1. Pink Sheet
  2. >>Geography
  3. >>Europe

Europe: Cross-Country HTA of Gene Therapy Libmeldy Calls For Price Cut

 
• By Francesca Bruce

Joint price negotiations for Orchard’s gene therapy Libmeldy could follow outcome of multi-country health technology assessment.

Europe
European countries join forces on Libmeldy HTA • Source: Shutterstock

Orchard’s one-time gene therapy Libmeldy (atidarsagene autotemcel) should only be reimbursed if the company offers a significant price reduction, concludes a health technology assessment (HTA) report from BeNeLuxA, a cross-country initiative in Europe focused on access to medicines. Joint pricing and reimbursement negotiations between Orchard and three countries over what is reported to be the world’s most expensive drug could now follow.

BeNeLuxA aims to make access to medicines more sustainable through cooperation on HTA, pricing and reimbursement, policy exchange and horizon scanning. It is made up of Belgium, the Netherlands, Luxembourg, Austria and Ireland. Only Ireland, the Netherlands and Belgium joined forces for this assessment of Libmeldy, for treating children with metachromatic leukodystrophy (MLD), which is a rare, life-limiting neurodegenerative disorder

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

More from Geography

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.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.