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Table 67: Antiviral Agents


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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

Drug
Notes

acyclovir buccal tablet Sitavig PA  
acyclovir capsule, tablet test   A90
acyclovir injection test  
acyclovir suspension Zovirax test   # , A90
cidofovir test  
famciclovir test   A90
foscarnet test   MB
ganciclovir injection test  
letermovir Prevymis PA  
maribavir Livtencity PA  
valacyclovir Valtrex test   # , A90
valganciclovir Valcyte test   # , 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.

  • 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
  • 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

Drug
Notes

acyclovir / hydrocortisone Xerese test   BP
acyclovir cream Zovirax test   BP, A90
acyclovir ointment Zovirax test   #
penciclovir Denavir PA   A90
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.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
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: 

  • Herpes labialis (Sitavig)
  • Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (Prevymis)
  • Recurrent herpes labialis (penciclovir)
  • Treatment of CMV infection post-transplant that is refractory to standard treatment in adult and pediatric patients ≥ 12 years of age and who weigh ≥ 35 kg (Livtencity)

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.
  • 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.

   

Livtencity

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 12 years of age and weighs ≥35 kg; and 
    • prescriber is an infectious disease specialist or consultation notes from an infectious disease specialist are provided; and
    • appropriate dosing; and
    • member will not be receiving concurrent antiviral therapy with cidofovir, foscarnet, ganciclovir, or valganciclovir; and
    • one of the following:
      • inadequate response or adverse reaction to ganciclovir or valganciclovir; or
      • contraindication to cidofovir, foscarnet, ganciclovir, and valganciclovir; or
      • both of the following:
        • contraindication to both ganciclovir and valganciclovir; and
        • inadequate response or adverse reaction to cidofovir or foscarnet. 

penciclovir

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 12 years of age; and 
    • inadequate response or adverse reaction to one or contraindication to both of the following: acyclovir cream or ointment, Xerese; and
    • one of the following:
      • requested quantity is ≤ five grams/30 days; or
      • medical necessity for exceeding five grams/30days.

Prevymis

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

Sitavig

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to oral acyclovir; and
    • inadequate response (in a previous or current episode), adverse reaction, or contraindication to both of the following: oral famciclovir, valacyclovir; and
    • one of the following:
      • requested quantity is ≤ two tablets/30 days; or
      • medical necessity for exceeding two tablets/30 days.

 


Original Effective Date: 01/2013

Last Revised Date: 03/2024


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Last updated 05/16/24

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