colchicine capsules (Mitigare™), colchicine tablets (Colcrys®), and colchicine oral solution (Gloperba®) Approval Criteria:
- A quantity of six tablets for a three day supply is available without prior authorization for treatment of acute gouty attacks; AND
- Failure of allopurinol after six months of treatment defined by persistent gouty attacks with serum urate levels greater than 6.0mg/dL; AND
- Patient-specific, clinically significant reason why colchicine/probenecid would not be a viable option for the member; AND
- For authorization of Gloperba®, a patient-specific, clinically significant reason why the member cannot use colchicine tablets or capsules must be provided; AND
- A quantity limit of 60 tablets/capsules per 30 days or 300 mL per 30 days will apply for gout; AND
- Members with the diagnosis of Familial Mediterranean Fever verified by genetic testing will be approved for up to 2.4mg per day.
lesinurad/allopurinol (Duzallo®) Approval Criteria:
- Member must be 18 years of age or older; AND
- An FDA approved indication for the treatment of symptomatic hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone; AND
- Failure of allopurinol or febuxostat alone defined by serum urate levels greater than 6.0mg/dL; AND
- Prior to starting treatment with Duzallo®, member must be on at least 300mg of allopurinol daily, unless creatinine clearance (CrCl) is less than 60mL/min then 200mg daily is required. Duzallo® 200mg/200mg will only be approved for members with a CrCl less than 60mL/min; AND
- Prescriber must verify that member has a CrCl greater than 45mL/min prior to initiating treatment. For continued approval, prescriber must verify CrCl is greater than 45mL/min and serum creatinine is not greater than two times baseline when Duzallo® was initiated; AND
- Prescriber must document member has no contraindications for use of Duzallo® including any of the following: Tumor lysis syndrome or Lesch-Nyhan syndrome, severe renal impairment (CrCl less than 30mL/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis.
- A quantity limit of one tablet daily will apply.
pegloticase (Krystexxa®) Approval Criteria:
- An FDA approved diagnosis of gout; AND
- Member must have symptomatic gout with:
- ≥3 gout flares in the previous 18 months; OR
- ≥1 gout tophus; OR
- Gouty arthritis; AND
- Failure of the following urate lowering therapies: allopurinol, febuxostat, lesinurad, AND probenecid titrated to the maximum tolerable dose for at least 3 months; AND
- Pegloticase must be administered in a health care setting by a health care provider prepared to manage anaphylaxis; AND
- Prescriber must attest that the member will be pre-medicated with antihistamines and corticosteroids to reduce the risk of anaphylaxis; AND
- Prescriber must document that member does not have glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting pegloticase; AND
- Member must discontinue oral urate-lowering agents prior to starting pegloticase; AND
- Member must receive gout flare prophylaxis with non-steroidal anti-inflammatory drug(s) (NSAIDs) or colchicine at least 1 week before initiation of pegloticase therapy and continue for at least 6 months unless medically contraindicated or member is unable to tolerate therapy.
- Approvals will be for the duration of 6 months. Reauthorizations may be granted if the prescriber documents the member is responding well to treatment, and member has not exceeded >4 consecutive weeks without therapy.
Prior Authorization form
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