Currentalign_powered_by_sanford_health_planPolicy N/A

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.

Policy Summary

PayerAlign Powered By Sanford Health Plan

PolicyStep therapy (prior authorization) criteria for selected pharmacy & specialty drugs

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateNov 1, 2025

Last ReviewOct 1, 2025

Next Review DateOct 1, 2025

Key ActionProvide documentation of the required prior therapy trial(s) with prior authorization requests (e.g., trial of two generics for specified antidepressants or trial of listed alternatives for each drug).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9drug/group entries listed in this partial document

1required prior therapy trials (per item)

Yescontinuation permitted for prior users

11/01/2025

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Currentalign_powered_by_sanford_health_planPolicy N/A

Step therapy (prior authorization) criteria for selected pharmacy & specialty drugs

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Sign up for all align_powered_by_sanford_health_plan policy alerts

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Policy Summary

PayerAlign Powered By Sanford Health Plan

PolicyStep therapy (prior authorization) criteria for selected pharmacy & specialty drugs

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateNov 1, 2025

Last ReviewOct 1, 2025

Next Review DateOct 1, 2025

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9drug/group entries listed in this partial document

1required prior therapy trials (per item)

Yescontinuation permitted for prior users

11/01/2025

Coverage criteria — Initial and continuation therapy

Actinic Keratosis - Initial Therapy

Diclofenac Sodium GEL 3% covered when the following is met:

Actinic keratosis step: Trial of either topical fluorouracil or topical imiquimod1 trial

Antidepressants - Initial Therapy

Selected branded antidepressants covered when ALL of the following are met:

Antidepressant step: Trial of two generics from the listed formulary products (bupropion, mirtazapine, citalopram (tablet or solution), desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline (tablet or solution), venlafaxine hydrochloride)2 trials

Approve for continuation of prior therapy.

Atypical Antipsychotics - Initial Therapy

Fanapt products covered when ALL of the following are met:

Atypical antipsychotic step: Trial of two oral generic formulary atypical antipsychotic agents (asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)2 trials

Approve for continuation of prior therapy.

Invega Hafyera - Initial Therapy

Invega Hafyera covered when ALL of the following are met for new starts:

Invega Hafyera step: Trial of one of: Invega Sustenna or Invega Trinza1 trial

Step applies to new starts only. Approve for continuation of prior therapy.

Namzaric - Initial Therapy

Namzaric covered when the following is met:

Namzaric step: Trial of generic memantine extended-release1 trial

Relistor - Initial Therapy

Relistor covered when the following is met:

Relistor step: Trial of one of: lubiprostone, Constulose, Enulose, Generlac, or lactulose1 trial

Relistor - Initial Therapy (prior agent trial required)

Covered when the specified prior agent trial is documented

Relistor initial step: Member has trialed one of: lubiprostone OR Constulose OR Enulose OR Generlac OR lactulose1 trial of any listed agent

Rytary - Initial Therapy

Covered when the specified prior agent trial is documented

Rytary initial step: Member has trialed one generic carbidopa/levodopa formulation1 trial of generic carbidopa/levodopa

Zonisade - Initial and Continuation Therapy

Covered when the specified prior agent trial is documented

Zonisade initial step: Member has trialed generic zonisamide capsule1 trial of generic zonisamide

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:

Actinic keratosis step: Trial of either topical fluorouracil or topical imiquimod1 trial

inv-45: Antidepressants initial step

Selected branded antidepressants covered when ALL of the following are met:

Approve for continuation of prior therapy.

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

Prior Authorization

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.

Step Therapy

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.

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

Continuation approval - antidepressants: Approve continuation of prior antidepressant therapy when documented

inv-54: Atypical antipsychotics continuation — continuation allowed when prior therapy documented

Continuation allowed when prior therapy documented

Continuation approval - atypical antipsychotics: Approve continuation of prior atypical antipsychotic therapy when documented

inv-55: Invega Hafyera continuation — continuation allowed when prior therapy documented

Continuation allowed when prior therapy documented

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

inv-42: Trial of two generics — definition of required trial of two different generic formulary agents

DefinitionDocumented trial of two different generic formulary antidepressant or antipsychotic agents from the enumerated list (e.g., bupropion, mirtazapine, citalopram [tablet or solution], desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline [tablet or solution], venlafaxine HCl).

Required trial countTwo distinct generic formulary agents must be tried and documented prior to approval.

ApplicabilityApplies to members initiating the specified branded antidepressant or antipsychotic products subject to this step therapy requirement.

ContinuationContinuation of prior therapy should be approved when documentation of prior use is provided.

DocumentationProviders must supply evidence of trials (medication name, dates, duration, and reason for discontinuation if applicable).

Policy Summary

PayerAlign Powered By Sanford Health Plan

PolicyStep therapy (prior authorization) criteria for selected pharmacy & specialty drugs

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateNov 1, 2025

Last ReviewOct 1, 2025

Next Review DateOct 1, 2025

SourceLink

On This Page

inv-46: Atypical Antipsychotics initial step

Fanapt products covered when ALL of the following are met:

Atypical antipsychotic step: Trial of two oral generic formulary atypical antipsychotic agents (asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)2 trials

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:

Invega Hafyera step: Trial of one of: Invega Sustenna or Invega Trinza1 trial

Step applies to new starts only. Approve for continuation of prior therapy.

inv-48: Namzaric initial step

Namzaric covered when the following is met:

Namzaric step: Trial of generic memantine extended-release1 trial

inv-49: Relistor initial step

Relistor covered when the following is met:

Relistor step: Trial of one of: lubiprostone, Constulose, Enulose, Generlac, or lactulose1 trial

inv-50: Relistor initial therapy — 1 top-level node

Relistor covered when the specified prior agent trial is documented

Relistor initial therapy: Trial of lubiprostone, Constulose, Enulose, Generlac, or lactulose required1 trial of any listed agent

inv-51: Rytary initial therapy — 1 top-level node

Covered when the specified prior agent trial is documented

Rytary initial step: Trial of one generic carbidopa/levodopa formulation required1 trial of generic carbidopa/levodopa

inv-52: Zonisade initial therapy — 1 top-level node

Covered when the specified prior agent trial is documented

Zonisade initial step: Trial of generic zonisamide capsule required for new starts1 trial of generic zonisamide

Continuation of prior therapy approved

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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

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).

Documentation Required

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.

Documentation Required

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.

Documentation Required

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).

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Documentation Required

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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 approval - Invega Hafyera: Approve continuation of prior Invega Hafyera therapy when documented

Step applies to new starts only.

inv-56: Zonisade continuation — continuation allowed

Continuation allowed

Zonisade continuation: Approve continuation for members already on Zonisade prior to this requirementN/A

Step applies to new starts only

inv-43: New starts — definition noting step therapy applies to members initiating therapy

DefinitionStep therapy requirement that applies to members who are initiating (new starts) the specified product; prior therapy users are eligible for continuation approval.

Example requirementFor Invega Hafyera new starts: trial of Invega Sustenna or Invega Trinza is required (one trial).

Continuation policyApprove continuation of prior therapy when documentation of prior use is provided; the step applies only to new starts.

DocumentationProviders must document the prior trial (agent name and treatment dates) for new-start requests to meet the step requirement.