Cathal Crowe (Clare, Fianna Fail)
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613. To ask the Minister for Health when evenity (romosozumab) will be made available a person (details supplied) suffering from osteoporosis; if evenity will be covered by the drugs payment scheme; and if he will make a statement on the matter. [41197/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. The HSE have provided the following update regarding Romosozumab (Evenity®):

The HSE must commit to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available to it.

The HSE must also robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

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.

The HSE considers the following criteria prior to making any decision on pricing / reimbursement, in line with the Health (Pricing and Supply of Medical Goods) Act 2013:

(1) The health needs of the public,

(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,

(3) The availability and suitability of items for supply or reimbursement,

(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,

(5) The potential or actual budget impact of the item or listed item,

(6) The clinical need for the item or listed item,

(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,

(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and,

(9) The resources available to the HSE.

In terms of the specific details of the application for pricing and reimbursement of Romosozumab (Evenity®):

• The HSE received an application for pricing and reimbursement of Romosozumab (Evenity®) on the 20^th April 2021 from UCB Pharma (the applicant) indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
• 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 21^st April 2021.
• The NCPE Rapid Review assessment report was received by the HSE on the 27^th May 2021. A full HTA was recommended to assess the clinical effectiveness and cost effectiveness of Romosozumab (Evenity®) compared with the current standard of care.
• The HSE commissioned a full Health Technology Assessment (HTA) on the 28^th June 2021 as per agreed processes.
• The NCPE Health Technology Assessment report () was received by the HSE on the 7^th of March 2023. The NCPE recommended that Romosozumab (Evenity®), for the treatment of women who are postmenopausal with severe osteoporosis who have experienced a MOF (hip, vertebrae, distal radius, proximal humerus) within the previous 24 months and who are at imminent risk of another fragility fracture, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
• 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. The Drugs Group met in August 2023 and reviewed the pharmacoeconomic report along with the outputs of commercial negotiations, and patient group submissions. The Drugs Group recommended the reimbursement of Romosozumab (Evenity®) subject to a Managed Access Protocol (MAP) being implemented.
• 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.
• Reimbursement of Romosozumab (Evenity®) on the High Tech Arrangement is supported for a sub-group of the licensed population who meet the criteria outlined in a managed access protocol (MAP), i.e. women who are postmenopausal, with severe osteoporosis, who have experienced a major osteoporotic fracture (MOF) within the previous 24 months and who are at imminent risk of another fragility fracture. All criteria must be satisfied in order for reimbursement to be supported.
• Evenity® will be made available under a MAP operated by the HSE Medicines Management Programme (MMP) in the coming months.