Pegloticase (Krystexxa) (Medicaid Expansion)

Policy ID: ME-I-29-013-05

Section: Injections

Effective Date: January 01, 2022

Revised Date: May 30, 2025

Revision Effective Date: August 01, 2025

Last Reviewed: June 10, 2025

Applies To: Medicaid Expansion Only

Description

Pegloticase (Krystexxa™) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult individuals' refractory to conventional therapy. Pegloticase achieves its therapeutic effect by catalyzing the oxidation of uric acid to allantoin, a purine metabolite readily excreted in the urine, thereby lowering serum uric acid.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The use of pegloticase (Krystexxa) may be considered medically necessary when ALL of the following criteria are met:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
Pegloticase (Krystexxa) must be prescribed by, or in consult with, a rheumatologist; and
The individual must have failed a three (3)-month trial of two of the following, as evidenced by paid claims or pharmacy print outs:
- allopurinol; or
- febuxostat; or
- allopurinol or febuxostat in combination with probenecid; and
The failure of previous trials must be documented by both of the following:
- Serum uric acid level greater than or equal to 6 mg/dL within the past month; and
- One of the following;
  - At least three (3) gout flares in the previous 18 months that were inadequately controlled; or
  - One (1) gout tophus or gouty arthritis.

Initial Authorization: Six (6) months

Reauthorization Criteria

Continuation of therapy with pegloticase (Krystexxa) may be considered medically necessary when the following is met:

The individual is not experiencing infusion reactions; and
The individual must have experienced and maintained clinical benefit since starting treatment with pegloticase (Krystexxa), as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including both of the following:
- Serum uric acid levels less than 6mg/dl within the past month; and
- Decrease in gout flares or nonrevolving tophaceous deposits.

The use of pegloticase (Krystexxa) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J2507

