Skip to Content

Table 47: Antifungal Agents - Oral and Injectable


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Anti-infectives

Medication Class/Individual Agents: Antifungal Agents - Oral and Injectable

I. Prior-Authorization Requirements

 Oral and Injectable Antifungal Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

clotrimazole troche test   A90
fluconazole Diflucan test   # , A90
flucytosine Ancobon test   BP, A90
griseofulvin suspension, tablet test   A90
ibrexafungerp Brexafemme PA  
isavuconazonium Cresemba PA  
itraconazole 100 mg capsule Sporanox test   # , A90
itraconazole 65 mg capsule Tolsura PA  
itraconazole solution Sporanox test   BP, A90
ketoconazole tablet test   A90
miconazole buccal tablet Oravig PA  
nystatin oral suspension test   A90
oteseconazole Vivjoa PA  
posaconazole injection, suspension Noxafil PA   BP, A90
posaconazole powder for oral suspension Noxafil PA  
posaconazole tablet Noxafil test   # , A90
rezafungin Rezzayo PA  
terbinafine tablet test   A90
voriconazole injection, 200 mg tablet Vfend test   #
voriconazole suspension, 50 mg tablet Vfend PA   A90

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

Please see below criteria update based on the Centers for Disease Control and Prevention (CDC) recommendations regarding voriconazole suspension and tablet.

  • Terbinafine is only FDA-approved for the treatment of onychomycosis of the toenail and fingernail due to dermatophytes.
  • Certain azole antifungals have medication specific adverse events:
    • Fluconazole is associated with alopecia.
    • Itraconazole is associated with aldosterone-like effects and should be avoided in patients with a history of heart failure.
    • Voriconazole is associated with abnormal vision and rash.
  • Voriconazole is an effective agent for aspergillus, scedosporium, and fusarium infections.
  • Isavuconazonium and posaconazole are the only azole antifungals with activity against zygomycosis (mucormycosis) infections.
  • Azole antifungals are potent inhibitors of various CYP450 enzymes:

Cytochrome P-450 Metabolism of Oral Antifungals

Agent

2C19 2C9 3A4 1A2 2A6 2E1 2D6

fluconazole

X(S) X(S) X(M)        
itraconazole     X(S)        
voriconazole X(W) X(W) X(M)        
posaconazole     X(S)        
ketoconazole     X(S) X(M) X(M) X(M)  
clotrimazole     X(M)        
terbinafine     X(S)       X(S)
isavuconazole     X(M)        

S=Strong, M=Moderate, W=Weak


  • Hepatic function abnormalities are associated with the azole class, including terbinafine, and as such, careful monitoring of liver function tests are recommended in all patients receiving these agents. Specific monitoring recommendations include:
    • isavuconazonium: at initiation and during course of treatment
    • itraconazole: for all patients being treated for longer than one month
    • posaconazole: at the start of and during the course of therapy
    • terbinafine: before initiation and should be repeated if used for > six weeks
    • voriconazole: at initiation and during course of treatment
 
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Aspergillosis, blastomycosis, and histoplasmosis – Tolsura
  • invasive Aspergillus infections – Cresemba, voriconazole suspension, 50 mg tablet
  • prevention of invasive Aspergillus and Candida infections – posaconazole injection, posaconazole oral suspension
  • candidemia – Rezzayo, voriconazole suspension, 50 mg tablet
  • disseminated candidiasis  – voriconazole suspension, 50 mg tablet
  • esophageal candidiasis – voriconazole suspension, 50 mg tablet
  • fungal infections caused by Fusarium and Scedosporium – voriconazole suspension, 50 mg tablet
  • invasive candidiasis – Rezzayo
  • oropharyngeal candidiasis – posaconazole oral suspension
  • recurrent vulvovaginal candidiasis – Vivjoa
  • vulvovaginal candidiasis – Brexafemme
  • zygomycosis (mucormycosis) – Cresemba

Non FDA-approved, for example:

  • Aspergillus endophthalmitis and keratitis – voriconazole suspension, 50 mg tablet
  • esophageal candidiasis – posaconazole oral suspension
  • fungal infections caused by Fusarium and Scedosporium – Cresemba
  • oropharyngeal candidiasis – voriconazole suspension, 50 mg tablet
  • prevention of invasive Aspergillus and Candida infections – voriconazole suspension, 50 mg tablet
  • zygomycosis (mucormycosis) – posaconazole injection, posaconazole oral suspension

Note: The above lists may not include all FDA-approved and non-FDA approved indications.

