Tuesday, 13 October 2020
Department of Health
National Centre for Pharmacoeconomics
494. To ask the Minister for Health if his Department has examined the use of the quality-adjusted life year in determining drug funding; the conclusions made to its effectiveness; and if he will make a statement on the matter. [30007/20]
The Quality-adjusted life Years (QALY) is the economic evaluation system which is used to set a threshold of cost-effectiveness when assessing medicines in Ireland. The QALY is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life gained for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person’s ability to carry out the activities of daily life, and freedom from pain and mental disturbance.
In March 2018, the Report on Evaluating Orphan Drugs published by the Joint Committee on Health, was received by my Department. The Committee’s report put forward a number of recommendations including the recommendation that ‘the QALY process is revised completely and replaced with a new assessment process. Such a process should be specific and appropriate to orphan drugs’. This recommendation was carefully considered by my Department, the Health Service Executive and the National Centre for Pharmacoeconomics.
It was determined that the QALY is the best metric we have in the area of health economics to express health outcomes. The QALY provides a useful way of assessing the value of a health intervention as this system combines mortality and morbidity into a single metric. The use of a generic measure of outcome such as the QALY makes it possible to compare outcomes from different technologies across different activities in the healthcare sector.
Calculation of cost-effectiveness ratios using QALYs also facilitates characterisation of the value of an intervention by making it possible to compare those ratios with common benchmarks. The value benchmark in Ireland for drugs ranges from €20,000-€45,000/QALY. This benchmark represents the “value” of a QALY; i.e. the “willingness to pay” to gain 1 QALY of health. Interventions with lower cost-effectiveness ratios below the threshold are said to have a favourable value. Interventions with higher ratios are considered to have unfavourable value.
The NCPE has advised that until such time as a comprehensive, reliable, scientifically validated alternative to the QALY can be found, we should continue to use the QALY to express health outcome benefits from the medicines that we assess for value for money. Removing the QALY would have serious financial implications and currently there is not a comprehensive, reliable and validated methodology to replace it with.
In this context, it is important to note that the statutory 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 the reimbursement of medicines, requires the HSE to take account of a range of objective factors and expert opinion as appropriate and not just cost-effectiveness under the QALY system. There is a list of criteria which the HSE is required to consider including the magnitude of the clinical effect, cost effectiveness, budget impact and the unmet need.