Written Answers Nos. 1603-1627
1603. Deputy Róisín Shortall asked the Minister for Health if there is a body of evidence on the use of ivermectin to reduce the incidence of Covid-19 transmission, severe disease development or in vitro replication; and if he will make a statement on the matter. [14821/21]
View answerThe Deputy is advised that, at the request of the NPHET, the HIQA conducted a rapid evidence review to identify studies on the effectiveness of (i) pharmaceutical and (ii) non-pharmaceutical interventions, in the ambulatory setting, aimed at reducing progression to severe disease in individuals with confirmed or suspected COVID-19. This evidence review included a review of relevant studies in relation to Ivermectin.
Low certainty or very low certainty evidence was identified in relation to a small number of interventions. However, the HIQA noted the low quality of the evidence available including the high risk of bias, small sample sizes and short durations of follow-up different trials and advised that results from these studies should not be used to inform decision-making with respect to effectiveness.
The HIQA’s overall finding was that there is currently insufficient evidence of either effectiveness or safety to support the use of any pharmaceutical intervention in the community setting to reduce the risk of progression to severe disease in patients who have been diagnosed with COVID-19 unless as part of an ongoing monitored clinical trial. Furthermore, no evidence was identified for the effectiveness or safety of any non-pharmaceutical intervention in the community setting.
As confirmed by the HIQA’s COVID-19 Expert Advisory Group: (https://www.hiqa.ie/sites/default/files/2021-02/Interventions-to-prevent-progression_Advice.pdf), evidence regarding the effectiveness of pharmaceutical treatments intended for systemic use, must be subject to the highest standards of rigour. Where a pharmaceutical intervention is recommended in the absence of appropriate supportive evidence, there is a significant potential for harm to the patient. Whereas this risk of harm may be justified in certain circumstances (e.g. the intervention poses minimal risk, or the setting involves patients with high potential to gain due to almost certain risk of severe adverse consequences in absence of any intervention) this is less likely to be the case in the setting of mild disease, where a great number of otherwise well patients would potentially receive the intervention.
The HIQA has also advised my Department that several international health technology assessment or guideline development organisations have specifically reviewed the evidence to date on ivermectin in COVID-19 and have cautioned or advised against the use of ivermectin outside the setting of clinical trials on the basis of the current evidence. The HIQA has also advised that the pharmaceutical company MSD (Merck, USA), which holds a license in the USA for the use of ivermectin as an antiparasitic agent, on 4th February 2021 published a statement including the following:
“It is important to note that, to-date, our analysis has identified:
- No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;
- No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and;
- A concerning lack of safety data in the majority of studies.
We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.”
I trust that the above information satisfactorily addresses your question.
1604. Deputy Gary Gannon asked the Minister for Health the estimated annual cost of providing discretionary medical cards to all cancer patients at the time of their diagnosis until their treatment has finished; and if he will make a statement on the matter. [14826/21]
View answer1605. Deputy Gary Gannon asked the Minister for Health the estimated annual cost of providing life-long medical cards for all survivors of childhood or adolescent cancers; and if he will make a statement on the matter. [14827/21]
View answerI propose to take Questions Nos. 1604 and 1605 together.
Under the Health Act 1970 (as amended), eligibility for a medical card is based primarily on means. The Act obliges the HSE to assess whether a person is unable, without undue hardship, to arrange general practitioner services for himself or herself and his or her family, having regard to his or her overall financial position and reasonable expenditure.
However, every effort is made by the HSE, within the framework of the legislation, to support applicants in applying for a medical card and, in particular, to take full account of the difficult circumstances in the case of applicants who may be in excess of the income guidelines. The HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income threshold where they face difficult financial circumstances, such as extra costs arising from, the social and medical impacts of an illness.
The issue of granting medical cards based on having a particular disease or illness was previously examined in 2014 by the HSE Expert Panel on Medical Need and Medical Card Eligibility. The Group concluded that it was not feasible, desirable, nor ethically justifiable to list medical conditions in priority order for medical card eligibility. In following the Expert Group’s advice, a person’s means remains the main qualifier for a medical card. However, I also recognise that patients require a responsive and compassionate health system to meet their medical needs, particularly in cases of terminal illness. I am therefore pleased to confirm that the Government recently agreed to introduce an administrative arrangement for up to 12 months on an interim basis, that will enable persons who have been certified by their treating Consultant as having a prognosis of 24 months or less, to be awarded a medical card. These applications will not require a means assessment nor will they be reassessed.
