Incidence of skeletal related events in patients with bone metastasis receiving denosumab every four weeks compared to intervals greater than every four weeks

Objective Denosumab is a monoclonal antibody used for prevention of skeletal related events in patients with bone metastasis from solid tumors and is administered every four weeks. In our practice, denosumab is often given at different frequencies more similar to patient’s chemotherapy regimens to decrease frequency of clinic visits. The purpose of this study is to compare the incidence of skeletal related events, incidence of hypocalcemia, and cost with denosumab given at every four weeks and denosumab given at other frequencies. Methods This retrospective study at Duke University Health System included solid tumor patients with an age ≥18 years who received denosumab for prevention of skeletal related events. Results A total of 94 patients were included, with 29 in the every four-week group and 65 in the greater than every four-week group. Patients who received denosumab every four weeks had a 41.4% incidence of skeletal related events compared to 26.2% incidence of skeletal related events in patients who received denosumab at intervals greater than every four weeks (OR: 0.50; p = 0.14). There was no statistically significant difference in incidence of hypocalcemia. Based on average wholesale price, when the frequency of denosumab is extended to greater than every four weeks, annual cost savings per patient ranged from $4700 (every 5 weeks) to $18,800 (every 12 weeks). Conclusion While this study raises the possibility of decreasing the frequency of denosumab administration, further data are necessary to confirm that less frequent administration is non-inferior to every four-week administration.

Recent Case Developments in Health Law

In September 2009, the First Circuit Court of Appeals decided Blue Cross & Blue Shield v. AstraZeneca Pharmaceuticals LP, part of the class action suit known as In re Pharmaceutical Industry Average Wholesale Price Litigation. The First Circuit upheld a Massachusetts District Court finding that AstraZeneca violated Massachusetts’ consumer protection laws by manipulating the “average wholesale price” of its physician-administered injectable cancer drug Zoladex, leading to overpayment by the government, third-party payers, and consumers. This case, which highlights the persistent tension between pharmaceutical pricing flexibility and consumer protection, has important implications for similar pending class actions.Between 1991 and 2003, Medicare, as well as many private insurance companies, pegged reimbursement for certain pharmaceutical products to a national “average wholesale price” (AWP) for each drug. Although the amended 1991 Medicare Part B regulations3 that introduced the term “average wholesale price” failed to define it explicitly, there is some indication in the legislative history that AWP was intended to refer to the prices that physicians and pharmacists actually pay to the drug manufacturers.

Marketing Survey of Acid Lime and Hill Lemon in Nepal

A market survey was undertaken visiting 14 major markets of the country during 2001/03 to assess the marketing system, demand and supply situation and price behavior of acid lime and hill lemon in Nepal. Different levels of market intermediaries involved in lime and hill lemon marketing were selected for survey and group discussion. A standard semi structured interview schedule was used to gather the information and daily transaction of lime was recorded in Kalimati wholesale market for one year. The total annual consumption of lime at 14 major markets of Nepal was over 2327 mt. of which, 85% was consumed in Kathmandu only. The volume of sale was higher during main season of production in all markets except Nepalgunj, Bhairahawa and Krishnanagar, where the volume of sale was higher in off-season. Over 90 percent of total lime marketed in Nepal was imported from India. In Kalimati wholesale market, the domestic lime contributed only 5.5% to total supply in the season and the rest was supplied from India. However, the share of Nepalese lime in other 13 major markets, outside the Kathmandu valley, was 32%. The total volume of import was 2108 t. valued at Rs. 50.4 millions. In contrast to lime, lemon was not imported from India. The demand of lime was higher during off-season from January to August and lower during the main season of production, i.e. September to December. The wholesale and retail prices of lime and hill lemon showed temporal and spatial variation. The average wholesale price of two years (2001-2003) in Kalimati market was Rs. 1.2 to 2.6 and retail Rs. 1.5 to 3.05/fruit, whereas in 13 major markets the wholesale price varied from Rs. 0.64/fruit in September to Rs. 0.95 in April. Average retail price was the lowest in August (Rs. 1.4/fruit) and the highest in April (Rs. 1.93/fruit). Similarly, the average wholesale price of hill lemon varied from Rs. 1.6/fruit in October to Rs. 6.0/fruit in April and the average retail price was the lowest in October (Rs. 2.4/fruit) and the highest in April (Rs. 7.0/fruit). The prices of lime and hill lemon were the lowest during the season of production and the highest during off-season, i.e. summer months. Different types of traders as suppliers, wholesalers, retailers, doke, four-wheelers, collectors and commission agents were involved in the marketing of lime and hill lemon. There were four different channels involved in the marketing of lime and hill lemon. Shares of those channels in business varied with markets. The marketing through commission agent (6%) was not common, whereas the collectors were significant (57%) in marketing. The common uses of lime and hill lemon were as fresh green salad, juice and processed products such as juice, squash, chuk, and pickle. The post-harvest loss during marketing was up to 20 -25% due to poor management of fruits. Development of technology for the higher productivity, off-season production, post harvesting handling and processing of fruits, and strengthening market facilities including cold storage are suggested to reap the tremendous internal market opportunities and substitute the imports. Key words: Acid lime, hill lemon, marketing J. Inst. Agric. Anim. Sci. 26:107-116 (2005)

Supplying the New York Market with High-Quality Puerto Rican Mangos

Improved varieties of mangos have been introduced to Puerto Rico for evaluation in several micro-climates and for market testing. During 1970, 20 consecutive weekly shipments of these mangos consisting of 1,926 flats were made to New York to acquire experience with export procedures, and to determine the extent of sales and fluctuation of prices as affected by season and size preferences. The fruit was shipped by ocean or air freight in ventilated cardboard flats containing approximately 12 pounds of mangos each. Marketing costs to New York City were estimated at $1.48 per flat. Wholesale prices varied from a high of $6.08 per flat in May to $2.67 during the flush of the season when heavy shipments of Florida mangos arrive on the market. Price differences between flats of large and medium fruit were minimal, but a sharp break in price occurred with small mangos. The average wholesale price received for the 20 shipments was $4.14 per flat. The results suggest that it would be advantageous to ship fruit to the New York market when prevailing wholesale prices are above $3.48 per flat. No deterioration of quality or spoilage were reported during the trial. Based on criteria of size, bearing season and productivity, Springfels may be rated first choice as a commercial variety, followed by Irwin, Haden, and Kent.