Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Hypothyroidism
Treatment: Tirosint 175 microgram (mcg) Capsule
The insurer denied coverage for Tirosint 175 mcg Capsule
The denial is overturned.

This case involves a patient diagnosed with hypothyroidism, who had a history of thyroid cancer, type 2 diabetes, and vitamin D deficiency. Her treatment had involved levothyroxine, Tirosint 350 mcg, Cytomel 5 mcg daily, radioactive iodine (124Ci 4/2011), and thyroidectomy proceeding with both right and left neck dissection. Her current medication list included Cytomel 5 mcg and Tirosint 175 mcg capsule (2 daily). The patient received a notice of adverse determination regarding Tirosint 175 mcg capsules. The policy states that this medication may be approved when there is a clinical reason the member is unable to take an alternative dosage form of the requested drug in the formulary due to her condition. Formulary alternatives include levothyroxine tablet, Levoxyl, liothyronine, Synthroid, and Unithroid with requirements to include 3 in a class with 3 or more alternatives, two in class with 2 alternatives, or 1 in a class with only 1 alternative.  

She was seen for follow-up of hypothyroidism, thyroid cancer, type 2 diabetes, and vitamin D deficiency. The report references the patient's thyroid-stimulating hormone results from four months prior at 0.77, which decreased to 0.03. The physician stated that the patient's goal thyroid stability hormone should be approximately 1.0. On physical examination, the patient's body mass index was 35.18. Blood pressure and pulse were stable. The thyroid bed was empty with a well-healed surgical scar. The patient's thyroid cancer is stable with no evidence of disease progression. She had for the last several years her thyroid stimulating hormone too suppressed whereupon plans were to reduce to 175mcg+150mcg. The treating physician submitted an appeal stating that the patient had been under care for management of thyroid cancer since her diagnosis. Following a thyroidectomy, the patient was initially treated with Synthroid. She briefly tried generic levothyroxine as well but switched to Tirosint. With Synthroid and levothyroxine, the physician was unable to adequately control hypothyroid symptoms to include fatigue, brain fog, and irritability.  The physician ultimately added a low dose of liothyronine to the Tirosint and reported that this regimen had controlled the hypothyroid symptoms and kept her thyroid stimulating hormone (TSH) in the appropriate range for years. She underwent bariatric surgery to lose weight several years ago, was hospitalized for a severe case of gallstone pancreatitis, with both surgeries leaving her with problems absorbing properly. The patient has had success absorbing Tirosint as it is well-known that Tirosint is more quickly and easily absorbed than levothyroxine in tablet preparation. 

For these reasons, and considering the patient's thyroid cancer history, it would be inappropriate to change her medications at this time. A switch in medications could completely destabilize the hypothyroidism control and significantly affect her quality of life. 

The formulary drugs were tried, and the patient did have an adverse reaction or contraindication. The formulary drug is expected to be ineffective. The non-formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Tyrosine 175 microgram (mcg) capsule to treat hypothyroidism is overturned.