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Krystexxa (pegloticase)

Policy Number: PH-0158

 

(Intravenous)

Last Review Date: 10/02/2018

Date of Origin: 02/07/20103

Dates Reviewed: 11/2013, 08/2014, 07/2015, 07/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018

 

  1. Length of Authorization

Coverage is provided for six months and will be eligible for renewal.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Krystexxa 8 mg/mL single-use vial: 2 vials every 28 days
  1. Max Units (per dose and over time) [Medical Benefit]:
  • 16 billable units every 28 days
  1. Initial Approval Criteria

Coverage is provided in the following conditions:

Chronic Gout †

  • Patient is at least 18 years old; AND
  • Patient has one of the following:
    • At least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine and/or nonsteroidal anti-inflammatory drugs (NSAIDS) or oral or injectable corticosteroids; OR
    • At least 1 gout tophus or has chronic gouty arthritis; AND
  • Documentation of baseline serum uric acid level > 8 mg/dL (current lab reports are required for renewal); AND
  • Documented contraindication, intolerance, or clinical failure (inability to reduce serum uric acid to < 6 mg/dL) during a minimum (3) month trial on previous therapy with maximum tolerated dose of xanthine oxidase inhibitors (e.g., allopurinol or febuxostat); AND
  • Patient is NOT receiving other urate lowering therapies such as allopurinol, febuxostat, probenecid, lesinurad, etc.; AND
  • Patients at higher risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency should be screened and found negative for G6PD before starting Krystexxa

FDA-labeled indication(s)

  1. Renewal Criteria

Authorizations can be renewed based on the following criteria:

  • Patient continues to meet the criteria identified in section III; AND
  • Disease response with treatment (i.e., reduction of symptoms, reduction of tophi); AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: anaphylaxis; infusion reactions; exacerbation of congestive heart failure; AND
  • Documentation of serum uric acid level <6 mg/dL prior to scheduled infusion
  1. Dosage/Administration

Indication

Dose

All indications

8 mg given as an intravenous infusion every two weeks

  • Patient should receive gout flare prophylaxis with a NSAID or colchicine starting at least 1 week prior to therapy and continuing for at least 6 months
  1. Billing Code/Availability Information

Jcode:

J2507 – Injection, pegloticase, 1 mg: 1 billable unit = 1mg

NDC:

Krystexxa 8 mg/mL single-use vial: 75987-0080-xx

  1. References
  1. Krystexxa [package Insert]. Lake Forest, IL; Horizon Pharma Rheumatology, LLC; July 2018. Accessed August 2018.
  2. Khanna D, Fitzgerald JD, Khanna PP, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 1: Systematic Nonpharmacologic and Pharmacologic Therapeutic Approaches to Hyperuricemia.  Arthritis Care Res (Hoboken). 2012 Oct; 64(10):1431-46.
  3. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis.  Arthritis Care Res (Hoboken). 2012 Oct; 64(10):1447-61.
  4. Richette P, Doherty M, Pascual E, et al.  2016 updated EULAR evidence-based recommendations for the management of gout.  Annals of the Rheumatic Diseases 2017;76:29-42.
  5. Qaseem A, Harris RP, Forciea MA, et al. Management of Acute and Recurrent Gout: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017;166(1):58-68.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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)

M1A.0190

Idiopathic chronic gout, unspecified shoulder, without tophus (tophi)

M1A.0191

Idiopathic chronic gout, unspecified shoulder, with tophus (tophi)

M1A.0210

Idiopathic chronic gout, right elbow, without tophus (tophi)

M1A.0211

Idiopathic chronic gout, right elbow, with tophus (tophi)

M1A.0220

Idiopathic chronic gout, left elbow, without tophus (tophi)

M1A.0221

Idiopathic chronic gout, left elbow, with tophus (tophi)

M1A.0290

Idiopathic chronic gout, unspecified elbow, without tophus (tophi)

M1A.0291

Idiopathic chronic gout, unspecified elbow, with tophus (tophi)

M1A.0310

Idiopathic chronic gout, right wrist, without tophus (tophi)

M1A.0311

Idiopathic chronic gout, right wrist, with tophus (tophi)

M1A.0320

Idiopathic chronic gout, left wrist, without tophus (tophi)

M1A.0321

Idiopathic chronic gout, left wrist, with tophus (tophi)

