CurrentAetnaPolicy 0726

Human papillomavirus (HPV) vaccine (Gardasil 9)

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Defines Aetna's coverage stance on the 9‑valent HPV vaccine (Gardasil 9), including medical necessity, investigational indications, coding guidance, limitations, and background; applies to Aetna members and providers submitting claims.

Policy Summary

PayerAetna

PolicyHuman papillomavirus (HPV) vaccine (Gardasil 9)

Policy CodePolicy 0726

Change TypeNo material change

Effective DateJun 30, 2006

Last ReviewOct 4, 2023

Next Review DateAug 8, 2024

Key ActionDocument vaccine product and dosing and verify member benefits and prior authorization requirements before vaccinating adults >26 years.

SourceLink

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CurrentAetnaPolicy 0726

Human papillomavirus (HPV) vaccine (Gardasil 9)

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Sign up for Aetna Policy 0726 alerts

Get alerted when Policy 0726 changes without checking for updates manually.

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Policy Summary

PayerAetna

PolicyHuman papillomavirus (HPV) vaccine (Gardasil 9)

Policy CodePolicy 0726

Change TypeNo material change

Effective DateJun 30, 2006

Last ReviewOct 4, 2023

Next Review DateAug 8, 2024

Key ActionDocument vaccine product and dosing and verify member benefits and prior authorization requirements before vaccinating adults >26 years.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9-45Age range covered

9-valentVaccine formulation

90651Primary CPT code

90649,90650Not covered CPTs

3-doseStandard series

Coverage Criteria for Gardasil 9 (9vHPV)

Medical Necessity (Gardasil 9)

Covered when ALL of the following are met

Primary coverage criteria: Administration of Gardasil 9 (9‑valent HPV vaccine) to persons aged 9 to 45 years is considered medically necessary.age 9-45 years

If prior vaccine product is unknown or transitioning to Gardasil 9, Gardasil 9 may be used to continue or complete a 3‑dose series.

Indications by age and dosing

Coverage and recommended use described by age and indication

Routine adolescent vaccination: Routine vaccination is recommended for females and males at ages 11–12; series may be initiated as early as age 9.age 11-12 primary, start as early as 9

ACIP routine recommendation for 11–12 year olds

Catch-up and special group recommendations: Catch-up vaccination for unvaccinated females through age 26; males through age 21 (and through 26 for men who have sex with men and immunocompromised persons).females <=26, males <=21 (<=26 for MSM/immunocompromised)

ACIP catch-up guidance

Dosing by age at series initiation: For persons starting at ages 9–14, a 2-dose schedule given 6–12 months apart is recommended; persons aged 15–26 require a 3-dose series (0,2,6 months).2-dose if start 9-14; 3-dose if start 15-26

ACIP dosing guidance

Shared decision-making for 27–45 years: Persons aged 27–45 may receive Gardasil 9 based on shared clinical decision-making; public health benefit is minimal but some individuals may benefit if not adequately vaccinated.age 27-45 shared decision-making

FDA expanded age; ACIP recommends shared decision-making

Prevention of recurrence of ano-genital warts

Evidence summary regarding secondary prevention of ano-genital warts (AGWs):

AGW secondary prevention meta-analysis: A systematic search identified 824 potentially relevant studies; 2 RCTs (656 subjects) met eligibility and the pooled effect estimate for recurrence of AGWs showed no difference between vaccine and control (overall effect 1.02; 0.75–1.38).

Authors concluded vaccination did not provide secondary benefit for recurrence of AGWs but evidence is limited and not generalizable

Vaccine effectiveness by number of doses

Effectiveness by number of doses (post-licensure observational studies):

Dose-response effectiveness summary: Most post-licensure studies report highest effectiveness with 3 doses; many report effectiveness with 2 doses and some with 1 dose, but biases may inflate effectiveness estimates for fewer doses.

Future studies should vaccinate prior to sexual initiation and reduce bias

HPV vaccine in head and neck cancer

Therapeutic vaccine research for HPV+ head and neck cancer and regulatory status:

Therapeutic vaccine trials for HPV+ HNC: Systematic review identified 11 studies (n=376); preliminary immunogenicity responses occurred in some incurable cases and reported toxicity was predominantly grade 1–2; clinical outcome data are limited and heterogeneous.

Therapeutic vaccines are promising but insufficient data for conclusions

Regulatory action: On June 12, 2020 the FDA expanded Gardasil 9 indication to include prevention of oropharyngeal and other head and neck cancers caused by specified HPV types under accelerated approval; continued approval is contingent on confirmatory trials.

