CurrentAetnaPolicy 0115

Varicella and Herpes Zoster Vaccines (Clinical Policy Bulletin)

Clinical policy bulletin describing medical necessity, experimental/investigational determinations, and coding related to varicella (including MMRV) and herpes zoster (Shingrix, Zostavax) vaccines for Aetna members.

Policy Summary

PayerAetna

PolicyVaricella and Herpes Zoster Vaccines (Clinical Policy Bulletin)

Policy CodePolicy 0115

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit vaccine CPT codes (e.g., 90750, 90710, 90716) with supporting ICD-10 diagnosis codes to demonstrate eligibility per the policy selection criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2-doseShingrix primary series

Adults ≥50Primary indicated age

Not sold since Nov 18, 2020Zostavax availability note

03/22/2023Last review date

03/25/1996Effective date (original)

≈81

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Coverage Criteria for Varicella and Herpes Zoster Vaccines

Covered Indications

Aetna considers varicella and herpes zoster vaccines medically necessary for the following indications:

Varicella (primary prevention): Varicella (chicken pox) vaccine as a preventive service according to CDC ACIP recommendations.

MMRV (ProQuad): Combination measles, mumps, rubella, and varicella vaccine (MMRV/ProQuad) as an alternative to separate MMR and varicella vaccines for children when simultaneous administration is indicated.age 12 months to 12 years

Varicella vaccination in select HIV-infected persons: Primary varicella vaccination for VZV‑negative, HIV‑infected persons >8 years with CD4 >200 cells/µL, and for HIV‑infected children 1–8 years with CD4% >15%.CD4 >200 cells/µL in persons >8 years; CD4% >15% in children 1–8 years

Recombinant zoster vaccine (Shingrix) — primary indications: Shingrix (2‑dose series) for any of the following: (1) prevention of herpes zoster in adults ≥50 years; OR (2) prevention in adults ≥50 years who previously received Zostavax; OR (3) prevention in adults ≥18 years who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression (examples: autologous HCT, hematologic malignancy, solid organ transplant, solid tumor chemotherapy, HIV infection, primary immunodeficiencies, autoimmune/inflammatory conditions on immunosuppressive therapy).age and risk conditions as listed

Repeat (booster) beyond the primary two‑dose Shingrix series is considered experimental/investigational.

Re‑vaccination after HSCT: Re‑vaccination with Shingrix for hematopoietic stem‑cell transplant recipients if ≥24 months have passed since HSCT, the recipient does not have graft‑versus‑host disease, and the member is considered immunocompetent.>=24 months post‑HSCT; no GVHD

Coverage-related clinical recommendations

Guidance and criteria referenced from ACIP/CDC and FDA approvals:

ACIP / FDA age‑based recommendation: Shingrix is recommended for immunocompetent adults aged ≥50 years; ACIP prefers Shingrix over Zostavax and FDA originally approved Shingrix for adults ≥50 years.age >=50

ACIP preference and FDA approval noted.

Shingrix in immunocompromised adults (expanded approval): In July 2021 FDA expanded Shingrix approval to include prevention of shingles in adults ≥18 years who are or will be immunodeficient or immunosuppressed; in October 2021 ACIP recommended two doses for adults ≥19 years who are or will be immunodeficient/immunosuppressed. For these patients a shorter 1–2 month interval between doses may be used when appropriate.age >=18 (FDA) / >=19 (ACIP) with immunodeficiency/immunosuppression

Second dose interval may be shortened to 1–2 months for immunocompromised adults.

Hematopoietic cell transplant (HCT) guidance:

Clinical evidence and timing considerations

Summarized findings and recommended timing/considerations for vaccination in special populations:

Chronic kidney disease (CKD): HZ vaccination associated with reduced risk of herpes zoster in CKD patients (HR 0.55; 95% CI: 0.37–0.82) without increased adverse events in pooled studies; consider active vaccination in CKD patients.

Systematic review/meta‑analysis of 8 studies including 404,561 individuals.

