Dáil Éireann Debate, Tuesday - 27 July 2021
3199. Deputy Christopher O'Sullivan asked the Minister for Health his views on whether sativex oromucosal spray could possibly be introduced as an approved medicine under the long-term illness scheme for multiple sclerosis patients; and if he will make a statement on the matter. [40755/21]
View answerThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of 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 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:
(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 2014, the HSE notified Almirall (the applicant) that there was significant uncertainty around the cost-effectiveness of Sativex (on the basis of the then application: www.ncpe.ie/wp-content/uploads/2013/01/Summary-v1.pdf ) and as a consequence did not support reimbursement of Sativex (at that time).
The HSE received a revised application from Almirall for pricing / reimbursement of Sativex on the 9th February 2018.
In terms of the specific details of the revised application for pricing and reimbursement of Sativex, indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy, the HSE advise the following:
- The first step in the process is the submission of a rapid review dossier. The HSE commissioned the rapid review process on the 12th February 2018. Following receipt of a rapid review dossier, the National Centre for Pharmacoeconomics (NCPE) advised the HSE (3rd April 2018) that a full Health Technology Assessment (HTA) was required to assess the clinical effectiveness and cost effectiveness of Sativex compared with the current standard of care
- The HSE commissioned a full HTA on 19th April 2018 as per agreed processes.- The NCPE HTA report was received by the HSE on the 15th July 2021. The NCPE recommended that Sativex not be considered for reimbursement unless 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. I am advised that the HSE-CPU is currently reviewing the HTA report and thereafter will liaise with the applicant company to arrange a suitable date to discuss any issues arising from the report
- The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The final HTA report will be reviewed by the HSE Drugs Group, along with any outputs of commercial negotiations, and any patient group submission(s) received during the HTA process.
- As decision-making authority, the HSE EMT will, following receipt of the outcome of the HSE Drugs Group's deliberations, make a decision on whether Sativex will be reimbursed.
The application remains under consideration with the HSE. I am advised that the HSE cannot make any comment on possible outcomes from the ongoing process.
