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Judicial Watch • 2011 provenge-point-2

2011 provenge-point-2

2011 provenge-point-2

Page 1: 2011 provenge-point-2

Category:Obtained Document

Number of Pages:6

Date Created:March 30, 2011

Date Uploaded to the Library:July 30, 2013

Tags:trials, significant, medicare, research, evidence, chief, public, officer, review, staff, meeting, National, IRS, ICE, CIA

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Dear Dr. Jacques: behalf Dendreon Corporation (Dendreon), submitting the following comments the opening national coverage analysis (NCA) for autologous cellular immunotherapy treatment metastatic prostate cancer..Dendreon the manufacturer PROVENGE (sipuleucel-T),
[1] autologous cellular immunotherapy indicated for the treatment asymptomatic minimallysymptomatic metastatic castrate resistant (hormone refractory) prostate cancer. PROVENGE 
the first new class biological products designed induce tumor-specific immune response. The Center for Biologics Evaluation and Research (CBER) the Food and DrugAdministration approved PROVENGE April 29, 2010 under biologic license application(BLA, license number 1749). Bringing PROVENGE market has been 15-year journey that has 
involved more than thousand patients, clinical trials, and nearly one billion dollars funding research and development. 
Dendreon appreciates the numerous opportunities have had meet with the Centers for 
Medicare and Medicaid Services (CMS) discuss PROVENGE both pre-and post-FDA approval.We believe that the agency should very familiar with PROVENGE clinical benefits and manufacturing process result these meetings and all the additional information have provided other various forms. Specifically, just the past few months, Dendreon applied for Healthcare Common Procedure System (HCPCS) code and for pass-through biological status under the hospital prospective payment system (OPPS). Each application requires substantial clinical and product information that further demonstrates 
the appropriateness and reasonableness immediate Medicare coverage. describe further detail below, are now enhancing the breadth and depth evidence PROVENGE effectiveness the Medicare population including recently published study the New England Journal Medicine. Based upon the overwhelming clinical evidence showing significant improvement overall survival this patient population, the "gold standard'' all endpoints oncology clinical trials, ask CMS reconsider whether NCA necessary. make this request based the fact that CMS initiation this process was highly unusual. Since the current NCA process was implemented after the Medicare Modernization Act 2003 (MMA), this the time CMS has internally initiated NCA for approved use innovative new cancer biological. The evidence have submitted demonstrates that consistent with other drugs and biologicals CMS currently covers, PROVENGE clearly reasonable and necessary for the treatment asymptomatic minimally symptomatic metastatic castrate rsistant prostate cancer. Dendreon believes that upon further review, CMS should conclude that the NCA can closed this time, without the need for further evaluation, technology assessment (TA), Medicare Evidence Development and Coverage Advisory Committee (MedCAC) meeting. 
Under CMS Guidance for the Public, Industry and CMS Staff: Factors CMS Considers Opening National Coverage Determination, CMS identifies several circumstances which CMS could internally initiate NCA for new technology. Although not know the precise reason CMS opened this NCA, think the agency may have initiated based belief that 
"significant uncertainty exists concerning the health benefits, patient selection, 
appropriate facility and staffing requirements for the new stated above, believe that any uncertainty about the health benefits, patient ,selection, and appropriate 
provision PROVENGE can addressed without.further analysis CMS. FDA review 
PROVENGE was comprehensive and rigorous. The agency reviewed data from randomized trials 
involving over 900 patients. The pivotal registration study was conducted under Special 
Protocol Assessment agreement with the FDA and demonstrated statistically significant 
survival benefit. Similar were seen previous randomized trial. 

July 29, 2010, presents the results the double-blind, well summarizes the findings from 
that the "use sipuleucelT prolonged described the New England sipuleucel-T has shown evidence efficacy reducing the risk death among men with metastatic castration-resistant prostate cancer. the randomized double-blind, placebo-controlled, multicenter phase III 

compared 0.98; 
was 0.77; 

men alive 

Additionally, PROVENGE has favorable side effect profile. The most common adverse (AEs), reported patients the sipuleucel-T group rate 15%, were chills, fever, back pain, nausea, joint ache, and headache'. The majority AEs trials were grades The most 
common 2%) Grade 3-5 adverse events reported the sipuleucel-T
group were back pain and chills. The percentage patients each arm experiencing serious AEs (SAEs) was comparable, including 
the percentage with cerebral vascular accidents which none were attributed sipuleucel-T. 
raised earlier the FDA the incidence CVAs are addressed Risk 
Management Plan submitted amendment the BLA and post-marketing registry study. 

with asymptomatic castration-resistant prostate cancer. 
serve the foundation for coverage CMS. treatment men with metastatic castrate receive new, innovative, safe, and proven extend their lives with minimal daily interruptions. 

