CurrentHumanaPolicy N/A

Medicare Part B step strategy for frontline metastatic non-small cell lung cancer (NSCLC)

Defines Humana's 2025 Medicare Part B step strategy requiring preferred use of Libtayo for new frontline metastatic NSCLC starts; affects Humana Medicare Advantage members, providers initiating therapy, and prior authorization processes.

Policy Summary

PayerHumana

PolicyMedicare Part B step strategy for frontline metastatic NSCLC

Policy CodePolicy N/A

Change TypeNew step therapy requirement

Effective DateJan. 1, 2025

Next Review Date

Key ActionFor new utilizers, providers must document a medical reason why Libtayo (single-agent for PD-L1 ≥50% or Libtayo + platinum-based chemotherapy for any PD-L1) cannot be initiated.

SourceLink

POLICY UPDATE CHANGES

Starting Jan. 1, 2025, Humana's Medicare Part B step strategy will require use of the preferred product Libtayo for frontline metastatic NSCLC new starts.

Existing utilizers with claims within the previous 365 days for nonpreferred PD-(L)1 agents for NSCLC require no action at this time.

Providers must document a medical reason why Libtayo single-agent (PD-L1 ≥50%) or Libtayo plus platinum-based chemotherapy (any PD-L1) cannot be initiated for new utilizers.

2025-01-01policy effective date

365lookback period (days)

1preferred required

6nonpreferred listed

Coverage Criteria

Initial therapy and grandfathering criteria

Covered when the following apply for frontline metastatic NSCLC new starts:

Step therapy initial requirement: New utilizer initiating frontline metastatic NSCLC therapy must start with preferred product Libtayo.

Preferred product selection depends on PD-L1 status: single-agent for PD-L1 >= 50% or Libtayo plus platinum-based chemotherapy for any PD-L1.

Exceptions for use of nonpreferred agents: Provider documents a medical reason why Libtayo (single-agent for PD-L1 >= 50% or Libtayo + platinum-based chemotherapy for any PD-L1) cannot be initiated.

Documentation must be supplied for prior authorization or coverage of nonpreferred products.

Existing utilizer grandfathering: Members with claims for nonpreferred PD-(L)1 products within the prior 365 days are not required to change therapy at this time.

Policy Summary

PayerHumana

PolicyMedicare Part B step strategy for frontline metastatic NSCLC

Policy CodePolicy N/A

Change TypeNew step therapy requirement

Effective DateJan. 1, 2025

Next Review Date

Key ActionFor new utilizers, providers must document a medical reason why Libtayo (single-agent for PD-L1 ≥50% or Libtayo + platinum-based chemotherapy for any PD-L1) cannot be initiated.

SourceLink

On This Page

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Grandfathering applies only to those with recent claims; policy applies only to new starts.

This policy applies only to frontline metastatic non-small cell lung cancer (NSCLC) new starts under Humana Medicare Part B. It does not apply to members who are already receiving therapy with the listed nonpreferred PD-(L)1 agents; existing utilizers with qualifying claims in the prior 365 days are not required to change therapy at this time.

Coding and Clinical Thresholds

inv-03: claims lookback

Claims lookback period365 days

PurposeIdentify existing utilizers eligible for grandfathering (no action required)

Applies toMembers with claims for Keytruda, Opdivo, Tecentriq, Imfinzi, Imjudo, or Yervoy within prior 365 days

inv-04: PD-L1 threshold for single-agent Libtayo

PD-L1 threshold for single-agent Libtayo>= 50%

ContextSingle-agent Libtayo is the preferred regimen for patients with PD-L1 >= 50%

Alternative regimen noteFor any PD-L1 status, Libtayo + platinum-based chemotherapy is preferred if single-agent is not appropriate

Provider Actions and Operational Requirements

Step Therapy

Medicare Part B Step Therapy Requirement for New Starts

Starting Jan. 1, 2025, Humana's Medicare Part B step strategy applies to frontline metastatic non-small cell lung cancer (NSCLC) for new starts only and requires use of the preferred product as specified below.

