Maria Lopes, MD, MS, explains how the setting of care for spesolimab may impact coverage policies and access to the medication.
Ryan Haumschild, PharmD, MS, MBA: Dr Lopes, I want to turn to you because you as a medical director have a lot of experience in evaluating new treatments for rare diseases like generalized pustular psoriasis [GPP]. When we think about spesolimab, it is given in a variety of settings. We’ve talked about inpatient, when a patient’s acutely ill and needs to be admitted; and also in an infusion center. They might present with different severity of episodes depending on the patient type. My question to you is, what are some of the key considerations around coverage policies, and for medication administration, what are some important considerations for spesolimab that our clinicians and payer colleagues should be aware of? Because we have infusion center and inpatient [settings], what should we be thinking about as we’re approving or considering this agent for formulary approval?
Maria Lopes, MD, MS: Absolutely. In a pharmacy and therapeutics [P&T] committee, whether it’s happening on the hospital side or on the health plan side; on the hospital side, usually the admission is under what’s called a DRG [diagnosis-related group reinbursement]. That’s a global payment that the hospital’s going to receive irrespective of what drugs are being used, irrespective of sometimes even the patient spending 3 days in the ICU [intensive care unit] or 5 days in the ICU. It’s a global payment. From a P&T perspective, there are usually 3 slides that are presented. The first slide is always background disease state awareness. This is where we spend our time educating payers and educating those who serve on the P&T committee about the severity of the condition, how it presents, how it’s diagnosed, and what treatment options are relevant. We usually refer to guidelines, national guidelines. We’ll refer to up-to-date [guidelines], so it’s really important that the guidelines reflect the new standard of care that’s emerging.
The second slide is usually what’s new in terms of the world of treatment. What has the clinical trial shown? The frequency of drug administration, is it infused, is it oral, how is it administered? Also the relevant end points from the trial like response rate, and how quickly the onset of action occurs. It’s the mechanism of action, but then the relevance of that tied to the clinical presentation. If you’re a hospital, you care about the length of stay because each day that patients are in the ICU, you’re getting a DRG, and that’s eating into that DRG reimbursement. The argument to a hospital for carrying this drug is, [the patient’s case is] life-threatening. They come into the ED [emergency department] direct admit, and they may stay 30 days in the hospital. In those 30 days, the hospital may end up losing money as a result of that admission.
In the outpatient world, the health plan is paying for that. We usually manage what’s called a setting of care. Usually, it’s anywhere but the hospital outpatient at that point. Can it occur in an infusion center? Can it occur in the home? Can it occur in a doctor’s office? Usually, there’s prior authorization, so once you meet medical necessity criteria, then you’re looking at opportunities to reduce the cost because the same drug in a hospital outpatient setting costs more. You’re usually paying what’s called a percentage of bill charges, whereas in an alternate setting, it could be under what’s called an ASP [average sales price] if it’s in a physician’s office or infusion center, or even in the home where it’s appropriate and safe. These are the considerations.
The other is the frequency of administration; are we treating acute flares, or is this going to be a chronic medication that’s going to be administered over time? If we’re treating acute flares, that educational component is very important because once you leave the hospital setting, the transition and care piece, if this happens again, where will the patient be directed to make sure that drug is available for that patient? Because there is no time for prior authorization. Under the best of circumstances, even if you have a specialty pharmacy involved in the distribution, it can take a day or two to get that drug to that patient in that setting of care. These are all important considerations. As we think beyond the acute flare and the acute hospital event, where can that patient receive the best treatment that’s approved, so they can have rapid triage and available medication on hand?
Ryan Haumschild, PharmD, MS, MBA: That was a great overview of the different settings of care. I agree with it. As inpatient hospital, sometimes we look for the best, most appropriate phase of care to treat that patient in the outpatient setting. And sometimes with that outpatient setting, we know we can reduce the cost of care for the hospital. The more we help the patient and not tie up a bed [because] the increased length of stay causes more expenses per day. A lot of times the best care for that patient is getting them stabilized, potentially to an infusion center. Oftentimes I think with generalized pustular psoriasis, the difficulty is if you get them to the infusion centers, providers want to treat them right away because we want to resolve their symptoms. But sometimes we run into a bit of difficulty in terms of scheduling the patient, getting that precertification approved, and then finally having that chair appointment so that the patient can be treated.
Transcript edited for clarity.