| Assessment Status | Assessment process complete |
| HTA ID | - |
| 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.
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.