Furthermore, since 2015 medical cards are awarded without the need of a financial assessment to all children under 18 years of age with a diagnosis of cancer, for a period of five years.
With regard to the cost of providing a medical card in the manner sought, this information is not readily available at this time.
1606. Deputy Gary Gannon asked the Minister for Health if he will review the practice of hospitals using debt collection agencies; if his attention has been drawn to the fact that patients currently undergoing treatment for cancer and other illnesses are charged €80 per day for outpatient treatment and if payment is not received within 47 days this can be passed onto debt collection agencies; his views on whether this practice is patient centred; and if he will make a statement on the matter. [14828/21]
View answerThe current framework is set out in the Health Act 1970 (as amended). It provides that all persons ordinarily resident in the country are eligible, subject to certain charges, to public patient hospital services including consultant services. All persons, irrespective of illness or condition, accessing public in-patient (including day case) services in a public hospital are liable for the statutory in-patient daily charge of €80 up to a maximum of €800 in any period of 12 consecutive months, subject to a number of exemptions which include:
- medical card holders;
- people receiving treatment for prescribed infectious diseases - including Coronavirus (Covid-19);
- people who are subject to 'long-stay' charges;
- children referred for treatment from child health clinics and school board examinations;
- people who are eligible for hospital services because of EU Regulations;
- women receiving maternity services;
- children up to 6 weeks of age;
- people with hepatitis C who have a Health Amendment Card;
- people who are part of the Redress Scheme for Women Resident in Certain Institutions.
The vision of Sláintecare is to achieve a universal single-tier health and social care system where everyone has equitable access to services based on need and not ability to pay. In its report, the Houses of the Oireachtas Committee on the future of healthcare called for "universal health system accessible to all on the basis of need, free at the point of delivery (or at the lowest possible cost)" (2017, p56). Over time, the vision is that everyone will have entitlement to a comprehensive range of primary, acute and social care services at no cost or at a substantially reduced cost and that the vast majority of this care will be provided in primary and community settings.
Sláintecare Implementation Strategy & Action Plan 2021 contains the following key workstream in the Development of a Citizen Care Masterplan as part of its Reform Programme: Addressing Health Inequalities:
Develop policy proposals and options for achieving universal eligibility across hospital and community settings
The aim of this workstream is to consider the current eligibility and entitlement policies, and review how they align with population needs as identified in other workstreams, with a view to achieving universal eligibility/entitlement. The following will be considered:
- the range of services to be provided on a universal basis
- the rationale and methodology for phased eligibility/entitlement for the services, and
- financial mechanisms and phasing
This analysis will then inform the preferred future eligibility framework to deliver universal access to healthcare for decision by Government.
1607. Deputy Gary Gannon asked the Minister for Health if he will review the reduction of intern positions for newly qualified doctors and maintain the 2020 number of intern positions to retain non-EU newly qualified doctors in addition to managing the waiting lists in hospitals which have grown as a result of the Covid-19 pandemic; and if he will make a statement on the matter. [14829/21]
View answerOver the past number of weeks, my Department and the HSE have been reviewing the option to increase the number of medical intern places for July 2021.
I have announced an increase of 120 medical intern posts for July 2021. The increase in the number of intern places will be supported with accompanying increases in postgraduate training places, to ensure these doctors can avail of the next step in the training pathway following completion of an internship.
Over the next number of months, the HSE will be undertaking a formal review of the number of intern posts and postgraduate training positions to ensure the number of intern places are in line with future medical workforce planning requirements of the health service. As part of this review the clinical sites where additional intern posts are most needed will be considered to ensure that the current configuration provides the most efficient and educationally appropriate model.
1608. Deputy Richard Boyd Barrett asked the Minister for Health if the HSE is refusing to reimburse the antigen costs for nursing homes (details supplied); if so, the reason for the decision; if he is considering reversing this decision; and if he will make a statement on the matter. [14833/21]
View answerThe Temporary Assistance Payment Scheme (TAPS) for nursing homes was established in April 2020 to provide financial assistance to contribute towards the costs incurred by private nursing homes in acting to suppress and manage COVID-19. €78.2m has been paid to date in respect of claims under the Scheme, which has been extended until the end of June 2021.
