Politics & Policy: May 2007

By Prachi Patel-Predd
Published: Thursday, Aug 12, 2010


CDC Adopts Advisory Panel's HPV Vaccine Recommendation

The Centers for Disease Control and Prevention (CDC) has adopted the recommendations of its advisory committee on immunization practices (ACIP) for girls and women ages 11 through 26 years to routinely receive the human papillomavirus vaccine Gardasil. The ACIP vaccination guidelines were published in the CDC’s Morbidity and Mortality Weekly Report, which finalizes the advisory committee’s recommendations. The guidelines are available to physicians.

Clinical trials have shown that Merck’s Gardasil is effective against HPV strains 16 and 18, which lead to about 70% of cervical cancer cases. In July 2006, the US Food and Drug Administration approved the vaccine for sale and marketing to girls and women ages 9 to 26 years. Later that month, the CDC’s advisory committee voted unanimously to recommend Gardasil for girls aged 11 and 12. The guidelines allow for girls as young as nine to receive the vaccine, and they also say that females aged 13 to 26 get vaccinated if they have not already done so or have not completed the full series.

Even with the CDC’s recommendations, there is expected to be some resistance at the state level (see below in the State Focus).

Changes in Medicare Coverage of ESAs for Cancer-Related Anemia

Following the US Food and Drug Administration’s advisory on erythropoetic stimulating agents (ESAs), the Centers for Medicare and Medicaid Services (CMS) has issued an instruction to local Medicare carriers that would prohibit Medicare coverage of the agents—darbepoetin alfa and epoetin alfa—when used for the treatment of cancer-related anemia, according to the American Society of Clinical Oncology (ASCO). However, ESAs that are used to treat anemia resulting from chemotherapy would not be affected by this policy change.

The CMS has not yet made public its instructions to local Medicare carriers. “ASCO was contacted by physicians who had  conversations with their Medicare carrier medical directors regarding the CMS directive,” Jenny Heumann, assistant director of public affairs at ASCO, told Oncology & Biotech News. “ASCO spoke with CMS about the directive; however, the publication details regarding the directive were not disclosed.”

On March 9, the FDA issued a public health advisory and outlined new safety information for ESAs, including updated product labeling. The advisory was based on four new studies in cancer patients, which have found a higher chance of death or life-threatening side effects such as blood clots, strokes and heart attacks with the use of ESAs. The studies were analyzing off-label drug dosage, a patient population for which the agents are not approved, or a new unapproved ESA. But because all ESAs work in the same manner, the FDA believes that the concerns apply to the entire class of drugs and is now re-evaluating the safeuse of the class.

The FDA’s warning issuance prompted the CMS to announce that it was reviewing all Medicare policies related to the  administration of ESAs. “We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount,” Leslie Norwalk, CMS acting administrator, said in that statement. “We will carefully examine the effect of these labeling changes on Medicare’s policies and we encourage treating physicians to review the warnings and to take them into account when prescribing ESAs for their patients.”

At the time Oncology & Biotech News went to press, not all Medicare Part B carriers had announced or implemented a change in their Medicare coverage policy, according to ASCO. By March 13, five Medicare Part B contractors that cover 24 states  announced policy changes for one or both drugs and one carrier had plans for a meeting to discuss policy changes.



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