CurrentCignaPolicy IP0536

Posaconazole (Oral) for Individual and Family Plans

Cigna drug coverage policy defining prior authorization recommendations, covered FDA indications and other supported uses, approval durations, brand/generic preferred product criteria, and criteria for specific formulations (delayed-release tablets, oral suspension, PowderMix) for Individual and Family Plans.

Policy Summary

PayerCigna

PolicyPosaconazole (Oral) for Individual and Family Plans

Policy CodePolicy IP0536

Change TypeAnnual revision — title, added formulations, and multiple duration updates

Effective DateSep 15, 2025

Next Review Date

Key ActionPrior Authorization is recommended for prescription benefit coverage of Noxafil/posaconazole (oral); approvals are provided for the durations specified per indication and measured in months (1 month = 30 days).

SourceLink

POLICY UPDATE CHANGES

Updated title to 'Antifungals - Posaconazole (Oral) for Individual and Family Plans' and added Noxafil delayed-release tablets and Noxafil oral suspension to the policy.

Changed duration of approval for Aspergillus Infection - Treatment to 6 months (previously 3 months).

Changed duration of approval for Mucormycosis - Maintenance Treatment to 12 months (previously 6 months).

Added Cryptococcal Meningitis - Treatment as a condition of approval (12 months).

Changed duration for Fungal Infection (Systemic) in a Patient with HIV Infection - Treatment to 6 months (previously 3 months).

Added note listing example cancers predisposing to neutropenia (myelodysplastic syndrome, acute myeloid leukemia, post-allogeneic hematopoietic cell transplant).

Added 'Mouth and Esophageal Infection (Refractory to Other Azole Antifungals) - Treatment' to Other Uses with Supportive Evidence.

15Listed approved indications/uses

IP0536Policy number

2025-09-15Policy effective date

Coverage Summary

This policy covers oral posaconazole for Individual and Family Plans and defines prior authorization requirements, approved indications and durations, and formulation-specific preferred product criteria. The policy title was updated to "Antifungals - Posaconazole (Oral) for Individual and Family Plans" and Noxafil delayed-release tablets and Noxafil oral suspension were added to the policy.

Coverage stance: covered_with_criteria — prior authorization is recommended for prescription benefit coverage and approvals are provided when Preferred product criteria are met. The policy scope includes the following formulations: delayed-release tablets, oral suspension, and PowderMix for delayed-release oral suspension, and applies to Individual and Family Plans.

Key thresholds and quick facts

Policy effective date2025-09-15

Last review date2024-11-01

Policy numberIP0536

Pediatric weight threshold (tablets)> 40 kg (delayed-release tablets indicated in pediatric patients ≥ 2 years who weigh > 40 kg)

Pediatric age threshold (oral suspension)≥ 13 years of age (oral suspension)

Pediatric PowderMix indication≥ 2 years of age who weigh ≤ 40 kg

Listed approved indications count15 (listed approved indications/uses)

Prior Authorization / Initial Therapy Criteria

Prior Authorization / Coverage Criteria (general)

Prior Authorization is recommended for prescription benefit coverage. Approvals provided for specified durations when preferred product criteria are met as listed in the policy.

PA requested: Prior Authorization requested for Noxafil/posaconazole (oral) prescription benefit
Preferred product criteria met: Preferred product criteria is met for the product as listed in the policy's preferred product table (brand vs bioequivalent generic) or exceptions per formulation criteria

Prior Authorization

FDA-Approved Indications (Initial / Short-term Approvals)

FDA-Approved Indications (Approved when Preferred product criteria met)

Approve for the durations below if Preferred product criteria is met for the products as listed in the table.

Approve for listed indication and duration

Aspergillus Infection - Prophylaxis
Approve for 6 months
Aspergillus Infection - Treatment
Approve for 6 months
Candida Infection (Systemic) - Prophylaxis
Approve for 6 months
Oropharyngeal Candidiasis - Treatment

Other Uses with Supportive Evidence (Non-FDA Uses)

Other Uses with Supportive Evidence (Approved when Preferred product criteria met)

Approve for the durations below if Preferred product criteria is met for the products as listed in the table.

Other uses with supportive evidence

Esophageal Candidiasis in a Patient with HIV - Chronic Suppressive Treatment
Approve for 6 months
Fungal Infection (Systemic) in a Patient With Cancer and Neutropenia - Prophylaxis
Approve for 6 months. Examples of cancers predisposing neutropenic patients include: myelodysplastic syndrome, acute myeloid leukemia, patients post-allogeneic hematopoietic cell transplant
Fungal Infection (Systemic) in a Patient with Graft-versus-Host Disease - Prophylaxis
Approve for 6 months

Formulation-specific Preferred-product Exceptions

Formulation-specific preferred-product exception criteria

Criteria to allow brand Noxafil when generic bioequivalent tried and not tolerated due to inactive ingredients, or PowderMix criteria.

