Finian McGrath (Dublin Bay North, Independent) | Oireachtas source

I thank Deputies Funchion and McGuinness for raising this very important and serious issue. The Deputies described in great detail the sad case of John Holmes.

I wish to inform the Deputies that pembrolizumab is available to public cancer patients in Ireland for a number of licensed indications and is included on the HSE reimbursement list for some of those indications. Furthermore, pembrolizumab is currently being assessed by the HSE, using the criteria as set out in the Health (Pricing and Supply of Medical Goods) Act 2013, for a number of other indications for which it has received marketing authorisation.

The Deputies will be aware that the Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013. This Act gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. The Act specifies the criteria to be applied in the making of reimbursement decisions which 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 and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, it must first submit an application to have the new medicine added to the reimbursement list. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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, NCPE. The NCPE conducts health technology assessments, HTAs, for the HSE and makes recommendations on reimbursement to assist decisions. It uses a decision framework to assess systematically whether a drug is cost effective as a health intervention. Clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for a range of other possible indications which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are granted and applications received by the HSE.

The Deputies will be aware that as an exceptional measure, the Government made a decision in May 2018 to put in place a package of support measures for women and families affected by issues related to CervicalCheck. These measures included medicines which might not be approved for reimbursement, including pembrolizumab, once they are prescribed by the treating clinician. The establishment of such a comprehensive support package reflected the impact of the lack of disclosure of the result of clinical audit and the ensuing controversy on individual women and their families. In January 2019, after careful consideration of the situation which had arisen in respect of patients with cervical cancer who were not encompassed by the terms of the support package agreed by the Government for those affected by the CervicalCheck clinical audit non-disclosure issue, it was agreed the HSE would put in place arrangements to facilitate access to pembrolizumab for cervical cancer patients on a case-by-case basis in public hospitals when a treating clinician determined this to be in the patient’s best interests. The Minister for Health has no role in how doctors manage or the care of individual patients. All prescribing decisions are entirely a mailer for the treating clinician, in line with patient safety protocols and the Medical Council guide to professional conduct and ethics.

Additional information not given on the floor of the House

The Deputies may also be aware that on 29 March 2019, the VHI sent a circular to oncologists advising them that it was extending cover to a number of new cancer medicines, including pembrolizumab. This decision by the VHI applies only to private care for VHI private patients in private hospitals and will have no impact on the provision of care in public hospitals. The effect of the VHI decision will be that VHI private patients in private hospitals may have access to a medicine not yet available in the public hospital system. A number of the medicines or indications which the VHI has now decided to cover are at various stages of the HSE assessment and reimbursement process in accordance with the provisions laid down in the 2013 Act.

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