Written answers

Tuesday, 8 September 2020

Department of Health

Medicinal Products

Photo of Patrick CostelloPatrick Costello (Dublin South Central, Green Party)
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1226. To ask the Minister for Health when publicly funded adjuvant immunotherapy specifically Nivolumab and Pembrolizumab will be available under the public healthcare system as laid out in the National Cancer Strategy 2017-2026. [21648/20]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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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 Act specifies the criteria for decisions on the reimbursement of medicines.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

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

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).

The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE at all times ensures that the systems that it has in place are designed to provide equitable access to all medicines across all therapeutic areas, cancer and non-cancer, from the resources provided to it.

I am advised by the HSE that it has received pricing and reimbursement applications for the indications listed below:

- Nivolumab (Opdivo®) as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

- Pembrolizumab (Keytruda®) as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

The HSE has confirmed that health technology assessments have been completed by the NCPE for both these indications. These applications for reimbursement are now being assessed by the HSE in line with the 2013 Health Act.

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