Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 Diabetes.
Treatment: Rybelsus 7 milligrams (mg) tablet.
The insurer denied coverage for Rybelsus 7 milligrams (mg) tablet.
The denial is upheld.
 
The patient is an adult who has a medical diagnosis of type two diabetes mellitus. According to the treating provider, the patient was initially prescribed Rybelsus 3 milligrams (mg) for 30 days. The dose was titrated to Rybelsus 7 mg. The patient was unable to tolerate Glucagon-like peptide-1 receptor agonists (GLP-1 RA) agents. The patient has tried and failed Ozempic and Trulicity with severe headaches. Per the treating provider, the patient tolerated Rybelsus. The request is for Rybelsus 7 mg.

The requested drug would not be more effective than the formulary drug.

Head-to-head studies show Victoza is not inferior to Rybelsus. 

"Oral semaglutide was non-inferior to subcutaneous liraglutide and superior to placebo in decreasing Hemoglobin A1c (HbA1c), and superior in decreasing bodyweight compared with both liraglutide and placebo at week 26. Safety and tolerability of oral semaglutide were similar to subcutaneous liraglutide. Use of oral semaglutide could potentially lead to earlier initiation of GLP-1 receptor agonist therapy in the diabetes treatment continuum of care"(Pratley, R. et al. 2019).

As stated by Fonseca, V. A. et al. (2020), "Semaglutide, a once-weekly glucagon-like peptide 1 (GLP-1) analog approved for the use in patients with type 2 diabetes (T2D), demonstrated superior body weight (BW) reductions and decreased insulin resistance (IR) vs comparators across the SUSTAIN 1-3 clinical trials."

"Indications and usage: Rybelsus is a glucagon-like peptide-1 (GLP-1) receptor agonist
indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

1) Not recommended as first-line therapy for patients inadequately controlled on diet and exercise.
2) Has not been studied in patients with a history of pancreatitis.
3) Not indicated for use in patients with type 1 diabetes mellitus or treatment of diabetic ketoacidosis" (Rybelsus Package Insert).

Finally, "Oral semaglutide (Rybelsus) is a glucagon-like peptide-1 (GLP-1) receptor agonist labeled as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It reduces hyperglycemia by increasing insulin secretion and decreasing glucagon secretion.

Safety: Similar to other medications in this class, semaglutide carries the risk of an increased incidence of thyroid C-cell tumors, including medullary thyroid carcinoma. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 should not be prescribed oral semaglutide. Serious adverse effects are similar to those of other GLP-1 receptor agonists, including pancreatitis, diabetic retinopathy complications, hypoglycemia with concomitant use of insulin secretagogues or insulin, acute kidney injury, and hypersensitivity reactions (less than 1% to 3%). Oral semaglutide has not been studied in pregnant patients or breastfed infants." (Semenya, A. M., &amp; Wilson, S. A. 2020).

The formulary drugs are not expected to cause adverse effects. 

Rybelsus is an oral version of semaglutide, which is the same drug as Ozempic. The GLP-1 analogs all have similar side effects. The patient has not tried and failed Victoza.

All of the formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The patient has not tried and failed Victoza. The patient has tried and failed Ozempic and Trulicity. As GLP-1 analogs all have similar side effects, it is reasonable for the patient to trial Victoza. 

The formulary drug is not expected to be ineffective.

The not formulary drug is not expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Rybelsus 7 mg Tablet to treat type 2 diabetes is upheld.