Prior Authorization, Exceptions & Appeals for Commercial Plans

Prior Authorization, Exceptions & Appeals for Commercial Plans

There are three primary categories of requests:

  • Prior authorizations
  • Coverage determinations (including exception requests)
  • Appeals

Click here for a brochure that has been developed to help healthcare providers understand the information that payers may require for coverage of medically necessary drug therapies.

Sample Letter of Medical Necessity

Below is a sample Letter of Medical Necessity that you can use to create and submit your letter for medical necessity with either the initial claim to support the medical necessity of treatment with INVEGA TRINZA® for your patient or submit to support the medical necessity of treatment with INVEGA TRINZA® when requesting reconsideration of a denied claim.

Sample Letter of Medical Necessity (editable)

Sample Exception Letter

Each payer follows a different process when filing exceptions. Below is a sample letter you can use to create and submit your own exception request letter when requesting an exception for INVEGA TRINZA®.

Sample Exception Letter (editable)

Prior Authorization

Some health plans in select states must use their state's uniform prior authorization request form. Click here to see if your state is included.

Uniform Prior Authorization Information for Select States

Other payers follow a different process. Please see table below or contact Janssen CarePath at 877-524-3579 for assistance in obtaining prior authorization forms.

The information provided is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice, nor does it promise or guarantee coverage, levels of reimbursement, payment, or charge. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Please refer to the applicable plan's Web site, or contact the plan for more information about coverage or any restrictions or prerequisites that may apply. We strongly recommend you consult the payer organization for its reimbursement policies.

Janssen CarePath does not endorse and is not responsible for the content on any of the Web sites listed below, or the services provided by these organizations. Clicking on any of the links below will take you to a Web site to which our Privacy Policy does not apply. We encourage you to read the privacy policy of every Web site you visit.

Click on the payer link to be taken to the payer's Web site.

