Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 2 Diabetes Mellitus

Treatment: Rybelsus 7 milligram tablet

The insurer denied coverage for Rybelsus 7 milligram tablet

The denial is overturned

The insurer has denied coverage for Rybelsus 7 milligram (mg) tablet. In their Final Adverse Determination letter, they write that this medication may be approved when there is a clinical reason the patient is unable to take an alternative dosage form of the requested drug on the formulary due to their condition. Formulary alternatives are Ozempic, Trulicity, and Victoza. Requirement is 3 in a class with 3 or more alternatives, 2 in a class with 2 alternatives, or 1 in a class with only 1 alternative. 

In an appeal letter, the physician writes that the patient is using Rybelsus for uncontrolled type 2 diabetes mellitus with hyperglycemia. The patient has tried Metformin, but therapy was discontinued after experiencing abdominal pain. The patient's diabetes was poorly controlled with the use of Januvia. The patient has a strong fear of needles making an injectable not an option. The patient was given samples of Rybelsus in the office and has responded well to treatment.

According to the medical records, this a patient with history of (h/o) Type 2 Diabetes mellitus (DM) (Hemoglobin A1c (A1c) 10.4%), on Farxiga, Glipizide, and Januvia. The treating provider is requesting Rybelsus.

Per the notes, patient has a fear of needles and all formulary medications, Victoza, Ozempic, and Trulicity are in the needle form. Patient therefore should not have to try formulary given cannot take these medications. The patient's A1c is very high and the patient needs additional agents to control diabetes.      

"Victoza 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" (4).

"TRULICITY 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" (3).

"OZEMPIC 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.  To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease" (2).

"For individuals with mild to moderate fear of needles, potential psychological interventions may include education or cognitive behavioral therapy programs inclusive of relaxation and cognitive restructuring techniques. In the current review, psychological strategies to reduce fear included stress management, distraction, and relaxation. Education about treatment and needling, including use of visual and written materials was recommended; however only one study described formal evaluation of an educational program which resulted in a reduction in needle distress, despite not including targeted interventions for this. Therapeutic modifications, such as changes to needling devices and offering alternative treatments (i.e. without needles) were also recommended" (1).     

As the requested medication is in pill form, it will support compliance, and the patient will take medication.                                                       

The formulary drugs are not expected to cause adverse effects.
 
The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective.

The non formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Rybelsus 7 mg (milligram) tablet to treat diabetes is reversed.