Dáil Éireann Debate, Tuesday - 14 February 2023
647. Deputy Paul Murphy asked the Minister for Health in view of the NCPE's recent negative recommendation in relation to Evusheld, the action he will take on behalf of immunosuppressed people; if he will direct the HSE to make Evusheld available to all who need it; and if he will make a statement on the matter. [6729/23]
Amharc ar fhreagraThe National Centre for Pharmacoeconomics (NCPE) has responsibility for assessing evidence for comparative effectiveness and cost-effectiveness of technologies for use by patients in Ireland. This is done through assessment of evidence submitted by manufacturers and independent systematic review.
The NCPE has conducted a Health Technology Assessment (HTA) on Evusheld. This is a standard approval process for all new therapeutics, including those indicated for COVID-19. Following assessment of the submission made by AstraZeneca in respect of Evusheld, the NCPE has recommended that Evusheld not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
In addition, available scientific evidence raises concerns in terms of the efficacy of Evusheld in light of emerging/increasing variants, and for that reason there is also significant risk around utilising the product as a potential contingency given the uncertainty around new variants, and the current evolutionary pattern towards sub-lineages of Omicron strains. The European Medicines Agency’s Emergency Task Force and the U.S. Food and Drug Administration have outlined concerns around the declining efficacy of these treatments and have cautioned that monoclonal antibodies currently authorised for COVID-19, including Evusheld, are unlikely to be effective against emerging strains of SARS-CoV-2.
The status of Evusheld and other existing and emerging COVID-19 therapeutics will continue to be monitored and assessed in order to ensure both the public interest and the capacity of the health system and service delivery is protected. Any individual who has concerns about an underlying condition or their level of risk in relation to COVID-19 should continue to seek advice from their GP or treating clinician.
