Steven Levine, MD: Carrie, can you tell us about what getting intranasal esketamine entails? [Spravato]the different paths, whether purchasing and billing or specialty pharmacy, and the challenges or obstacles you encountered in this process?
Carrie Jardine: There are 2 ways to get the medicine. One is to order through the patient’s specialty pharmacy, and then the pharmacy bills the insurance company. This removes some of the financial liability from the supplier of this drug. The medicine is then sent to the office for us to give to the patient. The other way is buy and bill i.e. we buy the medicine directly from a REMS [Risk Evaluation and Mitigation Strategy]– certified provider, we pay for this drug, then we bill the insurance company on behalf of the patient once this drug is administered to the patient.
At the beginning, it is important to see if you can take the financial risk of the drugs because reimbursement can take a long time. There are payers who take 30-45 days to pay claims. These are treatments in which patients receive several rather expensive treatments over a few days each week. If you buy and invoice, this can represent quite a significant financial liability for the individual supplier. Depending on the size of your practice, you can sometimes assume this responsibility and wait for payers to pay.
The other thing is that some patients’ plans have specifications on whether they want you to go through a specialty pharmacy or whether you can buy and bill. There are also financial considerations on the patient’s side, because whether you are using pharmacy benefits or medical benefits, there may also be different responsibilities for the patient. These are all things to consider when deciding whether you want to purchase and bill for the drugs or go through the patient’s specialty pharmacy.
Steven Levine, MD: Let’s dive deeper into some of the billing and coding considerations to support patient access to intranasal esketamine and other alternative therapies. I’m going to lean pretty heavily on Ms. Jardine here, but let’s start with Dr. Rosenzweig. Can you tell us a bit about the strategies you use for TRD [treatment-resistant depression] treatments to ensure appropriate access?
Martin Rosenzweig, MD: That’s a great question because there’s this mistaken belief that insurers are in place to create barriers. I would like to talk a bit about the process we have for reviewing treatment approval. Much of what is covered is determined by benefit design, which is how the employers who use us design what they want to cover or exclude. We are all subject to parity. This is also a key factor behind it. When we review a specific treatment, the general rule is that we follow the FDA [Food and Drug Administration] guidelines. If a treatment is FDA approved, there may be a lag of a month or 2, but that’s generally what our policy follows. With esketamine, that’s pretty much what our policy looks like. It follows what the federal government recommends.
The problem with some of the treatments, including ECT [electroconvulsive therapy], is that it may require prior authorization in some regimes. A die [responsibilities] as cost stewards is to ensure that there is appropriate use of these expensive resources. SMT [transcranial magnetic stimulation] certainly has its place, but one of the concerns we have with new treatments is whether they are being used appropriately. In our experience, the majority of providers try to do what is right for the patient. there is no doubt. But there is a small subset where there is a risk of fraud, waste or abuse. Part of our role is to put things in place to ensure that there is no overuse or inappropriate use. This is part of the reason for the prior authorization process in some areas.
To give an example with transcranial magnetic stimulation, it is approved and covered by most plans, but the risk is that it will be overused. Someone can show up and it’s the first thing they’re offered just because [the provider] has this expensive machine and you need a volume of patients to cover the cost. It’s not appropriate. A big part of what drives this is the concern that we reserve resources where they are most appropriate. I also talked about the choice of drugs. Start with those that are most cost-effective for the patient as well as in terms of co-payments, using generics.
We have 2 processes. There is a pharmacy and therapeutics committee that reviews all of this and the recommendations and then writes the policy. Under my medical policy team, we also have a Technology Assessment Committee, or TAC, that reviews these emerging technologies and data, researching whether the evidence is strong enough to support their adoption. The reason for this is that the benefit design only supports evidence-based or FDA-approved treatments. I will give an example. With intravenous ketamine, there is preliminary literature that it may be effective. We don’t have robust, multicenter, placebo-controlled studies, but it’s not FDA-cleared for this use, so we have to stick with the wording of the benefit until the research is there. Understand it also from our point of view. It is the need for evidence that the treatment is effective.
Transcripts edited for clarity.