Hematopoietic stem cell transplant (HCT) recipients and peri‑transplant vaccination: HCT recipients should be revaccinated after transplant; live varicella, zoster, and MMR vaccines may be given ≥24 months post‑HCT if no GVHD and patient is immunocompetent. Inactivated or recombinant zoster vaccines administered peri‑/post‑transplant demonstrated efficacy (e.g., auto‑HSCT trials showing ~63.8%–68.2% efficacy) with acceptable safety profiles.>=24 months for live vaccines post‑HCT; recombinant schedules studied with doses beginning ~50–70 days post‑auto‑HSCT

Phase II/III trial evidence summarized.

Auto‑HSCT peri‑transplant inactivated vaccine findings:

Coverage-relevant clinical criteria

Key coverage-related clinical points supported by the evidence presented:

Vaccination timing and vaccine type for immunosuppressed patients: Ideally administer needed live vaccines (e.g., zoster) ≥4 weeks before initiating immunosuppression. Most inactivated (non‑live) vaccines can be given while on immunosuppressive therapy. Live zoster vaccine is contraindicated in immunosuppressed patients, with exceptions per ACIP for short‑term or low‑to‑moderate corticosteroid therapy and certain low‑dose immunomodulators.see definitions for corticosteroid and immunomodulator dose thresholds

Based on ACIP and guideline reviews.

Vaccine effectiveness summary: Pooled evidence indicates ZVL effectiveness around ~45.9% against HZ, while RZV demonstrates substantially higher effectiveness (pooled/post‑hoc estimates ~79.2%) and superior efficacy versus ZVL across multiple analyses.

Systematic reviews and meta‑analyses reported.

Safety and reactogenicity considerations: RZV is more reactogenic (higher rates of injection‑site and systemic reactions) than placebo but does not increase serious adverse events; trials of live or inactivated vaccines in immunosuppressed populations reported acceptable safety with no excess serious vaccine‑related events in studied cohorts (monitor for reactogenicity and document timing relative to immunosuppression/transplant).

Aetna considers recombinant herpes zoster vaccine (Shingrix) experimental and investigational for the treatment of zoster or postherpetic neuralgia (PHN), for the prevention of primary varicella infection (chickenpox), and for all other indications not established, because effectiveness for these indications has not been demonstrated.

The live-attenuated zoster vaccine (Zostavax) is not indicated for prevention of primary varicella infection (chickenpox) and is not indicated for treatment of zoster or postherpetic neuralgia (PHN) per the FDA package insert. Note that Zostavax is no longer available for use in the United States as of November 18, 2020.

ACIP guidance indicates that the live zoster vaccine is contraindicated in immunosuppressed patients, but notes exceptions where certain patients are not considered sufficiently immunosuppressed to preclude vaccination — for example, those receiving short-term corticosteroid therapy (<14 days) or low-to-moderate dose corticosteroids (<20 mg/day), and patients on certain low-dose immunomodulators (e.g., methotrexate ≤0.4 mg/kg/week, azathioprine ≤3.0 mg/kg/day, or 6-mercaptopurine ≤1.5 mg/kg/day).

Live zoster vaccine (Zostavax) is contraindicated in immunosuppressed patients. Live zoster vaccine should generally be avoided in persons with immunodeficiency or receiving immunosuppressive therapies.

Clinical Policy Bulletins are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. They provide only a partial description of plan or program benefits and do not constitute a contract; coverage determinations may differ by plan and treating providers are responsible for medical decisions.

Aetna considers repeat (booster) administration of recombinant herpes zoster vaccine (Shingrix) beyond the primary two-dose series to be experimental and investigational. Re-vaccination is addressed specifically for HSCT recipients under defined conditions, but routine additional booster doses beyond the two-dose primary series are not considered established.

Coding and Diagnostic Requirements

Varicella / MMRV related CPT codes covered if selection criteria are metCPTCovered

90710	Measles, mumps, rubella, and varicella vaccine (MMRV), live, for subcutaneous use.
90716	Varicella virus vaccine (VAR), live, for subcutaneous use.
90707	Measles, mumps, and rubella vaccine (MMR), live, for subcutaneous use.

Zoster recombinant vaccine CPTCPTCovered

90750

Zoster (shingles) vaccine (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection [Shingrix].

Other CPT codes referenced (Zostavax listed as not covered for indications in CPB; transplant code referenced)CPT

90736	Zoster (shingles) vaccine (HZV), live, for subcutaneous injection [Zostavax] (not covered for indications listed).
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.

