Senators Ask Why Medicare Is Reviewing Provenge
2 CommentsBy Ed Silverman // August 26th, 2010 // 7:04 am
The latest people to object to the recent decision by the Centers for Medicare & Medicaid Services to open a National Coverage Analysis of the Provenge prostate cancer vaccine happen to be two US Senators. John Kerry and Arlen Specter, Democrats from Massachusetts and Pennsylvania, respectively, wrote an Aug. 20 letter to the agency questioning the rationale for the review and voicing suspicion the move will lead to restricted coverage.
At issue is the extent to which CMS believes coverage is reasonable and necessary. As noted previously, an NCA is uncommon for new drugs, but CMS officials have ranged from silent to vague in explaining their decision. Although marketed for $93,000, price is not supposed to factor into the analysis. Presumably, the undertaking was prompted by regional Medicare contractors, most of which have signaled their intent to provide coverage, according to Dendreon, which sells the vaccine. Dendreon execs have also indicated they believe the NCA is related to ensuring off-label usage does not occur, although the senators appear to believe this is not an issue.
“Only three times in the past has CMS issued a National Coverage Analysis on a new treatment for cancer, each time focusing on the need to restrict potential off-label usage of such drugs,” they wrote in their letter. “These assessments have not focused on whether or not to cover appropriate on-label use of such a therapy as this review appears to be.”
In any event, the letter comes amid ongoing controversy over the CMS decision, which generated numerous comments on the CMS web site last month as many physicians, patients and investors remarked on the agency move (look at this) and many expressed concern that coverage would be limited. Among those registering their anger at CMS was the American Society of Clinical Oncology (see here). The CMS review will be completed by next June.
Separately, a new survey of 100 oncologists by RW Baird analyst Chris Raymond finds that awareness of the vaccine has jumped to 84 percent in June from just 47 percent in March. Meanwhile, only 8 percent of the docs practice at a site where Provenge is available, but two-thirds have received reimbursement. Most significantly, 59 percent say they intend to prescribe Provenge and that 37 percent of their patients would be candidates, up from 33 percent in March.
staring at a deep rabbit hole
why is the united states senate interfering with the approval and reimbursement of drugs? it would be more acceptable if kerry and specter wrote as private individuals; it is completely unacceptable for them to leverage their institutional position, especially since now they are submitting this “letter” after the close of the public comments period by the CMS (as defined by regulations). why are kerry and specter leveraging their official positions as elected officials but clearly disregarding the regulations of the process? they have to follow protocol, especially if their voters had requested this letter (though more likely it’s a favor requested by indiana senator evan bayh, whose wife sits on the dendreon board). congress also interfered within the FDA, when approval proceedings on this drug were rolling. how can approval and reimbursement considerations remain independent when congressmen are bunting with public letters clearly outside procedural margins? the FDA and the CMS should operate free of congressional pressure. someone should sensitize the US government accountability office (US-GOA) about this, it’s about time.
David Paladin
Just a couple thoughts on Rabbit hole’s comment:
Why would somebody complain about a couple Senator’s, or for that matter innacurately describe their(Senators) role as “pulic servents”? They’re there to oversee overreaching beyond their(CMS’), prescibed by congress, boundaries. If they had made an meaningful attempt to get involved in the FDA debacle in 2007 there would still be with us tens of thousands of Fathers, Veterans, Brothers, Sons, ad infinitum.
How does one not understand Senators are not the public, therefor they do not fall under the CMS ‘public comment’ rule? In fact, the public comment period was established by congress and that CMS will adhere to it(Paraphrazing).
Sensitize Government(?), right; sensitize them to keep charge of the apparent unruliness(read as abusive overruliness) by entities who’ve become corrupt, rude, and unaccountable; even causing unnecessary deaths. Sensitize them alright, to get off their(Senators)duffs and keep these people(CMS/FDA/SEC/FCC,ETC.)within the boundaries; more importantly, sensitize them to the publics needs(I’m not talking about entitlements here)not the Governments.