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CDC Advisors Recommend Prevnar 13 Vaccine for Older Adults

Medicare coverage may be a problem

In a 13-to-2 vote, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein] [PCV13], Pfizer) for routine use to help protect adults 65 years of age and older against pneumococcal disease, which includes pneumonia caused by the 13 pneumococcal serotypes included in the vaccine.

Specifically, ACIP voted to recommend the following:

  • Adults 65 years of age or older who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23 (pneumococcal polysaccharide vaccine [Pneumovax, Merck]).
  • Adults 65 years of age or older who have not previously received PCV13 and who have previously received one or more doses of PPSV23 should receive a dose of PCV13.
  • The recommendations for routine PCV13 use among adults 65 years of age and older (if approved by ACIP and the CDC’s director) should be re-evaluated in 2018 and revised as needed.

The panel expressed concern, however, that the Medicare insurance program for the elderly currently is unable to cover Prevnar 13 for patients who have already received Pneumovax. A Medicare official, speaking to the panel in Atlanta, said his agency would have to change its rules in order to qualify such patients for reimbursement, and that its evaluation would likely extend until January 2016.

The new recommendations, including the time intervals between vaccine administration, will be forwarded to the director of the CDC and to the U.S. Department of Health and Human Services for review and approval; if approved, the recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report.

Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the U.S.

Current indications for the use of Prevnar 13 in the U.S. are as follows:

  • In children 6 weeks through 5 years of age (prior to the 6th birthday), Prevnar 13 is indicated for 1) active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 2) active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F.
  • In children 6 years through 17 years of age (prior to the 18th birthday), Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
  • In adults 50 years of age and older, Prevnar 13 is indicated for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

Pneumococcal disease refers to a group of illnesses caused by S. pneumoniae bacteria. Invasive pneumococcal disease occurs when bacteria enter the bloodstream or another site that is normally sterile. Noninvasive pneumococcal pneumonia occurs when the bacteria cause infection in the lungs but are not detected concurrently in the blood. In adults, pneumonia is the most common presentation of pneumococcal disease. For every case of invasive pneumococcal pneumonia in adults, it is estimated that at least three cases of noninvasive pneumococcal pneumonia occur. While noninvasive forms of pneumococcal disease are typically more common, the invasive types are generally more severe.

Pneumococcal pneumonia is the most common type of community-acquired bacterial pneumonia in the U.S. Approximately 900,000 Americans develop pneumococcal pneumonia each year, nearly half of whom end up in a hospital. Among adults 50 years of age and older, approximately 440,000 cases of pneumococcal pneumonia occur each year in the U.S., with approximately 25,000 pneumococcal disease-related deaths annually.

Sources: Pfizer; August 13, 2014; Reuters; August 13, 2014; and Prevnar 13 Prescribing Information; February 2014.

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