Accelerated approval per FDA

Post-treatment vaccination and CIN recurrence

Post-treatment HPV vaccination for women undergoing excisional treatment for CIN:

Meta-analysis results: Nine studies (19,971 women) included; using fixed-effect model on 2 RCTs the OR for recurrence of CIN2+ was 0.29 (95% CI: 0.16–0.53); observational studies showed reduced recurrence in unadjusted analyses but effect attenuated and was not significant when adjusted.

Serious risk of bias and heterogeneity limit confidence; large RCTs needed

Adjuvant use in JoRRP

HPV vaccine as adjuvant therapy for juvenile-onset RRP:

JoRRP evidence: Systematic review identified 12 studies (3 experimental, 3 case series, 6 case reports); 8 of 12 reported potential benefit (fewer surgeries, longer inter-surgical intervals), but overall evidence remains uncertain.

Prospective multi-center studies with larger sample sizes needed

Guideline updates (ACS, ACOG)

Guideline positions on vaccination timing and age limits:

ACS recommendations: The American Cancer Society recommends routine HPV vaccination between ages 9 and 12, encourages starting at age 9, and recommends catch-up through age 26; ACS does not recommend catch-up for adults older than 26 and does not endorse routine shared decision-making for 27–45 due to low effectiveness in this age group.

Providers should inform individuals aged 22–26 that vaccination at older ages is less effective

ACOG recommendations: ACOG strongly recommends HPV vaccination to eligible patients, emphasizes greatest effectiveness before sexual activity, recommends vaccinating unvaccinated persons through age 26, and supports shared decision-making for some individuals aged 27–45 based on individual risk.

Encourages stocking/administering vaccine in offices when feasible

Aetna considers administration of Gardasil 9 (9‑valent HPV vaccine) not medically necessary when the member has already completed a documented three‑dose series with Gardasil (quadrivalent) or Cervarix (bivalent). An exception applies when the prior vaccine product is unknown or unavailable — in those situations, use of Gardasil 9 to continue or complete the three‑dose series is considered medically necessary.

Not all benefit plans provide coverage for preventive services. Providers should verify member benefit plan descriptions and prior authorization requirements before administering Gardasil 9, since coverage for preventive vaccination is plan‑dependent and may vary by contract.

Gardasil 9 will not prevent disease caused by HPV types not contained in the vaccine and is not therapeutic for established HPV infections or lesions. Vaccination does not accelerate clearance of pre‑existing HPV infection and should not be used to treat active genital warts or established cervical, vulvar, or vaginal disease.

The American Cancer Society recommends routine HPV vaccination beginning between ages 9 and 12 years and supports catch‑up vaccination through age 26 years for persons not adequately vaccinated. The ACS does not endorse routine catch‑up vaccination for adults older than 26 years and advises that vaccination after young adulthood is less effective in lowering cancer risk.

This Clinical Policy Bulletin provides a general, partial description of plan or program benefits and is intended to assist in administering benefits. It does not constitute a contract; coverage and any prior authorization requirements are subject to the member's specific plan terms.

Gardasil 9 is considered not medically necessary for indications listed in this policy as experimental or investigational, including uses for which effectiveness has not been established (see policy list). Services inconsistent with plan benefits or policy criteria may be denied under the member's plan terms.

Use of HPV vaccine as a therapeutic intervention for persons already infected — for example, to accelerate viral clearance or to treat active genital warts — is not supported by available evidence and is considered not medically necessary. Randomized trial data do not show increased viral clearance in persons vaccinated while infected.

Available randomized controlled trial evidence on vaccination to prevent recurrence of ano‑genital warts is limited. A systematic search identified 824 potentially relevant studies but only 2 RCTs (656 subjects) met eligibility; the pooled estimate showed no secondary preventive benefit (overall effect 1.02; 95% CI 0.75–1.38). These findings do not support HPV vaccination as effective for preventing AGW recurrence after treatment.

Coding Guidance

Covered CPT Codes (if selection criteria met)CPTCovered

90651

Human Papillomavirus vaccine types 6, 11, 16, 18, 31, 33, 45, 52, 58, nonavalent (9vHPV), 3 dose schedule, for intramuscular use.

CPT Codes not covered for indications listed in CPBCPTNot Covered

90649	Human Papillomavirus vaccine, types 6, 11, 16, 18, quadrivalent (4vHPV), 3 dose schedule, for intramuscular use.
90650	Human papillomavirus vaccine, types 16, 18, bivalent (2vHPV), 3 dose schedule, for intramuscular use.

Related CPT Codes (administration)CPT

90471	Immunization administration; one vaccine (single or combination vaccine/toxoid).
90472	Each additional vaccine (single or combination vaccine/toxoid).

