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DESCRIPTIONGout is a type of arthritis that occurs when uric acid builds up in the joints. Although acute gout is a painful condition that typically affects one joint, chronic gout is repeated episodes of pain and inflammation which may involve one or more joints.
Gout is caused by having higher than normal levels of uric acid in the body. The body may make too much uric acid or have a difficult time getting rid of uric acid. If too much uric acid builds up in the synovial fluid, uric acid crystals form. The crystals cause the joint to swell up and become inflamed.
The exact cause of gout is unknown. It is more common in males, postmenopausal women, people who drink alcohol, and can occur after taking medications that interfere with the removal of uric acid.
Symptoms develop suddenly and usually involve only one or a few joints. The big toes, knees, or ankle joints are most often affected. The pain frequently starts during the night and is often describing as throbbing, crushing, or excruciating. The joint is usually very tender and appears warm and red. The attack may go away in several days but return from time to time.
Some people may develop chronic gouty arthritis, but others may have no further attacks. Those with chronic gouty arthritis develop joint deformities and loss of motion in the joints. Tophi are lumps below the skin usually around joints that may develop after a patient has had the disease for many years.
FDA APPROVED INDICATIONS
POLICYPrior Authorization is required.
Krystexxa® (pegloticase) is considered medically necessary for adult patients with chronic gout who are refractory to conventional therapy. Gout refractory to conventional therapy is defined as failure to normalize serum uric acid levels and experiencing signs and symptoms of gout despite treatment with xanthine oxidase inhibitors at the maximum medically appropriate dose for at least six months. An initial serum uric acid level is required, and serum uric acid levels should be monitored before each infusion. Krystexxa® should be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/04/2011: Policy added.
SOURCE(S)Krystexxa® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.