Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Hypothyroidism.
Treatment: Formulary Exception for Tirosint 88 Mcg [micrograms] Capsule to Treat Low Thyroid.

The insurer denied coverage for the Formulary Exception for Tirosint 88 Mcg Capsule to Treat Low Thyroid.  The denial is overturned.

This is a female patient who has a diagnosis of hypothyroidism. She presented to an office visit with an Endocrinologist for the evaluation of hypothyroidism. The patient has positive antibodies for Hashimoto's. She was originally treated with Synthroid to which she had a reaction. The patient is currently taking 88 micrograms (mcg) of oral (PO) Tirosint a day (QD). The physician recommended continuing Tirosint.

Based on the medical facts from the available records, claim documentation, and any additional information obtained from the treating provider(s) from the perspective of Endocrinology, Diabetes, & Metabolism/Internal Medicine, the requested formulary medication Tirosint (branded) is approved.

The patient has a history of reactions to Synthroid and Levothyroxine. There is evidence that gel capsule Levothyroxine (aka Brand Tirosint) has better absorption in patients with gastritis, malabsorption and it is dye free, gluten free and is less likely to cause an allergic reaction. It also results in consistently lower thyroid stimulating hormone (TSH) levels as it is more bioavailable. In one study it resulted in more favorable lipid and glucose profile. 

According to Benvenga, S. (2019), "L-T4 [Levothyroxine] ingested as liquid solution or softgel capsule is more bioavailable compared to L-T4 ingested as tablet, and it is slightly superior to capsule L-T4 only in the absence of co-ingestion of interfering medications."

"Levothyroxine (L-T4) absorption can be impaired by various causes: a) L-T4 ingestion during breakfast, or with food; b) conditions of reduced gastric acidity; c) intestinal procedures and diseases such as bariatric surgery, lactose intolerance (LI), celiac disease (CD), inflammatory bowel disease; d) drugs that alter L-T4 absorption, increasing the gastric pH [potential of hydrogen], or preventing the dissolution of tablets. The development of new oral formulations, i.e. the liquid preparation and the soft gel capsule, represents the most recent advance regarding L-T4 therapy. Treating hypothyroidism with L-T4 tablets can lead to an improper control of thyroid-stimulating hormone (TSH) in ~10%-15% of patients. The improperly elevated TSH [thyroid stimulating hormone] is usually managed by increasing the L-T4 daily dose, and revaluating TSH upon 2-6 months. The increase of the L-T4 dosage may cause iatrogenic hyperthyroidism, especially when the underlying disorders are cured. Liquid L-T4 can be administered in patients unable to swallow capsules or tablets, and this is one of its major benefits. Liquid L-T4 can: 1- overcome food and beverages interference; 2- bypass the malabsorption associated with an increased gastric pH; 3- circumvent the issue of malabsorption in patients who underwent bariatric surgery; 4-maintain TSH values under control better than L-T4 tablets in hypothyroid patients with typical or atypical CD, or in patients with LI. Few clinical studies evaluated soft gel L-T4 with encouraging findings in patients with gastric- or coffee-related malabsorption, or hypothyroid patients without malabsorption. Additional research is necessary to investigate liquid L-T4, or soft gel capsule, in other conditions of altered L-T4 absorption" (Fallahi, P. et al. 2021).

The denial of the Formulary Exception for Tirosint 88 Mcg Capsule to Treat Low Thyroid is overturned.