CurrentBaylor Scott & White Health PlanPolicy 306

Step Therapy Policy - Commercial plans

Defines step therapy requirements for commercial plans administered by Baylor Scott & White Health Plan, listing drug classes and preferred vs non-preferred agents and specifying clinical exceptions and plan references. Affects providers requesting coverage for medical benefit outpatient drugs for commercial members.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyStep Therapy Policy - Commercial plans

Policy CodePolicy 306

Change TypeNo material changes

Effective DateMar 1, 2026

Next Review DateFeb 26, 2027

Key ActionTry all preferred drugs in the same class (unless contraindicated or intolerant) before requesting coverage of a non-preferred agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~30+drug products or biosimilars listed across classes

Commercialplans covered by this policy

Applies to Texas mandatesTexas regulatory exceptions referenced

4 cross-referencesOther BSWHP policies referenced

Coverage Criteria

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General step therapy coverage criteria

Covered when ALL of the following are met

Primary requirement: Member must have failure of an adequate trial of or clinically significant intolerance or contraindication to ALL preferred drugs in the same class that can also be used for the requested indication.

Exception: Non-preferred drugs requested due to failure of an adequate trial of biosimilars of preferred products do not meet medical necessity.

Regulatory exceptions (Texas): For plans subject to Texas Department of Insurance requirements, step therapy will not be required for a non-preferred drug when use is: (1) consistent with best practices for treatment of stage-four advanced/metastatic cancer or an associated condition; (2) supported by peer-reviewed, evidence-based literature; and (3) approved by the U.S. Food and Drug Administration (per TIC sec. 1369.213).

Per TIC sec. 1369.0546, step therapy will also not be required when use is contraindicated or expected to be ineffective or cause harm based on submitted clinical documentation and/or medical literature.

Plan-specific clinical criteria: Member must meet additional clinical coverage criteria per the applicable BSWHP plan policy and the class-specific table in this policy.

Follow referenced BSWHP policies (e.g., 215, 219) for indication-specific clinical criteria and prior authorization requirements.

Class-specific listings

Drug-class specific preferred vs non-preferred listings (selection shown — full table in policy)

Bendamustine: Preferred: Belrapzo; Bendeka; Bendamustine (Treanda). Non-Preferred: Bendamustine 505b2 formulations; Vivimusta.

See BSWHP policy 219 Cancer Chemotherapy / Therapy Guidelines.

Bevacizumab (oncology): Preferred: Mvasi; Zirabev. Non-Preferred: Avastin (J9035); Alymsys; Avzivi; Vegzelma; other bevacizumab biosimilars.

For oncology indications only; see BSWHP policy 219.

Bone antiresorptive therapy (oncology indications): Preferred: Zoledronic Acid. Non-Preferred: Aukelso; Bomyntra; Bilprevda; Osenvelt; Wyost; Xbryk; Xgeva; Xtrenbo; other denosumab biosimilars.

Applies for oncology indications only and does NOT apply to prostate or breast cancer; see BSWHP policy 219.

This step therapy policy applies to Baylor Scott & White Health Plan commercial medical outpatient drugs listed in the class-specific tables. ALL OTHER MEDICAL OUTPATIENT DRUGS (NOT LISTED ABOVE) are covered at parity and are not subject to the step therapy requirements in this policy. Certain class-specific exceptions also apply as noted in the listings — for example, the bone antiresorptive therapy rules apply only for oncology indications and do NOT apply to prostate or breast cancer (see drug-class listings and cross-referenced BSWHP policies).

Requests for non-preferred drugs that are based solely on failure of an adequate trial of a biosimilar of a preferred product do not meet medical necessity and are not sufficient to satisfy the step therapy requirement.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required per the specific drug or device policy. See the applicable drug or device medical policy for prior authorization requirements before submitting requests under this step therapy policy.

See specific drug or device policy for prior authorization requirements

Step Therapy

General Step Therapy Rule

A trial of preferred therapeutic alternatives is required before coverage of a non-preferred drug or device for the requested indication. Apply Baylor Scott & White Health Plan medical policies first, then the step therapy requirements in this supplemental policy. Exceptions (see below) may apply.

Preferred alternatives must be tried and documented prior to non-preferred coverage
Baylor Scott & White Health Plan medical policies are applied prior to this supplemental step therapy policy

Documentation Required

Clinical Documentation for Exceptions

When requesting an exception to step therapy (for example, claiming intolerance, contraindication, or regulatory exception), include clinical documentation that clearly supports the reason for the exception. Documentation should demonstrate prior treatment history, clinical rationale, laboratory or diagnostic results when relevant, and any specialist evaluations that support why preferred alternatives are not appropriate.

