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Cigna posaconazole (oral) Coverage Update | OpenPayer

CurrentCignaPolicy IP0536

Antifungals - Posaconazole (Oral) for Individual and Family Plans

This policy governs prior authorization and medical necessity criteria for oral posaconazole (Noxafil and generics) for Individual and Family Plans administered by Cigna, covering delayed‑release tablets, oral suspension, and PowderMix delayed‑release oral suspension.

Policy Summary

PayerCigna

PolicyAntifungals - Posaconazole (Oral) for Individual and Family Plans

Policy CodePolicy IP0536

Change TypeMultiple material revisions (title/formulations, durations, added indication)

Effective DateSep 15, 2025

Next Review Date

Key ActionObtain prior authorization and document trial of the bioequivalent generic posaconazole (or a formulation-based contraindication) before requesting coverage for brand Noxafil tablets or suspension.

SourceLink

POLICY UPDATE CHANGES

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

Duration of approval for Aspergillus infection - Treatment changed from 3 months to 6 months.

Duration of approval for mucormycosis maintenance treatment changed from 6 months to 12 months.

Cryptococcal meningitis was added as a condition of approval under Other Uses with Supportive Evidence.

Duration of approval for systemic fungal infection in a patient with HIV (treatment) changed from 3 months to 6 months.

15+distinct FDA or supportive-use indications included

6 motypical approval duration

3 mo

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Coverage Criteria for Oral Posaconazole

Initial and Other Indications

Noxafil/posaconazole is considered medically necessary when ANY one of the indication-specific criteria below is met. Approvals require that preferred product criteria are satisfied (see formulation criteria) and are for the duration specified per indication.

Aspergillus infection - prophylaxis: Patient meets criteria for prophylaxis of invasive Aspergillus infection.approve for 6 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Aspergillus infection - treatment: Patient meets criteria for treatment of invasive Aspergillus infection.approve for 6 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Candida infection (systemic) - prophylaxis: Patient meets criteria for systemic Candida infection prophylaxis.approve for 6 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Oropharyngeal candidiasis - treatment: Patient meets criteria for treatment of oropharyngeal candidiasis.approve for 3 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Esophageal candidiasis in HIV (chronic suppressive treatment): Patient with HIV meets criteria for chronic suppressive treatment of esophageal candidiasis.approve for 6 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Fungal infection (systemic) in a patient with cancer and neutropenia - prophylaxis: Patient with cancer-associated neutropenia (e.g., myelodysplastic syndrome, acute myeloid leukemia, post-allogeneic HCT) meets criteria for prophylaxis of systemic fungal infection.approve for 6 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Fungal infection (systemic) in a patient with graft-versus-host disease - prophylaxis: Patient with graft-versus-host disease meets criteria for prophylaxis of systemic fungal infection.approve for 6 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Fungal infection (systemic) in a patient with HIV - treatment: Patient with HIV meets criteria for treatment of systemic fungal infection.approve for 6 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Fusariosis, invasive - treatment: Patient meets criteria for treatment of invasive fusariosis.approve for 3 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Mouth and esophageal infection refractory to other azoles - treatment: Patient has mouth or esophageal infection refractory to other azole antifungals.approve for 3 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Mucormycosis - maintenance treatment: Patient meets criteria for maintenance treatment of mucormycosis.approve for 12 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Scedosporium infection - treatment: Patient meets criteria for treatment of Scedosporium infection.approve for 3 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Other systemic fungal infection susceptible to posaconazole - treatment: Patient has a systemic fungal infection known to be susceptible to posaconazole.approve for 3 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Cryptococcal meningitis - treatment: Patient meets criteria for cryptococcal meningitis treatment to complete the course of therapy.approve for 12 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Patient currently receiving posaconazole: Patient is currently receiving posaconazole and requires completion of the current course of therapy.approve for 3 months

Preferred product criteria must be met (trial of bioequivalent generic or documented contraindication).

Duration Criteria

Duration-based approval nodes (apply when the corresponding indication above is met). 1 month = 30 days.

6-month approvals: Approvals for 6 months: Aspergillus infection (prophylaxis or treatment); systemic Candida prophylaxis; esophageal candidiasis chronic suppressive treatment in HIV; prophylaxis for fungal infection in cancer with neutropenia; prophylaxis for fungal infection in graft-versus-host disease; systemic fungal infection in HIV (treatment).approve for 6 months

Preferred product criteria must be met.

3-month approvals: Approvals for 3 months: Oropharyngeal candidiasis treatment; fusariosis invasive treatment; mouth and esophageal infection refractory to other azoles; Scedosporium treatment; other systemic fungal infections susceptible to posaconazole; continuation to complete course when currently receiving posaconazole.approve for 3 months

Used for many treatment indications; preferred product criteria must be met.

12-month approvals:

Formulation and Preferred Product Criteria

Formulation-specific coverage conditions and preferred-product requirements.

Brand delayed-release tablets and oral suspension (Noxafil): For Noxafil delayed-release tablets and Noxafil oral suspension, patient must have tried the bioequivalent generic posaconazole formulation (delayed-release tablets or oral suspension as applicable) AND cannot take the generic due to a formulation difference in inactive ingredient(s) that, per the prescriber, would cause a significant allergy or serious adverse reaction.trial of generic required or documented contraindication

Receipt of sample product does not satisfy criteria requirements.

