Specialty pharmacies are having interruptions in the availability of tocilizumab and are held to allocations—meaning they can order only what they had previously ordered on average for the past several months. In mid-October of 2021, patients across the country were notified the Genentech Access Solutions program may not have tocilizumab to consistently ship to patients who receive medications through the patient financial assistance program and could be added to a waiting list to receive their drug when the product becomes available.
It is difficult to predict how many patients worldwide this issue affects. However, at one academic medical center, the University of Kentucky, 18% of patients on Actemra were relying on the manufacturer patient assistance program for their medication, and 50% of those patients had to be switched to an alternate therapy. Upon changing a patient to a different therapy, the prescribing and financial assistance process is started over, which can result in a delay in therapy. This process includes prescribing, prior authorization, appeal and application to a new patient assistance program, which can result in months without therapy and worsening of disease status.
What You Can Do
In August 2021, the ACR issued a statement supporting the substitution of the IV formulation with the SQ formulation, and if the SQ formulation was unavailable, switching the medication to one with a similar mechanism of action.7 This is consistent with what pharmacists are reporting in clinical practice according to pharmacy network chats on the Vizient Community website.
With the current issues surrounding acquisition of Actemra, and other biologic agents that are being used for COVID-19 indications, our personal recommendation would be to reserve prescribing of these agents to those who are already stable on therapy and for those whose disease has no alternative approved treatments.
For patients on these medications who are having issues when trying to refill their medication, providers will need to make a patient-centered decision based on the patient’s disease status, stability on the medication, improvement from baseline and previously tried therapies. Options include:
- Finding a pharmacy with a consistent inventory of affected medications;
- Reducing the frequency of doses; or
- Switching to a different medication within the same class.
Keep in mind that these options may be less effective for the patient and lead to increased disease activity and deteriorating health.
Communication with prescribers and patients, pharmacies and manufacturers is important. For example, the University of Kentucky specialty pharmacy and rheumatology clinic collaborated to generate an active list of patients on the affected medications. Then, each patient was assessed on where they were filling their medication and if their pharmacy was able to obtain the medication consistently at that time, and staff troubleshooted accordingly. Open communication with patients and the interdisciplinary team is imperative to ensure patients are not without medication.