Dáil Éireann Debate, Tuesday - 27 July 2021
2891. Deputy Jackie Cahill asked the Minister for Health if the drug romosozumab (details supplied) will shortly be regulated by the Health Products Regulatory Authority in Ireland and be made available on the drug payment scheme and to medical card holders; and if he will make a statement on the matter. [39492/21]
View answerThe 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.
The HSE is committed to providing access to as many medicines as possible in as timely a fashion as possible from the resources available (provided) to it. The HSE robustly assesses 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.
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 HSEFollowing EMA marketing authorization in 2019 the HSE received an application for pricing / reimbursement of Romosozumab (Evenity®) on the 20th April 2021 from UCB Pharma (the applicant) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
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 first step in the process is the submission of a rapid review dossier.
The HSE commissioned the rapid review process on the 21st April 2021. Following receipt of a rapid review dossier, the National Centre for Pharmacoeconomics (NCPE) advised the HSE (27th May 2021) that a full Health Technology Assessment (HTA) was required for this medicine to assess the clinical effectiveness and cost effectiveness of Romosozumab compared with the current standard of care.
The HSE commissioned a full Health Technology Assessment on the 28th June 2021 as per agreed processes www.ncpe.ie/drugs/romosozumab-evenity-hta-id-21016/.
The application remains under consideration with the HSE. The HSE advise that it cannot make any comment on possible outcomes from the ongoing process.
