Colorado Rocky Mountain Health Plans Krystexxa Coverage Update

Coverage Criteria for Krystexxa (pegloticase)

Initial Therapy — Krystexxa (pegloticase)

Krystexxa (pegloticase) is medically necessary for chronic gout when ALL of the following are met:

Initial Therapy - All criteria: 1) Diagnosis of symptomatic gout defined by ANY of: history of ≥2 gout flares in the previous 12 months OR at least 1 gouty tophus OR chronic gouty arthropathy; AND 2) History of contraindication, intolerance, or treatment failure (i.e., failure to normalize uric acid to < 6 mg/dL) after ≥3 months of therapy at maximally medically appropriate doses with BOTH allopurinol and febuxostat; AND 3) Submission of laboratory values demonstrating baseline serum uric acid level > 6 mg/dL; AND 4) Prescriber attests that serum uric acid levels will be monitored prior to each infusion and that discontinuation of treatment will be considered if pre-infusion levels increase above 6 mg/dL; AND 5) Prescribed by a rheumatologist or nephrologist; AND 6) Krystexxa is initiated and titrated according to FDA-labeled dosing; AND 7) Initial authorization will be for no more than 12 months.

Follow FDA dosing; specialist prescriber required.

Continuation Therapy — Krystexxa (pegloticase)

Continuation of therapy is covered when ALL of the following are met:

Continuation Therapy - All criteria: 1) Patient has previously received Krystexxa; AND 2) Patient has experienced a positive clinical response (e.g., serum uric acid < 6 mg/dL, tophus reduction); AND 3) Patient has not had two consecutive serum uric acid levels > 6 mg/dL after initiating treatment; AND 4) Prescribed by a rheumatologist or nephrologist; AND 5) Continued per FDA-labeled dosing; AND 6) Reauthorization will be for no more than 12 months.

Evidence of ongoing response required for reauthorization.

Not Medically Necessary / Unproven Use

Unproven indication: Krystexxa (pegloticase) is unproven and not medically necessary for the treatment of asymptomatic hyperuricemia.

Important limitation of use: not for asymptomatic hyperuricemia.

Initial therapy / FDA indication

Covered when ALL of the following are met

Initial coverage criteria: 1) Patient is an adult with chronic gout; AND 2) Patient is refractory to conventional therapy as evidenced by failure to normalize serum uric acid or inadequate symptom control despite xanthine oxidase inhibitors at the maximum medically appropriate dose or intolerance/contraindication to these agents; AND 3) For patients with frequent flares or non-resolving tophi, alternative agents have been tried or documented as inappropriate; AND 4) Use is not for asymptomatic hyperuricemia.

Reflects FDA indication and EULAR/ACR guidance for pegloticase use.

ACR criteria for switching to pegloticase

Consider switching to pegloticase when ALL of the following OR conditional criteria are met

ACR-based consideration: - Strongly consider pegloticase for patients who have failed xanthine oxidase inhibitor treatment, uricosurics, and other interventions AND who continue to have frequent gout flares (≥ 2 flares/year) OR have non-resolving subcutaneous tophi. - Strongly recommend against switching to pegloticase for patients who have failed other ULTs but have infrequent flares (< 2 flares/year) AND no tophi.>= 2 flares/year

Reflects 2020 ACR recommendations.

Use of Krystexxa (pegloticase) for asymptomatic hyperuricemia is unproven and not medically necessary. The policy limits coverage to patients meeting the documented criteria for symptomatic, refractory chronic gout and does not support use solely to lower serum uric acid in the absence of clinical manifestations.

Important limitation: Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia. Requests where the primary indication is asymptomatic elevation of serum uric acid will not meet the policy’s coverage criteria.

Krystexxa (pegloticase) is explicitly considered not medically necessary for asymptomatic hyperuricemia. Coverage is reserved for patients with symptomatic chronic gout who meet the policy’s diagnostic and prior-therapy requirements.

Per guideline-based recommendations, pegloticase should not be used as a first-line urate-lowering therapy. The ACR strongly recommends against choosing pegloticase as initial therapy and advises that pegloticase generally be reserved for patients who have failed other urate-lowering therapies; it is also strongly recommended against switching to pegloticase for patients with infrequent flares (<2 flares/year) and no tophi.

Relevant Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J2507

Injection, pegloticase, 1mg

Applicable ICD-10 Codes (partial list shown in document)ICD-10

M1A.00X0	Idiopathic chronic gout, unspecified site, without tophus (tophi).
M1A.00X1	Idiopathic chronic gout, unspecified site, with tophus (tophi).
M1A.0110	Idiopathic chronic gout, right shoulder, without tophus (tophi).
M1A.0111	Idiopathic chronic gout, right shoulder, with tophus (tophi).
M1A.0120	Idiopathic chronic gout, left shoulder, without tophus (tophi).
M1A.0121	Idiopathic chronic gout, left shoulder, with tophus (tophi).

