Australasian Science Magazine

By Jessica Pace and Wendy Lipworth, Sydney Health Ethics

The withdrawal or reduction of a medication or surgical technique can make healthcare safer, cheaper and more effective. However, practical and ethical challenges mean that we can't solely rely on this to ensure a fair distribution of healthcare.

Systems that fund healthcare, such as Australia’s Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS), face two key challenges. First, health technologies are expensive, and are getting more so. Second, people often want fast access to new technologies, sometimes even when evidence of safety, effectiveness and value for money is lacking.

One way to respond to these challenges is ‘disinvestment’: removing a health technology from the market or restricting its use to situations that offer best value for money. By disinvesting from ‘low value’ technologies (i.e. those that offer little or no net benefit), we free up resources to use for safer, more effective or more cost-effective technologies.

Countries around the world have begun to look for ways of systematically disinvesting from low value health care. You may, for example, have heard of the Choosing Wisely campaign, which aims to encourage a reduction in wasteful medical tests, procedures and treatments. In Australia, this campaign has identified and led to recommendations on issues such as the routine use of opioid-based painkillers in patients who don’t actually need these addictive drugs.

One of the supposed advantages of disinvestment is that it allows interventions to be “conditionally approved” by regulators and funders even if the necessary evidence is not yet known. In other words, regulators and funders are able to say “yes, but…”: yes, they can be used, but only on the condition that the missing data will be gathered. If this evidence goes on to show that the intervention doesn’t live up to the required standards, then regulatory approval or subsidy will be withdrawn.

A number of countries—including the US, Canada, Italy, France, Switzerland and Australia—have implemented these sorts of schemes. One example in Australia is the conditional funding of medicines to treat some lung cancers and certain kinds of melanoma.
While this “yes, but” approach has the advantage of speeding up access to healthcare interventions while the evidence catches up, it also means that we, as a society, will increasingly be asked to make difficult choices about taking interventions away from groups of patients. It is, therefore, crucial that we develop an ethical approach to doing so.

First and foremost we need to protect the interests of patients. By removing access to interventions that are not as safe or don’t work as well as expected, disinvestment can actually benefit patients and protect them from harm. But, we have the potential to cause other harms too: what if patients are benefitting from a treatment that is subsequently taken away and don’t have any other treatment options? And what if they suffer psychological distress or an increased financial burden due to changes in their treatment regimen?

Second, we need to ensure a fair distribution of benefits and burdens. Directing resources from low value interventions to higher value ones can promote the ethical concept of justice by allocating resources more efficiently. But what if patients have contributed to our knowledge about an intervention by participating in a clinical trial or post-marketing study? Another ethical concept, reciprocity, may dictate that it is unfair to remove the intervention from these patients.

Impacts on patient and clinician autonomy (the ability to make decisions that are in accordance with our values) are also important. Disinvestment may hinder autonomy by removing worthwhile options. On the other hand, it may promote autonomy if it is combined with actions that promote access to other, higher value interventions.

Finally, we need to ensure that we use a fair process when deciding whether to disinvest. This includes being transparent and reasonable about the reasons for disinvestment, and framing these in an accessible way; ensuring decision-makers are unbiased; and monitoring all impacts of a disinvestment decision for patients and the community.

However, even if disinvestment appears to be the most ethical and logical course of action in a particular instance, that does not necessarily mean it will be easy. After all, nobody likes having things taken away from them! It is noteworthy that there are very few instances of successful disinvestment. The process is usually drawn out and the decision fiercely resisted. This, in turn, means that while disinvestment will have an increasingly prominent place in the fair distribution of healthcare, we cannot rely on it entirely. Instead, we need to continue to think hard about which interventions we approve and fund in the first place.