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Medicinal Products

Dáil Éireann Debate, Tuesday - 8 December 2020

Tuesday, 8 December 2020

Questions (695, 699)

Jennifer Carroll MacNeill

Question:

695. Deputy Jennifer Carroll MacNeill asked the Minister for Health the status of a drug being assessed for reimbursement (details supplied) by the National Centre for Pharmacoeconomics; when a decision will be made; and if he will make a statement on the matter. [41857/20]

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Jackie Cahill

Question:

699. Deputy Jackie Cahill asked the Minister for Health further to Parliamentary Question No. 756 of 10 November 2020, the status of ,application submissions made to the National Centre for Pharmacoeconomics in July 2020 regarding the reimbursement of epidiolex; if the process will be expedited; the reason the process has taken a long time in view of the vital importance of the medication, in particular for a person (details supplied); and if he will make a statement on the matter. [41894/20]

View answer

Written answers

I propose to take Questions Nos. 695 and 699 together.

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 licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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 it received two applications in February 2020 for the reimbursement of Cannabidiol (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.

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 rapid reviews with respect to each of these indications.  The NCPE recommended full HTAs to assess the clinical effectiveness and cost effectiveness of Cannabidiol compared with the current standard of care with respect to each of the above indications. On 16 March 2020, the HSE commissioned full HTAs for both of these indications.

Applicant submissions are required in order to proceed with commissioned HTAs. In July 2020, applicant submissions were received by the NCPE for both of the above indications and the HTAs are underway.

These applications will be assessed by the HSE in line with the 2013 Health Act.

Question No. 696 answered with Question No. 617.
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