CurrentMass General Brigham Health PlanPolicy N/A

Gout Agents Krystexxa (pegloticase injection) Effective 06/01/2025

Pharmacy clinical prior authorization policy for Krystexxa (pegloticase injection) governing coverage criteria, initial and continuation authorization durations, limitations, contact info, and step-through therapy / prior-agent requirements for Mass General Brigham Health Plan (MassHealth UPPL).

Policy Summary

PayerMass General Brigham Health Plan

PolicyGout Agents Krystexxa (pegloticase injection) Effective 06/01/2025

Policy CodePolicy N/A

Change TypeRevised criteria and benefit listing

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization required; contact All Plans Phone: 877-519-1908 or Fax: 855-540-3693 and provide physician attestation of inadequate response or contraindication to prior agents, including allopurinol (≥800 mg/day x4 weeks), with specified serum urate values.

SourceLink

POLICY UPDATE CHANGES

Allopurinol step-through dose threshold increased to 800 mg/day from 600 mg/day per clinical guidelines and FDA maximum dosing.

Removed certain agents (Allopurinol 200 mg tablet, Gloperba, Mitigare, and Uloric) from medical benefit listing because they are pharmacy benefit only.

Performed annual medical criteria review and updated formatting & references.

1Covered Indication (gout)

3Required prior-agent pathways

6 moInitial approval duration

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Coverage Summary

This is a pharmacy benefit prior authorization policy for Krystexxa (pegloticase) — a PEGylated uric acid–specific enzyme — with a coverage stance of covered_with_criteria. The policy governs prior authorization criteria, step-through therapy and prior-agent requirements, initial and continuation authorization durations, limitations, and contact information for Mass General Brigham Health Plan in alignment with the MassHealth UPPL; effective date is 06/01/2025 and the subject is Krystexxa (pegloticase) prior authorization.

Key limits & thresholds

Age>= 18 years

Allopurinol dose threshold>= 800 mg/day for 4 weeks

Serum urate (allopurinol inadequate response)>= 6.0 mg/dL

Serum urate (febuxostat/uricosuric inadequate response)> 6.0 mg/dL

Renal dysfunction contraindicationCrCl < 30 mL/min

Initial approval duration6 months

Reauthorization duration12 months

Initial Authorization Criteria

Authorization may be granted when ALL of the following are met:

ALL of the following

Diagnosis of gout
Member is ≥ 18 years of age>= 18 years
Physician attestation of inadequate response to allopurinol at a dose of at least 800 mg/day for four weeks (defined by serum urate levels ≥ 6.0 mg/dL)>= 800 mg/day for 4 weeks; serum urate >= 6.0 mg/dL
Allopurinol dose threshold updated from 600 mg/day to 800 mg/day per revision
ONE of the following (allopurinol alternative/blocking reasons)

Continuation / Reauthorization Criteria

Reauthorization by physician will infer a positive response to therapy:

ALL of the following

Physician reauthorization (documenting ongoing response to therapy)

Initial approvals will be granted for 6 months, and reauthorizations will be granted for 12 months as specified under the policy’s duration rules.

Authorization Review for Members New to Plan

Case-by-case review applies when members are new to the plan and currently receiving the medication (exclusions apply):

ALL of the following

Authorization may be reviewed case-by-case for members new to the plan currently receiving requested medication
Authorization review excludes products obtained as samples or via manufacturer's patient assistance programs

Prior Authorization

New-to-plan treatment review

Authorization may be reviewed case-by-case for members new to the plan who are currently receiving the requested medication. This review excludes products obtained as samples or via manufacturer's patient assistance programs.

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required. For pharmacy benefit requests, contact All Plans Phone: 877-519-1908; Fax: 855-540-3693.

Documentation Required

Physician attestations required

Providers must attest to inadequate response or an adverse reaction/contraindication to prior agents. Required attestations include inadequate response to allopurinol at a dose of at least 800 mg/day for four weeks (defined by serum urate levels ≥ 6.0 mg/dL), inadequate response or contraindication to febuxostat, and inadequate response or contraindication to a uricosuric agent; serum urate values as specified in the criteria must be provided.

Applicable Codes & Benefit

Benefit / Programmixed

Pharmacy Benefit

Krystexxa covered under Pharmacy Benefit per header

Clinical Evidence & Definitions

References include: ACR 2020 gout guideline; EULAR 2016 recommendations; Krystexxa package insert (2021); and multiple UpToDate topics.

Definitions: Inadequate response — physician attestation defined by serum urate levels ≥ 6.0 mg/dL for allopurinol, and serum urate levels > 6.0 mg/dL for febuxostat/uricosuric agents after the specified trials.

Background & Policy Scope

Background: Krystexxa is indicated for treatment of chronic gout refractory to conventional therapy and is a PEGylated uricase enzyme. The policy aligns prior authorization requirements with the MassHealth UPPL and clinical guidelines, and applies as a pharmacy clinical prior authorization policy for Krystexxa (pegloticase injection) governing coverage criteria, durations, limitations, contact information, and step-through therapy/prior-agent requirements for Mass General Brigham Health Plan.

The policy explicitly aligns prior authorization requirements and step-through dosing thresholds with MassHealth UPPL and clinical guidelines — including raising the allopurinol step-through dose threshold to 800 mg/day per the referenced updates and ensuring PA requirements reflect MassHealth UPPL guidance.

Revision History

2023-02-08policy_created

Policy created and matched to MassHealth UPPL criteria; effective 04/01/2023.

2023-09-13review_update

Allopurinol 200 mg tablet formulation added to criteria requiring prior authorization; brand preferred and mandatory generic language added under Limitations; effective 10/02/2023.

2025-05-15annual_review

Performed annual medical criteria review; formatting and references updated to reflect agents on pharmacy benefit (removed Allopurinol 200 mg tablet, Gloperba, Mitigare, and Uloric from medical benefit listing); criteria updated to increase allopurinol step-through dose threshold to 800 mg/day from 600 mg/day per clinical guidelines and FDA maximum dosing; effective 06/01/2025.