Dáil Éireann Debate, Wednesday - 27 February 2019
95. Deputy Clare Daly asked the Minister for Health his views on whether a two-tier system of cancer patients has been created by the granting of free access to the cancer drug Pembro to those persons suffering with cervical cancer but not to other cancer sufferers. [9777/19]
View answerAs the Deputy will be aware, the Government decision of 11 May 2018 put in place a package of support measures for the women and families affected by the issues related to CervicalCheck. Those 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.
Following that decision, concerns were raised regarding the provision of Pembrolizumab to other cervical cancer patients on the same basis as encompassed by the Government decision of 11 May 2018. In the light of those concerns, following discussions between my Department and the HSE, the HSE has put in place arrangements, on an exceptional basis, to facilitate access to Pembrolizumab for cervical cancer patients on a case-by-case basis in public hospitals, when a treating clinician determines that this is in the patient’s best interests. It is important to note that all prescribing decisions will be entirely a matter for the treating clinician, in line with patient safety protocols and the Medical Council Guide to Professional Conduct and Ethics.
Pembrolizumab has been granted marketing authorisation in Ireland and the EU for a number of indications and is included on the HSE reimbursement list for some of those indications.
Furthermore, Pembrolizumab is being assessed by the HSE using the criteria in the 2013 Act for a number of other indications for which it has received marketing authorisation.
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.
