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Gout 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
Prior 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
11/04/2011: Policy added.
04/01/2014: Policy reviewed; no changes.
08/03/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number L.5.01.462 added. Policy Guidelines updated to add medically necessary definition.
06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
Krystexxa® Prescribing Information
This 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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.