Step therapy (prior authorization) criteria for selected pharmacy & specialty drugs
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Defines step therapy (prior authorization) requirements for specific drugs and drug groups for Align Powered By Sanford Health Plan members; affects prescribers requesting coverage for the listed products.
No material clinical or coverage changes in this revision.
Coverage criteria — Initial and continuation therapy
Actinic Keratosis - Initial Therapy
Diclofenac Sodium GEL 3% covered when the following is met:
Antidepressants - Initial Therapy
Selected branded antidepressants covered when ALL of the following are met:
Approve for continuation of prior therapy.
Atypical Antipsychotics - Initial Therapy
Fanapt products covered when ALL of the following are met:
Approve for continuation of prior therapy.
Invega Hafyera - Initial Therapy
Invega Hafyera covered when ALL of the following are met for new starts:
Step applies to new starts only. Approve for continuation of prior therapy.
Namzaric - Initial Therapy
Namzaric covered when the following is met:
Relistor - Initial Therapy
Relistor covered when the following is met:
Relistor - Initial Therapy (prior agent trial required)
Covered when the specified prior agent trial is documented
Rytary - Initial Therapy
Covered when the specified prior agent trial is documented
Zonisade - Initial and Continuation Therapy
Covered when the specified prior agent trial is documented
Step applies to new starts only; continuation of prior therapy is approved
The step therapy requirement for Zonisade applies only to members who are initiating Zonisade therapy. For new starts, coverage requires documentation of a trial of a generic zonisamide capsule. Members who were already receiving Zonisade prior to this requirement may continue therapy without meeting the step (continuation is approved).
Initial therapy — step therapy requirements per product
inv-44: Actinic Keratosis initial step
Diclofenac Sodium GEL 3% covered when the following is met:
inv-45: Antidepressants initial step
Selected branded antidepressants covered when ALL of the following are met:
Approve for continuation of prior therapy.
inv-46: Atypical Antipsychotics initial step
Fanapt products covered when ALL of the following are met:
Approve for continuation of prior therapy.
inv-47: Invega Hafyera initial step
Invega Hafyera covered when ALL of the following are met for new starts:
Step applies to new starts only. Approve for continuation of prior therapy.
inv-48: Namzaric initial step
Namzaric covered when the following is met:
inv-49: Relistor initial step
Relistor covered when the following is met:
inv-50: Relistor initial therapy — 1 top-level node
Relistor covered when the specified prior agent trial is documented
inv-51: Rytary initial therapy — 1 top-level node
Covered when the specified prior agent trial is documented
inv-52: Zonisade initial therapy — 1 top-level node
Covered when the specified prior agent trial is documented
Continuation of prior therapy approved
Step therapy table — required prior trials
| Product / Indication | Required prior trial | Notes |
|---|---|---|
| Diclofenac Sodium GEL 3% (actinic keratosis) | ||
| Trial of either topical fluorouracil OR topical imiquimod | ||
| Documentation of trial required; failure to document may result in denial |
| Product(s) | Required prior trial(s) | Notes |
|---|---|---|
| Selected branded antidepressants (e.g., Auvelity, Emsam, Exxua and listed products) | ||
| Trial of two different generics from the formulary list: bupropion; mirtazapine; citalopram (tablet or solution); desvenlafaxine succinate ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline (tablet or solution); venlafaxine hydrochloride | ||
| Approve continuation of prior therapy when documented; documentation of trials required for new starts |
| Product(s) | Required prior trial(s) | Notes |
|---|---|---|
| Fanapt products (including Fanapt Titration Packs and related listed products) | ||
| Trial of two oral generic formulary atypical antipsychotic agents from: asenapine; aripiprazole; olanzapine; paliperidone; quetiapine; risperidone; ziprasidone | ||
| Approve continuation of prior therapy when documented |
| Product | Required prior trial | Notes |
|---|---|---|
| Invega Hafyera | ||
| Trial of one of: Invega Sustenna OR Invega Trinza | ||
| Step applies to new starts only; approve continuation of prior therapy when documented |
| Product | Required prior trial | Notes |
|---|---|---|
| Namzaric (memantine/donepezil ER) | ||
| Trial of generic memantine extended‑release | ||
| Document trial of generic memantine ER prior to approval |
| Product | Required prior trial | Notes |
|---|---|---|
| Relistor | ||
| Trial of one of: lubiprostone; Constulose; Enulose; Generlac; OR lactulose | ||
| Documentation of trial required; failure to document may result in denial |
| Product | Required prior trial (examples) | Notes |
|---|---|---|
| Relistor | ||
| Trial of one of: lubiprostone; Constulose; Enulose; Generlac; OR lactulose | ||
| Document trial of one of the specified laxatives before Relistor; provide evidence with prior authorization request |
| Product | Required prior trial | Notes |
|---|---|---|
| Rytary | ||
| Trial of one generic carbidopa/levodopa containing formulation | ||
| Document prior trial of a generic carbidopa/levodopa before approval |
| Product | Required prior trial | Notes |
|---|---|---|
| Zonisade | ||
| Trial of generic zonisamide capsule | ||
| Step applies to new starts only; approve continuation of prior Zonisade therapy when documented |
What providers must document and submit
Actinic Keratosis — trial of topical fluorouracil or imiquimod required
Prior authorization requests for Diclofenac Sodium GEL 3% must document a trial of either topical fluorouracil or topical imiquimod before approval is granted.
