Biosimilar and follow-on biologic formulary preferences and authorization expectations
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Defines Kern Family Health Care's preferred biosimilar products and authorization expectations for requests of innovator/reference biologic drugs; affects providers prescribing or requesting coverage for listed biologics for KFHC members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Coverage with preferred biosimilar and medical necessity requirement
Covered when ALL of the following are met
Preferred biosimilars listed in document.
Lack of documentation may result in denial.
Automatic pharmacy-level substitution of biosimilars is constrained by existing brand/generic interchangeability laws and therefore may not occur without appropriate regulatory or pharmacy processes. Clinically, biosimilars deliver the same outcomes as their reference biologics, but providers should not assume a biosimilar will be automatically dispensed in place of a reference product at the pharmacy level due to these legal and technical limitations. (See KFHC note that pharmacy substitution may not occur and that documentation is required when a non‑preferred formulation is requested.)
Provider Actions and Requirements
Authorization requires medical necessity if preferred biosimilar exists
KFHC will authorize requests for the innovator/reference drugs only when documentation demonstrating medical necessity is provided to justify use of a formulation other than the plan’s preferred biosimilar; the plan lists preferred biosimilars to be used in place of the reference products.
- Plan will authorize innovator/reference drug requests only with medical necessity documentation.
- Preferred biosimilars are listed as the plan’s preferred products and expected to be used when clinically appropriate.
Preferred biosimilars are the plan’s expected product
The policy positions the listed biosimilars as the plan’s preferred products and expects utilization of those biosimilars in place of the reference/innovator biologics unless medical necessity for the reference product is documented.
- Preferred biosimilars are listed beside each reference drug as the plan’s preferred listing.
- Use of the reference/innovator product is implied to require justification when a preferred biosimilar is available.
Provide medical necessity documentation to justify non-preferred formulation
Documentation demonstrating medical necessity must be provided to justify use of formulations other than the plan’s preferred biosimilar.
- This documentation is required at the time of request for the innovator/reference drug.
- Lack of such documentation may result in non-authorization.
Medical necessity documentation required for non-preferred biologics
Requests for innovator/reference biologics when a preferred biosimilar is available will require documentation demonstrating medical necessity to justify the non-preferred biologic; failure to provide this documentation may lead to denial or non-authorization.
- KFHC will authorize listed innovator/reference drugs only with medical necessity documentation.
- Preferred biosimilars listed include Renflexis, Nivestym, Ruxience, Kanjinti, and Retacrit in place of their reference drugs.
Background
A biosimilar is a biological product approved on evidence demonstrating it is highly similar to an FDA‑approved reference product with no clinically meaningful differences in safety or effectiveness. Kern Family Health Care lists specific preferred biosimilars to be used in place of their corresponding reference biologics (for example, Renflexis for Remicade and Kanjinti for Herceptin) and notes that these biosimilars may offer cost advantages. When a provider requests the innovator/reference drug instead of the plan’s preferred biosimilar, documentation demonstrating medical necessity must be provided to justify the non‑preferred formulation.
Definitions
Preferred Biosimilars and Related Innovator Products
Renflexis preferred — Remicade requests need medical necessity
Renflexis (infliximab-abda) is listed as the preferred biosimilar in place of Remicade (infliximab); requests for Remicade require documentation demonstrating medical necessity to justify use over Renflexis.
Nivestym preferred — Neupogen requests need medical necessity
Nivestym (filgrastim‑AAFI) is listed as the preferred biosimilar in place of Neupogen (filgrastim); requests for Neupogen require documentation demonstrating medical necessity to justify use over Nivestym.
Ruxience preferred — Rituxan requests need medical necessity
Ruxience (rituximab‑PVVR) is listed as the preferred biosimilar in place of Rituxan (rituximab); requests for Rituxan require documentation demonstrating medical necessity to justify use over Ruxience.
Kanjinti preferred — Herceptin requests need medical necessity
Kanjinti (trastuzumab‑ANNS) is listed as the preferred biosimilar in place of Herceptin (trastuzumab); requests for Herceptin require documentation demonstrating medical necessity to justify use over Kanjinti.
Retacrit preferred — Epogen/Procrit requests need medical necessity
Retacrit (epoetin‑EPBX) is listed as the preferred biosimilar in place of Epogen/Procrit (epoetin); requests for Epogen/Procrit require documentation demonstrating medical necessity to justify use over Retacrit.
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