Navigating the Approval Process for Systemic Medications

While assessing and diagnosing a problem, educating the patient, and picking an appropriate treatment are essential pieces of almost every new patient encounter, ensuring the patient actually acquires this treatment can be an entirely separate battle. G. Michael Lewitt, MD, took us to the front lines to highlight key challenges in obtaining biologic medications for both our patients and our offices. Dermatologists are often hindered by a lack of knowledge and significant time required, which may be compounded if the practice lacks a “biologic coordinator”. Dr. Lewitt’s first tip is to find a biologic mentor who can recommend a good specialty pharmacy, provide examples of prior authorization letters, and support when denials inevitably return. Patients can be discouraged by the prior authorization process as well because it requires adequate medical literacy to negotiate insurance claims, seek a provider who is willing to prescribe treatment, and switch pharmacies. 

Despite these hurdles, Dr. Lewitt encouraged us to stick with the process not only because there is significant demand and a paucity of providers, but because patient improvement can be dramatic. Consider that before biologics, most generic medications for inflammatory conditions consisted of topical steroids. For patients with severe disease, the amount they can progress with a shift from topicals to biologics is life-changing. While biologics may make up only ~10% of prior authorizations, in a study from a single academic center, they take up almost 25% of staff time. Some options that exist to assist patients in obtaining needed medications are copay cards and assistance programs. Copay cards are used to place payment ceilings on drugs for commercially-insured patients, and is set nationally, whereas patient assistance programs (PAPs) are unique to each pharmaceutical company. PAPs may be a good option for low-income individuals who are uninsured or insured but denied coverage; they can also assist Medicare Part D enrollees by operating outside of the Part D benefit. Lastly, bridge programs are generally short-lived programs during coverage caps or delays for newer medications. 

Dr. Lewitt also reviewed some important terminology in the approval process: accumulators, maximizers, and step therapy. Accumulator programs apply only to medications without biosimilars or generic alternatives and work to exclude a patient’s copay cards or any manufacturer support in their contribution to their deductible or out-of-pocket maximum as a way to control drug spending. However, an important lawsuit in September 2023 may lead to the appeal of this rule which could have far-reaching impact on patients and manufacturers alike. Maximizers set an individual’s cost-sharing amount as the maximum manufacturer copay assistance either broken into even monthly intervals or frontloaded into the early months, after which the maximizer would cover the full cost of the drug. The last definition he reviewed was step therapy which is implemented by insurance companies to start patients on the most cost-saving drug options, however he emphasized that documentation is the best offense in this situation.