Written Answers Nos. 540-559
540. Deputy Colm Burke asked the Minister for Health if consideration will be given to establishing an oncology-specific managed access fund enabling access to new oncology medicines while clinical uncertainties are being addressed through evidence development and the criteria for routine reimbursement is satisfied (details supplied); and if he will make a statement on the matter. [12597/22]
View answer541. Deputy Colm Burke asked the Minister for Health if consideration will be given to multi-year-multi-indication agreements with regard to oncology medicines in Ireland during the reimbursement pathway (details supplied); and if he will make a statement on the matter. [12598/22]
View answer542. Deputy Colm Burke asked the Minister for Health if he will consider expanding the next agreement with an organisation (details supplied) to include a forward-looking funding framework over a rolling four-year period for new medicines to improve the reimbursement system in helping to deliver faster access for patients and greater budget predictability for the Government; and if he will make a statement on the matter. [12599/22]
View answerI propose to take Questions Nos. 540 to 542, inclusive, together.
As the Deputy will be aware, the Oireachtas put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013 which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.
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.
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).
The degree of clinical benefit and value for a given medicine may vary considerably between indications. The HSE therefore advises that the current pricing/reimbursement assessment process for new uses of currently reimbursed medicines derives significant value for the health service.
I am advised by the HSE and NCPE that a process of pre-approval enabling of reimbursement while further clinical evidence and data are collected on a given medicine is not recommended. The HSE and NCPE have indicated that such a process would be founded upon the assumption that the collected data would support a positive reimbursement recommendation, which is often not the case.
It is clear from an analysis of trends over the last few years that the overriding factor in the approval of medicines for reimbursement is the availability of Exchequer resources.
- In 2020 there was no dedicated funding allocated for new drugs and the HSE approved 11 new medicines / new uses of existing medicines in the area of cancer treatment. This represents 48% of all approvals that year. Such decisions had been pending with the HSE Executive Management Team (EMT) since 2019 until a dedicated funding stream for new medicines in 2021 was confirmed in Budget 2021.
- In 2021, the HSE was allocated €50 million for the reimbursement of new medicines and approved 26 new medicines / new uses of existing medicines in the area of cancer treatment. That represents 50% of approvals that year.
- Budget 2022 allocated €30 million to the HSE for the approval of new medicines. As of 15 February, the HSE has approved 10 new medicines / new uses of existing medicines in 2022.
In December 2021, I announced two new Framework Agreements on Pricing and Supply of Medicines.
The multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in reducing the cost of medicines and improving access to innovative new medicines for patients for the years 2021 to 2025.
543. Deputy Colm Burke asked the Minister for Health if consideration will be given to the development of a clear budget structure for medicines that includes minimum annual funds necessary to support access to new medicines (details supplied); and if he will make a statement on the matter. [12600/22]
View answerCurrently, the legislation underpinning the budgetary framework for current expenditure caters only for an annual budgeting process for the health service. The Sláintecare Implementation Strategy commits to reform the funding system to support new models of care and drive value to make better use of resources.
The Government acknowledges the pipeline of new medicines and recognises the value of investment in new drugs where cost-effective. It is estimated that in the region of 97 new indications will receive market authorisation in Europe each year over the next 5 years. This of course poses a funding challenge in the context of the many competing demands on the Exchequer. This challenge will be ameliorated to a degree by the two new Framework Agreements on Pricing and Supply of Medicines finalised late in 2021. The multiannual agreements, with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) respectively, represent an important step in reducing the cost of medicines and facilitating access to innovative new medicines for patients for the years 2021 to 2025.
The dedicated funding of €30m provided for new medicines in Budget 2022 will facilitate access for patients to new medicines, including those for rare diseases. The HSE and National Centre for Pharmacoeconomics (NCPE) advise that there are currently a significant number of new drugs currently undergoing assessment. The HSE will robustly assess all of these in line with the criteria contained in the Health Act 2013.
544. Deputy Steven Matthews asked the Minister for Health if his attention has been drawn to the campaign to make a drug (details supplied) available under the drugs payment scheme; if this is under review; and if he will make a statement on the matter. [12603/22]
View answerThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, 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.
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).
