Vraylar Prior Authorization Criteria: How to Get Approved

Vraylar Prior Authorization Criteria

Vraylar (cariprazine) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia and bipolar I disorder. Like other branded prescription drugs, Vraylar often requires prior authorization from insurance providers before they will cover the cost. This review will examine the typical prior authorization criteria for Vraylar and provide tips for how patients can get approval.

Understanding Prior Authorizations for Medications

Prior authorization is the process of getting approval from insurance before they will pay for a prescribed medication. This allows the insurer to verify if the drug is medically necessary and covered under the patient's plan.

Some of the reasons insurers require prior authorization include:

• It is a newer, more expensive branded medication when generic alternatives are available.
• There are safety concerns or it has a high potential for abuse.
• It is only approved for certain medical conditions.
• There are specific requirements for prescribers or medical documentation.

The prior authorization process requires the prescriber to submit information like medical records, diagnosis codes, previous treatments tried, and clinical rationale. This is reviewed to determine if the patient meets the set criteria for approval.

Why Vraylar Requires Prior Authorization

As a newer branded antipsychotic, Vraylar is often subject to prior authorization requirements from insurers and health plans. Some key reasons include:

• It is patented and more expensive than older antipsychotic options.
• Safety concerns like increased cholesterol, weight gain, and movement disorders.
• Limited FDA approval for schizophrenia and bipolar I disorder only.
• Potential for abuse or diversion due to mild stimulant effects.

Requiring prior authorization ensures Vraylar is only prescribed when medically warranted based on diagnosis, medication history, and previous responses to treatment. This controls costs for the insurer.

Typical Vraylar Prior Authorization Criteria

While specific authorization protocols vary, most insurers have similar criteria that must be met for Vraylar approval. This often includes:

• Diagnosis of schizophrenia or bipolar I disorder - Vraylar is only FDA-approved for these two conditions, so diagnosis must be verified.
• Prescribed by a psychiatrist or mental health specialist - Ensures appropriate prescriber for the psychiatric medication.
• Patient age 18-65 - Vraylar safety and efficacy have not been established outside this age range.
• Prior antipsychotic trials and responses - Failed trials of other antipsychotics show medical need for Vraylar.
• Dosing within FDA limits - Maximum FDA-approved doses are 1.5-6mg once daily for schizophrenia and 1.5-3mg once daily for bipolar I.
• Lack of contraindications - No history of conditions making Vraylar unsuitable or unsafe.

Meeting these baseline prior authorization criteria provides the clinical justification for use of Vraylar instead of other covered antipsychotic alternatives.

Provide Sufficient Documentation and Details

To increase the chances of getting Vraylar approved, it is essential to provide complete medical records and documentation that addresses the prior authorization criteria. This includes:

• Citing the specific qualifying DSM-5 diagnosis code for schizophrenia or bipolar I.
• Listing psychiatric specialists previously seen for condition treatment.
• Detailing past medication regimens tried, duration, dosage, and patient response/outcome.
• Explaining the clinical rationale for use of Vraylar over other options.
• Sharing relevant clinical notes, mental status exams, testing, and medical history.

Providing all applicable medical details in the prior authorization request demonstrates why Vraylar is the appropriate next treatment option.

Consider Step Therapy Protocols

Some insurers require step therapy for branded drugs like Vraylar. This means patients must try one or more preferred medications first before advancing to second-line options. Common medications required in step therapy include:

• Older generic antipsychotics like haloperidol, chlorpromazine, fluphenazine, perphenazine, risperidone, olanzapine, quetiapine, ziprasidone.
• First generation antipsychotics to treat positive symptoms of schizophrenia.
• Mood stabilizers like lithium, valproate, lamotrigine for bipolar disorder.

Keep step therapy protocols in mind and be prepared to document failed treatment attempts with required medications before approval for Vraylar.

Request Prior Authorization Early

Don't wait until your Vraylar prescription is ready to submit the prior authorization request. The review process can take several days to weeks for approval. Starting the authorization process early prevents delays in accessing Vraylar treatment.

As soon as the decision is made with your mental health provider to try Vraylar, have them initiate the prior authorization paperwork. This gets the ball rolling ahead of time.

Be Persistent with Denials and Appeals

If your prior authorization request is denied, don't give up. First carefully review the reason for denial and determine if additional information is needed to meet approval criteria. Ask your prescriber to provide this in an updated request or peer-to-peer call with the insurer's review doctor.

If that fails, formally appeal the denial. Keep records of all correspondence and continue requesting appeals if needed. Being persistent pays off in many cases to ultimately get coverage approval.

Consider Manufacturer Copay Programs

If you exhaust all options and still get denied coverage for Vraylar, check if you qualify for the manufacturer's copay assistance program. This can provide significant savings on your out-of-pocket costs for Vraylar if you meet program eligibility requirements.

The Vraylar Savings Card offers 12 monthly prescriptions for as little as $5 for patients with commercial insurance. Uninsured patients may pay as little as $850 per monthly fill. This can make the medication more affordable even without insurance approval.

Appealing a Prior Authorization Denial

Don't let an initial prior authorization denial stop you from ultimately getting coverage for Vraylar. Doing a formal appeal provides another opportunity to get approval. Here are some tips to strengthen your appeal case:

• Act quickly within the insurers appeal window, usually 180 days from denial.
• Request a case review by a different provider than the first reviewer.
• Highlight details in medical records that meet approval criteria.
• Get an advocacy or peer support letter from your mental health provider.
• Research your plans exceptions policy for extenuating circumstances.
• Cite supporting clinical guidelines and efficacy data for Vraylar.

Persevering through the appeals process is worthwhile to get the treatment your doctor recommends. You can even take a denial to external review or litigation, but appeals are often successful.

Other Coverage Options if Denied Approval

If you ultimately exhaust all options for getting Vraylar approved by your insurer, there may still be other avenues to get coverage:

• Manufacturer coupons - Vraylar's copay program brings out-of-pocket costs down significantly.
• Patient assistance programs - Uninsured or underinsured patients may get Vraylar free or at low cost directly from the manufacturer.
• Change to different plan - Switch to an insurer more amenable to Vraylar coverage during open enrollment.
• Independent review - External third-party reviewers may overturn a denial.
• Legal action - Pursuing legal advocacy may be an option if denials violate parity laws.

While challenging, there are usually still ways to ultimately obtain needed Vraylar treatment through persistence and exploring all options.

The Bottom Line

Gaining prior authorization approval for branded specialty medications like Vraylar can certainly be difficult. But understanding the typical criteria used by insurers, providing comprehensive medical documentation, and advocating aggressively for your case can help overcome barriers.

Work closely with your mental health providers and do your own research on prior authorization requirements. And rememberan initial denial is just the first step. Pursuing appeals, coupons, or legal remedies may ultimately lead to success in getting your Vraylar approved and covered.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.