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Drug Category: Anti-Gout Agents

Medication Class/Individual Agents: Anti-Gout Agents

I. Prior-Authorization Requirements

 Anti-Gout Agents

Clinical Notes
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status
allopurinol Zyloprim # test  
colchicine capsule Mitigare PA  
colchicine tablet Colcrys PA  
febuxostat Uloric BP PA  
lesinurad Zurampic PA  
lesinurad / allopurinol Duzallo PA  
pegloticase Krystexxa PA  
probenecid test  
probenecid / colchicine test  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

allopurinol:

  • This agent can be started during an acute attack if appropriate anti-inflammatory prophylaxis has been started or after the acute flare has resolved.
  • If a patient is already being treated with allopurinol, the agent should not be discontinued during an acute attack.
  • Serum urate levels begin to fall within two days of allopurinol administration and reach stable levels in one to two weeks.
  • The therapeutic goal of urate lowering therapy is to promote urate dissolution and prevent crystal formation. This is achieved by maintaining the serum urate level at ≤ 6 mg/dL.

colchicine capsule:

  • FDA approved for prophylaxis of gout flares in adults.

colchicine tablet:

  • FDA approved for treatment of acute gout flares in adults, prophylaxis of gout flares in adults, and treatment of Familial Mediterranean Fever.
  • The FDA approved dosing for acute gout is: 1.2 mg orally at the first sign of a flare followed by 0.6 mg one hour later; maximum dose is 1.8 mg over 1 hour (3 tablets per acute attack).

febuxostat:

  • A xanthine oxidase inhibitor but unlike allopurinol, it is not a purine-based analogue.
  • Elimination occurs through hepatic metabolism and renal dose adjustment is unnecessary in patients with mild to moderate renal dysfunction.

lesinurad:

  • FDA approved for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.

lesinurad/allopurinol:

  • A combination product of lesinurad, a URAT1 inhibitor, and allopurinol, a xanthine oxidase inhibitor (XOI).
  • FDA-approved for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone
  • This agent is not recommended for the treatment of asymptomatic hyperuricemia.

pegloticase:

  • A recombinant modified mammalian uricase enzyme indicated for the treatment of chronic gout in adults refractory to conventional therapy.
  • This agent is not recommended for the treatment of asymptomatic hyperuricemia.

probenecid:

  • A uricosuric agent that promotes renal clearance of uric acid in the proximal tubule.
  • The agent is known to increases urinary calcium excretion in gout patients and should be avoided in patients with prior nephrolithiasis.
 
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example: 

  • Familial Mediterranean Fever (colchicine tablet)
  • Gout (colchicine capsule, colchicine tablet, Duzallo, febuxostat, Krystexxa, Zurampic)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

  

colchicine tablet for Familial Mediterranean Fever (FMF) 

  • Documentation of the following is required:
    • diagnosis of FMF.

 

colchicine tablet for Acute Gout Attacks 

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • an inadequate response, adverse drug reaction, or contraindication to one NSAID; and
    • an inadequate response, adverse drug reaction, or contraindication to one corticosteroid.
  • For recertification beyond the same year, documentation of response to therapy is required.
  • For recertification within the same year, documentation of an inadequate response to the FDA-approved regimen of three tablets per attack is required.

  

colchicine tablet and capsule for Gout Prophylaxis in Combination with Urate Lowering Therapy

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • documentation that member will be initiated on a urate lowering treatment with allopurinol, febuxostat, or probenecid.
  • For recertification, documentation of a diagnosis of tophaceous gout is required.

  

colchicine tablet and capsule for Gout Prophylaxis without Urate Lowering Therapy

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol at a dose of at least 600 mg/day for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to allopurinol; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to febuxostat at a dose of 80 mg/day for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to febuxostat; and
    • member is ≥ 18 years of age.
  • For recertification, documentation of a diagnosis of tophaceous gout is required.

 

Duzallo for Gout

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol at a dose of at least 600 mg/day for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to allopurinol at this dose range; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to febuxostat at a dose of 80 mg/day for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to febuxostat; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to probenecid, in combination with allopurinol or febuxostat for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to probenecid

 

febuxostat for Gout 

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol at a dose of at least 600 mg/day for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to allopurinol; and
    • requested quantity does not exceed 30 tablets/month.

  

Krystexxa for Gout

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol at a dose of at least 600 mg/day for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to allopurinol; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to febuxostat at a dose of 80 mg/day for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to febuxostat; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to a uricosuric agent in combination with allopurinol or febuxostat for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to a uricosuric agent; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to Zurampic (lesinurad) at a dose of 200 mg/day in combination with allopurinol or febuxostat for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to Zurampic (lesinurad).

  

Zurampic for Gout 

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol at a dose of at least 600 mg/day for a minimum of four weeks or adverse reaction to allopurinol; or
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to febuxostat at a dose of 80 mg/day for a minimum of four weeks or adverse reaction to febuxostat; and
    • one of the following:
      • an inadequate response (defined by serum urate levels > 6.0 mg/dL) to probenecid in combination with allopurinol or febuxostat for a minimum of four weeks; or
      • an adverse drug reaction or contraindication to probenecid; and
    • requested agent will be used concurrently with either allopurinol or febuxostat; and
    • requested quantity does not exceed 30 tablets/month.
  • For recertification, documentation of continued combination therapy is required.

Original Effective Date: 05/2012

Last Revised Date: 08/2019

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Last updated 11/18/19