Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Stephen Donnelly (Wicklow, Fianna Fail)
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The Rapid Review process has been a core component of the NCPE’s assessment pathway for 14 years. It facilitates the identification of drugs which require additional assessment in the form of a full Health Technology Assessment (HTA), while maintaining a robust appraisal of the relevant clinical and economic evidence for drugs which do not require further assessment. It allows for appropriate resource prioritization within a national HTA agency and is considered to be an efficient way of determining the requirement for a full HTA and targeting resources for those drugs where there is most value in conducting a HTA.

The objective of the Rapid Review is to provide a recommendation to the HSE on the need for a full HTA and, in some cases, on reimbursement. Following the Rapid Review, a full HTA will subsequently be required for those drugs for which additional information and/or analysis is required to inform a reimbursement recommendation. Where a full HTA is not required, a reimbursement recommendation may be made to the decision-maker at this stage. Reimbursement decisions in Ireland are made by the HSE on the basis of decision-making criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013, which includes additional criteria to those assessed by the NCPE.

Factors which are evaluated during Rapid Review and thus inform the requirement for a full HTA include: the cost of the drug relative to potential comparators; uncertainty in relation to comparative clinical effectiveness; uncertainty in relation to cost effectiveness; and the potential drug budget impact. Further details in relation to Rapid Review recommendations and interpretation are outlined in a recent journal article authored by NCPE staff which is available here: doi.org/10.1007/s40273-021-01093-8.

The Framework Agreement on the Supply and Pricing of Medicines (2021-2025) outlines that the NCPE endeavour to complete the Rapid Review within a 4-week timeframe. The NCPE review process involves critical appraisal of the Applicant submission using standard formal criteria, independent targeted literature review, validation of inputs and assumptions and independent clinical opinion. In summary, the formal criteria assessed by the NCPE Review Group include:

• The disease epidemiology and the eligible population.
• The licensed indication and the proposed place in therapy of the pharmaceutical within relevant treatment guidelines and clinical pathways.
• Potential comparators (defined as current standard of care treatments). Clinical opinion may be sought to establish clinical pathways and current standard of care for patients in Ireland.
• The robustness of the clinical and safety evidence, in particular whether there is direct clinical trial evidence versus current standard of care to determine comparative effectiveness and safety.
• Economic considerations, including the cost of the drug relative to potential comparators, and net and gross drug budget impact estimates.
• Other indications for which the drug is being investigated or for which a license is sought.
• The outcomes of HTAs from other jurisdictions, if available at the time of assessment.
• The critical appraisal of the Rapid Review submission determines the requirement for a full HTA. The criteria that may deem a full HTA unnecessary in order for reimbursement to be recommended at this stage are:
• Robust clinical efficacy data indicating that the drug is non-inferior or is superior relative to the standard-of-care comparator(s) while being equal or lower in cost;
• A small eligible population with an unmet need and a low estimated net drug budget impact.
• A low estimated net drug budget impact, along with the potential for a system to allow usage to be restricted to particular subgroups or indications (e.g. via the High Tech Hub or a Managed Access Programme). This may facilitate a positive recommendation. Here, the NCPE will recommend reimbursement if a process may be introduced to ensure that the appropriate place in therapy / net drug budget impact may be realised as outlined in the Applicant submission.
• Similarly, where there is no evidence of therapeutic advantage associated with a drug that is considerably more expensive than the appropriate comparator(s), a full HTA may be deemed unnecessary in order to make a recommendation against reimbursement.
• Where the clinical efficacy and safety is similar to current standard of the care, the NCPE may advise a price reduction (so that the drug is equal or lower in cost relative to the comparator) in order to recommend reimbursement.
• Therefore, there are multiple criteria involved in the determination of the Rapid Review recommendation and this is made by careful consideration of the evidence and the experience and judgement of the NCPE Review Group.

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health (Pricing and Supply of Medical Goods) Act 2013 provides a rigorous process for the assessment of new medicines for reimbursement. This allows taxpayers to be confident both that the right medicines are chosen, and that those medicines are approved at a price that can sustainably be afforded in a budget-limited health service. Economic assessment is valuable to stretch the funds granted to the HSE as far as possible, allowing them to provide a range of services as well as innovative medicines for all citizens.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the 2013 Act. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority. In line with the 2013 Act, and the national framework agreed with industry, a company must first submit an application to the HSE to have a new medicine added to the reimbursement list.

The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. Describing timelines for reimbursement from EMA approval to HSE reimbursement approval does not consider this important factor and misrepresents the process, as statutorily the HSE is precluded from approving or assessing a drug for reimbursement a drug until an application is received from the company holding the market authorisation.

When an application is made to have a product added to the reimbursement list in Ireland, the HSE is required, under the 2013 Act, to decide within 180 days of receiving the application, to either add the medicine to the reimbursement list or refuse to reimburse the medicine. In assessing the application, the HSE is required by statute to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.

The principal factors in determining how quickly a reimbursement decision is made are the price at which a manufacturer applies for the reimbursement of a product and the level of engagement by the applicant company with the HSE’s rigorous assessment process as to its clinical and cost-effectiveness.

In terms of the time taken from application to a decision on reimbursement, the HSE advise that the biggest impediments to achieving the 180-day timeline is often the failure of companies to provide sufficient evidence to support the efficacy of some medicines, and the need for the HSE to get involved in protracted negotiations in seeking to achieve better prices for the State.

In 2024, there will be significant investment in additional staff resources to enhance the HSE’s medicines pricing and reimbursement process. This is a recommendation of the working group established following the publication of the Mazars ‘Review of the Governance Arrangements and the Resources in place to support the HSE’s reimbursement and pricing decision-making process’ in February 2023.

Investing in this capacity will support agencies to operate to the fullest of their ability, providing timely and efficient evaluation of medicines for reimbursement.

The State?is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 - 2023 provided almost €100 million of dedicated funding for new drugs. This enabled the HSE to approve 148 new drugs, 61 of which are for cancer.

I have secured a further €20 million in funding for new medicines in 2024. I will also ensure that my Department, the HSE and all relevant agencies and stakeholders place a priority focus on achieving the most efficient and effective use of available resources across the acute and community settings, supporting cost reduction which can then be considered for reinvestment, as appropriate.

As Minister for Health, I regulate the private health insurance market. This is a voluntary market, which is underpinned by certain principles, including minimum benefit, that are set out in law. The Health Insurance Act 1994 (Minimum Benefit) Regulations 1996 require insurers to offer a minimum level of cover to every insured person. I do not have a role in the commercial decision-making of any private health insurer.

Private Health Insurance companies operate as commercial entities in a competitive private health insurance market. Beyond prescribing under the Regulations the minimum level of coverage that health insurers must provide, I am not in a position to direct any insurer to provide cover for any particular procedure or service or medicine, or direct how that cover is to be provided.