Wednesday, 14 July 2021
Department of Health
335. To ask the Minister for Health the progress that has been made by the HSE in relation to making the drug zolgensma available to persons who have a diagnosis of spinal muscular atrophy; the outcome of the recent health technology assessment; and if he will make a statement on the matter. [30961/21]
345. To ask the Minister for Health the status of the availability of the drug Zolgensma for the treatment of spinal muscular atrophy type 1; and if he will make a statement on the matter. [31008/21]
363. To ask the Minister for Health when a decision will be made on allowing the drug zolgensma to be used in the treatment for spinal muscular atrophy type 1; and if he will address the matter given that it only pertains to one child (details supplied). [31109/21]
379. To ask the Minister for Health the status of HSE talks with regard to whether zolgensma can be made available to a child (details supplied) who has spinal muscular atrophy type 1; and if he will make a statement on the matter. [31216/21]
382. To ask the Minister for Health the timeline in which the drug zolgensma will be approved by the HSE for children under the age of two who have been diagnosed with the rare genetic disease spinal muscular atrophy type 1 (details supplied); and if he will make a statement on the matter. [31248/21]
383. To ask the Minister for Health the position regarding the drug zolgensma; if the drug can be expedited here given the known case of a person (details supplied); and if he will make a statement on the matter. [31249/21]
387. To ask the Minister for Health when the result of the full health technology assessment which was due to be concluded in April 2021 will be available in relation to the gene therapy treatment zolgensma; and if he will make a statement on the matter. [31273/21]
400. To ask the Minister for Health when the gene therapy drug zolgensma will be approved for reimbursement by the HSE; if same will be made available at an early date to a person (details supplied) for the treatment of spinal muscular atrophy; and if he will make a statement on the matter. [31388/21]
415. To ask the Minister for Health the status of the reimbursement process for the drug zolgensma; the progress made to date to make this drug available and publicly funded for persons diagnosed with spinal muscular atrophy; and if he will make a statement on the matter. [31484/21]
427. To ask the Minister for Health if an application for reimbursement has been submitted for the drug zolgensma; the status and timeline of same; and if he will make a statement on the matter. [31496/21]
I propose to take Questions Nos. 335, 342, 345, 363, 367, 377, 379, 381 to 384, inclusive, 387, 400, 402, 404, 415, 422, 427, 431, 433 and 439 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, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the 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).
I am advised by the HSE that, in April 2020, the NCPE received a reimbursement application dossier for Onasemnogene abeparvovec (Zolgensma). On 13 May 2020, the NCPE completed a rapid review with respect to this application and recommended a full Health Technology Assessment (HTA) to assess the clinical effectiveness and cost effectiveness of Zolgensma compared with the current standard of care.
The HTA was undertaken as a part of the Beneluxa collaboration between Ireland, the Netherlands and Belgium, with Austria acting as a reviewer in the Belgian procedure.
The HTA was completed in May 2021 and an assessment summary is available on the NCPE's website. At the conclusion of this HTA, the NCPE recommended that Zolgensma not be considered for reimbursement unless cost effectiveness could be improved relative to existing treatments. Pricing/reimbursement negotiations have commenced July 2021.
A final decision on the pricing/reimbursement application for Zolgensma will be made in accordance with the 2013 Health Act.
Questions relating to specific individual patients are an operational issue and are therefore a matter for the HSE. Section 6 of the HSE Governance Act 2013 bars me as Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is on-going, and the HSE is working hard to restore its IT capacity and resume normal services. Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.