Diagnosis: Hyperkalemia.
Treatment: Lokelma 5 grams Powder for suspension.
The insurer denied coverage for Lokelma 5 grams Powder for suspension.
The denial is overturned.

This patient has a history of ischemic heart failure and reduced ejection fraction, valvular heart disease status post mechanical mitral valve and left ventricular assist device placement. Left ventricular assist device (LVAD) was removed due to bacteremia and patient was listed for heart transplant. Additional history includes hyperkalemia not responsive to polystyrene sulfonate oral suspension that resolved following treatment with Lokelma. Documents submitted by the provider states that formulary alternatives failed to control potassium levels.

This patient suffers from hyperkalemia and severe left ventricular dysfunction requiring guideline directed medical therapy. Hyperkalemia is defined as potassium levels above 5.0 milliequivalents per liter (mEq/L) and is frequently noted in patients with heart failure. Hyperkalemia is associated with increased levels of all-cause mortality in patients with heart failure. (Reference 1) In studies of patients with heart failure and hyperkalemia, Lokelma allowed for sufficient reduction in potassium levels to allow for titration of guideline directed medical therapy and a concurrent improvement in left ventricular function. (Reference 3) This patient clearly benefits from Lokelma therapy and documentation submitted states that formulary alternatives were not efficacious. In conclusion, the formulary drug is not efficacious, and the requested drug is more effective than the formulary alternative.

The insurer's denial of coverage for Formulary Exception for Lokelma 5 grams Powder for suspension is overturned.