Actinic keratosis — prior topical therapy required

Diclofenac Sodium GEL 3% requires a prior trial of either topical fluorouracil or topical imiquimod before authorization. Document the trial of one of these topical therapies when submitting an initial prior authorization request.

• Required trial: topical fluorouracil OR topical imiquimod
• Applies to initial starts for Diclofenac Sodium GEL 3%

Antidepressant — two generic trials required (or continuation)

Branded antidepressants listed (e.g., Emsam, Exxua) require documentation of trials of two generic formulary antidepressants from the specified list, or the request must be for continuation of prior therapy. Include dates, agents, and treatment outcomes for each generic trial in the prior authorization submission.

• Required trials: two generic formulary antidepressants (agents listed in policy: bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine HCl)
• Continuation requests: approve for continuation of prior therapy

Atypical antipsychotic — two generic trials required (or continuation)

Listed atypical antipsychotics require a trial of two oral generic formulary atypical antipsychotics (agents enumerated in the policy) prior to approval for new therapy; continuation of prior therapy is allowed. Provide documentation of the two generic agent trials when requesting initial approval.

• Required trials: two oral generic atypical antipsychotics (asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)
• Continuation requests: approve for continuation of prior therapy

Invega Hafyera — Sustenna/Trinza trial required for new starts

For new starts of Invega Hafyera, a trial of Invega Sustenna or Invega Trinza is required before Invega Hafyera will be approved; members already receiving therapy may be approved for continuation. Include documentation of the prior Sustenna or Trinza trial for initial requests.

• Required trial (new starts): Invega Sustenna OR Invega Trinza
• Step applies to new starts only; continuation of prior Hafyera therapy is approved

Relistor — trial of listed laxatives required

Relistor requires a prior trial of alternative constipation agents (examples listed in the policy) before authorization. Submit documentation of a trial of one of the listed agents when requesting initial coverage for Relistor.

• Required trial options: lubiprostone, Constulose, Enulose, Generlac, lactulose, OR Movantik
• Document agent, dates, and response/failure

Rytary — generic carbidopa/levodopa trial required

Rytary requires a documented trial of one generic carbidopa/levodopa containing formulation prior to approval for initial therapy. Provide specific documentation of the generic formulation trial in the prior authorization request.

• Required trial: one generic carbidopa/levodopa formulation
• Document agent name, dates, and reason for switching if applicable

Prior authorization — required evidence of prior trials for initial starts

Prior authorization for initial starts requires evidence of the specified prior trial(s) described in the policy; continuation requests for members already on therapy (where noted, e.g., Zonisade, Invega Hafyera, certain antidepressants/antipsychotics) may be approved without repeating the step.

• Initial approvals: submit documentation of required prior trial(s)
• Continuation approvals: allowed for prior users where policy notes continuation is approved (e.g., Zonisade, Invega Hafyera, certain antidepressants/antipsychotics)

Diclofenac (actinic keratosis) — step therapy requires topical fluorouracil or imiquimod

Step therapy for Diclofenac Sodium GEL 3% requires a prior trial of topical fluorouracil or topical imiquimod before coverage will be granted. Ensure the prior trial is documented for initial authorization requests for diclofenac gel.

• Step required: topical fluorouracil OR topical imiquimod
• Applies prior to Diclofenac Sodium GEL 3% coverage

Antidepressant — two generic formulary trials required as step

For the listed branded antidepressants (Emsam, Exxua, etc.), step therapy requires trials of two generic formulary antidepressants from the policy’s specified list; continuation of prior therapy is permitted. Include documentation of both generic trials for initial requests.

• Required step: two generic formulary antidepressants (see policy list)
• Continuation: prior therapy may be approved without repeating step

Atypical antipsychotic — two generic oral trials required

Step therapy for the listed atypical antipsychotics requires trials of two oral generic formulary atypical antipsychotics prior to approval; continuation of prior therapy is allowed. Provide documentation of the two generic oral atypical antipsychotic trials for initial authorization.

• Required step: two oral generic atypical antipsychotics (asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)
• Continuation: approve for members already on therapy

Invega Hafyera — new-start step requires Sustenna or Trinza

Invega Hafyera’s step requirement applies to new starts only and requires trial of Invega Sustenna or Invega Trinza; prior users may be approved for continuation. For initial requests, include documentation of the Sustenna or Trinza trial.

• Step (new starts): Invega Sustenna OR Invega Trinza
• Step waived for continuation of prior Hafyera therapy

Relistor — step requires trial of listed laxatives

Relistor step therapy requires trial of one of the listed alternative constipation agents (lubiprostone, Constulose, Enulose, Generlac, lactulose, or Movantik) before authorization. Document the tried agent and response when requesting approval.

