ModifiedCignaPolicy N/A

Valacyclovir (Valtrex) — Drug Quantity Management (per Rx) coverage criteria

Defines Cigna's drug quantity limits and exception criteria for valacyclovir (Valtrex and generic) tablets for retail and home delivery dispensing for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyValacyclovir (Valtrex) — Drug Quantity Management (per Rx) coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revisions and additions to exception criteria

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must document the specific indication on the prescription to match quantity override criteria when requesting larger per‑dispensing quantities.

SourceLink

POLICY UPDATE CHANGES

Override criteria for valacyclovir for treatment of 'mucocutaneous herpes' were clarified to treatment of 'herpes simplex virus'.

Quantity limits when obtained via home delivery were updated to reflect existing home delivery limits (e.g., 3x retail quantities).

Override criteria for HSV suppression in pregnancy from 36 weeks to delivery were updated to allow up to 60 tablets per retail dispensing or 180 tablets per home delivery.

Added hematopoietic cell transplantation to prevention indication for cytomegalovirus prophylaxis with valacyclovir 1,000 mg.

Added override to approve up to 90 tablets retail (270 home delivery) for treatment of varicella zoster virus infection in immunocompromised patients using 1,000 mg tablets.

One-time override for 60 tablets for prophylaxis of herpes gladiatorum was removed.

30max tablets per retail Rx (standard)

90max tablets per home delivery Rx (standard)

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retail cap for 500 mg exceptions

180home delivery cap for 500 mg exceptions

240retail cap for 1 g CMV prophylaxis

720home delivery cap for 1 g CMV prophylaxis

Coverage Criteria and Exceptions

Drug Quantity Limits and Exception Criteria

Valacyclovir tablets (500 mg and 1 gram) are covered when the Drug Quantity Management limits or specified exception criteria per strength are met. Any other exception is considered not medically necessary.

Default quantity limits: Standard maximum per Rx for both 500 mg and 1 gram strengths: 30 tablets per dispensing at retail or 90 tablets per dispensing at home delivery.30 retail / 90 home delivery

500 mg tablet exceptions

Chronic HSV suppression in immunocompromised: Medication requested for chronic suppression or prevention of herpes simplex virus in an immunocompromised patient.
HSV suppression in pregnancy: Medication requested for suppression of herpes simplex virus in pregnancy from 36 weeks of gestation until delivery.
Post-transplant VZV prophylaxis: Medication requested for prophylaxis of herpes zoster/varicella zoster virus following solid organ transplantation or hematopoietic cell transplantation.
Viral ophthalmic infection: Medication requested for a viral ophthalmic infection.

1 gram tablet exceptions

CMV prevention after transplant: Medication requested for prevention of cytomegalovirus infection after solid organ transplantation or hematopoietic cell transplantation.
HSV treatment in immunocompromised: Medication requested for treatment of herpes simplex virus infection in an immunocompromised patient.
Acute dermatomal herpes zoster in immunocompromised: Medication requested for treatment of acute local dermatomal herpes zoster in an immunocompromised patient.
VZV infection in immunocompromised: Medication requested for treatment of varicella zoster virus infection in an immunocompromised patient.
Viral ophthalmic infection:

Exclusions: Any exception not listed in the criteria is considered not medically necessary; requests for additional quantities for non-covered indications (e.g., multiple sclerosis or chronic fatigue) are excluded.

Valacyclovir 1,000 mg — Authorized quantities per indication

Approve the requested quantity up to the indicated per-dispensing limits when the medication is requested for the specified indications:

CMV prevention after transplant: If requested for prevention of cytomegalovirus infection after solid organ transplantation or hematopoietic cell transplantation, approve up to 240 tablets per dispensing at retail or 720 tablets per dispensing at home delivery.240 retail / 720 home delivery

HSV treatment in immunocompromised: If requested for treatment of herpes simplex virus infection in an immunocompromised patient, approve up to 60 tablets per dispensing at retail or 180 tablets per dispensing at home delivery.60 retail / 180 home delivery

Acute local dermatomal herpes in immunocompromised: If requested for treatment of acute local dermatomal herpes zoster in an immunocompromised patient, approve up to 90 tablets per dispensing at retail or 270 tablets per dispensing at home delivery.

Any exception not explicitly listed in the coverage criteria is not medically necessary. Coverage is limited to the standard Drug Quantity Management limits and the specific exception criteria defined for each valacyclovir strength; requests that do not match a listed exception will be denied as not medically necessary.

Additional quantities of valacyclovir requested for non-covered indications — specifically for the treatment of multiple sclerosis or chronic fatigue — are expressly excluded and will not be approved.

Requests that exceed the standard per‑dispensing quantity limits (the Drug Quantity Management maximums for retail and home delivery) and that do not meet one of the specified exception criteria are considered not medically necessary and will not be authorized.

Provider Requirements and Operational Notes

Billing Rule

Quantity limit enforcement and approval duration

If the point-of-service Drug Quantity Management rule is not met, coverage will be determined by the criteria in this policy. All approvals granted under this policy are valid for 1 year from the date of approval. Quantity limits are enforced at the point of service per dispensing: retail limits apply to retail fills and home delivery limits apply to home delivery fills.

