Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gout
Treatment: Krystexxa 8 mg/ml (milligrams/milliliter) INJ (injection)
The insurer denied coverage for Krystexxa 8 mg/ml INJ
The denial is upheld.
 
The patient is an adult male with a history of chronic tophaceous gout, chronic kidney disease (CKD), and coronary artery disease (CAD). He has tried and failed allopurinol and is not a candidate for Uloric. The patient's treating provider is requesting plan approval for treatment of the patient's gout with Krystexxa.

Allopurinol should be discontinued before starting Krystexxa.      

Krystexxa eight (8) milligrams per milliliter (mg/ml) is not considered medically necessary for this patient. 

Other urate-lowering therapies should not be given to patients receiving pegloticase (Krystexxa) because they may mask recognition of the increasing serum urate levels associated with an increased risk for infusion-related reactions and loss of effectiveness resulting from the effects of high titer pegloticase antibodies." (Up to Date)

As such, until allopurinol is discontinued, Krystexxa cannot be approved and started.

"Pegloticase is a pegylated, recombinant uricase (urate-oxidase) Food and Drug Administration (FDA)-approved in 2010 for its use in the management of chronic gout refractory to standard therapy in adult patients. Conventional therapy for chronic gout includes xanthine oxidase inhibitors such as allopurinol and febuxostat. Patients with unresponsive uric acid levels and or have two or more gout flares, and subcutaneous tophi persisting despite treatment at maximum dosages of conventional therapy are considered refractory and qualify as indications for pegloticase. Patients with increased uric acid levels and not experiencing gout symptoms are not recommended for treatment with pegloticase.

"Pegloticase (peg loe' ti kase) is a recombinant DNA-produced form of the porcine enzyme uricase that metabolizes urate to allantoin, an inert and water-soluble purine metabolite that, unlike uric acid, is rapidly cleared by the kidney. Infusions of pegloticase decrease serum uric acid concentrations and can alleviate the symptoms and complications of gout. Pegloticase was approved in the United States in 2010 for use in patients with chronic symptomatic gout who are refractory to conventional therapy with uricourics and xanthine oxidase inhibitors, which should be discontinued before pegloticase is started. It is available as a sterile concentrate of 8 mg in a single use vial under the brand name Kystexxa. The recommended dose 8 mg given intravenously every two weeks. Common side effects of pegloticase include local and systemic infusion reactions, nausea, vomiting, constipation, chest pain and nasopharyngitis. Pegloticase infusions are associated with paradoxical flares of clinical gout during the first 3 months of therapy in up to 80% of patients. Severe adverse reactions may include anaphylaxis (in up to 7% of patients), severe infusion reactions, hemolysis and methemoglobinemia and congestive heart failure. Because resistance to pegloticase is associated with antibodies to the molecule and with rise of uric acid levels and initial control, it is recommended that patients be monitored for uric acid levels and that pegloticase be stopped if uric acid levels rise above 6" (LiverTox, 2018).

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for Krystexxa 8 milligrams / milliliter (mg/ml) INJ is not substantiated.