Krystexxa (pegloticase) — Prior Authorization and Coverage Criteria
Customize your policy alerts
Sign up for Viva Health Policy IC-0158 alerts
Get alerted when Policy IC-0158 changes without checking for updates manually.
Monitor payer policy activity
Defines prior authorization, dosing limits, initial and renewal medical necessity criteria, and billing/coding for intravenous Krystexxa (pegloticase) for members eligible under Viva Health.
No material clinical or coverage changes in this revision.
Coverage criteria for Krystexxa (pegloticase)
Initial Therapy
Covered when ALL of the following are met:
Renewal Criteria
Renewal may be approved when ALL of the following are met:
Therapy with pegloticase must not be administered in combination with other urate‑lowering therapies. The policy explicitly prohibits concurrent use with agents such as allopurinol, febuxostat, probenecid because combination use is not supported by the coverage criteria and raises safety/efficacy concerns. In addition, providers should note there is no controlled trial data supporting safe retreatment after a drug‑free interval >4 weeks; due to the drug’s immunogenicity, retreatment carries an increased risk of anaphylaxis and infusion reactions and requires careful monitoring.
When pegloticase is used for chronic gout, it is expected to be started with appropriate gout flare prophylaxis and—when indicated—co‑administered with methotrexate to improve response. The policy requires documentation that prior medication trials and concomitant treatment decisions meet the indication‑specific requirements (see initial and renewal criteria).
This policy section applies to non‑Medicare coverage determinations. Providers billing Medicare Part B should consult CMS guidance for applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) prior to submitting claims. The policy’s Appendix 2 points users to the CMS Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx) for jurisdiction‑specific Part B coverage rules; the appendix notes that in this document segment the listed Medicare Part B covered diagnosis codes are N/A.
Include the appropriate Medicare‑applicable codes and documentation on claims when Medicare guidance applies; where a Medicare NCD/LCD/LCA exists, compliance with that Medicare policy is required.
Initial approval requires documentation of an adequate prior trial of xanthine oxidase inhibitors or uricosuric agents unless clearly contraindicated or not tolerated. Specifically, the member must have a documented contraindication, intolerance, or clinical failure (inability to reduce serum uric acid to < 6 mg/dL) after a minimum 3‑month trial at maximum tolerated doses of agents such as allopurinol or febuxostat, or a uricosuric (e.g., probenecid).
Age and contraindication exceptions: the member must be at least 18 years old and must not have FDA‑labeled contraindications (for example, G6PD deficiency or a history of serious hypersensitivity to pegloticase). Requests for members younger than 18 years, or for members with those contraindications, do not meet initial medical necessity criteria per this policy.
Billing, codes and lab thresholds
| J2507 | Injection, pegloticase, 1 mg; 1 billable unit = 1mg |
| 75987-0058-xx | Krystexxa 8 mg/50 mL (0.16 mg/mL) Ready-to-Use single-dose vial |
| 75987-0080-xx | Krystexxa 8 mg/mL To-be-Diluted single-dose vial |
| M1A.00X0 | Idiopathic chronic gout, unspecified site, without tophus (tophi). |
| M1A.00X1 | Idiopathic chronic gout, unspecified site, with tophus (tophi). |
| M1A.0620 | Idiopathic chronic gout, left knee, without tophus (tophi). |
| M1A.0621 | Idiopathic chronic gout, left knee, with tophus (tophi). |
| M1A.0690 | Idiopathic chronic gout, unspecified knee, without tophus (tophi). |
| M1A.0691 | Idiopathic chronic gout, unspecified knee, with tophus (tophi). |
| M1A.0710 | Idiopathic chronic gout, right ankle and foot, without tophus (tophi). |
| M1A.0711 | Idiopathic chronic gout, right ankle and foot, with tophus (tophi). |
| M1A.0720 | Idiopathic chronic gout, left ankle and foot, without tophus (tophi). |
| M1A.0721 | Idiopathic chronic gout, left ankle and foot, with tophus (tophi). |
| M1A.0790 | Idiopathic chronic gout, unspecified ankle and foot, without tophus (tophi). |
| M1A.0791 | Idiopathic chronic gout, unspecified ankle and foot, with tophus (tophi). |
What providers must do
Obtain prior authorization and submit supporting labs
Prior authorization is required. Initial approvals are valid for 180 days (6 months); renewals may be approved every 365 days (12 months). Submit supporting laboratory results and documentation described in the initial and renewal criteria with the prior authorization request.
- Include baseline serum uric acid (sUA) for initial requests and current sUA for renewals.
- Reference HCPCS J2507 on claims (injection, pegloticase, 1 mg).
