Marcella Corcoran Kennedy (Offaly, Fine Gael) | Oireachtas source

I thank Deputies Griffin and Rabbitte for raising this issue. The Minister for Health, Deputy Harris, has asked me to extend his apologies for not being available to be here.

I am very aware, as we all are, that access to potentially beneficial drug treatment is an important issue for people with cystic fibrosis and that cystic fibrosis sufferers and their families face enormous day-to-day challenges in dealing with this progressive and debilitating condition. It is important to point out, however, that it is the HSE which has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug scheme, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013, as Deputies are probably aware.

Decisions on which medicines are licensed for use in Ireland and which are reimbursed by taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. It is a team of clinicians, pharmacists, pharmacologists and statisticians that evaluates the benefits and costs of medical technologies and provides advice to the HSE.

It conducts health technology assessments of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making process. Since July of this year, a revised and more transparent assessment process for the reimbursement of new medicines by the HSE has been in place. Importantly, this process includes consideration of the budget impact of individual new medicines, the opportunity cost of the treatment and resources available to the HSE. I understand how patients and their families must feel in the circumstances, as they await decisions from the HSE on reimbursement. However, as with all new drugs developed, the HSE must follow a process.

Orkambi is indicated for the treatment of cystic fibrosis in patients aged 12 years and older who have a particular mutation in the CFTR gene. Following a request from the HSE, the NCPE completed a health technology assessment for Orkambi and submitted to the HSE in June 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness or value for money from using the drug. The NCPE has confirmed that all relevant costs were included in the analysis.

The five-year gross budget impact of reimbursing Orkambi is estimated at more than €390 million and the NCPE noted the significant opportunity costs associated with reimbursing the drug. The biggest barrier to access of such medicines is the price being charged by companies. The HSE has since had further engagements with the manufacturer in an effort to secure significant price reductions for Orkambi. The HSE is considering the outcome of these engagements, together with the NCPE recommendation and other expert advice, in making a final decision on reimbursement. The HSE has advised that the decision will be made on objective, scientific and economic grounds, in line with the 2013 Act.

In regard to Kalydeco, I am informed that, following a request from the HSE, the NCPE carried out an assessment of the manufacturer's economic dossier of ivacaftor, the brand name for which is Kalydeco, for the treatment of cystic fibrosis patients aged two years and older weighing less than 25 kg. In October of this year, the NCPE recommended that Kalydeco should not be reimbursed by the HSE. The five-year gross budget impact of reimbursing Kalydeco is estimated at more than €21 million and the NCPE noted the significant opportunity cost associated with reimbursing the drug.

The HSE will enter into negotiations with the manufacturer in an effort to secure significant price reductions for Kalydeco. The HSE will consider the outcome of these engagements, together with the NCPE recommendation and other expert advice, in making a final decision on reimbursement. As already stated, the HSE has advised that it will make this decision on objective, scientific and economic grounds.

It is appropriate that these should not be political decisions and that a scientific and evidence-based approach is taken in determining the extent to which patients would benefit from treatment with expensive new drugs, the opportunity cost of such decisions on the public service and whether this represents cost-effectiveness for the health service and taxpayer.

It is essential that the HSE has everyone's support in getting the best results for patients.

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