DEVELOPING YOUR MEDICAL STRATEGY

The medical function of a healthcare company takes the lead early on to formulate the strategy by which the company does good (helping patients), in order to help it do well (maximizing shareholder value). The heart of medical strategy lies in improving patient outcomes by ensuring patients have access to the best medical treatments available. The No. 1 task of medical and scientific leadership is to develop, steer and execute the medical strategy.

The complex and regulated layers of strategies and tactics can be boiled down to a simple “tripod” consisting of evidence generation, KOL/KEE engagement, and medical education, with each leg firmly rooted in the rigors of compliance. In a large company, there are multiple ongoing strategies that need to be woven together, while in smaller firms, the entire focus may be to develop or execute a single strategy and secure investor support for it.

The Anatomy of a Medical Strategy

Successful strategy delivers clearly defined and prioritized objectives that support the overall organizational goals and enables good communication and delegation. Once your team understands the rationale and high-level strategy and objectives, they are in a better position to work out how to execute on these objectives. This can also help remove silos and conflicting efforts across the organization.

You may have been hired to manage the ongoing clinical trials strategy, prepare for regulatory submission and launch, develop the claims expansion strategy or reinvigorate a legacy product. In any case, start with key questions and a clear approach: what are you trying to achieve? Your mission and vision statements should clearly describe what success looks like, and your charter should outline how you will differentiate your roles and assign who is responsible for which deliverables. Without these essential documents, you will not be able to manage resources and expectations.When you are ready for tactics, two approaches you need to become familiar with (if you aren’t already) are the tools of KPIs and OKRs that support the process of setting, evaluating and achieving objectives. Just as your car’s navigation system tracks the speed, direction, and ETA to assure you are on the right route and will arrive on time, Key Performance Indicators (KPIs) allow you to track your organization’s progress. Objectives and Key Results (OKRs) are your plans and commitments: did you pack everything, fuel the car, bring snacks so you don’t have to stop? Even better, did you plan far enough ahead to leave early so you can enjoy the ride?

These tools are especially important when dealing with complex and long-term objectives which underlie most medical strategies. Radical Focus by Christina Wodke is an excellent guide to using the KPI approach, and Google offers excellent resources for OKRs. At their most powerful, KPIs and OKRs are visible to other colleagues so you have accountability partners and colleagues to share in the celebration of your success.

Key Questions

1. What is the strategy?

Your first step is to understand the current medical strategy and its relationship to the mission and vision of the company. The stated strategy needs to be described succinctly and explained in terms of how all the parts fit together for your non-Medical colleagues. Here is where you’ll differentiate the roles and the deliverables of R&D, Clinical Development and Medical Affairs, if you are making these distinctions. If your company is entering a new market, include positioning and competitive intelligence. I’ll send you a simplified example if you send me an email from my https://creedenconsulting.com site.

2. What is the Disease Area?

As the core internal resource for medical (and/or scientific) expertise, it is important to demonstrate Medical’s mastery of the topics crucial for the business. The disease area overview should include epidemiology and patient flows across the diagnostic and treatment journey, and should be agreed upon by Commercial as the “single source of truth” for market analysis and sales segmentation. This may further evolve into a Disease Area Strategy if that focus is important enough to company strategy, or if you have a broad portfolio that needs prioritization.

For example, your decision support services may be useful across all cancers (as is the case for broad-panel genomic profiling), but for an upcoming initiative you may want to focus on prostate cancer to drive awareness of your company’s services to prostate cancer specialists based on recent publications. Your overall medical strategy in oncology may then include a disease area strategy in prostate cancer. Similarly, testing that is routinely done in the cardiovascular disease management setting (in the presence of risk or overt disease) may also be informative to elite athletes and the worried well, and so may inspire a marketing campaign to that new population.

3. What is your patient engagement and access strategy?

Educating patients about their condition and involving them in shared decision-making has shown to be a significant factor in helping to achieve the triple aim of improved health outcomes, better patient care, and lower costs. Consider how you will you provide patients with clear and accessible information about their health so they can make informed decisions and take an active role in their care. This can include multimedia tools like interactive quizzes, videos and digital apps.

4. Do you have a system in place for evidence gap analysis and new evidence generation?

You will need to work with Clinical Development, R&D, and your Payer team to update or build a list of evidence gaps and collaborate on an innovation process to address them. Consider the existing body of evidence to support your products and services, and identify the gaps you are trying to address. Ask “What would you like the company to be able to say, but currently can’t because of insufficient evidence?” Then adjust for impact (how would this evidence move the needle for the company?) and develop your value messages from those elements.

Weigh these elements against the risk and cost to get a sense of how much the evidence is worth to the company, which you will need for budget discussions. Finally, depending on the stakeholders you are trying to influence, determine the level of evidence that is needed to gain their support: a whitepaper, case series, clinical trial? Regulators and payers have different expectations about evidence, so adjust your plan accordingly. Medical’s source of inspiration for new evidence generation typically flows from three main sources: the medical strategy, proposals from external collaborators, and field insights. Field insights are queries that come from your stakeholders through your field sales and medical forces that highlight an evidence gap or opportunity for claims extension. Payers can be particularly helpful at highlighting evidence gaps but you usually have to negotiate their wishlists down to more pragmatic deliverables.

