Pharmaceutical Lifecycle Management (PH141)

Pharmaceutical Life Cycle Management Report Sample

The following is excerpted from Chapter 3, "Strategic Considerations for Lifecycle Management Plans." The full chapter explores the myriad factors needed to drive a successful LCM plan and presents solutions to common obstacles.

Of all measures, time is the single most important driver in setting LCM strategy. Figure 3.6 shows that 97% of all companies surveyed consider this factor important; over one-third feel that time constraints are a vitally important consideration when setting strategy for most drugs. And in many cases, teams bump up against patent expiration before their LCM strategy has been completed; 38% of companies indicate patent expiration is a critical consideration when setting strategy (Figure 3.6 appears in accompanying summary).

According to one interviewed executive, 10-year long-haul thinking is relatively rare within pharmaceutical companies. Having faced tough or impossible deadlines in the past, this executive recommends always considering the two-, five- and ten-year horizon of a drug's lifecycle. "My legal team tells me that we are expecting generic competition in 2023," he says. "I am already thinking about 2023." Other interviewees, who may not have had the experience of tight or missed deadlines, are not as dedicated to this level of long-term planning.

Many executives interviewed are pessimistic about where their drugs might sit in five or 10 years. An LCM leader explained that, in the past few years, his products' exclusivity periods have shrunk from eight years to six and a half, as generics companies became more aggressive in their efforts to invalidate patents. Patents that do not protect new chemical entities may not survive court challenges — a fact that threatens exclusivity for franchise additions such as new formulations.

One of the largest benefits an LCM team can provide is to ensure that long-term lifecycle planning is taking place, especially since motivating brand managers to commit funds for long-term returns can be difficult. Allocating adequate time for scientific strategies, for example, is often a challenge because the most promising and aggressive tactics should begin around the launch of the first-generation product — a time when the company is far more focused on recouping its long-term investment than on starting another.

The following is excerpted from Chapter 4, "Assessment of Lifecycle Management Tactics." The full chapter contains in-depth profiles for 11 key LCM strategies; disease management is one of them. Each profile includes timing, budget, ROI and overall effectiveness metrics.

Disease Management Programs

In the context of lifecycle management, disease management programs exist to increase and maintain patient adherence through patient education and support. They allow brands to establish relationships with patients by providing support in a supportive, non-commercial manner.

Improved patient adherence translates into higher sustained sales, but the concept goes beyond the simple arithmetic that ties revenues and refills. Brands that provide patient services cast themselves in a favorable light with their many stakeholders, including patients, prescribing physicians, payers, nurses, caregivers and patient groups. Physicians faced with a decision between a treatment with an excellent support program and one without will be more inclined to prescribe the former, since it will drive desired outcomes. Similarly, the public — especially patient advocate groups — is more likely to support such brands and their companies.

Some standard disease management program tools include support websites and call centers; online content featuring information and discussion about a disease; techniques to improve patient lifestyle and health; dose and refill reminder calls, emails and texts; and other tools to ensure that patients understand their conditions and treatments. These types of initiatives not only aid the patient by helping maintain motivation and adherence, but also by providing education about lifestyle choices that are critical components of treating many chronic diseases.

Timing

Many teams initiate disease management and patient education programs at a later stage than other LCM tactics. This makes sense in that one must have patients in order to retain them. However, as Figure 4.24 (Figure 4.24 is found in the accompanying summary) shows, many teams wait until relatively late in their products' lives to take advantage of such programs.

The majority of companies do not initiate disease management planning until after the 2nd and 3rd year on the market and before the 11th year. The distribution of companies across these times is fairly even, with 8 to 10 years on the market being the most popular time to begin planning (27% of surveyed companies).

This window appears to be particularly late considering the relative ease of implementation and positive returns of disease management programs. In short, teams may miss an opportunity by waiting to launch such patient outreach. Better prepared teams constitute the 27% of companies that start planning disease management programs during product development, either in Phase 3 (18% of companies) or during regulatory filing (9%).