Dáil Éireann Debate, Wednesday - 6 November 2019
143. Deputy Michael Lowry asked the Minister for Health the position regarding anti-calcitonin gene-related peptide medication for the preventative treatment of chronic migraine; if the National Centre for Pharmacoeconomics has completed its full health technology assessment on the medication erenumab; when erenumab and fremanezumab will be made available to chronic migraine patients; and if he will make a statement on the matter. [45684/19]
View answerThe 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.
In line with the 2013 Act and the National Framework Agreement on the Supply and Pricing of Medicines with industry, if a company would like a medicine to be reimbursed by the HSE, it must submit an application to the HSE to have the medicine added to the reimbursement list. Reimbursement is considered for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, including on the advice of the National Centre for Pharmacoeconomics (NCPE).
In August 2018, the NCPE recommended a full health technology assessment (HTA) for erenumab (Aimovig), indicated for the treatment of chronic and episodic migraine in adults who have at least 4 migraine days per month when initiating treatment with erenumab.
On 30 September 2019, the NCPE completed its review and gave the following recommendations for erenumab:
- For chronic migraine, the NCPE recommended that erenumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.
- For episodic migraine, the NCPE recommended that erenumab not be considered for reimbursement.
The final decision will take into consideration the NCPE's recommendation and the statutory criteria contained in the 2013 Health Act.
In April 2019, the NCPE recommended a full HTA for fremanezumab (Ajovy), indicated for prophylaxis of migraine in adults who have at least four migraine days per month. On 26 September 2019, the NCPE received a submission from the manufacturer and its assessment is ongoing.
As outlined in the Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine or refuse to reimburse the medicine.
