Step Therapy Policy - Commercial plans
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Defines step therapy rules for commercial plan medical outpatient drugs managed by Baylor Scott & White Health Plan, listing drug classes with preferred and non-preferred agents and referencing related Plan policies and exceptions. Affects providers requesting coverage for non-preferred medical outpatient drugs for commercial members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial coverage criteria (general)
Covered when ALL of the following are met
Exceptions in Texas and other regulatory notes apply as described in policy
Per TIC sec. 1369.0546, step therapy will not be required when use is contraindicated or expected to be ineffective or cause harm based on submitted clinical documentation and/or medical literature.
Apply referenced BSWHP policies (e.g., 215, 219, 314) before applying supplemental step therapy rules in this policy.
Class- and agent-specific mappings
Drug-class specific mapping (preferred vs non-preferred) — examples from the policy
See BSWHP policy 219 Cancer Chemotherapy / Therapy Guidelines for additional guidance.
Applies to oncology indications only; see BSWHP policy 219.
Does NOT apply to prostate or breast cancer; see BSWHP policy 219.
See BSWHP policy 215 Medications Covered Under Medical Insurance Policy.
Refer to chunks 3–7 for the complete class listings and referenced Plan policies (215, 219, 314).
The policy includes class-specific exceptions and applicability notes. Bone antiresorptive therapy mapping applies only for oncology indications and does NOT apply to prostate or breast cancer; preferred agents are listed as Zoledronic Acid and non-preferred agents include other denosumab products and listed biosimilars (e.g., Xgeva, Xbryk, Aukelso) per the class listing in the policy (see referenced oncology policy guidance).
Certain ophthalmic and oncology products are handled with class-specific notes: ophthalmic VEGF inhibitors are listed separately with preferred and non-preferred ophthalmic agents identified (e.g., Eylea, Lucentis, Beovu, Susvimo, Vabysmo, Byooviz) and oncology-only mappings (for example, bevacizumab mappings apply to oncology indications only). Referenced Plan policies (for example, BSWHP policy 219 and policy 215) provide additional class-specific clinical guidance and applicability.
Where a class listing includes multiple branded, biosimilar, and unbranded products, the policy’s mapping determines preferred versus non-preferred status for step therapy purposes and any class exceptions described above govern whether the mapping applies to a particular cancer type or ophthalmic indication.
Requests for a non-preferred drug based solely on failure of an adequate trial of a biosimilar of a preferred product do not meet medical necessity. The policy requires an adequate trial of the Plan’s preferred drugs (or clinical documentation of contraindication or intolerance) rather than a biosimilar-only trial to satisfy step therapy.
Providers seeking an exception to step therapy must supply the clinical documentation supporting contraindication, intolerance, or expected ineffectiveness as described in the regulatory notes; without such documentation, a non-preferred request driven only by prior biosimilar use will not be approved.
Coding
| J9035 | Avastin (bevacizumab) — code listed in non-preferred bevacizumab (oncology indications only) |
Provider Actions & Requirements
Obtain prior authorization as specified
Prior authorization is required per the specific drug or device policy; after applying referenced Plan medical policies, the supplemental step therapy requirements in this policy must be applied for medical outpatient drugs.
Document trials of ALL preferred class agents
Before coverage of a non‑preferred drug, document that the member has failed an adequate trial of, or has a clinically significant intolerance or contraindication to, ALL preferred drugs in the same class that can be used for the requested indication.
- Biosimilar-only trials of a preferred product do not satisfy the requirement for non-preferred drug requests.
Provide clinical documentation for step therapy exceptions
Submit clinical documentation to support any claimed contraindication, intolerance, or expected ineffectiveness when requesting an exception to step therapy; Texas Insurance Code provisions also permit exemption when supported by documentation or medical literature.
- Per TIC sec. 1369.0546, step therapy is not required when use is contraindicated or expected to be ineffective or cause harm based on submitted clinical documentation and/or medical literature.
- For plans subject to Texas requirements, HB1584 and TIC sec. 1369.213 describe statutory exemptions for certain stage‑four metastatic cancer uses supported by peer‑reviewed evidence and FDA approval.
Risk of denial without documented trials
Failure to document an adequate trial of ALL preferred drugs in the same class for the requested indication may result in denial of coverage for the non‑preferred drug.
Background
Step therapy is a utilization management approach that requires completion of a trial of the Plan’s preferred therapeutic alternatives before coverage of a non-preferred medical outpatient drug for a specified indication. Under this policy, the member must have failure of an adequate trial of, or a clinically significant intolerance or contraindication to, ALL preferred drugs in the same class that can be used for the requested indication.
Regulatory exceptions are recognized where applicable: for plans subject to Texas requirements, step therapy will not be required when use of a non-preferred drug is consistent with best practices for stage-four advanced/metastatic cancer, supported by peer-reviewed evidence, and FDA-approved per HB1584 and TIC sec. 1369.213, or when step therapy is contraindicated or expected to be ineffective or harmful based on submitted clinical documentation per TIC sec. 1369.0546.
Definitions
Initial Therapy Criteria
Initial therapy rules
Initial step therapy requirement
Biosimilar-only trials of preferred products do NOT satisfy the requirement for requests of non-preferred drugs; documentation supporting exception is required.
Failure to document an adequate trial of ALL preferred drugs or appropriate exception documentation may lead to denial.
Apply Plan-specific prior authorization rules before applying these step therapy rules.
Step Therapy Requirements
| Requirement | Details / documentation | Notes |
|---|---|---|
| Documented trial of ALL preferred agents in the same drug class for the requested indication | ||
| Must include dates of therapy, agent names, dosing, duration, and reason for discontinuation (lack of efficacy, intolerance, or contraindication). Clinical records, clinic notes, or prior authorization history should demonstrate an adequate trial for each preferred agent. | ||
| Failure to document adequate trials for all preferred drugs may result in denial; biosimilar-only trials of a preferred product do NOT satisfy the requirement for coverage of a non-preferred agent. |
Site of Care
Medical benefit applies — site-of-care notes
These agents are billed under the medical benefit as medical outpatient drugs; site-specific notes (infusion center, hospital outpatient, office) and oncology/ophthalmic class rules apply per the class listings and referenced Plan policies.
- Follow the referenced BSWHP policies (e.g., policy 219, 215) for class-specific site-of-care guidance.
Biosimilar Notes
Denosumab biosimilar status differs for Xgeva vs Prolia
Denosumab biosimilars were added to the bone antiresorptive therapy class for Xgeva (oncology indications) but denosumab biosimilars were removed for Prolia; see policy history and class listings for details.
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