The HSE received an application for pricing / reimbursement of Liraglutide (Saxenda®) on the 17th September 2019 from Novo Nordisk (the applicant) as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of 30 kg/m² (obesity), or 27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
The HSE commissioned a rapid review process on the 18th September 2019. Following receipt of a rapid review dossier, the National Centre for Pharmacoeconomics (NCPE) advised the HSE (24th October 2019) that a full Health Technology Assessment (HTA) was required for this medicine. The HSE commissioned a full Health Technology Assessment on the 29th October 2019 as per agreed processes.
The NCPE Health Technology Assessment (HTA) report was received by the HSE on the 10th February 2021. The NCPE recommended that Liraglutide (Saxenda®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. The HTA was conducted in a defined subgroup of the full licensed indication, namely Liraglutide (Saxenda®) as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with a body mass index of 35kg/m2 with pre-diabetes and high risk of cardiovascular disease.
The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU engaged in commercial negotiations with Novo Nordisk in March 2021 regarding their application for Liraglutide (Saxenda®). Novo Nordisk confirmed their intent to pursue reimbursement for a defined subgroup of the full licensed indication, namely as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with a body mass index of 35kg/m2 with pre-diabetes and high risk of cardiovascular disease.
The 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. Liraglutide (Saxenda®) was considered by the Drugs Group in September 2021. The final HTA report was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations, and the patient group submission received during the HTA process. The HSE Drugs Group made a recommendation to support reimbursement of Liraglutide (Saxenda®) as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with a body mass index of 35kg/m2 with pre-diabetes and high risk of cardiovascular disease. The positive recommendation is conditional on the implementation of a managed access programme.
The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE EMT considered the recommendation of the Drugs Group and subsequently supported reimbursement of Liraglutide (Saxenda®) under the Community Drugs Schemes.
As a condition of reimbursement, an individual patient approval system will now be implemented by the Primary Care Reimbursement Service (PCRS) to enable reimbursement for patients who meet the pre-defined criteria as per a Medicines Management Programme (MMP) devised managed access programme. The processes necessary to implement this required managed access programme (MAP) are currently being developed by the HSE MMP along with relevant internal stakeholders.
545. Deputy Fergus O'Dowd asked the Minister for Health his position with regard to the business case submission by an organisation (details supplied) seeking investment for additional staff and capital investment to expand its services and increase its clinical facilities; if a commitment to fully support the business case will be provided; and if he will make a statement on the matter. [12620/22]
View answerAs this may refer to service issues, I have referred the query to the HSE for direct reply.
546. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes aged 18 years and over who are waiting on a first appointment to the outpatient diabetes clinic in Cork University Hospital; and the number of those persons who are waiting six to 12, 12 to 18, 18 to 24, 24 to 36, 36 to 48 and more than 48 months, in tabular form. [12622/22]
View answer547. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes aged 18 years and over who are waiting on a first appointment to the outpatient type 1 diabetes clinic in Cork University Hospital; and the number of those persons who are waiting six to 12, 12 to 18, 18 to 24, 24 to 36, 36 to 48 and more than 48 months, in tabular form. [12623/22]
View answer548. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes aged 18 years who were previously attending the Cork University Hospital paediatric diabetes clinic and over who are waiting on a first appointment to the outpatient type 1 diabetes clinic; and the number of those persons who are waiting six to 12, 12 to 18, 18 to 24, 24 to 36, 36 to 48 and more than 48 months, in tabular form. [12624/22]
View answer549. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes who are waiting on a first appointment to the outpatient diabetes clinic in Cork University Hospital; and the number of those persons who are aged 18 to 24, 25 to 34, 35 to 44, 45 to 54, 55 to 64, 65 to 74, 75 to 84 and over 85 years of age, in tabular form. [12625/22]
View answer550. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes who are waiting on a first appointment to the outpatient type 1 diabetes clinic in Cork University Hospital; and the number of those persons who are aged 18 to 24, 25 to 34, 35 to 44, 45 to 54, 55 to 64, 65 to 74, 75 to 84 and over 85 years of age, in tabular form. [12626/22]
View answerI propose to take Questions Nos. 546 to 550, inclusive, together.
As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly as soon as possible.
551. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes aged 18 years and over who were admitted through the emergency or medical assessment units of any South/Southwest Hospital Group hospital due to diabetic ketoacidosis in each of the years 2017 to 2021, in tabular form. [12627/22]
View answer552. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes aged 18 years and over who were admitted through the emergency or medical assessment units of any South/Southwest Hospital Group hospital due to diabetic ketoacidosis; and the number of those admissions that were persons diagnosed prior to admission with diabetes in each of the years 2017 to 2021, in tabular form. [12628/22]
View answer553. Deputy Sean Sherlock asked the Minister for Health the number of persons with diabetes aged 18 years and over who were admitted through the emergency or medical assessment units of any South/Southwest Hospital Group hospitals due to severe hypoglycaemia in each of the years 2017 to 2021, in tabular form. [12629/22]
View answerI propose to take Questions Nos. 551 to 553, inclusive, together.
As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly as soon as possible.
554. Deputy Bernard J. Durkan asked the Minister for Health when an updated green folder incorporating the relevant documentation for the wedding on 16 July 2022 of persons will be furnished in the case of a person (details supplied); and if he will make a statement on the matter. [12630/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
555. Deputy Peadar Tóibín asked the Minister for Health if the latest announcement from the British Government that it will soon end telemedicine abortion will inform Irish public policy on this issue given the HSE acknowledgement that it relies upon literature from Britain to inform the policy of telemedicine abortion in Ireland. [12636/22]
View answerAs part of the Government’s ongoing efforts to protect public health and limit the spread of Covid-19, the Department of Health and the HSE worked together in 2020 to put arrangements in place to allow termination of pregnancy services in early pregnancy to be provided remotely.
For the duration of the Covid-19 public health emergency, where the need for social distancing, reducing personal contacts and reducing the burden on medical practitioners are paramount, it became possible for a woman to access a termination under section 12 of the Health (Regulation of Termination of Pregnancy) Act 2018 (i.e., before 12 weeks) from her medical practitioner by telephone or video conference consultation.
There is ongoing engagement between the Department of Health and the HSE to monitor service provision, facilitate the smooth-running of the service and resolve any issues that may arise. However, as restrictions are beginning to ease, the Department is currently reviewing whether remote consultation as part of a blended approach to termination of pregnancy care should be continued post the COVID-19 public health emergency period. A decision is expected in the coming weeks.
556. Deputy David Cullinane asked the Minister for Health his views on a recent report (details supplied) published by the World Health Organisation; if there are plans to implement the recommendations of the report; and if he will make a statement on the matter. [12645/22]
View answerI welcome the very recent publication of the World Health Organization report “How the Marketing of Formula Milk Influences Our Decisions on Infant Feeding”. The report covers eight countries: Bangladesh, China, Mexico, Morocco, Nigeria, South Africa, the UK and Vietnam.
Encouraging mothers to breastfeed is a priority for the Department of Health. To deliver on this priority, the HSE is working to achieve the aims and objectives of “Breastfeeding in a Healthy Ireland – HSE Action Plan 2016-2021”. Due to the impact of the COVID-19 pandemic on the delivery of some actions, the HSE has extended the implementation of the Breastfeeding Action Plan into 2022 and continue to work on priority outstanding actions.
In 2021, significant investment towards implementing the HSE Breastfeeding Action Plan was announced, with €1.58 million of funding to provide an additional 24 lactation consultants across hospital and community settings. These additional lactation consultants will help ensure timely skilled assistance for mothers who wish to breastfeed and support enhanced training, skills and knowledge to frontline staff.
Officials in the Department will consider in detail the recommendations in the report.
557. Deputy Brendan Griffin asked the Minister for Health if additional care will be provided for a person (details supplied); and if he will make a statement on the matter. [12646/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
558. Deputy Niamh Smyth asked the Minister for Health if the case of a person (details supplied) will be reviewed; the status of occupational therapy and physiotherapy appointments for them; and if he will make a statement on the matter. [12649/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
559. Deputy Fergus O'Dowd asked the Minister for Health if a commitment will be made to a full national review of pay and conditions for staff in women and children's refuges across the country given refuge staff are currently aligned to the HSE social care scales as recommended in the Murphy report 2008, but this is not reflected in the budgetary process and staff have not had a pay rise or increase of increment in 12 years; and if he will make a statement on the matter. [12667/22]
View answerThe Deputy may wish to raise this question with the Minister for Equality, Disability, Integration and Youth whose remit includes the refuges mentioned by the Deputy. I have no role in this regard.