ICD-10 codes (covered and not covered as listed)ICD-10

B20	Human immunodeficiency virus [HIV] disease.
Z21	Asymptomatic human immunodeficiency virus [HIV] infection status.
Z23	Encounter for immunization.
B01.9	Varicella without complication [prevention of chickenpox].
B02.0 - B02.9	Zoster (herpes zoster).
D89.810 - D89.813	Graft-versus-host disease.

Shingrix age indication — primary ages and immunocompromised exception

Primary age indicationAdults aged ≥ 50 years for routine prevention of herpes zoster (Shingrix two-dose series)

Younger immunocompromised indicationAdults aged ≥ 18 years who are or will be immunodeficient or immunosuppressed (examples: HCT recipients, hematologic malignancies, SOT recipients, chemotherapy, HIV-infected adults) — Shingrix two-dose series

Previous Zostavax recipientsAdults aged ≥ 50 years who previously received Zostavax are indicated to receive Shingrix (two-dose series)

Booster/Repeat dosingRepeat (booster) with Shingrix beyond the primary two-dose series is considered experimental and investigational

HIV/CD4 thresholds for varicella vaccination eligibility

Provider Actions, Documentation, and Billing Guidance

Denial Risk

Potential Denial Triggers

Claims may be denied if billed with ICD-10 diagnosis codes that are listed as not covered for the indications in this Clinical Policy Bulletin. Providers should verify that the diagnosis supports the vaccine indication before submission.

Potential denial triggers: submission of vaccines with ICD-10 codes specifically listed as not covered for the CPB indications.
Verify member eligibility and indication against the CPB before billing.

Billing Rule

Required Coding & Diagnosis Documentation

Use appropriate CPT/HCPCS codes and supporting ICD-10 diagnosis codes on claims to reflect the immunization encounter and clinical indication. Common documentation codes include Z23 (encounter for immunization). For Shingrix use CPT 90750; for varicella/MMRV use 90716 and 90710 as applicable. Do not bill live zoster vaccine codes for indications excluded by this CPB.

Background and Clinical Context

ACIP recommends varicella vaccination as a 2-dose series beginning at 12 months of age for children, and varicella vaccination for susceptible adolescents and adults per ACIP guidance. Herpes zoster results from reactivation of varicella-zoster virus, and risk of herpes zoster and postherpetic neuralgia increases with age and immunosuppression.

Definitions

Post-herpetic neuralgia (PHN)

PHN definitionPost-herpetic neuralgia (PHN) is significant pain or dysaesthesia present 3 months or more following herpes zoster (HZ)

Clinical diagnosisDiagnosis is usually clinical based on typical unilateral dermatomal pain and rash; prodromal symptoms (pain, itching, malaise) are common

Epidemiology noteMore than 5% of the elderly have PHN at 1 year after acute HZ

Zostavax (ZVL) — definition and description

Vaccine typeZoster vaccine live (Zostavax) is a live attenuated virus vaccine administered subcutaneously as a single injection (0.65 mL)

Indications & limitationsOriginally FDA-approved to reduce risk of HZ in older adults; not indicated for treatment of zoster or PHN and not for prevention of primary varicella infection

Policy Summary

PayerAetna

PolicyVaricella and Herpes Zoster Vaccines (Clinical Policy Bulletin)

Policy CodePolicy 0115

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit vaccine CPT codes (e.g., 90750, 90710, 90716) with supporting ICD-10 diagnosis codes to demonstrate eligibility per the policy selection criteria.

SourceLink

On This Page

Varicella, zoster, and MMR vaccines may be administered after HCT if 24 months have passed since HCT, the patient does NOT have graft‑versus‑host disease, and is considered immunocompetent (CDC guidance).

>=24 months post‑HCT; no GVHD; immunocompetent

CDC guidance referenced.

An inactivated VZV vaccine given peri‑transplant showed vaccine efficacy of ~63.8% for prevention of HZ in auto‑HSCT recipients with similar serious AE rates to placebo but increased local reactogenicity.

multi‑dose peri‑transplant schedules as described in trials

Trial efficacy and safety data cited.

