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Table 33: Inflammatory Bowel Disease Agents


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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

Drug
Notes

balsalazide Colazal test   #
budesonide extended-release tablet Uceris 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 test  
mesalamine delayed-release Lialda test   #
mesalamine enema Rowasa test   #
mesalamine extended-release Apriso test   BP
mesalamine high dose delayed-release Asacol HD test   BP
mesalamine kit Rowasa Kit PA  
mesalamine suppository Canasa test   #
olsalazine Dipentum test  
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:

  • Sulfasalazine is effective for treating symptoms of mild to moderate active Crohn’s disease.
  • Controlled release budesonide should be used for induction of remission for patients with mild to moderate ileocecal Crohn’s disease.
  • Oral corticosteroids can be used for short-term for alleviating symptoms in moderate to severe active Crohn’s disease.
  • Thiopurines and methotrexate are effective and should be considered for steroid-sparing and maintenance of remission in Crohn’s disease.
  • Anti-TNF agents (infliximab, adalimumab, certolizumab pegol) should be used in Crohn’s disease that is resistant to corticosteroids and Crohn’s disease refractory to thiopurines and methotrexate.
  • For patients with moderate to severe active Crohn’s disease, anti-integrin therapy (vedolizumab) should be considered for induction of symptomatic remission.
  • Ustekinumab should be given for moderate to severe Crohn’s disease who failed previous treatment with corticosteroids, thiopurines, methotrexate, or anti-TNF agents or who have had no prior exposure to anti-TNF agents.
  • Anti-TNF agents should be considered to treat severe active Crohn’s disease.
  • Infliximab may be administered to treat fulminant Crohn’s disease.
  • Infliximab is effective and should be considered in treating perianal fistulas.
  • Adalimumab and certolizumab pegol may be effective and should be considered in treating perianal fistulas.
  • Thiopurines may be effective and should be considered in treating fistulizing Crohn’s disease.
  • Anti-TNF agents, vedolizumab, and ustekinumab should be used to maintain remission in Crohn's disease.
  • In mild active ulcerative proctitis, rectal 5-ASA therapies for induction and maintenance of remission is recommended.
  • In mild active left-sided ulcerative colitis, rectal 5-ASA enemas combined with oral 5-ASA is recommended for induction of remission.
  • In mild active left-sided ulcerative colitis without response to oral and rectal 5-ASA, oral budesonide MMX is recommended for induction of remission.
  • In mild to moderate active ulcerative colitis not responding to oral 5-ASA, oral budesonide MMX is recommended for induction of remission.
  • In mild active left-sided or extensive ulcerative colitis, oral 5-ASA is recommended for maintenance of remission.
  • In moderate active ulcerative colitis, oral budesonide MMX is recommended.
  • In moderate to severe active ulcerative colitis, anti-TNF agents (adalimumab, golimumab, infliximab), vedolizumab, and tofacitinib is recommended for induction of remission.
  • In moderate to severe active ulcerative colitis with failure to anti-TNF agents, vedolizumab and tofacitinib is recommended for induction of remission.
  • Anti-TNF agents, vedolizumab, and tofacitinib should be used to maintain remission.

1. Rubin DT, Ananthakrishnan AN; 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. 2019 Mar;114(3):384-413.
2. Lichtensterin GR, Loftus EV; 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. 2018 Apr;113(4):481-517.

 
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.

  

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.

  

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 hydrocortisone enema; or
      • inadequate response (defined by at least three weeks of therapy) or adverse reaction to hydrocortisone foam; or
      • contraindication to hydrocortisone enema and hydrocortisone foam.


Original Effective Date: 04/2003

Last Revised Date: 04/2020


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Last updated 06/29/20

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