Diana Brixner, RPh, PhD: Part of my decision-making process would be very similar to any therapy. I would like to understand what we use today to treat a specific disease. What is the added cost and added benefit of this PDT compared to how we currently provide treatment options for a particular disease state? The additional thing 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 isn’t there are not enough behavioral therapists to treat and meet all the needs of current patients. It is particularly noted in the Medicaid population. There is also a potential benefit to these PDTs filling a gap in available providers that perhaps has additional consideration, worthy of examining both outcomes and economy in treatments for many of these disorders.
My initiative would be to cover this as part of the pharmaceutical benefit. I consider them therapeutic. When I think of a product covered by medical benefits, it is a product that must be initiated at the doctor’s office or an expensive biologic that is injected or IV [intravenous] or sub-Q. When you look at the characteristics and criteria of a PDT in relation to the therapies covered by a pharmaceutical benefit or a medical benefit, it corresponds more to the therapies covered by the pharmaceutical benefit. Most payers will probably look at this as part of the pharmacy benefit. Another advantage is to look at the results after using PDT because if that is the pharmacy advantage, you have better access to whether patients are actually using the product and then you can link it to the results of medical and pharmaceutical claims to see the impact of using this product.
I try not to look at them differently from other therapies. If you take a mental health disorder, call it depression. First, what is the target population? For what patient population do you recommend this product be used, and within that patient population, what currently available treatments do you propose it replaces or complements? I know that some PDTs are stand-alone products, and other PDTs are recommended with therapeutic pharmaceuticals to have varying levels of additional effect. If I looked at the value, I would like to understand what the incremental health benefit is for a population that was before the introduction of PDT versus after the introduction. I would also be interested in the use of health care resources and the overall economy. If it is a supplement, the overall cost may increase. Next, I want to understand what health benefit will I get from this additional cost increase? Will some of this additional cost increase be offset by savings in other areas of the healthcare spectrum?
PDTs have some unique aspects. I expect that in a form committee, if PDTs are being reviewed and it’s a mental health disorder, it makes a lot of sense for a cognitive therapist -behavioural participates in the discussion on this product. The other big question is whether they stand alone or are they part of an electronic medical records system? It may make sense. There is probably preliminary work with an IT specialist. Is it possible to integrate the PDT into the provider’s workflow, then describe it electronically to the pharmacy and dispense it to the patient? It would be very helpful to have representation from these two groups in a formulary committee discussion of TDPs.
Is there a benefit design that maybe allows a patient access if they pay more? If it is pre-authorization, the provider will come to the plan and explain 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 employers want to better understand how PDTs can benefit their employee population. We talked earlier about the lack of cognitive behavioral therapists. If you have an employee who is unable to access a particular health care need, there are consequences. PDTs are helping fill that gap, and employers are starting to recognize that it could be a potential alternative to one-on-one interactions that can be hard to come by due to a shortage of vendors. I believe that awareness of the search for alternatives for this population, particularly in mental health, is growing. This will ultimately lead to these benefit designs and health plans, as well as benefit coordinators when they start meeting with employers. This conversation will start happening more often.
Arwen Podesta, MD: As payers move into using digital therapies, FDA-cleared prescription digital therapies, I think it’s important to think about what the prescriber and what the patient is going to experience. There are new specialty drugs and devices for which the payer’s authorization is in conflict. Perhaps a product will go through medical for 2 or 3 main insurers, then through pharmacy for the rest of the insurers. My patients are stuck. I remain stuck. That’s a lot of intense organization on my part. If we want to make PDTs simple tools in any prescriber’s toolkit, we want to make them easy for the clinician, the patient, and the payer. I’m asking the payers to come together and ask themselves, “Should we put him on drug benefits or medical benefits?” For those who have some under one and others under the other, it becomes very difficult on my side.
This transcript has been edited for clarity.