CORONAVIRUS (COVID-19)

Resources on COVID-19 and how BCBSND is responding to help protect all North Dakotans

Pegloticase (Krystexxa™)

Section: Injections
Effective Date: February 01, 2020
Revised Date: November 26, 2019

Description

Pegloticase (KrystexxaaTM) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients' 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. 

Criteria

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

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website. 

Pegloticase (Krystexxaa) may be considered medically necessary who meet BOTH of the following criteria: 

  • For the treatment of chronic gout in adult patients refractory to conventional therapy. Refractory will be defined as: 
    • Failure to normalize serum uric acid to less than 6 mg/dL after three months of maximum medically appropriate dose of xanthine oxidase inhibitors (e.g., allopurinol, febuxostat); or
    • Contraindication to xanthine oxidase inhibitors; and
  • Adult patients must have a documented diagnosis of symptomatic gout. Pegloticase is not recommended for the treatment of asymptomatic hyperuricemia. Symptomatic is defined as one of the following: 
    • Greater than or equal to three gout flares in the previous 18 months; or 
    • Greater than or equal to one gout tophus; or 
    • Gouty arthritis. 

Pegloticase should be administered in a healthcare setting by a healthcare provider prepared to manage anaphylaxis. Patients should receive pre-infusion medications (e.g. antihistamines, corticosteroids), to minimize infusion reactions. Glucose-6-phosphate dehydrogenase (G6PD) Deficiency:Before starting Pegloticase, patients at higher risk for G6PD deficiency (e.g. those of African and Mediterranean ancestry should be screened due to risk of hemolysis and methemoglobinemia). G6PD deficiency is contraindication for pegloticase. 

The use of pegloticase for any other indication is considered experimental/investigational, and therefore, not covered because the safety and/or effectiveness of this use cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

J2507

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J2507

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.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

N/A

Links