More than 500 prescriptions have been written for Dendreon's Provenge since it was approved on April 29, the company said during its second-quarter earnings call.

The company had previously given guidance that it expected 2,000 prescriptions for the prostate cancer vaccine in the first 12 months on the market and it reiterated that guidance during the Aug. 3 call. FDA approved Provenge for treating asymptomatic or minimally symptomatic prostate cancer that is metastatic and resistant to standard hormone treatment.

Dendreon pointed out also that reimbursement for the product is going well, despite the announcement by CMS in June that the agency has opened a national coverage analysis to determine if the product is "reasonable and necessary" for patients in Medicare (Also see "Is Provenge "Reasonable And Necessary"? CMS Analysis For Medicare Coverage Seeks To Find Out" - Pink Sheet, 1 July, 2010.). Dendreon has already submitted its comments on the NCA process to CMS (Also see "Provenge Should Be "Very Familiar" To CMS Now, Dendreon Says About NCA" - Pink Sheet, 30 July, 2010.).

Until the NCA is complete and CMS issues a national coverage decision, should it decide one is necessary, the 15 local Medicare Administrative Contractors will determine Medicare Part B coverage policy for their contract areas, Dendreon noted. So far, nine MACs have published positive coverage guidelines, another three have issued written confirmation of coverage to physicians and two have given verbal confirmation of coverage, it said. Only one MAC has issued a non-coverage decision.

In addition, a number of large private payers such as Aetna, Emblem Health, Humana, Kaiser Permanente and many Blues plans are covering Provenge, the company said.

Dendreon also highlighted the strong endorsement of Provenge in the National Comprehensive Cancer Network's medical practice compendium as a positive development for its reimbursement prospects (Also see "Provenge Poised For Broad Insurance Coverage, Despite Grumbles On Price" - Pink Sheet, 24 May, 2010.). Reimbursement decisions for the physician-infused product are being watched carefully by investors since the product has a price tag of $93,000 for each three-dose course of treatment.

The company reported revenues of $2.8 million for Provenge in the quarter ending in June, with most of those sales in June, since May was the "start-up" month for the product, the company said. Dendreon added that revenues have continued to climb since the end of the quarter, with revenues of $5.2 million in July.

-Scott Steinke (s.steinke@elsevier.com )

Provenge Tops 500 Scripts Since Approval; Most Local Medicare Contractors Will Cover Product

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