Use of adherence monitoring in drug contracts tied to outcomes

Theodore Bartholomew, GP specialty registrar, and colleagues examine how contracts linking drug payments to effectiveness may affect patient trust and autonomy

CREDIT: This is an edited version of an article that originally appeared on The BMJ

Healthcare payers, including NHS England, are making increasing use of outcomes-based contracts for new drugs. Under these contracts payment for drugs is tied to real world effectiveness instead of a fixed price per unit. A typical agreement might entail a manufacturer either wholly or partially refunding drug costs if the agreed outcome threshold (cure, reduction in mortality, biochemical outcome) is not met. Although these contracts can facilitate access to new drugs where cost effectiveness is unclear, they present challenges with measuring outcomes and have potential for political and commercial conflicts of interests.

Patients’ adherence to drugs attains new importance in outcomes-based contracts. Manufacturers may argue that sub-optimal adherence is responsible for a poor outcome, rather than ineffectiveness, whereas payers may argue the opposite. Medication non-adherence is widespread, with rates of up to 50% reported in hypertension, diabetes, asthma and cancer; the reasons for this are complex and poorly understood. 

One way to help assess whether outcomes reflect effectiveness is to include a requirement for adherence monitoring in outcomes-based contracts. This has clear measurement advantages for both manufacturer and payer, but whether it is in the interests of patients is unclear. Here we consider how outcomes-based contracts and adherence monitoring might affect patients within a nationalised health system such as the NHS.

Implications for patients

Patients have a clear interest in their health but whether a patient wishes, or is able, to be adherent depends on numerous complex factors, many of which are grounded in the relationships they have built with their medical teams and the communication between those teams.

Patients, however, often cite forgetfulness as a factor, and find adherence more challenging the more frequently a medication has to be taken. Typically, adherence is high for patients with acute conditions but drops steeply for chronic conditions after six months of treatment. Consequently, if patients choose to use adherence monitoring as part of a shared decision-making process, it may support them to act autonomously. Conversely, monitoring (particularly objective monitoring alone, which simplistically measures adherence as a number without understanding the barriers a patient may face to being adherent) may increase responsibility on patients in ways that offer no or marginal additional benefit and undermine, rather than support, their interests.

Patients have many reasons for not taking their medications. Side-, for example, are a major predictor of non-adherence because they reduce quality of life; adherence may also depend on the drug’s perceived benefit. While adherence monitoring may help improve clinicians’ understanding of side-effects, patients may feel uncomfortable if monitoring causes them to be labelled, in an unqualified manner, as ‘non-adherent.’

Societal perspective can influence personal responsibility

An important consideration, from the societal perspective, is the patient’s moral (and, in some cases, legal) obligations to consider how non-adherence may affect the health of others. Public health risk, for example, is the justification for using directly observed therapy in some patients with tuberculosis. The international response to the COVID-19 pandemic shows that public health can motivate obligations that go far beyond the individual. In principle, the case for using adherence monitoring on public interest grounds strengthens as risk of harm to others increases – yet, it also increases healthcare professionals’ obligations to communicate with patients about the reasons why adherence may be important, which is difficult to do properly with limited consultation time.

Risks to patient-provider relationship and health system

Critically, adherence monitoring seems likely to affect one of the fundamental tenets of healthcare – the patient-provider relationship. The interactions between professionals and patients are already highly variable, and trust can be eroded if medications do not have the desired consequences, if professionals fail to communicate effectively, and if the patients have concerns about being taken advantage of.

Combining outcomes-based contracts with adherence monitoring is likely to have unpredictable consequences. Physicians, for example, may exert implicit or explicit pressure on patients to use adherence monitoring to gain insights into how they take their medications. Behaviours may also be influenced by the amount of public information available for each contract, including knowledge of the potential financial implications of non-adherence. Both the UK National Institute for Health and Care Excellence (NICE) and the Association of the British Pharmaceutical Industry (ABPI) acknowledge that all relevant information about drugs being appraised should be put in the public domain. However, clinical and economic data of importance to patients, clinicians and researchers are often redacted. Contractual stipulations relating to adherence monitoring, and the effect of non-adherence on reimbursement, are of direct relevance to patients, the public and health system and should, therefore, be in the public domain.

Patient-centred approach

Use of outcomes-based contracts is likely to continue to increase, driven by the commercial interests of manufacturers and the economic interests of payers to limit the budgetary impact of high cost drugs. Patients, society and health providers – particularly in a nationalised system using collective resources such as the NHS – have a right to greater involvement in how these contracts develop and are negotiated. This process should begin with the creation of a new transparency agreement between ABPI and NICE that is co-developed with patients. Additionally, we echo calls for the regulation of data transparency in drug appraisals.

The importance of using both subjective and objective adherence monitoring must be recognised, as well as a more nuanced appreciation of the multi-level and multi-dimensional nature of non-adherence. The effect on patients who are reluctant to use adherence monitoring must also be considered.

The effects on behaviour and patient-provider relationships are likely to vary considerably according to disease characteristics, patient population and the transparency with which contracts have been negotiated. Patient and public expectations will also be different across nationalised, privatised and insurance-based health systems, and will vary according to cultural and societal contexts.

Wider debate and more qualitative research need to be undertaken with patients, healthcare professionals and policy makers on outcomes-based contracts and adherence monitoring to understand acceptability and feasibility.

Both adherence monitoring technologies and the contracts they are meant to support will fail if they are not created in partnership with patients and with patient-centredness as the overarching goal.