CurrentCapital BluecrossPolicy MP 2.373

STEP THERAPY TREATMENT OF STAGE FOUR, ADVANCED METASTATIC CANCER AND SEVERE RELATED HEALTH CONDITIONS

Defines Capital BlueCross coverage policy that patients with stage four/advanced metastatic cancer (and certain severe related hematologic conditions) are exempt from step therapy requiring prior failure of other drugs; coverage follows FDA indications and NCCN/AHFS/DrugDex evidence criteria. Applies to applicable Capital BlueCross products with benefit variations.

Policy Summary

PayerCapital Bluecross

PolicySTEP THERAPY TREATMENT OF STAGE FOUR, ADVANCED METASTATIC CANCER AND SEVERE RELATED HEALTH CONDITIONS

Policy CodePolicy MP 2.373

Change TypeNo material change

Effective DateJan 1, 2026

Next Review Date

Key ActionDo not require patients with stage four advanced metastatic cancer to fail other drugs before coverage when FDA/NCCN criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Stage 4disease stage covered by waiver

NCCN 1/2Aevidence levels accepted

FDA approvalregulatory requirement

Variesproduct applicability

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Coverage Criteria — Step Therapy Waiver

Coverage for drugs in stage four/advanced metastatic cancer

Covered when ALL of the following are met

Primary coverage criteria: 1) Use is consistent with best clinical practices for the treatment of stage four, advanced metastatic cancer or a severe adverse health condition resulting from stage four, advanced metastatic cancer and is supported by peer-reviewed medical literature, evidenced by a level of evidence of 1 or 2A from NCCN Clinical Practice Guidelines in Oncology OR the American Hospital Formulary System (AHFS) OR DrugDex; AND 2) The drug is approved by the FDA for the indication for which it is being used. In the event of a discrepancy between FDA indications and NCCN guidelines, the NCCN guideline will be followed.NCCN 1 or 2A; FDA approval

Applies to stage four/advanced metastatic cancer and specified hematologic advanced stages.

This policy does not enumerate specific excluded procedure or billing codes. Identification of a code in the coding section does not by itself determine coverage; coverage is determined by the terms of the member's benefit information and eligibility for the applicable product or program.

Therapies that are not FDA-approved for the specific indication and that are not supported by peer-reviewed compendia (NCCN Category 1 or 2A, AHFS, or DrugDex) do not meet the coverage criteria in this policy and therefore would not be covered under the criteria described.

Coding and Evidence Thresholds

Coding applicabilitymixed

Specific codes do not apply

The policy states that specific codes do not apply to this policy and that the list may not be all-inclusive.

NCCN evidence threshold

Accepted NCCN evidence levelsLevel of evidence 1 or 2A (NCCN Categories 1 and 2A accepted)

Alternate compendia acceptedAHFS or DrugDex may be used when supporting peer-reviewed literature is required

FDA vs NCCN precedenceIn event of discrepancy between FDA indications and NCCN guidelines, follow NCCN guidelines describing best clinical practice

Provider Actions, Documentation & Prior Auth

Prior Authorization

Prior authorization depends on product

This policy applies only to certain Capital BlueCross programs and products and is subject to benefit variations; prior authorization requirements depend on the member's benefit program and product. The policy explicitly states that specific codes do not apply to this policy.

Policy applicability varies by product/program administered by Capital BlueCross.
Specific codes do not apply to this policy; refer to member benefit for prior auth requirements.

Step Therapy

Step therapy waiver for stage four disease

Per Pennsylvania Act 6 of 2020, Capital BlueCross does not require patients with stage four, advanced metastatic cancer to first fail other drugs before coverage of a covered drug is provided; when sequential use is indicated, follow FDA and/or NCCN determinations.

Step therapy waiver applies to patients with stage four, advanced metastatic cancer.

Line of Therapy Applicability

first-line

Line of therapy note: Policy exempts patients from step therapy requirement regardless of prior-line failures; when sequential use is indicated, follow FDA and/or NCCN determinations.

Per Pennsylvania Act 6 of 2020, step therapy does not apply for stage four disease.

Definitions

CHEMOTHERAPY

Definition of ChemotherapyDrug therapy used to treat infections, cancers, and other diseases and conditions.

ScopeEncompasses systemic therapies intended to treat malignant and certain non-malignant conditions as described in policy.

ContextUsed within policy to define treatments considered under coverage rules for advanced disease stages.

STAGE FOUR, ADVANCED METASTATIC CANCER

Core definitionCancer that has spread from the primary or original site of the cancer to nearby tissues, lymph nodes or other areas or parts of the body.

Policy examples includedAdvanced lymphoma (stage 4); advanced myeloma (stage 3); chronic leukemias in blastic phase or Rai stage 3-4; acute leukemias with active disease/relapse or when treatment is not desired.

Background

Stage four, or advanced metastatic, cancer describes disease that has spread beyond the primary tumor site to other tissues, lymph nodes, or distant organs and generally carries a poor prognosis. The policy specifically treats advanced hematologic stages (for example, advanced lymphoma stage 4; advanced myeloma stage 3; chronic leukemias in blastic phase or Rai stage 3–4; and acute leukemias with active disease or relapse or when treatment is not desired) as part of the stage four/advanced metastatic population eligible for the step-therapy waiver and the coverage considerations described herein.