For the second time in as many months, the Centers for Medicare & Medicaid Services is being sued by an organization that has deep suspicions about the reason the agency chose to conduct a so-called National Coverage Analysis of the controversial Provenge prostate cancer vaccine, which was approved last spring by the FDA.
This time around, Judicial Watch is demanding that CMS hand over documents that the organization believes will shed light on the review process, which the organization contends may have been undertaken in an effort to begin rationing healthcare. In explaining the reason for filing its lawsuit, Judicial Watch maintains that "cost is the major factor in the unusual decision by CMS" (read the statement). The Dendreon vaccine costs $93,000 per patient, although some analysts say the price tag may be no costlier than treating some patients with chemotherapy.
The lawsuit comes two months after a CMS advisory panel voted that Dendreon’s Provenge shows “clinically significant” improvement in survival as part of the NCA process, which was triggered by questions raised by Medicare contractors amid concerns over off-label use. Such a meeting is unusual, though, given that Medicare generally pays automatically for FDA-approved oncology meds (read what one former CMS official had to say here).
Provenge was approved based on a study showing a four-month survival benefit and most patients who qualify for Provenge treatment also qualify for Medicare. However, the outcome of the recent advisory panel meeting is not the final word. CMS will not issue a coverage proposal until March and a final decision is not expected until June.
Last month, an activist patient and investor group called Care To Live filed a similar lawsuit because, like Judicial Watch, its efforts to obtain documents were rebuffed (read this). The group has argued government bureaucrats conspired with financially conflicted cancer specialists and behind-the-scenes investors in rival treatments to continually delay Provenge from becoming available.
Meanwhile, RW Baird analyst Chris Raymond issued an investor note this morning that physician awareness of Provenge is rising - 90 percent of oncologists, up from 84 percent in August and 47 percent in May. Also, he writes that, despite limited availability, twice as many oncologists in his survey (16 out of 90) have treated a patient with Provenge versus eight out of 84 in August. And the average number of patients treated was five, up from just one.
He adds that four out of four physicians say they were reimbursed for Provenge, up from 67 percent last summer. Obviously, he is dealing with small sample sizes, but he pointed out the insurers include such big names as Aetna and Blue Cross/Blue Shield and Medicare. Finally, he writes that 69 percent of docs expect to prescribe Provenge, compared with 59 percent last August.