- Provide evidence of trial of topical fluorouracil OR topical imiquimod with the PA request.
Antidepressants — trial of two generic antidepressants required
Prior authorization for the specified branded antidepressants requires documentation that the member has trialed two different generic formulary antidepressants from the enumerated list before approval.
- Acceptable generics include bupropion, mirtazapine, citalopram (tablet or solution), desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline (tablet or solution), or venlafaxine hydrochloride.
- Approve continuation when prior therapy is documented.
Atypical Antipsychotics — trial of two oral generic atypical antipsychotics required
Prior authorization for Fanapt and its titration packs requires documentation of trials of two oral generic formulary atypical antipsychotics prior to approval.
- Acceptable generics include asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone.
- Continuation of prior atypical antipsychotic therapy should be approved when documented.
Invega Hafyera — trial of Sustenna or Trinza required for new starts
For new starts of Invega Hafyera, prior authorization must document a trial of Invega Sustenna or Invega Trinza; continuation of previously established Invega Hafyera therapy is approved when documented.
- Step applies to new starts only; provide evidence of prior trial of Invega Sustenna OR Invega Trinza with the PA request.
Namzaric — trial of generic memantine ER required
Prior authorization for Namzaric requires documentation of a prior trial of generic memantine extended‑release before approval.
- Provide evidence of a trial of generic memantine ER with the PA submission.
Relistor — trial of specified laxatives required
Relistor requests require documentation that the member has trialed one of the specified laxatives (lubiprostone, Constulose, Enulose, Generlac, or lactulose) prior to approval.
- Provide evidence of trial of lubiprostone OR Constulose OR Enulose OR Generlac OR lactulose with the PA request.
Prior authorization required — show fulfillment of step therapy
All products subject to this policy require prior authorization and the PA request must demonstrate fulfillment of the applicable step therapy requirement specified under each product’s details.
- Include documented evidence of the required prior trial(s) with the PA request (see product-specific details).
Actinic Keratosis — document trial of fluorouracil or imiquimod
Diclofenac Sodium GEL 3% requests must include documentation of a trial of either topical fluorouracil or topical imiquimod; missing this documentation may lead to denial.
- Attach records showing the trial of topical fluorouracil OR topical imiquimod to avoid denial.
Antidepressants — document two generic trials (dates, dose, duration)
For branded antidepressant PA requests, document trials of two different generic formulary antidepressants from the listed agents; continuation may be approved when prior therapy is documented.
- List dates, dosages, and duration of each generic trial in the PA submission.
- Continuation approvals are permitted when prior therapy is adequately documented.
Atypical Antipsychotics — document two generic oral trials
PA requests for Fanapt products must include documentation of trials of two oral generic atypical antipsychotics; continuation of prior therapy should be approved when documented.
- Provide medication history showing two generic atypical antipsychotic trials (agent names, dates, doses).
Invega Hafyera — document prior Sustenna or Trinza trial for new starts
For new starts of Invega Hafyera, document a prior trial of Invega Sustenna or Invega Trinza with the PA request; continuation of established Invega Hafyera therapy is approved when documented.
- Include evidence of the Sustenna or Trinza trial (dates, administration records) for new‑start requests.
Namzaric — document trial of generic memantine ER
PA requests for Namzaric must include documentation of a trial of generic memantine ER prior to approval.
- Provide prior medication records confirming trial of generic memantine extended‑release.
Relistor — document trial of specified laxatives; missing documentation may cause denial
Relistor PA requests must document a trial of one of the listed laxatives (lubiprostone, Constulose, Enulose, Generlac, or lactulose); failure to document this trial may result in denial.
- Attach clinical notes or pharmacy records showing trial of one of the specified laxatives.
Relistor — required laxative trial (re-emphasized)
Relistor requires a documented trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose prior to approval; include that evidence with the PA request.
- Ensure documentation clearly identifies which listed laxative was trialed and the trial outcome.
Rytary — trial of one generic carbidopa/levodopa required
Prior to approval of Rytary, document a trial of one generic carbidopa/levodopa formulation (provide medication name, dates, and dosing).
- Include evidence of the generic carbidopa/levodopa trial with the PA request.
Zonisade — trial of generic zonisamide capsule required for new starts; continuation allowed
Zonisade PA requests for new starts must document a trial of a generic zonisamide capsule; members already on Zonisade may be approved to continue when prior therapy is documented.
- Step applies to new starts only — include prior generic zonisamide trial details for initial requests.
- Continuation approvals permitted when prior use is documented.
Prior therapy documentation — include clear evidence with PA requests
Attach documented evidence of all required prior therapy trials (agent name, dates, dose, duration, and outcome) to prior authorization requests; failure to provide required prior‑trial documentation may lead to denial.
- Evidence may include pharmacy fill history, clinic notes, or prior authorization history showing the trial and outcome.
- Missing required prior trial documentation is a common cause for step therapy denial.
Actinic Keratosis — missing documentation may result in denial
Failure to document a trial of topical fluorouracil or topical imiquimod for Diclofenac Sodium GEL 3% may result in denial of the step therapy request.
- Ensure the PA includes documentation of the required topical trial to avoid denial.
Antidepressants — missing generic trials may cause denial for branded products
Not documenting trials of two eligible generic antidepressants may lead to denial for the listed branded antidepressants (e.g., Auvelity, Emsam, Exxua).
- Provide documentation of two generic trials to reduce risk of denial for branded antidepressant PA requests.
Atypical Antipsychotics — missing required generic trials may lead to denial for Fanapt
Failure to document trials of two oral generic atypical antipsychotics may result in denial for Fanapt products.
- Document the two prior generic atypical antipsychotic trials (agent names and dates) with the PA request.
Invega Hafyera — missing required trial may result in denial for new starts
Not documenting a prior trial of Invega Sustenna or Invega Trinza for new starts of Invega Hafyera may lead to denial of the PA request.
- For new‑start requests, include administration records or relevant documentation showing the Sustenna or Trinza trial.
Namzaric — missing generic memantine ER trial may lead to denial
Failure to document a trial of generic memantine ER may result in denial for Namzaric requests.
- Include pharmacy records or chart notes showing the generic memantine ER trial to support the PA.
Relistor — missing required laxative trial may cause denial
Not documenting a trial of the specified laxatives (lubiprostone, Constulose, Enulose, Generlac, or lactulose) may result in denial for Relistor.
- Attach evidence of a trial of one of the listed laxatives to avoid denial.
Missing required prior trial — may result in denial
Failure to document the required prior trial(s) for the products listed in this policy may lead to denial of coverage; ensure all required prior therapy evidence is submitted with the PA.
- Review the product-specific step requirements and include supporting documentation for each required trial.
- Missing prior‑trial documentation is explicitly identified as a denial risk in this policy.
Continuation therapy — when prior therapy users are permitted to continue
inv-53: Antidepressants continuation — continuation allowed when prior therapy documented
Continuation allowed when prior therapy documented
inv-54: Atypical antipsychotics continuation — continuation allowed when prior therapy documented
Continuation allowed when prior therapy documented
inv-55: Invega Hafyera continuation — continuation allowed when prior therapy documented
Continuation allowed when prior therapy documented
Step applies to new starts only.
inv-56: Zonisade continuation — continuation allowed
Continuation allowed
Step applies to new starts only
Background and scope
This policy section defines step therapy rules that affect Align Powered By Sanford Health Plan members requesting coverage for specified products. Specifically, the policy requires a prior trial of a generic zonisamide capsule before approving Zonisade for new starts only. The requirement does not apply to members already on Zonisade; continuation of prior therapy is approved when documented.
Definitions used in this policy
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