Preferred Products for Medicare Advantage — Preferred and Non‑Preferred Drug Listings (Medicare Advantage)
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Lists Highmark Delaware's preferred and non-preferred drugs (including HCPCS/J-codes and biosimilars) for Medicare Advantage products and notes that preferred product status is used as a utilization management tool consistent with CMS guidance. Affects providers submitting claims or requesting prior authorization for Medicare Advantage members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Formulary Status
Therapeutic category preferred status (partial)
Preferred and Non-Preferred listings per therapeutic category (partial document).
CIDP and CRSwNP preferred status
Category-level preferred vs non-preferred designations (partial).
Partial fragmentary table
Biosimilars and neuromuscular disease products
Eculizumab biosimilars and generalized myasthenia gravis listings (partial).
Formulary status groupings
Formulary coverage is presented as Preferred or Non‑Preferred for product groups and specific HCPCS/Q‑codes
Document provides mappings by product and HCPCS/Q-code; chart is partial
Approval criteria for non-preferred products
Non-preferred products may be approved when ALL of the following are met:
New therapy = no prior utilization in 365 days.
None explicitly stated in the provided portions of this document beyond the listing of products as Preferred or Non‑Preferred. The policy text references CMS guidance supporting the use of preferred products as a utilization management tool and indicates that coverage for preferred products applies to FDA‑labeled indications when medically necessary, but it does not include standalone exclusion language in the chunks reviewed here.
Certain originator biologic products are presented in the table as Non‑Preferred while their biosimilars are shown as Preferred. For example, infliximab originator (Remicade) is listed as Non‑Preferred while infliximab biosimilars such as Avsola (Q5121) and Inflectra (Q5103) are shown as Preferred, which implies formulary substitution preference for biosimilars when clinically appropriate and subject to the policy’s therapeutic‑trial requirements for non‑preferred products.
The chart provides product‑to‑product preferred/non‑preferred mappings. Examples include: Mvasi (Q5107) listed as Preferred while Avastin (bevacizumab/J9035) is shown as Non‑Preferred; pegfilgrastim biosimilars and originators are grouped with Preferred designations for Neulasta (J2506) and Non‑Preferred listings for specific biosimilars; and trastuzumab mappings (multiple Q/J codes) indicate which trastuzumab products are Preferred versus Non‑Preferred. These pairings in the table determine which HCPCS/J/Q code the plan prefers for coverage and utilization management.
The document excerpts do not include explicit statements using the phrase "Not Medically Necessary". Instead, coverage status is expressed as Preferred or Non‑Preferred in the product tables, and the requirement for medical necessity is referenced in connection with FDA‑labeled indications and CMS guidance.
Throughout the table and supporting text the plan indicates products as either Preferred or Non‑Preferred. The policy relies on that designation (rather than an explicit Not Medically Necessary label) to guide utilization management, with approval for non‑preferred agents dependent on meeting the stated trial and documentation requirements.
Use of a Non‑Preferred product without documentation of an adequate therapeutic trial and documented failure or intolerance to Preferred product(s) may be denied. The policy requires evidence of an adequate therapeutic trial (typically 6 months, but class‑specific trial durations are noted in the chart) and documentation of drug therapy failure or intolerance before a non‑preferred product will be approved.
HCPCS / J‑code / Q‑code Mappings
| J9333 | Appears in non-preferred long list (context unclear in partial document) |
| J1602 | Listed in extended non-preferred text (context unclear) |
| J7323 | Hyaluronan injection code mentioned |
| J7318 | Hyaluronate injection code mentioned |
| J7321 | Hyaluronate related code |
| J7328 | Hyaluronate related code |
| J7320 | Listed among hyaluronan codes |
| J7326 | Listed among hyaluronan codes |
| J7327 | Listed among hyaluronan codes |
| J7324 | Listed among hyaluronan codes |
| J9356 | trastuzumab-qyyp |
| Q5113 | hyaluronidase-oysk (listed) |
| Q5112 | listed Q-code (documented in chart) |
| Q5116 | listed Q-code (documented in chart) |
| J2506 | pegfilgrastim (Neulasta and biosimilars) |
| Q5108 | Fulphila (pegfilgrastim-jmdb) |
| Q5111 | Neulasta Onpro (pegfilgrastim) Q-code listing |
| J1449 | listed J-code in pegfilgrastim group |
| J9361 | Rolvedon (eflapegrastim-xnst) |
| Q5101 | Zarxio (filgrastim-sndz) |
Prior Authorization, Billing, and Documentation Requirements
Prior authorization requirement
Certain drugs listed (including J- and Q-codes) may require prior authorization to ensure safe and effective use consistent with Medicare rules and CMS guidance; providers must obtain PA where indicated prior to administration or billing.
PA tied to Preferred / Non‑Preferred status
Prior authorization requirements are applied in the context of formulary status: oncology and biologic agents are designated Preferred or Non‑Preferred by HCPCS/Q‑code and may require PA according to their formulary designation and plan rules.
PA requirement for non‑preferred products
Requests for non‑preferred products require prior authorization with documentation showing an adequate therapeutic trial and documented failure or intolerance to preferred products before approval.
