April 2013 Vol 6 No 3 Payers’ Guide to New FDA Approvals

The American Cancer Society estimated that in 2012 more than 143,000 people in the United States would be diagnosed with colorectal cancer (CRC) and more than 51,000 people would die from it.1

Prostate cancer is one of the most common cancers in men. Nearly 2.5 million men in the United States have prostate cancer or have a history of prostate cancer.1 One of 6 men will be diagnosed with prostate cancer during their lifetime. The median age at diagnosis of prostate cancer is 67 years.1

Glaucoma is a group of chronic eye diseases that cause irreversible damage to the optic nerve, which leads to serious vision loss and blindness.1 Often associated with increased intraocular pressure, glaucoma affects an estimated 2.2 million people in the United States.1 The population affected by glaucoma is expected to increase to nearly 3 million people by 2020.1 Moreover, glaucoma is projected to become more prevalent as the aging US population increases.2

Constipation is the most common gastrointestinal (GI) complaint in the United States, affecting between 2% and 28% of the population.1 Although it is usually relatively benign, the condition can be serious and can negatively affect a patient’s quality of life, as well as the ability to perform daily activities and overall work productivity.2

Breast cancer is the most common cancer and the second leading cause of cancer death among women worldwide.1 In the United States, an estimated 39,500 women died of breast cancer in 2011.2

Judging by the number of drugs that are currently in the pipeline, drug development may be changing in nature but is not showing real signs of slowing down, despite the many uncertainties in the marketplace and the recent economic instabilities in the United States and worldwide. Overall, the number of new drugs approved by the US Food and Drug Administration (FDA) in 2012 exceeded the total annual approvals in the past decade (with the exception of 2009). And this trend is likely to continue in 2013, based on the number of drugs already approved in the first quarter of the year.  

Leukemias are cancers involving the bone marrow and blood, and they account for approximately 4% of cancer deaths.1 The majority of leukemias occur in adults aged >20 years, and the incidence is higher in men than in women. Leukemias are classified by the type of cell involved (ie, lymphocytic or myeloid) and the rate of progression (ie, acute or chronic). Chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL) account for approximately 2.5% and 6%, respectively, of deaths resulting from leukemia.1

Obesity has reached epidemic proportions in the United States.1 Obesity, which is defined as a body mass index (BMI) of ≥30 kg/m2, affects an estimated 78.1 million Americans—more than 35% of all men and women.2,3 Moreover, more than 34% of adults aged ≥20 years are overweight, which is defined as a BMI of ≥25 kg/m2.3

Rheumatic conditions comprise a broad spectrum of more than 100 different diseases that affect approximately 50 million Americans. Some of these diseases are seen frequent­­ly, such as rheumatoid arthritis (RA) and gout, and others are relatively rare, including relapsing polychondritis and polymyalgia rheumatica.1,2 The most familiar rheumatic diseases affect the muscles, joints, and bones, and cause chronic joint pain, swelling, stiffness, and fatigue.

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by inflammation of the joints and surrounding tissues. The cause is unknown, but some evidence suggests that infection, genetics, and hormone changes may be associated with RA.1 Approximately 1.3 million Americans are estimated to have RA.2 Although RA can occur at any age, the peak age of onset is between 30 and 55 years.1,2 RA affects women 2 to 3 times more than men.1,3

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  •  Association for Value-Based Cancer Care
  • Value-Based Cancer Care
  • Value-Based Care in Rheumatology
  • Oncology Practice Management
  • Rheumatology Practice Management
  • Urology Practice Management
  • Inside Patient Care: Pharmacy & Clinic
  • National Association of Specialty Pharmacy
  • Lynx CME