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

clotrimazole troche test  
fluconazole Diflucan # test  
flucytosine Ancobon # test  
griseofulvin 125 mg, 250 mg tablet Gris-Peg # test  
griseofulvin 500 mg tablet Grifulvin V # test  
griseofulvin suspension test  
isavuconazonium Cresemba PA  
itraconazole 100 mg capsule Sporanox # test  
itraconazole 200 mg tablet Onmel PA  
itraconazole 65 mg capsule Tolsura PA  
itraconazole solution Sporanox BP test  
ketoconazole tablet test  
miconazole buccal tablet Oravig PA  
nystatin oral suspension test  
posaconazole Noxafil BP PA  
terbinafine tablet Lamisil # test  
voriconazole injection Vfend # test  
voriconazole suspension, tablet Vfend PA  

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. Prior authorization 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.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Aspergillosis, blastomycosis, and histoplasmosis – Tolsura
  • invasive Aspergillus infections – Cresemba, voriconazole suspension, tablet
  • prevention of invasive Aspergillus and Candida infections – posaconazole injection, posaconazole oral suspension and DR tablet
  • candidemia and disseminated candidiasis  – voriconazole suspension, tablet
  • esophageal candidiasis – voriconazole suspension, tablet
  • fungal infections caused by Fusarium and Scedosporium – voriconazole suspension, tablet
  • onychomycosis –  Onmel
  • oropharyngeal candidiasis – Oravig, posaconazole oral suspension
  • zygomycosis (mucormycosis) – Cresemba

Non FDA-approved, for example:

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

Note: The above list may not include all 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.
  • 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 the member’s condition and requested medication (see below).

   

Prevention of invasive aspergillus and candida fungal infections (posaconazole injection)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • clinical rationale for use of injectable formulation over 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).

Prevention of invasive aspergillus and candida fungal infections (posaconazole oral suspension and DR tablet)

  • Documentation of the following is required:
    • 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).

Prevention of invasive aspergillus and candida fungal infections (voriconazole suspension, tablet)

  • Documentation of the following is required:
    • 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).

Treatment of aspergillosis, blastomycosis, and histoplasmosis (Tolsura)

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

Treatment of oropharyngeal candidiasis (posaconazole oral suspension)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 13 years of age; and
    • inadequate response, adverse reaction, or contraindication to all of the following:
      • oral fluconazole; and
      • itraconazole. 

Treatment of oropharyngeal candidiasis (Oravig)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to nystatin suspension; and
    • inadequate response, adverse reaction, or contraindication to clotrimazole troches.

Treatment of onychomycosis (Onmel)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the 200 mg tablet instead of the 100 mg capsule.

Treatment of zygomycosis (mucormycosis) (posaconazole injection)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • clinical rationale for use of injectable formulation over oral formulations.

Treatment of zygomycosis (mucormycosis) (posaconazole oral suspension and DR tablet)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 13 years of age.

SmartPA: Claims for posaconazole oral suspension and DR tablet 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.

Treatment of zygomycosis (mucormycosis) (Cresemba)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • if the request is for the injectable formulation, prescriber provides clinical rationale for use over oral capsule.

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.

Treatment of esophageal candidiasis (posaconazole oral suspension)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 13 years of age; and
    • inadequate response, adverse reaction, or contraindication to all of the following:
      • oral fluconazole; and
      • itraconazole; and
      • voriconazole.

Treatment of aspergillus infections (Cresemba)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to voriconazole; and
    • if the request is for the injectable formulation, prescriber provides clinical rationale for injectable formulation over oral capsule.

Treatment of aspergillus, scedosporium, and fusarium infections (voriconazole suspension, tablet)

  • Documentation of the following is required:
    • appropriate diagnosis.

SmartPA: Claims for voriconazole suspension or 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.

Treatment of candidemia and disseminated candidiasis infections (voriconazole suspension, tablet)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to oral fluconazole.

Treatment of esophageal candidiasis (voriconazole suspension, tablet)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all of the following:
      • oral fluconazole; and
      • itraconazole.

Treatment of oropharyngeal candidiasis (voriconazole suspension, tablet)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to one of the following:
      • nystatin suspension; or 
      • clotrimazole troches; or
      • miconazole troches; and
    • inadequate response, adverse reaction, or contraindication to oral fluconazole; and
    • inadequate response, adverse reaction, or contraindication to itraconazole; and
    • inadequate response, adverse reaction, or contraindication to posaconazole.

Treatment of aspergillus endophthalmitis and keratitis (voriconazole suspension, tablet)

  • Documentation of the following is required:
    • appropriate diagnosis.

 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: 10/2019


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 10/09/19