The TAPS Standard Assistance Payment is eligible to be spent on costs that have arisen in executing a number of measures that are specific to COVID-19. All nursing home providers are made aware of eligible costs under TAPS. Nursing Homes are currently not reimbursed under the Temporary Assistance Payment Scheme for antigen tests. The current Health Protection Surveillance Centre guidance on this issue only provides for the use of antigen tests in certain locations and in limited circumstances and under the direction of the local Public Health Department. This guidance can be accessed by following this link:
https://www.hpsc.ie/az/respiratory/coronavirus/novelcoronavirus/guidance/guidanceforhealthcareworkers/publichealthguidance/
1609. Deputy Cathal Crowe asked the Minister for Health when youth workers who are considered essential workers can expect to receive their Covid-19 vaccine; and if he will make a statement on the matter. [14834/21]
View answerOn the 23rd of February 2021, I announced an update to Ireland’s COVID-19 Vaccine Allocation Strategy.
In comprising the initial Vaccine Allocation Strategy, the NIAC listed several conditions associated with increased risk of severe disease and death. In the intervening period, national and international evidence has become available which has enabled a more detailed analysis of underlying conditions that may increase the risk of developing severe disease or death.
The NIAC has now been able to more comprehensively identify those medical conditions and to distinguish between those which place a person at very high or high risk of severe disease if they contract the virus. Medical conditions and the magnitude of the risk they pose will continue to be monitored and periodically reviewed.
The NIAC continues to monitor data around this disease and indeed emerging data on effectiveness of vaccines on a rolling basis. Further details are available at the following link:
https://www.gov.ie/en/press-release/b44b2-minister-donnelly-announces-update-to-vaccine-allocation-strategy/
The next cohort to be vaccinated (Cohort 4) are those aged 16-69 and at very high risk of severe illness and death. Vaccination of this group began in March.
The ongoing review process will continue to look at the other priority groups yet to be vaccinated, along with the competing needs of those working or living in high-risk situations, carers who deliver essential services to highly dependent individuals in the home setting, and those who are socially vulnerable/disadvantaged.
It is important to emphasise that vaccination is only one part of our response to the prevention of COVID-19 infection. People who are vaccinated need to continue with all the public health measures that have been proven to reduce the risk of infection, i.e., limiting our social contacts, physical distancing, wearing a mask, hand hygiene, cough etiquette and avoiding non-essential travel until a sufficiently large proportion of the population are immune.
1610. Deputy Christopher O'Sullivan asked the Minister for Health if he will consider prioritising members of An Garda Síochána for vaccinations after those who are deemed medically vulnerable have been vaccinated (details supplied); and if he will make a statement on the matter. [14835/21]
View answerOn the 23rd of February 2021, I announced an update to Ireland’s COVID-19 Vaccine Allocation Strategy.
In comprising the initial Vaccine Allocation Strategy, the NIAC listed several conditions associated with increased risk of severe disease and death. In the intervening period, national and international evidence has become available which has enabled a more detailed analysis of underlying conditions that may increase the risk of developing severe disease or death.
The NIAC has now been able to more comprehensively identify those medical conditions and to distinguish between those which place a person at very high or high risk of severe disease if they contract the virus. Medical conditions and the magnitude of the risk they pose will continue to be monitored and periodically reviewed.
The NIAC continues to monitor data around this disease and indeed emerging data on effectiveness of vaccines on a rolling basis. Further details are available at the following link.
https://www.gov.ie/en/press-release/b44b2-minister-donnelly-announces-update-to-vaccine-allocation-strategy/
The next cohort to be vaccinated (Cohort 4) are those aged 16-69 and at very high risk of severe illness and death. Vaccination of this group began in March.
The ongoing review process will continue to look at the other priority groups yet to be vaccinated, along with the competing needs of those working or living in high-risk situations, carers who deliver essential services to highly dependent individuals in the home setting, and those who are socially vulnerable/disadvantaged.
It is important to emphasise that vaccination is only one part of our response to the prevention of COVID-19 infection. People who are vaccinated need to continue with all the public health measures that have been proven to reduce the risk of infection, i.e., limiting our social contacts, physical distancing, wearing a mask, hand hygiene, cough etiquette and avoiding non-essential travel until a sufficiently large proportion of the population are immune.
