Paul Murphy (Dublin South West, RISE)
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1851. To ask the Minister for Health if his attention has been drawn to the fact that in September 2020 the National Centre for Pharmacoeconomics refused reimbursement for the life-changing gene therapy luxturna unless cost effectiveness can be improved relative to existing treatments; if his attention has been further drawn to the fact that there are no existing treatments for inherited retinal disease (details supplied); if he will request that the National Centre for Pharmacoeconomics review its decision and include the drug in the list of drug treatments approved for reimbursement; and if he will make a statement on the matter. [19135/21]

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 the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Alan Kelly (Tipperary, Labour)
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1852. To ask the Minister for Health when patients will have access to fremanezumab; and if he will make a statement on the matter. [19140/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The HSE has advised that, on 16 April 2019, it received an application for the reimbursement of Fremanezumab (Ajovy) for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

On 1 May 2019, following the completion by the NCPE of a rapid review, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication, as per agreed processes.

On 26 September 2019, the NCPE received the applicant’s submission for this assessment. On 7 September 2020, the NCPE completed its assessment and recommended that:

- Fremanezumab for the prophylaxis of migraine in adult patients with chronic migraine who have failed three or more migraine-preventive treatments be considered for reimbursement

- Fremanezumab for the prophylaxis of migraine in adult patients with episodic migraine who have failed three or more migraine-preventive treatments be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.

In March 2021, the HSE Drugs Group considered Fremanezumab for the prophylaxis of migraine in adult patients with chronic migraine who have failed three or more migraine-preventive treatments. This was the defined subgroup of the full licensed indication for which the applicant sought reimbursement approval.

The HSE Drugs Group considered the final HTA report, alongside the outputs of commercial negotiations which took place in November 2020 and the patient group submission received during the HTA process. The Drugs Group recommended that reimbursement for Fremanezumab should be supported for the above subgroup of the full licensed indication, conditional on the establishment of a HSE managed access programme to support reimbursement for that patient subgroup.

The HSE will now implement an individual patient approval system to enable reimbursement for patients who meet the pre-defined criteria, as per the HSE Medicines Managed Programme devised managed access protocol which is currently in development.

Processes required to implement the managed access programme, as per the HSE Drugs Group’s recommendation, are currently ongoing with a view to formalising the HSE’s approval of this application.

The HSE Executive Management Team is the final decision-making body for the reimbursement of medicines under the Health Act 2013.