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Judicial Watch • Provenge Point 2

Provenge Point 2

Provenge Point 2

Page 1: Provenge Point 2


Number of Pages:6

Date Created:March 30, 2011

Date Uploaded to the Library:February 20, 2014

Tags:prostate, metastatic, sipuleucel, survival, Immunotherapy, Cellular, Autologous, PROVENGEs, patients, cancer, dendreon, treatment, Journal, tracking, provenge, coverage, sheet, jacques, medicare, point, Group

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From: Dolina, Elaine (CMS/OCSQ) 
Sent: Thursday, July 29, 2010 7:51 

To: Jacques, Louis (CMS/OCSQ); Rollins, James (CMS/OCSQ); PASERCHIA, LORI 
(CMS/OCSQ); Fitterman, Leslye (CMS/OCSQ) Subject: RE: NCA Tracking Sheet for Autologous Cellular lmmunotherapy Treatment Metastatic Prostate Cancer (CAG-00422N) went ahead and entered the comment. 
https://www. cms. gov/mcd/publiccomment_popup.asp?comment_id=21547 We can worry about the attachments later. They might difficult make 508 compliant. 

-----Original Message----From: Jacques, Louis (CMS/OCSQ) 
Sent: Wednesday, July 28, 2010 11:23 
To: Rollins, James (CMS/OCSQ); PASERCHIA, LORI (CMS/OCSQ); Fitterman, Leslye (CMS/OCSQ); 
Dolina, Elaine (CMS/OCSQ) 
Subject: FW: NCA Tracking Sheet for Autologous Cellular Immunotherapy Treatment Metastatic 
Prostate Cancer (CAG-00422N) 

-----Original Message----From: Larson, Tricia [mailto:tlarson@Dendreon. com] Sent: Wed 7/28/2010 10:25 To: Jacques, Louis (CMS/OCSQ) Cc: Bishop, Hans; Frohlich, Mark; Lockett, Chris Subject: NCA Tracking Sheet for Autologous Cellular Immunotherapy Treatment Metastatic Prostate Cancer (CAG-00422N) 

July 28, 2010 
Louis Jacques, Director, Coverage and Analysis Group Centers for Medicare Medicaid Services Mail Stop S3-02-01 7500 Security Blvd. Baltimore, 21244 

Re: NCA Tracking Sheet for Autologous Cellular Immunotherapy Treatment Metastatic Prostate Cancer (CAG-00422N) 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 [1] Dendreon the manufacturer PROVENGE (sipuleucel-T), autologous cellular immunotherapy indicated for the treatment asymptomatic minimally symptomatic 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 Drug Administration (FDA) approved PROVENGE April 29, 2010 under biologic license appljcation (BLA, license number 1749). Bringing PROVENGE market has been 15-year journey that has involved more than thousand courageous 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. believe that the agency should very familiar with PROVENGE's 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 Coding System (HCPCS) code and for pass-throughbiological status under the hospital outpatient 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's 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's initiation this process was highly unusual. Since the current NCA process was implemented after the Medicare Modernization Act 2003 (MMA), this the first 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 resistant 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's 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 technology."[2] stated above, believe that any uncertainty about the health benefits, patient.selection, and appropriate provision PROVENGE can addressed without further analysis CMS. FDA's 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 results were seen previous smaller randomized trial. addition the data relied upon the FDA, the attached article, published the New 
ngland Journal Medicine July 29, 2010, presents the results the double-blind, placebo-controlled phase III trial for PROVENGE, well summarizes the findings from earlier phase III trials. The article concludes that the "use sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer."[3] described the New England Journal Medicine article, 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 "IMPACT" trial, randomly assigned 512 patients with median age 71, 2:1 ratio receive either sipuleucel-T (341 patients) placebo (171 patients) administered intravenously every weeks, for total infusions. 
The primary endpoint this study was overall survival, the most meaningful clinical outcome for patients, analyzed means stratified Cox regression model adjusted for baseline levels serum prostate-specific antigen (PSA) and lactate dehydrogenase. the sipuleucel-T group, there was relative reduction 22% the risk death compared with the placebo group (hazard ratio (HR), 78; 95% confidence interval (CI), 98; 03). There was 1-month improvement median survival (25. months the sipuleucel-T group vs. 21. months the placebo group). The 36-month survival probability was 31. the sipuleucel-T group versus 23. the placebo group. The treatment effect was also observed with the use unadjusted Cox model and log-rank test (HR, 77; 95% CI, 0.61 97; 02) and after adjustment for use docetaxel after the study therapy (HR, 0.78; 95% CI, 0.62 0.98; 0.03). 

Importantly, the results the IMPACT trial confirmed the results the earlier D9901 study, published the attached article the Journal Clinical Oncology. [4] Specifically, this study there was relative reduction of.41% the risk death the sipuleucel-T group compared with the placebo group (HR, 586; 95% CI, 388 884; P=0. 010). There was month improvement median survival (25. months the sipuleucel-T group vs. 21. months the placebo group). this study, 34% the men were alive the year follow-up compared 11% the placebo group. integrated survival analysis completed with these results together with the results from the D9902A[5] trial and IMPACT demonstrated p-value