Approvals duration: 1 year
Enforcement: Per Rx at point-of-service (retail vs home delivery)

Prior Authorization

Quantity override per indication

Overrides to permit quantities above the standard per-Rx limits may be approved for specific clinical indications. Examples of approved override limits for valacyclovir 1,000 mg (1 gram) tablets include: prevention of cytomegalovirus after solid organ or hematopoietic cell transplantation (up to 240 tablets retail / 720 tablets home delivery); treatment of HSV in immunocompromised patients (up to 60 tablets retail / 180 tablets home delivery); treatment of acute local dermatomal herpes zoster in immunocompromised patients (up to 90 tablets retail / 270 tablets home delivery); treatment of varicella zoster in immunocompromised patients (up to 90 tablets retail / 270 tablets home delivery); and viral ophthalmic infections (up to 240 tablets retail / 720 tablets home delivery). Prescriptions should indicate the specific approved indication to match the override criteria.

Per-Dispensing Quantity Limits by Strength and Indication

Standard retail limit (500 mg)

DrugValtrex (valacyclovir) 500 mg tablets

Standard retail limit30 tablets per Rx (retail)

Approval durationApprovals provided for 1 year (per policy)

Standard home delivery limit (500 mg)

DrugValtrex (valacyclovir) 500 mg tablets

Standard home delivery limit90 tablets per Rx (home delivery)

Rationale

Dispensing Setting Differences

Billing Rule

Retail vs home delivery: standard and exception caps differ

Quantity limits differ by dispensing setting: standard maximum per Rx is 30 tablets at retail or 90 tablets for home delivery for both 500 mg and 1 g strengths; certain exception caps are higher and vary by indication and dispensing method.

Standard limits: 30 tablets retail / 90 tablets home delivery (both strengths)
Exception caps for 500 mg: up to 60 retail / 180 home delivery (some indications); viral ophthalmic infection up to 90 retail / 270 home delivery

Billing Rule

Specify retail or home delivery—different per‑dispensing limits apply

Permitted dispensing settings include retail pharmacy (per‑dispensing caps) and home delivery (larger per‑dispensing caps—commonly three times retail); ensure the dispensing method is indicated when requesting quantities that exceed retail limits.

Home delivery limits are typically larger (e.g., 90 → 270 or 240 → 720 depending on indication).
Indicate retail vs home delivery when submitting quantity requests.

Key Definitions

Valacyclovir (marketed as Valtrex and generics) is an oral deoxynucleoside analogue DNA polymerase inhibitor indicated for treatment and suppression of herpes simplex and varicella‑zoster virus infections in adults and certain pediatric populations. Under this Drug Quantity Management policy, standard per‑dispensing maximums are set for both strengths and dispensing settings to promote dose consolidation; specific exception criteria permit larger per‑dispensing quantities for defined clinical indications.

Valacyclovir — definition

TermValacyclovir

DefinitionAn oral deoxynucleoside analogue DNA polymerase inhibitor marketed as Valtrex (valacyclovir tablets) indicated for multiple HSV and VZV infections in adults and some pediatric populations.

Clinical noteEfficacy and safety in immunocompromised patients is limited to specific uses such as suppression of genital herpes in HIV-1; other immunocompromised uses are specified in policy exceptions.

Home delivery — definition

Policy Summary

PayerCigna

PolicyValacyclovir (Valtrex) — Drug Quantity Management (per Rx) coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revisions and additions to exception criteria

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must document the specific indication on the prescription to match quantity override criteria when requesting larger per‑dispensing quantities.

SourceLink

On This Page

Medication requested for a viral ophthalmic infection.

90 retail / 270 home delivery

Varicella zoster infection in immunocompromised: If requested for treatment of varicella zoster virus infection in an immunocompromised patient, approve up to 90 tablets per dispensing at retail or 270 tablets per dispensing at home delivery.90 retail / 270 home delivery

Viral ophthalmic infection: If requested for a viral ophthalmic infection, approve up to 240 tablets per dispensing at retail or 720 tablets per dispensing at home delivery.240 retail / 720 home delivery

Prevention of CMV post solid organ or hematopoietic cell transplant: ≤240 tablets retail / ≤720 tablets home delivery
HSV treatment in immunocompromised patients: ≤60 tablets retail / ≤180 tablets home delivery
Acute dermatomal herpes zoster in immunocompromised patients: ≤90 tablets retail / ≤270 tablets home delivery
Varicella zoster in immunocompromised patients: ≤90 tablets retail / ≤270 tablets home delivery
Viral ophthalmic infection: ≤240 tablets retail / ≤720 tablets home delivery

Documentation Required

Coverage determination considerations

When making coverage determinations, consider: 1) the applicable benefit plan document in effect on the date of service; 2) any applicable federal or state laws and regulations; 3) relevant collateral materials including Cigna coverage policies; and 4) the specific facts of the individual case. Medical directors may exercise clinical judgment in individual determinations.

