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NICE Again Rejects Xarelto, This Time In DVT Indications

 
• By John Davis

U.K. cost watchdog NICE asks for further data on use of Bayer's Xarelto for the treatment and prevention of deep vein thrombosis, having made similar demands at the start of the year on its use in atrial fibrillation.

The National Institute for Health and Clinical Excellence (NICE) says it will reject the use of Bayer AG's oral anticoagulant Xarelto (rivaroxaban) for the treatment and prevention of deep vein thrombosis unless it receives further analyses of the drug’s use in certain subgroups, or as a long-term therapy.

Rivaroxaban, developed in collaboration with Johnson & Johnson which markets it in the U.S., costs 100 times more to acquire than the drugs most commonly used for the condition, warfarin/heparin. Warfarin is available generically in the U.K. for around £2.00 ($3.14) for 28 x 5mg tablets (around a month's supply), while rivaroxaban costs £2.10 per tablet. The cost of rivaroxaban treatment is estimated to be £235.86 for three months therapy, £427.61 for six months and £811

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More from United Kingdom

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

More from Europe

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.