Dr Brixner highlights the important factors a payer must look at when determining PDT coverage, and Dr Podesta comments from the provider perspective.
Diana Brixner, RPh, PhD: A portion of my decision-making process would be very similar to any therapeutic. I would want to understand what we are using today to treat a specific disease. What is the incremental cost and the incremental benefit of this PDT vs how we're currently providing therapy options for a particular disease state? The additional component that is worth considering with PDTs is what I mentioned earlier about provider shortages, and particularly in behavioral therapy, there's a lot of evidence that there are not enough behavioral therapists to treat and meet all needs of current patients. It's particularly noted in the Medicaid population. There's also a potential benefit of these PDTs filling in a gap of available providers that perhaps has some additional consideration, worthy both in looking in outcomes and economics in the treatments of many of these disorders.
My initiative would be to cover this under the pharmacy benefit. I consider them therapeutics. When I think about a medical benefit-covered product, it's a product that needs to be initiated in the physician's office or is a high-cost biologic that is injected or IV [intravenous] or sub-Q. When you look at the characteristics and criteria of a PDT compared to therapeutics covered under a pharmacy benefit or medical benefit, it's more in line with therapeutics covered under the pharmacy benefit. Most payers are probably going to look at this under the pharmacy benefit. Another advantage is to look at outcomes post utilization of the PDT because if it's on the pharmacy benefit, you have better access to whether patients are actually utilizing the product and then being able to link it to medical and pharmacy claims outcomes to see the impact of the use of that product.
I try to not look at them any differently than other therapeutics. If you take a mental health disorder, say it's depression. First, what's the target population? What patient population do you recommend that this product should be utilized for, and within that patient population, what currently available treatments do you propose it should either replace or supplement? I know some PDTs are standalone products, and other PDTs are recommended with pharmaceutical therapeutics to have different levels of incremental effect. If I was looking at the value, I would want to understand what the incremental health benefit of a population that was pre PDT introduction vs post introduction. I'd also be interested in health care resource utilization and overall economics. If it's supplemental, the overall cost may increase. Then I want to understand what health benefit am I going to get from that incremental increase in cost? Will any of that incremental increase in cost be offset by savings in other areas across the health care spectrum?
There are some unique aspects of the PDTs. I would anticipate that on a formulary committee, if the PDTs are being reviewed and if it's a mental health disorder, it's very logical that you would have a cognitive behavioral therapist participate on the discussion around that product. The other big question is are they standalone, or are they an integral part of an electronic medical record system? It may make sense. There's probably some pre work with IT specialist. Is it possible to have the PDT integrated into the workflow of the provider and then electronically be described to the pharmacy and dispensed to the patient? It would be very valuable to have representation from both of those groups on a formulary committee discussion around PDTs.
Is there a benefit design that perhaps allows a patient access if they pay more? If it's under a prior authorization, then the provider would come to the plan and make a case as to why they should have coverage for the product. The plan would probably be to put criteria in place, which would perhaps be approved.
I believe there is an interest by employers in better understanding how the PDTs can benefit their employee population. We talked earlier about the lack of cognitive behavioral therapists. If you have an employee that's not able to access a particular health care need that you have, there are consequences. PDTs help fill in that gap, and employers are beginning to acknowledge that this could be a potential alternative to having 1-on-1 interactions that may be difficult to get based on a provider shortage. I believe that awareness of looking at alternatives for this population, particularly in mental health, is becoming greater. That will ultimately lead to these benefit designs and health plans, as well as benefit coordinators as they begin meeting with employers. That conversation will start to take place more often.
Arwen Podesta, MD: As payers are getting on board with using digital therapeutics, prescription FDA-authorized digital therapeutics, I think it's important to think of what the prescriber and what patient is going to experience. There are new specialty medications and devices that have conflicted payer authorization. Maybe a product will go through medical for 2 or 3 main insurers and then through pharmacy for the rest of the insurers. My patients get stuck. I get stuck. It's a lot of intense organization from my end. If we want to make PDTs easy tools in all prescribers’ toolboxes, then we want to make easy for the clinician, patient, and payer. I request that payers put their heads together and ask, ‘Should we put it under pharmacy benefit or under medical benefit?’ For those that have some under one and some under the other, it becomes very challenging on my end.
This transcript has been edited for clarity.