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Xarelto®

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Prior Authorization Form, Exceptions & Appeals

Prior Authorization Form, Exceptions & Appeals

There are three primary categories of requests:

  • Prior Authorization Forms
  • 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 XARELTO® for your patient or submit to support the medical necessity of treatment with XARELTO® 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 XARELTO®.

Sample Exception Letter (editable)

Prior Authorization Form

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

Uniform Prior Authorization Form Information for Select States

Other payers follow a different process. Please see table below or contact Janssen CarePath at 877-CarePath (877-227-3728) for assistance in obtaining Prior Authorization Form 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. Nothing herein may be construed as an endorsement, approval, recommendation, representation, or warranty of any kind by any plan or insurer referenced herein. This communication is solely the responsibility of Janssen.

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 Form Exception Form
Aetna Prior Authorization Form Exception Form
American Postal Workers Union (APWU) Prior Authorization Form N/A
Anthem BCBS of KY Prior Authorization Form Exception Form
Avera Health Plans Prior Authorization Form Exception Form
Florida Blue Prior Authorization Form Exception Form
Blue Cross and Blue Shield of Kansas Prior Authorization Form Exception Form
Federal Employee Program Prior Authorization Form N/A
Blue Cross Blue Shield of Arizona Prior Authorization Form N/A
Blue Cross Blue Shield of Massachusetts Prior Authorization Form Exception Form
Blue Cross and Blue Shield of North Carolina Prior Authorization Form Exception Form
Blue Cross & Blue Shield of Rhode Island Prior Authorization Form Exception Form
Blue Cross and Blue Shield of Vermont Prior Authorization Form Exception Form
Blue Shield of California Prior Authorization Form N/A
Blue Cross and Blue Shield of Louisiana Prior Authorization Form Exception Form
Regence Prior Authorization Form N/A
Capital District Physicians' Health Plan (CDPHP) Prior Authorization Form Exception Form
Centene Corporation Prior Authorization Form N/A
CommunityCare Prior Authorization Form Exception Form
Dean Health Plan Prior Authorization Form Exception Form
TRICARE Prior Authorization Form Exception Form
U.S. Department of Veterans Affairs N/A Exception Form
EmblemHealth Prior Authorization Form N/A
Excellus Prior Authorization Form Exception Form
Fallon Health Prior Authorization Form Exception Form
Government Employees Health Association (GEHA) Prior Authorization Form N/A
Group Health Cooperative of South Central Wisconsin Prior Authorization Form Exception Form
Harvard Pilgrim Health Care Prior Authorization Form Exception Form
HMSA Prior Authorization Form Exception Form
Health Alliance Plan (HAP) Prior Authorization Form Exception Form
Health New England Prior Authorization Form Exception Form
HealthNow New York Prior Authorization Form N/A
Highmark Prior Authorization Form Exception Form
Hometown Health Prior Authorization Form Exception Form
Horizon BCBSNJ Prior Authorization Form Exception Form
Humana Prior Authorization Form Exception Form
Mayo Health Employees Prior Authorization Form Exception Form
Medical Mutual of Ohio Prior Authorization Form Exception Form
MVP Health Care Prior Authorization Form Exception Form
Neighborhood Health Plan Prior Authorization Form Exception Form
PacificSource Health Plan Prior Authorization Form Exception Form
Premera Prior Authorization Form Exception Form
Presbyterian Health Plan Prior Authorization Form Exception Form
Priority Health Prior Authorization Form Exception Form
Providence Health Plan Prior Authorization Form Exception Form
Unity Health Insurance (Quartz) Prior Authorization Form Exception Form
Empire Plan (New York State Employees) Prior Authorization Form Exception Form
Utah Public Employees Health Plan (PEHP) Prior Authorization Form N/A
State Employees of Washington Prior Authorization Form N/A
Tufts Health Plan Prior Authorization Form N/A
UnitedHealthcare Prior Authorization Form Exception Form
University Health Alliance (UHA) Prior Authorization Form Exception Form
UPMC Health Plan Prior Authorization Form Exception Form
WPS Health Insurance Prior Authorization Form N/A

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INDICATIONS

XARELTO® is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

There are limited data on the relative effectiveness of XARELTO® and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

XARELTO® is indicated for the treatment of deep vein thrombosis (DVT). XARELTO® is indicated for the treatment of pulmonary embolism (PE). XARELTO® is indicated for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

XARELTO® is indicated for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

XARELTO® is indicated, in combination with aspirin, to reduce the risk of major cardiovascular events (cardiovascular [CV] death, myocardial infarction [MI], and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

Important Safety Information for XARELTO®

WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA

A. Premature discontinuation of XARELTO® increases the risk of thrombotic events

Premature discontinuation of any oral anticoagulant, including XARELTO®, increases the risk of thrombotic events. If anticoagulation with XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

B. Spinal/epidural hematoma

Epidural or spinal hematomas have occurred in patients treated with XARELTO® who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • Use of indwelling epidural catheters
  • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants, see Drug Interactions
  • A history of traumatic or repeated epidural or spinal punctures
  • A history of spinal deformity or spinal surgery
  • Optimal timing between the administration of XARELTO® and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

