Real-World Study Found XARELTO® Led to Cost Savings and Shorter Stays in U.S. Hospitals Compared to Warfarin When Used for Treatment of Blood Clots

SAN DIEGO, CA (March 7, 2016) – A new, real-world study found U.S. hospitals using XARELTO® (rivaroxaban) instead of warfarin to treat patients diagnosed with a venous thromboembolism (VTE) may save, on average, almost $2,000 per patient and shorten a patient’s hospital stay by approximately 1.5 days. The economic analysis, presented today at the Hospital Medicine 2016 congress, compared the cost savings associated with treatment with XARELTO®, a non-vitamin K antagonist oral anticoagulant (NOAC), to warfarin in the hospital setting.

VTE affects more than 900,000 Americans each year; one-third of these episodes will be fatal. VTE is a collective term encompassing deep vein thrombosis (DVT), a blood clot in a deep vein usually the leg, and pulmonary embolism (PE), when a clot travels to the lung. Published research in Thrombosis & Haemostasis shows VTEs cost the U.S. healthcare system between $13.5 and $27.2 billion each year.

“Venous thromboembolism, or VTE, represents a tremendous burden to our healthcare system, as the cost of treating these blood clots remains so high,” said Steven Deitelzweig, MD, System Chairman of Hospital Medicine, Medical Director of Regional Business Development, Ochsner Clinic Foundation, New Orleans, LA.

“This study found use of rivaroxaban was associated with lower total hospitalization costs, shorter hospital stays and a simplified treatment regimen compared to warfarin. While not a substitute for clinical trials, this analysis complements EINSTEIN, the Phase 3 clinical program used by regulatory authorities worldwide to approve rivaroxaban for the treatment of DVT and PE and long-term protection against the risk of VTE recurrence, and provides important insights for healthcare systems looking for ways to reduce the cost burden of managing these conditions,” he continued.

The study evaluated 2,446 people who were admitted to the hospital following a primary VTE diagnosis and were treated with either XARELTO® or warfarin. Patients were identified from the Truven MarketScan Hospital Drug Database between November 2012 and December 2013. Each group included 1,223 patients (751 PE patients and 472 DVT patients), with an average age of 64 years. Total hospitalization costs (which included room rate, laboratory tests, inpatient procedures, pharmacy costs and all other inpatient services) were evaluated; the analysis also looked at length of stay (LOS). Researchers found total hospitalization costs were significantly lower and LOS was significantly shorter for people taking XARELTO® compared to those receiving warfarin:

• For hospitalization costs, the XARELTO® group had an average savings of $1,888 per admission ($8,387 vs. $10,275, p<0.001) compared to the warfarin group.
• For LOS, people taking XARELTO® stayed at the hospital an average of 1.57 fewer days (3.7±3.1 days vs. 5.2±3.7 days, p<0.001). Shorter LOS also was observed for XARELTO® across stratified comparator groups, specifically provoked VTE (i.e., when VTE occurs with an identifiable cause) and unprovoked VTE (i.e., when VTE occurs in the absence of an identifiable cause) compared to the warfarin group.

In the study, researchers also examined how the use of parenteral anticoagulants, including low-molecular-weight heparin (LMWH) or unfractionated heparin, impacted LOS. These anticoagulants were administered intravenously or via infusion to approximately 64 percent of patients in each group. Findings showed the number of hospital days from first dose to discharge was lower for the XARELTO® group, when initiated with or without parenteral anticoagulants, compared to the warfarin group. Specifically, the number of hospital days for XARELTO® was 2.4±1.7 days vs. 3.9±3.7 days for warfarin with parenteral anticoagulants (p<0.001), and 2.7±1.7 days vs. 3.7±2.1 days, respectively, without parenteral anticoagulants (p<0.001).

“We’re committed to continuing our research that explores the value and cost savings our medicine offers healthcare systems,” said Paul Burton, MD, Vice President, Medical Affairs, Janssen. “Beyond our economic research, physicians can feel confident prescribing XARELTO® for their patients with DVT or PE based on the proven safety and efficacy profile as observed in the EINSTEIN trials and pooled analysis, which confirmed XARELTO® has similar efficacy and reduced the incidence of major bleeding by nearly half compared to enoxaparin, a low-molecular-weight heparin, and warfarin.”

It is important to note data may be subject to coding error and may not reflect full medical history because they were derived from and limited to the information within hospital billing records. Findings may not be representative of the entire U.S. population and the potential for unmeasured confounders may still exist.

Prior research, from both clinical trials and real-world studies, further underscores the value of XARELTO® for the treatment of VTE. For example, a post-hoc analysis of EINSTEIN found XARELTO® reduced hospital LOS by a mean of 1.6 days (p=0.0004) compared to those taking enoxaparin and warfarin, which resulted in a total cost savings of more than $3,400 per patient.1 More recently, a real-world study evaluated the likelihood of being admitted to a hospital when treated with the medicine, and found people diagnosed with DVT and treated with XARELTO® were admitted to the hospital less frequently than those treated with LMWH and warfarin (p<0.001), with no difference in subsequent hospital visits.²

Delivering Value to Patients, Physicians and Healthcare Systems

Along with its proven safety and efficacy profile, XARELTO® leads the NOAC class by having the strongest affordability and access position in the U.S. For qualifying people with commercial insurance using the XARELTO® CarePath™ saving card, XARELTO® has no cost.3 For people with Medicare and commercial insurance, XARELTO® is broadly reimbursed, with more than 93 percent of commercial patients and more than 95 percent of patients on Medicare Part D covered at the lowest branded co-pay. XARELTO® also has the lowest average out-of-pocket cost of any NOAC available in the U.S. today. More than 19 million prescriptions have been written for XARELTO® in the U.S. since its launch.

