Medical Policy
Effective Date:10/01/2020 Title:Krystexxa (pegloticase)
Revision Date: Document:BI656:00
CPT Code(s):J2507
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Krystexxa (pegloticase) requires prior authorization.

2)    Krystexxa is used to treat chronic gout in adult’s refractory to conventional therapy.

3)    Krystexxa is a specialty drug covered under the medical benefit.
Medical Statement

Krystexxa (pegloticase) is considered medically necessary for members meeting the following criteria (initial approval for 6 months):

 

1)    Diagnosis of chronic gout;

2)    Age >18 years;

3)    Positive for symptomatic gout with one or more of the following:

a.    At least 3 gout flares in the previous 18 months;

b.    At least one gout tophus;

c.    Chronic gouty arthritis;

4)    Failure to normalize uric acid to < 6mg/dL with adherent use of allopurinol and Uloric at maximally indicated doses, each used for at least 3 months unless contraindicated or clinically significant adverse effects are experienced;

5)    Failure of adherent use of one uricosuric agent (e.g. probenecid or losartan), at maximally indicated doses, in combination with allopurinol or Uloric unless contraindicated or clinically significant adverse effects are experienced;

6)    Dose does not exceed 8mg (uricase protein) every two weeks.

 

Reauthorization Criteria (6 month approval):

 

1)     Member is responding positively to therapy;

2)    Member is not concurrently taking any oral urate-lowering agents (e.g. allopurinol, Uloric, probenecid).

 

Codes Used In This BI:

 

1)    J2507 Injection, pegloticase, 1mg
Limits
Intentially left empty
Reference

1)    Krystexxa Prescribing Information. Lake Forest, IL: Horizon Pharma USA, Inc.; July 2018.

2)    FitzGerald, JD, Dalbeth, N, Mikuls, T, et al. 2020 American College of Rheumatology Guideline for the Management of Gout. Arthritis Care & Research. Arthritis Care & Research. Vol. 0, No. 0, June 2020, 1-17.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.