Asset Publisher

ph-1126

print Print

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
  • Acute infective exacerbation of chronic obstructive pulmonary disease (Mild to Moderate)
  • Acute otitis media
  • Bacterial conjunctivitis
  • Bacterial sinusitis, acute (Mild to Moderate)
  • Chancroid
  • Chlamydia trachomatis infection, Including cervicitis or urethritis
  • Chlamydia trachomatis infection - Pelvic inflammatory disease
  • Community acquired pneumonia (Mild to Moderate)
  • Gonorrhea
  • Gonorrhea - Pelvic inflammatory disease
  • Infection of skin and/or subcutaneous tissue, Uncomplicated
  • Pelvic inflammatory disease due to Mycoplasma hominis
  • Streptococcal pharyngitis, alternative to first-line therapy
  • Streptococcal tonsillitis, alternative to first-line therapy

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

  1. Azithromycin. Micromedex. Accessed 03/24/2020
  2. 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:

  1. The requested agent is being used for a non-COVID-19 indication AND ONE of the following:
    1. 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

    1. 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

  1. The requested agent is being used for COVID-19 AND ONE of the following:
    1. The prescriber has provided information that the patient requires an additional course of therapy for treating COVID-19

OR

    1. 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

 

 

 

 

 

☐ Attestation only – Skip table 1, no documentation requirements allowed

☒ Validation – Go to table 1

☒ Documentation -requirements as noted within the policy

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*
  • Previous Plan PA
  • FDA max dose
  • Dose optimization

Validation options

☐ Prerequisites

  • Claims validation- specific look-back defined in program summary. 
  • New to plan or indefinite look-back and > 1 prerequisite, then collect information from prescriber.

☐ Grandfathering

  • Claims validation-specific lookback defined in program summary
  • New to plan or indefinite look-back, then attestation
  • Risk with change (if applicable)-collect information from prescriber

☐ Required Concomitant Therapy

  • Claims validation to assess if overlap
  • New to plan, then attestation

☐ Diagnosis (general FDA labeled, or compendia supported)- collect information

☐ Diagnostic criteria- collect test results from prescriber

☐ Lab values- collect lab values from prescriber

☐ Contraindication, intolerance, or hypersensitivity to prerequisites- prescriber to explain

☐ Renewal – check for specific efficacy/improvement

☒ Other

☒ prescriber has provided information that the patient requires an additional course of therapy for treating COVID-19

*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):

 

☐ PA

 

☐ PAQL

 

☐ MDC

 

☐ ST

 

☐ Other_________

 

☐ STQL

Preferred Product (if client allowed to specify and not specifically noted in criteria):

 

☐ Not applicable

 

☐ Yes: [List preferred(s)]

Target Drugs (if varies or client allowed to specify and not specifically noted in criteria):

 

☐ Not applicable

 

☐ Yes: [List targets]

NDC level set-up in RxClaim:  ☐ Yes  ☐ No

PA Required at NDC Level: ☐ Yes  ☐ No

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:

  • Temp QL: 60 tab all strength/180 D

 

 

 

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

 

  1. Is the requested agent being used for COVID-19?

If yes, continue to 4.

If no, continue to 2.

 

  1. 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.

 

  1. 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.

 

  1. 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.

 

  1. 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