Effective date: 2025-01-01
Applies only to Medicare Part B members and to new starts (no change required for existing utilizers with claims in the prior 365 days)

Step Therapy

Humana Medicare Part B NSCLC Step Strategy

Humana Medicare Part B NSCLC Step Strategy: For new utilizers beginning Jan. 1, 2025, the preferred immunotherapy is Libtayo. Use Libtayo as a single agent for patients with PD-L1 ≥ 50% or Libtayo in combination with platinum-based chemotherapy for patients of any PD-L1 status, unless a documented medical reason prevents initiation.

Preferred product: Libtayo (single-agent for PD-L1 ≥ 50% or Libtayo + platinum-based chemotherapy for any PD-L1 status)
Nonpreferred products: Keytruda, Opdivo, Tecentriq, Imfinzi, Imjudo, Yervoy

Documentation Required

Required Clinical Justification for Nonpreferred Agents

When requesting a nonpreferred agent for a new utilizer, providers must document the clinical rationale explaining why the preferred regimen (Libtayo single-agent or Libtayo plus platinum-based chemotherapy as described) cannot be used for the member.

Documentation must describe the medical contraindication, intolerance, or other clinical justification.
Include relevant clinical data (PD-L1 status, prior therapies, comorbidities, adverse reaction history) to support the exception request.

Denial Risk

Denial Risk for Nonpreferred Agents Without Documentation

New-start requests for nonpreferred agents may be denied if a documented medical reason why the preferred regimen cannot be used is not provided.

Existing utilizers with claims within the previous 365 days for nonpreferred agents do not need to take action at this time.
For questions or to submit clinical rationale, contact Evolent: 844-926-4528 (option 3); OncoHealth: 888-916-2616; or Humana Clinical Pharmacy Review Medical Team: 866-461-7273.

Background

Humana's Pharmacy and Therapeutics committee reviewed relevant clinical guidelines and literature and implemented a Medicare Part B step strategy effective Jan. 1, 2025 to promote clinically appropriate and cost-effective care for Humana Medicare Advantage members with frontline metastatic NSCLC. Under the strategy, the committee designated Libtayo as the preferred product for new starts and specified that Libtayo be used as a single agent for patients with PD-L1 ≥ 50% or in combination with platinum-based chemotherapy for any PD-L1 status.

To operationalize the step strategy, the committee required that new patients begin treatment with the preferred regimen and that providers document a medical justification when a nonpreferred PD-(L)1 agent is requested instead. Requests for nonpreferred agents for new starts may be denied unless a documented medical reason is provided explaining why Libtayo (single-agent for PD-L1 ≥50% or Libtayo plus platinum-based chemotherapy for any PD-L1) cannot be initiated.

Definitions

inv-10: New utilizer

DefinitionNew utilizer = member initiating frontline metastatic NSCLC therapy who is a new start under the Medicare Part B step strategy

Operational triggerPolicy applies only to new starts beginning Jan. 1, 2025

Provider requirementFor new utilizers, providers must document why preferred Libtayo regimens cannot be initiated to use nonpreferred agents

inv-11: Existing utilizer

DefinitionExisting utilizer = member with claims for Keytruda, Opdivo, Tecentriq, Imfinzi, Imjudo, or Yervoy for NSCLC within the prior 365 days

ImplicationNo additional action required from providers at this time for these members

Applies toMembers currently in a Humana Medicare Advantage plan

Initial Therapy Criteria

Required initial regimens

Initial therapy requirement for new utilizers

Preferred initial regimen: Libtayo single-agent for patients with PD-L1 >= 50% OR Libtayo in combination with platinum-based chemotherapy for any PD-L1 status.PD-L1 >= 50% for single-agent

New starts must use preferred product unless documented medical reason prevents its use.

Continuation / Grandfathering Criteria

Grandfathering/Continuation

Existing utilizers

Continuation for existing utilizers: If there are claims within the previous 365 days for Keytruda, Opdivo, Tecentriq, Imfinzi, Imjudo, or Yervoy for NSCLC, no additional action is needed at this time.365 days

Applies to members currently in a Humana Medicare Advantage plan.

Step Therapy Details

Step	Requirement	Notes
1
New starts must initiate frontline metastatic NSCLC therapy with the preferred product Libtayo.
Applies only to new starts; effective Jan. 1, 2025. Preferred product is Libtayo; nonpreferred agents are Keytruda, Opdivo, Tecentriq, Imfinzi, Imjudo and Yervoy.