Michael Lowry (Tipperary, Independent)
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497. To ask the Minister for Health the reason that linaclotide (constella® 290mg) is not covered by the drugs payment scheme or for persons who are in receipt of a medical card; and if he will make a statement on the matter. [38872/24]

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 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.

I have asked the HSE to provide an update and they have advised that in terms of Linclotide (Constella®):

Following scientific assessment by the European Medicines Agency (EMA), Linaclotide (Constella® 290 micrograms hard capsules) for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults received marketing authorisation in November 2012.

The Corporate Pharmaceutical Unit (CPU) is the unit within the HSE that is responsible for accepting and considering pricing and reimbursement applications from the pharmaceutical industry. The CPU received a pricing and reimbursement application for Linaclotide (Constella®) under the Community Drugs Schemes in May 2013.

Following a Rapid Review by the National Centre for Pharmacoeconomics ( ), the HSE considered Linaclotide (Constella®) for reimbursement under the Community Drugs Schemes. However, the applicant (Almirall Limited) subsequently disengaged from the pricing and reimbursement process. Reimbursement of Linaclotide (Constella®) has not been pursued to date.

The CPU have not received a communication from any pharmaceutical company indicating an imminent pricing and reimbursement application for Linaclotide.