CurrentBaylor Scott & White Health PlanPolicy 050

Cancer Treatment Vaccines

Defines Baylor Scott & White Health Plan's medical coverage position on cancer treatment vaccines across lines of business, including Medicare and Medicaid considerations, and lists tumor types for which vaccine therapy is considered experimental/investigational and not medically necessary. Notes FDA-approved melanoma therapies are addressed in a separate policy.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyCancer Treatment Vaccines

Policy CodePolicy 050

Change TypeAdministrative review (no material changes)

Effective DateJun 1, 2026

Next Review DateMay 28, 2027

Key ActionProviders must review the member's Evidence of Coverage (EOC) or Summary Plan Description (SPD) for specific benefit coverage details because medical necessity as defined by this policy does not ensure the benefit is covered.

POLICY UPDATE CHANGES

Reviewed 05/28/2026 - No changes

Updated 05/13/2024 - Added guidance on FDA approved melanoma vaccine therapies and other formatting/business entity updates

13Tumor types listed as experimental/not medically necessary

2FDA-approved melanoma therapies referenced (covered elsewhere)

1Associated policy for FDA-approved agents (Policy 219)

Coverage Summary

Scope: This policy defines Baylor Scott & White Health Plan's medical coverage position on cancer treatment vaccines across lines of business (applies to all lines of business including Medicare and Medicaid where plan-specific rules and NCD/LCD or TMPPM/HB1584 mandates may also apply). It lists tumor types for which vaccine therapy is considered experimental/investigational and not medically necessary because clinical evidence is insufficient. The policy notes that FDA-approved melanoma therapies are addressed in a separate policy.

Background summary: Tumor (cancer) vaccines are immunotherapies intended to stimulate the patient's immune system to respond to tumor antigens. The policy applies broadly across plan products and directs providers to review the member's Evidence of Coverage or Summary Plan Description for benefit details; Medicare and Medicaid providers should confirm applicable NCD/LCD or TMPPM/HB1584 guidance. Coverage for FDA-approved melanoma vaccine therapies is handled in a separate policy (see citations).

Key policy facts

Tumor types listed as experimental/not medically necessary13

FDA-approved melanoma therapies referenced (covered elsewhere)2

Associated policy for FDA-approved agents (Policy 219)1

Effective date06/01/2026

Last review date05/28/2026

Next review date05/28/2027

Medical Necessity / Coverage Criteria

General coverage statement

BSWHP considers vaccine therapy experimental/investigational and not medically necessary for the following cancers because clinical evidence is insufficient:

ALL of the following

Breast cancer
CNS cancers (e.g., glioblastoma and neuroblastoma)
Colorectal cancer
Gallbladder cancer
Gastric cancer
Glioma
Head and neck cancer
Hepatic cancer
Lung cancer
Oral squamous cell carcinoma
Ovarian cancer
Pancreatic cancer

Melanoma vaccines

BSWHP considers the following melanoma vaccine therapies experimental, investigational and unproven and not medically necessary:

ALL of the following

Melanoma vaccines (e.g., Theraccine, Oncophage)
Helper multi-peptide (6MHP) vaccine for metastatic melanoma

FDA-approved melanoma therapies

Note regarding coverage guidance for FDA-approved therapies:

ANY of the following

T-VEC (Imlygic) and Amtagvi (Lifileucel) have FDA approval; coverage guidance for these therapies is provided in Medical Coverage Policy 219 - Cancer Chemotherapy / Therapy Guidelines

Not Medically Necessary / Experimental Therapies

Policy stance: Tumor vaccines for the cancers listed in the General coverage statement are considered experimental, investigational, and not medically necessary because clinical evidence is insufficient to permit conclusions on health outcomes. Likewise, the melanoma-specific therapies listed in the Melanoma vaccines section (for example, Theraccine, Oncophage, and helper multi-peptide (6MHP) vaccine for metastatic melanoma) are considered experimental, investigational and not medically necessary for the indicated uses. See the General coverage statement and Melanoma vaccines criteria groups for the specific listed cancers and melanoma vaccine examples; the policy treats these vaccine therapies as not medically necessary rather than listing each possible product here.

Coding

ICD-10 Codes (may apply)ICD-10

C00.0-C14.8	Malignant neoplasm of lip, oral cavity and pharynx
C16.0-C16.9	Malignant neoplasm of stomach
C18.0-C21.8	Malignant neoplasm of colon, rectum, rectosigmoid junction, and anus
C22.0-C22.9	Malignant neoplasm of liver and intrahepatic bile ducts
C23	Malignant neoplasm of gallbladder
C25.0-C25.9	Malignant neoplasm of pancreas
C34.00-C34.92	Malignant neoplasm of bronchus and lung
C43.0-C44.99	Malignant melanoma of skin
C50.011-C50.929	Malignant neoplasm of breast
C51.0-C51.9	Malignant neoplasm of vulva

1–10 of 22

1/3

Provider Actions

Documentation Required

Refer to Evidence of Coverage / Plan documents

Providers must review the member's Evidence of Coverage (EOC) or Summary Plan Description (SPD) for specific benefit coverage details because medical necessity as defined by this policy does not ensure the benefit is covered.

Prior Authorization

Prior authorization not applicable

Policy states prior authorization: Not applicable; no PA requirement imposed by this policy.

Documentation Required

Medicare and Medicaid plan-specific confirmation

For Medicare plans, refer to appropriate Medicare NCDs or LCDs. For Medicaid plans, confirm coverage per the Texas Medicaid Provider Procedures Manual (TMPPM) and Texas Mandate HB1584 where applicable.

Billing Rule

Coverage of FDA-approved melanoma therapies referenced elsewhere

T-VEC (Imlygic) and Lifileucel (Amtagvi) are FDA-approved melanoma therapies; coverage and billing for these agents are managed under Medical Coverage Policy 219 — providers should bill and seek guidance per that policy.

Background

Background — tumor vaccine types: Tumor vaccines are immunotherapies designed to stimulate the patient's immune system to respond to tumor antigens. Investigational vaccine platforms include purified antigen vaccines (single proteins, gangliosides, or peptide fragments), cell lysate vaccines, whole-cell vaccines (autologous or allogeneic), heat-shock protein–peptide complexes, shed antigen vaccines, dendritic cell vaccines (autologous dendritic cells pulsed with peptides, lysates, or nucleic acid), genetically modified tumor vaccines (tumor cells transduced with cytokine/antigen/co-stimulatory genes), and anti-idiotype vaccines (monoclonal antibodies targeting tumor antigen–reactive antibodies).

Emphasis: Current melanoma vaccine development is largely focused on personalized neoantigen vaccines delivered by platforms such as mRNA and on combining these vaccines with checkpoint blockade strategies.

Evidence / regulatory note: T-VEC (Imlygic) and Amtagvi (Lifileucel) have FDA approval; coverage guidance for these FDA-approved melanoma therapies is provided in Medical Coverage Policy 219 (Cancer Chemotherapy / Therapy Guidelines).

Revision History

2024-05-13administrative_update