Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

I apologise for the inability of the Minister for Health to be here for this debate. Deputy Kelly could have withdrawn his Topical Issue if he had wished. I have been asked to respond to him on behalf of the Minister. I will read the reply that has been furnished to me. If the Deputy is not happy with it, I am sure some other arrangements can be made.

I thank him for raising this issue. The Minister appreciates that cancer diagnoses place enormous stress on patients and their families. Sadly, very few people in Ireland have been untouched by cancer. Access to potentially beneficial medicines for cancer treatment is an extremely important issue for people. The Oireachtas put in place a robust legal framework when it agreed the Health (Pricing and Supply of Medical Goods) Act 2013, which gives the HSE full statutory power to assist in making decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. The 2013 Act specifies the criteria to be applied when reimbursement decisions are being made. Those criteria include the clinical and cost-effectiveness of the product, the opportunity cost and the impact on resources available to the HSE. In line with the 2013 Act, a company that would like a medicine to be reimbursed by the HSE, must first apply to have the new medicine added to the reimbursement list.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds on the advice of the National Centre for Pharmacoeconomics, which conducts health technology assessments for the HSE and makes recommendations on reimbursement to assist decisions. The National Centre for Pharmacoeconomics uses a decision framework to assess systematically whether a drug is cost-effective as a health intervention. The drug mentioned by Deputy Kelly, pembrolizumab, is reimbursed for four indications: advanced melanoma in adults, first-line treatment for non-small-cell lung cancer, advanced melanoma in adults with combination therapy, and Hodgkin's lymphoma. The HSE has commissioned health technology assessments on the use of this medicine for two other cancers. When the output of this process for each of the additional indications is available, it will be considered by the HSE under the statutory process. The HSE is also deliberating on one further indication for reimbursement. In May 2018, a Government decision put in place a package of support measures for women and families affected by issues relating to CervicalCheck. As part of this package, all out-of-pocket medical costs incurred by the women affected may be met if they are not already covered under existing public schemes or by private health insurance. This exceptional commitment includes medicines which might not be approved for reimbursement, as long as they are prescribed by the treating clinician. Therefore, pembrolizumab would be encompassed under the support package if it is prescribed by a woman’s consultant.

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