Stelara biosimilars formulary placement and related provider guidance
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Governance of Sanford Health Plan's formulary changes for Stelara and newly preferred biosimilars, who this affects (providers prescribing Stelara or its biosimilars and Sanford members), and related portal/authorization guidance for providers.
Three biosimilars to Stelara (Selarsdi, Wezlana, Yesintek) were added to the Sanford Health Plan formulary as preferred options.
No prior authorization is required for patients currently treated with Stelara to be switched to one of the biosimilars; exceptions to remain on Stelara require prior authorization.
Guidance encouraging providers to begin new patients on biosimilars and to discuss switching current patients to biosimilars.
Coverage Criteria and Policy Rules
Stelara and Biosimilar Coverage Rules
Covered when plan-preference and authorization rules are followed.
New patients require prior authorization as noted by the plan.
Exceptions to remain on Stelara require prior authorization and case-by-case review.
Providers should be aware of interchangeability status when counseling patients.
ADD-E: Initiation and Continuation & Maintenance
Coverage/performance expectations for the ADD-E HEDIS measure.
One visit between days 31 and 300 may be an e-visit or virtual check-in. Schedule visits at approximately 30, 60 and 180 days; consider an initial two-week supply and follow-up prescriptions for 30 days.
APP/APM: Psychological care and metabolic monitoring
Expectations for antipsychotic prescribing quality measures (APP and APM).
Use EHR reminders and coordinate care with pediatricians, dietitians and specialists to ensure monitoring and documentation.
There is no explicit blanket exclusion of Stelara in the policy. However, the document specifies that exceptions to remain on Stelara require prior authorization and will be reviewed on a case-by-case basis; requests to remain on the originator may be denied if not supported by case-specific documentation.
This portion of the policy does not list any explicit exclusions. It instead focuses on clinical follow-up and documentation practices (for example, scheduling follow-ups at 30, 60 and 180 days for new ADHD medication starts) rather than naming services or indications that are categorically excluded.
The policy does not state that remaining on originator Stelara is "not medically necessary," but it implements a plan-level preference: starting April 1, 2025 the biosimilars will be on the preferred brand tier with the lowest member cost-share, while patients who remain on Stelara will be placed on the highest-cost tier. This creates an implied non-preference through differential cost-share rather than an explicit medical necessity denial.
There are no explicit "not medically necessary" statements
Key Operational Thresholds and Coding-Adjacent Values
Provider Responsibilities, Authorizations, and Documentation
Prior authorization required for new starts and exceptions
New patients starting treatment with Stelara or any of the listed biosimilars require prior authorization; requests to remain on originator Stelara instead of switching to a preferred biosimilar also require prior authorization for exception review.
- Prior authorization is required for all new patient starts.
- Requests to remain on Stelara (exception to switching) must be submitted for case-by-case prior authorization review.
Use Epic for service authorizations
Use the Epic-based Provider Portal for service authorizations; authorization numbers may be 3–4 digits and the portal or authorization letter contains the reference number and detailed status.
- Access the Provider Portal to view authorization details and status.
- Refer to the authorization number on the letter or in the portal (may be 3–4 digits).
- Open the specific authorization to view full status because the main summary page may not show current status.
Preferred initiation on biosimilars
When initiating therapy for a new patient, providers are strongly encouraged to start with one of the preferred biosimilars; prior authorization is still required for new patient starts.
- Begin new patients on a biosimilar (Selarsdi, Wezlana, Yesintek) per plan preference.
- Submit a prior authorization for any new start.
First-line psychological care expectation
For children/adolescents considered for antipsychotic therapy, prioritize and document first-line psychological care (therapy or behavioral interventions) before or alongside prescribing antipsychotics.
- Document the use of psychotherapy or behavioral interventions as first-line care when appropriate.
- Coordinate and record behavioral treatment prior to relying primarily on antipsychotic medication.
Concurrent review submission steps
To submit a concurrent review on an active authorization, locate the authorization in the portal, open it, use the add note/attachment function to add a summary and supporting medical documentation, then add the note to send the request to utilization management for review.
- Patient List > Authorization by Member to locate active authorization.
- Open the authorization and click add note/attachment (top left).
- Add request/notes in the free-form section, include a summary, attach supporting medical documentation, then click add note to submit.
