Subject: Krystexxa 1803-A SGM P2022

Drug

KRYSTEXXA  (pegloticase)

Policy:

I.    INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. 

FDA-Approved Indication
Krystexxa is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. 

Limitations of Use
Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia. 

All other indications are considered experimental/investigational and not medically necessary. 

II.  DOCUMENTATION 

Submission of the following information is necessary to initiate the prior authorization review for continuation of therapy requests: documentation (e.g., chart notes, lab test results) of a response to therapy (e.g., serum uric acid levels < 6 mg/dL, reduction of tophi, reduction of symptoms and/or flares).

III. CRITERIA FOR INITIAL APPROVAL 

Chronic gout
Authorization of 12 months may be granted for members with a diagnosis of chronic gout when ALL of the following criteria are met:
A.   Member is 18 years of age or older.
B.   Krystexxa will NOT be used concomitantly with oral urate-lowering therapies.
C.   The member has at least 2 flares per year that were inadequately controlled by colchicine or NSAIDs or
      at least 1 gout tophus or gouty arthritis.
D.   Member has had an inadequate response to or a clinical reason for not completing at least a three-month
      trial (see Appendix) with the following medications at the medically appropriate maximum doses:
      1.   Allopurinol or febuxostat
      2.   Probenecid (alone or in combination with allopurinol or febuxostat) 

IV. CONTINUATION OF THERAPY 

Authorization of 12 months may be granted for continued treatment in all members (including new members) requesting reauthorization for chronic gout when ALL of the following criteria are met:
A.   Member meets ALL initial authorization criteria
B.   Member has NOT had two consecutive uric acid levels above 6 mg/dL since starting treatment with Krystexxa
C.   Member is experiencing benefit from therapy (e.g., serum uric acid levels < 6 mg/dL, reduction of tophi,
      reduction of symptoms and/or flares)

Special Notes:

V.   APPENDIX 

Clinical reasons for not completing a three-month trial with allopurinol, febuxostat, and probenecid (examples, not all inclusive):
A.  Member experienced a severe allergic reaction to the medication
B.  Member experienced toxicity with the medication
C.  Member could not tolerate the medication
D.  Member’s current medication regimen has a significant drug interaction
E.  Member has severe renal dysfunction (allopurinol)
F.   Member has known blood dyscrasias or uric acid kidney stones (probenecid)
G.  Member has renal insufficiency (i.e., glomerular filtration rate 30 mL/minute or less) (probenecid)
H.  Member has end stage renal impairment (febuxostat)
I.   Member has a history of CVD or a new CV event (febuxostat)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Krystexxa [package insert]. Deerfield, IL: Horizon Therapeutics USA, Inc.; March 2021.
2. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at http://www.micromedexsolutions.com. Accessed October 26, 2021.
3. 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. 2012;64(10):1431-1446.
4. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017;76:29-42.
5. 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. 2012;64(10):1447-1461.
6. Hui M, Carr A, Cameron S, et al. The British Society for Rheumatology Guideline for the Management of Gout. Rheumatology. 2017;56(7):e1–e20. Available at https://doi.org/10.1093/rheumatology/kex156.
7. Sivera F, Andres M, Carmona L, et al. Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative. Ann Rheum Dis. 2014;73(2):328-335.
8. Probenecid [package insert]. Parsippany, NJ: Actavis Pharma, Inc.; December 2016.
9. Febuxostat [package insert]. Eatontown, NJ: Hikma Pharmaceuticals USA Inc.; July 2019.
10. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for the Management of Gout [published correction appears in Arthritis Care Res (Hoboken). 2020 Aug;72(8):1187]. Arthritis Care Res (Hoboken). 2020;72(6):744-760.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

May 16, 2022