RZV (recombinant) in immunocompromised populations: RZV demonstrated reduced HZ incidence and immunogenicity in auto‑HSCT recipients (~68% efficacy) and induced humoral and cell‑mediated responses in patients with solid tumors and hematologic malignancies; reactogenicity higher than placebo but serious adverse events similar.2‑dose series in studies

Phase III and other trials summarized.

Hematologic malignancies versus solid tumors: Inactivated VZV vaccine effective in patients with solid tumors receiving chemotherapy (efficacy ~63.6%) but was not effective for HZ prevention in patients with hematologic malignancies (efficacy ~16.8% in that group).

Trial subgroup results.

Inflammatory bowel disease (IBD) and immunosuppression timing: IBD patients should ideally be vaccinated prior to initiating immunosuppression; most inactivated vaccines can be given while on therapy. Live zoster vaccine is contraindicated in immunosuppressed patients, though short‑term (<14 days) or low‑to‑moderate dose (<20 mg/day prednisone equivalent) corticosteroid therapy and certain low‑dose immunomodulators may not preclude live vaccine per ACIP. Live vaccines should ideally be given ≥4 weeks before starting immunosuppression.>=4 weeks before immunosuppression for live vaccines; corticosteroid and immunomodulator dosing thresholds per definitions

Guideline and review sources summarized.

Trial and systematic review data cited.

Adults >8 years with HIVVaricella primary vaccination may be considered in HIV-infected, VZV-seronegative persons aged > 8 years with CD4 cell counts > 200 cells/µL

Children 1–8 years with HIVVaricella primary vaccination may be considered in HIV-infected children aged 1 to 8 years with CD4 percentages > 15%

Not recommended with low CD4Zoster (live) vaccine is specifically not recommended for HIV-infected patients with CD4 cell count < 200 cells/µL per guidance cited

Submit vaccine CPT (e.g., 90750 for Shingrix) with a supporting ICD-10 diagnosis that documents the indication.
Include Z23 for routine immunization encounters when appropriate.

Documentation Required

Herpes Zoster Live Vaccine Contraindication

The live zoster vaccine (Zostavax; CPT 90736) is contraindicated for use in immunosuppressed patients and is not indicated for primary varicella prevention or treatment of zoster/PHN. Zostavax supply was discontinued in the U.S.; remaining stock may be used until it expires but is not covered for CPB-listed indications where live vaccine is contraindicated.

Do NOT administer or bill live zoster vaccine for immunosuppressed members or for indications excluded by this policy.
If live vaccine is used from existing stock, ensure indication and member immune status meet any applicable plan rules.

Documentation Required

Documentation for Hematopoietic Cell Transplant (HCT) Recipients

Document clinical evidence when vaccinating transplant recipients or immunocompromised patients. For hematopoietic cell transplant (HCT) recipients, document that at least 24 months have passed since HCT, absence of graft-versus-host disease (GVHD), and that the patient is considered immunocompetent prior to administration of varicella/zoster/MMRV vaccines per CPB guidance.

Document date of HCT and that ≥24 months have elapsed.
Document absence of graft-versus-host disease and clinical assessment of immunocompetence.

Documentation Required

Document Timing Relative to Transplant or Immunosuppression

Document timing of vaccination relative to planned immunosuppression or transplant. Whenever possible, administer live vaccines ≥4 weeks before initiating immunosuppressive therapy. For Shingrix in immunocompromised persons, follow ACIP and FDA guidance on dosing intervals (2–6 months for immunocompetent; 1–2 months may be used for certain immunocompromised schedules).

Document planned or current immunosuppressive therapies and vaccination dates relative to therapy/transplant.
If vaccinating prior to immunosuppression, note the timing (e.g., ≥4 weeks before therapy).

Step Therapy

Preferred Vaccine Sequencing and Step Therapy

ACIP recommends recombinant zoster vaccine (Shingrix) over zoster live vaccine (Zostavax). For patients previously vaccinated with Zostavax, Shingrix is preferred and may be administered according to ACIP guidance. There are no step therapy requirements in this CPB — RZV superiority to ZVL is described but no step edits or step therapy rules are specified.

Preferred sequencing: RZV (Shingrix) preferred over ZVL; previously vaccinated persons with Zostavax may receive Shingrix.
No step therapy rules or requirements are specified in this Clinical Policy Bulletin.

