The art and science of improving patients’ compliance with medical care has always been complex. Measuring patient compliance – and linking the level of compliance to health outcomes – is rarely straightforward. And there is another step: using health economics analysis in the attempt to quantify the benefits on health outcomes of compliance enhancing initiatives.
Put all these together and you have the challenging situation facing more and more of us working in reimbursement.
The Pharmaceutical Benefits Advisory Committee recognises the need for greater insight into the role of compliance on health outcomes. As a result, the Compliance to Medicines Working Group (CMWG) was established under the Drug Utilisation Sub Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC). The CMWG has prepared an insightful and comprehensive review of the available literature. Maxine Robinson (Pharmaceutical Benefits Branch) presented the findings of the Compliance to Medicines Working Group Report at the recent ARCS Congress in Canberra.
These are some of the highlights of the draft report:
- Health benefits from improved compliance are often assumed rather than demonstrated in health technology assessments.
- Statistical differences in measured levels of compliance do not necessarily translate into clinically meaningful differences in health outcomes.
- It is often suggested that a compliance level of at least 80 per cent is necessary, but little evidence exists to support this (the exception being in the use of protease inhibitor therapy in HIV).
- Compliance to medicines is difficult to measure, particularly compliance with long-term, self-administered therapies. There is also significant variance when different methods are applied, even within a single study.
- The usual hierarchy of evidence for studies of efficacy and safety may not necessarily apply to studies of consumer compliance. Pragmatic and ‘real-world’ studies may play a greater role.
- Study design and statistical methodology is evolving: administrative data (such as prescription refills) analysis is increasingly used to assess consumer compliance.
- The current lack of comprehensive linked health data in Australia poses major challenges in this research area, and for making reimbursement and funding decisions.
- For a compliance-enhancing intervention to be cost-effective, an economic evaluation should demonstrate that the intervention improves compliance in a way that can be linked to a health gain.
- Changes in compliance affect both the numerator and the denominator of the incremental cost-effectiveness ratio (ICER). Compliance’s effect on an ICER is therefore not always predictable.
- Using current methods, it is particularly challenging to establish whether any measured improvement in compliance is attributable to a combination item alone. Controlling for bias in this research is difficult.
- Measured differences in compliance over short times frames such as 6 months may not be relevant when considering compliance to medicines for treatment of chronic lifelong conditions.
- Given that combination items will often replace widely-prescribed medicines for common conditions such as cardiovascular disease, there can be substantial financial implications from exempting combination items from future price reductions.
The Working Group’s draft report is currently available for public consultation and comment on the website www.pbs.gov.au. After the public consultation period, the final report will be publicly available to inform and assist those working in this developing research area.
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