Genomic Health Announces New Evidence Further Demonstrating Clinical Utility and Cost-

January 23, 2013

Genomic Health Announces New Evidence Further Demonstrating Clinical Utility and Cost- Effectiveness of Oncotype DX in Colon Cancer Data Presented at the 2013 Gastrointestinal Cancers Symposium Show Test Significantly Changes Treatment Decisions, May Reduce Medical Costs While Increasing Patient Well-Being Journal of Clinical Oncology Accepts for Publication Second Successful Validation Study Confirming Oncotype DX Colon Cancer Test Provides Value Beyond Conventional Markers click here for more info.

*WSMOS is not responsible for the accuracy or content of material submitted by our corporate members.

RAC Audits on Same Day Neulasta

As we discussed in the most recent WSMOS newsletter, we have been working with Dr. Bernice Hecker, CMD for Noridian (NAS) and ASCO to resolve the RAC audits on Neulasta when administered the same day as chemotherapy. Today, November 20, an article providing support for the administration of Neulasta on the same day as chemotherapy was posted on the Noridian (NAS) website. In addition, ASCO recently sent a letter to CMS requesting that these audits be halted. Click Here to read ASCO’s letter.

The positive response by NAS (through publication of the supportive article) and ASCO's letter to CMS, prompted by the engagement of WSMOS and other state societies, demonstrate the importance and value of staying engaged and supporting WSMOS and the value of ASCO's new State Affiliate Council (SAC)

Below is the text and click here for the full NAS article.

Medicare Part B

PEGFILGRASTIM (NEULASTA) - J2505

Medicare covers the use of Pegfilgrastim (Neulasta), J2505, to decrease the incidence of infection, as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The initial 2002 FDA approval and label specified administration starting 24 hours after and no sooner than 14 days before delivery of cytotoxic chemotherapy.

Coverage of Same Day Dosing
Within two years of drug approval, presentations on the utility and non-inferiority of same day dosing of Neulasta with chemotherapeutic agents appeared as abstracts. By 2009, Whitworth and Schuman independently proclaimed the administration of “pegfilgrastim on day 1 appears to be safe, effective and convenient” and “same day…may be determined to be a convenient, safe and effective approach” respectively. A 2010 metaanalysis concluded “the results indicated that same-day administration was statistically non-inferior to next-day administration according to neutropenia duration.” Based on the evidence, the administration of same-day pegfilgrastim has become an accepted standard of care and in particular, in situations where patients are believed to be a higher risk of potential non-compliance with day 2 administration.

Coverage of Less than 14 Day Dosing
In multiple trials of every other week myelosuppressive chemotherapy, pegfilgrastim given within 14 days of the next cycle has been shown to be effective in maintaining dose-density and reducing neutropenic events without any significant concerns for safety. on this evidence, the administration of pegfilgrastim before the traditional 14 day window has become an accepted standard of care to maintain dose-density or reduce neutropenic complications in regimens with substantial myelosuppression.

Sources for Same Day Dosing:
• Gynecologic Oncology, Volume 112 dated March 2009, Pgs. 601-604 “The safety and efficacy of day 1 versus day 2 administration of pegfilgrastim in patients receiving myelosuppressive chemotherapy for gynecologic malignancies”
• Journal of Support Oncolology, Volume 7, Issue 6 dated November-December 2009, Pgs. 225-8 “Pegfilgrastim dosing on same day as myelosuppressive chemotherapy for ovarian or primary peritoneal cancer”
• Journal of Oncology Practice, Volume 6, Issue 3 dated May 2010, Pgs. 133-40 “Pegfilgrastim on the Same Day Versus Next Day of Chemotherapy in Patients With Breast Cancer, Non-Small-Cell Lung Cancer, Ovarian Cancer, and Non-Hodgkin's Lymphoma: Results of Four Multicenter, Double-Blind, Randomized Phase II Studies”

