As insurance companies and governments are focusing more on outcomes, the reward model for the pharmaceutical industry is changing from being able to sell the most drugs to providing the best healthcare service. The increasing number of patients with chronic diseases has especially upped the pace and creates significant challenges for pharmaceutical companies to keep up with. In order to provide a full healthcare service, taking drugs is no longer sufficient, the patient’s behavior should also be monitored and modified to achieve the best possible outcome.
The patient’s behaviors and mechanisms to monitor and influence these effectively should already be considered in the early clinical development stage, where Pharmaceutical companies need to demonstrate that their drug adds value to patients with specific context. This is both a risk and an opportunity as influencing people’s behaviors can greatly affect the measured outcome for good or for bad.
A health service comprises of the interaction between the patient, medical practitioner(s) and a drug or a treatment, all working together to relieve the identified disorder. Although relevant for most illnesses, this is especially relevant for sufferers of chronic diseases, lifestyle-management and physical activity become key to help patients managing their conditions.
In academic literature, we consider a treatment as a health service when characterized with two types of human actions
1) High level actions; and
2) Low level actions.
Let me talk about that in some detail below.
High level actions are main therapy stages/guidelines that need to be executed by a human agent(s) -patient or medical practitioner- to achieve a satisfactory outcome. For example in Diabetes high level actions might be 1) maintaining a regular insulin treatment, 2) following a specific diet, 3) maintaining a specific level of physical activity. Those high level actions can be executed in different ways, but normally lead to quite similar outcomes.
Low level actions are atomic events that are performed in the free living enviornment by patient/clinician in a very specific way, in case of diabetes low level tasks are: 1) inject x dose of insulin, 2) walking for x minutes, 3) eat x amount of wholegrain bread, etc.
Generally, High level tasks are:
- Goal oriented;
- Characterized by planning and maneuvering protocols; and
- Not described by single Low level task sequence (e.g. a single drug intake per day), but a flexible combination of low level tasks such as interventional procedure, life-style management and conditioned drug intake, and thus the high level task may be performed in various ways.
Until now, the gold standard to demonstrate efficacy and safety of new drugs and therapies is through a Randomized Clinical Trial (RCT). Although providing sound scientific results, RCTs are limited by its strict data collection criteria as any deviation from those criteria can jeopardize the scientific validity of its results. These strict criteria prevent the use of RCTs to be applied on packaged health services in many situations.
My next blog will talk further about the RCT criteria and how these limit RCT usage in real work scenarios.