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The Honolulu Advertiser

Posted at 2:04 a.m., Thursday, February 15, 2007

Generic biotech meds could save nearly $300 million

News Release

Generic biotech medicines could save U.S. plan sponsors and patients $71 billion over 10 years, with $3.5 billion of the savings occurring the first year, according to a report issued Wednesday by Express Scripts in St. Louis, one of the nation's largest managers of pharmacy benefit plans.

In Hawai'i, the 10-year savings for residents and plan sponsors is predicted to be $288,896,721, according to an Express Scripts news release issued Wednesday night.

Savings for plan sponsors could amount to $1,900 in the first year for a multiple sclerosis patient with a therapy treatment that includes biotech medicines.

"Given the savings potential for plan sponsors and the patient, we believe it is critical that an approval pathway for generic biotech medicines be established," says Steve Miller, Express Scripts chief medical officer and vice president, specialty pharmacy.

A pathway for generic biotech medicines would be created with the enactment of The Access to Life Saving Medicine Act of 2007, which is sponsored by Senators Charles Schumer (D-NY), Hillary Rodham Clinton (D-NY), David Vitter (R-LA) and Susan M. Collins (R-ME) and Representatives Henry Waxman (D-CA) and Jo Ann Emerson (R-MO). Miller says, "Express Scripts applauds and supports this important legislation to make biotech drugs more affordable."

In addition to increased savings for plan sponsors and patients, the use of generic medicines has been shown to lead to better outcomes such as improved medication adherence for chronic conditions.

Most biotech medicines are injectable, infused, oral or inhaled and generally require special handling along with close supervision and monitoring of the patient's medication therapy. These medicines treat chronic or complex illnesses that affect less than three percent of the general population, but they come with a significant price tag — these patients account for 25 to 30 percent of a company's overall pharmacy costs.

Biotech medicines differ from traditional drugs in that they are derived from living sources such as humans, animals or microorganisms as opposed to drugs synthesized using chemical reactions in the lab.

The $71 billion savings potential could be achieved if the Food and Drug Administration (FDA) were able to release guidelines for the approval of generic biotech medicines. Without the guidelines, generic manufacturers are unable to offer Americans the lower-cost alternatives to brand biotech medicines.

Controlling the cost of biotech medicines, one of the fastest growing segments of health care, is a top priority for employers, insurers and the federal government. Spending for biotech medicines in the U.S. is expected to reach $90 billion in 2009. Increasing the use of generics is a proven tool in decreasing costs.

The report's conclusions were based on a review of four biotech medicine therapy classes for which key patents have already expired. The therapy classes represent medicines used to treat multiple sclerosis, anemia, growth hormone deficiencies, and diabetes.

The largest estimated savings of $40.7 billion over ten years is found in erythropoietins, the class of medicines used to treat anemia. There are 350,000 dialysis patients and 450,000 oncology patients using erythropoietins.

There are 15 million Americans diagnosed with diabetes. More than 25 percent of the market could move to a generic biotech medicine and save $797 million in the first year.

Fifty percent of the 320,000 multiple sclerosis patients treated with interferons could move to a generic biotech medicine and achieve a $678 million savings in the first year.

Generic biotech medicines could be used to treat 80 percent of patients with a growth hormone deficiency, leading to $27.7 million in first year savings.

The report also includes an analysis of savings for each state and the District of Columbia. Twenty-six states would save more than $1 billion dollars over a ten year period with California and New York achieving the greatest savings of $7.7 and $5.8 billion respectively.

The Express Scripts analysis used a conservative discount of 25 percent off the branded equivalent medicine. This is consistent with the discount on the biotech medicine somatropin, which was released last year in Europe. The analysis is also based on an 83 percent generic market share and a 15 percent annual increase in biotech medicine costs, which is consistent with industry forecasts.

Both the discount and the generic biotech medication fill rate are more conservative numbers than used for traditional drugs where a 95 percent market share can be achieved and, on average, a generic drug costs approximately 60 percent less than a brand name drug.

Additionally, the analysis assumes that once the FDA guidelines are issued, generic biotech medicine manufacturers would quickly begin production and distribution. To view a copy of the study go to: http://www.express-scripts.com/ourcompany/news/outcomesresearch/online publications/.

10-Year Savings by State Savings

California: $7,715,778,789

South Carolina: $951,990,002

New York: $5,838,087,017

Oregon: $800,330,633

Texas: $4,873,089,817

Oklahoma: $762,586,938

Florida: $4,324,688,078

Iowa: $695,314,621

Pennsylvania: $3,407,429,578

Kansas: $643,970,417

Ohio: $2,985,859,433

Mississippi: $635,709,705

Illinois: $2,974,175,774

Arkansas: $592,763,131

Michigan: $2,243,581,980

Nevada: $483,913,418

New Jersey: $2,239,246,247

West Virginia: $465,977,176

Massachusetts: $2,068,874,768

Nebraska: $447,538,902

North Carolina: $2,032,819,727

Utah: $446,717,395

Georgia: $1,888,873,398

Maine: $364,475,390

Virginia: $1,634,206,146

New Mexico: $364,018,997

Tennessee: $1,531,791,574

New Hampshire: $317,558,197

Indiana: $1,504,134,163

Rhode Island: $313,405,022

Missouri: $1,497,379,547

Hawaii: $288,896,721

Washington: $1,472,004,101

District of Columbia: $276,939,227

Wisconsin: $1,425,360,744

Idaho: $262,791,046

Minnesota: $1,418,971,243

Delaware: $240,336,514

Maryland: $1,388,575,474

Montana: $208,662,845

Arizona: $1,111,088,576

South Dakota: $200,447,773

Louisiana: $1,086,169,522

Alaska: $192,552,175

Alabama: $1,080,418,971

North Dakota: $180,183,927

Kentucky: $1,031,995,682

Vermont: $164,347,092

Colorado: $1,023,004,741

Wyoming: $105,016,012

Connecticut: $1,002,832,174