Prior authorization validity and renewals

Prior authorization is required. Initial authorization is valid for 6 months (180 days); renewals may be granted every 12 months (365 days).

Provide covered ICD-10 diagnosis code

Include an appropriate ICD-10 diagnosis code from Appendix 1 (e.g., M1A.* series) on the prior authorization request; Medicare providers must also follow any applicable NCD/LCD/LCA requirements.

Prior therapy requirement (3-month trial)

Document a contraindication, intolerance, or clinical failure after a minimum 3-month trial on a maximum tolerated dose of xanthine oxidase inhibitors (e.g., allopurinol or febuxostat) or uricosuric agents (e.g., probenecid) before initiating Krystexxa.

• Clinical failure defined as inability to reduce serum uric acid to < 6 mg/dL during the trial.

Required serum uric acid and renewal labs

Submit documentation of baseline serum uric acid ≥ 7 mg/dL; for renewals provide current labs demonstrating serum uric acid ≤ 6 mg/dL prior to the scheduled infusion, along with clinical documentation of response and absence of unacceptable toxicity.

• Baseline lab report showing serum uric acid ≥ 7 mg/dL is required for initial approval.
• For renewal, provide current serum uric acid ≤ 6 mg/dL prior to scheduled infusion and evidence of disease response.

Support covered diagnosis with Appendix 1 code

Documentation must support one of the ICD-10 diagnosis codes listed in Appendix 1 to establish a covered indication for Krystexxa.

Denial triggers: age, contraindications, missing baseline UA

Requests may be denied if the member is under 18 years of age, has an FDA-labeled contraindication to Krystexxa (e.g., G6PD deficiency or prior serious hypersensitivity), or lacks documentation of baseline serum uric acid ≥ 7 mg/dL.

• Examples of FDA-labeled contraindications include G6PD deficiency and history of serious hypersensitivity to Krystexxa or its components.

Renewal denial risks: toxicity or inadequate uric acid control

Renewal requests may be denied for unacceptable toxicity (examples: anaphylaxis, infusion reactions, exacerbation of congestive heart failure, hemolytic reactions) or if documentation does not show serum uric acid ≤ 6 mg/dL prior to the scheduled infusion.

• Provide documentation that there is absence of unacceptable toxicity and that continuation is necessary to maintain response/remission.

Comply with Medicare NCDs/LCDs/LCAs for Medicare members

Follow applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) where relevant; noncompliance with these Medicare policies may affect coverage determinations for Medicare members.

• Use the CMS Coverage Database to search for relevant NCDs/LCDs/LCAs: https://www.cms.gov/medicare-coveragedatabase/search.aspx.