M1A.0390

Idiopathic chronic gout, unspecified wrist, without tophus (tophi)

M1A.0391

Idiopathic chronic gout, unspecified wrist, with tophus (tophi)

M1A.0410

Idiopathic chronic gout, right hand, without tophus (tophi)

M1A.0411

Idiopathic chronic gout, right hand, with tophus (tophi)

M1A.0420

Idiopathic chronic gout, left hand, without tophus (tophi)

M1A.0421

Idiopathic chronic gout, left hand, with tophus (tophi)

M1A.0490

Idiopathic chronic gout, unspecified hand, without tophus (tophi)

M1A.0491

Idiopathic chronic gout, unspecified hand, with tophus (tophi)

M1A.0510

Idiopathic chronic gout, right hip, without tophus (tophi)

M1A.0511

Idiopathic chronic gout, right hip, with tophus (tophi)

M1A.0520

Idiopathic chronic gout, left hip, without tophus (tophi)

M1A.0521

Idiopathic chronic gout, left hip, with tophus (tophi)

M1A.0590

Idiopathic chronic gout, unspecified hip, without tophus (tophi)

M1A.0591

Idiopathic chronic gout, unspecified hip, with tophus (tophi)

M1A.0610

Idiopathic chronic gout, right knee, without tophus (tophi)

M1A.0611

Idiopathic chronic gout, right knee, 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)

M1A.08X0

Idiopathic chronic gout, vertebrae, without tophus (tophi)

M1A.08X1

Idiopathic chronic gout, vertebrae, with tophus (tophi)

M1A.09X0

Idiopathic chronic gout, multiple sites, without tophus (tophi)

M1A.09X1

Idiopathic chronic gout, multiple sites, with tophus (tophi)

M1A.30X0

Chronic gout due to renal impairment, unspecified site, without tophus (tophi)

M1A.30X1

Chronic gout due to renal impairment, unspecified site, with tophus (tophi)

M1A.3110

Chronic gout due to renal impairment, right shoulder, without tophus (tophi)

M1A.3111

Chronic gout due to renal impairment, right shoulder, with tophus (tophi)

M1A.3120

Chronic gout due to renal impairment, left shoulder, without tophus (tophi)

M1A.3121

Chronic gout due to renal impairment, left shoulder, with tophus (tophi)

M1A.3190

Chronic gout due to renal impairment, unspecified shoulder, without tophus (tophi)

M1A.3191

Chronic gout due to renal impairment, unspecified shoulder, with tophus (tophi)

M1A.3210

Chronic gout due to renal impairment, right elbow, without tophus (tophi)

M1A.3211

Chronic gout due to renal impairment, right elbow, with tophus (tophi)

M1A.3220

Chronic gout due to renal impairment, left elbow, without tophus (tophi)

M1A.3221

Chronic gout due to renal impairment, left elbow, with tophus (tophi)

M1A.3290

Chronic gout due to renal impairment, unspecified elbow, without tophus (tophi)

M1A.3291

Chronic gout due to renal impairment, unspecified elbow, with tophus (tophi)

M1A.3310

Chronic gout due to renal impairment, right wrist, without tophus (tophi)

M1A.3311

Chronic gout due to renal impairment, right wrist, with tophus (tophi)

M1A.3320

Chronic gout due to renal impairment, left wrist, without tophus (tophi)

M1A.3321

Chronic gout due to renal impairment, left wrist, with tophus (tophi)

M1A.3390

Chronic gout due to renal impairment, unspecified wrist, without tophus (tophi)

M1A.3391

Chronic gout due to renal impairment, unspecified wrist, with tophus (tophi)

M1A.3410

Chronic gout due to renal impairment, right hand, without tophus (tophi)

M1A.3411

Chronic gout due to renal impairment, right hand, with tophus (tophi)

M1A.3420

Chronic gout due to renal impairment, left hand, without tophus (tophi)

M1A.3421

Chronic gout due to renal impairment, left hand, with tophus (tophi)

M1A.3490

Chronic gout due to renal impairment, unspecified hand, without tophus (tophi)

M1A.3491

Chronic gout due to renal impairment, unspecified hand, with tophus (tophi)

M1A.3510

Chronic gout due to renal impairment, right hip, without tophus (tophi)

M1A.3511

Chronic gout due to renal impairment, right hip, with tophus (tophi)

M1A.3520

Chronic gout due to renal impairment, left hip, without tophus (tophi)

M1A.3521

Chronic gout due to renal impairment, left hip, with tophus (tophi)

M1A.3590

Chronic gout due to renal impairment, unspecified hip, without tophus (tophi)

M1A.3591

Chronic gout due to renal impairment, unspecified hip, with tophus (tophi)

M1A.3610

Chronic gout due to renal impairment, right knee, without tophus (tophi)

M1A.3611

Chronic gout due to renal impairment, right knee, with tophus (tophi)

M1A.3620

Chronic gout due to renal impairment, left 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)

M1A.38X0

Chronic gout due to renal impairment, vertebrae, without tophus (tophi)

M1A.38X1

Chronic gout due to renal impairment, vertebrae, with tophus (tophi)

M1A.39X0

Chronic gout due to renal impairment, multiple sites, without tophus (tophi)

M1A.39X1

Chronic gout due to renal impairment, multiple sites, with tophus (tophi)

M1A.40X0

Other secondary chronic gout, unspecified site, without tophus (tophi)

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)

M1A.4221

Other secondary chronic gout, left elbow, with tophus (tophi)

M1A.4290

Other secondary chronic gout, unspecified elbow, without tophus (tophi)

M1A.4291

Other secondary chronic gout, unspecified elbow, with tophus (tophi)

M1A.4310

Other secondary chronic gout, right wrist, without tophus (tophi)

M1A.4311

Other secondary chronic gout, right wrist, with tophus (tophi)

M1A.4320

Other secondary chronic gout, left wrist, without tophus (tophi)

M1A.4321

Other secondary chronic gout, left wrist, with tophus (tophi)

M1A.4390

Other secondary chronic gout, unspecified wrist, without tophus (tophi)

M1A.4391

Other secondary chronic gout, unspecified wrist, with tophus (tophi)

M1A.4410

Other secondary chronic gout, right hand, without tophus (tophi)

M1A.4411

Other secondary chronic gout, right hand, with tophus (tophi)

M1A.4420

Other secondary chronic gout, left hand, without tophus (tophi)

M1A.4421

Other secondary chronic gout, left hand, with tophus (tophi)

M1A.4490

Other secondary chronic gout, unspecified hand, without tophus (tophi)

M1A.4491

Other secondary chronic gout, unspecified hand, with tophus (tophi)

M1A.4510

Other secondary chronic gout, right hip, without tophus (tophi)

M1A.4511

Other secondary chronic gout, right hip, with tophus (tophi)

M1A.4520

Other secondary chronic gout, left hip, without tophus (tophi)

M1A.4521

Other secondary chronic gout, left hip, with tophus (tophi)

M1A.4590

Other secondary chronic gout, unspecified hip, without tophus (tophi)

M1A.4591

Other secondary chronic gout, unspecified hip, with tophus (tophi)

M1A.4610

Other secondary chronic gout, right knee, without tophus (tophi)

M1A.4611

Other secondary chronic gout, right knee, with tophus (tophi)

M1A.4620

Other secondary chronic gout, left knee, without tophus (tophi)

M1A.4621

Other secondary chronic gout, left knee, with tophus (tophi)

M1A.4690

Other secondary chronic gout, unspecified knee, without tophus (tophi)

M1A.4691

Other secondary chronic gout, unspecified knee, with tophus (tophi)

M1A.4710

Other secondary chronic gout, right ankle and foot, without tophus (tophi)

M1A.4711

Other secondary chronic gout, right ankle and foot, with tophus (tophi)

M1A.4720

Other secondary chronic gout, left ankle and foot, without tophus (tophi)

M1A.4721

Other secondary chronic gout, left ankle and foot, with tophus (tophi)

M1A.4790

Other secondary chronic gout, unspecified ankle and foot, without tophus (tophi)

M1A.4791

Other secondary chronic gout, unspecified ankle and foot, with tophus (tophi)

M1A.48X0

Other secondary chronic gout, vertebrae, without tophus (tophi)

M1A.48X1

Other secondary chronic gout, vertebrae, with tophus (tophi)

M1A.49X0

Other secondary chronic gout, multiple sites, without tophus (tophi)

M1A.49X1

Other secondary chronic gout, multiple sites, with tophus (tophi)

M1A.9XX0

Chronic gout, unspecified, without tophus (tophi)

M1A.9XX1

Chronic gout, unspecified, with tophus (tophi)

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC