Written answers

Tuesday, 3 November 2020

Department of Health

Medicinal Products

Photo of Pádraig O'SullivanPádraig O'Sullivan (Cork North Central, Fianna Fail)
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167. To ask the Minister for Health if the reimbursement of onpattro or patisiran will be included in the extra €50 million for new medicines access as committed to in Budget 2021; and if he will make a statement on the matter. [33312/20]

Photo of Patricia RyanPatricia Ryan (Kildare South, Sinn Fein)
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1274. To ask the Minister for Health if he will fund gene-silencing treatment for amyloidosis such as patisiran and equivalent drugs; and if he will make a statement on the matter. [32884/20]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 167 and 1274 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 whether a drug is cost-effective as a health intervention.

The additional funding of €50m provided for new medicines in Budget 2021 will allow the HSE to provide access to medicines which have been recommended by the HSE Drugs Group, on the basis of efficacy and value for money in line with the 2013 Health Act, and ultimately provide more medicines to Irish citizens.

I am advised by the HSE that it received an application in December 2018 for the reimbursement of patisiran (Onpattro®) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

In January 2019, a full HTA was commissioned by the HSE. This assessment was completed in February 2020, with the NCPE recommending that patisiran (Onpattro®) not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.

The HTA report with respect to patisiran (Onpattro®) was reviewed by the HSE Drugs Group, along with the outputs of commercial discussions with the applicant which took place in May 2020, and the patient group submission received during the HTA process. The HSE Drugs Group have requested patient and clinician engagement input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE EMT regarding reimbursement of patisiran (Onpattro®). This medicine is currently under review with the RDTRC.

The application for patisiran (Onpattro®) remains under consideration with the HSE and is being assessed in line with the 2013 Health Act.

I am further advised by the HSE that it has received an application in August 2019 for the reimbursement of inotersen (Tegsedi®) for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

On 26 August 2019, the HSE commissioned a rapid review with respect to this indication. Following receipt of a rapid review dossier, the NCPE advised the HSE on 7 October 2019 that a full Health Technology Assessment (HTA) was required for this medicine to assess the clinical effectiveness and cost effectiveness of inotersen compared with the current standard of care.

The HSE commissioned a full HTA on 9 October 2019 as per agreed processes. To date, the applicant has not submitted a HTA dossier to the NCPE for assessment. A completed HTA is required to progress this application, as per the formal processes governing the pricing and reimbursement of medicines.

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