CurrentGeorgia Department of Community HealthPolicy N/A

Macrolides and Ketolides Prior Authorization (Azithromycin, Clarithromycin, Erythromycin)

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Defines prior authorization, quantity limit exception, and coverage criteria for macrolide and ketolide oral products (including azithromycin, clarithromycin, erythromycin) for Georgia Medicaid Fee-for-Service members and providers.

Policy Summary

PayerGeorgia Department of Community Health

PolicyMacrolides and Ketolides Prior Authorization (Azithromycin, Clarithromycin, Erythromycin)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization through OptumRx for non-preferred oral erythromycin; approvals limited to gastroparesis, inpatient initiation, or documented failure/intolerance/contraindication to azithromycin or clarithromycin.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultipleDrug names referenced

ListedQLL exceptions

VariesAuthorization length

OptumRx

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CurrentGeorgia Department of Community HealthPolicy N/A

Macrolides and Ketolides Prior Authorization (Azithromycin, Clarithromycin, Erythromycin)

Customize your policy alerts

Sign up for all Georgia Department of Community Health policy alerts

Know when Georgia Department of Community Health releases new policies or updates existing guidance.

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Policy Summary

PayerGeorgia Department of Community Health

PolicyMacrolides and Ketolides Prior Authorization (Azithromycin, Clarithromycin, Erythromycin)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultipleDrug names referenced

ListedQLL exceptions

VariesAuthorization length

OptumRx

Coverage and Approval Criteria

Non-Preferred Oral Erythromycin Approval

Approvals for non-preferred oral erythromycin products are permitted when ONE of the following is met:

Non-preferred erythromycin approval: Member has a diagnosis of gastroparesis.

From PA criteria (chunk 2)

Non-preferred erythromycin approval: Therapy was started while the member was in the hospital (inpatient initiation).

From PA criteria (chunk 2)

Non-preferred erythromycin approval: Member has inadequate response, documented resistance, allergy, contraindication, clinically significant drug–drug interaction, or intolerable side effect to azithromycin or clarithromycin.

From PA criteria (chunk 2)

Quantity Level Limit (QLL) Exceptions

Authorization to exceed the QLL may be approved for specific azithromycin and clarithromycin strengths when used for enumerated diagnoses:

Azithromycin 200 mg/5 mL (30 mL) QLL exception: Approved for: cryptosporidiosis in immunocompromised members unable to swallow solid dosage forms; Lyme disease in members unable to swallow solid dosage forms; prevention of Mycobacterium avium complex (MAC) infection in HIV-infected children; cystic fibrosis (Pseudomonas); cat-scratch disease in members with hepatosplenic bartonellosis or in immunocompromised members; prevention or treatment of MAC infection in an adult who is unable to swallow solid dosage forms.

Chunk 3

Azithromycin 250 mg tablet QLL exception: Approved for: cryptosporidiosis in immunocompromised members; Lyme disease; prevention of MAC infection in HIV-infected children; cystic fibrosis (Pseudomonas); cat-scratch disease in members with hepatosplenic bartonellosis or in immunocompromised members; granulomata inguinale (donovanosis).

Chunk 3

Azithromycin 500 mg tablet QLL exception: Approved for: cryptosporidiosis in immunocompromised members; Lyme disease; prevention of MAC infection in HIV-infected children; cystic fibrosis (Pseudomonas); granulomata inguinale (donovanosis); prevention or treatment of MAC infection in HIV-infected adults; pulmonary MAC infection in HIV-negative adults.

Chunk 4

Exceptions to the policy’s coverage conditions are considered through the prior authorization process. Requests for exceptions — including initiation of therapy with non-preferred agents while the member is in the hospital — must be submitted via PA for review.

Use of non-preferred oral erythromycin products is limited to specific, approvable circumstances: a documented diagnosis of gastroparesis, therapy that was initiated in the hospital, or when the member has inadequate response, resistance, allergy, contraindication, a drug–drug interaction, or intolerable side effect to azithromycin or clarithromycin. Use outside these listed indications is not supported by the PA criteria and requires prior authorization to be considered.

