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Azithromycin Quantity Limit Criteria
Policy Number: PH-1126
Azithromycin Quantity Limit Criteria
FDA APPROVED INDICATIONS AND DOSAGE1
Agent |
Indication |
Dosage & Administration |
Zithromax (azithromycin)a
power packs, suspension, tablets |
|
Dosing is dependent on indication and ranges from 250 mg – 2000 mg daily |
a – generic equivalent available
CLINICAL RATIONALE
While not FDA approved for use in COVID-19, azithromycin has been used in the treatment of COVID-19 infection at the following dose:
- 500 mg on day 1, then 250 mg once daily for 5 days2
Safety
Azithromycin is contraindicated in:
- Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic
- Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
REFERENCES
- Azithromycin. Micromedex. Accessed 03/24/2020
- Gautret P, Lagier J, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobiology Agents 2020.
Document History
Original Prime Standard Criteria to be approved by P&T UM Committee March 2020
Azithromycin Quantity Limit
The program quantity limit is set to allow for a cumulative of 60 tabs of azithromycin in 180 days. Those previously on therapy with either one claim of 29 day supply, or 2 or more claims of 10 day supply prior to start of the program will be able to continue therapy at previous doses. New start therapies beyond the quantity limit will require prior authorization.
TARGET AGENTS
Zithromax (azithromycin)a
a - generic equivalent available
PROGRAM QUANTITY LIMITS
Brand (generic) |
GPI |
Multisource Code |
Quantity Limit |
Zithromax (azithromycin)a |
|||
250 mg tablet |
03400010000320 |
M, N, O, or Y |
Cumulative 60 tablets / 180 days for all dosage strengths |
500 mg tablet |
03400010000334 |
M, N, O, or Y |
|
600 mg tablet |
03400010000340 |
M, N, O, or Y |
a – generic equivalent available
QUANTITY LIMIT AUTHORIZATION CRITERIA FOR APPROVAL
Requests above the set quantity limit will be approved when ONE of the following is met:
- The requested agent is being used for a non-COVID-19 indication AND ONE of the following:
- The requested quantity (dose) and duration are within FDA label for the requested indication or supported in compendia (DrugDex 1 or 2a level of evidence, AHFS, NCCN 1 or 2a level of evidence, AHFS)
OR
-
- The requested quantity (dose) and/or duration is greater than the maximum FDA label for the requested indication or greater than what is supported in compendia (DrugDex 1 or 2a level of evidence, AHFS, NCCN 1 or 2a level of evidence, AHFS) AND the prescriber has provided information in support of therapy with a higher dose and/or duration for the requested indication
OR
- The requested agent is being used for COVID-19 AND ONE of the following:
- The prescriber has provided information that the patient requires an additional course of therapy for treating COVID-19
OR
-
- The prescriber has provided information for COVID-19 dosing that is above the set limit (clinical references needed)
Length of Approval:
1 month for COVID-19
Up to 12 months for all other indications
CLINICAL OPERATIONS PROGRAM SET-UP TYPE
|
||||
If selecting Attestation, it must be selected alone. Neither Validation nor Documentation can be used with Attestation.
Attestation: Prescriber answers questions in reviewing system. Clinical Operations accepts answers as provided.
Validation: Prescriber inputs free text information in reviewing system or there is a requirement to validate data in RxClaims. Information is reviewed by Clinical Operations.
Documentation: Prescriber must submit documentation such as medical records, chart notes or lab reports. Documented information is reviewed by Clinical Operations. Use “medical record required” wording for general use. If a specific document type, such as lab reports or logs, is needed, specifically call it out instead of “medical record required”
Table 1 – Validation Requirements
*Baseline validation applies to all programs with validation and/or documentation
|
||||
|
Table 2- Other information
Other (RxClaims system set-up, additional instruction for CRU etc.)
|
Formularies Applied to (include implementation date if some delayed):
Program types implemented by client (check all that apply):
|
|
|
|
|
|
Preferred Product (if client allowed to specify and not specifically noted in criteria):
|
|
Target Drugs (if varies or client allowed to specify and not specifically noted in criteria):
|
|
NDC level set-up in RxClaim: PA Required at NDC Level:
Other e.g. AGF of PA program not called out otherwise, e.g. requirement to term existing PA if switching therapies, special PA detailing requirements. Custom POS messaging:
|
Azithromycin Quantity Limit
ELECTRONIC EDIT
The quantity limit edit for the azithromycin (GPIs in table above, all multisource codes) allows an automatic approval for patients prescribed quantities at or below the program limits.
PRIOR AUTHORIZATION CRITERIA QUESTION SET
Evaluation
- Is the requested agent being used for COVID-19?
If yes, continue to 4.
If no, continue to 2.
- Is the requested quantity (dose) and duration within FDA label for the requested indication or supported in compendia (DrugDex 1 or 2a level of evidence, AHFS, NCCN 1 or 2a level of evidence, AHFS?
If yes, pharmacist must review and may approve for the requested quantity for up to 12 months.
If no, continue to 3.
- Has the prescriber provided information in support of therapy with a higher dose and/or duration for the requested indication?
If yes, pharmacist must review and may approve the requested quantity for up to 12 months.
If no, approve at FDA labeled or supported compendia dose for the requested indication for up to 12 months.
- Has the prescriber provided information that the patient requires an additional course of therapy for treating COVID-19?
If yes, pharmacist must review and may approve the requested quantity for 1 month.
If no, continue to 5.
- Has the prescriber provided information for COVID-19 dosing that is above the set limit (clinical references needed)?
If yes, pharmacist must review and may approve requested quantity for 1 month.
If no, deny.
PS_azithromycin_QL_0320