Actinic keratosis — prior topical therapy required

Diclofenac Sodium GEL 3% requires documented evidence of a prior trial of either topical fluorouracil or topical imiquimod before coverage is approved.

• Required prior trial: topical fluorouracil OR topical imiquimod

Antidepressants — two generic trials required

Emsam, Exxua (and Exxua Titration Pack), Fetzima (and Fetzima Titration Pack) require trials of two generic antidepressants from the specified formulary list prior to approval; continuation is allowed for members already on therapy.

• Required trials: two generics from bupropion, mirtazapine, citalopram, desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine hydrochloride
• Continuation of prior therapy may be approved without repeating step

Atypical antipsychotics — two generic trials required

Fanapt and related products (Fanapt titration packs, Lybalvi, Secuado) require trials of two generic formulary atypical antipsychotics from the listed agents prior to approval; continuation of prior therapy is permitted.

• Required trials: two of asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone
• Continuation of prior therapy may be approved without repeating step

Invega Hafyera — prior LAI trial for new starts

For new starts of Invega Hafyera, a prior trial of Invega Sustenna or Invega Trinza is required; members already on Invega Hafyera may be continued without meeting the new-start step.

• Required prior LAI trial for new starts: Invega Sustenna OR Invega Trinza
• Step applies to new starts only; continuation of prior therapy approved

Relistor — prior laxative trial required

Relistor requires documentation of a prior trial of an acceptable laxative before approval.

• Acceptable laxatives: lubiprostone, Constulose, Enulose, Generlac, or lactulose
• One trial of an acceptable laxative is required per criteria

Rytary — prior carbidopa/levodopa trial required

Rytary requires a prior trial of one generic carbidopa/levodopa–containing formulation before coverage is approved.

• Required trial: one generic carbidopa/levodopa containing formulation

Zonisade suspension — prior authorization and trial

Zonisade (Zonisade suspension) requires prior authorization for new starts with documentation of a trial of a generic zonisamide capsule; members already receiving zonisamide may be continued.

• Required prior trial for new starts: generic zonisamide capsule
• Continuation allowed for members already on therapy

Carbidopa/levodopa — prior authorization requirement

Carbidopa/levodopa products listed in the index require documentation of a prior trial of one generic carbidopa/levodopa formulation as a condition of coverage.

• Required trial: one generic carbidopa/levodopa containing formulation

Actinic keratosis — step therapy requirement

Diclofenac Sodium GEL 3% must be preceded by a trial of either topical fluorouracil or topical imiquimod (step 1) before approval is granted.

• Step 1 requirement: trial of topical fluorouracil OR topical imiquimod

Antidepressant group — step therapy requirement

The antidepressant group (Emsam, Exxua, Fetzima and their titration packs) requires trials of two generic formulary antidepressants (from the specified list) as the step requirement; continuation of prior therapy is allowed.

• Step 1 requirement: two generic trials from the listed antidepressant agents
• Continuation of prior therapy may be approved

Atypical antipsychotics — step therapy requirement

Fanapt, Lybalvi, Secuado and related products require trials of two generic formulary atypical antipsychotics (step 1) prior to approval; continuation of prior therapy is allowed.

• Step 1 requirement: two trials from asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone
• Continuation of prior therapy may be approved

Invega Hafyera — step therapy for new starts

For new starts of Invega Hafyera, the step requirement is a trial of Invega Sustenna or Invega Trinza (step 1); members already on therapy may be continued without meeting this step.

• Step 1 requirement for new starts: Invega Sustenna OR Invega Trinza
• Step applies to new starts only; continuation approved

Relistor — step therapy requirement

Relistor’s step requires a prior trial of one of the specified laxatives before approval (lubiprostone, Constulose, Enulose, Generlac, or lactulose).

• Step 1 requirement: trial of lubiprostone, Constulose, Enulose, Generlac, OR lactulose

Rytary — step therapy requirement

Rytary’s step therapy requires a trial of one generic carbidopa/levodopa formulation (step 1) prior to approval.

• Step 1 requirement: trial of one generic carbidopa/levodopa containing formulation

Step therapy example — carbidopa/levodopa

Example step definition: step 1 corresponds to a trial of one generic carbidopa/levodopa–containing formulation (used as the example step entry in the criteria index).

• Example: Step 1 = trial of one generic carbidopa/levodopa formulation

Zonisade — step therapy for new starts

Zonisade step therapy requires a trial of a generic zonisamide capsule for new starts (step 1); continuation is approved for members already on zonisamide without meeting the step.

• Step 1 requirement (new starts): trial of generic zonisamide capsule
• Step applies to new starts only; continuation of prior therapy approved

Continuation of prior therapy — document status

When continuation of prior therapy is applicable, approve continuation and document the member’s prior therapy status in the request.

• Document that member is already receiving the product to allow continuation approval

Zonisade — required documentation for new starts

For Zonisa­de new starts, documentation must demonstrate a trial of a generic zonisamide capsule; include prior therapy history to support continuation if applicable.

• Provide records showing trial of generic zonisamide capsule for new starts
• Include prior medication history if requesting continuation

Carbidopa/levodopa — documentation requirement

For carbidopa/levodopa step requirements, document a prior trial of one generic carbidopa/levodopa–containing formulation as specified in the criteria index.

• Record the product name and dates of the generic carbidopa/levodopa trial

Actinic keratosis — denial risk for missing prior trial

Coverage for Diclofenac Sodium GEL 3% may be denied if there is no documentation of a prior trial of either topical fluorouracil or topical imiquimod.

• Lack of the required prior topical trial can result in denial

Antidepressants — denial risk for missing prior trials

Coverage for the listed antidepressants may be denied if documentation does not show trials of two required generic antidepressants from the formulary list.

• Absence of two documented generic trials can lead to denial

Atypical antipsychotics — denial risk for missing prior trials

Coverage for Fanapt and related atypical antipsychotic products may be denied if two trials of generic formulary atypical antipsychotics are not documented.

• Failure to document two required generic atypical antipsychotic trials may result in denial

Invega Hafyera — denial risk for missing LAI trial

For new starts of Invega Hafyera, absence of a documented trial of Invega Sustenna or Invega Trinza may lead to denial.

• New starts without documentation of the required LAI trial risk denial

Relistor — denial risk for missing prior laxative trial

Coverage for Relistor may be denied if there is no documentation of a trial of an acceptable laxative (lubiprostone, Constulose, Enulose, Generlac, or lactulose).

• Absence of a documented laxative trial can result in denial

Rytary — denial risk for missing prior trial

Coverage for Rytary may be denied if there is no documentation of a trial of one generic carbidopa/levodopa–containing formulation.

• Missing documentation of the required generic carbidopa/levodopa trial may lead to denial

Zonisade — denial risk for missing step on new starts

For Zonisade new starts, failure to document a trial of a generic zonisamide capsule may trigger denial; the step applies only to new starts.

• Step applies to new starts only; document the generic trial to avoid denial

Carbidopa/levodopa — denial risk for missing step

Carbidopa/levodopa entries require a documented trial of one generic carbidopa/levodopa formulation per the criteria; absence may result in denial.

• Document the generic formulation trial to meet step requirement