BioHorizon » Muskuloskeletal

DePuy Spine’s Charite Artificial Disc for Replacement of Spinal Discs

admin — Tue, 26 Oct 2004 18:38:17 +0000

On October 26, 2004 DePuy Spine Inc. announced that the FDA had approved the Charite™ Artificial Disc. The Charite Artificial Disc, a device made of two metallic endplates and a movable high-density plastic center, is the first FDA approved artificial replacement for spinal discs. The standard surgical intervention for this indication is lumbar fusion surgery which limits range of motion and may have consequences for discs above and below the fusion site. DePuy maintains that once implanted the Charite™ Artificial Disc is designed to help align the spine and preserve its ability to move. We have assigned this technology 90 points for innovation.

The burden of illness associated with low back pain in the United States is substantial. Back injuries have been the leading cause of disability in the United States in the under 45 age cohort and the most expensive health care problem for the 30 to 50-year-old age group. In 1995 low back pain accounted for almost a quarter or $8.8 billion of total workers’ compensation payments. Spinal fusion surgery, a common surgical treatment for low back pain or degenerative disc disease, is performed at least 200,000 times per year in the United States. This corresponds to a procedure incidence of 69/100 000 and a BioHorizon burden of illness score of 25.

In March 2004, clinical trial data comparing artificial disc replacement to spinal fusion surgery was presented at the 20th Annual Meeting of the AANS/CNS. DePuy indicated that patients treated with the Charite artificial disc maintained flexibility, experienced improvements in pain and function, and left the hospital sooner and were more satisfied with the procedure than spinal fusion treated patients. Data from this trial formed part of the Premarket Approval Application (PMA) submitted to the FDA earlier this year. Based upon FDA approval, we have scored the efficacy variable at 100.

Demand/Diffusion assessments around this emerging technology are problematic. Estimates by industry analysts span a range from between 100 million and 1 billion dollars per year. Competition from evolving minimally invasive fusion procedures may play a role. We currently score the demand/diffusion variable at 25.

The BioHorizon Emerging Health Technology Impact Score for the Charite artificial disc is currently 60, placing it in the Moderate/High Impact category. Health services delivery clients should commence preliminary assessment activities focusing on their spinal surgeons’ plans for integration of this disc replacement into practice.

Technology Details
Target Disease / Indication: Low Back Pain/Degenerative Disc Disease
Technology Classification: Device
Body System: Musculoskeletal
Program Area: Surgery/Orthopedics
Regulatory Status: Approved
BioHorizon Impact Score: 60/100-Moderate/High Impact

Humira (adalimumab) for rheumatoid arthritis

admin — Fri, 09 Apr 2004 15:53:53 +0000

In December of 2002, Abbott Laboratories received FDA approval for Humira®, its human monoclonal antibody for the treatment of adults with moderate to severe rheumatoid arthritis. At that time, Biohorizon placed Humira in its High Impact Technology category and recommended preliminary assessment activites. In an April 2004 company news release, Abbott announced that worldwide sales of Humira had reached $149 million for the first quarter ending March 31, 2004 and provided worldwide sales guidance of more than $1.2 billion for 2005.

Humira is a human monoclonal antibody that is thought to exert its effect by interfering with the function of an inflammatory cytokine known as tumor necrosis factor alpha (TNF-a). TNF-a is thought to play a critical role in mediating the immune response that causes the signs and symptoms of rheumatoid arthritis and other autoimmune diseases. Humira is given subcutaneously by injection every two weeks. Other currently existing treatments for rheumatoird arthritis include Enbrel®, and Remicade® (both TNF-a biological response modifiers) and Amgen’s Kineret® (an Interleukin-1 inhibitor), all of which are relatively new.

Rheumatoid arthritis is a chronic autoimmune disease that causes pain and swelling of the joints and may progress to the point of joint destruction. It has been estimated that the incidence of rheumatoid arthritis in the United States is 70/100, 000 per year, with 1 to 2 % of the population ultimately affected.

Biohorizon has currently assigned Humira to the High Impact Technology category. At approximately $1200 per patient per month, it produces a significant cost increase when compared to the traditional disease modifying anti-rheumatic drugs such as methotrexate. Based on Abbott’s own reported and predicted sales numbers, diffusion seems to be occurring at an impressive rate. Biohorizon reiterates the need for health services organizations to plan for the continued and increased presence of Humira in rheumatoid arthritis treatment regimens.

Technology Details
Target Disease / Indication
Rheumatoid Arthritis

Technology Classification
Drug

Body System
Musculoskeletal System

Program Area
Medicine/Rheumatology

Regulatory Status
Approved

BioHorizon Impact Score
67/100 – High

Preos osteoporosis drug

admin — Fri, 02 Apr 2004 15:47:02 +0000

On March 30, 2004 NPS Pharmaceuticals Inc. said that its Phase III osteoporosis drug, Preos, significantly reduced spinal fractures or worsening of fractures in a study of 2, 600 postmenopausal women. The 18-month study on Preos involved postmenopausal women with mild to moderate osteoporosis. 81% of participants had no previous history of vertebral fracture. The trial consisted of a treatment arm (patients received daily injections of Preos and supplements of calcium and vitamin D) and a control arm (patients received placebos along with the same supplements). NPS said its drug met the main goal of a statistically significant reduction in the incidence of new or worsened vertebral fractures. It reported a 59% reduction in new or worsened fractures in the treatment versus control arms of the study. That is, 1.4% of women taking Preos had new or worsened fractures by the end of the trial compared to the fracture rate of 3.4% among those taking placebos. Patients taking Preos who had not had a fracture prior to entering the trial experienced a relative reduction of 68%. NPS indicated that it would seek U.S. approval this year for Preos. Preos would compete with Eli Lilly and Co.’s Forteo, a similar injectable drug.

Preos is an injectable, bioengineered version of human parathyroid hormone. Parathyroid hormone is secreted by the thyroid gland and regulates the level of calcium in various body tissues. A similar drug, Eli Lilly’s Forteo, was approved in November 2002 for the treatment of osteoporosis in the United States. Forteo, an injectable bioengineered human parathyroid hormone fragment, is reported to have had sales of $65 million last year. Estimated future annual sales of both injectable drugs has been gauged at about $400 million by several Wall Street analysts.

According to the National Osteoporosis Foundation (NOF), osteoporosis is responsible for more than 1.5 million fractures annually in the United States. The most common fractures are vertebral (700, 000), hip (300, 000), and wrist (250, 000).

Biohorizon has maintained its Moderate Impact Technology designation for Preos. Available treatment options for clinicians treating osteoporosis are considerable with bisphosphonates (Fosamax®, Actonel®), calcitonin (Miacalcin®), estrogen/hormone therapies, parathyroid hormone (Forteo®), and selective estrogen receptor modulators (Evista®). No assessment activities are currently recommended for Preos.

Technology Details
Target Disease / Indication
Osteoporosis

Technology Classification
Drug

Body System
Musculoskeletal System

Program Area
Medicine/Rheumatology

Regulatory Status
Phase III

BioHorizon Impact Score
56/100 – Moderate