Related HCPCS Codes (dental/vaccine administration)HCPCS

D1781	Vaccine administration – human papillomavirus – Dose 1.
D1782	Vaccine administration – human papillomavirus – Dose 2.
D1783	Vaccine administration – human papillomavirus – Dose 3.

ICD-10 Codes not covered for indications listed in CPBICD-10Not Covered

A63.0	Anogenital (venereal) warts.
C44.520	Squamous cell carcinoma of anal skin.
C51.0 - C53.9	Malignant neoplasm of vulva, vagina and cervix uteri.
D06.0 - D07.2	Carcinoma in situ of cervix uteri, vulva and vagina.
D10.0 - D10.9	Benign neoplasm of mouth and pharynx [benign squamous papilloma].
D14.1	Benign neoplasm of larynx [benign squamous papilloma][Juvenile-onset recurrent respiratory papillomatosis].
K62.82	Dysplasia of anus.
N87.0 - N87.9	Dysplasia of cervix uteri.

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior authorization / coverage headline

Gardasil 9 (CPT 90651) is considered medically necessary for persons age 9 to 45 years when selection criteria are met; verify member benefits and plan coverage prior to vaccine administration.

Covered code: CPT 90651 (9‑valent HPV vaccine, 3‑dose schedule)
Not all plans cover preventive services; check benefit plan descriptions for specifics

Prior Authorization

Shared decision‑making for ages 27–45

For persons aged 27–45, vaccination should be based on shared clinical decision‑making because public health benefit is minimal but some individuals who are not adequately vaccinated may benefit.

ACIP recommends shared clinical decision‑making for persons 27–45 years
FDA expanded age indication for Gardasil 9 supports individualized decision making

Background and Rationale

Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States and can cause several cancers and ano‑genital warts. Gardasil 9 is the only HPV vaccine currently distributed in the U.S. and protects against nine HPV types — seven oncogenic types (16, 18, 31, 33, 45, 52, 58) and two low‑risk types (6, 11). Vaccination is most effective when given before exposure and routine immunization is recommended to begin at age 9, with the routine target ages of 11–12 years.

Key Definitions

Gardasil nine‑valent — Gardasil 9 (9vHPV)

TermGardasil nine‑valent (9vHPV)

ManufacturerMerck

HPV types coveredOncogenic types 16,18,31,33,45,52,58 and low-risk types 6,11

Human papillomavirus vaccine, 9‑valent, 3 dose schedule — CPT 90651

CPT code90651

DescriptionHuman Papillomavirus vaccine, types 6,11,16,18,31,33,45,52,58, nonavalent (9vHPV), 3-dose schedule, for intramuscular use.

Related administration codes90471, 90472

Policy Summary

PayerAetna

PolicyHuman papillomavirus (HPV) vaccine (Gardasil 9)

Policy CodePolicy 0726

Change TypeNo material change

Effective DateJun 30, 2006

Last ReviewOct 4, 2023

Next Review DateAug 8, 2024

Key ActionDocument vaccine product and dosing and verify member benefits and prior authorization requirements before vaccinating adults >26 years.

SourceLink

On This Page

Prior Authorization

Verify coverage and prior authorization for >26 years

Verify member benefits and any prior authorization requirements before administering HPV vaccine to adults older than 26 years, since vaccination after age 26 may not be covered by payers.

Clinicians and patients should be aware vaccination after age 26 may not be covered by insurance providers
Check benefit plan descriptions for coverage details

Prior Authorization

Prior authorization determined by member's plan

This Clinical Policy Bulletin is intended to assist in administering plan benefits; prior authorization requirements are determined by the member's plan and are not specified in this bulletin—confirm plan‑specific rules.

Prior authorization determination rests with the member’s plan
Bulletin does not constitute a contract or complete benefit description

Step Therapy

No step therapy specified

No step therapy requirements for Gardasil 9 are specified in this Clinical Policy Bulletin.

Documented policy sections list no step therapy requirements

Step Therapy

Step therapy not specified in excerpt

Affirmation: the provided policy sections do not specify step therapy requirements for HPV vaccination in this bulletin.

Documentation Required

Document vaccine product and dosing

When administering Gardasil 9, document the vaccine product and dosing—include whether the dose completes or continues a series and the dosing schedule used.

Record vaccine product (Gardasil 9) and CPT code (90651)
Indicate whether dose completes a 3‑dose series or continues a series

Documentation Required

Document vaccination dates and dosing schedule

Record vaccination dates and the dosing schedule administered: for the 3‑dose series note doses at 0, 2, and 6 months; for the 2‑dose schedule (ages 9–14) document the 6–12 month interval and patient age at initiation.

