Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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487. To ask the Minister for Health his views on the Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021; if he supports the proposed amendment to the Health Act; and if he will make a statement on the matter. [38269/22]

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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490. To ask the Minister for Health his plans to amend the Health Act 2007 to account for the unique context surrounding orphan medicinal products and advanced therapy medicinal products such as gene therapy; and if he will make a statement on the matter. [38272/22]

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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492. To ask the Minister for Health his plans to expedite the drug reimbursement process to account for the life-threatening nature of rare diseases; if he intends to make changes to the reimbursement process in Ireland that would enable expedited access for patients with severe unmet needs; and if he will make a statement on the matter. [38274/22]

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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495. To ask the Minister for Health his views on the continued use of the QALY threshold is respect of the drug reimbursement process; if his attention has been drawn to the negative consequences the use of the QALY as a cost-effectiveness tool can have on serving the unmet needs of rare disease patients; and if he will make a statement on the matter. [38277/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 487, 490, 492 and 495 together.

The 2013 Health (Pricing and Supply of Medical Goods) Act is a clear, robust, statutory framework under which all new medicinal products must be assessed by the HSE. The HSE is the statutory decision-maker for the reimbursement of such products, and the Act ensures that these decisions are made on an objective and scientific basis.

The Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021 seeks to remove any threshold incremental cost-effectiveness ratio (ICER) informed by the Quality-Adjusted Life Years (QALY) metric from the assessment of orphan medicinal products while retaining the responsibility for the HSE to consider cost-effectiveness under modified criteria.

The QALY is the economic evaluation system which is used to set a threshold of cost-effectiveness when assessing medicines. Using the QALY, the National Centre for Pharmacoeconomics (NCPE) can systematically assess new medicines for cost effectiveness. Disregarding a validated systematic evidence-based scientific methodology to inform decision-making would greatly limit the HSE’s capacity to determine whether the submitted price for orphan drugs represents value for money. In the absence of cost-effectiveness information on orphan drugs, the HSE would enter commercial negotiations in an uninformed, and therefore disadvantageous position.

The 2013 Health Act does not provide for a different ruleset when assessing orphan medicines. However, the criteria that apply to the evaluation process allow the HSE to have particular regard for the unique circumstances surrounding orphan drugs. The statutory framework in the 2013 Act requires the HSE to take account of a range of objective factors and not just cost-effectiveness under the QALY system. In making reimbursement decisions, there is a list of criteria contained in the Act which the HSE is required to consider, including the magnitude of the clinical effect, cost effectiveness, budget impact, available resources, and unmet medical need.

Consequently, the QALY economic evaluation system does not restrict the HSE from applying discretion particularly in seeking to address unmet medical need. In making reimbursement decisions, the HSE often reimburses orphan medicines in excess of a cost per QALY of €45,000 in cases where the potential to address unmet need is supported by robust clinical evidence.

Budget 2021 allocated €50 million for the approval of new drugs and nineteen of the fifty-two new medicines approved by the HSE in 2021 were orphan medicines, representing over one third of approvals. Budget 2022 allocated a further €30 million for the approval of new drugs. The HSE has approved 36 new medicines/new uses of existing medicines to date in 2022 including three medicines for the treatment of rare diseases.

Notwithstanding the concerns outlined above, the Bill is honourable in its intent and must serve as an opportunity to explore the policy options available to us. We all want an assessment process for orphan medicines which provides our most vulnerable patients with access to the innovative treatments which they deserve. The Bill represents an opportunity to comprehensively look at the current system and consider how issues such as transparency and communication can be improved, and I have asked my officials to do that.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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488. To ask the Minister for Health his plans to expedite the reimbursement process given that it currently takes, on average, 870 days for a patient to gain access to an EMA-approved orphan medicine in Ireland; the work his Department is doing in partnership with the HSE to ensure that this delay improves; and if he will make a statement on the matter. [38270/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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.

Reimbursement is for licenced indications which have been granted market authorisation either by the European Medicines Agency (EMA) or by the Health Products Regulatory Authority. The majority of new, innovative medicines are evaluated by the EMA and authorised via the European Commission’s centralised procedure in order to be marketed in the EU.

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.

In line with the 2013 Health Act and the national framework agreed with industry, once a new medicine has received marketing authorisation, a company must submit an application to the HSE to have the product added to the reimbursement list.

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 final decision-making authority in the HSE is the HSE Executive Management Team (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.

As outlined in the Framework Agreement with industry on the pricing and supply of medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving a company’s pricing/reimbursement application (or a longer period if further information is sought from the company), whether to approve a new medicine for reimbursement.

The HSE must ensure that the best possible price is achieved for new medicines as these commitments often represent multimillion-euro investments over several years. This can lead to protracted commercial negotiations.