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

M10.00

M10.011

M10.012

M10.019

M10.021

M10.022

M10.029

M10.031

M10.032

M10.039

M10.041

M10.042

M10.049

M10.051

M10.052

M10.059

M10.061

M10.062

M10.069

M10.071

M10.072

M10.079

M10.08

M10.09

M10.10

M10.111

M10.112

M10.119

M10.121

M10.122

M10.129

M10.131

M10.132

M10.139

M10.141

M10.142

M10.149

M10.151

M10.152

M10.159

M10.161

M10.162

M10.169

M10.171

M10.172

M10.179

M10.18

M10.19

M10.20

M10.211

M10.212

M10.219

M10.221

M10.222

M10.229

M10.231

M10.232

M10.239

M10.241

M10.242

M10.249

M10.251

M10.252

M10.259

M10.261

M10.262

M10.269

M10.271

M10.272

M10.279

M10.28

M10.29

M10.30

M10.311

M10.312

M10.319

M10.321

M10.322

M10.329

M10.331

M10.332

M10.339

M10.341

M10.342

M10.349

M10.351

M10.352

M10.359

M10.361

M10.362

M10.369

M10.371

M10.372

M10.379

M10.38

M10.39

M10.40

M10.411

M10.412

M10.419

M10.421

M10.422

M10.429

M10.431

M10.432

M10.439

M10.441

M10.442

M10.449

M10.451

M10.452

M10.459

M10.461

M10.462

M10.469

M10.471

M10.472

M10.479

M10.48

M10.49

M10.9

M1A.00X0

M1A.00X1

M1A.0110

M1A.0111

M1A.0120

M1A.0121

M1A.0190

M1A.0191

M1A.0210

M1A.0211

M1A.0220

M1A.0221

M1A.0290

M1A.0291

M1A.0310

M1A.0311

M1A.0320

M1A.0321

M1A.0390

M1A.0391

M1A.0410

M1A.0411

M1A.0420

M1A.0421

M1A.0490

M1A.0491

M1A.0510

M1A.0511

M1A.0520

M1A.0521

M1A.0590

M1A.0591

M1A.0610

M1A.0611

M1A.0620

M1A.0621

M1A.0690

M1A.0691

M1A.0710

M1A.0711

M1A.0720

M1A.0721

M1A.0790

M1A.0791

M1A.08X0

M1A.08X1

M1A.09X0

M1A.09X1

M1A.10X0

M1A.10X1

M1A.1110

M1A.1111

M1A.1120

M1A.1121

M1A.1190

M1A.1191

M1A.1210

M1A.1211

M1A.1220

M1A.1221

M1A.1290

M1A.1291

M1A.1310

M1A.1311

M1A.1320

M1A.1321

M1A.1390

M1A.1391

M1A.1410

M1A.1411

M1A.1420

M1A.1421

M1A.1490

M1A.1491

M1A.1510

M1A.1511

M1A.1520

M1A.1521

M1A.1590

M1A.1591

M1A.1610

M1A.1611

M1A.1620

M1A.1621

M1A.1690

M1A.1691

M1A.1710

M1A.1711

M1A.1720

M1A.1721

M1A.1790

M1A.1791

M1A.18X0

M1A.18X1

M1A.19X0

M1A.19X1

M1A.20X0

M1A.20X1

M1A.2110

M1A.2111

M1A.2120

M1A.2121

M1A.2190

M1A.2191

M1A.2210

M1A.2211

M1A.2220

M1A.2221

M1A.2290

M1A.2291

M1A.2310

M1A.2311

M1A.2320

M1A.2321

M1A.2390

M1A.2391

M1A.2410

M1A.2411

M1A.2420

M1A.2421

M1A.2490

M1A.2491

M1A.2510

M1A.2511

M1A.2520

M1A.2521

M1A.2590

M1A.2591

M1A.2610

M1A.2611

M1A.2620

M1A.2621

M1A.2690

M1A.2691

M1A.2710

M1A.2711

M1A.2720

M1A.2721

M1A.2790

M1A.2791

M1A.28X0

M1A.28X1

M1A.29X0

M1A.29X1

M1A.30X0

M1A.30X1

M1A.3110

M1A.3111

M1A.3120

M1A.3121

M1A.3190

M1A.3191

M1A.3210

M1A.3211

M1A.3220

M1A.3221

M1A.3290

M1A.3291

M1A.3310

M1A.3311

M1A.3320

M1A.3321

M1A.3390

M1A.3391

M1A.3410

M1A.3411

M1A.3420

M1A.3421

M1A.3490

M1A.3491

M1A.3510

M1A.3511

M1A.3520

M1A.3521

M1A.3590

M1A.3591

M1A.3610

M1A.3611

M1A.3620

M1A.3621

M1A.3690

M1A.3691

M1A.3710

M1A.3711

M1A.3720

M1A.3721

M1A.3790

M1A.3791

M1A.38X0

M1A.38X1

M1A.39X0

M1A.39X1

M1A.40X0

M1A.40X1

M1A.4110

M1A.4111

M1A.4120

M1A.4121

M1A.4190

M1A.4191

M1A.4210

M1A.4211

M1A.4220

M1A.4221

M1A.4290

M1A.4291

M1A.4310

M1A.4311

M1A.4320

M1A.4321

M1A.4390

M1A.4391

M1A.4410

M1A.4411

M1A.4420

M1A.4421

M1A.4490

M1A.4491

M1A.4510

M1A.4511

M1A.4520

M1A.4521

M1A.4590

M1A.4591

M1A.4610

M1A.4611

M1A.4620

M1A.4621

M1A.4690

M1A.4691

M1A.4710

M1A.4711

M1A.4720

M1A.4721

M1A.4790

M1A.4791

M1A.48X0

M1A.48X1

M1A.49X0

M1A.49X1

M1A.9XX0

M1A.9XX1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy effective 1-1-2022

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Updated initial and renewal criteria based on the DHHS PDL Version 2023.4

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 6-10-2025 Effective August 01, 2025

Annual review no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: ME-I-29-013-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: July 10, 2024

Revision Effective Date: September 01, 2024

Last Reviewed: July 16, 2024

Archived Date: July 31, 2025

Applies To: Medicaid Expansion Only

Description

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The use of pegloticase (Krystexxa) may be considered medically necessary when ALL of the following criteria are met:

The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
Pegloticase (Krystexxa) must be prescribed by, or in consult with, a rheumatologist; and
The individual must have failed a three (3)-month trial of two of the following, as evidenced by paid claims or pharmacy print outs:
- allopurinol; or
- febuxostat; or
- allopurinol or febuxostat in combination with probenecid; and
The failure of previous trials must be documented by both of the following:
- Serum uric acid level greater than or equal to 6 mg/dL within the past month; and
- One of the following;
  - At least three (3) gout flares in the previous 18 months that were inadequately controlled; or
  - One (1) gout tophus or gouty arthritis.

Initial Authorization: Six (6) months

Reauthorization Criteria

Continuation of therapy with pegloticase (Krystexxa) may be considered medically necessary when the following is met:

The individual is not experiencing infusion reactions; and
The individual must have experienced and maintained clinical benefit since starting treatment with pegloticase (Krystexxa), as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including both of the following:
- Serum uric acid levels less than 6mg/dl within the past month; and
- Decrease in gout flares or nonrevolving tophaceous deposits.