Visit scheduling and visit type documentation
Document scheduling and completion of follow-up visits at approximately 30, 60 and 180 days from the initial visit; note that only one visit between days 31 and 300 may be an e-visit or virtual check-in.
- Schedule follow-up visits while the patient is still in the office and document their dates.
- Prescribe an initial two-week supply and follow-up prescriptions for 30 days to ensure return.
- If an e-visit is used, ensure no more than one e-visit occurs between days 31 and 300 and document it.
Prior authorization for exceptions to switching
Requests to remain on originator Stelara instead of switching to a preferred biosimilar require prior authorization and may be denied if case-specific clinical justification is not provided.
- Submit an exception prior authorization with case-specific documentation to justify staying on Stelara.
- Without adequate justification, exception requests to remain on Stelara may be denied.
Follow-up timing noncompliance
Failure to schedule and document the required follow-up visits at the specified intervals (initiation within 30 days and continuation visits within the continuation window) risks not meeting measure expectations and may affect authorization/coverage performance.
- Ensure the initiation follow-up occurs within 30 days of starting medication.
- Ensure additional continuation follow-ups occur per plan guidance (e.g., 60 and 180 days) and document them.
Background and Rationale
Biosimilars are described as clinically highly similar to the originator and were added to the formulary after review by the Pharmacy & Therapeutics Committee. The plan states that clinical trials demonstrated high efficacy and safety for the biosimilars and positions them as preferred options to reduce member cost-share. This rationale supports encouraging use of biosimilars as equivalent, lower-cost alternatives to the originator biologic.
Definitions and Measure Terms
Initial Therapy Preferences and Requirements
Initial Therapy Preference
Initiation guidance from the plan.
Prior authorization is required for new patients; this is a plan preference to reduce member cost-share.
Initial therapy scheduling and behavioral-first guidance
Initial treatment instructions and behavioral-first recommendation.
Only one visit between days 31 and 300 may be an e-visit or virtual check-in; arrange follow-ups while patient is still in office where possible.
Continuation and Exception Rules
Continuation on Originator Stelara
Rules for patients currently on originator Stelara who wish to continue on it.
Approval is case-by-case; otherwise plan cost-share favors biosimilars and patients who remain on Stelara will be on the highest-cost tier.
Step Therapy and Treatment Sequencing
| Step | Policy statement |
|---|---|
| 1 | When a new patient starts treatment, the plan strongly encourages initiation with one of the Stelara biosimilars (preferred); prior authorization is required for new patient starts. |
| Notes | Providers should begin conversations with patients currently on Stelara about switching to a biosimilar; prior authorization is required for new starts. |
| Step | Policy statement |
|---|---|
| 1 | Prioritize and document first-line psychological care (therapy or behavioral interventions) for children and adolescents — especially for conditions such as ADHD, depression, and anxiety — before relying primarily on antipsychotic medications. |
| Notes | Collaborate with mental health professionals and educate families to support nonpharmacological treatment options and ensure access to evidence-based psychotherapy when appropriate. |
Biosimilar Formulary Placement
Stelara — Added to formulary as preferred biosimilar; lowest cost-share starting April 1, 2025
Selarsdi, Wezlana, and Yesintek have been added to the formulary as preferred biosimilars and will be placed on the preferred brand tier with the lowest member cost-share effective April 1, 2025.
- Biosimilars become lowest cost-share on 2025-04-01.
- Preferred biosimilars: Selarsdi, Wezlana, Yesintek.
Stelara — Added to formulary as preferred biosimilar and identified as interchangeable
Wezlana is designated an interchangeable biosimilar and, along with the other biosimilars added to the formulary, is preferred with the lowest member cost-share effective April 1, 2025; pharmacists may dispense Wezlana without requiring a new prescription where substitution laws allow.
- Wezlana noted as interchangeable—no new prescription required for substitution when allowed.
- Lowest cost-share for preferred biosimilars effective 2025-04-01.
Stelara — Added to formulary as preferred biosimilar; lowest cost-share starting April 1, 2025
Selarsdi and Yesintek (the listed biosimilars) are added as preferred formulary options and will carry the lowest member cost-share beginning April 1, 2025.
- Preferred biosimilars: Selarsdi, Yesintek.
- Effective date for lowest cost-share: April 1, 2025.
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