Stephen Donnelly
Ceist:214. Deputy Stephen S. Donnelly asked the Minister for Health the status of measures to expand access to Pembrolizumab to all clinically suitable women with cervical cancer. [3688/19]
Amharc ar fhreagraThursday, 24 January 2019
Ceisteanna (214)
Freagraí scríofa
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. Those measures included medicines which might not be approved for reimbursement including Pembrolizumab, once they are prescribed by the treating clinician.
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, I asked the HSE to examine ways in which other women with cervical cancer could be afforded access to Pembrolizumab if prescribed by their treating clinician.
That examination would have to have regard to the fact that the drug Pembrolizumab does not have a marketing authorisation in Europe and accordingly cannot be considered for reimbursement through the HSE statutory process. Furthermore, any decision would have to have regard to the fact that Pembrolizumab is an off label investigational medicine for the treatment of cervical cancer and that supporting evidence for the use of this drug to treat cervical cancer is limited.
Following discussions between my Department and the HSE, the HSE has put in place arrangements which will 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. 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. The HSE has communicated this approach to hospitals and medical oncologists.
This arrangement will apply to cervical cancer patients only. The statutory responsibility of the HSE for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013, remains unchanged.