Applicability

These step-therapy criteria apply to Quartz Medicare Advantage and Dual Eligible members for medications covered under Medicare Part D benefits.

Invega Hafyera — new starts only

For new starts of Invega Hafyera, the patient must have a trial of Invega Sustenna or Invega Trinza; continuation of prior Invega Hafyera therapy is approved and not subject to the step requirement.

Rytary — generic carbidopa/levodopa trial required

Prior to coverage of Rytary, document a trial of one generic carbidopa/levodopa–containing formulation.

Zonisade — generic zonisamide trial for new starts

For new starts of Zonisade Suspension, document a trial of a generic zonisamide capsule; patients already on Zonisade may continue without redoing the step.

Actinic keratosis — alternate topical trial required

Before Diclofenac Sodium GEL 3% is covered for actinic keratosis, document a trial of either topical fluorouracil or topical imiquimod.

Antidepressants — two generic trials required

For covered branded antidepressants listed (e.g., Fetzima and related products), document trials of two generic formulary antidepressants from the specified list prior to approval; continuation of prior therapy is approved.

• Required trial list includes: bupropion, mirtazapine, citalopram (tablet or solution), desvenlafaxine succinate ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine hydrochloride.

Atypical antipsychotics — two generic trials required

For the listed atypical antipsychotics, document trials of two oral generic formulary atypical antipsychotics from the specified list prior to approval; continuation of prior therapy is approved.

• Required trial list includes: asenapine, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone.

Invega Hafyera — LAI trial required for new starts

New starts of Invega Hafyera require a documented trial of either Invega Sustenna or Invega Trinza; members already receiving Invega Hafyera may be continued without meeting this step.

Relistor — laxative trial required

Before prescribing Relistor, document a trial of one of the listed laxatives: lubiprostone, Constulose, Enulose, Generlac, or lactulose.

• Acceptable prior agents: lubiprostone; Constulose; Enulose; Generlac; lactulose.

Rytary — trial of generic carbidopa/levodopa required

Document a trial of one generic carbidopa/levodopa formulation before Rytary will be covered.

Rytary step-therapy requirement

Rytary has a step-therapy requirement: a trial of one generic carbidopa/levodopa–containing formulation is required prior to Rytary.

Zonisade step-therapy requirement

Zonisade Suspension’s step is: document trial of a generic zonisamide capsule for new starts; continuation of prior Zonisade therapy should be approved without repeating the step.

Continuation approval (Invega Hafyera)

Documentation that the member previously received Invega Hafyera or another listed Invega LAI suffices to approve continuation of therapy without requiring the new-start step.

Continuation approval across classes

Multiple entries state 'Approve for continuation of prior therapy' — document prior use of the specified agent(s) to avoid triggering the step requirement.

Rytary — documentation of generic trial required

For Rytary new starts, include documentation of the prior trial of one generic carbidopa/levodopa formulation when submitting for authorization.

Zonisade — documentation of generic zonisamide trial

For Zonisade new starts, provide documentation that the patient tried a generic zonisamide capsule; members on existing Zonisade therapy may be continued without reauthorizing the step.

Denial risk — actinic keratosis topical trial

Failure to document a trial of topical fluorouracil or topical imiquimod before Diclofenac Sodium GEL 3% may result in denial of coverage.

Denial risk — two generic antidepressant trials

For the listed branded antidepressants, failure to document trials of two generic formulary antidepressants from the specified list may lead to denial.

Denial risk — two generic atypical antipsychotic trials

For the listed atypical antipsychotics, failure to document trials of two oral generic formulary atypical antipsychotics from the specified list may lead to denial.

Denial risk — Invega Hafyera prior LAI trial

For new starts of Invega Hafyera, lack of documented trial of Invega Sustenna or Invega Trinza may result in denial.

Denial risk — Relistor laxative trial

Failure to document a trial of an acceptable laxative (lubiprostone, Constulose, Enulose, Generlac, or lactulose) prior to Relistor may result in denial.

Denial risk — Rytary generic carbidopa/levodopa trial

For Rytary, failure to document a trial of a generic carbidopa/levodopa formulation may lead to denial of the request.

Denial risk — Rytary step requirement

Not providing documentation of the required trial of one generic carbidopa/levodopa formulation may trigger denial under Rytary’s step-therapy requirement.

Denial risk — Zonisade generic zonisamide trial

For new starts of Zonisade Suspension, prescriptions lacking documentation of a trial of a generic zonisamide capsule may be denied; continuation of prior therapy should be approved.