3‑dose schedule: 0, 2, and 6 months
2‑dose schedule (start ages 9–14): 6–12 months apart; document dates for each dose

Documentation Required

Document indication/rationale for patients >26 years

When vaccinating patients aged 27–45, document the clinical rationale (for example: low likelihood of prior HPV exposure, planned future risk, or occupational exposure) because coverage and benefits may vary in this age group.

Record indication/rationale for vaccination in 27–45 age group
Verify and note benefit coverage if insurance may not cover vaccination after age 26

Documentation Required

Provider responsibility for medical advice and benefits verification

Treating providers are responsible for medical advice and treatment of members; this bulletin is a partial description of plan benefits and does not replace clinical judgment or plan‑specific rules.

Providers are independent contractors and responsible for medical care
Bulletin is not a contract and may be updated

Denial Risk

Non‑covered CPT codes (90649, 90650) — denial risk

Claims billed with CPT codes 90649 (quadrivalent) or 90650 (bivalent) are not covered for the indications listed in this Clinical Policy Bulletin and may be denied if used for those indications.

Do not bill 90649 or 90650 for indications covered by this CPB
Use CPT 90651 for Gardasil 9 when selection criteria are met

Denial Risk

Contraindications — anaphylaxis and pregnancy

Do not administer HPV vaccine to individuals with a history of anaphylactic reaction to any component (including excipients) of the vaccine or to persons who are pregnant; these are contraindications that may trigger denial or adverse events.

History of anaphylaxis to any vaccine component is a contraindication
Pregnancy is a contraindication to vaccination

Denial Risk

Coverage risk for adults >26 years

Inform clinicians and patients that insurers may not cover HPV vaccination after age 26; this coverage risk should be considered when deciding to vaccinate adults older than 26.

Vaccination after age 26 may not be covered by insurance providers or payers
Verify benefits and prior authorization before administration

Denial Risk

Denial risk for services not consistent with plan or policy

Services that are inconsistent with plan benefits or with the criteria in this policy may be denied; the Clinical Policy Bulletin is intended to assist administering plan benefits but does not guarantee coverage.

Services not meeting policy criteria may be denied per plan terms
Bulletin provides only a partial, general description of benefits

Per-protocol population — Study population naive to vaccine HPV types through one month after the third dose

DefinitionStudy population naive to vaccine HPV types through one month after the third dose used for primary efficacy analyses.

ContextDefined in randomized clinical studies used to determine efficacy of Gardasil 9 in females ages 16–26 and immunobridging in younger adolescents.

PurposeEnsures efficacy assessment in participants unexposed to vaccine HPV types at baseline and shortly after series completion.

Catch-up vaccination — Definition for catch-up in persons beyond routine age

DefinitionVaccination recommended for persons beyond the routine age who have not been previously vaccinated or completed the series.

Age groups specifiedCatch-up: females through age 26; males through age 21 (through 26 for men who have sex with men and immunocompromised persons).

Dosing implicationsPersons initiating at ages 9–14 may follow a 2-dose schedule; older initiators require a 3-dose series to complete catch-up.

Ano-genital warts (AGWs) — Definition and note on uncertain secondary preventive benefit

DefinitionWarts in the anogenital area caused by HPV (condyloma acuminata).

Secondary prevention evidenceRandomized trial meta-analysis found no reduction in recurrence of AGWs with vaccination (pooled effect 1.02; 0.75–1.38); evidence limited.

Clinical noteVaccination is not established as a therapeutic intervention to prevent recurrence after treatment based on current RCT data.

CIN2+ — Definition used as outcome in post-treatment vaccination analyses

DefinitionCervical intraepithelial neoplasia grade 2 or worse (CIN2+), a high-grade precancerous lesion of the cervix.

Use as outcomeOutcome measure in post-treatment vaccination studies assessing recurrence after excisional treatment.

Meta-analysis resultIn 2 RCTs the pooled OR for CIN2+ recurrence after post-treatment vaccination was 0.29 (95% CI: 0.16–0.53), though study quality concerns remain.

Juvenile-onset recurrent respiratory papillomatosis (JoRRP) — Definition and investigational adjuvant use

DefinitionJuvenile-onset recurrent respiratory papillomatosis (JoRRP): rare HPV-induced disease in children with recurrent papillomas of the respiratory tract.

Investigational useHPV vaccine has been investigated as an adjuvant therapy; systematic review identified 12 studies with mixed/uncertain evidence of benefit.

Evidence gapExisting studies include case series and reports; larger prospective multicenter studies are needed to determine efficacy.