Back to top


III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

Brexafemme

  • Documentation of the following is required for the treatment of acute vulvovaginal candidiasis:
    • appropriate diagnosis; and
    • member is post-menarchal; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to oral fluconazole; or
      • Candida species is fluconazole-resistant. 
  • Documentation of the following is required for the treatment of recurrent vulvovaginal candidiasis:
    • appropriate diagnosis; and
    • results from a potassium hydroxide (KOH) test to confirm diagnosis; and 
    • member has had ≥ 3 acute VVC episodes within the last 12 months; and 
    • requested quantity is ≤ 24 tablets for one course of therapy; and 
    • member is post-menarchal; and
    • one of the following:
      • inadequate response (defined as ≥ 24 weeks of therapy or recurrence of infection while on maintenance therapy), adverse reaction, or contraindication to oral fluconazole; or 
      • candida species is fluconazole-resistant.

    

Cresemba

  • Documentation of the following is required for the treatment of aspergillus infections:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to both of the following: posaconazole, voriconazole; and
    • for the injectable formulation, medical necessity for the injectable formulation instead of oral capsule formulation.
  • Documentation of the following is required for the treatment of zygomycosis (mucormycosis):
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • for the injectable formulation, medical necessity for use of the IV formulation instead of oral capsule formulation; and 
    • inadequate response, adverse reaction, or contraindication to posaconazole. 

SmartPA: Claims for Cresemba capsule will usually process at the pharmacy without a PA request for members who are ≥ 18 years of age with a history of MassHealth medical claims for zygomycosis (mucormycosis) within the last 365 days.

 

Oravig

  • Documentation of the following is required for the diagnosis of oropharyngeal candidiasis:
    • appropriate diagnosis; and
    • member is ≥ two years of age; and
    • inadequate response, adverse reaction, or contraindication to both of the following: clotrimazole troches, nystatin suspension.

    

posaconazole injection

  • Documentation of the following is required for the prevention of invasive aspergillus and candida fungal infections:
    • appropriate diagnosis; and
    • member is ≥ two years of age; and
    • medical necessity for use of the injectable formulation instead of oral formulations; and
    • member has a diagnosis of one of the following:
      • hematologic malignancy (e.g., acute myelogenous leukemia, myelodysplastic syndromes) with neutropenia; or
      • hematopoietic stem cell transplantation (HSCT); or
      • graft-versus-host disease (GVHD).
  • Documentation of the following is required for the treatment of invasive aspergillosis fungal infections:
    • appropriate diagnosis; and
    • member is ≥ 13 years of age; and
    • medical necessity for use of the IV formulation instead of oral formulations.
  • Documentation of the following is required for the treament of zygomycosis (mucormycosis):
    • appropriate diagnosis; and
    • member is ≥13 years of age; and
    • medical necessity for use of the IV formulation instead of oral formulations.

 

posaconazole oral suspension

  • Documentation of the following is required for the prevention of invasive aspergillus and candida fungal infections:
    • appropriate diagnosis; and
    • member is ≥ 13 years of age; and
    • member has a diagnosis of one of the following:
      • hematologic malignancy (e.g., acute myelogenous leukemia, myelodysplastic syndromes) with neutropenia; or
      • hematopoietic stem cell transplantation (HSCT); or
      • graft-versus-host disease (GVHD).
  • Documentation of the following is required for the treatment of esophageal candidiasis:
    • appropriate diagnosis; and
    • member is ≥ 13 years of age; and
    • inadequate response, adverse reaction, or contraindication to all of the following: oral fluconazole, itraconazole, voriconazole.
  • Documentation of the following is required for the treatment of oropharyngeal candidiasis:
    • appropriate diagnosis; and
    • member is ≥ 13 years of age; and
    • inadequate response, adverse reaction, or contraindication to both of the following: oral fluconazole, itraconazole. 
  • Documentation of the following is required for the treatment of zygomycosis (mucormycosis):
    • appropriate diagnosis; and
    • member is ≥ 13 years of age.

