Róisín Shortall (Dublin North West, Social Democrats)
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933. To ask the Minister for Health if immunotherapy drugs, pembrolizumab or nivolumab, will be made available on the medical card to persons with late stage cancers; and if he will make a statement on the matter. [36779/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE applies the same process on an administrative basis to the assessment of hospital medicines.

As Minister for Health, I do not have any statutory power or functions in relation to the reimbursement of medicines.

Immunotherapy drugs such as pembrolizumab and nivolumab are administered in a hospital setting only and all persons ordinarily resident in Ireland are eligible for hospital services as public patients.

Pembrolizumab is currently reimbursed for the following indications:

- as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.

- as monotherapy 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.

The HSE is currently deliberating on the reimbursement of pembrolizumab for the following indications:

- 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

- 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 HSE has commissioned the National Centre for Pharmacoeconomics to conduct Health Technology Assessments in respect of 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.

Nivolumab is currently reimbursed for the following indications:

- as a monotherapy treatment for patients diagnosed with unresectable metastatic melanoma.

- for the treatment of relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin

- for the treatment of advanced renal cell carcinoma after prior therapy in adults.

- for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.

- Nivolumab (Opdivo) plus ipilimumab (Yervoy) for the treatment of advanced melanoma.

The HSE approved nivolumab for reimbursement from 03 September 2018, as a new option for the treatment of locally advanced or metastatic NSCLC after previous chemotherapy in adults.

The HSE is currently deliberating on the reimbursement of nivolumab for the following indications:

- 2nd line use in locally advanced unresectable or metastatic urothelial carcinoma.

- Adjuvant melanoma.