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NICE Price: Zytiga On Track In England After Discount

 
• By Faraz Kermani

Janssen’s decision to offer the NHS a discount for its oral prostate cancer treatment Zytiga appears to have paid off, giving the drug a boost and head start over potential rivals in the EU.

The second time turned out to be the charm for Janssen Inc.’s Zytiga (arbiratone): on May 16, the National Institute for Health and Clinical Excellence of England reversed its negative recommendation for the second-line treatment for castration-resistant metastatic prostate cancer. Unsurprisingly, a significant discount appears to have done the trick for Janssen and – together with the recent positive decision from Germany’s IQWiG – catapults the drug towards securing a meaningful portion of the European prostate cancer market.

Whilst NICE’s change of heart in the Final Appraisal Determination appears to be a giant U-turn, the reality is that a positive recommendation was always plausible, provided Janssen was prepared...

More from Europe

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

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.

More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.