PowderMix delayed-release oral suspension (Noxafil): Coverage for Noxafil PowderMix delayed-release oral suspension requires ONE of the following: patient is unable to swallow tablets or has difficulty swallowing tablets; OR patient weight is ≤ 40 kg.one of listed conditions

Supports pediatric or swallowing-impaired patients; dosing, frequency, duration, and site of care should be clinically appropriate and evidence-based.

Posaconazole (Noxafil) for any use not specifically listed in this policy is considered not medically necessary and is not covered.

Use of posaconazole for indications outside those explicitly listed in this policy is considered not medically necessary and may be denied.

Initial Therapy

Initial Therapy

Initial therapy is approved when the indication-specific criteria are met and preferred product requirements are satisfied.

Initial approval when indication met: Approve posaconazole for the duration specified for the indication provided preferred product criteria are met (trial of bioequivalent generic or documented contraindication for brand products) and dosing/duration are clinically appropriate.indication + preferred product criteria

See formulation-specific criteria for PowderMix and brand products; receipt of sample product does not satisfy criteria.

Continuation of Therapy

Continuation of Therapy

Continuation (renewal) is allowed to complete an ongoing course of therapy when the member is already receiving posaconazole.

Currently receiving posaconazole: Patient currently receiving posaconazole may be approved to complete the current course of therapy.approve for 3 months

Applies when patient is mid-course; preferred product criteria must be met for branded products.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is recommended/required for oral posaconazole (Noxafil) for prescription benefit coverage. Approvals are provided for the duration noted in the policy (months = 30 days each). Document clinical indication and duration requested.

Affected products: posaconazole (Noxafil) delayed‑release tablets, oral suspension, PowderMix for delayed‑release oral suspension

Step Therapy

Preferred Product Requirement

Preferred product requirement — Prescriber should try the bioequivalent generic posaconazole product prior to requesting brand Noxafil (tablets or suspension) unless a formulary exception is documented.

Try bioequivalent generic posaconazole product before brand Noxafil tablets or suspension.

Definitions and Formulations

Posaconazole formulations

Delayed‑release tabletsIndicated in adults and pediatric patients ≥2 years who weigh >40 kg; used for prophylaxis of invasive Aspergillus and Candida and treatment of invasive aspergillosis (adults and pediatric ≥13 years).

Oral suspensionIndicated in adults and pediatric patients ≥13 years of age; used for prophylaxis and treatment of oropharyngeal candidiasis including cases refractory to itraconazole or fluconazole.

Noxafil PowderMix (delayed‑release oral suspension)Intended for pediatric patients ≥2 years of age who weigh ≤40 kg or for patients unable to swallow tablets; supports pediatric dosing for ≤40 kg.

Formulation‑specific age/weight notesTablets: adults and pediatric ≥2 years who weigh >40 kg; Oral suspension: adults and pediatric ≥13 years; PowderMix: pediatric ≥2 years and ≤40 kg.

Preferred product requirement for brand formulationsFor Noxafil delayed‑release tablets and oral suspension, patient must try the bioequivalent generic formulation and document inability to take it due to a significant allergy or serious adverse reaction to inactive ingredients per prescriber.

Step Therapy Requirements

Step	Requirement / Exception
1. Try bioequivalent generic posaconazole formulation
Prescriber must document trial of the bioequivalent generic posaconazole delayed‑release tablets or oral suspension before approval of brand Noxafil tablets or suspension; receipt of sample product does not satisfy this requirement.
Exception: documented formulation‑based allergy or serious adverse reaction
If the patient cannot take the generic due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) that the prescriber states would cause a significant allergy or serious adverse reaction, brand Noxafil (tablets or suspension) may be approved without a generic trial.
PowderMix specific exception
Coverage for Noxafil PowderMix (delayed‑release oral suspension) is allowed when the patient is unable to swallow tablets or weighs ≤ 40 kg (one of these conditions must be met).

Site of Care and Dosing Considerations

Note

Ensure dosing, duration and site of care are clinically supported

Dosage, frequency, duration, and site of care must be reasonable, clinically appropriate, and supported by evidence‑based literature; requests should include rationale and references as needed to justify nonstandard dosing or site of care.

Adjust dosing/duration based on severity, alternative treatments, and prior response to therapy.
Documentation should support outpatient (home) or other site‑of‑care decisions when atypical.

Background

Posaconazole is an extended‑spectrum azole antifungal active against a broad range of molds and yeasts, including Aspergillus and Candida species. It is used both for prophylaxis in high‑risk, severely immunocompromised patients and for treatment of invasive and certain refractory or rare fungal infections. Formulations include delayed‑release tablets, oral suspension, and PowderMix delayed‑release oral suspension, with formulation choice and dosing dependent on age, weight, and clinical circumstances. Recommended durations vary by indication (for example, many prophylaxis and treatment approvals are for 6 months, some treatment courses for 3 months, and selected maintenance or extended therapies for 12 months), and clinical guidelines (IDSA, NCCN) support its use in specified populations.