Payer Prior Authorization Information
Aetna Formularies & Pharmacy Clinical Policy Bulletins
Provider Precertification List
Health Care Professional Forms: Specialty Pharmacy Precertification
Prior Authorization Form
Anthem Blue Cross Blue Shield
Anthem Blue Cross of California
Anthem Blue Cross and Blue Shield of Georgia
Prescription Drug Prior Authorization Information
California Prescription Drug Prior Authorization Information
California Prescription Drug Prior Authorization Request Form
Georgia Prescription Drug Prior Authorization Information
Blue Cross and Blue Shield of Alabama Drug Coverage Guidelines (Search by drug name)
Physician-Administered Drug Policies and Forms (Acceptance required to view)
General Prescription Drug Coverage Authorization Request Form
Blue Cross and Blue Shield of Florida/Florida Blue Prior Authorization Program Information
Medical Pharmacy Prior Authorization Lists and Utilization Management
Medication Guides (Check for prior authorization requirements)
Member Prescription Drug Prior Authorization Forms
Online Prescription Drug Prior Authorization Form
Specialty Pharmacy Request Form
Blue Cross and Blue Shield of Illinois Prior Authorization and Step Therapy Programs
Specialty Drug Request Form
Preauthorization Request Physician Fax Form
Blue Cross Blue Shield of Massachusetts Prior Authorization - Pharmacy
Online Prior Authorization Requests
Blue Cross Blue Shield of Michigan Provider Prior Authorization for Medical Drugs
Prior Authorization and Step Therapy Coverage Criteria
Medication Prior Authorization Request
Blue Cross and Blue Shield of Minnesota Prescription Drugs (Search drug list for medication requirements)
Pharmacy Utilization Management
Tools & Resources For Health Care Providers: Electronic Prior-Authorization
Blue Cross and Blue Shield of Montana Prior Authorization and Step Therapy Programs
Provider Forms and Documents
Prior Authorization Request Form
Online Prior Authorization Form
Blue Cross and Blue Shield of New Mexico Prior Authorization and Step Therapy Programs
Prior Authorization Forms (Select pharmacy tab)
Preauthorization Request
Online Prior Authorization Form
Blue Cross and Blue Shield of North Carolina Prior Review and Limitations
Prior Authorization Facsimile Form
Online Prior Authorization Requests
Blue Cross and Blue Shield of Oklahoma Prior Authorization and Step Therapy Programs: Request Forms
Preauthorization Request Physician Fax Form
Online Prior Authorization Form
BlueCross BlueShield of Tennessee Pharmacy Resources & Forms
Specialty Medications Program
Prior Authorization Process for Provider-Administered Specialty Medications
BlueCross BlueShield of Texas Prior Authorization and Step Therapy Programs: Request Forms
Physician-Administered Drug Policies and Forms
Preauthorization Request Physician Fax Form
Online Prior Authorization Form
CareFirst BlueCross BlueShield Pharmacy Forms
Pharmacy Prior Authorization
Prior Authorization/Step Therapy Forms
Online Prior Authorization Form
Cigna Pharmacy Resources
Pharmacy Prior Authorization Forms (Select drug)
Medication Prior Authorization Form
CVS Caremark Prior Authorization Information
Clinical Prior Authorization Criteria Request Form
Specialty Pharmacy Services, Information and Forms
Prior Authorization Request Form
EmblemHealth Pharmacy Resources and Forms
Injectable and Specialty Drugs: Prior Approval Requirement
Prior Authorization/Precertification Portal
Harvard Pilgrim Health Care, Inc. Medication Prior Authorization Program
Medication Request Forms and Clinical Coverage Criteria
Medical Drugs Prior Authorization
Massachusetts Standard Form For Medication Prior Authorization Requests
Health Net Pharmacy and Prior Authorization Forms
Prior Authorization Forms for Specific Drugs
Highmark Blue Cross Blue Shield Prescription Drug Medication Request Form
Provider Resources for Prior Authorization Submissions
Horizon Blue Cross Blue Shield of New Jersey Pharmacy Guidelines
Prior Authorization/Medical Necessity Determination Medicine List
Online Prior Authorization Form
Humana Medical and Pharmacy Coverage Policies
For Prescribers: Specialty Pharmacy Medications
Pharmacy Prior Authorizations
Online Pharmacy Prior Authorization Portal (Members)
Medical Precertification Request Form
Independence Blue Cross Prior Authorization: Pharmacy Benefit
Specialty Medical Benefit Drugs
Prior Authorization Forms
Kaiser Permanente (Kaiser Foundation Health Plan, Inc.)
Kaiser Permanente Washington
Formulary and Formulary Exceptions Form (Select Region)
Pharmacy Forms (WA members)
Injectable Drugs Requiring Prior Authorization (WA members)
Non-Medicare Injectable Drugs Requiring Prior Authorization List (WA members)
Premera Blue Cross Drugs Requiring Approval
Pharmacy Services Prior Authorization Request Form
Wellmark Blue Cross and Blue Shield Provider Drug Information
Provider Prior Authorization

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Indication

INVEGA TRINZA® (paliperidone palmitate) a 3‑month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA® (1‑month paliperidone palmitate) for at least four months.

INVEGA SUSTENNA® (paliperidone palmitate) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.

IMPORTANT SAFETY INFORMATION FOR INVEGA TRINZA® (paliperidone palmitate) and INVEGA SUSTENNA® (paliperidone palmitate)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA‑RELATED PSYCHOSIS.

See full Prescribing Information for complete Boxed Warning

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA SUSTENNA® and INVEGA TRINZA® are not approved for use in patients with dementia-related psychosis.

Contraindications: INVEGA TRINZA® and INVEGA SUSTENNA® are contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any excipients of their formulation.

Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attacks), including fatalities, were reported at a higher incidence in elderly patients with dementia-related psychosis taking risperidone, aripiprazole, and olanzapine compared to placebo. No studies have been conducted with oral paliperidone, INVEGA SUSTENNA®, or INVEGA TRINZA® in elderly patients with dementia. These medications are not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including paliperidone. Clinical manifestations include muscle rigidity, fever, altered mental status, and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and close medical monitoring, and treatment of any concomitant serious medical problems.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. Avoid the use of drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Certain circumstances may increase the risk of the occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose, but can develop after relatively brief treatment at low doses. Elderly female patients appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. Prescribing should be consistent with the need to minimize the risk of TD (see full Prescribing Information). Discontinue drug if clinically appropriate. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, have been reported in patients treated with all atypical antipsychotics (APS). Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia during treatment should also undergo fasting blood glucose testing. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Orthostatic Hypotension and Syncope: INVEGA TRINZA® and INVEGA SUSTENNA® may induce orthostatic hypotension in some patients due to its alpha-adrenergic blocking activity. INVEGA TRINZA® and INVEGA SUSTENNA® should be used with caution in patients with known cardiovascular disease, cerebrovascular disease or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive medications). Monitoring should be considered in patients for whom this may be of concern.

Falls: Somnolence, postural hypotension, motor and sensory instability have been reported with the use of antipsychotics, including INVEGA TRINZA® and INVEGA SUSTENNA®, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including INVEGA TRINZA® and INVEGA SUSTENNA®. In patients with a history of clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC) or drug-induced leukopenia/neutropenia, perform a complete blood count frequently during the first few months of therapy. Consider discontinuing INVEGA TRINZA® and INVEGA SUSTENNA® at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue INVEGA TRINZA® and INVEGA SUSTENNA® in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC until recovery.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, INVEGA TRINZA® and INVEGA SUSTENNA® elevate prolactin levels, and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to risperidone, which is associated with higher levels of prolactin elevation than other antipsychotic agents.

Potential for Cognitive and Motor Impairment: Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with INVEGA TRINZA® and INVEGA SUSTENNA®. INVEGA TRINZA® and INVEGA SUSTENNA® have the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery, including motor vehicles, until they are reasonably certain that INVEGA TRINZA® and INVEGA SUSTENNA® do not adversely affect them.

Seizures: INVEGA TRINZA® and INVEGA SUSTENNA® should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. Conditions that lower seizure threshold may be more prevalent in patients 65 years or older.

Administration: For intramuscular injection only by a healthcare professional using only the needles provided in the INVEGA TRINZA® or INVEGA SUSTENNA® kits. Care should be taken to avoid inadvertent injection into a blood vessel.

Drug Interactions: Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John’s Wort) during a dosing interval for INVEGA TRINZA® or INVEGA SUSTENNA®. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets.

Pregnancy/Nursing: INVEGA TRINZA® and INVEGA SUSTENNA® may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare professional if they become pregnant or intend to become pregnant during treatment with INVEGA TRINZA® or INVEGA SUSTENNA®. Patients should be advised that there is a pregnancy registry that monitors outcomes in women exposed to INVEGA TRINZA® or INVEGA SUSTENNA® during pregnancy. INVEGA TRINZA® and INVEGA SUSTENNA® can pass into human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for INVEGA TRINZA® or INVEGA SUSTENNA® and any potential adverse effect on the breastfed infant from INVEGA TRINZA® or INVEGA SUSTENNA® or the mother’s underlying condition.

Commonly Observed Adverse Reactions for INVEGA TRINZA®: The most common adverse reactions (incidence ≥ 5% and occurring at least twice as often as placebo) were injection site reaction, weight increased, headache, upper respiratory tract infection, akathisia and parkinsonism.

Commonly Observed Adverse Reactions for INVEGA SUSTENNA®: The most common adverse reactions in clinical trials in patients with schizophrenia (incidence ≥ 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.

Please see full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA®.

Please see full Prescribing Information, including Boxed WARNING, for INVEGA TRINZA®.

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