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Medicinal Products

Dáil Éireann Debate, Tuesday - 9 June 2020

Tuesday, 9 June 2020

Questions (429)

Cathal Crowe

Question:

429. Deputy Cathal Crowe asked the Minister for Health the steps he will take in relation to the need to access a drug by a person (details supplied). [10413/20]

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Written answers

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

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 licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including the health needs of the public, cost effectiveness, potential or actual budget impact and efficacy.

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 HSE has received an application for pricing and reimbursement of pembrolizumab (Keytruda) indicated as monotherapy or in combination with platinum and 5-fluoroucil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a combined positive score.

In November 2019, the HSE commissioned an NCPE rapid review with respect to this indication. On 2 January 2020, the NCPE completed this rapid review and recommended that a full HTA be undertaken in order to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. In January 2020, a full pharmacoeconomic assessment was commissioned by the HSE and this assessment is now underway.

Question No. 430 answered with Question No. 427.
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