE and IQWiG have very different concerns on the reimbursement front, but it is only a matter of time before IQWiG gets its teeth into cost-benefit analyses

Differing decisions on prostate cancer therapies between the UK’s National Institute for Health and Clinical Excellence and Germany’s Institute for Quality and Efficiency in Healthcare highlight the different evidence base between the two health technology assessment authorities – but that could all change later this year when IQWiG expands its assessments to consider cost.

NICE is not likely to recommend Janssen Inc.’s Zytiga for castrate-resistant metastatic prostate cancer because it is too expensive...

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More from Europe

England Prioritizes SGLT-2s & GLP-1s In Diabetes Market Access ‘Shake Up’

 
• By Neena Brizmohun

Recommendations from the health technology assessment institute, NICE, reflect a strategic shift from treating type 2 diabetes to proactively preventing future complications of the condition.

UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments

 
• By Vibha Sharma

Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

More from Geography

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

Zimbabwe Tackles Medicines Falsification With New Requirements For Pharma

 
• By Neena Brizmohun

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.