RARITAN, NJ (November 18, 2014) — New data presented today at the American Heart Association (AHA) 2014 Scientific Sessions showed once-daily XARELTO® (rivaroxaban) is associated with significantly fewer hospitalization days and outpatient visits compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). Corresponding hospitalization and outpatient healthcare costs were also significantly lower for XARELTO® compared to warfarin in NVAF patients, according to longitudinal, real-world findings from this observational study.
"When examining the cost and value of anticoagulant treatment more holistically in this study, including the cost of the medicine, we observed the overall all-cause and non-valvular atrial fibrillation-related costs remain comparable between XARELTO and warfarin. This is due to the cost savings from a reduced hospital length of stay for patients treated with XARELTO offsetting the price of the medicine," said Concetta Crivera, PharmD, MPH, Director, HECOR Cardiovascular, Janssen Scientific Affairs, LLC. (Janssen). "This research provides insight into the value of XARELTO, an alternative to the standard of care without the need for routine blood monitoring and no known dietary restrictions, and is especially important, as growing healthcare costs pose a concern for payers, providers and patients."
From May 2011 to December 2012, researchers analyzed medical and pharmacy healthcare claims from more than 4,500 patients in the Humana integrated claims database, which includes over 11.3 million commercial and Medicare insurance members across the U.S. The total number of hospitalization days, resource utilization (defined as hospitalizations, outpatient visits and emergency room [ER] visits), and healthcare costs including costs of the medicine, were reported.
Findings from the study suggest the cost burden associated with XARELTO® for all-cause and NVAF-related hospitalization costs, as well as all-cause outpatient visit costs, was significantly lower than that associated with warfarin in patients with NVAF. Additionally, the mean all-cause and NVAF-related total of hospitalization days were significantly fewer for XARELTO® compared to warfarin (2.71 vs. 3.87 days; 2.11 vs. 3.02 days).
"For patients with NVAF, XARELTO may simplify care through once-daily dosing, available to most patients at the lowest branded co-pay," said Dr. Crivera. "A wealth of published data, including findings presented today, further illustrates how XARELTO offers value to patients and providers alike, including hospitalization cost-savings over standard of care."
Today's findings expand on existing data for XARELTO®, which demonstrate the treatment is associated with reduced hospitalization costs across indications compared to warfarin, including:
- Multi-Indication: A cross-indication economic model published in the Journal of Medical Economics using treatment regimens from the ROCKET-AF, EINSTEIN-DVT and PE, and RECORD1-3 randomized clinical trials shows XARELTO® was associated with an overall mean cost-savings of $1,520 per hospitalized patient, across five of its six approved indications. The distribution of hospital admissions used in the model across the different populations was derived from the 2010 Healthcare Cost and Utilization Project database. Of note, the distribution of patients across indications used in the model may not be generalizable to all hospitals, where practice patterns may vary, and average length of stay (LOS) cost may not reflect the actual reimbursements that hospitals received.
- VTE: Data from a post-hoc analysis of the North American sub-set of patients from the randomized, open-label EINSTEIN trial program published in the Journal of Medical Economics show hospitalized patients with venous thromboembolism (VTE) treated with XARELTO®had a significantly shorter LOS compared to standard of care, resulting in total cost-savings of more than $3,400 per patient. XARELTO®use was associated with a 1.6-day mean reduction in LOS (median=1 day) compared with enoxaparin/VKA (median=3 vs. 4 days). Cost savings in the study were estimated based on average cost per day rather than actual cost reductions due to shorter LOS. In addition, both clinicians and patients may demonstrate different behaviors when they are being studied, so results may not reflect real-world practice.
- A retrospective, matched analysis using the Premier Perspective Comparative Hospital Database compared the hospital length of stay of patients who were treated with XARELTO® versus warfarin. These data published in Current Medical Research & Opinionshow XARELTO® was associated with cost-savings of $1,284 per hospitalization compared to warfarin in patients with NVAF. Of note, hospital data included in analysis may have possible inaccuracies or omissions in diagnoses due to evaluation of claims, completeness of baseline characteristics, and patients were matched based only on information available during hospitalizations occurring at the same hospital.
- A separate analysis of the same data published in Current Medical Research and Opinion found NVAF patients receiving XARELTO® have a significantly lower hospital LOS as compared to patients receiving warfarin (median= 1 day [3 days for XARELTO® vs. 4 days for warfarin]). Of note, hospital data included in analysis may have possible inaccuracies or omissions in diagnoses due to evaluation of claims, completeness of baseline characteristics, and patients were matched based only on information available during hospitalizations occurring at the same hospital.
In the U.S., XARELTO® has the strongest access position of any novel oral anticoagulant. For patients with commercial insurance using a co-pay card, XARELTO® costs only $5 a month, similar to warfarin. It is broadly reimbursed, with 93 percent of patients on Medicare Part D and 92 percent of commercial patients covered at the lowest branded co-pay. XARELTO® also has the lowest average out-of-pocket cost of any novel oral anticoagulant available in the U.S. market today.
As part of its ongoing commitment to patients, Janssen offers a comprehensive patient education, support and access program – XARELTO® CarePath™ – which includes print and digital education materials, refill reminders, care coordinators available by phone and prescription savings cards. The XARELTO® CarePath™ Support Program is a resource designed for healthcare providers, patients and caregivers. Visitwww.xareltocarepath.com or call 1-888-XARELTO to learn more about the XARELTO® CarePath™ resources focused on access, education and adherence. For more information about XARELTO®, visit www.xarelto-us.com.
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:
- 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.
- To treat patients with deep vein thrombosis (DVT).
- To treat patients with pulmonary embolism (PE).
- To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism.
- To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.
- To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery.
Janssen and Bayer HealthCare together are developing rivaroxaban.
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: visithttp://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.
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. Please visit JanssenMD.com for more information.
Tel: (908) 927-2416
Mobile: (201) 213-4115
Investor Relations Contacts:
Johnson & Johnson
Tel: (732) 524-6491
Johnson & Johnson
Tel: (732) 524-2524