Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Overactive Bladder

Treatment: Myrbetriq Tab 50 milligrams (mg)

The insurer denied coverage for Myrbetriq Tab 50 milligrams (mg).

The denial is overturned.

According to the medical records, the patient has a history of overactive bladder (OAB), mixed incontinence, dry eye, uveitis, blepharitis and irritable bowel syndrome (IBS). The patient is taking dicyclomine for irritable bowel syndrome. The patient has had good clinical response to Myrbetriq for the last eight years. Request is for coverage of Myrbetriq 50 milligrams (mg).

The formulary drugs are likely to cause an adverse reaction for the enrollee. The enrollee is taking dicyclomine and other anticholinergic medications (formulary drugs) are contraindicated due to high risk of an adverse interaction.      

The formulary drugs have not been tried because they are contraindicated for the enrollee.     

The requested drug (Myrbetriq) would be more effective than the formulary drugs because the formulary drugs are contraindicated for this enrollee and Myrbetriq has worked well.

"Conclusions: The evidence-based statements are provided for diagnosis and overall management of OAB (overactive bladder), as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable." (Lightner, D. J. et al.).

"The state of the art pharmacological treatment for OAB is the use of anticholinergic (also called antimuscarinics) drugs. The intended end result of these drugs is to achieve some relaxation of the detrusor muscle and consequently to improve patient symptoms. This drug family improves the OAB symptoms by 2 mechanisms. The first mechanism of action works at the level of the neuromuscular junction on cholinergic-muscarinic receptors producing a competitive inhibition of the process through which parasympathetic stimulation leads to detrusor muscle contractions. In addition, a second mechanism of action may work on urothelial sensory receptors inhibiting afferent nerve activity. Several anticholinergic drugs used today are available and prescribed worldwide and are recommended by the International Consultation on Incontinence (Oxford guidelines)" (Leron, E. et al.).

"MYRBETRIQ is a beta-3 adrenergic agonist indicated for the treatment of over active 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 (mirabegron extended-release tablets) PRESCRIBING INFORMATION). 

The formulary drugs are 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 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 Myrbetriq Tab 50mg (milligrams) to treat overactive bladder is reversed.