Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Overactive bladder
Treatment: Formulary Exception for Myrbetriq (mirabegron)
The insurer denied coverage for Formulary Exception for Myrbetriq (mirabegron)
The denial is upheld

The patient is an adult with overactive bladder and post-menopausal condition. The request is for coverage of Myrbetriq (mirabegron).

The patient states to have been taking Myrbetriq for years and having failed all other treatment options.

The formulary drugs are not likely to cause the patient an adverse reaction. 

The medical records do not show that the patient has tried and failed any of the formulary drugs. There are no listed contraindication to the use of the available formulary alternatives. As such, the formulary drugs have not been shown to cause adverse reactions for this patient. 

The formulary drugs have not been ineffective based on the patient's clinical history. 

The medical records do not show that the patient has tried any of the formulary drugs. As such, the records have not shown that the formulary drugs have been ineffective for the patient's overactive bladder. 

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

The records do not show that the patient's has tried any of the formulary drugs. As such, the requested Myrbetriq has not been shown to be more effective than any of the formulary drugs.

"The International Continence Society definition of overactive bladder (OAB) is "urinary urgency, usually accompanied by frequency, nocturia, with or without urge urinary incontinence." It is important to understand that OAB is not an exact disease but rather a symptom complex with multiple, distinct etiologies. It is an incredibly embarrassing condition, and many patients are uncomfortable discussing it with their providers. The treatment of OAB includes a three-step algorithm starting with lifestyle modification, then medication, and lastly, minimally invasive intervention. Lifestyle and behavioral modification including paying close attention to fluid consumption and bladder irritants, bladder training, and pelvic muscle floor therapy. The second line includes using anticholinergics or beta-3 adrenoceptor agonists. The third line consists of the injection of onabotulinum-toxin A, sacral neuromodulation, and percutaneous posterior tibial nerve stimulation" (Dawood, O., and El-Zawahry, A. 2021).

"Myrbetriq is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Myrbetriq, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency." (Myrbetriq Package Insert, 2018).

"Overactive bladder (OAB) is a symptom complex that includes urinary urgency, frequency, incontinence, and nocturia. It is highly prevalent, affecting up to 12% of the adult population, and can significantly impact quality of life. The diagnosis of OAB is made by history, physical examination, and a urinalysis to rule out underlying infections or other concerning potential etiologies. The need for additional testing is based on the initial evaluation findings and is recommended in cases of underlying urinary tract infection, microscopic hematuria, obstructive voiding symptoms, and symptoms refractory to previous treatments. Initial management includes behavioral modification with attention to total daily fluid intake, avoidance of bladder irritants, treatment of constipation, weight loss, timed voiding, urge-suppression techniques, and pelvic floor physical therapy. Options for oral medications include antimuscarinic agents and adrenergic agents and can be used following or in conjunction with behavioral treatment." (Raju, R., and Linder, B. J., 2020).

The carrier's denial of a request for a Formulary Exception for Myrbetriq is upheld.