SmartPA: Claims for posaconazole oral suspension will usually process at the pharmacy without a PA request for members who are ≥ 13 years of age with a history of MassHealth medical claims for zygomycosis (mucormycosis) within the last 365 days.

    

posaconazole powder for oral suspension

  • Documentation of the following is required for the prevention of invasive aspergillus and candida fungal infections:
    • member has a diagnosis of one of the following:
      • hematologic malignancy (e.g., acute myelogenous leukemia, myelodysplastic syndromes) with neutropenia; or
      • hematopoietic stem cell transplantation (HSCT); or
    • member is ≥ 18 years of age; and
    • prescriber is an infectious disease specialist or consult notes from a specialist are provided; and
    • inadequate response, adverse reaction, contraindication, or Candida isolate is resistant to ALL of the following: anidulafungin, caspofungin, micafungin; and
    • requested quantity is ≤ six vials for one course of therapy.

   

Rezzayo

  • Documentation of all of the following is required:
    • member has a diagnosis of one of the following:
      • candidemia; or
      • invasive candidiasis; and
    • member is ≥ 18 years of age; and
    • prescriber is an infectious disease specialist or consult notes from a specialist are provided; and
    • inadequate response, adverse reaction, contraindication, or Candida isolate is resistant to all of the following: anidulafungin, caspofungin, micafungin; and
    • requested quantity is ≤ six vials for one course of therapy.

    

Tolsura

  • Documentation of the following is required for the treatment of aspergillosis, blastomycosis, and histoplasmosis:
    • appropriate diagnosis; and
    • medical necessity for the 65 mg capsule instead of the 100 mg capsule.

 

Vivjoa

  • Documentation of the following is required for the treatment of recurrent vulvovaginal candidiasis:
    • appropriate diagnosis; and
    • results from a potassium hydroxide (KOH) test to confirm diagnosis; and
    • member has had ≥ three acute VVC episodes within past 12 months; and
    • requested quantity is ≤ 18 capsules for one course of therapy; and 
    • one of the following:
      • member is ≥ 12 years of age and not of reproductive potential; or
      • member is post-menopausal; and
    • one of the following:
      • inadequate response (defined as ≥ 24 weeks of therapy or recurrence of infection while on maintenance therapy), adverse reaction, or contraindication to oral fluconazole; or
      • Candida species is fluconazole resistant.

 

voriconazole suspension, 50 mg tablet

  • Documentation of the following is required for the prevention of invasive aspergillus and candida fungal infections:
    • member has a diagnosis of one of the following:
      • hematologic malignancy (e.g., acute myelogenous leukemia, myelodysplastic syndromes) with neutropenia; or
      • hematopoietic stem cell transplantation (HSCT); or
      • graft-versus-host disease (GVHD).
  • Documentation of the following is required for the treatment of aspergillus, scedosporium, and fusarium infections:
    • appropriate diagnosis.
  • Documentation of the following is required for the treatment of aspergillus endophthalmitis and keratitis:
    • appropriate diagnosis.
  • Documentation of the following is required for the treatment of candidemia and disseminated candidiasis infections:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to oral fluconazole.
  • Documentation of the following is required for the treatment of esophageal candidiasis:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following: oral fluconazole, itraconazole.
  • Documentation of the following is required for the treatment of oropharyngeal candidiasis:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all of the following: oral fluconazole, itraconazole, posaconazole.

SmartPA: Claims for voriconazole suspension or 50 mg tablet will usually process at the pharmacy without a PA request for members with a history of MassHealth medical claims for aspergillus within the last 365 days.

 

 Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 02/2010

Last Revised Date: 03/2024


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 05/16/24

Feedback