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Medicare Announces Expanded Coverage for Anticoagulation Patients, Opening the Door for More Patients to Test PT/INR at Home
Date:3/19/2008

Self-testing could assist physicians in achieving better outcomes for AF,

venous thromboembolism patients

INDIANAPOLIS, March 19 /PRNewswire/ -- Medicare Part B will now cover and pay for meter training, equipment and supplies for all long-term warfarin users who monitor their own PT/INR results at home with portable meters, such as the CoaguChek XS System for Patient Self-Testing. This expansion opens the door to increased patient access to testing, which could lead to better outcomes.

Medicare previously reimbursed these expenses only for patient self- testers who had mechanical heart valves. The new coverage expands to include those on anticoagulant medication with chronic atrial fibrillation and venous thromboembolism.

"The decision to expand coverage to additional disease states allows physicians to manage more of their patients on warfarin therapy through home testing," said Dr. Alan Jacobson, cardiologist, Loma Linda University School of Medicine. "Studies show that more frequent PT/INR testing leads to improved clinical outcomes. The benefits of providing patients with improved access to testing are reductions in strokes, bleeds and deaths."

According to a 2006 international meta-analysis led by Dr. Carl Heneghan and published in the Lancet, patient self-monitoring of oral anticoagulation leads to a significant one-third reduction in death from all causes. The study also showed that thromboembolism was decreased by 55 percent and major hemorrhage was also decreased.(1)

Studies suggest that anticoagulation patients who self-test may experience fewer complications overall than those who do not because self-testing may increase patient time in therapeutic range. A 2001 study published in Z Kardiol reported that over a two-year period, 80 percent of PT/INR values recorded by mechanical heart valve patients who performed self-testing were in target therapeutic range, compared to only 64.9 percent of PT/INR values monitored by family practitioners.(2)

Studies also suggest that PT/INR self-testing is just as accurate as testing performed by a healthcare professional.

In a 2001 study published by the American Journal of Clinical Pathology, there were no significant differences between PT/INR results gathered from the laboratory and self-testing patients.(3) Performance testing with the CoaguChek XS System also showed a 97-percent correlation between results obtained by healthcare professionals and by patients testing themselves.(4)

"I feel comfortable with more of my patients monitoring from home because handheld meters like the CoaguChek XS System are easy to use, cause less pain and improve compliance," said Dr. Jacobson. "I also know the results will be consistent with the results from our office meter and from the lab."

Patients prefer fingerstick testing over painful venous draws, according to a 2002 study measuring the results of the Prothombin Office-Testing Benefit Evaluation (PROBE) published in Cardiovascular Reviews and Reports.(5) Several studies also show that the accuracy of results from fingerstick testing is comparable to that of outside laboratories.(6, 7)

For more information on the CoaguChek XS System for Patient Self-Testing, visit http://www.poc.roche.com .

About Anticoagulation Monitoring

Certain patients with atrial fibrillation, a mechanical heart valve or deep vein thrombosis require protection against thrombosis, or blood clots. They are typically put on lifelong oral anticoagulation therapy with warfarin sodium (e.g., Coumadin) to thin their blood. Each patient reacts differently to anticoagulant medications, so it is imperative to monitor therapeutic effects closely to minimize potential risks.

About CoaguChek products

Physicians have been using CoaguChek instruments for point-of-care PT/INR testing since 1994. Today, in the U.S., more point-of-care PT/INR tests are performed with a CoaguChek system than with all other devices combined.(8) The CoaguChek XS System represents the fifth generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007, sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested more than 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com.

References

(1) Heneghan C., Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E,

Glasziou P. Lancet. 2006; 367:404-411.

(2) Kortke H, Minami K, Breymann T, et al. INR self-management after

mechanical heart valve replacement: ESCAT. Z Kardiol. 2001;90(6)118-

124.

(3) Oral Anticoagulation Group. American Journal of Clinical Pathology.

2001; 115: 280-287.

(4) CoaguChek XS system package insert. Indianapolis, IN. Roche

Diagnostics Corporation; 2006.

(5) Giles TD, Roffidal L. Results of the Prothrombin Office-Testing

Benefit Evaluation (PROBE). CVR&R. 2002;23:27-28, 30, 32-33.

(6) Bussey HI, Chiquette E, Bianco TM, et al. A statistical and clinical

evaluation of fingerstick and routine laboratory prothrombin time

measurements. Pharmacotherapy. 1997;17(5): 861-866.

(7) Kaatz SS, White RH, Hill J, et al. Accuracy of laboratory and portable

monitor international normalized ratio determinations. Comparison with

a criterion standard. Arch Intern Med. 1995;155:1861-1867.

(8) Second Quarter 2007 total market share of projected distributor unit

sales of the Point of Care Testing Coagulation Reagents and Kits

product class by HPIS Market Intelligence, a division of GHX Global

Healthcare Exchange.

All trademarks used or mentioned in this release are legally protected by law.

For further information please contact:

Media : Physicians and Patients :

Lori McLaughlin

Corporate Communications

Roche Diagnostics Corporation,

Indianapolis, Ind.

Phone: 317-521-3112 Phone: 800-852-8766

lori.mclaughlin@roche.com Option 2 for Healthcare

Professionals and Option 4 for Patients


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SOURCE Roche
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