Verify Medicare (Part B) coverage and local CMS policies
Check CMS guidance for Medicare Part B coverage where applicable. Use the CMS Medicare Coverage Database to identify any applicable NCDs, LCDs, or LCAs that govern Part B reimbursement and coverage determinations.
- Search NCD/LCD/LCA documents at https://www.cms.gov/medicare-coverage-database/search.aspx.
- Medicare Part B Covered Diagnosis Codes in this document are listed as N/A — verify local Medicare coverage guidance prior to billing.
Document prior medication trial of xanthine oxidase inhibitor or uricosuric for ≥3 months
Document a minimum 3-month trial of maximally tolerated xanthine oxidase inhibitors (e.g., allopurinol or febuxostat) or uricosuric agents unless the member is intolerant or has a contraindication.
- Record trial duration (≥3 months), medication names, doses, and reason for failure/intolerance or contraindication.
Provider note: use Appendix 1 and follow policy sections for documentation
Providers must note that Appendix 1 lists covered ICD-10 diagnosis codes and that the policy requires clinical documentation per the criteria in sections III and IV (see referenced policy sections).
- Appendix 1 contains the specific covered ICD-10 codes to reference on requests and claims.
- Ensure clinical documentation aligns with the policy’s initial and renewal criteria.
Submit baseline and renewal labs plus prior-trial and concomitant therapy documentation
Provide required clinical documentation with the PA request and for renewals: baseline serum uric acid ≥ 7 mg/dL for initial authorization; for renewal, documentation of sUA ≤ 6 mg/dL prior to scheduled infusion, evidence of clinical response, and absence of unacceptable toxicity.
- Document prior trials of xanthine oxidase inhibitors or uricosurics (≥3 months) including inability to reduce sUA <6 mg/dL when applicable.
- Include current laboratory reports with dates and values for both initial and renewal requests.
Include an Appendix 1 ICD-10 diagnosis code on requests and claims
Include an appropriate ICD-10 diagnosis code from Appendix 1 on the prior authorization and on claims to support medical necessity for Krystexxa (pegloticase).
- Appendix 1 lists the covered diagnosis codes (e.g., the M1A.* series) to select the applicable code.
- Ensure the diagnosis code matches the clinical documentation provided.
Do not request therapy for members <18 or with FDA‑labeled contraindications
Requests for members under 18 years of age or members with FDA-labeled contraindications (e.g., G6PD deficiency or history of serious hypersensitivity to Krystexxa) will not meet initial criteria and should be denied or require exception documentation.
- Confirm member age ≥18 on the request.
- Document absence of FDA-labeled contraindications (e.g., G6PD deficiency, serious hypersensitivity).
Demonstrate failure/intolerance to alternatives and document concomitant therapy for renewals
For renewals, document clinical failure, intolerance, or contraindication to alternative therapies and confirm required concomitant therapy status (e.g., methotrexate co-administration when indicated) or justify why methotrexate is not used.
- Provide evidence of clinical response (reduction of symptoms/tophi) and sUA ≤ 6 mg/dL prior to infusion.
- If methotrexate is not used, document contraindication or clinical rationale for single-agent use.
Ensure Medicare claims comply with applicable NCDs/LCDs/LCAs
Claims for Medicare beneficiaries may be subject to applicable NCDs, LCDs, or LCAs; providers must ensure compliance with those Medicare policies where they exist in addition to the plan’s non‑Medicare criteria.
- Use the CMS Medicare Coverage Database to identify relevant NCDs/LCDs/LCAs prior to billing for Part B.
- The policy’s preceding information is intended for non‑Medicare coverage determinations; verify Medicare-specific rules before submission.
Background and drug information
Krystexxa (pegloticase) is an intravenous, pegylated uricase indicated for refractory chronic gout in adults. It enzymatically converts uric acid to allantoin, lowering serum uric acid in patients who have not achieved target levels with conventional therapies. The drug is immunogenic and associated with infusion‑related reactions and potentially serious hemolytic events; the policy specifically highlights the risk in patients with G6PD deficiency and requires exclusion of members with FDA‑labeled contraindications.
Recommended dosing for chronic gout in this policy is 8 mg IV every 2 weeks; gout flare prophylaxis should begin at least one week before initiation and continue for at least six months unless contraindicated. When used with methotrexate, methotrexate should be started (typically weekly oral 15 mg with folic/folinic acid supplementation) at least four weeks before initiating pegloticase to improve response and reduce immunogenicity.
Because pegloticase is immunogenic, there is no controlled trial data supporting retreatment after stopping therapy for more than four weeks; retreatment after a drug‑free interval may increase the risk of anaphylaxis and infusion reactions and therefore requires careful monitoring.
Key definitions used in this policy
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.