Noxafil delayed-release tablets (brand): Patient has tried the bioequivalent generic posaconazole delayed-release tablets AND cannot take it due to a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) resulting per prescriber in a significant allergy or serious adverse reaction
Noxafil oral suspension (brand): Patient has tried the bioequivalent generic posaconazole oral suspension AND cannot take it due to a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) resulting per prescriber in a significant allergy or serious adverse reaction
Noxafil PowderMix for delayed-release oral suspension

Unproven / Exclusions

Not Medically Necessary

Conditions not covered

Not Medically Necessary: Noxafil/posaconazole for any other use is considered not medically necessary

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Applicable Codes / Drug Identifiers

Drug identifiers (mentioned formulations/brands)NDC|mixed

Noxafil (posaconazole) delayed-release tablets	Brand formulation included in policy
posaconazole delayed-release tablets (generic)	Bioequivalent generic referenced for step requirement
Noxafil oral suspension	Brand oral suspension included in policy
posaconazole oral suspension (generic)	Bioequivalent generic referenced for step requirement
Noxafil PowderMix for delayed-release oral suspension	PowderMix formulation included with specific criteria

Drug identifiers (mentioned formulations/brands)NDC|mixed

Noxafil (posaconazole) delayed-release tablets	Brand formulation included in policy
posaconazole delayed-release tablets (generic)	Bioequivalent generic referenced for step requirement
Noxafil oral suspension	Brand oral suspension included in policy
posaconazole oral suspension (generic)	Bioequivalent generic referenced for step requirement
Noxafil PowderMix for delayed-release oral suspension	PowderMix formulation included with specific criteria

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization required / recommended

Prior Authorization is recommended for prescription benefit coverage of Noxafil/posaconazole (oral). Approvals are provided for the durations specified per indication and measured in months (1 month = 30 days).

Documentation Required

Documentation of prior trial or intolerance to generic

For brand Noxafil delayed-release tablets or oral suspension, the provider must document trial of the bioequivalent generic product and a prescriber rationale that differences in inactive ingredients would cause a significant allergy or serious adverse reaction.

Clinical Evidence & Guidance Sources

Key evidence sources cited in the policy include clinical practice guidelines and the manufacturer prescribing information:

Guideline sources: IDSA aspergillosis and candidiasis guidelines (2016), NCCN Prevention and Treatment of Cancer-Related Infections (v1.2025), and HIV opportunistic infections guidelines (last updated July 9, 2024 / referenced 2024–2025).

Manufacturer prescribing information: Noxafil prescribing information, Merck; September 2024.

Background

Posaconazole is an azole antifungal indicated for prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, treatment of invasive aspergillosis, and treatment of oropharyngeal candidiasis (including fluconazole-refractory disease). Formulations include delayed-release tablets, oral suspension, and PowderMix for delayed-release oral suspension. The duration of therapy varies by indication and clinical context (for example, the recommended total duration for treatment of invasive aspergillosis is 6 to 12 weeks, and duration for other indications depends on recovery from neutropenia, degree of immunosuppression, and clinical response).

Definitions

Definition: Preferred product criteriaRequirement to use bioequivalent generic product first; brand may be approved if prescriber documents allergy or serious adverse reaction to inactive ingredients or other specified formulation-based exceptions (e.g., inability to swallow tablets or weight-based PowderMix criteria).

Revision History

2024-11-01revised

Updated title to 'Antifungals - Posaconazole (Oral) for Individual and Family Plans' and added Noxafil delayed‑release tablets and Noxafil oral suspension to the policy.

2024-11-01revised

Changed duration of approval for Aspergillus Infection - Treatment to 6 months (previously 3 months).

2024-11-01revised

Changed duration of approval for Mucormycosis - Maintenance Treatment to 12 months (previously 6 months).

Policy Summary

PayerCigna

PolicyPosaconazole (Oral) for Individual and Family Plans

Policy CodePolicy IP0536

Change TypeAnnual revision — title, added formulations, and multiple duration updates

Effective DateSep 15, 2025

Next Review Date

SourceLink

On This Page

Prior authorization required / recommended

Approve for 3 months

title": "FDA-Approved Indications (Approved when Preferred product criteria met)"

Billing Rule

Approval duration enforcement

Approvals are issued for specified durations (months) per indication; when approval is authorized in months, 1 month = 30 days.

Fungal Infection (Systemic) in a Patient with HIV Infection - Treatment

Approve for 6 months

Fusariosis, Invasive - Treatment

Approve for 3 months

Mouth and Esophageal Infection (Refractory to Other Azole Antifungals) - Treatment

Approve for 3 months

Mucormycosis - Maintenance Treatment

Approve for 12 months

Scedosporium Infection - Treatment

Approve for 3 months

Fungal Infection (Systemic) that is Susceptible to Posaconazole - Treatment

Approve for 3 months

Cryptococcal Meningitis - Treatment

Approve for 12 months to complete the course of therapy

Patient is Currently Receiving Posaconazole

Approve for 3 months to complete the course of therapy

Unable to swallow tablets: Patient is unable to swallow tablets or has difficulty swallowing tablets

Weight ≤ 40 kg: Patient is ≤ 40 kg

Documentation Required

Documentation of prior trial or intolerance to generic

Documentation Required

PowderMix eligibility documentation

For Noxafil PowderMix, the provider must document that the patient is unable to swallow tablets or that the patient weighs ≤ 40 kg to meet eligibility for PowderMix formulation.

Documentation Required

PowderMix eligibility documentation

For Noxafil PowderMix, the provider must document that the patient is unable to swallow tablets or that the patient weighs ≤ 40 kg to meet eligibility for PowderMix formulation.

Billing Rule

Approval duration enforcement

Approvals are issued for specified durations (months) per indication; when approval is authorized in months, 1 month = 30 days.

2024-11-01added

Added Cryptococcal Meningitis - Treatment as a condition of approval (12 months).

2024-11-01revised

Changed duration for Fungal Infection (Systemic) in a Patient with HIV Infection - Treatment to 6 months (previously 3 months).

2024-11-01clarified

Added note listing example cancers predisposing to neutropenia (myelodysplastic syndrome, acute myeloid leukemia, post-allogeneic hematopoietic cell transplant).

2024-11-01addedLatest

Added 'Mouth and Esophageal Infection (Refractory to Other Azole Antifungals) - Treatment' to Other Uses with Supportive Evidence.