Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Right ventricular systolic dysfunction.
Treatment: Carvedilol Phosphate Extended Release (ER).

The insurer denied Carvedilol Phosphate Extended Release (ER).  The denial is overturned.

The patient is a male with a history of tetralogy of Fallot, transannular patch repair and surgical, followed by transcatheter, pulmonic valve replacement for severe pulmonic regurgitation. His left ventricular size and systolic function are normal; his right ventricle is mildly to moderately dilated with mildly reduced left ventricular systolic function. The patient has been treated with carvedilol 3.125 milligrams (mg) twice daily. When seen his blood pressure was 105/68 millimeters of mercury (mmHg) with a heart rate of 88 beats/minute. His carvedilol prescription was changed to carvedilol phosphate extended release (ER) 10 mg daily; in the past the patient did not tolerate carvedilol 6.25 mg twice daily. Coverage for extended release carvedilol is at issue.

The health plan's determination is overturned.

This patient has mild right ventricular systolic dysfunction for which he has been treated with carvedilol 3.125 mg twice daily. Previously, he was unable to tolerate 6.25 mg twice daily. In an effort to increase his dose to a maximally tolerated dose, 10 mg extended release carvedilol has been prescribed.

The role of beta-adrenergic blockers, specifically carvedilol (including extended release carvedilol), bisoprolol and metoprolol succinate, in patients with left ventricular systolic dysfunction and congestive heart failure has been well-defined. Dose titration to the maximally tolerated dose is recommended. While conclusive evidence regarding the benefits of beta-blockers in patients with right ventricular dysfunction is lacking, there are some data suggesting that they may be of benefit, and they are often prescribed for this indication. This patient has been taking low dose carvedilol (total daily dose 6.25 mg). He was unable to tolerate 12.5 mg daily. Since 10 mg extended release capsules are available, this was prescribed in an effort to increase the patient's daily dose to a level more than 6.25 mg and less than 12.5 mg, in hopes that it would be tolerated. While a dose of 3.125 mg three times daily would be an option, in order to achieve consistent levels, this would have to be administered every eight hours. This is not only difficult to regularly accomplish, it would require the patient to be consistently limited to less than eight hours of sleep per night, which is an unreasonable burden for many people. The lowest dose bisoprolol is available in is 5 mg; one half of a 5 mg tablet is equivalent to 12.5 of carvedilol, which the patient previously did not tolerate. The lowest dose metoprolol succinate is available in is 25 mg; one half of a tablet is equivalent to 12.5 mg of carvedilol. Thus, the most practical way for this patient to have a trial of a dose of carvedilol that is somewhere between 6.25 mg daily and 12.5 mg daily is to take extended release carvedilol 10 mg daily. While the other beta-blockers that are approved for heart failure (bisoprolol and metoprolol succinate) are not likely to be ineffective, they are more likely to cause side effects in this patient.