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Janssen Secures Only Partial Win In Appeal Against English Funding Snub For Spravato

 
• By Neena Brizmohun

Of the nine specific appeal points raised against NICE’s rejection of the company’s antidepressant nasal spray, Spravato, just one was upheld.

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There is an unmet need for effective treatment options for treatment-resistant depression in England • Source: Shutterstock

England’s health technology assessment institute NICE failed to act fairly when it rejected Janssen’s depression nasal spray, Spravato (esketamine), because it did not explain fully how the uncertainties in the evidence were taken into account in its decision making, an independent appeal panel has ruled.

NICE’s appraisal committee is to reconvene next month to address this point, although it is not obliged to change the final appraisal document (FAD) it issued in May, which recommended against making Spravato available on the National Health Service in England for treatment-resistant major depressive disorder (TRD)

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More from United Kingdom

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

 
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• 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.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

More from Europe

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.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.