• Required step options: lubiprostone; Constulose; Enulose; Generlac; lactulose; Movantik
• Document treatment duration and outcome

Rytary — step requires generic carbidopa/levodopa trial

Rytary’s step therapy requires a trial of one generic carbidopa/levodopa containing formulation before initial approval. Include the generic formulation name and trial dates in the prior authorization documentation.

• Required step: one generic carbidopa/levodopa formulation
• Document product name, dates, and reason for inadequate response if applicable

Step trial requirements — specified generic trials required for initial starts

Step trial requirements across the policy consolidate that initial starts require documented trials of the specified generic formulations (for example, Rytary requires a generic carbidopa/levodopa trial; Zonisade requires a generic zonisamide capsule trial). For products where continuation is allowed, do not repeat the step for members already on therapy.

• Examples: Rytary — trial of one generic carbidopa/levodopa; Zonisade — trial of generic zonisamide capsule (step applies to new starts only)
• Continuation of prior therapy may be approved without repeating the step

Actinic keratosis prior therapy documentation required

For diclofenac gel, prior therapy documentation must show a trial of topical fluorouracil or topical imiquimod. Include agent name(s), dates, duration, and reason for failure or intolerance in the submission.

• Documentation required: topical fluorouracil OR topical imiquimod trial
• Include dates, duration, and outcome

Antidepressant — trial documentation required

For branded antidepressants, document trials of two generic formulary antidepressants (agents listed in the policy) or provide evidence of continuation of prior therapy. Include agent names, trial dates, durations, and treatment response.

• Documentation required: two generic antidepressant trials OR evidence of continuation
• Provide dates, durations, and reason for inadequate response or intolerance

Atypical antipsychotic — trial documentation required

For atypical antipsychotics, submit documentation of trials of two oral generic atypical antipsychotics or evidence of continuation of prior therapy. Include agent names, dates, durations, and clinical response.

• Documentation required: two oral generic atypical antipsychotic trials OR continuation history
• Include dates, duration, and reason for switching

Required documentation — specific generic trial evidence

For initial approvals that require a generic-formulation trial (e.g., Rytary, Zonisade), provide documentation of the specific generic trial used to meet the step requirement. Continuation requests for members already on therapy may be approved without repeating the step when the policy specifies.

• Required documentation: evidence of prior trial of the specified generic formulation (e.g., generic carbidopa/levodopa for Rytary; generic zonisamide for Zonisade)
• Continuation: prior users may be approved without repeating the step where noted

Denial risk — actinic keratosis prerequisite topical therapy missing

Failure to document a prior trial of topical fluorouracil or topical imiquimod for diclofenac gel may result in denial of the request. Ensure the required topical trial is clearly documented for initial diclofenac gel approvals.

• Denial risk: no documented trial of topical fluorouracil or topical imiquimod for diclofenac gel

Denial risk — antidepressant step trials absent

For the listed branded antidepressants, absence of documented trials of two generic formulary antidepressants may trigger denial. Provide complete documentation of both generic trials or evidence of continuation to avoid non-approval.

• Denial risk: lack of two documented generic antidepressant trials for initial branded antidepressant requests

Denial risk — atypical antipsychotic step trials absent

For listed atypical antipsychotics, failure to show trials of two oral generic formulary atypical antipsychotics may lead to denial. Ensure both generic agent trials are documented for initial approvals.

• Denial risk: absence of two documented generic oral atypical antipsychotic trials

Denial risk — Invega Hafyera new-start trial missing

For new starts of Invega Hafyera, not documenting a prior trial of Invega Sustenna or Invega Trinza may result in non-approval. Provide evidence of the required Sustenna or Trinza trial for initial requests.

• Denial risk: no documented trial of Invega Sustenna or Invega Trinza for new starts

Denial risk — Relistor prior laxative trial missing

For Relistor, absence of a trial of one of the listed laxatives (lubiprostone, lactulose, Movantik, etc.) may trigger denial. Document the prior laxative trial with dates and response when submitting the request.

• Denial risk: no documented trial of listed alternative constipation agents

Denial risk — Rytary generic trial missing

For Rytary, failure to document a prior trial of a generic carbidopa/levodopa formulation may trigger denial of the initial request. Include the generic trial details in the prior authorization.

• Denial risk: no documented trial of generic carbidopa/levodopa prior to Rytary

Denial risk — missing step trial documentation

Failure to document the required prior trial(s) with the specified generic formulations (for example, generic carbidopa/levodopa for Rytary or generic zonisamide capsule for Zonisade) may result in denial. Ensure all step trials required by the policy are supported with documentation in the request.

• Denial risk: incomplete or missing documentation of required prior trials for initial starts
• Include agent names, dates, durations, and clinical rationale for failure