Review the member's benefit plan document and any plan-specific exclusions
Apply applicable laws/regulations
Use relevant collateral materials (coverage policies)
Assess the individual clinical facts and documentation provided

Documentation Required

Indication documentation

Prescriptions and prior authorization requests must document the specific clinical indication for use (e.g., prevention of CMV post-transplant, HSV suppression/treatment in pregnancy or immunocompromised patients, ophthalmic viral infection) to match the applicable quantity-override criteria. Requests lacking a specific indication that aligns with an override criterion may be processed under the standard Drug Quantity Management rule and subject to the default per-dispensing limits.

Include clear clinical indication on the prescription or PA request
If indication does not match an override criterion, coverage limited to standard per-Rx quantity limits
Documentation should support immunocompromised status or transplant/prophylaxis need when applicable

Denial Risk

Exclusions (denial risk)

Requests for additional quantities for indications that are excluded by this policy (for example, multiple sclerosis or chronic fatigue) will not be approved as quantity overrides.

Exclusions include requests for additional quantities for non-covered indications such as multiple sclerosis or chronic fatigue

Home delivery permits larger per-dispensing quantities (commonly 3x retail)

Standard retail limit (1 gram)

DrugValacyclovir 1 gram (1,000 mg) tablets

Standard retail limit30 tablets per Rx (retail)

NoteStandard limits apply to 1 gram strength unless an exception criteria is met

Standard home delivery limit (1 gram)

DrugValacyclovir 1 gram (1,000 mg) tablets

Standard home delivery limit90 tablets per Rx (home delivery)

NoteHome delivery commonly allows 3x the retail per-dispensing limit

Retail exception cap (500 mg)

DrugValacyclovir 500 mg tablets (exception caps)

Retail cap (exceptions)Up to 60 tablets per dispensing (retail)

Typical indicationsChronic HSV suppression in immunocompromised patients; HSV suppression in pregnancy from 36 weeks until delivery; post-transplant prophylaxis

Home delivery exception cap (500 mg)

DrugValacyclovir 500 mg tablets (exception caps)

Home delivery cap (exceptions)Up to 180 tablets per dispensing (home delivery)

Typical indicationsChronic HSV suppression in immunocompromised patients; HSV suppression in pregnancy from 36 weeks until delivery; post-transplant prophylaxis

Retail cap — viral ophthalmic infection (500 mg)

DrugValacyclovir 500 mg tablets (viral ophthalmic infection)

Retail capUp to 90 tablets per dispensing (retail)

IndicationViral ophthalmic infection

Home delivery cap — viral ophthalmic infection (500 mg)

DrugValacyclovir 500 mg tablets (viral ophthalmic infection)

Home delivery capUp to 270 tablets per dispensing (home delivery)

IndicationViral ophthalmic infection

Retail cap — CMV prophylaxis (1 gram)

DrugValacyclovir 1 gram tablets (CMV prophylaxis)

Retail capUp to 240 tablets per dispensing (retail)

IndicationPrevention of cytomegalovirus after solid organ or hematopoietic cell transplantation

Home delivery cap — CMV prophylaxis (1 gram)

DrugValacyclovir 1 gram tablets (CMV prophylaxis)

Home delivery capUp to 720 tablets per dispensing (home delivery)

IndicationPrevention of cytomegalovirus after solid organ or hematopoietic cell transplantation

Retail range — immunocompromised indications (1 gram)

DrugValacyclovir 1 gram tablets (other immunocompromised indications)

Retail range60–240 tablets per dispensing (retail) depending on indication

ExamplesHSV treatment in immunocompromised (60 retail) to CMV prophylaxis (240 retail)

Home delivery range — immunocompromised indications (1 gram)

DrugValacyclovir 1 gram tablets (other immunocompromised indications)

Home delivery range180–720 tablets per dispensing (home delivery) depending on indication

ExamplesHSV treatment in immunocompromised (180 home delivery) to CMV prophylaxis (720 home delivery)

Common cap (1,000 mg)

DrugValacyclovir 1,000 mg tablets

Common cap240 tablets per dispensing (retail) — common higher-limit grouping

Home delivery noteHome delivery limits may be higher (up to 720 tablets for some indications)

Retail exception level (1,000 mg)

DrugValacyclovir 1,000 mg tablets

Retail exception level60 tablets per dispensing (retail) for certain indications

IndicationsTreatment of HSV in immunocompromised patients (example)

Cap 90 (1,000 mg)

DrugValacyclovir 1,000 mg tablets

Cap — 90 tablets90 tablets per dispensing (retail) or 90 tablets per dispensing retail/home delivery for certain indications

ContextUsed for acute dermatomal herpes or VZV in immunocompromised patients (90 retail / 270 home delivery)

Cap 240 (1,000 mg)

DrugValacyclovir 1,000 mg tablets

Higher-limit grouping240 tablets per dispensing (retail) — repeated higher-limit grouping for select indications

NotesIncludes viral ophthalmic infection and CMV prophylaxis-related limits

DefinitionDispensing method permitting larger per-dispensing quantities; policy reflects home delivery limits commonly three times retail per-dispensing limits (e.g., 90 vs 30 retail).

Operational noteQuantity limits differ by retail vs home delivery; providers should request correct setting and indicate indication to match override criteria.