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REP. WYDEN PRESSES NCI TO PUSH FOR TAXOL PRICES AT LOWEST LEVEL

Executive Summary

REP. WYDEN PRESSES NCI TO PUSH FOR TAXOL PRICES AT LOWEST LEVEL of recently-introduced cancer treatments. In an Oct. 23 letter to NCI Division of Cancer Treatment Director Bruce Chabner, MD, Rep. Wyden (D-Ore.) questioned the current discourse between the National Cancer Institute and Bristol-Myers Squibb and urged NCI to seek information on full production, marketing and promotion costs for the cancer treatment. Until NCI collects that information, Wyden urged the institute to try to get Bristol to price taxol in the range of $100-$200 per monthly treatment. Wyden's comments stem from oversight of the ongoing discussions between NCI and Bristol. The Oregon Democrat has been interested in the cancer product since an agreement to harvest the Pacific yew tree was signed by Bristol, the Forest Service and the Bureau of Land Management in June 1991 ("The Pink Sheet" Aug. 19, 1991, T&G-2). Wyden does not have direct jurisdiction over the Bristol-NCI CRADA agreement, but he is clearly expressing his interest in remaining involved in the ongoing process of bringing the product to commercial availability. From minutes of recent meetings between NCI and Bristol, Wyden estimates that the eventual taxol price may be close to the current price for Platinol (see related story, above). Picking up on a statement by NCI that taxol's price should fall "near the median" of current prices for 13 recently-introduced cancer drugs, Wyden assumes that the Platinol price of $680 per month is a target in NCI's view. "Until there is evidence that the 'median' price level proposed for taxol is supported by a development cost analysis," Wyden declares, "I would suggest that taxol be priced at the level of the lowest cost drugs on your list." The lowest monthly cost for recent introductions are levamisole ($100) and flutamide ($ 216). Citing prices obtained by the NIH pharmacy, NCI lists the monthly treatment costs of 15 products: 13 cancer therapies approved for marketing since 1988; cisplatin; and recombinant human growth hormone. The cisplatin price of $680 per month was fifth on the list. The lowest priced product was levamisole; GM- CSF was the highest ($4,095 per month). The congressional oversight comes while NCI is feeling its way into its new position as a de facto arbiter of a fair price for taxol. Wyden's attempt to step into the discussions may be a complicating factor. However, it may indirectly strengthen NCI's position by emphasizing to the company the relatively favorable prospect of working toward a mutual agreement with NCI. Wyden's price comparisons to existing products are more draconian than the approach being pursued by NCI. Wyden is also demanding that NCI seek a wide range of Bristol's internal pricing and production information. For example, Wyden has asked NCI: "How soon could Bristol-Myers and NCI prepare [a pricing analysis] for my review, including a discussion of both tangible and intangible costs to produce taxol?" NCI has been more reticent about seeking that material. NCI notes a number of issues are important to pricing: the probable length of exclusivity for a product; its relative efficacy; and possible expanded indications and markets. NCI recognizes several factors supporting a premium price for taxol. One is the probable term of exclusive marketing. The institute has gone into the discussions with Bristol aware that taxol may have a relatively short period of exclusive marketing. The institute notes that Rhone-Poulenc Rorer is making progress with its patented Taxotere. At a meeting with Bristol, NCI's Chabner suggested that short exclusivity for taxol should be accounted for because of the RPR project. NIH Office of Technology Transfer Director Reid Adler also noted that the percentage of responding patients needs to be calculated into price.

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