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Drug Category: Inflammatory Bowel Disease Agents

Medication Class/Individual Agents: Inflammatory Bowel Disease Agents

I. Prior-Authorization Requirements

 Inflammatory Bowel Disease Agents

Clinical Notes
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status
balsalazide Colazal # test  
balsalazide 1.1 gram tablet Giazo PA  
budesonide extended-release tablet Uceris BP PA  
budesonide rectal foam Uceris PA  
budesonide-Entocort Entocort # test  
hydrocortisone enema Cortenema # test  
hydrocortisone foam Cortifoam test  
hydrocortisone hemorrhoidal cream Anusol-HC # test  
mesalamine capsule Delzicol DR # test  
mesalamine controlled-release Pentasa PA  
mesalamine delayed-release Lialda # test  
mesalamine enema Rowasa # test  
mesalamine extended-release Apriso test  
mesalamine high dose delayed-release Asacol HD BP test  
mesalamine kit Rowasa Kit PA  
mesalamine suppository Canasa # test  
olsalazine Dipentum PA  
sulfasalazine Azulfidine # test  
sulfasalazine delayed-release Azulfidine EN-Tabs # 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.

Guidelines from the American College of Gastroenterology (ACG) include the following recommendations:

  • Patients with mild to moderate distal colitis may be treated with oral aminosalicylates, topical mesalamine or topical steroids.
  • Mesalamine suppositories are effective in the maintenance of remission in patients with proctitis, whereas mesalamine enemas are effective in patients with distal colitis.
  • Sulfasalazine, mesalamine compounds, and balsalazide are also effective in maintaining remission in distal colitis.
  • Patients with mild to moderate extensive colitis should begin therapy with oral sulfasalazine or oral aminosalicylates; oral steroids are reserved for refractory disease or rapid improvement.
  • Sulfasalazine, olsalazine, mesalamine and balsalazide are effective in reducing relapses in mild to moderate extensive colitis.
  • Patients with severe colitis refractory to prednisone, oral aminosalicylate and topical medications may be treated with infliximab if urgent hospitalization is not necessary.
  • Patients with mild to moderate Crohn’s disease may be treated with sulfasalazine, budesonide or corticosteroids based upon ileal, ileocolonic or colonic involvement.  Evidence suggests oral mesalamine is less effective than budesonide or corticosteroids.
  • Patients with moderate-to-severe Crohn’s disease may be treated with corticosteroids. Infection or abscess requires antibiotic therapy or drainage. Azathioprine, mercaptopurine, methotrexate, infliximab, adalimumab and certolizumab pegol can be considered for steroid-dependent or steroid refractory Crohn’s disease.

1. Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
2. Lichtensterin GR, Hanauer SB; Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s Disease in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2009 Feb; 104(2):465-84.

 
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:

  • Crohn's disease
  • Ulcerative colitis

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 diagnosis and/or requested medication (see below).

  

budesonide extended-release tablet

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response (defined by at least 30 days of therapy) or adverse reaction to one oral corticosteroid; and
    • one of the following:
      • inadequate response (defined by at least 30 days of therapy) or adverse reaction to one oral sulfasalazine, balsalazide, olsalazine, or mesalamine product; or
      • contraindication to all oral sulfasalazine, balsalazide, olsalazine, and mesalamine products; and
    • clinical rationale for use of budesonide extended-release over other available budesonide products.

Dipentum

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined by at least 30 days of therapy) or adverse reaction to balsalazide or sulfasalazine; or
      • contraindication to balsalazide and sulfasalazine; and
    • inadequate response (defined by at least 30 days of therapy), adverse reaction, or contraindication to one oral mesalamine product.

SmartPA: Claims for Dipentum will usually process at the pharmacy without a PA if the member has a history of paid MassHealth pharmacy claims for at least 90 days out of the last 120 days of the requested agent.†

Giazo

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is male; and
    • member is ≥ 18 years of age; and
    • inadequate response (defined by at least eight weeks of therapy) or adverse reaction to balsalazide disodium capsules; or
    • medical records documenting an allergy or contraindication to an inactive ingredient found in balsalazide disodium capsules but not in Giazo.

mesalamine enema kit

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the requested medication; or
    • prescriber can demonstrate that the requested medication provides a significant or unique therapeutic advantage over the conventionally-packaged formulation.

Pentasa

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response (defined by at least 30 days of therapy) or adverse reaction to two oral mesalamine products.

SmartPA: Claims for Pentasa will usually process at the pharmacy without a PA if the member has a history of paid MassHealth pharmacy claims for at least 90 days out of the last 120 days of the requested agent.†

Uceris foam

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • inadequate response (defined by at least three weeks of therapy) or adverse reaction to mesalamine enemas; or
      • inadequate response (defined by at least three weeks of therapy) or adverse reaction to mesalamine suppositories; or
      • contraindication to mesalamine enemas and mesalamine suppositories.

 

† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.

Original Effective Date: 04/2003

Last Revised Date: 08/2019

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Last updated 11/25/19