Note

Provider Responsibility and Plan Provisions

Providers are responsible for making treatment decisions and must follow plan benefit provisions. This CPB is informational and does not guarantee coverage; verify specific member benefits and prior authorization requirements with the payer.

Confirm member coverage, benefit limits, and any plan-specific prior authorization requirements before administering vaccines.
Document clinical rationale for vaccination in the medical record.

Note

Additional Provider Actions / When CPB Is Silent

General provider action reminders and placeholders: when requirements are not explicitly stated in the CPB (e.g., prior authorization rules), refer to plan-specific provisions and payer portals or contact the payer directly for clarification.

If prior authorization is required by the specific member plan, follow plan portals/processes even if CPB does not list PA rules.
Maintain immunization record, informed consent, and screening for contraindications/allergies prior to administration.

ContraindicationsContraindicated in immunosuppressed persons, those on immunosuppressive therapy (including high-dose corticosteroids), and pregnant women

Shingrix (HZ/su) — definition and description

Vaccine typeShingrix (zoster vaccine recombinant, adjuvanted; HZ/su) is a non-live recombinant subunit vaccine containing glycoprotein E with the AS01B adjuvant, given intramuscularly

Dosing scheduleAdministered as a two-dose series (two 0.5 mL IM doses) with the standard interval of 2 to 6 months; for some immunocompromised adults a shortened 1–2 month interval may be used

Indication & efficacyFDA-approved for prevention of herpes zoster in adults aged ≥50; demonstrated >90% efficacy across age groups in pooled phase 3 analyses and reduces incidence of PHN

Zostavax description and supply discontinuation note

Supply/discontinuation noteZostavax was no longer sold in the U.S. starting July 1, 2020; existing stock could be used until it expired (by November 18, 2020)

Reason for discontinuationManufacturer decision unrelated to product safety or manufacturing issues per notification (Merck)

Current practical pointSome pharmacies/clinics may have remaining Zostavax stock but it is not being newly distributed in the U.S.

HCT / HSCT (hematopoietic cell transplant) — definition

DefinitionHematopoietic cell transplant (HCT) involves ablation of the bone marrow followed by reimplantation of the person’s own or donor stem cells

Clinical consequenceHCT results in immunosuppression from ablative therapy and GVHD-related treatments, with decreased antibody titers to vaccine-preventable diseases if not revaccinated

Vaccination timingVaricella, zoster, and MMR vaccines may be administered after HCT if ≥24 months have passed since HCT, the patient does NOT have graft-versus-host disease, and is considered immunocompetent

RZV (recombinant zoster vaccine) — definition and indication summary

DefinitionRZV (recombinant zoster vaccine; e.g., Shingrix) is an adjuvanted, non-live, recombinant subunit vaccine containing glycoprotein E and AS01B adjuvant

IndicationsIndicated to prevent herpes zoster in adults (FDA approval ≥50 years; expanded indications for certain immunocompromised adults aged ≥18 years by July 2021)

Clinical evidence in immunocompromised populationsDemonstrated efficacy and immunogenicity in immunocompromised groups including auto-HSCT recipients (≈68% efficacy) and patients with hematologic malignancies or solid tumors; more reactogenic than placebo but acceptable safety profile

Low-to-moderate dose corticosteroid — definition

Threshold definitionLow-to-moderate dose corticosteroid: less than 20 mg/day of prednisone (or equivalent) or short-term therapy (<14 days)

Implication for live vaccinePatients receiving short-term (<14 days) or low-to-moderate dose (<20 mg/day) corticosteroids are not considered sufficiently immunosuppressed to preclude live zoster vaccination per ACIP guidance cited

LimitationThis ACIP opinion does not extend to other live vaccines and does not apply to patients on anti-TNF therapy

Low-dose immunomodulators — definitions and live vaccine relevance

Defined thresholdsLow-dose immunomodulators considered compatible with live zoster vaccine per ACIP: methotrexate ≤ 0.4 mg/kg/week; azathioprine ≤ 3.0 mg/kg/day; 6-mercaptopurine ≤ 1.5 mg/kg/day

Clinical implicationPatients on these low-dose regimens may not be considered sufficiently immunosuppressed to preclude receiving the live zoster vaccine (ACIP-cited guidance)

Scope noteThis guidance does not extend to other live vaccines or to patients on anti-TNF therapy