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 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 in March 2017 an application was received for the reimbursement of teduglutide (Revestive®) indicated for the treatment of patients aged 1 year and above with short bowel syndrome. In April 2017, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication. In July 2017, the NCPE received the applicant’s submission for this assessment. In March 2018, the NCPE completed its assessment and recommended that teduglutide not be considered for reimbursement at the submitted price.

The final HTA report concerning teduglutide was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations which took place in May 2018. In May 2018, the Drugs Group agreed to request patient and clinician engagement input via the Rare Diseases Technology Review Committee (RDTRC) to assist the Group in making its recommendation.  The RDTRC report on this indication was received by the Drugs Group in May 2019.

In November 2019, the HSE Drugs Group considered all the evidence, including the RDTRC report and further commercial negotiations which took place in May 2019, and gave a recommendation to the HSE Executive Management Team (EMT) supporting reimbursement of teduglutide for the treatment of patients aged 1 year and above with short bowel syndrome.

The final decision-making authority in the HSE is the HSE Executive Management Team (EMT). Teduglutide remains under consideration with the HSE EMT and a final decision will be made in line with the 2013 Health Act.