CurrentEmblemHealthPolicy N/A

Cyramza (ramucirumab) clinical coverage

Defines accepted indications, exclusions, and prior authorization requirements for Cyramza (ramucirumab) for EmblemHealth members managed by Evolent; applies to network ordering providers submitting medication requests. Affects commercial, exchange/marketplace, and Medicaid lines of business.

Policy Summary

PayerEmblemHealth

PolicyCyramza (ramucirumab) clinical coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required for Cyramza medication requests processed by Evolent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9308HCPCS code for ramucirumab 5 mg

May be usedSecond-line gastric/GEJ/esophageal

Not supportedColorectal carcinoma

Not supportedHepatocellular carcinoma

Not supportedNSCLC combinations

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Gastric/Gastroesophageal Junction/Esophageal adenocarcinoma — second line

Covered when ALL of the following are met

Second-line gastric/GEJ/esophageal adenocarcinoma: Patient has advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma and Cyramza (ramucirumab) is being used as second-line therapy either as monotherapy or in combination with paclitaxel (Taxol).second-line

Based on policy statement permitting use in this indication

Colorectal carcinoma

Colorectal carcinoma: Cyramza (ramucirumab) with or without chemotherapy is not supported by Evolent Policy for the treatment of colorectal carcinoma due to a large meta-analysis showing increased serious (including fatal) treatment-related toxicities with negligible benefits compared to recommended alternatives (e.g., Evolent Pathways).not_applicable

Explicit non-coverage statement

Hepatocellular carcinoma

Hepatocellular carcinoma: Cyramza (ramucirumab) is not supported by Evolent Policy for the treatment of hepatocellular carcinoma based on a network meta-analysis demonstrating lack of clinically meaningful overall survival improvement (HR > 0.82) versus regorafenib (Stivarga) or cabozantinib (Cabometyx) in the second-line setting.not_applicable

Explicit non-coverage statement

Non-Small Cell Lung Cancer (NSCLC)

NSCLC: Cyramza (ramucirumab) combined with docetaxel (Taxotere) or erlotinib (Tarceva) is not supported by Evolent Policy for the treatment of metastatic non-small cell lung cancer based on a large meta-analysis showing increased serious (including fatal) treatment-related toxicities with negligible benefits compared to recommended alternatives.not_applicable

Explicit non-coverage statement for specified combinations

Coverage exclusions for Cyramza (ramucirumab) include the following circumstances: disease progression while taking Cyramza; dosing that exceeds a single dose of 10 mg/kg; and use that is investigational or for an off‑label indication without sufficient supportive evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy details criteria for adequate evidence, including whether the patient and regimen are represented in the published data, whether outcomes are clinically meaningful (for example, ASCO thresholds such as HR < 0.80 and at least a 3‑month OS/PFS benefit), and the types of study designs that may or may not provide adequate support (e.g., randomized trials versus case reports or abstracts).

Evolent does not support the use of Cyramza (ramucirumab) for certain indications based on available evidence. Specifically, Cyramza is not supported for colorectal carcinoma and is not supported for hepatocellular carcinoma due to meta‑analyses and network meta‑analyses showing limited or non‑clinically meaningful overall survival benefit compared with recommended alternatives. In addition, Cyramza combined with docetaxel (Taxotere) or erlotinib (Tarceva) is not supported for metastatic NSCLC because pooled trial evidence demonstrated increased serious (including fatal) treatment‑related toxicities with negligible benefit versus Evolent recommended alternatives. Providers should refer to Evolent Pathways for recommended alternative agents and regimens.

Regimens and Combinations

Regimen	Indication	Coverage
Ramucirumab monotherapy	Second-line treatment of advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma	Covered when used as second-line therapy per policy
Ramucirumab in combination with paclitaxel (Taxol)	Second-line treatment of advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma	Covered when used as second-line therapy per policy

Regimen	Indication	Coverage
Ramucirumab + docetaxel (Taxotere)	Metastatic non-small cell lung cancer (NSCLC)	Not supported by policy due to meta-analysis showing increased serious treatment-related toxicities with negligible benefit compared to recommended alternatives
Ramucirumab + erlotinib (Tarceva)	Metastatic non-small cell lung cancer (NSCLC)	Not supported by policy due to meta-analysis showing increased serious treatment-related toxicities with negligible benefit compared to recommended alternatives

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for medication requests for Cyramza (ramucirumab) processed by Evolent. This requirement applies to Commercial, Exchange/Marketplace, and Medicaid lines of business.

