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SCOS Newsline

FDA Approves Updates to Prescribing Information for Velcade

November 21, 2011. Millennium: The Takeda Oncology Company announced that the U.S. Food and Drug Administration (FDA) has approved updates to the Velcade prescribing information that include additional long-term (median follow-up 60.1 months) overall survival data from the VISTA trial. The landmark VISTA trial examined the use of Velcade with melphalan+prednisone (MP) vs MP in patients with previously untreated multiple myeloma. Velcade is the first and only FDA-approved agent to deliver an overall survival advantage in combination with MP in patients with previously untreated MM. The 5-year follow-up data demonstrated that patients treated with Velcade+MP continued to have a significantly longer overall survival (median 56.4 months vs 43.1 months, P<0.05) than those treated with MP alone, a recognized standard of care. These results translated into a 43.9% improvement in overall survival when patients received the Velcade-containing regimen.

The prescribing information is also being updated to provide the information that the concomitant use of strong CYP3A4 inducers with Velcade is not recommended.

SCOS Registers Concern About Drug Shortages

The Board of Directors, on behalf of its members and cancer patients in South Carolina, recently communicated its concern about state and national shortages of chemotherapeutics and related drugs for cancer treatment to South Carolina’s elected representatives in the US Congress. Also included in the letter was support for federal legislation, S. 296, Preserving Access to Life-Saving Medications, which addresses these shortages. In addition, the same letter of concern was sent to representatives of four pharmaceutical companies and officials at the Food and Drug Administration (FDA).

To view SCOS’s letter, please click here. SCOS encourages members to also write their elected representatives in Washington, DC in support of S. 296 and to share with them the problems these shortages are causing in planning the most effective treatment regimens for patients. In addition, members should report any shortages their practices are experiencing to the FDA at http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm.

SCOS’s letter has already elicited a response from APP Pharmaceuticals. Please click here to see the letter from APP President and CEO, John Ducker.

Connolly Consulting, the Medicare Recovery Audit Contractor (RAC) for Region C, identified on its website CMS-approved audit issues.

The following claims will be edited automatically and monies recouped in these areas if they were billed incorrectly:

  • Pegfilgastim claims not billed with the 6 mg unit of service (Florida, Georgia, South Carolina)
  • Newborn pediatric CPT codes billed for patients exceeding age limit
  • Once in a lifetime procedures (Florida, Georgia, South Carolina)
  • Excessive units - Untimed codes (Alabama, Florida, Georgia, South Carolina)
  • Excessive units - Blood transfusions (Alabama, Florida, Georgia, South Carolina)
  • Excessive units - Bronchoscopy
  • Excessive units - IV hydration (Alabama, Florida, Georgia, South Carolina)
  • CSWs billing during an inpatient stay (Florida Only)

Posted 9/17/09


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