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Table 62: Gout Agents


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Drug Category: Gout Agents

Medication Class/Individual Agents: Gout Agents

I. Prior-Authorization Requirements

 Anti-Gout Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

allopurinol 100 mg, 300 mg tablet Zyloprim test   # , M90
allopurinol 200 mg tablet PA   M90
colchicine capsule Mitigare PA   BP, A90
colchicine solution Gloperba PA  
colchicine tablet Colcrys test   # , A90
febuxostat Uloric PA   M90
pegloticase Krystexxa PA   MB
probenecid test   M90
probenecid / colchicine test   M90

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, solution:

  • 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.

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. PA 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.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 
M90 Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply.
 

II. Therapeutic Uses

FDA-approved, for example: 

  • Gout (allopurinol 200 mg tablet, colchicine capsule, febuxostat, Gloperba, Krystexxa)

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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

   

allopurinol 200 mg tablet 

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • medical necessity for use of the requested agent instead of two allopurinol 100 mg tablets available without PA; and
    • medical records documenting inadequate response or adverse reaction to two allopurinol 100 mg tablets available without PA.

   

colchicine capsule 

  • Documentation of all of the following is required for gout prophylaxis in combination with urate lowering therapy:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member will be initiated on a urate lowering treatment with allopurinol, febuxostat, or probenecid; and
    • clinical rationale for use of the requested agent instead of colchicine tablet.
  • Documentation of all of the following is required for gout prophylaxis without urate lowering therapy:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol 600 mg/day for four weeks; or
      • adverse reaction or contraindication to allopurinol; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to febuxostat 80 mg/day, or 40 mg/day if creatinine clearance (CrCL) < 30 mL/min, for four weeks; or
      • adverse reaction or contraindication to febuxostat; and
    • clinical rationale for use of the requested agent instead of colchicine tablet.
  • For recertification, documentation of a diagnosis of tophaceous gout is required.

 

febuxostat

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol 600 mg/day for four weeks; or
      • adverse reaction or contraindication to allopurinol; and
    • one of the following:
      • requested quantity is ≤ one tablet/day; or
      • medical necessity for exceeding quantity limit.

 

Gloperba 

  • Documentation of all of the following is required for gout prophylaxis in combination with urate lowering therapy:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member will be initiated on a urate lowering treatment with allopurinol, febuxostat, or probenecid; and
    • medical necessity for the use of a solution formulation.
  • Documentation of all of the following is required for gout prophylaxis without urate lowering therapy:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol 600 mg/day for four weeks; or
      • adverse reaction or contraindication to allopurinol; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to febuxostat 80 mg/day, or 40 mg/day if CrCL < 30 mL/min, for four weeks; or
      • adverse reaction or contraindication to febuxostat; and
    • medical necessity for the use of a solution formulation.
  • For recertification, documentation of a diagnosis of tophaceous gout is required.

   

Krystexxa

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to allopurinol 600 mg/day for four weeks; or
      • adverse reaction or contraindication to allopurinol; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to febuxostat 80 mg/day, or 40 mg/day if CrCL < 30 mL/min, for four weeks; or
      • adverse reaction or contraindication to febuxostat; and
    • one of the following:
      • inadequate response (defined by serum urate levels > 6.0 mg/dL) to a uricosuric agent in combination with allopurinol or febuxostat for four weeks; or
      • adverse reaction or contraindication to a uricosuric agent.


Original Effective Date: 05/2012

Last Revised Date: 03/2024


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Last updated 03/04/24

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