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.

Immediate Action Required to Protect Community Cancer Care

During recent negotiations of the federal budget and the national debt, several proposals to cut Medicare and Medicaid have been discussed including a proposal to reduce reimbursement for physician administered Medicare Part B drugs from the current ASP +6% to ASP +4%. Such a reduction in drug reimbursement would jeopardize cancer care in the community setting. 

In response to the proposed ASP cut, ACCC, ASCO, Amerisource Bergen, Community Oncology Alliance (COA), the Healthcare Distribution Management Association, McKesson, the National Coalition for Cancer Survivorship, the National Patient Advocate Foundation, US Oncology Network and UPMC Cancer Centers signed a joint letter to the White House and national debt ceiling negotiators opposing the cuts to cancer drugs and biologicals under the Medicare Part B program. Click Here to read the letter.  

If you haven’t already done so please out to your Representatives, Senators and the President urging them to oppose this reduction to cancer care. You can easily contact your legislators through ASCO's ACT Network.  The link provides contact information, a summary of the proposed ASP reduction and talking points when speaking to your elected officials. It is important to act as soon as possible.

 

New website

Welcome to the new website.

On this site you'll be able register for events online, renew your membership electronically, and subscribe to the WSMOS news feed. To subscribe to the news feed, and automatically receive email alerts when a news item has been added, click on "Subscribe in a reader" on the top right-hand side of this page. 

We will continue to add new features and resources.

Stay tuned.