England Reimburses Ultra-Rare Disease Drug Joenja, While EU Regulatory Review Drags On

Pharming has convinced NICE to reverse its rejection of its treatment for APDS by providing the health technology assessment institute with more data. It has also dropped the price it was asking for the drug, which has a list price of £352,000 per year per patient.

Close-up shot of pills with stamped pound sterling GBP symbol on them
NICE believes that Joenja is cost-effective
Key Takeaways
  • Joenja has secured reimbursement in England for the treatment of people aged 12 years and over with the ultra-rare immune disorder, activated phosphoinositide 3-kinase delta syndrome.
  • NICE, England’s health technology institute, said that Pharming had addressed its uncertainties about the product that had previously led to it rejecting the drug.
  • It was able to apply quality-adjusted life year (QALY) weighting that increased the threshold at which the treatment could be considered a cost-effective use of National Health Service resources, from £100,000 per QALY to around £180,000.
  • Joenja, which is approved for marketing in the UK, the US and Israel, is experiencing a protracted regulatory review in the EU.
  • Marketing applications are under review in other countries.

England has become the first European country to agree to reimburse Joenja (leniolisib), Pharming’s ultra-rare immune disorder drug, which received UK marketing approval last September but is undergoing a protracted...

Joenja, for treating people aged 12 years and over with activated phosphoinositide 3-kinase delta syndrome (APDS), was recommended for use via England’s National Health Service...

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