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Drug Category: Antiviral Agents

Medication Class/Individual Agents: Antiviral Agents

I. Prior-Authorization Requirements

 Antiviral Agents – Oral and Injectable

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

acyclovir buccal tablet Sitavig PA  
acyclovir capsule, suspension, tablet Zovirax # test  
acyclovir injection test  
famciclovir Famvir # test  
ganciclovir injection Cytovene # test  
letermovir Prevymis PA  
valacyclovir Valtrex # test  

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.

  • The 2015 Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines state that topical antiviral therapy offers minimal clinical benefit for the treatment of genital herpes and does not recommend their use.1
  • The CDC guidelines recommend the use of oral antiviral agents, including acyclovir, famciclovir, and valacyclovir for recurrent and suppressive therapy in genital herpes.1
  • Generic oral antiviral agents (acyclovir, famciclovir and valacyclovir) are available without PA.
  • Acyclovir is also available as an oral suspension.
  • Letermovir therapy is limited to 100 days post-transplant.

 

1Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines [homepage on the Internet]. Atlanta: Centers for Disease Control and Prevention: 2015 [updated 2015 Jun 5]; [cited 2018 May 31]. Available from: https://www.cdc.gov/std/tg2015/tg-2015-print.pdf.

 

 Antiviral Agents – Topical

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

acyclovir / hydrocortisone Xerese PA  
acyclovir cream Zovirax BP PA  
acyclovir ointment Zovirax PA  
penciclovir Denavir PA  
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: 

  • Herpes genitalis (acyclovir ointment)
  • Herpes labialis (acyclovir cream, Denavir, Sitavig, Xerese)
  • Non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients (acyclovir ointment)
  • Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (Prevymis)

Note: The above list may not include all FDA-approved indications.

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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, application frequency, and tube size.
  • 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.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

 

Prevymis

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is at high risk for CMV reactivation; and
    • for the injection formulation, clinical rationale for use instead of the tablet formulation.

 

Sitavig

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • adverse reaction or contraindication to oral acyclovir; and
    • one of the following:
      • inadequate response to oral famciclovir and valacyclovir; or
      • adverse reaction or contraindication to oral famciclovir and valacyclovir; and
    • if requesting more than two tablets per month, medical necessity for quantity must be provided.

  

All Topical Antiviral Agents

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response to two different oral antiviral agents (acyclovir, famciclovir or valacyclovir); or
      • adverse reaction or contraindication to an oral antiviral agent; and
    • if requesting more than one tube per month, medical necessity for quantity must be provided.

Please note:

  • For pediatric members < 12 years of age, trial with acyclovir alone is sufficient (acyclovir is available as an oral solution).


Original Effective Date: 01/2013

Last Revised Date: 04/2019


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Last updated 07/15/19