Gary M. Owens, M.D., explains how an organization weighs the potential clinical outcomes for patients versus the cost of novel therapies for vitiligo.
Dr. Heather Woolery-Lloyd: Let’s talk about cost of medication. We’ve been talking about cost, and I think that’s important. I am happy we’re discussing this. Medication costs, we’re always concerned about how much our patients have to pay. But, (Dr. Owens), cost is really a consideration for the payer, right? How does your organization weigh the potential clinical outcomes for patients versus the cost of these novel therapies for vitiligo?
Dr. Gary M. Owens: P&T (pharmacy and therapeutics) committees basically look at the following parameters. First of all, you look at the efficacy of the drug and how it’s backed up by whatever clinical trials got the drug approved. The reality is, if a drug is not efficacious, number one, it may not get approved by the FDA, in which case it’s a nonissue, but if it is approved by the FDA, then you begin to do mostly indirect comparisons to whatever else we have out there. The reason is we don’t have good head-to-head data when new drugs come to market. Then we look at safety and balance, safety and efficacy together, and then if the safety and efficacy look reasonable, then we look at monthly cost effectiveness. If we can do that, and again, we don’t have a lot of good cost effectiveness studies out there. In the United States, we don’t have any particular parameters for cost effectiveness thresholds like a cost-per-quality analysis like they do in the in the UK (United Kingdom), for instance; in my suite, we don’t have that. It’s more of a cost effectiveness gestalt, but in the end it’s really more about the safety and efficacy of a product, and then cost becomes an issue. I guess the best way to put it is if a drug is highly effective but costly, we’re going to manage that less aggressively than a drug that’s moderately or just barely effective and costly. The idea being you want patients to have better access to those drugs that work the best and at the same time, you want to be at least a little more watchful in who gets those medications that are less efficacious.
Dr. Heather Woolery-Lloyd: That’s so interesting to me. From a payer perspective, there’s a huge emphasis placed on those clinical trials. Those phase 3 clinical trials, are those really combed through and looked at, like the efficacy rates and all of those details are examined when you’re looking at coverage for a new pharmaceutical drug?
Dr. Gary M. Owens: Exactly that. We have pharmacists on staff who prepare dossiers for our P&T committee, and there’s always disease background to the dossier. It can be rather extensive, if this is a rare disease that no one may have ever seen, for the most part, or it can be very brief (in the case of) something like diabetes or other common disorders. The majority of the P&T dossiers are basically a summary of the evidence tables, as well as the safety tables from the clinical trials. Very often clinical pharmacists will prepare indirect comparative tables, recognizing of course that we’re looking at cross-trial comparisons and all the hazards in doing that, but it’s really the only thing you have to go on. It’s those tables that weigh a lot on decisions of formulary placement as well as tier placement for drugs. We also do rely on expert input. We don’t have every specialty on the P&T committee, but we have access to every specialty by going out to consulting positions in our panels who are willing to do that, so that the efficacy data and the safety data are really paramount.
Dr. Heather Woolery-Lloyd: I do have one other question, because this is so interesting to me. For a new medication that (has) no comparator, you just have to go off of the clinical trial, but if there was a comparator, if there’s something else approved for a condition, then you will compare it to an existing approved treatment?
Dr. Gary M. Owens: We do. We’d love to have those in head-to-head data. We’ve seen some head-to-head trials in psoriasis, MS (multiple sclerosis), rheumatoid arthritis, where those targeted immunomodulatory therapies or targeted therapies have been on the market for a while. Let’s say we fast-forward into the future and there are three JAK (Janus kinase) inhibitors on the market—and I’m really just making this up. Yeah, we would look at indirect comparisons of those trials if neither of those trials included an active comparator arm.
Dr. Heather Woolery-Lloyd: Very interesting. Thank you. Because I’m learning so much. I did not realize that that was a part of the whole process.
Dr. Gary M. Owens: I chaired a P&T committee for over three decades. So, certainly, I have seen lots of dossiers over that time period.
Dr. Heather Woolery-Lloyd: Very interesting. Moving on, still talking about utilization management strategies, what can payers implement to help manage the cost while also ensuring access to the appropriate patients?
Dr. Gary M. Owens: Yeah. As much as it’s the bane of everybody’s existence, the reality of prior authorization is here, at least here for the time being, until we find better ways. But, and the big but is, payers need to make sure that their prior authorization criteria are reasonable and don’t make patients and their doctors go through unnecessary hurdles, as you heard me say earlier. Initially, there was a lot of thought about, well, why shouldn’t we make these patients at least have tried and failed a TCI (target-controlled infusion) or a topical corticosteroid? Then a lot of payers came to realize that many of the vitiligo patients have had the disease for a very long time and they’ve already done that, so why be asking questions that have an obvious answer? And (because) we now have a highly effective therapy, as long as the patient has a diagnosis of vitiligo that basically a dermatologist is prescribing the treatment and that the patient has the appropriate benefit, let it move forward so that we can simplify not only your lives, but ours as well.
Dr. Heather Woolery-Lloyd: You brought up an interesting point. You said a dermatologist is prescribing. If a primary care provider wanted to prescribe this new treatment for vitiligo, would there be different criteria?
Dr. Gary M. Owens: Well, most payers right now have a criterion in place that it needs to be at least initially prescribed by a dermatologist or in consultation with a dermatologist. After that, if the PCP wants to renew it and the patient qualifies for it, no problem.
Dr. Heather Woolery-Lloyd: Okay. That’s very interesting to know.
Dr. Gary M. Owens: But that’s not any different than drugs for MS, rheumatoid arthritis or plaque psoriasis, once you get into the biologics. It’s really just an assurance that somebody who is an expert has agreed that this is the appropriate approach to this patient.
Dr. Heather Woolery-Lloyd: Right. I think that is actually interesting, and I do think it’s an important step, is that a dermatologist is prescribing it. I just didn’t realize that the payers look specifically that we as dermatologists were the ones who were prescribing the medication. That’s very helpful for us to know.
Transcript edited for clarity.