Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

114. To ask the Minister for Health if epidiolex will be approved for funding by the HSE drug reimbursement programme as a matter of urgency; and if he will make a statement on the matter. [28445/21]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

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.

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 HSE advises that, on 5 February 2020, it received two applications for the reimbursement of Epidyolex:

- for use as adjunctive therapy of seizures associated with Lennox-Gastaut Syndrome in conjunction with clobazam, for patients two years of age and older.

- for use as adjunctive therapy of seizures associated with Dravet Syndrome in conjunction with clobazam, for patients two years of age and older.

On 5 February 2020, the HSE commissioned the NCPE to complete rapid reviews with respect to each of these indications.  The NCPE recommended full health technology assessments (HTAs) to assess the clinical effectiveness and cost effectiveness of Epidyolex compared with the current standard of care with respect to the above indications. On 16 March 2020, the HSE commissioned a full pharmacoeconomic assessment for these indications.

In July 2020, the applicant’s HTA submissions for both of the above indications were received by the NCPE.

On 8 March 2021, the NCPE completed its assessments of these indications, recommending in both cases that Epidyolex not be approved for reimbursement unless cost effectiveness could be improved relative to existing treatments.

The final HTA reports will be reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations which took place in April 2021, and any patient group submissions received during the HTA process. The HSE Drugs Group will consider all the evidence and make a recommendation to the HSE Executive Management Team (EMT).

The HSE has also advised that a further pricing/reimbursement application was received with respect Epidyolex on 9 June 2021 for the following indication:

- for use as an adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2years of age and older.

On 9 June 2021, the HSE commissioned a rapid review with respect to this indication. On 8 July 2021, the NCPE completed this rapid review and recommended a full HTA to assess the clinical effectiveness and cost effectiveness of Epidyolex compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

The HSE EMT is the decision-making body for the reimbursement of medicines under the Health Act 2013 and it will, following receipt of the outcome of the Drugs Group's deliberations, make the decisions on whether Epidyolex will be reimbursed for the above indications.

Given the disruption caused by the cyberattack on its IT systems, the HSE is currently working to restore all of its operations, in accordance with the priority needs for the safe and effective functioning of the health service. The timelines for medicine pricing/reimbursement applications to be deliberated on by the HSE EMT may therefore be outside of those usually expected.