Sources for Less than 14 Day Dosing:
Haematologica, Volume 91, Issue 4 April dated 2006, Pgs. 496-502 “Dose-dense R-CHOP-14 supported by pegfilgrastim in patients with diffuse large B-cell lymphoma: a phase II study of feasibility and toxicity”
• Journal of Clinical Oncology, Volume 23, Issue 33 dated November 20, 2005, Pgs. 8340-7, “Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy”
• British Journal of Cancer, Volume 100, Issue 2 dated January 27, 2009, Pgs. 305-10, “A randomized pilot Phase II study of doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) given 2 weekly with pegfilgrastim (accelerated) vs 3 weekly (standard) for women with early breast cancer”
• Clinical Colorectal Cancer, Volume 9, Issue 2 dated April 2010, Pgs. 95-101, “A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy”
• Lung, Volume 184, Issue 5 dated September-October 2006, Pgs. 279-85, “Achieving full-dose, on-schedule administration of ACE chemotherapy every 14 days for the treatment of patients with extensive small-cell lung cancer”

A new option for advanced NSCLC

ABRAXANE® is now indicated for the first-line treatment of locally advanced or metastatic non–small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

ABRAXANE® prescribing info: here

More information: here

BOSULIFR (bosutinib) tablets Approval

Pfizer’s BOSULIF (Bosutinib) which was just recently approved by the FDA. Click here to visit www.bosulifhcp.com for more information. Pfizer anticipates BOSULIF to be available broadly at retail and specialty pharmacy.

Please see the full Prescribing Information at http://www.pfizer.com/files/products/uspi_bosulif.pdf

New Product Announcement from Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals

Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals are pleased to announce that STIVARGA® (regorafenib) has been approved by the FDA for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild-type, an anti-EGFR therapy.

Learn more here

There will be a special broadcast event that will feature several physician experts discussing the results. Click the link below to register.

http://www.RevealInformEducate.com

 

Genomic Health Announces Results of Eighteen Studies Covering Colon, Prostate and Breast Cancers at the American Society for Clinical Oncology (ASCO) 2012 Annual Meeting

Oncotype Dx Colon

A large, prospectively-designed, independent validation study involving 892 patients demonstrates that the Oncotype DX Colon Cancer Recurrence Score predicts risk of recurrence, disease-free survival and overall survival in stage II and stage III colon cancer patients receiving adjuvant chemotherapy in the landmark randomized NSABP C-07 clinical trial (p<0.001 for all endpoints). These new data reconfirm the value of the colon cancer Recurrence Score result in revealing underlying biology that provides quantitative information regarding recurrence risk not available with conventional factors, such as T-stage, N-stage, mismatch repair (MMR) status, tumor grade, and nodes examined. The study also indicates that risk assessment with Recurrence Score result enables better discrimination of the expected absolute benefit of adding oxaliplatin to adjuvant 5FU chemotherapy 

Oncotype Dx DCIS score

Previously, ECOG investigators presented positive validation study results in 327 women with DCIS (ductal carcinoma in situ of the breast) at the San Antonio Breast Cancer Symposium in December 2011 demonstrating that the Oncotype DX DCIS Score result can help identify patients who are at high or low risk for a local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. Additional results from the E5194 DCIS clinical validation study presented at ASCO provide further evidence that the DCIS Score result provides clinical value beyond traditional factors, such as tumor grade. Moreover, the results indicate that the DCIS Score result cannot be predicted using the available clinical or pathology factors. The Oncotype DX test for DCIS, which was launched at the end of last year, can identify both lower risk DCIS, which may be treated with surgery alone, and higher risk DCIS, for which radiation should be considered in addition to surgery.

*Genomic Health is a contracted (in-network) provider for over 95% of privately insured lives.

Since individual policies differ, reimbursement for a specific patient and Insurer can be determined

prior to a test being completed. More Information visit http://www.oncotypedx.com/

 

New FDA Approval for Metastatic Colorectal Cancer

Sanofi US and Regeneron Pharmaceuticals, Inc. are pleased to announce that the U.S. Food and Drug Administration (FDA) has approved ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion. 

ZALTRAP®, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. The recommended dose of ZALTRAP administered as an intravenous infusion over 1 hour, is 4 mg per kg of body weight every 2 weeks, prior to any component of the FOLFIRI regimen on the day of treatment. Click Here for more information.

 

PERJETA™

PERJETA™ (pertuzumab) is now FDA-approved in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.   

 

Click here to see attached Day 1 announcement

 

Click here to see full Prescribing Information

 

Important Safety Information Boxed WARNING:

Embryo-Fetal Toxicity 

Exposure to PERJETA can result in embryo-fetal death and birth defects. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Advise patients of these risks and the need for effective contraception