Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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537. To ask the Minister for Health if there is an appeals process for those who have been refused reimbursement by the HSE for the use of the breast cancer drug pertuzumab despite a consultant oncologist’s opinion that it would be beneficial to use as treatment in a particular case (details supplied); and if he will make a statement on the matter. [30191/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 Health 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.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria. These include the clinical and cost-effectiveness of the product, the health needs of the population, the opportunity cost, the budget impact and the resources available to the HSE.

In reaching its decision, the HSE examines all the evidence which may be relevant, including the information submitted by the company, and will take into account such expert opinions and recommendations which it may seek (for example, from the National Centre for Pharmacoeconomics (NCPE), the National Cancer Control Programme or the HSE Drugs Group).

The HSE has advised that pertuzumab (Perjeta) for the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (license extension) is currently in process and has now been formally reviewed by the HSE Drugs Group and the HSE Executive Management Team (EMT). The HSE Drugs Group provides recommendations to the HSE EMT. The HSE EMT is the decision-making authority within the HSE.

The HSE EMT considered this medicine and has supported the HSE Drugs Group recommendation which was not to support reimbursement of this indication. Where the HSE EMT team has considered a recommendation of the Drugs Group, and when circumstances arise where it is minded to accept a Drugs Group recommendation of non-reimbursement, the HSE is required (in line with the Health [Pricing and Supply of Medical Goods] Act 2013) to set out in detail a notice of any proposed decision to an applicant company. The HSE met the applicant company to explore whether further clinical evidence may become available. No further supporting evidence has been received to date.

The application for pertuzumab (Perjeta) remains under consideration with the HSE and is being assessed in line with the 2013 Health Act.