Update on Kalydeco – initial decision on innovative CF drug due in Mid-January 2013
As you know from the CFAI Spectrum
Magazine, the CF drug KALYDECO, also known as Ivacaftor, is currently being assessed in Ireland by the National Centre for Pharmaeconomics (NCPE). This process is known as a ‘Health Technology Assessment’ (HTA).
The CFAI recently met with the NCPE in a constructive meeting that provided us the opportunity to highlight once again the importance of KALYDECO for our members, especially those people with CF who have the G551D gene alteration.
The NCPE in turn let us know that the HTA is still in progress and they welcome the submissions and representations that have already been made from a patient perspective. The NCPE have also let us know that a decision on KALYDECO will be made in mid-January 2013.
Just to remind you, the HTA undertaken will determine if the NCPE/HSE considers:
- KALYDECO to be effective
- Whether the HSE will pay for KALYDECO, based on an assessment of the cost effectiveness of the drug.
Types of Decisions Open to the NCPE
As explained in our recent information seminars, it should be noted that the NCPE can make either a positive or a negative decision in mid-January. While we would hope of course for an initial positive verdict, we are also prepared for an initial negative decision by the NCPE. It should be noted that an initial negative decision is not a final verdict and will very likely trigger a second negotiating process whereby the NCPE/HSE will either:
- Seek to ensure the pharmaceutical company reduces the costs it seeks to charge for KALYDECO or
- A ‘shared risk’ agreement is negotiated whereby (for example) the company is only reimbursed for those patients with the G551D alteration that are proven to benefit from the new drug.
CFAI will keep you updated on further developments in January. For further background information on KALYDECO, see page 4 of the September/October edition of Spectrum.
CFAI again calls for our patients to have access to this drug, but also calls for a fair price to be negotiated between the HSE/NCPE and the pharmaceutical company Vertex.