Document prior trials of preferred drugs, including dates, doses, and reasons for discontinuation (e.g., adverse effects, lack of efficacy)
Provide clinical evidence (notes, labs, imaging) supporting intolerance or contraindication
Include peer-reviewed literature or FDA labeling when asserting regulatory exceptions

Denial Risk

Step Therapy Failure Requirement

Requests for non-preferred drugs may be denied if an adequate trial of all preferred alternatives is not demonstrated, or if clinical documentation does not support intolerance or contraindication. Ensure submitted records meet the documentation requirements to avoid denial.

Denial risk if adequate trial of preferred agents not shown
Denial risk if intolerance/contraindication not adequately documented

Background

Step therapy requires a trial of preferred agents within the same drug class prior to coverage of a non-preferred alternative for the requested indication. Under this policy the member must have failure of an adequate trial of, or documented clinically significant intolerance or contraindication to, ALL preferred drugs in the same class that can be used for the requested indication, unless a regulatory exception applies. For commercial plans subject to Texas Department of Insurance rules, step therapy is not required when use of a non-preferred drug is consistent with best practices for stage‑four advanced/metastatic cancer, is supported by peer‑reviewed evidence and FDA‑approved, or is contraindicated/expected to be ineffective or harmful as supported by submitted clinical documentation or literature.

Definitions

Step therapy — definition

DefinitionStep therapy: a requirement that a trial of a preferred therapeutic alternative be completed prior to coverage of a non-preferred drug or device for the requested indication.

ApplicationThis policy lists drugs/devices that require step therapy and directs that referenced Baylor Scott & White Health Plan medical policies be applied first, then the step therapy requirements in this supplemental policy.

ScopeApplies to commercial plans administered by Baylor Scott & White Health Plan unless otherwise indicated in the member's plan documents.

Failure of preferred therapy — definition and exceptions

Primary requirementMember must have failure of an adequate trial of, or clinically significant intolerance or contraindication to, ALL preferred drugs in the same class that can be used for the requested indication.

Biosimilar exceptionRequests for a non-preferred drug based solely on failure of biosimilars of preferred products do NOT meet medical necessity.

Regulatory exceptions (Texas)For plans subject to Texas TDI rules, step therapy is not required when use is consistent with best practices for stage‑four advanced/metastatic cancer, supported by peer‑reviewed evidence, and FDA‑approved (TIC sec. 1369.213), or when use is contraindicated or expected to be ineffective/harmful per submitted clinical documentation or literature (TIC sec. 1369.0546).

Step Therapy Implementation

Step	Requirement / Action	Notes / References
1	Apply BSWHP class-specific preferred and non-preferred listings for the requested drug class (see policy table for class-level preferred vs non-preferred agents).	Follow referenced BSWHP policies (e.g., 215, 219) for detailed clinical criteria and any prior authorization requirements; policy history documents class additions and updates.
2	Member must have failure of an adequate trial of, or documented clinically significant intolerance or contraindication to, ALL preferred drugs in the same class that can be used for the requested indication before a non-preferred drug will be covered.	Failure of biosimilars of preferred products does not meet medical necessity. See regulatory exceptions below (TIC provisions).
3	For plans subject to Texas Department of Insurance requirements, step therapy is not required when use of the non-preferred drug meets Texas mandates: consistent with best practices for stage‑four advanced/metastatic cancer, supported by peer‑reviewed evidence, and FDA‑approved; or when contraindicated/expected to be ineffective or harmful per submitted clinical documentation or literature (TIC sec. 1369.213 and 1369.0546).	Document supporting clinical literature or rationale in the prior authorization request.
4	Refer to the specific drug or device policy for prior authorization requirements; step therapy policy lists drugs that require step therapy and cross‑references other BSWHP policies to be applied first.	See BSWHP policy numbers noted in class listings and policy header for cross‑reference; policy history records updates and class additions.

Biosimilar Preferences

Billing Rule

Bevacizumab (Avastin) preferred biosimilars

For oncology bevacizumab, preferred products are the biosimilars Mvasi and Zirabev; Avastin (J9035) and other bevacizumab biosimilars are listed as non‑preferred.

Preferred: Mvasi, Zirabev
Non-preferred: Avastin (J9035), Alymsys, Avzivi, Vegzelma, other bevacizumab biosimilars

Billing Rule

Rituximab preferred vs non-preferred

Preferred rituximab products are Ruxience and Truxima; non‑preferred alternatives include Riabni and Rituxan.

Preferred: Ruxience, Truxima
Non-preferred: Riabni, Rituxan

OpenPayer