The fundamental challenge that applies to consideration of almost all new medicines in Ireland is their price and affordability in a budget-limited health service. However, the allocation of dedicated funding for new medicines has had a positive impact on the reimbursement of orphan drugs.

The allocation of €50m for new medicines in 2021 enabled the HSE to approve 52 new medicines/expanded uses of existing medicines in 2021, 19 of which were for the treatment of rare diseases. Budget 2022 has allocated a further €30m for new medicines this year which will provide access to new innovative medicines for patients.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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489. To ask the Minister for Health if Ireland is currently in breach of the European Union Transparency Directive 89/105/EEC; if his Department intends to reduce the ongoing delays for patients to gain access to European Medicines Agency-approved medicine in Ireland; and if he will make a statement on the matter. [38271/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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491. To ask the Minister for Health the work that is being carried out to enhance transparency and improve communication with patient groups and industry during the drug reimbursement process; if he will be open to providing a mechanism for patient groups and industry to establish communication with the HSE central processing unit throughout the reimbursement process; and if he will make a statement on the matter. [38273/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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.

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 NCPE has advised that it is unable to publicise all documents and information which it receives as part of the submissions from pharmaceutical companies, as much of this information is commercially sensitive and received in confidence. Companies insist that parts of the application are confidential.

The NCPE publish a Technical Summary Document for each completed Health Technology Assessment (HTA), which provides an overview of the clinical and economic dossier reviewed by the NCPE, and the outcomes of the economic assessment.

The NCPE’s website is updated in real time in respect of all steps in the HTA process. Additionally, their dedicated online section for patients includes information on the submission process, the drug reimbursement process and how to interpret NCPE recommendations.

The HSE has also confirmed that it faces significant challenges in publishing all of the information it uses in decision-making, as such information is also subjected to commercial confidentiality by the pharmaceutical companies.

The NCPE’s Patient Organisation Submission Process encourages consideration of the lived experience of patients, carers and their families, as well as their views on the difference a new medicine may make. This information is then used as part of the Health Technology Assessment of medicines undergoing evaluation.

The HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The role of the Drugs Group is to make a recommendation to the HSE Executive Management Team (EMT) in relation to each individual application having considered the criteria under the 2013 Act. The group also includes representation from the National Patient Forum.

When considering applications, the HSE can request the input of the Rare Disease Technology Review Committee (RDTRC). The RDTRC gives a voice to rare disease patients and also to clinicians with expertise in the specific illnesses in question. Using the guidance from the Committee, the HSE is able to take account of the challenges faced by patients in terms of unmet need and the potential impact of the drug, alongside considerations of cost effectiveness.

The Drugs Group considers the NCPE assessment, the outputs from commercial engagements, patient interest group submissions, and any other pertinent information in advance of providing its recommendation to the HSE EMT.

As the decision-making authority within the HSE, 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.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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493. To ask the Minister for Health if his Department has examined international best practice such as in Scotland and Germany on the matter of interim and early access reimbursement models; and if he will make a statement on the matter. [38275/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I can confirm that interim and early access reimbursement models have been examined. The HSE and the Department would not support a pathway enabling reimbursement in the Irish context while further clinical evidence and data is collected on a given medicine.

The HSE and NCPE advise that such a pathway would rest on the assumption that the collected data would support a positive reimbursement recommendation, which is often not the case.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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494. To ask the Minister for Health the engagement he has had with his Department officials and HSE officials regarding the use of innovative payment models between industry and the State in respect of the drug reimbursement process for rare disease therapies; if he is open to such innovative solutions to ensure greater access; and if he will make a statement on the matter. [38276/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes. The 2013 Health (Pricing and Supply of Medical Goods) Act is a clear, robust, statutory framework under which all new medicinal products must be assessed by the HSE. The HSE is the statutory decision-maker for the reimbursement of such products, and the Act ensures that these decisions are made on an objective and scientific basis.

The HSE Corporate Pharmaceutical Unit (CPU) is expected to deliver the best possible pricing positions in all negotiations so as to enable the HSE to reimburse as many medicines as possible, to as many patients as possible, within the resources provided to the HSE. In recent years, several steps have been taken to ensure that a high degree of communication exists between the HSE, the National Centre for Pharmacoeconomics (NCPE), and the pharmaceutical industry. The HSE Executive Management Team (EMT) decides on the basis of all the demands it is faced with (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 them.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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496. To ask the Minister for Health his plans to improve the health data infrastructure of the State; the way these plans can support innovative payment models in respect of the reimbursement of orphan medicinal products and advanced therapy medicinal products; and if he will make a statement on the matter. [38278/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.