- Adequate therapeutic trial typically = six months from first dose at FDA- or compendia-based therapeutic doses (may vary by class).
- New therapy = no utilization within the last 365 calendar days.
Coverage / PA applicability
Coverage for preferred products applies to FDA‑labeled indications when medically necessary; certain drugs listed in the document may require prior authorization consistent with CMS NCDs, LCDs, and LCAs.
Formulary grouping implies substitution/step
The formulary groups originator biologics with their biosimilars (e.g., bevacizumab and infliximab groupings), implying that plan-preferred biosimilars are the step or substitution of choice and originator products may be non‑preferred.
Step therapy / therapeutic trial required
A therapeutic trial of preferred agent(s) is required before approval of a non‑preferred agent; the trial duration is typically six months but may vary by therapeutic class as noted in the chart.
- Documented drug therapy failure or intolerance to preferred products is required for approval of the non‑preferred agent.
Coverage applies to FDA‑labeled indications; PA may still be required
Coverage is applicable to FDA‑labeled indications when medically necessary; for certain drugs the plan may still require prior authorization as noted in the policy.
Submit matching HCPCS / J‑code
Submit the exact HCPCS/J‑code that matches the dispensed product on requests and claims; the document maps specific codes to products and expects matching code submission.
- Billing the code that corresponds to the administered product (originator vs biosimilar) is required.
Documentation: show adequate trial and failure/intolerance
Required documentation for PA of non‑preferred products must demonstrate an adequate therapeutic trial and documented drug therapy failure or intolerance to preferred products, with trial duration per chart (typically six months).
- Document therapy start dates, doses consistent with FDA or compendia recommendations, and objective evidence of failure or intolerance.
UM actions may apply for non‑preferred products
Use of non‑preferred products or drugs that require prior authorization may result in utilization management actions consistent with CMS guidance; providers should follow PA and documentation requirements to avoid such actions.
Billing non‑preferred codes may trigger denial
Billing non‑preferred product codes when a preferred biosimilar or alternative is designated may trigger claim denial; submit PA and required documentation if billing a non‑preferred code.
Denial risk if adequate trial not documented
Requests for non‑preferred drugs can be denied unless the member has had an adequate therapeutic trial with documented drug therapy failure or intolerance to the preferred products.
- Adequate therapeutic trial is typically six months from first dose at FDA- or compendia-based therapeutic dosing; class-specific durations are noted in the chart.
CMS guidance underpins preferred‑product policy
CMS guidance is the basis for recognizing preferred products as a utilization management tool; follow CMS NCD/LCD/LCA rules when implementing PA and step requirements.
Key Definitions and Terms
Initial Coverage Conditions
Initial therapy requirement
Initial coverage condition for non-preferred agents
Chart contains class-specific deviations (e.g., some entries note 3–4 months).
Step Therapy and Substitution Rules
| Product group / example | Preferred | Non‑Preferred | Implication |
|---|---|---|---|
| Bevacizumab product group | |||
| Mvasi (Q5107); Zirabev (Q5118) listed as preferred biosimilars in chart | |||
| Avastin (bevacizumab) (J9035) listed as Non‑Preferred | |||
| Grouping indicates step/substitution to preferred biosimilar (e.g., Mvasi) is expected before coverage of originator Avastin |
| Product group / example | Required trial of preferred products | Failure/intolerance documentation | Approval condition for non‑preferred |
|---|---|---|---|
| Infliximab product group | |||
| Adequate therapeutic trial of preferred infliximab biosimilars (e.g., Avsola Q5121, Inflectra Q5103) is required | |||
| Documented drug therapy failure or intolerance to the preferred biosimilars must be provided | |||
| Non‑Preferred Remicade (infliximab) may be approved only after trial and documented failure/intolerance to preferred biosimilars |
Place of Service Applicability
Preferred designations apply to professional and facility claims
Preferred product designations in this policy apply to professional providers and facility claims across all Highmark Medicare markets, including office, infusion center, hospital outpatient, and professional settings.
Biosimilar Groupings and Notes
Soliris (eculizumab) listed in eculizumab grouping
Soliris (eculizumab) and its related biosimilar codes are listed in the eculizumab grouping with preferred vs non‑preferred designations shown in the chart.
Preserve Soliris code mappings in submissions
Table mappings include duplicate entries for Soliris (eculizumab) and associated biosimilars; preserve the chart mapping when submitting claims or PA requests.
Infliximab biosimilars preferred; Remicade non‑preferred
Infliximab biosimilars (e.g., Avsola Q5121, Inflectra Q5103) are presented as Preferred while the originator Remicade (infliximab) is shown as Non‑Preferred; document prior trials of preferred biosimilars if requesting the originator.
Originator products non‑preferred unless trial/failure of preferred shown
For groups such as pegfilgrastim, filgrastim, trastuzumab and denosumab, the chart assigns preferred vs non‑preferred status per product; non‑preferred originator products require an adequate trial and documented failure/intolerance of the preferred product(s) for approval.
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