Once you understand the development plans for your products and services, and which parts of those plans must be managed internally (company-sponsored) and which can be managed through external collaborations, you have a few more options. If your KEE and clinical research networks are not delivering the kind of investigator-initiated study (IIS) proposals that will address your evidence gaps, consider a request-for-proposals (RFP). In an external communication (typically the company website), describe the company’s interest in specific fields or topics where you would like to receive proposals. You will have to work with legal to establish a compliant approach, but this can enrich your pipeline for proposals that meet the company’s needs. Measure the number of proposals that are “on strategy” over time, and be sure they flow seamlessly into your publications pipeline. I have seen companies go as far as offering medical writing staff to help researchers frame up their work into publications (naturally, featuring the company’s services). While this approach would likely not be considered compliant for a pharmaceutical company, it can be tolerated in less-regulated industries such as diagnostics.

5. Do you have a Medical Education plan in place that is internally consistent and mutually supportive of the KEE engagement and evidence generation strategies?

Think of your medical field force as the “feet on the street” to manage the immediate needs of individual customers or collaborators. You also need an overarching communications strategy to educate the many physicians who will not meet your MSLs. How will you reach them? Digital engagement has come a long way in a short time, and offers many ways to reach interested physicians.

6. KEE Engagement: Is your team working actively with stakeholders?

By building alliances with key influencers and demonstrating your team’s reliability to them, you may be able to build momentum and sway them to your side at key negotiating moments, for example, when you launch an initiative. Small concessions over time can build incrementally into a much bigger commitment. Medical teams constantly invest in relationships with researchers and physicians to gain their trust and build future collaborations. Just the fact that physicians see a company delivering fair, balanced medical and scientific information through an MSL (giving), rather than only marketing messages through a sales force (taking), can go a long way toward building reasons to believe in a company’s commitment to improving patient care.

Operations vs Strategy

If you have a big enough portfolio, you will profit from separating meetings of Operations (doing things right) and Strategy (doing the right things) meetings. Even if you have the same people attending both types of meetings, the tone and pace and preparation should be different: Strategy meetings need open space for analysis, debate and decision making, and new proposals need to have circulated analyses and options. The leader’s role in strategy meetings is to moderate and make final calls as necessary. Operations meetings on the other hand should be crisp reviews of the project dashboard and traffic-light designations, run by your program or project manager, with deeper discussions of projects in the red (or any critical projects in yellow), with the responsible person providing updates and mitigation plans.

Any discussion that can’t be resolved in a few minutes should be taken to a separate meeting or escalated to the strategy meeting. The leader takes an observer role in the operations meetings, delegating 95 percent of the decision making to the competent and accountable team members. If you can’t justify separate strategy and operations meetings at least have clear agendas for these different types of work and set aside appropriate time for them.

Measuring Progress

Measure your progress and adapt as necessary: be sure your KPIs capture outcomes, or at least surrogate endpoints for your desired outcomes, not just activity. In clinical trials, surrogate endpoints are laboratory measures or physical signs used to determine treatment effect instead of a direct measure of how a patient feels, functions, or survives. For example, as cancer patients live longer from better targeted therapies, clinical trials are becoming longer and more expensive, and a patient may receive several different lines of therapy over the course of their disease. It becomes difficult to determine which of these combinations is responsible for longer overall survival. To address this, “progression-free survival” in often used in oncology trials: many patients’ cancers will progress as their tumor evolves, so many trials measure whether a new therapy can statistically prolong the time to progression or relapse, and take that time as a surrogate outcome for a longer overall survival time (the desired overall outcome).

Since Medical teams are typically not measured on sales, so you can’t be sure that your MSLs are increasing revenue (a very popular argument to cut Medical staffing budgets). What might be a surrogate endpoint for sales? If you have good products and evidence, you might assume that physicians who understand the latest evidence and guidelines are more likely to use your products and services, so you might place medical education as a surrogate endpoint in the form of “# of eligible HCPs participating in online continuing medical education (CME)” as a target. You can then test this hypothesis by observing whether regions that are served by a targeted CME campaign see higher uptake or utilization, but keep these analyses separate from marketing and sales targets.

Publications are another popular deliverable for Medical and Scientific teams, but publications for their own sake are not necessarily a surrogate endpoint for success if your external experts are not talking about your publications. Your team metrics might then look at on-time project milestones, or multiply quality and quantity. For example, if a critical mass of citations with significant impact factor is your desired outcome, the formula

publication target = (number of posters or publications) x (impact factor)

might be a good fit. Similarly, getting your desired changes into guidelines will not help reimbursement if your Payers don’t recognize those guidelines, so you might set a very specific goal around “inclusion in HCPCS level II codes” so you can start capturing utilization data.

The diagnostics industry struggles to establish reimbursement for many newer technologies, even after proving clinical utility, because many payers are incentivized to embrace older, cheaper technologies and disregard incremental benefits to patients if those benefits are not explicitly rewarded. In cases like this, you may have to work with policymakers and patient advocates to lobby for the reimbursement system to more explicitly reward those elements of patient benefit. Also, if you are aware of who will be unhappy with your efforts, their unhappiness can be a very helpful indicator of your progress. Be sure your boss is aware and can anticipate those indicators as well. In Medical Strategy, Part II, we will look at a real-world launch and the factors that supported its success, and near failure.

This article first appeared on the Leading Medical Affairs blog at leadingmedicalaffairs.com.