Diagnosis: Hyperkalemia.

Treatment: Formulary Exception for Lokelma to treat hyperkalemia.

The insurer denied coverage for Formulary Exception for Lokelma to treat hyperkalemia.

The denial is overturned.

This is a male patient with advanced chronic kidney disease secondary to hypertension. His condition was complicated with worsening hyperkalemia. He tried and failed Kayexalate and furosemide. His physician is requesting Lokelma to treat his condition.

The patient tried and failed Furosemide and Kayexalate (sodium polystyrene sulfonate) and continued to have significant elevated potassium level. The requested drug is likely to produce a more clinically beneficial outcome.

The efficacy of zirconium cyclosilicate in hyperkalemic outpatients was evaluated in two nearly identical phase III, randomized placebo-controlled trials both showed Lokelma is safe and effective in treating hyperkalemia (Up to Date).

Kionex does not appear to be more effective in removing potassium from the body than laxative therapy. Although uncommon, cation exchange resins can produce severe side effects, particularly intestinal necrosis, which may be fatal (Up to Date).

Long term use of sodium polystyrene sulfonate (Kionex) is known to cause fatal gastrointestinal injury and should be avoided if possible. There is no evidence it is safe or effective in treating chronic hyperkalemia. Lokelma in clinical trials significantly decreases serum potassium levels without severe adverse events. Therefore, Lokelma is medically necessary to treat this member's hyperkalemia.

The insurer's denial of coverage for Formulary Exception for Lokelma to treat hyperkalemia is overturned.