A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Inflammatory Bowel Disease Agents
Medication Class/Individual Agents: Inflammatory Bowel Disease Agents
I. Prior-Authorization Requirements
Inflammatory Bowel Disease Agents |
Clinical Notes |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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:
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. |
# | 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.
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
Clinical Criteria Main Page | Back to top | Previous | Next
Last updated 11/25/19