Niall Collins (Limerick County, Fianna Fail) | Oireachtas source

I am taking this matter on behalf of the Minister for Health. I thank Senator O'Reilly for raising this issue. Cystic fibrosis is a devastating disease for patients and their families. With Ireland having one of highest per capitarates of cystic fibrosis in the world, many of us will have been affected by the sadness it can cause for families. Access to effective treatments offers hope to those suffering from this disease, and the Minister aims to make this possible for every patient who needs it.

Kaftrio has been a life-changing drug for cystic fibrosis sufferers. Access to drugs like this was what we expected when the HSE signed its agreement with the drug's manufacturer, Vertex, in 2017. That deal stipulated that our patients would have access to Vertex's whole portfolio of cystic fibrosis drugs for a capped yearly cost. We made a ten-year commitment which has already seen us pay hundreds of millions of euro to Vertex. We entered this agreement in good faith, expecting that as new licences were approved for their medicines, the HSE would receive access at no additional cost. This had been the case previously when new indications were licensed. The agreement was amended in 2019 and 2020 to include these patient groups at no additional cost. However, for this particular subtype affecting a small group of children, Vertex is requesting additional funds to provide access. The HSE has statutory responsibility for the community drug schemes. It has structures in place to ensure our health services are available to provide the right care sustainably.Given the substantial budgetary impact of the additional funds sought by Vertex, it must complete the pricing and reimbursement process that is required in respect of all other medicines. This requires the National Centre for Pharmacoeconomics, NCPE to complete a health technology assessment, HTA, of Kaftrio for this patient group. Until recently, Vertex did not engage with this process. Following extensive efforts from the HSE's corporate pharmaceutical unit, CPU, Vertex supplied its HTA dossier to the NCPE in January 2023. The NCPE has agreed to treat this HTA as a priority. The Minister is pushing to have the HTA completed as soon as possible. In the meantime, the HSE's CPU continues its open dialogue with Vertex and met its representatives on a couple of occasions in January.

The Government is committed to providing access to innovative new medicines for Irish patients. Budgets 2021 and 2022 saw €80 million of funding dedicated to new medicines and 112 new medicines, or expanded uses of existing medicines, 34 of which were for the treatment of rare diseases, were provided since 2021.

I thank Cystic Fibrosis Ireland for its efforts in bringing attention to this situation. It provided valuable insight to the Minister during the meeting late last year. The voices of the parents of these children have also been heard and the Minister fully appreciates their concern. He and I are hopeful that this matter can be brought to a satisfactory conclusion for everyone involved.