When developing a drug commercialization strategy, there’s a misconception that patient service and program scalability are mutually exclusive. The prevailing wisdom is that, as a commercialization officer or CEO, you must choose one or the other—but you can’t have both.
In the rare and orphan drug market, this tension may seem irrelevant. After all, why focus on scalability when you’re serving small patient populations? Isn’t the purpose of scalability to focus on serving hundreds of thousands of patients? For patients who need rare or orphan drugs, shouldn’t your attention be on service?
In my experience, scalability is not only relevant for serving small patient populations, it is absolutely essential. It’s as critical as providing high-touch service to these patients. (In fact, having scalability is the only way to ensure you can provide this level of service over the long term; I’ll share more about that in a moment.)
If you must have service and scalability to succeed with these patients, how can you have both—at the same time? To begin with, eliminate the point-of-view that creates this false choice in the first place. If you need both, you must think about drug commercialization in an entirely different way.
You need a new model that focuses first on delivering the service that patients with rare and orphan disorders require. Then, as your patient population and compliance grow, anticipate the need for and scale up the appropriate resources to maintain service levels.
This is what it means to take a patient-first approach to drug commercialization. Making service your first priority gives you unprecedented visibility into your patient population, so you know when and how to scale up your program for maximum success. Why is this a proven model for small patient populations—and more importantly, how can you learn to implement the strategy for your own rare or orphan drug?
To get to the answer, let’s start by examining the traditional approach to scalability and service—and why it doesn’t work for small patient populations.
The wrong way to scale up
When you’re evaluating the ability of a hub services provider or specialty pharmacy (SP) to scale up as your patient population grows, you likely focus on three areas: care coordination, distribution and data. What questions would you ask?
- Care coordination: Do you have so many people throughout your organization that you can pull some into my team as needed to answer the phones?
- Distribution points: Are there multiple SPs available to ensure I can maximize coverage—no matter how large my patient population grows?
- Data capture and analysis: Will each stakeholder provide the data I need to help me make more informed decisions as I adjust my commercialization strategy?
These may be the right questions, but, in my experience, they fall short for serving small patient populations. Take a look at those three questions again and consider what they really imply:
- The quantity of care coordinators is more important than their expertise with my rare or orphan drug.
- The quantity of distribution points is more important than their ability to provide access and keep my patients compliant.
- The quantity of data is more important than its ability to deliver a unified, clear picture of my drug’s performance.
When you equate scalability with quantity, you’re creating needless infrastructure which will likely impede, not catalyze, your ability to serve patients.
Yet, I’ve heard biopharma companies defend the approach. They say, “If I build a large hub-and-spoke network with lots of people and technology, I’m covered no matter what happens.”
Let me make a couple of observations about this argument. First, you may be paying for infrastructure that you don’t need and may never use. The second—perhaps even larger—point is how and why you’ve surrounded yourself with so much infrastructure in the first place. If you don’t have a clear picture of your drug’s performance, how can you anticipate what resources are actually needed now and in the future? In effect, you’re scaling up by intuition, not insight.
The wrong approach to service
For mass market drug commercialization, technology can be a reliable tool for communicating with thousands of patients daily. For those who just want a fast and easy way to refill their cholesterol or A1C maintenance medications, mobile apps and IVR systems can work.
But what if you’re working with a disease that few have ever heard of—and fewer still actually have? These patients don’t have many places to turn for answers. Their physicians may not have much experience with managing the disorder. So imagine calling a hub service or SP with questions, and the care coordinator is under pressure to end the call within just a few minutes. What if the patient needs an hour? A system built for managing maintenance medications is ill-equipped to serve the time demands of small patient populations.
For rare and orphan drug patients, high tech is simply no substitute for high touch. These patients need a place to call home, where there are people who will listen and have the expertise to answer every question. When patients know they have a true advocate on their side, a remarkable thing happens. Patients are motivated to take better care of themselves.
I know of patients who were at the point of giving up and not taking their medications anymore. They weren’t getting the information and encouragement to keep going. When your conversations with care coordinators are capped at five or 10 minutes—and you receive robocall reminders for refills—you can see why patients may become discouraged.
Most importantly, the commitment to patient service should never waver. With mass market programs, a care coordinator may be expected to make a set number of calls across multiple programs every day. If a call goes to voice mail, there’s little if any time to try again. That won’t work with small patient populations.
The right way to get both service and scale
As you rethink your approach to commercializing rare and orphan drugs, start with what matters most: the patient’s needs. Once you do, you’ll see how the traditional approaches to scalability and service are ineffective. You’ll also see how the two are inseparable—and trying to select one over the other is a false choice, when you’re working with small patient populations. Indeed, you need both service and scalability to succeed, and a patient-first model is the way to achieve it.
What does a patient-first model look like? The foundation starts with creating an exclusive, single source program for a rare or orphan drug and building a team that is 100% dedicated to serving that drug’s patients. The team should include both patient hub services and specialty pharmacy all under one umbrella.
The intensive focus on a therapy enables the team to achieve a level of expertise that would be difficult if not impossible to replicate elsewhere. Team members are versed in every aspect of your drug, such as having the expertise to answer every question and concern from patients, physicians and payers; navigating the prior authorization process and knowing how to monitor and encourage compliance.
As the exclusive source, the team also has unprecedented visibility into your drug’s market. You have one set of comprehensive data that reveals where you are today and what your next steps can be to drive greater success. In contrast, a traditional hub-and-spoke model yields disjointed data from multiple stakeholders. The result: a needlessly complex and unclear view of your drug’s performance.
Above all, a patient-first model creates an intimate connection with and understanding of your patient population. So, you are better able to anticipate program growth and scale up just in advance of actual need. By taking this approach to scalability, you’re not investing in infrastructure that is “waiting around” in case it may be needed. Rather, you’re allocating more resources as the needs materialize.
The patient-first approach is proven to increase compliance as well, which is of course good for every stakeholder—patient, physician, payer and manufacturer. Outside this model, a compliance rate of 65 – 80% may be possible. In my experience using a patient-first model, you can achieve 90% or even higher.
Choose the patient-first model
Don’t fall into the trap of choosing between service or scalability. Use a patient-first model to focus on service. Then, leverage the unique visibility that this approach provides to identify how and when to scale up and add resources, as the demand for your therapy grows and you need more support to maintain the high service levels your patients require.