Chronic gout due to renal impairment / other secondary chronic gout codes (part 1)ICD-10

M1A.3620	Chronic gout due to renal impairment, right knee, without tophus (tophi).
M1A.3621	Chronic gout due to renal impairment, left knee, with tophus (tophi).
M1A.3690	Chronic gout due to renal impairment, unspecified knee, without tophus (tophi).
M1A.3691	Chronic gout due to renal impairment, unspecified knee, with tophus (tophi).
M1A.3710	Chronic gout due to renal impairment, right ankle and foot, without tophus (tophi).
M1A.3711	Chronic gout due to renal impairment, right ankle and foot, with tophus (tophi).
M1A.3720	Chronic gout due to renal impairment, left ankle and foot, without tophus (tophi).
M1A.3721	Chronic gout due to renal impairment, left ankle and foot, with tophus (tophi).
M1A.3790	Chronic gout due to renal impairment, unspecified ankle and foot, without tophus (tophi).
M1A.3791	Chronic gout due to renal impairment, unspecified ankle and foot, with tophus (tophi).

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Other secondary chronic gout / miscellaneous gout codes (part 2)ICD-10

M1A.40X1	Other secondary chronic gout, unspecified site, with tophus (tophi).
M1A.4110	Other secondary chronic gout, right shoulder, without tophus (tophi).
M1A.4111	Other secondary chronic gout, right shoulder, with tophus (tophi).
M1A.4120	Other secondary chronic gout, left shoulder, without tophus (tophi).
M1A.4121	Other secondary chronic gout, left shoulder, with tophus (tophi).
M1A.4190	Other secondary chronic gout, unspecified shoulder, without tophus (tophi).
M1A.4191	Other secondary chronic gout, unspecified shoulder, with tophus (tophi).
M1A.4210	Other secondary chronic gout, right elbow, without tophus (tophi).
M1A.4211	Other secondary chronic gout, right elbow, with tophus (tophi).
M1A.4220	Other secondary chronic gout, left elbow, without tophus (tophi).

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inv-14: Serum uric acid — baseline and pre-infusion thresholds (> 6 mg/dL)

Baseline requirementSubmission must include laboratory values demonstrating baseline serum uric acid level > 6 mg/dL.

Pre-infusion monitoringPrescriber must attest that serum uric acid levels will be monitored prior to each infusion; consider discontinuation if pre-infusion levels increase above 6 mg/dL.

Threshold rationaleFailure to normalize uric acid to < 6 mg/dL after prior therapy is used elsewhere in the criteria, linking the > 6 mg/dL threshold to treatment decision-making.

inv-15: Serum uric acid target guidance — SUA target often defined as < 6.0 mg/dL with guideline context

Common targetSerum uric acid (SUA) target often defined as < 6.0 mg/dL.

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Krystexxa (pegloticase). Initial authorizations (and reauthorizations) will be for no more than 12 months.

Prior authorization required for adults with chronic gout refractory to conventional therapy.
Initial and reauthorization limits: up to 12 months.

Step Therapy

Step Therapy and Prior Therapy Documentation

Requests for Krystexxa must document prior therapy and meet step-therapy expectations before approval. Prescriber must document failure, intolerance, or contraindication to both allopurinol and febuxostat (each used at maximally medically appropriate dose for ≥3 months) prior to initiation, unless contraindicated.

Step therapy prerequisite: documented failure/intolerance/contraindication to allopurinol and febuxostat (3 months at maximally appropriate dose).
Follow guideline-recommended step approach (xanthine oxidase inhibitors first-line; consider uricosurics or combination per EULAR/ACR recommendations).

Background and Policy Scope

Background: Krystexxa (pegloticase) is a PEGylated uricase indicated for the treatment of chronic gout refractory to conventional therapy. This policy distinguishes requirements for initial therapy—including documentation of symptomatic gout (history of ≥2 flares in the prior 12 months, at least one gouty tophus, or chronic gouty arthropathy), prior failure/intolerance/contraindication to both allopurinol and febuxostat, baseline serum uric acid > 6 mg/dL, specialist prescribing, and adherence to FDA dosing—from continuation therapy, which requires evidence of clinical benefit (for example, sustained serum uric acid < 6 mg/dL or tophus reduction), absence of two consecutive pre-infusion uric acid levels > 6 mg/dL, and reauthorization limits consistent with the initial approval period.

Definitions Used in This Policy

inv-25: Symptomatic gout (policy definition) — criteria: history of ≥2 flares in prior 12 months, ≥1 gouty tophus, or chronic gouty arthropathy

Definition (policy)Symptomatic gout defined by presence of at least one of: history of ≥2 gout flares in the previous 12 months; at least 1 gouty tophus; OR chronic gouty arthropathy.

Documentation implicationRequests lacking documentation that the patient meets one of these diagnostic options may be denied.

Use in coverage criteriaThis symptomatic gout definition is required as part of initial authorization criteria for Krystexxa.

inv-26: Refractory chronic gout — inability to normalize SUA and inadequate control despite xanthine oxidase inhibitors

DefinitionRefractory chronic gout: gout in which serum uric acid cannot be normalized and signs/symptoms remain inadequately controlled despite xanthine oxidase inhibitors at the maximum medically appropriate dose or when such drugs are contraindicated.

OpenPayer

Krystexxa (pegloticase) — Medical Benefit Drug Policy (coverage criteria)

Coverage Criteria for Krystexxa (pegloticase)

Relevant Billing and Diagnosis Codes

Prior Authorization, Documentation, and Step Therapy Requirements

Background and Policy Scope

Definitions Used in This Policy