Written answers

Wednesday, 5 December 2018

Department of Health

Medicinal Products Reimbursement

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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66. To ask the Minister for Health if access to experimental drugs such as Pembrolizumab will be provided to all women with cervical cancer in view of the decision to make such drugs available to women whose false negative screening results were uncovered during the audit of the CervicalCheck screening programme [50596/18]

Photo of Alan KellyAlan Kelly (Tipperary, Labour)
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105. To ask the Minister for Health when Pembrolizumab will be made available free of charge to all cervical cancer patients whose clinicians are of the view they require it [50824/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 66 and 105 together.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the 2013 Act. The Act specifies the criteria for decisions on the reimbursement of medicines.

In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, it must apply to have the new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

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 has market authorisation in Ireland/the EU for a number of indications.

The HSE has approved the reimbursement of pembrolizumab 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;

- as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

It should be noted that the first part of the last indication is not reimbursed because the HSE is already reimbursing another immunotherapy with similar efficacy (nivolumab) at lower cost. Patients who are transplant-ineligible and have failed BV can receive reimbursement support for pembrolizumab, as nivolumab does not have market authorisation for this sub-group of patients.

The HSE Drugs Group are reviewing the indication below:

- as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10.

The following indications are currently under health technology assessment with the NCPE:

- in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations;

- as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

No reimbursement application has been received to date for the following indication:

- as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy .

However, the HSE has approved reimbursement of nivolumab for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.

A reimbursement application for the following indication has been withdrawn by the applicant:

- as 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 pembrolizumab.

However, the HSE has approved reimbursement of nivolumab, which could also be used in this cohort of patients at a lower cost.

In October 2018, the Committee for Medicinal Products for Human Use (CHMP), which is the European Medicines Agency's committee responsible for human medicines, adopted a positive opinion recommending a change to the terms of the marketing authorisation for pembrolizumab to include a new indication as follows:

- as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection.

The HSE has commissioned a rapid review assessment for this indication.

There are no other indications for pembrolizumab approved in the European Union at this time. Clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for 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 granted and applications received.

A Government decision 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 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 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 regardless of this support package.

I am aware of the concerns raised in the Dáil and elsewhere regarding the question of providing medication to other cervical cancer patients on the same basis as encompassed by the Government decision of 11 May 2018. At my request, the HSE Medicines Management Programme is examining ways in which other woman with cervical cancer could be afforded access to Pembrolizumab if prescribed by their treating clinician. I have asked the HSE to revert to me as soon as possible in this regard.

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