“In addition to clinical and economic research, we want to provide support to people as they undergo treatment for their blood clots, and one way we help do so is through the XARELTO® Starter Pack. The XARELTO® Starter Pack helps simplify the treatment process and provides a convenient package that enables a seamless transition of care from diagnosis to follow-up during the first 30 days when people are most vulnerable to another event,” added Dr. Burton.

The XARELTO® Starter Pack is a clearly marked 30-day supply of XARELTO®. For the first 21 days, XARELTO® is dosed twice daily at 15 mg; on day 22, the dose switches to 20 mg once daily for the remainder of treatment. Launched in October 2014, XARELTO® is the only NOAC to offer the first 30 days of treatment for VTE in one package, with one prescription.

About XARELTO® (rivaroxaban)

XARELTO® works by blocking the blood clotting Factor Xa. XARELTO® does not require routine blood monitoring. XARELTO® has a broad indication profile and is approved for six indications that include:

1. To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
2. To treat patients with deep vein thrombosis (DVT).
3. To treat patients with pulmonary embolism (PE).
4. To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism.
5. To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.
6. To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery.

IMPORTANT SAFETY INFORMATION:

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

• For people taking XARELTO® for atrial fibrillation:
  People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.

Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke.

If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

• XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily and it may take longer for bleeding to stop.

You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:

• Aspirin or aspirin-containing products
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Warfarin sodium (Coumadin®, Jantoven®)
• Any medicine that contains heparin
• Clopidogrel (Plavix®)
• Other medicines to prevent or treat blood clots

Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

• Unexpected bleeding or bleeding that lasts a long time, such as:
  • Nosebleeds that happen often
  • Unusual bleeding from gums
  • Menstrual bleeding that is heavier than normal, or vaginal bleeding
• Bleeding that is severe or that you cannot control
• Red, pink, or brown urine
• Bright red or black stools (looks like tar)
• Cough up blood or blood clots
• Vomit blood or your vomit looks like “coffee grounds”
• Headaches, feeling dizzy or weak
• Pain, swelling, or new drainage at wound sites

Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

• A thin tube called an epidural catheter is placed in your back to give you certain medicine
• You take NSAIDs or a medicine to prevent blood from clotting
• You have a history of difficult or repeated epidural or spinal punctures
• You have a history of problems with your spine or have had surgery on your spine

If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).

XARELTO® is not for patients with artificial heart valves.

WHO SHOULD NOT TAKE XARELTO®?

Do not take XARELTO® if you:

• Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
• Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?

Before taking XARELTO®, tell your doctor if you:

• Have ever had bleeding problems
• Have liver or kidney problems
• Have any other medical condition
• Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby. Tell your doctor right away if you become pregnant while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss.
• Are breastfeeding or plan to breastfeed. It is not known if XARELTO® passes into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.

Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”

Especially tell your doctor if you take:

• Ketoconazole (Nizoral®)
• Itraconazole (Onmel™, Sporanox®)
• Ritonavir (Norvir®)
• Lopinavir/ritonavir (Kaletra®)
• Indinavir (Crixivan®)
• Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril™, Epitol®)
• Phenytoin (Dilantin-125®, Dilantin®)
• Phenobarbital (Solfoton™)
• Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
• St. John’s wort (Hypericum perforatum)

Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE XARELTO®?

Take XARELTO® exactly as prescribed by your doctor.

Do not change your dose or stop taking XARELTO® unless your doctor tells you to.

• Your doctor will tell you how much XARELTO® to take and when to take it.
• Your doctor may change your dose if needed.

If you take XARELTO® for:

• Atrial Fibrillation: Take XARELTO® 1 time a day with your evening meal.

If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

• Blood clots in the veins of your legs or lungs:
  • Take XARELTO® once or twice a day as prescribed by your doctor.
  • Take XARELTO® with food at the same time each day.
  • If you miss a dose of XARELTO®:
    • and take XARELTO® 2 times a day: Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
    • and take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

• Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
  
• If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®
• Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO®without talking to your doctor first.
• Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure
• Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.
• If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

Please see “What is the most important information I should know about XARELTO®?” above.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.

Janssen and Bayer together are developing rivaroxaban.

For more information about XARELTO®, visit www.xarelto.com. The XARELTO® CarePath™ Support Program is a resource designed for healthcare providers, patients and caregivers. Visit www.xareltocarepath.com or call 1-888-XARELTO to learn more about the XARELTO® CarePath™ resources focused on access, education and adherence.

About Janssen

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.Janssen.com for more information.

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