Bernard Durkan (Kildare North, Fine Gael)
Link to this: Individually | In context | Oireachtas source

806. To ask the Minister for Health if the HSE drugs group met in December 2020; if not, if it is scheduled to meet; the drugs being considered for reimbursement, in tabular form; and if he will make a statement on the matter. [44880/20]

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 drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The matter has therefore been referred to the HSE for reply to the Deputy.

Bernard Durkan (Kildare North, Fine Gael)
Link to this: Individually | In context | Oireachtas source

807. To ask the Minister for Health the status of the reimbursement of Onpattro; when the drug will be made available to eligible patients; and if he will make a statement on the matter. [44881/20]

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 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 licensed 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 HSE has advised 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 with respect to this indication was commissioned by the HSE. This assessment was completed in February 2020, with the NCPE recommending that Patisiran not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.

The HTA report with respect to Patisiran 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 is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members and clinicians.

The HSE Drugs Group requested patient and clinician input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE Executive Management Team (EMT) regarding reimbursement of Patisiran.

In September 2020, The RDTRC convened and reviewed the clinical data previously submitted as part of the established pricing and reimbursement process. The Committee also heard from Consultants involved in the specialist management of patients with hATTR amyloidosis.

The RDTRC continued its review of Patisiran at its subsequent meeting on 5 November 2020 which included patient input on the impact of hATTR amyloidosis.

Following these meetings, the Committee finalised a statement summarising the clinician and patient engagement on Patisiran which was forwarded to the HSE Drugs Group for consideration.

The HSE has advised that additional information has been submitted by the manufacturer following engagements in December 2020 and January 2021. This information will be considered by the HSE Drugs Group along with the statement from the RDTRC.

The HSE has advised that a HSE Drugs Group’s meeting has been scheduled for the afternoon of 12th January 2020, subject to the confirmed quorum being achieved. The HSE has indicated that there is a risk that it will not be possible to achieve the necessary quorum, as contributing clinicians are under significant pressures with competing priorities due to the pandemic. In the event that the quorum is not maintained, this meeting will need to be rescheduled.

The application for Patisiran remains under consideration in line with the 2013 Health Act. The HSE Executive Management Team is the decision-making body for the reimbursement of medicines and it will make the decision on whether Patisiran will be reimbursed in line with the criteria contained in the 2013 Health Act.

Bernard Durkan (Kildare North, Fine Gael)
Link to this: Individually | In context | Oireachtas source

808. To ask the Minister for Health if his attention has been drawn to the existence of specific antiviral treatment for Covid-19 or any other treatment currently undergoing trials or in respect of which trials have been completed; if it is planned for this medicine to be procured under Ireland’s participation in the European Commission joint procurement agreement; and if he will make a statement on the matter. [44886/20]

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

Officials in my Department have requested clarification from the Deputy's office regarding the specific antiviral treatment referred to in this question. Once this clarification is provided, a more detailed response will be issued directly to the Deputy.

To date, the European Medicines Agency has approved two medicines, dexamethasone and remdesivir, for the treatment of patients with Covid-19. Ireland is participating in the European Commission's joint procurement for remdesivir, and has received supplies of remdesivir under this mechanism. National guidance has been in place since March 2020 on the use of remdesivir in Irish hospitals for the treatment of Covid-19. Ireland also continues to support the WHO Solidarity Trial, an international clinical trial launched by the World Health Organization and partners to help find an effective treatment for COVID-19.

Seán Haughey (Dublin Bay North, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

810. To ask the Minister for Health if he has considered utilising the drug ivermectin to combat the spread of Covid-19; and if he will make a statement on the matter. [44895/20]

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

As this is an operational issue which is the responsibility of the Health Service Executive, I have asked the Executive to examine the issue raised and reply directly to the Deputy as soon as possible.