Thomas Gould
Ceist:785. Deputy Thomas Gould asked the Minister for Health the status of licensing and reimbursement of Jorveza used to treat eosinophilic oesophagitis. [44769/20]
Amharc ar fhreagraWednesday, 13 January 2021
Ceisteanna (785)
Freagraí scríofa
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 licensed 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 NCPE conducts health technology assessments (HTAs) 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 12 November 2018 it received an application for the reimbursement of Budesonide Orodispersible Tablets (Jorveza) for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
On 30 January 2019, following the completion by the NCPE of a rapid review, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication, as per agreed processes.
To date, the applicant has not submitted a HTA dossier to the NCPE for assessment.
The application remains under consideration with the HSE. As it currently stands a completed HTA is required to progress this application, as per the formal processes governing the pricing and reimbursement of medicines.