Pegloticase (Krystexxa®)

Restricted Product(s):

pegloticase (Krystexxa®) intravenous infusion for administration by a healthcare professional 

FDA Approved Use:

• For treatment of chronic gout in adults who are refractory to conventional therapy
• Limitations of use: Not for treatment of asymptomatic hyperuricemia 

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of chronic gout [medical record documentation required]; AND
3. The patient has a baseline serum uric acid level of > 6 mg/dL [medical record documentation required]; AND
4. The patient has ONE of the following [medical record documentation required]:
   1. Frequent gout flares (i.e., ≥ 2 flares/year); OR
   2. At least one subcutaneous tophi; OR
   3. Gouty arthritis; AND
5. ONE of the following [medical record documentation required]:
   1. The patient is currently receiving prophylaxis for gout flares with NSAIDs (e.g., ibuprofen, naproxen, celecoxib), colchicine, or both; OR
   2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to BOTH NSAIDs and colchicine; AND
6. ONE of the following: 
   1. The patient has tried and had an inadequate response (defined as uric acid levels > 6 mg/dL and/or presence of frequent gout flares [≥ 2 flares/year] or persistent unresolved subcutaneous tophi despite maximum therapeutic doses) to ALL of the following prerequisite agents [medical record documentation required]:
      1. Allopurinol at the maximum tolerated dose for ≥ 3 months; AND
      2. Febuxostat; AND 
      3. Uricosuric agent (e.g., probenecid); OR
   2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL prerequisite agents (i.e., allopurinol, febuxostat, and uricosuric agents) [medical record documentation required]; AND
7. The patient will NOT be using the requested agent in combination with an oral urate-lowering agent (e.g., allopurinol, febuxostat, probenecid) [medical record documentation required]; AND
8. The requested agent will NOT be used to treat asymptomatic hyperuricemia [medical record documentation required]; AND
9. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval:

1. The patient was approved through Blue Cross NC initial criteria for approval; OR
2. The patient would have met initial criteria for approval at the time they started therapy; AND
3. The patient has had a positive clinical response while using the requested agent, demonstrated by a current uric acid level ≤ 6 mg/dL [medical record documentation required]; AND
4. The patient will NOT be using the requested agent in combination with an oral urate-lowering agent (e.g., allopurinol, febuxostat, probenecid) [medical record documentation required]; AND
5. The requested agent will NOT be used to treat asymptomatic hyperuricemia [medical record documentation required]; AND
6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: 365 days (1 year)

*Maximum units allowed for duration of approval 

References:

All information referenced is from FDA package insert unless otherwise noted below.

1. Sundy JS, Baraf HS, Yood RA, et al. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011;306(7):711-20.
2. Fitzgerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology guideline for the management of gout. Arthritis Care Res. 2020 Jun;72(6):744-60. 

Policy Implementation/Update Information:

June 2021: Criteria change: Added requirements to continuation section of no concurrent use with an oral urate-lowering agent and no use for treatment of asymptomatic hyperuricemia; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.