Dáil Éireann Debate, Tuesday - 24 July 2018
1549. Deputy Richard Boyd Barrett asked the Minister for Health if he has announced that some women with cervical cancer will receive free access to the drug Pembrolizumab while the HSE confirms that other women with cervical cancer will not get free access to this drug; if he will address a matter regarding the case of a person (details supplied); and if he will make a statement on the matter. [33373/18]
Amharc ar fhreagraAs part of its response to the controversy surrounding CervicalCheck, the Government agreed to put in place a package of support measures for those women affected and their families. 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 includes 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.
The establishment of such a comprehensive support package was an exceptional measure that reflected the impact of the lack of disclosure of the result of clinical audit and the ensuing controversy on individual women and their families. 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.
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). Pembrolizumab is currently reimbursed for the following indications:
- Pembrolizumab (Keytruda) as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
- Pembrolizumab (Keytruda) as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
I have been informed by the HSE that they are currently deliberating on the following indications for reimbursement:
- Pembrolizumab (Keytruda) as a monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
- Pembrolizumab (Keytruda) as a monotherapy for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving Keytruda.
The NCPE recently completed a health technology assessment (HTA) for the latter indication and recommended that pembrolizumab (Keytruda) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. The HSE will now evaluate this application for reimbursement in line with criteria laid out within the 2013 Act before making a final reimbursement decision.
In addition to this, the HSE have commissioned HTAs on the following indications:
- Pembrolizumab (Keytruda) for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
- Pembrolizumab (Keytruda) as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
There are no other indications for Pembrolizumab approved in the European Union at this time.
It would be inappropriate for me to comment on the case of an individual patient, although I would note that Section 6 of the HSE Governance Act 2013 precludes me from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
