Michael Healy-Rae
Question:229. Deputy Michael Healy-Rae asked the Minister for Health if the use of a drug (details supplied) will be covered under the medical card; and if he will make a statement on the matter. [35689/20]
View answerWednesday, 11 November 2020
Questions (229)
Written answers
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.
Ministerial Licenses pursuant to Section 14 of the Misuse of Drugs Acts 1977-2016 are not required for medicinal products that have been granted a Marketing Authorisation by the EMA or the HPRA, including cannabidiol (Epidyolex®).
Epidyolex received a Marketing Authorisation valid throughout the EU on 19th September 2019 (Agency Product Number EMEA/H/C/004675). It is a medicine used in addition to clobazam to treat patients from the age of two years who have Lennox-Gastaut syndrome or Dravet syndrome.
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).
I am advised by the HSE that it has received two applications for the reimbursement of Epidyolex:
1. for use as adjunctive therapy of seizures associated with Lennox-Gastaut Syndrome in conjunction with clobazam, for patients two years of age and older.
In February 2020, the HSE commissioned the NCPE to complete a rapid review with respect to this indication. The NCPE recommended a full health technology assessment (HTA) to assess the clinical effectiveness and cost effectiveness of Epidyolex compared with the current standard of care. On 16 March 2020, the HSE commissioned a full pharmacoeconomic assessment for this indication.
2. for use as adjunctive therapy of seizures associated with Dravet Syndrome in conjunction with clobazam, for patients two years of age and older.
In February 2020, the HSE commissioned the NCPE to complete a rapid review with respect to this indication. The NCPE recommended a full HTA to assess the clinical effectiveness and cost effectiveness of Epidyolex compared with the current standard of care. On 16 March 2020, the HSE commissioned a full pharmacoeconomic assessment for this indication.
In July 2020, applicant submissions were received by the NCPE for both of the above indications. These applications will be assessed by the HSE in line with the 2013 Health Act.