Darren O'Rourke
Ceist:287. Deputy Darren O'Rourke asked the Minister for Health the reason that constella 290mg is not covered by the drugs payment scheme; and if he will make a statement on the matter. [36466/22]
Amharc ar fhreagraWednesday, 6 July 2022
Ceisteanna (287)
Freagraí scríofa
The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, 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 licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority. The formal reimbursement list is the same for the General Medical Services Scheme and the Drug Payment Scheme.
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. The Minister for Health has no role in these decisions.
In November 2012, following scientific assessment by the European Medicines Agency, 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.
The HSE received a pricing and reimbursement application for Linaclotide in May 2013. Following a Rapid Review by the National Centre for Pharmacoeconomics, the HSE considered Linaclotide for reimbursement under the Community Drug Schemes. However, the applicant company subsequently disengaged from the pricing and reimbursement process. The HSE have not received a further pricing and reimbursement application for Linaclotide from any pharmaceutical company.
Therefore, Linaclotide (Constella®) is not currently reimbursable under the General Medical Services Scheme or the Community Drug Schemes, including the Drug Payment Scheme.