Provider Responsibilities and Process

Prior Authorization

Prior authorization required for non-preferred erythromycin

Prior authorization is required for non-preferred oral erythromycin products; approvals are limited to specified clinical situations such as gastroparesis, initiation of therapy in the hospital, or when there is inadequate response, resistance, allergy, contraindication, drug-to-drug interaction, or intolerable side effect to azithromycin or clarithromycin.

Step Therapy

Approval requires prior failure/intolerance to preferred agents

Erythromycin non-preferred products are approvable only after the member has gastroparesis, was started on therapy in the hospital, or has an inadequate response, resistance, allergy, contraindication, drug–drug interaction, or intolerable side effect to azithromycin or clarithromycin.

Must document inadequate response, resistance, allergy, contraindication, drug–drug interaction, or intolerable side effect to azithromycin or clarithromycin when applicable.

Initial Therapy Considerations

Initial therapy considerations

When initial therapy with non-preferred agents is necessary:

Inpatient initiation: Initiation of non-preferred erythromycin while the member is in the hospital may be considered for approval via the prior authorization process.

Chunks 2 and 6

Step Therapy Requirements

Step therapy requirement	Coverage status
Member has a diagnosis of gastroparesis or therapy was initiated while in the hospital.
Member has inadequate response, resistance, allergy, contraindication, drug–drug interaction, or intolerable side effect to azithromycin or clarithromycin.

Quantity Level Limits and Exceptions

Azithromycin 200 mg/5 mL suspension (30 mL) — QLL exceptions

Drug strength / packageAzithromycin 200 mg/5 mL suspension — 30 mL package

QLL exception allowed forCryptosporidiosis in immunocompromised members unable to swallow solids

QLL exception allowed forLyme disease in members unable to swallow solids

QLL exception allowed forPrevention of MAC infection in HIV‑infected children

QLL exception allowed forCystic fibrosis (Pseudomonas)

QLL exception allowed forCat‑scratch disease with hepatosplenic bartonellosis or in immunocompromised members

Most actionable: QLL exception allowed for

Referenced Drug Products

Referenced drug products (no billing codes provided)NDC

azithromycin (powder, suspension, tablets)	Azithromycin powder packet, suspension and tablets generic
clarithromycin (suspension, IR, ER)	Clarithromycin suspension, immediate-release and extended-release generic
erythromycin products (non-preferred examples)	Non-Preferred = EryPed Suspension 400 mg/5 mL (erythromycin ethylsuccinate); Ery-Tab (erythromycin base); Erythrocin (erythromycin stearate); Erythromycin base generic; Erythromycin ethylsuccinate suspension (E.E.S.) 200 mg/5 mL generic; Erythromycin ethylsuccinate (E.E.S.) tablet 400 mg generic

Site-of-Care Exceptions

Note

Hospital initiation may be approved via PA

Initiation of therapy with non-preferred agents while a member is in the hospital is an approvable exception and should be addressed via the prior authorization process.

PA may be requested to cover initiation started in the hospital.

Definitions

Non‑Preferred Oral Erythromycin Products — definition / examples

TermNon‑Preferred Oral Erythromycin Products

Examples listedEryPed Suspension 400 mg/5 mL (erythromycin ethylsuccinate); Ery‑Tab (erythromycin base); Erythrocin (erythromycin stearate)

Other examplesErythromycin base generic; erythromycin ethylsuccinate suspension 200 mg/5 mL (generic); erythromycin ethylsuccinate tablet 400 mg (generic)

Background and Scope

This policy defines coverage and prior authorization expectations for macrolide and ketolide oral antibiotics for Georgia Medicaid Fee‑for‑Service. It specifies that prior authorization is required for non‑preferred oral erythromycin products and limits approvals to defined clinical scenarios (for example, gastroparesis, inpatient initiation, or documented failure/intolerance/contraindication to preferred agents).

Exceptions to the coverage rules are evaluated through the PA process; providers may initiate prior authorization by calling OptumRx at the number provided in the policy.