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Alexion’s Costly Soliris For AHUS Raises “Cost Of Life” Issues At NICE

 
• By Faraz Kermani

NICE is undeniably impressed with Alexion’s Soliris for treating aHUS but wants more data to justify its eye-watering price tag.

A new, highly effective but exceedingly expensive drug for treating a rare blood disorder has posed the key question of how much Britain is prepared to pay to extend life and improve its quality. Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) can offer over 10 years − perhaps even significantly more − a good quality life extension to sufferers of the rare disease atypical hemolytic uremic syndrome, but costs an astronomical £340,200 ($567,200) in the first year of treatment, says reimbursement watchdog NICE.

Admittedly, this price includes initial treatment at a dose of 900 mg for 4 weeks, then maintenance treatment at a dose of 1200 mg on week 5 and then every...

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More from Europe

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
• By Lauren Flynn Kelly

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.