The equation “number of units prescribed equals number of units sold” holds very rarely for pharmaceutical products whose consumption does not take place in controlled settings such as hospitals. Poor adherence to prescribed treatments may be due to a variety of factors, including intolerance to side effects, patient-perceived lack of effectiveness and administration difficulties (e.g. self-injections); this affects, to different degrees, the majority of diseases whose care takes place at the patient’s home. This issue has been increased by the recent trend, common in both Europe and the United States, of reducing hospitalization in favor of territorial care, in an effort to drive down the average cost per patient, especially for longer-term diseases.
Non-adherence represents one of the most relevant health-care challenges today: On the one hand, it costs billions of dollars in lost revenues to the global pharmaceutical industry; on the other hand, it often increases overall costs for health-care providers or insurers due to the higher likelihood of complications and hospitalizations. Studies on the incidence and impact of this phenomenon are usually pathology- focused; the punctual quantification of overall costs associated is complex, so that an accurate quantification of the overall financial impact is not readily available. However, with several medical studies confirming non-adherence rates often in the range of 20% to 30% of the prescribed population at 12 months for long-term diseases (e.g. Parkinson’s and multiple sclerosis), the economic relevance becomes manifest.
While adherence has traditionally been perceived as an issue of the health-care delivery system, taking the initiative to tackle the problem presents a growing opportunity for pharmaceutical companies to generate significant economic returns, directly and indirectly, especially in those therapy areas where the impact of lost revenues is highest.
These initiatives can lead to improvements in two significant areas:
How can a pharmaceutical company design, develop and implement such an initiative? There are two main steps to be followed:
Get to know and segment non-customers: What is the actual non-adherence incidence? What are the characteristics of the patients in which it is concentrated (previous treatment history, stage of the disease, access to insurance, socio-demographic factors)? What are the characteristics of patients with the highest risk of turning into “non-customers”? Are there patient clusters characterized by irregular consumption, while others who discontinue altogether? This preliminary activity can rely on a mix of retrospective studies analysis and ad hoc activities; it provides a comprehensive perspective on “non-customers,” including their characteristics, larger and smaller clusters, and a preliminary set of nonadherence predictors.
Identify adherence barriers along the whole patient flow: What are the main factors turning patients into “non-customers”? What are the most critical steps experienced by patients while moving across the different stages of their care path? At what stage do they discontinue treatment – if they ever started it? A detailed mapping and analysis of all the occurrences experi- enced by a patient and of all the interactions with the different actors (GPs, hospitals, specialists, health system, insurance, relatives, other care givers) from the time of initial presentation to the physician until the end of the care path highlights key consumption, barriers and the underlying rationales.
Map actionable levers: What are the main service components that could help overcome the barriers mapped along the patient flow? Is there anything the pharmaceutical company may do to lessen consumption barriers experienced by patients, eventually focusing on specific target clusters? What are the priority actions and the expected results? What are the desired interactions with institutional health providers and how can they be managed? Are there opportunities to build or improve the relationship with economic and administrative buyers?
Design intervention packages: Are there viable and cost-effective actions the pharmaceutical company may put in place to support treatment adherence – maximizing the value generated from actual prescriptions? What are the markets in which this solution is to be implemented? Are there specific legal issues or delivery requirements to be dealt with at the national level? Is it appropriate to envisage a “hot-housing” approach before planning a widespread launch? Who are the key individuals (medical, administrative) for whom an early involvement is to be planned?
Identifying and detailing a potential intervention strategy is not enough; its implementation must take place in someone else’s domain: that of the institutional health-care providers. Two different approaches and strategies may be envisaged, depending on the goals and priorities of the pharmaceutical company. At a minimum level, it can opt for a “low involvement” approach: communicate the initiative at the appropriate institutional level (national, regional), get all the required regulatory approvals and keep an update communication channel on the results of the initiative. Alternatively, the launch of an adherence adherencefocused initiative may involve a co-delivery with healthsystem actors, whereby the “front-end” provider is usually the health system, while the pharmaceutical company adds specific resources or components to reinforce some aspects of care provision. There are various factors that affect the results of these two models (there may be a range of different outcomes between the two extremes):
How widespread is this model today? Are there any potential pitfalls that must be taken into consideration while considering such an initiative? Do actual results justify this kind of investment? Adherence-focused initiatives sponsored and undertaken by pharmaceutical companies are somewhat more common in the US, mostly due to lower regulatory barriers and the size of the revenue potential to be gained back. Anyway, despite the difficulty of coping with a highly fragmented legislative environment, these kinds of initiatives are gaining
a foothold and demonstrating their relevance also in Europe, as the multiple sclerosis case suggests.
Beyond legislative concerns, there are at least two important potential pitfalls of the model that can explain why these initiatives have been lagging behind in EU with respect to the US, and can thus provide insights for developing and fine-tuning further efforts:
There are also important factors that point to an increased relevance of this kind of initiative for the sales and marketing strategies of pharmaceutical companies:
By Luca Vegetti, Project Manager, Tefen Italy