1611. Deputy Niamh Smyth asked the Minister for Health the reason a person (details supplied) has had home help hours removed from them; the reason the HSE has not yet had other carers in to replace the last carers that finished on 8 March 2021; and if he will make a statement on the matter. [14836/21]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1612. Deputy Catherine Connolly asked the Minister for Health the status of the recruitment of main lead paediatric pain consultant specialist roles by Children’s Health Ireland; the number of paediatric pain consultants employed full-time and part-time, respectively; the number of full-time and part-time paediatric pain consultant roles that are currently vacant; and if he will make a statement on the matter. [14837/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1613. Deputy Catherine Connolly asked the Minister for Health if the recently recruited multi-disciplinary team for children in chronic pain is currently seeing patients; if not, the reason for the delay; the timeline for when they will commence seeing patients; and if he will make a statement on the matter. [14838/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1614. Deputy Catherine Connolly asked the Minister for Health the number of children on the pain relief outpatient waiting list; if Children’s Health Ireland is currently taking referrals for children in need of chronic pain services; if not, the length of time it has been since it took these referrals; the reason it has not been taking these referrals; and if he will make a statement on the matter. [14839/21]
View answerI recognise that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic and acknowledge the distress and inconvenience for patients and their families
The HSE is currently recommending that only critical time dependent elective procedures are undertaken at this time due to the on-going and significant increased demand for bed capacity related to Covid-19.
This decision was made arising from the rapid increase in Covid-19 admissions and to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work.
Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.
The National Waiting List Management Policy is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures. It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1615. Deputy Catherine Connolly asked the Minister for Health if his attention has been drawn to the fact that the pain relief outpatient waiting list reports as listed on the website of the National Treatment Purchase Fund, collates data on waiting lists for pain relief in the age-groups 0 to 15 and 16 to 64 years, despite the commitment by Children’s Health Ireland to treat chronic pain patients up to 18 years of age; if he has concerns that this current age group breakdown makes it difficult to accurately ascertain the number of children up to 18 years of age who are currently awaiting pain relief; and if he will make a statement on the matter. [14840/21]
View answerI recognise that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic and acknowledge the distress and inconvenience for patients and their families
The HSE is currently recommending that only critical time dependent elective procedures are undertaken at this time due to the on-going and significant increased demand for bed capacity related to Covid-19.
This decision was made arising from the rapid increase in Covid-19 admissions and to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work.
Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.
The National Waiting List Management Policy is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures. It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1616. Deputy Pádraig O'Sullivan asked the Minister for Health his plans to produce vaccine certificates as part of implementation planning for a Covid-19 vaccination programme; and if he will make a statement on the matter. [14841/21]
View answerIt is important to differentiate between a vaccine certificate, the purpose of which is to provide evidence that a particular vaccine has been administered to a certain individual on a certain date, with the notion of an immunity passport which might exempt people from public health measures on the basis that the person is purportedly immune to SARS-CoV-2.
As well as providing a record of vaccination, vaccine certificates also facilitate follow up of adverse events. The HSE is planning for the production of vaccine certificates at part of its implementation planning for a COVID-19 vaccination programme.
Immunity passports are problematic on a number of grounds. It is not yet clear if the proposed vaccines for COVID-19 actually stop people getting the virus. It is also not clear whether the thresholds for protective immunity are the same in all groups e.g. older persons or those who are immunosuppressed. Thus, it is premature to discuss immunity passports due to the many uncertainties that still exist regarding immunity against the novel coronavirus. The WHO continues to caution governments against introducing immunity passports at this time.
On 17 March, the EU Commission published its proposal for Regulation for a Digital Green Certificate. This proposed regulation lays down a framework for the issuance, verification and acceptance of interoperable certificates to facilitate free movement. Ireland is carefully considering the proposal and its many policy, infrastructural and operational implications across a number of sectors and authorities.
1617. Deputy Pádraig O'Sullivan asked the Minister for Health if there have been instances of healthcare workers refusing the Covid-19 vaccine; and if he will make a statement on the matter. [14842/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1618. Deputy Brendan Griffin asked the Minister for Health if audiology services (details supplied) will be immediately reopened in County Kerry given the hardship it is causing patients; and if he will make a statement on the matter. [14844/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1619. Deputy Colm Burke asked the Minister for Health the number of referrals to HSE coronavirus community assessment hubs since they began operation; and if he will make a statement on the matter. [14849/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1620. Deputy Colm Burke asked the Minister for Health the number of patients diagnosed with Covid-19 who have been referred to hubs; the number of non-Covid-19 patients referred in tabular form; and if he will make a statement on the matter. [14850/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1621. Deputy Colm Burke asked the Minister for Health if additional community assessment hubs will be rolled out as part of the HSE Winter Plan 2020-2021; and if he will make a statement on the matter. [14851/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1622. Deputy Colm Burke asked the Minister for Health the general practice diagnostic services that are in place and have been provided as part of the HSE Winter Plan 2020-2021; and if he will make a statement on the matter. [14852/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1623. Deputy Colm Burke asked the Minister for Health the locations of community assessment hubs; and if he will make a statement on the matter. [14853/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1624. Deputy Colm Burke asked the Minister for Health the number of patients who were referred to hospital, sent to an isolation facility and that were sent home, respectively, having been assessed in a community hub; and if he will make a statement on the matter. [14854/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible
1625. Deputy Colm Burke asked the Minister for Health if information is available on the types of non-Covid-19 conditions that have been treated at community assessment hubs; and if he will make a statement on the matter. [14855/21]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1626. Deputy Alan Dillon asked the Minister for Health if consideration is being given to reprioritising An Garda Síochána and the Defence Forces in the vaccine allocation strategy for the Covid-19 vaccine roll-out; and if he will make a statement on the matter. [14856/21]
View answerOn the 23rd of February 2021, I announced an update to Ireland’s COVID-19 Vaccine Allocation Strategy.
