Dáil Éireann Debate, Tuesday - 12 July 2022
985. Deputy Colm Burke asked 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 provide a mechanism for patient groups and industry to establish communication with the HSE corporate pharmaceutical unit throughout the reimbursement process; and if he will make a statement on the matter. [37821/22]
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.
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.
