Navigating Rilonacept Therapy: Dose Adjustments, Discontinuation, and Patient Support Strategies

Rilonacept therapy management involves carefully evaluating patient disease stability, flare risks, and potential for discontinuation through a shared decision-making process. In an interview with Pharmacy Times®, Allan L. Klein, MD, FRCP (C), FACC, FAHA, FASE, FESC, director at Pericardial Disease Center and professor of medicine, and Sean Krohn, PharmD, CSP, MSCS, lead clinical pharmacist, specialty pharmacy, discussed the pharmacist's crucial role in navigating insurance approvals, prior authorizations, and financial assistance programs to ensure patient access to treatment with rilonacept. Klein and Krohn shared that clinicians are exploring tapering strategies and potential alternative approaches, such as the MAVERIC trial investigating cannabidiol for patients wanting to stop biologic treatments. The primary challenge is balancing patient desire to stop medication with the high recurrence rates of auto-inflammatory diseases, which can range from 50% to 75%.

Pharmacy Times: How do you approach dose adjustments or discontinuation of rilonacept therapy, and what information or insights from the pharmacist team are valuable in making these decisions?

Sean Krohn: We sometimes receive inquiries from patients, as well as some health care providers, about when patients can stop rilonacept. Understandably, patients don't want to inject longer than they must. We look at multiple factors, including how stable their disease is, the number of flares patients have experienced, if any, and if they are at higher risk of further flares, hospitalizations, or disease progression. We advise patients who may be interested in stopping rilonacept, of course, not to just stop on their own without consulting their provider, and that's where we may be able to intervene as pharmacists on our end. We all share the same electronic health record and document every patient interaction in the health record, and we have very easy access to reach out to the patient's provider to let them know of any questions or concerns that the patient has regarding their medication. You also look at sometimes the unfortunate situation of the patient's insurance, for example, no longer covering the medication, whether it's an insurance formulary change or, for example, a patient switches insurances due to a job change. We on our own help to navigate patients through that process as well.

Allan L. Klein: If I can add, there's a big debate in the field—I'll give you a scenario. Patients are on, often 2 years, plus more than 2 years on these biologics, especially rilonacept. We monitor their symptoms; they're actively exercising now, their CRPS is good, and their MRI looks good—it's improved, and they want to get off. And so, with 2 possibilities with shared decision-making, we decide whether they want to stop it, which the industry sort of supports, because it has a long half-life, roughly 7 days, so the washout is 4 to 6 weeks. Often patients want to taper it. We have a tapering schedule that every couple of months they're lowering the dose per month. It takes around 5 to 6 months to get off that. Often, we add that colchicine to the mix as well, and we have some studies comparing weaning it to stopping, and that's been submitted for publication. That's the biggest concern now with this field. The other thing is, there are some clinical trials that were being developed. It's called the MAVERIC pivotal trial. This involves a cannabidiol, which is like a CBD, a hemp, a pharmaceutical-grade hemp, that patients are going to get randomized to the CBD versus placebo in patients that want to come off the rilonacept or anakinra. That's an ongoing process, but that's one of the biggest questions. How do you get them off successful medicine? Some people even want to stay on it. If it isn’t broken, don't fix it. I think we were trying to work on that. These diseases could last up to 3 to 5 years. These are chronic diseases, so there's no rush necessarily to get them off. Similar to hypertension or diabetes, you won't necessarily stop the medicine. Once this auto-inflammatory cycle gets set up, often, there's a huge recurrence rate, up to 50% to 75%, so patients want to go very slow in terms of stopping the medicine.

Pharmacy Times: Given the cost implications of biologic therapies like rilonacept, how do you work together to ensure appropriate utilization and potentially navigate insurance approvals or patient assistance programs?

Krohn: Access to these very expensive biologic medications can be difficult. We have pharmacy technicians at our specialty pharmacy who specialize in the prior authorization process to help expedite initiation of treatment. They also handle the prior auth approvals for continuation of therapy to avoid any potential gaps in the patient's treatment. Our pharmacist team here at the Specialty Pharmacy documents insurance prior auth denials and informs the provider team of denial reasons, whether, for example, it is a non-preferred biologic on the patient's insurance formulary. For example, a patient must try an NSAID prior to a biologic being approved. Our team here also helps facilitate insurance appeal submission and the subsequent follow-up. And as we know, despite insurance prior authorization approval, out-of-pocket costs can remain unaffordable for the patient. Our dedicated technician team here will seek out the appropriate financial assistance options that the patient may be eligible for.