CurrentHighmark Blueshield NenyPolicy N/A

Preferred Products for Medicare Advantage — Preferred drug products and biosimilars

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.

Policy Summary

PayerHighmark Blueshield Neny

PolicyPreferred Products for Medicare Advantage — Preferred drug products and biosimilars

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization when using non-preferred products as required by the plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipletherapeutic categories

includesbiosimilars listed

Medicare Advantageapplies to

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.

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Provider Requirements and Utilization Management

Prior Authorization

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

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

Documentation Required

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

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

Preferred product — definition and intent for Medicare Advantage products

DefinitionA drug designated by the payer as preferred within a therapeutic category for Highmark Medicare Advantage products; selection is intended to support cost‑effective prescribing while maintaining access.

Intent / PurposeUsed as a utilization management tool to help achieve lower drug prices while maintaining access to covered services and drugs, consistent with CMS guidance (section 1852 of the Social Security Act).

Scope of CoverageCoverage for preferred products applies to FDA‑labeled indications when medically necessary and in accordance with CMS NCDs, LCDs, and LCAs.

Prior AuthorizationCertain drugs (particularly non‑preferred agents and some biologics) may require prior authorization to ensure safe and effective use under Medicare rules.

Change ManagementPreferred product designations are subject to change with new product launches, approvals, withdrawals, and other market changes.

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

Billing Rule

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

Billing Rule

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)

Billing Rule

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)

Billing Rule

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)

Note

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

Policy Summary

PayerHighmark Blueshield Neny

PolicyPreferred Products for Medicare Advantage — Preferred drug products and biosimilars

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization when using non-preferred products as required by the plan.

SourceLink

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