Jim O'Callaghan (Dublin Bay South, Fianna Fail)
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705. To ask the Minister for Health if he will provide an update on the reimbursement application for a treatment by a person (details supplied); the reason for the delay; when he expects this treatment to be made available; and if he will make a statement on the matter. [4503/23]

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.

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). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed. 

In terms of the specific details of the application for pricing and reimbursement of Apalutamide (Erleada®): 

The HSE received an application for pricing / reimbursement of a new indication for Apalutamide (Erleada®) on the 25th February 2020 from Janssen (the applicant) for Apalutamide (Erleada®) for the treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen-deprivation therapy (ADT). 

- The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Phamacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 26th February 2020.

- The NCPE Rapid Review assessment report was received by the HSE on the 23rd March 2020. The NCPE advised the HSE that a full HTA was recommended to assess the clinical effectiveness and cost effectiveness of Apalutamide (Erleada®) for this indication compared with the current standard of care. www.ncpe.ie/drugs/apaluatmide-erleada-hta-id-20010/ 

- The HSE commissioned a full Health Technology Assessment (HTA) on the 24th of March 2020 as per agreed processes. 

- The NCPE Health Technology Assessment was received by the HSE on the 3rd March 2022 (www.ncpe.ie/wp-content/uploads/2020/03/Summary-apalutamide-mHSPC-20010.pdf). The NCPE recommended that Apalutamide (Erleada®) in combination with androgen deprivation therapy (ADT) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. 

- The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. Apalutamide (Erleada®) for the treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen-deprivation therapy (ADT) was considered by the Drugs Group at the October 2022 meeting (minutes of this meeting are available online: www.hse.ie/eng/about/who/cpu/drugs-group-minutes/hse-drugs-group-minutes-october-2022.pdf. The HSE Drugs Group (by majority) recommended in favour of reimbursement of Apalutamide (Erleada®) for the treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen-deprivation therapy (ADT) subject to an improved commercial offering. 

- The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013. 

The application remains under consideration. The HSE cannot make any comment on possible outcomes from the ongoing process.