Colm Burke (Cork North Central, Fine Gael)
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539. To ask the Minister for Health the way capacity challenges at the National Centre for Pharmacoeconomics can be addressed to avoid significant delays in the evaluation process of oncology medicines in Ireland through the reimbursement pathway; and if he will make a statement on the matter. [12596/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The National Centre for Pharmacoeconomics (NCPE) was established in 1998. Its remit is to advise the HSE and the Department of Health in relation to the cost-effectiveness of medicines, through the carrying out of health technology assessments (HTAs).

The NCPE's workload has increased significantly in recent years, from fewer than 10 assessments per year in 2007 to 98 assessments in 2021. In addition, the complexity of individual assessments has increased.

Following an independent review of the NCPE's work in 2017, an additional €750,000 was allocated by the Minister for Health in 2018 to support the working of the NCPE, increasing its staffing from 10.5 to 20.5 WTEs.

The NCPE advises that cancer drugs account for 33% of the NCPE's rapid reviews and 50% of full Health Technology Assessments (HTAs). The average timelines for these are approximately 4 to 6 weeks for a rapid review and 158 days for full HTAs. Given the complexities involved in such assessments, these timelines can be considered within expectations.

As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving an application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.

Colm Burke (Cork North Central, Fine Gael)
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540. To ask 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]

Colm Burke (Cork North Central, Fine Gael)
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541. To ask 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]

Colm Burke (Cork North Central, Fine Gael)
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542. To ask 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]

Stephen Donnelly (Wicklow, Fianna Fail)
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I 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.

Colm Burke (Cork North Central, Fine Gael)
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543. To ask 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]

Stephen Donnelly (Wicklow, Fianna Fail)
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Currently, 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.

Steven Matthews (Wicklow, Green Party)
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544. To ask 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]

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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 17^thSeptember 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 18^thSeptember 2019. Following receipt of a rapid review dossier, the National Centre for Pharmacoeconomics (NCPE) advised the HSE (24^thOctober 2019) that a full Health Technology Assessment (HTA) was required for this medicine. The HSE commissioned a full Health Technology Assessment on the 29^thOctober 2019 as per agreed processes.

The NCPE Health Technology Assessment (HTA) report was received by the HSE on the 10^thFebruary 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/m²with 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/m²with 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/m²with 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.