Preferred Oncology Products (biosimilars and supportive care agents) — Coverage Criteria
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Non-Preferred Oncology Products
Approval criteria for non-preferred products
Non-preferred products may be approved when ALL of the following are met:
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.
Documentation of drug therapy failure or intolerance to preferred products is required for approval.
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
| 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 |
Prior Authorization, Step Therapy, and Documentation Requirements
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 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 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
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