Managing Bias

We all carry with us our own collection of experiences that inform the thousands of daily decisions—both large and small—that we make. There is nothing we can do to change our past experiences, but we can try to be more aware of how much we allow them influence us. I am a big believer in listening to you gut instincts. In business—as in many aspects of our lives—it’s important to weigh that instinctual message against a more objective set of questions and available information.

This article (Outsmart your own biases, HBR) describes a number of approaches to help manage our natural bias.

Some key insights:

  • Listen your instincts as well as well outside information
  • Acknowledge your mood or emotional strength—being mentally or physically tired can derail decision-making processes
  • Be aware of the natural human desire for certainty and don’t ignore or dismiss unconventional solutions too quickly

Try "brainswarming" instead of brainstorming

Let's face it: most of us do brainstorming without much of a framework. We gather the group, put ideas on a board, and then use only a few of the ideas if any. The challenge with the traditional brainstorming approach is that sometimes very few good ideas come out of the time spent.

This is a great approach that I have used successfully—even with groups that have done a lot of brainstorming. It's easy to adapt the core concept that is explained in this short video.

So the next time you need to do brainstorming, try brainswarming instead.

4 Factors for Successful EU Market Access

There are a lot of horror stories about dealing with the various “big 5” EU country (France, Germany, UK, Spain & Italy) drug approval and reimbursement authorities: NICE is a force to be reckoned with; the German authority seems impenetrable; Spain has been changing their policies to offset economic conditions; Italy may require “pay for performance”; France (and others) set budget limits for certain drugs.

A recent assignment highlighted some key considerations when launching a biopharma product in the EU, and some insights on developing a successful strategy emerged.

1. There may not be one EU strategy

Brand managers often express a need for one, all encompassing EU strategy for their brand. Each country has enough unique requirements that each will need its due course for approval, pricing and access negotiations. A clear overarching EU strategy must allow for each country’s nuances.

2. Strategic choices in patient population

The approved patient population will, of course, be based on the clinical trial design, but consideration of key sub-populations, especially at launch, may be worthwhile. A strategy to launch in a smaller population—where the product benefit is clear—and keep expanding into a larger population over time, as more clinical trial data become available and/or real world experience provides a rationale for expanding patient types, has been very effective. Brands that have a clear long-term strategy may be able to successfully implement this approach. They may start “small” in terms of patient population and price, but over time they continue to advance pricing and access as they add new indications and result in a win-win-win (payer/patient/company) scenario.

3. Be as transparent as possible. Then more so

Many companies approach the negotiations with the approval and pricing authorities (The two functions can be closely aligned or distinct depending on the country) as inevitably contentious. However, there are several examples of companies with very difficult challenges, e.g., a high-priced biologic entering a less expensive tablet market, having very successful outcomes both in terms of price and access. The one thread that seems to connect these success stories is that the companies went into the negotiations with complete transparency on not only their data—going above and beyond requirements—but also their long term clinical development plans. Sharing their vision for the benefits of their product in the target populations and how their clinical program supported that vision, often resulted in favorable pricing and access.

4. Shifting healthcare provider roles and site of patient acquisition

Some of the newer biologics being developed for diseases previously treated with a pill are causing a shift both in site of care and possibly where the patient acquires the drug. Certain countries may require injectables to be administered by a specialist whereas the patient had previously been prescribed a pill by a general practitioner. Similarly, higher cost drugs or drugs requiring special handling may be limited to hospital distribution versus a community pharmacy. These changes require companies to carefully consider how to provide the right support services, education and communication to physicians and patients to ensure that patients have access to their product.

The Sovaldi launch shone a bright light on the ever contentious topics of costs and access for patients. As the industry continues to produce more costly—and highly beneficial— biologics for large potential patient populations (e.g., lipid lowering, certain cancers, HepC), there will be more and more experience to draw from.