Dáil Éireann Debate, Tuesday - 8 September 2020
1185. Deputy David Cullinane asked the Minister for Health further to Parliamentary Question No. 745 of 8 May 2019, the position regarding new medication for the preventative treatment of chronic migraine (details supplied); the status of same; and if he will make a statement on the matter. [21509/20]
View answer1290. Deputy Róisín Shortall asked the Minister for Health further to Parliamentary Question No. 745 of 8 May 2019, if the National Centre for Pharmacoeconomics has completed its full health technology assessment of the new anti-calcitonin gene-related peptide used for the preventative treatment of chronic migraine; and if he will make a statement on the matter. [22004/20]
View answerI propose to take Questions Nos. 1185 and 1290 together.
The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.
The HSE has advised that on 16 April 2019, it received an application for pricing / reimbursement of Fremanezumab (Ajovy®) from the applicant company for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
The HSE commissioned the rapid review process and on 17 April 2019, the National Centre for Pharmacoeconomics (NCPE) advised the HSE that a full Health Technology Assessment (HTA) was required for this medicine.
On 01 May 2019, the HSE commissioned a full Health Technology Assessment. On 07 September 2020, the HSE received the NCPE health technology assessment report. The NCPE recommends that Fremanezumab (Ajovy®), for the prophylaxis of migraine in adult patients with chronic migraine who have failed three or more migraine-preventive treatments be considered for reimbursement.
For the prophylaxis of migraine in adult patients with episodic migraine who have failed three or more migraine-preventive treatments, the NCPE recommends reimbursement be considered if cost-effectiveness can be improved relative to existing treatments.
The HSE confirmed that on 10 August 2018, it received an application for pricing / reimbursement of Erenumab (Aimovig®) from the applicant company for the prophylaxis of migraine in adults who have at least 4 migraine days per month
On 19 July 2018, the HSE commissioned the rapid review process. Following receipt of a rapid review dossier, on 15 August 2018, the NCPE advised the HSE that a full HTA was required for this medicine
On 28 August 2018, the HSE commissioned a full HTA as per agreed processes. On 30 September 2019, the NCPE report was received by the HSE. For chronic migraine, the NCPE recommended that Erenumab (Aimovig®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. For episodic migraine, the NCPE recommended Erenumab (Aimovig®) not be considered for reimbursement
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 uses 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 HSE has advised that the applications for both Fremanezumab and Erenumab is currently under consideration in line with the 2013 Health Act.
