Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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537. To ask the Minister for Health if the approval of the drugs Nivolumab and Pembrolizumab will be expedited in order to prolong the life of certain cancer patients and in particular in the case of a person (details supplied); if they will be made VAT exempt and tax allowable in the circumstances in which a patient has no option but to self fund these drugs; and if he will make a statement on the matter. [30314/18]

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. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. In addition, 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. It would be inappropriate to comment on the cases of individual patients.

In Ireland the majority of patients’ access medicines through the publicly funded Community Drug Schemes.

In line with the Health (Pricing and Supply of Medical Goods) Act 2013, if a company would like a medicine to be reimbursed by the HSE and available through the community drugs schemes, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.

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 National Centre for Pharmacoeconomics (NCPE) completed a health technology assessment on 28 May 2018 for the latter indication. They 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. Clinical trials are ongoing globally in relation to 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 received.

Nivolumab is currently reimbursed for the following indications:

- Nivolumab (Opdivo) for monotherapy treatment for patients diagnosed with unresectable metastatic melanoma.

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

- Nivolumab (Opdivo) for the treatment of advanced renal cell carcinoma after prior therapy in adults.

- Nivolumab (Opdivo) 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 Department has been informed by the HSE that the following indications are currently in process for reimbursement:

- 2nd line use in locally advanced non-small cell lung cancer (NSCLC) in adult

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

- Adjuvant melanoma indication

These applications for reimbursement will be processed in line with the 2013 Act.

In relation to the issue of VAT exemption for self-funding patients, as you will appreciate that is a matter for my colleague Mr Paschal Donohoe TD, Minister for Finance and Public Expenditure and Reform for his attention.