The evidence provided CMS and contained the New England Journal Medicine article, demonstrates 
that PROVENGE reasonable 
and necessary for patients with asymptomatic minimally symptomatic metastatic castrate cancer and that the NCA not warranted. for patients navigate Now that CMS has adequately gathered "comments and additional policy under consideration, [6] time and resources into evaluating coverage PROVENGE. This particularly true the primary endpoint the IMPACT trial was overall survival, and the median age 
enrolled was 
years, with 75% the patients being age older and eligible for Medicare. The subgroup analysis patients years age older the integrated dataset for the randomized trials metastatic castrate resistant prostate cancer demonstrated consistency the PROVENGE treatment effect. The median survival was 23.4 months the PROVENGE group and 

17.1 months the placebo group. PROVENGE clearly shows 
effectiveness the Medicare patients with prostate Accordingly, PROVENGE, they apply its local contractors its local use. CMS should not 
new 	standard care; educate Medicare beneficiaries  
ensure all patien that this "substantial for whom indicated, "[7]  
Although  expressed  most recent  

meeting with you about the variations coverage PROVENGE between contractors, these Medicare contractors cover PROVENGE across their, resistant prostate this reinforces why the move forward with this NCA, should conclude the MedCAC meeting. believe that not needed the conditions listed 
the guidance document regarding factors CMS particular, "significant differences opinion among experts, shown the fact that PROVENGE was approved the FDA, the National Comprehensive Cancer Network (NCCN) listed PROVENGE the NCCN C-ljnical 
Practice Guidelines Oncology (NCCN GuidelinesT) for Prostate Cancer (version 2.2010) and 

NCCN Drugs 
category treatment recommendation for patients with category recommendation means that "the recommendation based high level evidence (e.g. randomized controlled trials) and there uniform NCCN consensus."[9] NCCN not-for-profit alliance the world's leading cancer centers. Its experts are world and its Prostate Cancer Panel members from the best cancer 

the country. inclusion PROVENGE 
with category recommendation 
shows the high level consensus 
regarding PROVENGE's clinical data well PROVENGE's role the treatment regimen for prostate cancer. the the Agency for Healthcare Research and
Furthermore, although the 

Quality (AHRQ) website recently was changed from "The Efficacy and Safety Sipuleucel "The Outcomes Sipuleucel "[10] continue concerned that the scope the assessment duplicates the review already conducted the FDA. For the same reasons, believe that meeting the MedCAC not needed assess the data PROVENGE, all which already has been reviewed CMS. CMS proceeds with the NCA, believe the agency should issue proposed decision soon possible covering 
PROVENGE under the same standards apply any other drug biological used anticancer chemotherapeutic regimen. Under the Social Security Act 

(SSA), any FDA-approved use drug biological anticancer chemotherapeutic drug 
regimen "medically accepted indication" that included the definition "drugs and 
biologicals" that may covered Medicare.[11] The use PROVENGE for asymptomatic 

minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer 
approved the FDA and thus "medically accepted indication" used anticancer 

chemotherapeutic drug regimen that should covered Medicare. addition, other uses 

FDA-approved drugs used anticancer chemotherapeutic drug regimens are "medically accepted 
the use supported authoritative compendia recognized the Secretary Health and Human and Biologics Compendium one these 
compendia, [13] and "asymptomatic minimally symptomatic 
patients with performance expectancy greater than months and 
visceral disease."[14] the NCCN would 
satisfy the criteria for not been for minimally symptomatic metastatic (hormone refractory) prostate cancer; therefore, undoubtedly its FDA-approved use. 

Thank you for your thoughtful consideration our comments. remind you that the patients serve have late-stage cancer and 
few, any, 
options available them, with only chemotherapy FDA-approved alternative. PROVENGE clearly reasonable and necessary for the minimally symptomatic metastatic castrate resistant prostate cancer, provides unambiguous survival benefit and real hope for patients battling their disease. Dendreon, many have been affected 'cancer, which why have dedicated our lives transforming the way cancer treated. The patients PROVENGE treats are our fathers, our husbands, our brothers and sons, 
our teachers and 
our veterans and our friends. urge you not deny them access PROVENGE 
allows cancer patients the freedom opportunity submit these comments and would pleased than 
agency any questions you may have. 


Hans Bishop, Chief Operating Officer Dendreon 

Mark Frohlich, Chief Medical Officer 

[1] NCA Tracking Sheet for Autologous Cellular Immunotherapy Treatment Cancer (CAG-00422N), June 30, 2010, Guidance National Coverage Determination, PW, Cancer. for the Public, Industry CMS Staff: Factors April 11, 2006, Sipuleucel-T Immunotherapy and CMS Considers Higano CS, al. for 
Engl Med 2010;363:411-22. Small EJ, Schellhammer PF, Higano CS, al. Placebo-controlled phase III