Bridging the Gap between Prescriptions and Sales

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:

• Boost to sales volumes at no incremental sales efforts, maximizing the value extracted from the existing prescription base;
• Improved relationships with the economic and administrative actors influencing the sales process of pharmaceutical products (e.g. regional agencies), supporting them in reaching their own health-care targets.

How can a pharmaceutical company design, develop and implement such an initiative? There are two main steps to be followed:

• deeply understanding patients, the “consumers”;
• defining how to approach the health system. This requires trying to get a deeper involvement (when improving the relationship with economic buyers is a primary goal of the initiative) with an “institutional marketing” approach, or aligning key actors to receive regulatory authorization. Gaining an in-depth understanding of the end-users of medical treatments provides excellent insights about the root causes of non-adherence behaviors and how these could be acted upon to eliminate, or at least reduce, consumption barriers; this usually can be achieved through a four-step process:

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):

• Pharmaceutical company goals: whether the primary objective is a sales growth by increasing treatment adherence, or strengthening the relationships with key influencers in administrative positions;
• Initiative interdependence with institutional health-care delivery: the more the initiative foreseen is interconnected to the existing care pathway (e.g. case management, such as in the first case discussed), the higher the need of co-delivery with the health system, while a more stand-alone approach can be undertaken in the case of an initiative that complements the health-care offering, for instance with a postprescription follow-up (e.g. the second case presented, on multiple sclerosis);
• Legislation: while some national legislations (in particular in the US) facilitate direct contact between a pharmaceutical company and a patient, others (such as, to different degrees, the European ones) impose more barriers, favoring
  (if not almost requiring) a co-delivery solution (where entities such as patient associations might be a substitute for health-system bodies). The final issue, once an initiative has been designed and the involvement of institutional health actors has been defined, is how to organize and align resources. At a higher level, this implies putting in place governance mechanisms: from an operational standpoint, detailing the competences needed and sizing the resources required to run the initiative. As the type of competences and the nature of resources required is somewhat different from the core of a pharmaceutical As the type of competences and the nature of resources required is somewhat different from the core of a pharmaceutical company’s operation and will likely have a temporary nature (due to product lifecycle and ROI considerations), different make-or-buy solutions must be evaluated to identify the most cost-effective solution.

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:

• The complexity of managing a multitude of health-system actors (usually different bodies at local, regional and national level) not always aligned in terms of priorities and agenda;
• The difficulty in quantifying a proven ROI, as these initiatives might be beneficial to the whole market for a given treatment, without significant impacts on market share (thus favoring competitors who did not invest money in the initiative).

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:

• Significant changes, both from new legislation issued in several key markets and from the ethical codes of pharmaceutical companies, on the scope of marketing instruments, and the necessity to find new destinations for part of the marketing budgets;
• A track of previous experience in the design and management of adherencefocused efforts, whose best practices can provide significant support in overcoming the two pitfalls mentioned above. The most relevant consideration remains the bottom-line impact. Data on actual non adherence enable a backof- the-envelope calculation of how large the potential revenues (and profits) to be recouped, while results from similar initiatives (the multiple sclerosis case discusses good examples) provide a sense of how such efforts can turn into a moneymaking tool, enabling the company to fully capitalize on its sales and marketing budgets.

By Luca Vegetti, Project Manager, Tefen Italy