CurrentHighmark West VirginiaPolicy N/A

Preferred Oncology Products (biosimilars and supportive care agents) — Coverage Criteria

Defines Highmark West Virginia preferred and non-preferred oncology products (including biosimilars and supportive care agents) and describes prior authorization and therapeutic trial expectations for non-preferred requests; applies to professional and facility claims.

Policy Summary

PayerHighmark West Virginia

PolicyPreferred Oncology Products (biosimilars and supportive care agents) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFor non-preferred oncology products submit prior authorization with documentation of an adequate therapeutic trial (typically six months) and evidence of failure or intolerance to preferred products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsAdequate trial definition

180 daysNew therapy window

multipleProduct listings

all marketsGeographic scope

Coverage Criteria for Non-Preferred Oncology Products

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Approval criteria for non-preferred products

Non-preferred products may be approved when ALL of the following are met:

Non-preferred approval conditions: The individual has had an adequate therapeutic trial of preferred product(s).typically six months from first dose at FDA or compendia-based therapeutic doses

Adequate therapeutic trial is typically defined as six months from first dose at FDA or compendia-based therapeutic doses of preferred product; new therapy = no previous utilization within the last 180 calendar days.

Non-preferred approval conditions: There is documented drug therapy failure or intolerance to the preferred product(s).

Documentation of drug therapy failure or intolerance to preferred products is required for approval.

Non-preferred approval conditions: Any required prior authorization criteria for the specific drug are satisfied.

Certain drugs may require prior authorization to ensure safe and effective use; prior authorization requirements must be met.

This policy does not enumerate clinical exclusions beyond the plan's product preference. It establishes preferred and non-preferred oncology products to guide coverage decisions and prior authorization, and notes that preferred product lists may change with market events such as new approvals or withdrawals.

The document does not list discrete "not medically necessary" scenarios. Instead, requests for non-preferred products require documentation that the member had an adequate therapeutic trial of preferred product(s) and experienced documented drug therapy failure or intolerance before approval will be considered. An adequate therapeutic trial is typically defined as six months at FDA- or compendia-based therapeutic doses, and new therapy is defined as no utilization in the prior 180 calendar days.

Relevant Product and Billing Codes

Bevacizumab / related product codesmixed

J9035	bevacizumab (listed as non-preferred in places)
Q5107	HCPCS/Q-code referenced in bevacizumab group
Q5118	HCPCS/Q-code referenced in bevacizumab group
Q5126	HCPCS/Q-code referenced as non-preferred
Q5129	HCPCS/Q-code referenced as non-preferred

Rituximab / related product codesmixed

J9312	rituximab (listed as non-preferred in places)
Q5115	HCPCS/Q-code referenced with rituximab products
Q5119	HCPCS/Q-code referenced with rituximab products
J9311	rituximab (alternate code listed)

Trastuzumab / related product codesmixed

J9355	trastuzumab (listed as non-preferred in places)
J9356	trastuzumab (alternate code listed)
Q5116	HCPCS/Q-code referenced with trastuzumab products
Q5117	HCPCS/Q-code referenced with trastuzumab products

Colony stimulating factors (pegfilgrastim, filgrastim) codesmixed

J2506	pegfilgrastim (listed in supportive care colony stimulating factors section)
Q5108	HCPCS/Q-code referenced with pegfilgrastim products
Q5111	HCPCS/Q-code referenced as non-preferred
Q5101	HCPCS/Q-code referenced with filgrastim products
J1442	filgrastim (Neupogen) listed as non-preferred
J1449	HCPCS code referenced

Denosumab / related product codesmixed

J0897	denosumab (Xgeva/Prolia) listed in supportive care section
Q5136	HCPCS/Q-code referenced as non-preferred denosumab biosimilars
Q5158	HCPCS/Q-code referenced
Q5162	HCPCS/Q-code referenced

Prior Authorization, Step Therapy, and Documentation Requirements

Documentation Required

Therapeutic Trial Documentation

Certain oncology and oncology-related drugs require prior authorization. For requests for non-preferred products to be approved, the member must have had an adequate therapeutic trial of preferred product(s) with documented drug therapy failure or intolerance.

Adequate therapeutic trial is typically defined as six months (180 days) from first dose of therapy at FDA- or compendia-based therapeutic doses of the preferred product.
New therapy is defined as no previous utilization within the last 180 calendar days.
Requests for non-preferred products require documentation of intolerance or treatment failure to preferred product(s).

Step Therapy

Step Therapy for Non-Preferred Products

Step therapy is enforced for non-preferred products. Approval of non-preferred agents generally requires documented trial and failure or intolerance of the applicable preferred product(s) before coverage will be granted.

Provider must document the preferred product(s) tried, dates of therapy, dose, and reason for discontinuation (e.g., lack of efficacy or adverse effect).
If the member cannot tolerate the preferred product for a clinically valid reason, provide supporting clinical documentation.
Preferred product lists are subject to change; verify current preferred agents at the time of request.

Prior Authorization

Prior Authorization and Denial Risk

Prior authorization may be required for certain oncology agents to ensure safe and effective use. Failure to provide adequate therapeutic trial documentation or step-therapy information may result in denial of the non-preferred drug request.

Prior authorization is required for certain drugs — confirm requirement at time of submission.
Incomplete documentation of a six-month therapeutic trial or missing evidence of intolerance/failure increases risk of denial.

Policy Background

Highmark defines preferred and non-preferred oncology products across biologic reference agents, biosimilars, and supportive-care therapies. The policy explicitly groups agents such as anti-VEGF, anti-CD20, and anti-HER2 reference and biosimilar products, as well as colony-stimulating factors (pegfilgrastim and filgrastim) and denosumab formulations, into preferred/non-preferred listings to guide formulary selection and prior authorization.

Key Definitions

Adequate therapeutic trial

DefinitionAdequate therapeutic trial is typically defined as six months from first dose of therapy at FDA or compendia-based therapeutic doses of a preferred product.

PurposeEstablishes timeframe for judging treatment exposure before considering non-preferred product approval.

Documentation requiredMedical record must show start date and dosing consistent with FDA or compendia recommendations to confirm the 6-month trial.

New therapy

DefinitionNew therapy = no previous utilization within the last 180 calendar days.

ImplicationTherapies with any use within prior 180 days are not considered 'new' for step-therapy/coverage decisions.

Use in authorizationUsed to determine eligibility for preferred product trial requirements and prior authorization assessments.