Procedure Code

J2507

Diagnosis Codes

M10.00

M10.011

M10.012

M10.019

M10.021

M10.022

M10.029

M10.031

M10.032

M10.039

M10.041

M10.042

M10.049

M10.051

M10.052

M10.059

M10.061

M10.062

M10.069

M10.071

M10.072

M10.079

M10.08

M10.09

M10.10

M10.111

M10.112

M10.119

M10.121

M10.122

M10.129

M10.131

M10.132

M10.139

M10.141

M10.142

M10.149

M10.151

M10.152

M10.159

M10.161

M10.162

M10.169

M10.171

M10.172

M10.179

M10.18

M10.19

M10.20

M10.211

M10.212

M10.219

M10.221

M10.222

M10.229

M10.231

M10.232

M10.239

M10.241

M10.242

M10.249

M10.251

M10.252

M10.259

M10.261

M10.262

M10.269

M10.271

M10.272

M10.279

M10.28

M10.29

M10.30

M10.311

M10.312

M10.319

M10.321

M10.322

M10.329

M10.331

M10.332

M10.339

M10.341

M10.342

M10.349

M10.351

M10.352

M10.359

M10.361

M10.362

M10.369

M10.371

M10.372

M10.379

M10.38

M10.39

M10.40

M10.411

M10.412

M10.419

M10.421

M10.422

M10.429

M10.431

M10.432

M10.439

M10.441

M10.442

M10.449

M10.451

M10.452

M10.459

M10.461

M10.462

M10.469

M10.471

M10.472

M10.479

M10.48

M10.49

M10.9

M1A.00X0

M1A.00X1

M1A.0110

M1A.0111

M1A.0120

M1A.0121

M1A.0190

M1A.0191

M1A.0210

M1A.0211

M1A.0220

M1A.0221

M1A.0290

M1A.0291

M1A.0310

M1A.0311

M1A.0320

M1A.0321

M1A.0390

M1A.0391

M1A.0410

M1A.0411

M1A.0420

M1A.0421

M1A.0490

M1A.0491

M1A.0510

M1A.0511

M1A.0520

M1A.0521

M1A.0590

M1A.0591

M1A.0610

M1A.0611

M1A.0620

M1A.0621

M1A.0690

M1A.0691

M1A.0710

M1A.0711

M1A.0720

M1A.0721

M1A.0790

M1A.0791

M1A.08X0

M1A.08X1

M1A.09X0

M1A.09X1

M1A.10X0

M1A.10X1

M1A.1110

M1A.1111

M1A.1120

M1A.1121

M1A.1190

M1A.1191

M1A.1210

M1A.1211

M1A.1220

M1A.1221

M1A.1290

M1A.1291

M1A.1310

M1A.1311

M1A.1320

M1A.1321

M1A.1390

M1A.1391

M1A.1410

M1A.1411

M1A.1420

M1A.1421

M1A.1490

M1A.1491

M1A.1510

M1A.1511

M1A.1520

M1A.1521

M1A.1590

M1A.1591

M1A.1610

M1A.1611

M1A.1620

M1A.1621

M1A.1690

M1A.1691

M1A.1710

M1A.1711

M1A.1720

M1A.1721

M1A.1790

M1A.1791

M1A.18X0

M1A.18X1

M1A.19X0

M1A.19X1

M1A.20X0

M1A.20X1

M1A.2110

M1A.2111

M1A.2120

M1A.2121

M1A.2190

M1A.2191

M1A.2210

M1A.2211

M1A.2220

M1A.2221

M1A.2290

M1A.2291

M1A.2310

M1A.2311

M1A.2320

M1A.2321

M1A.2390

M1A.2391

M1A.2410

M1A.2411

M1A.2420

M1A.2421

M1A.2490

M1A.2491

M1A.2510

M1A.2511

M1A.2520

M1A.2521

M1A.2590

M1A.2591

M1A.2610

M1A.2611

M1A.2620

M1A.2621

M1A.2690

M1A.2691

M1A.2710

M1A.2711

M1A.2720

M1A.2721

M1A.2790

M1A.2791

M1A.28X0

M1A.28X1

M1A.29X0

M1A.29X1

M1A.30X0

M1A.30X1

M1A.3110

M1A.3111

M1A.3120

M1A.3121

M1A.3190

M1A.3191

M1A.3210

M1A.3211

M1A.3220

M1A.3221

M1A.3290

M1A.3291

M1A.3310

M1A.3311

M1A.3320

M1A.3321

M1A.3390

M1A.3391

M1A.3410

M1A.3411

M1A.3420

M1A.3421

M1A.3490

M1A.3491

M1A.3510

M1A.3511

M1A.3520

M1A.3521

M1A.3590

M1A.3591

M1A.3610

M1A.3611

M1A.3620

M1A.3621

M1A.3690

M1A.3691

M1A.3710

M1A.3711

M1A.3720

M1A.3721

M1A.3790

M1A.3791

M1A.38X0

M1A.38X1

M1A.39X0

M1A.39X1

M1A.40X0

M1A.40X1

M1A.4110

M1A.4111

M1A.4120

M1A.4121

M1A.4190

M1A.4191

M1A.4210

M1A.4211

M1A.4220

M1A.4221

M1A.4290

M1A.4291

M1A.4310

M1A.4311

M1A.4320

M1A.4321

M1A.4390

M1A.4391

M1A.4410

M1A.4411

M1A.4420

M1A.4421

M1A.4490

M1A.4491

M1A.4510

M1A.4511

M1A.4520

M1A.4521

M1A.4590

M1A.4591

M1A.4610

M1A.4611

M1A.4620

M1A.4621

M1A.4690

M1A.4691

M1A.4710

M1A.4711

M1A.4720

M1A.4721

M1A.4790

M1A.4791

M1A.48X0

M1A.48X1

M1A.49X0

M1A.49X1

M1A.9XX0

M1A.9XX1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy effective 1-1-2022

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Updated initial and renewal criteria based on the DHHS PDL Version 2023.4

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Medical Policies Quick Search

Pegloticase (Krystexxa) (Medicaid Expansion)

Description

Policy Application

Criteria

Procedure Code

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Procedure Code

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer