Ivacaftor (Kalydeco®)

Assessment Status Assessment process complete
Drug Ivacaftor
Brand Kalydeco®
Indication For the treatment of cystic fibrosis in patients age 6 years and older who have the G551D mutation
Assessment Process
Rapid review commissioned 13/08/2012
Rapid review completed 22/08/2012
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 24/10/2012
NCPE assessment completed 21/01/2013
NCPE assessment outcome Reimbursement not recommended at the submitted price

21 January 2013

In view of the very high acquisition cost (€234,804 per patient per annum), the significant budget impact (approximately €28 million per annum) and the inability of the manufacturer to demonstrate cost-effectiveness the NCPE cannot recommend reimbursement of ivacaftor at the submitted price.

Technical Summary

01 February  2013

The NCPE recommendation led to follow-up discussions between the HSE Corporate Pharmaceutical Unit and the company, Vertex Pharmaceuticals. Following these discussions a positive recommendation was made by the HSE Drugs Group, supporting the provision of ivacaftor (Kalydeco®) for Irish CF patients, whilst at the same time significantly reducing the budget impact of the drug.