HCPCS J9308 should be submitted on prior authorization requests for ramucirumab (invoicing/billing per coding guidance).

Step Therapy

Preferred alternatives / pathway guidance

Evolent does not support use of Cyramza for colorectal carcinoma or hepatocellular carcinoma and recommends using alternative agents/regimens available through Evolent Pathways or other Evolent-recommended options.

Colorectal carcinoma: Cyramza +/- chemotherapy is not supported due to meta-analysis showing increased serious toxicities with negligible benefit.
Hepatocellular carcinoma: Cyramza is not supported based on network meta-analysis showing lack of clinically meaningful OS improvement versus regorafenib or cabozantinib.

Documentation Required

Evidence and documentation requirements

Provide supporting evidence for the requested use consistent with Evolent requirements: FDA-approved labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

Documentation must demonstrate that the indication, regimen, and patient population are adequately represented in the cited evidence and that reported outcomes are clinically meaningful per ASCO definitions where applicable.

Denial Risk

Exclusion-based denial triggers

Requests may be denied if any exclusion criteria are met: disease progression while taking Cyramza; dosing that exceeds the single-dose limit of 10 mg/kg; or investigational/off-label indications lacking sufficient evidence as defined by CMS compendia or acceptable peer-reviewed literature.

Insufficient evidence includes lack of adequate representation of the patient/cancer characteristics, regimen, or clinically meaningful outcomes in the published literature; reliance on case reports or meeting abstracts without full peer-reviewed articles may be inadequate.

Line of Therapy Definitions

second-line (context for gastric/GEJ/esophageal adenocarcinoma)

Context for second-line use in gastric/GEJ/esophageal adenocarcinoma

Definition of second-line use: Second-line therapy denotes treatment administered for advanced or metastatic disease after progression on or intolerance to first-line systemic therapy; Cyramza may be used as monotherapy or with paclitaxel in this setting for gastric, GEJ, or esophageal adenocarcinoma.second-line

Aligns with policy statement permitting ramucirumab as second-line monotherapy or with paclitaxel

second-line (context for NSCLC)

Context for second-line use in NSCLC

Second-line NSCLC context: Evolent does not support use of ramucirumab in combination with docetaxel or erlotinib for metastatic NSCLC due to evidence of increased serious toxicities with negligible benefit; such combinations are considered not supported rather than medically necessary in the second-line metastatic NSCLC setting.not_applicable

Explicit non-coverage context for specified NSCLC combinations

Definitions and Clinical Thresholds

Clinically meaningful outcomes (ASCO definition and thresholds)

ASCO-referenced hazard ratio thresholdHazard Ratio (HR) < 0.80 is used to define a clinically meaningful effect size.

Recommended survival benefit thresholdRecommended survival benefit for overall survival (OS) and progression-free survival (PFS) of at least 3 months to be considered clinically meaningful.

Context for applicabilityClinically meaningful outcome definitions apply when assessing whether published evidence adequately represents patient clinical characteristics, regimens, and outcomes.

Evidence standards impactStudies lacking randomization, with small uncontrolled case reports, or abstracts without full peer-reviewed articles are generally insufficient to establish clinically meaningful outcomes.

Use in investigational determinationsLack of clinically meaningful outcomes per these thresholds contributes to classifying an off-label use as investigational or not generally accepted absent CMS compendia or acceptable peer-reviewed literature.

OpenPayer

Cyramza (ramucirumab) clinical coverage

Coverage Criteria for Cyramza (ramucirumab)

Regimens and Combinations

Billing and Coding

Provider Actions and Authorization Requirements

Line of Therapy Definitions

Background and Mechanism

Definitions and Clinical Thresholds