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 

 

HB 1517

In January 2011, the State Legislature, recognizing the significant inequity between patients’ copays for oral and self-administered drugs compared to their deductibles for medical benefits for infused drugs, enacted a law to provide equity for these patients. WSMOS had provided comment to DSHS, expressing concerns about potential unintended consequences. Those comments are attached below. Unfortunately they were not addressed in the final bill and we have recently learned of numerous complaints from patients whose insurance companies have informed them that many injectables and some intravenous drugs will be handled administratively under their outpatient medical benefit which will significantly increase their financial responsibility. WSMOS is working with the Washington State Medical Association and other interested parties to have the 2012 session of the Legislature tighten the language of HB 1517 to prevent insurance companies from subverting the intent of the original legislation. We are also working with the Office of the Insurance Commissioner on this issue.

 

We encourage all oncologists to contact us about instances where your patients have been informed by their insurers that their benefits will be changed beginning January 2012 in contravention of HB 1517.

 

The actual legislation may be found at:

http://apps.leg.wa.gov/documents/billdocs/2011-12/Pdf/Bills/House%20Passed%20Legislature/1517.PL.pdf  

Medicare Denials on Chemotherapy Administration Claims

We have been working with Noridian to resolve a recent issue where chemotherapy administration codes have been denying in error. The
error seems to have occurred due to a claims audit change implemented by Noridian on September 2nd.

Noridian has informed us that they have identified and corrected the
cause of the denial errors and will reprocess the claims through a mass
adjustment.

We will let you know if we hear any further news about
this issue. In the meantime, please let your billing department know about this
issue.

Noridian Awarded A/B MAC

On Monday, August 22, CMS announced that Noridian Administrative Services (NAS) has been awarded the consolidated A/B MAC Jurisdiction F comprised of Alaska, Washington, Oregon, Idaho, North Dakota, South Dakota, Montana, Wyoming, Utah, and Arizona.

The announcement of the award is posted on the FebBizOpps.Gov website. In the past, the awarding of a MAC contract has often been followed by the announcement of a protest of the award so we will be following this and will report any protests filed.