What works for large patient populations isn’t necessarily a good fit for those with rare and orphan disorders.
The payer access strategy that provides adequate coverage and patient services for mass market therapies that treats millions—such as a hypertension drug—can fall well short of what’s required for an orphan drug that cares for just a few thousand or even less. Yet, many patient-minded commercialization executives are compelled to take on a strategy that was never optimized for the outcomes they truly want.
In my experience, there are six myths associated with the best way to gain payer access for rare and orphan drugs. I’m about to show you why each is a myth—and more importantly, how to overcome it to the benefit of manufacturers and patients alike. So, let’s get started by debunking the six myths.
Myth #1: You have greater control when using multiple specialty pharmacies (SPs).
Many commercialization executives believe they have greater control of their market and market share by using multiple SPs (specialty pharmacies). In a sense, they’re building their own SP network and deciding whom can participate.
In my experience, taking this approach actually diminishes the control that manufacturers have over access. For example, a commercialization executive might build a network of two large SPs owned by pharmacy benefits managers (PBMs) and then one smaller, niche SP that’s built to provide high-touch patient services. The CCO may believe it would be simple to direct patients to the niche SP, as warranted.
But here’s what really happens: once the PBM-owned SPs are in the network, they can wield greater control over where patients obtain drugs. Once those SPs have access, the PBMs can mandate that patients use them to obtain your drug. Otherwise, patients may be faced with an out-of-network rate. Suddenly, the CCOs vision of equitable, patient-friendly access has vanished. And the CCO may feel trapped by a plan of his or her own making.
Myth #2: Having multiple SPs is best for patient care.
This is a good follow up to the previous myth. If manufacturers lose more control when using multiple SPs, how does that impact patients?
Well, that may remain invisible to you if you don’t look under the hood or if nothing changes. But something always changes. What happens when there’s a major change that affects coverage—such as introducing a new payer or physician, or if the patient moves? Which pharmacy should the patient use then? How will that decision affect coverage, deductibles and co-pays? What about any discounts or patient assistance programs that are available? What if the patient changes jobs, has a new insurance company and is required to use a new SP?
This is what happens when a manufacturer allows multiple ways to access its product: patients are left to navigate a very complex environment on their own.
To avoid this challenge, choose a single SP with a built-in patient services hub. This “patient-first” alignment will yield the continuity of care that patients need—no matter what physician or job they have, or where they live.
Myth #3: If you change SPs once a drug is launched, you jeopardize payer access.
There is some perception that, once the payer model is set at a drug’s launch, the model can’t be changed later on for fear of losing payer access. What would motivate a pharmaceutical company to evolve its payer model in the first place—in effect, “changing horses in midstream?”
It’s all about momentum. A commercialization executive’s primary mission is to ensure the long-term success of a pharmaceutical. While the initial model may have the desired impact in the early years after launch, there may be a need to refresh the model to maintain and catalyze growth in Year Three or Year Four. Another motivator may be a commercialization executive who has simply inherited a drug portfolio—with a patient services hub and several SPs already in place—and wants to take a second look at and revitalize that model.
But regardless of the motivation, a commercialization executive may feel reluctant to make a change—again, for fear of disrupting not only payer access, but also the continuity of patient care itself. I have talked with manufacturers who have had multiple payer and SP relationships—and while they’re intrigued by the concept of a patient-first model—they’re concerned it may be too late to take advantage of it.
Not true! And once that exclusivity is in place, a manufacturer will have newfound leverage with payers, not to mention a surer path to maintaining continuity of care.
Myth #4: The patient-first model is too new for payers to accept.
Like the previous myth, this isn’t true, in my experience. Let’s start with the basic fact that—if you have one of the few products (or only product) that serves a small patient population—you will get coverage. Indeed, many payers and PBMs see the value of a patient-first model—and more importantly, take advantage of it.
One of the biggest mistakes that manufacturers can make is to go directly to payers to ask for their input on how to structure the distribution strategy. And while that would seem to create an opportunity for optimization and alignment with payers, it also creates an opportunity for payers to guide your efforts from only their perspective. As the commercialization officer, you can see the entirety of the system. From the drug research to the patient experience, your vision is what should guide the ultimate strategy that you would embrace. So allow that vision, and not the influence of “the way it has always been” to determine your course.
Myth #5: You need to work with a consultant to ensure payer access.
Building on the previous myth, your mission is to ensure the long-term success of the drug. That is, after all, the surest way to achieve the desired outcome for both manufacturer and patient. But what I call “legacy thinking” can get in the way. Here’s how it works.
Your #1 goal is to get your drug to market as quickly as possible, so you hire a consultant who recommends a payer that has its own SP network. Now you have instant access for your drug. But, you’ve abdicated how your drug is priced and how patients will be cared for long-term.
With this “solution” in place, your consultant exits—and now you have an approach that you feel you cannot change. Three or four years later, you may want to make some changes, to keep the momentum going. But, you believe you cannot.
If that sounds familiar, I can assure you there’s a better way. A tailored, one-stop approach obviates these challenges by working under an exclusive distribution model. This approach would limit the touch points in the patient care journey, which, most importantly, has been shown to increase patient compliance. So, fittingly, you gain leverage to always put patient needs above all others.
Myth #6: The only way to ensure coverage is via a payer-owned SP network.
It’s certainly true that this is the traditional approach for gaining coverage. There’s a perception that using a payer-owned (or PBM-owned) SP network actually increases coverage. But I’ve already discussed how that isn’t necessarily the case. Indeed, this approach can lead to lower pricing and a lesser focus on the high-touch patient care that patients with rare and orphan diseases require.
An alternative approach is to provide exclusive access to your drug, via the patient-first model we’ve been discussing. This greater control puts you in a better position to negotiate with payers. Because they have a mandate to provide access to your product, both parties are motivated to work together to serve the best interests of patients.
Putting patients first
What’s best for manufacturer and patient alike is to take greater control of the patient journey—helping to ensure consistent access, high-touch service and fair pricing. Casting aside the myths I’ve discussed here is a good first step. The next step is embracing a strategy that places patients first—and that is more than a set of talking points. In the rare and orphan drug industry, your ability to embrace this understanding and operationalize your commercialization strategy is critical.