Seanad debates

Wednesday, 18 May 2022

Nithe i dtosach suíonna - Commencement Matters

Medicinal Products

10:30 am

Photo of Mary ButlerMary Butler (Waterford, Fianna Fail) | Oireachtas source

I thank the Senator for raising this important issue. For Eimear, her mum Julie and the 35 other children he referred to, this is a very important issue, especially for families with children who suffer from debilitating conditions.

As the Senator will know, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes and for the administration of the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority. 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. The HSE robustly assesses applications for pricing and reimbursement to make sure it can deliver the best value in terms of each medicine and ultimately make more medicines available to Irish citizens who need them.

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 NCPE conducts health technology assessments for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost-effectiveness as a health intervention.

The HSE has advised that on 7 January 2022, the European Medicines Agency approved a change to the marketing authorisation for the medicinal product Kaftrio. This change expanded the group of cystic fibrosis patients for which this medicine is now licensed and that is good news. On 21 March 2022, the HSE received a rapid review dossier from the manufacturer for a pricing and reimbursement application for Kaftrio to treat a group of patients aged between six and 11 years covered by the EMA's expanded marketing authorisation. Following assessment by the HSE, and in line with agreed processes, reimbursement is in place from May for these children under the high-tech drug arrangements. The HSE has also advised that another pricing and reimbursement application with respect to Kaftrio for a further group of patients of the same age was received on 11 April 2022 and is currently undergoing assessment in line with the 2013 Act.

The HSE has, to date, engaged in five commercial meetings with the manufacturer between 6 January 2022 and 14 April 2022 to discuss this application. The NCPE rapid review assessment report for the application was received by the HSE on 10 May 2022. The NCPE advised that a full health technology assessment was recommended to assess the clinical effectiveness and cost-effectiveness of this indication compared with the current standard of care. The HSE advises that it commissioned a full health technology assessment on 16 May as per standard process.

The HSE executive management team is the decision-making body for the reimbursement of medicines under the Health Act 2013. It will, following the NCPE's assessment and receipt of the outcome of the drugs group's deliberations, make the decision on whether Kaftrio will be reimbursed for this indication.

To sum up, the Senator was quite right that this all about enhancing the quality of life of these children. A lot of work is under way behind the scenes. Four meetings have taken place, one of which was held as recently as 16 May. I am hopeful and confident that because this drug has been made available to some children who have cystic fibrosis, more progress will be made for the families to whom he referred.

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