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In this letter to the editor, investigators highlight the issues faced by patients with alopecia areata and the common barriers to JAK inhibitor access.
Despite Janus-Kinase (JAK) inhibitors’ widely known efficacy for alopecia areata, new research highlights that disparities in access remain due to such barriers as coverage denials for patients on public insurance versus private insurance.1
These data were expressed in a recent letter to the editor, with the analysis authored by such investigators as Carli D. Needle, an MD candidate from the Ronald O. Perelman Department of Dermatology at New York University Grossman School of Medicine. Needle and colleagues noted that historically, alopecia areata was treated using oral or intralesional corticosteroids, various other systemic immunosuppressive drugs, and minoxidil.
“However, in 2022, the United States (US) Food and Drug Administration (FDA) approved baricitinib as the first oral JAKi for adults with severe [alopecia areata], followed by approval of ritlecitinib in 2023 for patients aged 12+ with severe [alopecia areata],” Needle and colleagues wrote.1,2 “These medications have been effective for many [alopecia areata] patients and offer hope for those recalcitrant to prior therapies.”
The investigative team noted that many individuals in the US frequently deal with substantial barriers in their securing of insurance coverage for JAK inhibitors (JAKi) as a result of these therapeutics' high costs. Additionally, the team pointed to another challenge in that JAKi are only approved by the FDA for patients who report living with more severe forms of alopecia areata.
Traditionally, severity of this condition has been evaluated by clinicians via the Severity of Alopecia Tool (SALT), a too designed to measure the extent of one's hair loss on the scalp. A SALT score shown to be 50 or higher is generally accepted as the level required for JAK inhibitor prescription. Given this fact, Needle and colleagues suggested that there is a lack of insurance authorization commonly-faced by individuals reporting less extensive scalp involvement.
Patients with alopecia areata have lived experiences that the investigative team noted involves much more than simply loss of scalp hair. Elements such as treatment resistance, loss of eyelashes and eyebrows, and psychosocial burden all are factors that contribute to the hair loss condition significantly.
The investigators pointed to the fact that Alopecia Areata Scale (AASc) was developed for the purposes of a more comprehensive assessment of alopecia areata. They highlighted that this multidimensional tool can be useful for healthcare providers seeking not to solely rely on evaluations of scalp involvement.
When patients who initially qualify for therapy after showing a SALT score ≥50 show clinical improvement can drop below this threshold and, thus, face a new complication. Such individuals may then lose their insurance coverage despite needing ongoing medications to maintain their regrowth progress.
Longer-term therapies are often needed by those with alopecia to sustain hair regrowth and remission, a fact Needle et al. explained was demonstrated in the BRAVE-AA1 study. Specifically, about 80% of patients who had switched to placebo ended up relapsing by Week 152 versus only 7% of trial subjects who remained on a baricitinib regimen.
In terms of additional hurdles faced by patients, insurance issues can emerge when a patient has only a partial response to one JAK inhibitor and needs to transition to another. For instance, the investigators used the example of someone who improves their SALT score of 100 to 40 as they are treated with baricitinib but who may still not reach a cosmetically acceptable outcome—commonly defined as a SALT score <20.
However, the investigative team noted that as such a patient's score is currently below 50, they could be disqualified from implementing an alternative JAKi under existing criteria for treatment approval. Such cases were used by the team to underscore the urgent need for greater transparency from insurers in addition to more nuanced decision-making processes. They noted that rigid adherence to numerical cutoffs are not optimal.
Needle and colleagues expressed the value of writing detailed appeal letters to insurance providers, for despite their time-intensive nature, they notewd that such messages can make a difference in providing help to patients. For many, such forms of patient advocacy are the only avenues for JAKi treatment acess, given the monthly out-of-pocket costs in the US known to range from $2,898 - $4,348.
Moving forward, the investigators pointed to the necessity of continued advocacy and focused research. Such tools will be essential to improving equity and access in alopecia areata care, they noted.
“Ultimately, although JAKi has revolutionized the treatment of AA, equitable access remains a challenge worldwide,” they wrote.1,3 “Publicly insured patients face higher denial rates than patients on private health insurance, and few can afford the $2,898–$4,348 USD monthly out-of-pocket costs in the United States.”
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