CONTRAINDICATIONS

  • Active pathological bleeding
  • Severe hypersensitivity reaction to XARELTO® (eg, anaphylactic reactions)

WARNINGS AND PRECAUTIONS

  • Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including XARELTO®, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO® to warfarin in clinical trials in atrial fibrillation patients. If XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
  • Risk of Bleeding: XARELTO® increases the risk of bleeding and can cause serious or fatal bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue in patients with active pathological hemorrhage.
    • An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable.
    • Concomitant use of other drugs that impair hemostasis increases risk of bleeding. These include aspirin, P2Y12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, NSAIDs, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs).
  • Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. To reduce the potential risk of bleeding associated with concurrent use of XARELTO® and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of XARELTO®. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of XARELTO® is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. An indwelling epidural or intrathecal catheter should not be removed before at least 2 half-lives have elapsed (ie, 18 hours in young patients aged 20 to 45 years and 26 hours in elderly patients aged 60 to 76 years), after the last administration of XARELTO®. The next dose should not be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of XARELTO® for 24 hours. Monitor frequently to detect signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), or bowel and/or bladder dysfunction. Instruct patients to immediately report any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
  • Use in Patients with Renal Impairment:
    • Nonvalvular Atrial Fibrillation: Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly. Consider dose adjustment or discontinuation in patients who develop acute renal failure while on XARELTO®. Clinical efficacy and safety studies with XARELTO® did not enroll patients with CrCl ≤30 mL/min or end-stage renal disease (ESRD) on dialysis.
    • Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE: Avoid the use of XARELTO® in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamics effects in this patient population.
    • Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: Avoid the use of XARELTO® in patients with CrCl <30 mL/min due to an expected increase in rivaroxaban exposure and pharmacodynamics effects in this patient population. Observe closely and promptly evaluate signs or symptoms of blood loss in patients with CrCl 30 to 50 mL/min. Patients who develop acute renal failure while on XARELTO® should discontinue treatment.
    • Reduction of Risk of Major Cardiovascular Events in Patients with Chronic CAD or PAD: For patients with CrCl <15 mL/min, no data are available, and limited data are available for patients with a CrCl of 15-30 mL/min. In patients with CrCl ≤30 mL/min, a dose of 2.5 mg XARELTO® twice daily is expected to give an exposure similar to that in patients with moderate renal impairment, whose efficacy and safety outcomes were similar to those with preserved renal function. Clinical efficacy and safety studies with XARELTO® did not enroll patients with end-stage renal disease (ESRD) on dialysis.
  • Use in Patients with Hepatic Impairment: No clinical data are available for patients with severe hepatic impairment. Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy, since drug exposure and bleeding risk may be increased.
  • Use with P-gp and Strong CYP3A Inhibitors or Inducers: Avoid concomitant use of XARELTO® with known combined P-gp and strong CYP3A inhibitors or inducers.
  • Risk of Pregnancy-Related Hemorrhage: In pregnant women, XARELTO® should be used only if the potential benefit justifies the potential risk to the mother and fetus. XARELTO® dosing in pregnancy has not been studied. The anticoagulant effect of XARELTO® cannot be monitored with standard laboratory testing. Promptly evaluate signs or symptoms suggesting blood loss (eg, a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress).
  • Patients with Prosthetic Heart Valves: Safety and efficacy of XARELTO® have not been studied in patients with prosthetic heart valves. Use of XARELTO® is not recommended in these patients.
  • Acute PE in Hemodynamically Unstable Patients/Patients Who Require Thrombolysis or Pulmonary Embolectomy: Initiation of XARELTO® is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

DRUG INTERACTIONS

  • Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase risk of bleeding.
  • Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase risk of thromboembolic events.
  • XARELTO® should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (eg, erythromycin) unless the potential benefit justifies the potential risk.
  • Coadministration of enoxaparin, warfarin, aspirin, clopidogrel, and chronic NSAID use may increase risk of bleeding.
  • Avoid concurrent use of XARELTO® with other anticoagulants due to increased bleeding risk, unless benefit outweighs risk. Promptly evaluate signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: The limited available data on XARELTO® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use XARELTO® with caution in pregnant patients because of the potential for pregnancy-related hemorrhage and/or emergent delivery. The anticoagulant effect of XARELTO® cannot be reliably monitored with standard laboratory testing. Consider the benefits and risks of XARELTO® for the mother and possible risks to the fetus when prescribing to a pregnant woman.
    • Fetal/Neonatal adverse reactions: Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate.
    • Labor or delivery: The risk of bleeding should be balanced with the risk of thrombotic events when considering use in this setting.
    • There are no adequate or well-controlled studies of XARELTO® in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.
  • Lactation: Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for XARELTO® and any potential adverse effects on the breastfed infant from XARELTO® or from the underlying maternal condition.
  • Females and Males of Reproductive Potential: Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.
  • Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

OVERDOSAGE

  • Overdose of XARELTO® may lead to hemorrhage. Discontinue XARELTO® and initiate appropriate therapy if bleeding complications associated with overdosage occur. An agent to reverse the anti-factor Xa activity of rivaroxaban is available.

ADVERSE REACTIONS IN CLINICAL STUDIES

  • Most common adverse reactions with XARELTO® were bleeding complications.

Please see full Prescribing Information, including Boxed WARNINGS.

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