The HSE has statutory responsibility for medicine pricing and reimbursement decisions in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013 which specifies the criteria for decisions on the reimbursement of medicines.
Before any medicinal product can be assessed for reimbursement by the HSE, it is required to have been granted a marketing authorisation by either the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) in accordance with the criteria under the 2013 Act.
In that respect, 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.
However, Pembrolizumab has not been granted a marketing authorisation by either the EMA or by HPRA for the treatment of cervical cancer and accordingly, in accordance with the 2013 Act, it cannot be assessed by HSE for reimbursement for cervical cancer, using the standard criteria.
The Deputy will be aware that a 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. As part of this package, all out of pocket medical costs incurred by the women affected will be met to the extent that they are not already covered either under existing public schemes or any private health insurance policy that an individual might hold. This commitment included medicines which might not be approved for reimbursement, once they are prescribed by the treating clinician. Although not specifically referenced, Pembrolizumab would be encompassed under this aspect of the support package.
I am aware of the concerns raised by the Deputy and other public representatives regarding the question of providing Pembrolizumab to other cervical cancer patients on the same basis as encompassed by the Government decision of 11 May 2018. In the light of these concerns, I have requested the HSE to examine ways in which other women with cervical cancer could be afforded access to Pembrolizumab if prescribed by their treating clinician.
This is not a straightforward matter and there is a range of issues to be addressed in pursing such an approach. These include the question of supply of the product and any terms (including financial ones) under which it might be supplied, the cooperation of the clinical community and the development of appropriate governance and management arrangements, the method of selection of patients suitable to commence treatment and the criteria that would govern clinical decisions in respect of continuation or discontinuation of treatment. Any proposals must place patient safety as a priority, given that this is not a licensed medicine for the treatment of cervical cancer.
I too am anxious to see early progress in this matter and I have asked the HSE to revert to me as a matter of urgency.