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Health Alliance Announces Promising Nine-Month Results from First Ever Outcome-Based Reimbursement Program for Actonel(R) (risedronate sodium) Tablets

October 29, 2009

URBANA, Ill., Oct. 29 /PRNewswire/ -- Health Alliance Medical Plans, Inc., a leading provider-sponsored health insurer, covering more than 310,000 commercial plan members in Illinois and Iowa, has announced positive outcomes from a nine-month Fracture Protection Program pilot launched in partnership with the makers of Actonel, a prescription drug for the treatment and prevention of postmenopausal osteoporosis.

Through the program with Health Alliance, the makers of Actonel agreed to reimburse a maximum number of non-spinal osteoporotic fractures per 1,000 patients over one year. During the first nine months of the pilot, the reimbursement rate was 79 percent lower than the maximum outlined in the agreement based on the number of non-spinal fractures which met eligibility criteria for reimbursement among Actonel patients. The incidence of non-spinal fractures was consistent with clinical trial data for Actonel.

Christina Barrington, Health Alliance Pharmacy Director, said, "The Fracture Protection Pilot Program was launched to highlight the effectiveness of Actonel through medical outcomes reimbursement. Initially, we had hoped that this program could lower insurance costs not only for Health Alliance, but for our subscribers as well. As a result, Health Alliance independently chose to help our subscribers by lowering their costs. We look forward to continuing and building upon this successful pilot."

Through the program, the Alliance for Better Bone Health, a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S., covered the average medical expenses incurred to treat certain non-spinal osteoporotic fractures in women correctly taking Actonel, by proportionally reducing Health Alliance's cost of purchasing Actonel.

"We have reviewed the Fracture Protection Program and are enthusiastic about the opportunity to partner with the makers of Actonel to tie expected outcomes to drug utilization in our patient population," said Raulo Frear, Pharmacy Director, Regence Health Plan. "This program is an example of an innovative way plans and pharmaceutical manufacturers can partner and bring value to our plan sponsors."

Dan Hecht, General Manager, P&G Pharmaceuticals, North America, said, "Our confidence in the fracture efficacy of Actonel has been further reinforced by the excellent results of the pilot program. The Alliance for Better Bone Health is proud to have taken such a large step to stand behind our osteoporosis medication in a way that has not been done by other companies."

"We're extremely pleased with the results of the Fracture Protection Program pilot and hope to expand and implement this program on a national level to reach even more patients," said Brent Ragans, Vice President, General Therapeutics, sanofi-aventis U.S.

About Osteoporosis

Osteoporosis is often a silent disease that affects millions of postmenopausal women, making their bones weak and more likely to fracture over time. In fact, in the U.S. today, 8 million women are estimated to already have osteoporosis, and almost 27 million more are estimated to have low bone mass, placing them at increased risk for fracture. Each year the incidence of osteoporosis-related fractures is greater than the incidence of heart attacks, strokes, and breast cancer combined. The good news is that there are prescription medications available that effectively reduce both vertebral and nonvertebral fracture risk.

About Actonel (risedronate sodium) Tablets

Actonel is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Bisphosphonates, including Actonel, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers. Actonel should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur. There have also been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates.

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Actonel. Patients who develop ONJ while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan (including the consideration of discontinuation of bisphosphonate therapy) of each patient based on individual benefit/risk assessment.

Most common adverse reactions reported in >10% of patients treated with Actonel and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely.

Please see full prescribing information for Actonel® for additional safety information. For a copy of the full prescribing information for Actonel visit the Actonel Web site at www.actonel.com/global/prescribing_information.pdf

About Health Alliance Medical Plans, Inc.

Health Alliance Medical Plans is a leading provider-sponsored health insurer in the Midwest, providing health care coverage to more than 310,000 members in Illinois and Iowa. Health Alliance is named one of 'America's Best Health Plans' in the 2008 U.S. News and World Report and National Committee for Quality Assurance (NCQA) rankings of commercial and Medicare health plans. Additionally, in recognition of its exceptional commitment to quality, Health Alliance has maintained the highest accreditation possible from NCQA for its HMO, POS and Medicare HMO plans since 1997.

About the Alliance for Better Bone Health

The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.

SOURCE Health Alliance Medical Plans, Inc.

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