FDA-approved, for example: 

• Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (Prevymis, valganciclovir powder for oral solution)
• Prophylaxis of CMV infection post-solid organ transplant (valganciclovir powder for oral solution)
• Prophylaxis of CMV infection post-kidney transplant (Prevymis)
• 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)
• Treatment of CMV retinitis (valganciclovir powder for oral solution)

non-FDA-approved, for example: 

• Prophylaxis of CMV infection post-solid organ transplant (non-kidney, non-hematopoietic stem cell transplant) (Prevymis)

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

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 
  • member weight is ≥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.

Prevymis

• Documentation of the following is required for prophylaxis of cytomegalovirus (CMV) infection post-allogeneic hematopoietic stem cell transplant:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is an infectious disease specialist, hematologist, or transplant specialist or consult notes are provided; and
  • member is at high risk for CMV reactivation; and
  • for 240 mg tablet, the requested agent will be used in combination with cyclosporine; and
  • for tablet, requested quantity is ≤ one tablet/day; and
  • for the injection formulation, medical necessity for use of the requested formulation instead of the tablet formulation.

• Documentation of the following is required for prophylaxis of CMV infection post-kidney transplant:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is an infectious disease specialist, hematologist, or transplant specialist or consult notes are provided; and
  • member is at high risk for CMV reactivation; and
  • inadequate response, adverse reaction, or contraindication to valganciclovir; and
  • for 240 mg tablet, the requested agent will be used in combination with cyclosporine; and
  • for tablet, requested quantity is ≤ one tablet/day; and
  • for the injection formulation, medical necessity for use of the requested formulation instead of the tablet formulation.

• Documentation of the following is required for prophylaxis of CMV infection post-solid organ (non-kidney, non-HSCT) transplant:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is an infectious disease specialist, hematologist, or transplant specialist or consult notes are provided; and
  • member is at high risk for CMV reactivation; and
  • inadequate response, adverse reaction, or contraindication to valganciclovir; and
  • for 240 mg tablet, the requested agent will be used in combination with cyclosporine; and
  • for tablet, requested quantity is ≤ one tablet/day; and
  • for the injection formulation, medical necessity for use of the requested formulation instead of the tablet formulation.

valganciclovir powder for oral solution

• Documentation of the following is required:
  • appropriate diagnosis; and
  • for a diagnosis of CMV retinitis, member is ≥ 18 years of age; and
  • medical necessity for the use of a solution formulation as noted by one of the following:
    • member utilizes tube feeding (G-tube/J-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow; or
    • member is < 13 years of age; and
  • requested quantity is ≤ 18 mL/day.