Medical Device Daily Washington Editor

The idea of saving a buck is especially popular in healthcare policy, even if nobody seems to know how to pull it off.

Many popular studies of healthcare economics are limited to systemic features, but an article appearing in the Aug. 8 edition of the Journal of the American Medical Association (JAMA) examines cost in smaller detail, namely the cost-effectiveness of bone densitometry followed by treatment of osteoporosis in older men. However, the metric applied in the study, quality-adjusted life years (QALYs), is itself the subject of some controversy, if only because assigning a reasonable value to a year of life is not objective.

Into this breach marches a team of researchers with a paper examining this issue, its lead author John Schousboe, MD, a rheumatologist at the St. Louis Park, Minnesota clinic of Park Nicollet Health Services (Minneapolis, Minnesota). The team concluded that in some circumstances, it does indeed make sense to check and treat older men for osteoporosis.

The article says, "White men at age 60 have a 29% chance of experiencing" an osteoporotic fracture in their remaining lifetimes, and while men account for only a third of all hip fractures, those fractures are "associated with as much morbidity and higher mortality" than hip fractures in women.

The article points out that osteoporosis is much less common among men than women, but increased age correlates with higher rates of fracture and osteoporosis. The authors state that "it is unclear a priori if bone densitometry followed by treatment … is cost effective at any age" over 65, and the lack of consensus has led to "very low rates of clinical intervention for osteoporosis in men."

The authors offer several cautions about the study's limitations, including that "age-adjusted rates are significantly lower among Hispanic and especially African American men." The study also does not examine the impact of atypical risk factors, such as long-term use of systemic glucocorticoids.

In developing a model for cost effectiveness, the authors use the average wholesale cost of alendronate (Fosamax) in 2004, roughly $1,000 a year at standard dosing. The authors note that the patent on alendronate will expire next year and that a significant drop in price would change the study's results.

The authors also assumed that the adverse effects of the use of Fosamax "would generate only trivial medical costs."

The authors write that the cost for each QALY gained by treatment for men age 65 who had no history of bone fractures would be almost $130,000, but for men who had a history of bone break or fracture, it was a bit more than $47,000.

At the opposite end of the age spectrum in the study, men aged 85, the QALY score for those with no prior fractures was $33,666 and for men who had broken a bone, the QALY score was $4,700.

The authors commented that if $50,000 is the amount used as a benchmark for one QALY gained, bone density testing and treatment with alendronate for men with a femoral neck score of -2.5 or lower "may be cost effective for men aged 65 and older with a history" of fracture, but that for men with no history, the floor age for treatment rises to 80.

They also note that universal bone density testing for men age 70 and older "does not appear to be justifiable" at the current cost of alendronate.

Med-tech, all patent applications up

The World Intellectual Property Organization (WIPO; Geneva), the body that serves as the United Nations for conflicts over patents, trademarks and copyrights, reported last week that northeast Asia was the most active region for new patents across the globe in 2005, with Japan leading the region and the world in new patent applications.

However, the U.S. still holds the most existing patents at 28% of the worldwide total and Japan holds second place at 21%. The total number of global patents stands at 5.6 million.

According to the WIPO report summary, roughly 1.66 million new patents were filed in 2005, and worldwide filings "have grown at an average annual rate of 4.7% since 1995." The report states that the growth rate in patent applications "is comparable to the overall increase in economic activity over the same period."

However, the use of the patent system "remains highly concentrated with only five patent offices (China, Japan, the European Patent Office, the Republic of Korea and the United States of America) accounting for 77% of all patents filed and 74% of all patents granted," according to the report.

Apparently the U.S. Patent and Trademark Office (PTO) is not the only such entity with an increasing load. The report says that increasing demand for patents at PTO has imposed a backlog of about one million patents, but Japan's patent office faces a similar backlog, about 800,000 patents. However, the backlog in Japan is seen as an artifact of a change in that nation's patent system, and most observers expect the government to sort through the backlog within a few years.

Patent harmonization, like harmonization of global device regulations, is an ongoing process, and WIPO members have chipped away at the job with only marginal progress. Among the issues that have arisen over the past couple of years are the compatibility of searchable databases and the first-to-file vs. first-to-invent question.

The U.S. has traditionally employed a first-to-invent approach to patent approval, but the Patent Reform Act of 2007 would reverse that approach (Medical Device Daily , July 23) and bring the U.S. in line with other nations.

WIPO's numbers indicate that the total number of patent applications for medical technology in 2006 topped 11,000, a sharp upward spike from 2002 when inventors filed only 7,360 patent applications. In that same period, biotech patents fell from 9,001 to 7,026 while pharmaceutical patent applications rose from 9,654 to 13,470.