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

I am taking this matter on behalf of the Minister for Health. I thank Deputy Troy for raising this important issue.

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 manufacturer, Vertex Pharmaceuticals, in 2017. The deal stipulated 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 that 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 Kaftrio's medicines, the HSE would receive access at no additional cost. This has 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 sub-type that affects 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 service is able 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 of all other medicines. This requires the NCPE to complete a 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, Vertex supplied its HTA dossier to the NCPE last month. The NCPE has agreed to treat this HTA as a priority case. The Minister is pushing to have the HTA completed as soon as possible. In the meantime, the HSE's corporate pharmaceutical unit continues its open dialogue with Vertex and met the company a couple of times 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. Some 112 new medicines, or expanded uses of existing medicines, of which 34 were for the treatment of rare diseases, have been provided since 2021. I thank Cystic Fibrosis Ireland for its efforts in bringing attention to this situation. The organisation provided valuable insight to the Minister during their meetings late last year. The voices of parents and of these children have also been heard and the Minister fully appreciates their concern. He and I are hopeful this situation will be brought to a satisfactory conclusion for everyone shortly.

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