Non-adherence to medications, whether due to missed doses, drugs taken at the wrong time, or not taken at all, is a huge issue in healthcare, and can mean worse outcomes for patients. This has an economic impact on healthcare systems for two reasons. Firstly, there is the cost of wasted medication, particularly if prescriptions are filled but the medications not taken. Secondly, there can be an increased cost in treating the sequelae of worsening chronic disease that could have been avoided through treatment. Examples of this include chronic kidney disease associated with hypertension, or neuropathy and retinopathy occurring as a result of poorly-controlled type 2 diabetes. There is also a knock-on impact to the biopharma industry; if prescriptions are not filled, then a loss of income reduces the cash that can be reinvested into R&D.
The issue of adherence is a significant one. In developed countries, only around half of patients with chronic diseases take their medications as instructed. In a study in Spain, published in BMC Family Practice, just 55.5% of people with chronic diseases adhered to their treatment. Adherence to oral cancer medications can be as low as 20% in particular subgroups, such as adolescents.
A study in BMJ Open, based around discussions with Finnish general practitioners, revealed a number of barriers to medication adherence for patients with chronic diseases. These included:
- A lack of education — Ignorance about the illness or the medication, fear of the medication, or receipt of poor information from the media or from reliance on friends and family.
- Need for help with treatment management — Lack of patient’s ability to self-manage their condition, challenges pertaining to dosage and administration, or lack of symptoms leading to a perceived lack of need.
The pharma industry can use digital tools to help to meet the adherence challenges
The pharma industry can use these barriers as opportunities to create services for both patients and physicians, which could provide education and information, empower people to manage their own health, and provide feedback to reinforce the reason for taking the treatment. This may be particularly important for symptomless conditions, such as hypertension.
The digital approach, from phone apps to technology in pills, fits in well with an increasingly digital world, where many people have smartphones and are accustomed to using health and activity tracking devices such as a Fitbit. Several products offering digital support for adherence are in advanced development or have reached the market.
An example comes from the sphere of infection diseases. Tuberculosis (TB) requires long periods of treatment with antibiotics, and breaks in the treatment risk the development of drug-resistant disease. The World Health Organization has traditionally endorsed directly observed therapy (DOT), a standardized treatment regimen observed by a healthcare worker for a certain period of time, as a way to maximize adherence to TB treatments, but this requires a lot of input from health professionals. Proteus has developed a digital pill formulation containing the antibiotics isoniazid and rifampin for the treatment of TB. When the pill dissolves in the stomach acid, a biodegradable sensor sends a signal to a wearable patch, which in turn alerts a smartphone. If the signal is not received, the user gets a reminder text message or phone call. In a study published in PLoS One, this wirelessly-observed therapy, or WOT, was as effective as DOT, and all the patients preferred WOT over DOT.
Proteus has already used the same technology in Abilify MyCite, a digital pill form of Otsuka Pharmaceuticals’ Abilify (aripiprazole) for the treatment of schizophrenia, and in chemotherapy for cancer. An alert can also go to a healthcare professional to allow them to provide extra support.
Digital efforts have also been advanced in diabetes, a chronic disease for which effective management is complex. Patients need to take a range of medications for the disease itself and any co-morbidities, be aware of their blood glucose levels, manage their diets and activity, and monitor their overall health. The Food and Drug Administration (FDA) has put rules and guidance in place to foster innovation in diabetes treatment, including devices and software. Sanofi, with collaborator Verily, has launched a “virtual diabetes clinic” that links monitoring and insulin delivery devices with individualized advice and coaching to help patients manage their own health and welfare.
By working with digital technology companies, pharma and biotech can make the most of these opportunities to improve outcomes for patients, support time-pressured physicians, and create return on investment that allows more funding to be directed back into R&D. The most valuable efforts will be focused on conditions likely to bring the biggest benefits to patients or save the most costs to providers, rather than simply creating more apps that will sit unused on smartphones.