Dáil Éireann Debate, Wednesday - 28 April 2021
1074. Deputy Michael Moynihan asked the Minister for Health the status of the treatment lanadelumab for hereditary angioedema; when he expects a final decision to be made on its funding; and if he will make a statement on the matter. [22173/21]
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 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 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 14 March 2019, it received an application for the reimbursement of Lanadelumab (Takhzyro) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
On 28 May 2019, following the completion by the NCPE of a rapid review, the HSE commissioned a full health technology assessment (HTA) with respect to this indication, as per agreed processes.
On 4 October 2019, the NCPE received the applicant’s submission for this assessment. On 26 June 2020, the NCPE completed its assessment and recommended that Lanadelumab not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.
In December 2020, the HSE Drugs Group considered the pricing/reimbursement application for Lanadelumab. In formulating its recommendation, the Drugs Group considered the final HTA report, alongside the outputs of commercial negotiations which took place in August 2020. The Drugs Group recommended that reimbursement for Lanadelumab be approved, conditional on the establishment of a HSE managed access programme and clinical guideline to support its reimbursement.
The final decision-making authority in the HSE is the Executive Management Team (EMT). In January 2021, the EMT supported reimbursement of Lanadelumab subject to the implementation of the HSE managed access programme.
Processes required to implement an individual patient approval system are currently ongoing with a view to enabling reimbursement for patients who meet the pre-defined criteria as per the HSE Medicines Management Programme devised managed access protocol that is currently in development.
The HSE decision with respect to Lanadelumab will be formalised in accordance with the 2013 Health Act.
