New FDA Approval for Vectibix

On May 23, 2014 the Food and Drug Administration (FDA) approved a new indication for Vectibix® (panitumumab) as follows: 

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:

  • As first-line therapy in combination with FOLFOX
  • As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy

Vectibix® is not indicated for the treatment of patients with KRAS-mutant mCRC or for whom KRAS mutation status is unknown.  

Please click here to link to the Vectibix® Prescribing Information (PI), including Boxed WARNING.

 

UPDATE: SGR PATCH & ICD-10 DELAY

On March 31, Congress passed another temporary fix to the flawed sustainable growth rate (SGR) formula. This is the 17th temporary fix to the SGR formula. The bill, Protecting Access to Medicare Act of 2014 (H.R. 4302) is expected to be signed by President Obama and would delay until March 2015 the pending 24% cut to Medicare physician payments.

Among other provisions, the bill includes:

  • A 12-month patch for the SGR and continues the 0.5% update through calendar year 2014 and a zero percent payment update from January 1, 2015 to March 31, 2015;
  • An extension of the work GPCI floor until April 1, 2015;
  • A minimum 1-year delay (the bill language states HHS may not adopt ICD-10 as the standard code set until October 1, 2015) in transition from ICD–9 to ICD–10 code sets;
  • The establishment of a market-based payment system for diagnostics under the Clinical Laboratory Fee Schedule (CLFS);
  • Development of quality incentives, including penalties for certain computed tomography services to improve radiation dosing safety  and to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging.;
  • A delay of the Recovery Audit Contractor enforcement of the “two-midnight rule” through March 31, 2015;
  • A new skilled nursing facility value based purchasing program (SNF VBP) to begin in fiscal year 2019;
  • An extension of the Qualifying Individual (QI) Program that assists Medicare beneficiaries with incomes between 120%-135% of the federal poverty level (FPL) by covering the cost of their Medicare Part B premiums.

New MOC Rules

Maintenance of certification (MOC) rules on Board Certification changed on January 31, 2014 and all US Board certified oncologists, including those who are "grandfathered" must enroll with ABIM by March 31 to ensure they are reported as meeting MOC requirements. ABIM will begin publicly reporting physicians’ status as Certified or Not Certified and Meeting MOC Requirements or Not Meeting MOC requirements.  After March 31, physicians can change their reported status by logging in ABIM.org and enrolling in the program.

If you do not log in and activate your program by March 31 you will be reported as "Certified, Not Meeting MOC Requirements."  Enroll now through the ABIM physician portal at :

https://www.abim.org/online/default.aspx

The Centers for Medicare and Medicaid Services (CMS) have granted ZALTRAP® (Ziv-Aflibercept) Injection for Intravenous Infusion a permanent J Code. J9400.

The Centers for Medicare and Medicaid Services (CMS) have granted ZALTRAP® (Ziv-Aflibercept) Injection for Intravenous Infusion a permanent J Code. J9400. This new HCPCS code is effective for dates of service on or after January 1, 2014. Please be sure to prepare your systems for the introduction of this new code. 

Click here for info.

 

Effective January 1, 2014, CMS has assigned a new HCPCS code for Neupogen®, J1442 injection, filgrastim 1 mcg.

On November 29, 2013, CMS released the Healthcare Common Procedure Coding System (HCPCS) code set updates that will be effective January 1, 2014. • Effective January 1, 2014, CMS has assigned a new HCPCS code for Neupogen®, J1442 injection, filgrastim 1 mcg. This new HCPCS code replaces the old Neupogen® HCPCS codes of J1440 for 300 mcgs and J1441 for 480 mcgs. • As a result of the new Neupogen® HCPCS code, providers will need to enter the Neupogen® units used in the billing process to distinguish which Neupogen® dose was used (e.g. 300 mcg single use vial/prefilled syringe or 480 mcg single use vial/prefilled syringe). • For additional details relative to this change, here is the CMS website: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html For the full Prescribing Information on Neupogen® (filgrastim), please go to: http://www.neupogen.com

New FDA Approval for Xalkori

On November 20, 2013 the FDA granted regular approval for crizotinib (Xalkori, Pfizer, Inc.) capsules for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.html

New FDA Approval for NEXAVAR

On November 22, 2013, the FDA approved sorafenib (NEXAVAR tablets, Bayer Healthcare Pharmaceuticals Inc.) for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. Sorafenib was previously approved for treatment of renal cell carcinoma (2005) and hepatocellular carcinoma (2007). More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376547.htm

FDA Approves New Treatment for Chronic Lymphocytic Leukemia (CLL)

Genentech's GAZYVA (obinutuzumab) is a new FDA-approved anti-CD20 monoclonal antibody indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

GAZYVA was studied in a three arm, open label, randomized, multicenter, phase III trial.1 Please see the attached announcement for further details on why GAZYVA is an important new treatment option for patients with CLL, as well as GAZYVA full Prescribing Information for additional Important Safety Information, including Boxed Warnings.
 
The FDA designated GAZYVA a “Breakthrough Therapy” in May 2013. This designation is granted to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.

•       Access the FDA approval press release
•       Click here for Full Prescribing Information