Table 41: Antibiotics - Topical
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: Dermatological
Medication Class/Individual Agents: Antibiotics
I. Prior-Authorization Requirements
Topical Antibacterials |
Clinical Notes |
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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.
Warnings and Precautions:
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Vaginal Antibiotics |
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| # | 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. |
| * | The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without PA. |
| 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. |
II. Therapeutic Uses
FDA-approved, for example:
- Bacterial vaginosis - Clindesse, Nuvessa, Xaciato
- Treatment of impetigo - mupirocin cream, Xepi
- Infected traumatic lesions - mupirocin cream
Note: The above list may not include all FDA-approved indications.
III. Evaluation Criteria for Approval
- 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.
Clindesse, Nuvessa, Xaciato
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to both of the following: oral metronidazole tablets, metronidazole 0.75% vaginal gel; and
- inadequate response or adverse reaction to one or contraindication to both of the following: clindamycin vaginal cream, Cleocin Vaginal Ovule; and
- appropriate dosing.
mupirocin cream for impetigo or infected traumatic lesions
- Documentation of the following is required:
- appropriate diagnosis; and
- medical records documenting an inadequate response, adverse reaction, or contraindication to mupirocin ointment; and
- requested quantity is ≤ one package/30 days.
Xepi
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ two months of age; and
- medical records documenting an inadequate response or adverse reaction to one or contraindication to both of the following: mupirocin cream, mupirocin ointment; and
- requested quantity is ≤ one package/30 days.
Original Effective Date: 07/2005
Last Revised Date: 03/2024
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Last updated 04/01/24