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

The Cordis Carotid System is comprised of the Precise® Nitinol Self-Expanding Stent and the Angioguard™ Emboli Capture Guidewire. These products are currently approved outside the U.S for use in carotid arteries. The Angioguard is delivered beyond the lesion, where it opens into a tiny perforated basket designed to catch plaque particles dislodged during the angioplasty and stent procedure, while allowing continuous blood flow. Once the stent is implanted to hold the artery open, the protective basket is closed and removed. Cordis has positioned its Carotid System as a minimally invasive alternative to carotid endarterectomy in high-risk patients with carotid artery disease.

Carotid artery disease refers to a buildup of atherosclerotic plaque (fatty material) in the neck’s carotid arteries that supply blood to the brain. In some patients, pieces of this plaque may break off or embolize and cause a stroke. According to CDC surveillance data, stroke is the third leading cause of death in the U.S after heart disease and cancer. Some estimates place the number of carotid endarterectomies performed annually in the U.S in the 100,000 range.

Clients with significant CVT surgery exposure should review carotid endarterectomy volume. Some preliminary clinical epidemiology detailing numbers of procedures on high risk patients is suggested at this time. Biohorizon recommends consultation with CVT surgeons concerning plans for device use if final FDA approval is obtained.

Technology Details
Target Disease / Indication: Carotid Artery Disease
Technology Classification: Device
Body System: Cardiovascular System
Program Area: Surgery/CVT Surgery
Regulatory Status: Investigational
BioHorizon Impact Score: 45/100 – Moderate

Unlike traditional or ‘bare metal’ stents, the Taxus stent is coated with a substance named paclitaxel and a unique polymer. The stent props the blocked coronary artery open while the polymer gradually releases the paclitaxel into the vessel wall to stop the growth of scar tissue which causes restenosis. The pivotal Boston Scientific sponsored Taxus IV clinical trial reported an in-segment (stented vessel segment plus 5 mm beyond each end of the stent) binary restenosis (50% or greater vessel re-occlusion) rate of 7.9% in the Taxus group compared with 26.6% in the control group (P=<0.0001). The study also reported a target lesion revascularization (TLR) rate of 3.0% in the Taxus group compared with 11.3% in the control group (P=<0.0001). TLR (or retreatment) rate is one of the most accurate indicators of the performance of drug-eluting stent technology.

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range with some predicting a 5 billion dollar market within the next 2 years. The actual direct cost increase associated with Taxus compared to a bare metal stent is significant. Each Taxus stent will likely cost between $2500 and $3000. This represents an increase of 200-300% over the per unit cost of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The Taxus Express stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.

Technology Details
Target Disease / Indication: Coronary Artery Disease
Technology Classification: Combination Drug/Device
Body System: Cardiovascular System
Program Area: Cardiology
Regulatory Status: Approved

BioHorizon Impact Score: 84/100 – High

Wet AMD is a disease that causes a loss of central vision. It is caused by choroidal neovascularization (CNV), a growth of abnormal blood vessels under the central part of the retina, or the macula. These vessels leak fluid and cause scar tissue that attacks central vision, resulting in a deterioration of sight over a period that can range from a few months to three years. About 500,000 people are diagnosed with the eye disease each year, with 400,000 of those in the United States and Europe. Of those, 125,000 are classic, 175,000 are minimally classic and 200,000 have the occult form of the disease.

Visudyne therapy is a two-step procedure. Following intravenous administration, Visudyne is activated by a non-thermal laser light directed at the eye. This process is known as photodynamic therapy. Visudyne selectively targets abnormal blood vessels under the retina, resulting in a reduction in their growth, without affecting normal/healthy retina tissue. This in turn stops the leakage associated with wet AMD. Together with its partner Novartis, QLT reported Visudyne sales of $357 million dollars for the year ended Dec 31, 2003. Wall Street analysts have projected earnings in the $500 million dollar range for 2004. There are currently no competing, approved, photodynamic therapies for the treatment of wet AMD. In November 2003, a competing treatment showed “no improvement” over QLT’s treatment. According to a QLT statement, data from phase III trials for Macugen, a drug being developed by Pfizer and Eyetech Pharmaceuticals “do not appear to offer any treatment benefit over (Visudyne) “.

We feel Visudyne represents true innovation, and based upon our assessment of disease prevalence, treatment efficacy, and demand/diffusion characteristics have designated it a High Impact health technology. We are advising clients to initiate preliminary assessment activities.

Technology Details
Target Disease / Indication: Age Related Macular Degeneration
Technology Classification: Drug-Photodynamic Therapy
Body System: Nervous System
Program Area: Surgery/Ophthalmology
Regulatory Status: Approved
BioHorizon Impact Score: 73/100 – High