Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Psoriasis

Treatment: Taltz Autoinjector 80 milligrams/milliliter

The insurer denied Taltz Autoinjector 80 milligrams/milliliter. The denial was upheld.

This is a female patient with a history of arthritis and psoriasis. The patient presented with complaints with a scaling rash located on the scalp that had been there several years; she described it to be itchy. She also reported having it on her face and nose; 3-10% of her body surface area was affected. It was noted that the patient had taking over the counter medications that included medium/high potency steroids, Humira, prednisone and anthralin, calcipotriene, or taxarote; all with failed results. The patient expressed the desire to become pregnant and wanted to have the ability to stop the treating medication upon confirmation of pregnancy.  Taltz Autoinjector was recommended. 

According to Porter, Lockwood & Kimball (2017), "Because pregnant women are commonly excluded from clinical trials, large, controlled studies of TNF-alpha inhibitors and newer biologic agents, such as ustekinumab (IL-12/23 inhibitor), secukinumab (IL-17 inhibitor), and ixekizumab (IL-17 inhibitor), are lacking. Most of our limited observations come from data from animals, case reports or case series, small retrospective studies, and, most recently, surveillance registries that collect outcomes from pregnant patients who are treated with biologic agents." As a result, the safety of using biologics during pregnancy is unclear, and not recommended. 

According to Gottlieb, Ryan & Murase (2019), "Overall, safety data on anti-IL agents are currently scarce, and because their mechanism of action is distinct from that of anti-TNFs, large pharmacovigilance studies on the safety of these agents during pregnancy are needed. At present, the ustekinumab and secukinumab labels suggest avoidance of their use during pregnancy as a precautionary measure, due to the lack of adequate data on use in pregnant women. No clinical data on the use of the newer, small molecule apremilast during pregnancy are available at present; however, a pregnancy registry has been established (NCT02775500; MotherToBaby, 2019)." This study also indicates that the requesting medication, anti-IL drug (Taltz) is not preferred over the formulary drug, TNF drug (Enbrel). 

According to Gotestam, et al. (2016), "Among biologics tumour necrosis factor inhibitors are best studied and appear reasonably safe with first and second trimester use. Restrictions in use apply for the few proven teratogenic drugs and the large proportion of medications for which insufficient safety data for the fetus/child are available. Effective drug treatment of active inflammatory rheumatic disease is possible with reasonable safety for the fetus/child during pregnancy and lactation. The dissemination of the data to health professionals and patients as well as their implementation into clinical practice may help to improve the management of pregnant and lactating patients with rheumatic disease." This literature supports the use of formulary drug, Enbrel, over the requesting drug, Taltz if the patient's refractory symptoms required biologic therapy during the first and second trimester.      

Based on this literature review, the requested drug is not considered more effective or safer than the formulary drug.  

The insurer's denial of a Formulary Exception for Taltz Autoinjector 80 milligrams/milliliter is upheld.