In comprising the initial Vaccine Allocation Strategy, the NIAC listed several conditions associated with increased risk of severe disease and death. In the intervening period, national and international evidence has become available which has enabled a more detailed analysis of underlying conditions that may increase the risk of developing severe disease or death.
The NIAC has now been able to more comprehensively identify those medical conditions and to distinguish between those which place a person at very high or high risk of severe disease if they contract the virus. Medical conditions and the magnitude of the risk they pose will continue to be monitored and periodically reviewed.
The NIAC continues to monitor data around this disease and indeed emerging data on effectiveness of vaccines on a rolling basis. Further details are available at the following link:
https://www.gov.ie/en/press-release/b44b2-minister-donnelly-announces-update-to-vaccine-allocation-strategy/
The next cohort to be vaccinated (Cohort 4) are those aged 16-69 and at very high risk of severe illness and death. Vaccination of this group began in March.
The ongoing review process will continue to look at the other priority groups yet to be vaccinated, along with the competing needs of those working or living in high-risk situations, carers who deliver essential services to highly dependent individuals in the home setting, and those who are socially vulnerable/disadvantaged.
It is important to emphasise that vaccination is only one part of our response to the prevention of COVID-19 infection. People who are vaccinated need to continue with all the public health measures that have been proven to reduce the risk of infection, i.e., limiting our social contacts, physical distancing, wearing a mask, hand hygiene, cough etiquette and avoiding non-essential travel until a sufficiently large proportion of the population are immune.
1627. Deputy Michael Lowry asked the Minister for Health the steps he will take to expedite funding and approval for patisiran Onpattro or an equivalent drug used to manage the condition hereditary transthyretin amyloidosis; and if he will make a statement on the matter. [14857/21]
View answerThe 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 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 health technology assessment (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 in July 2020, 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 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.
The RDTRC convened on 24 September 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 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. This was received by the HSE Drugs Group on 26 November.
The HSE has advised that it met with the applicant company in December 2020 and in early January 2021 for further discussions and deliberations on the pricing position.
At its January 2021 meeting, the HSE Drugs Group reviewed all the relevant documentation concerning the application, including information provided by the RDTRC. The HSE has advised that, having considered all of the criteria of which is obliged to take account, the HSE Drugs Group was unable to recommend in favour of reimbursement.
The decision-making authority in the HSE is the HSE EMT. The HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Health Act.
The HSE has confirmed that it issued notice to the applicant company of the proposed decision of the EMT not to support reimbursement of Patisiran on 9 February.
Where the HSE EMT has considered a recommendation of non-reimbursement from the HSE Drugs Group and proposes to accept such a recommendation, the HSE is legally required (in line with the 2013 Health Act) to set out in detail a notice of any proposed decision to an applicant company.
The HSE is also legally required in such circumstances to provide at least a 28-day period (from the formal written notice of proposal) to enable an applicant company to consider the proposal not to reimburse and to make representations to the HSE. The HSE is legally required to consider any such representations in advance of a formal decision.
The HSE advises that the applicant company submitted representations on the 5 March 2021 in response to the EMT’s proposed decision. The HSE Drugs Group will review these representations before making a recommendation to the HSE EMT on the basis of all of the available evidence, in line with the 2013 Health Act.
The application for the reimbursement of Patisiran remains under consideration with the HSE. As decision-making authority, the HSE EMT will, following receipt of the outcome of the HSE Drugs Group's deliberations, make a decision on whether Patisiran will be reimbursed.
