Preferred Products for Medicare Advantage — Preferred drug products and biosimilars
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Lists preferred and non-preferred pharmaceutical products and biosimilars for Highmark Medicare Advantage plans and describes that preferred-product utilization management (including prior authorization) applies to FDA-labeled indications consistent with CMS guidance.
No material clinical or coverage changes in this revision.
Preferred and Non-Preferred Products
This policy identifies specific branded and generic products designated as non-preferred or preferred for Highmark Medicare Advantage. Examples of non-preferred products listed in the policy include Prolia (denosumab), Xgeva (denosumab), and Evenity (romosozumab-aqqg). Within the Colony Stimulating Factors category, Neulasta / Neulasta Onpro (pegfilgrastim) and other pegfilgrastim products (generic pegfilgrastim) are shown as preferred, while Udenyca (pegfilgrastim‑cbqv) is listed as non-preferred. The policy similarly distinguishes preferred and non-preferred biosimilars and reference biologics across multiple therapeutic categories.
Provider Requirements and Utilization Management
Prior Authorization Expected
Certain drugs, particularly non-preferred products and some biologic agents, may require prior authorization to ensure safe and effective use and to align with Medicare rules (CMS NCDs, applicable LCDs/LCAs). Providers should expect that use of non-preferred products may trigger prior authorization and utilization management consistent with Medicare guidance.
- Affected products: non-preferred drugs and select biologics
- Documentation: clinical rationale and records supporting FDA-labeled indication and medical necessity
- Policy changes: preferred product lists may change with new product launches, approvals, or withdrawals
Step Therapy / Utilization Management
The preferred-product program functions as a utilization management tool. Highmark may implement step therapy or other utilization management strategies to promote use of preferred products before non-preferred alternatives are authorized.
- Step therapy may require trial of one or more preferred agents prior to approval of a non-preferred product
- Utilization management consistent with Medicare policies and CMS guidance
Medical Necessity and Documentation
Coverage determinations apply to FDA-labeled indications and are made based on medical necessity in accordance with CMS guidance. Providers must document clinical indications, prior treatments, and any supporting clinical information to substantiate medical necessity.
- Medical necessity aligned to FDA-labeled indications and CMS rules
- Include prior treatment history, clinical findings, and rationale for non-preferred product when applicable
Prior Authorization and Utilization Management Expectations
Use of non-preferred products may require prior authorization and will be subject to utilization management consistent with Medicare. Providers should verify product status (preferred vs non-preferred) and follow prior authorization workflows when submitting requests.
- Verify current preferred-product list prior to prescribing
- Submit prior authorization with complete documentation if requesting non-preferred product
- Requests may be reviewed under step-therapy or other utilization management protocols
Policy Background and Purpose
Preferred-product lists are used as a utilization management tool to support cost-effective prescribing while maintaining access. Coverage of preferred products under this policy applies to FDA-labeled indications when determined medically necessary and when consistent with CMS national and local coverage determinations. The program may require prior authorization or step edits for non-preferred agents and is subject to change as new products are approved or market availability evolves.
Key Definitions
Step Therapy Expectations
| Expectation | Provider action |
|---|---|
| Prescribers are expected to select preferred agents within a therapeutic category first when clinically appropriate. | When a non‑preferred product is prescribed, the prescriber may be required to provide additional clinical justification or obtain prior authorization per plan requirements; failure to obtain required prior authorization may result in denial of coverage. |
| Preferred‑product status applies to FDA‑labeled indications when medically necessary and consistent with CMS NCDs, LCDs, and LCAs. | Preferred‑product listings are subject to change with new product launches, approvals, withdrawals, and market changes; check current formulary/coverage rules before prescribing. |
Biosimilars and Reference Biologics
Preferred pegfilgrastim products
Neulasta / Neulasta Onpro (pegfilgrastim) and generic pegfilgrastim are listed as preferred pegfilgrastim products in the preferred list.
- Preferred Product(s): Neulasta/Neulasta Onpro
- Preferred Generic: pegfilgrastim
Non-preferred pegfilgrastim biosimilar (Udenyca)
Udenyca (pegfilgrastim‑cbqv) is listed as a non‑preferred pegfilgrastim biosimilar on the preferred products list.
- Non‑Preferred Product(s): Udenyca (pegfilgrastim‑cbqv)
Preferred filgrastim biosimilar (Zarxio)
Zarxio (filgrastim‑sndz) is listed as a preferred filgrastim biosimilar on the preferred-products list.
- Preferred Product(s): Zarxio (filgrastim‑sndz)
Non-preferred filgrastim product (Neupogen)
Neupogen (filgrastim) is listed among non‑preferred filgrastim products in the policy's preferred/non‑preferred listings.
- Non‑Preferred Product(s): Neupogen (filgrastim)
Inflectra and mappings to reference biologics
Inflectra is listed as a preferred agent mapped across multiple oncology/biologic categories and is associated with multiple reference biologics (e.g., bevacizumab, rituximab, trastuzumab, infliximab) in the document.
- Inflectra mapped to multiple originator biologics (bevacizumab, trastuzumab, etc.)
- Inflectra appears as preferred in several oncology/biologic category listings
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