Pharmacy Prior Authorization Criteria

Krystexxa (pegloticase)

For diagnosis of Refractory gout
Indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
Limitations of Use: Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Trial and failure, contraindication, or intolerance to maximum recommended doses to both of the following conventional therapies: [A]

AND

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Months [B]

Patient demonstrates positive clinical response to therapy as demonstrated by both of the following:

Serum urate level has decreased since initiating therapy
Clinical improvement in the signs and symptoms of gout (e.g., decrease in tophi size or frequency of gouty flares per year from baseline or improvement in chronic arthropathy or quality of life)

2024-07-18, 2023-10-03, 2023-07-21, 2022-07-22, 2021-07-07

Krystexxa Prescribing Information. Horizon Therapeutics, Inc. Deerfield, IL. November 2022.
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.
Fitzgerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for Management of Gout. Arthritis Care Res (Hoboken). 2020 Jun;72(6):774-60.
Becker MA, Baraf HS, Yood RA. Long-term safety of pegloticase in chronic gout refractory to conventional treatment. Ann Rheum Dis. 2013;72(9):1469-74.

Additional inclusion criteria in pivotal trials were as follows: Contraindication to treatment with allopurinol or history of failure to normalize serum uric acid despite 3 or more months of treatment with the maximum medically appropriate allopurinol dose (determined by the treating physician) [2]. Febuxostat is another first-line pharmacologic agent for the treatment of gout [3]
The efficacy and safety profile of long-term pegloticase treatment (mean follow-up of 2.5 years) has been shown to be consistent with that observed in the 6 month pivotal trials. [4]

2024-07-18: 2024 annual review: no criteria changes.
2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
2023-07-21: Annual review - Removed drug name from reauth and formatting update with no changes to clinical intent.
2022-07-22: Annual review: no criteria changes.
2021-07-07: Annual review: Updated criteria and background.