COMMENTARY

Pneumococcal Vaccine in Older Adults: New ACIP Recommendations

Sandra Adamson Fryhofer, MD

Disclosures

October 23, 2014

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Hello. I'm Dr Sandra Fryhofer. Welcome to Medicine Matters. The topic: pneumococcal vaccination. The Advisory Committee on Immunization Practices (ACIP) issued a new recommendation for seniors, just in time for this year's flu vaccination clinics. But who's covering the bill? Here's why it matters.

Pneumococcal infection—infection with Streptococcus pneumoniae, AKA pneumococcus—is a major cause of morbidity and mortality.[1] It kills as many as 4000 people in the United States each year, mostly adults. It's a leading cause of serious illness: bacteremia, meningitis, and pneumonia. Risk for invasive pneumococcal disease (IPD) is increased in adults who are immunocompromised. In fact, disease rates for immunocompromised adults are 20 times higher than that for adults without high-risk medical conditions. That's why in June 2012, ACIP recommended routine use of pneumococcal conjugate vaccine (PCV13) for immunocompromised adults in addition to the pneumococcal polysaccharide vaccine (PPSV23).

Older adults are also at increased risk for invasive disease. Incidence of invasive disease in adults aged 18-34 years is 3.8 per 100,000. Incidence of invasive disease in older adults, those aged 65 years or older, is nearly 10 times higher: 36.4 per 100,000. Because ACIP recommendations are now evidence-based, the decision was made to defer further expansion of the recommendation for routine use until results of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPITA), a randomized controlled trial of efficacy of PCV13 against pneumococcal pneumonia, were released.[2] CAPITA was conducted in The Netherlands and was designed to look at the efficacy of PCV13 at preventing vaccine-type community-acquired pneumonia in adults aged 65 years or older.

In the trial, nearly 85,000 seniors were randomized to receive either PCV13 or placebo. The results? PCV13 was effective: 75% effective at preventing vaccine-type IPD, and 45% effective in preventing vaccine-type nonbacteremic pneumonia (NBP). These data were presented to ACIP at the June 2014 meeting. The findings were so impressive that ACIP called an emergency meeting on August 13, 2014, to vote on routine PCV13 vaccine procedures. The vote was 13 to 2 in favor of routine PCV13 vaccination for adults aged 65 years or older.[3]

Timing and the order of the two pneumococcal vaccines, one conjugate and the other polysaccharide, is important because it can affect vaccine effectiveness.

Adults aged 65 years or older who have never received any type of pneumococcal vaccine should receive PCV13 first, followed by PPSV23 6-12 months later.

Adults aged 65 years or older who have already received PPSV23 should also be given one dose of PCV13, but timing is important. Wait at least a year after receiving PPSV23 before giving PCV13.

For those who need PPSV23 revaccination, wait at least 5 years after the last dose of PPSV23 and 6-12 months after receiving PCV13 to revaccinate.

There's one more glitch: Medicare coverage. Currently, there is no mechanism in place to cover routine use of a second pneumococcal vaccine. Remember: Pneumococcal vaccination is covered under Medicare Part B, not under Medicare Part D. Current Centers for Medicare & Medicaid Services (CMS) rules routinely cover only one dose of pneumococcal vaccine for all Medicare beneficiaries. For those at high risk, revaccination with PPSV23 is also covered.

CMS representatives told ACIP that a Medicare rule change would be needed in order to get an additional routine pneumococcal vaccination covered. To make a rule change, there is a certain process that must be followed. All in all, it could be a year, maybe a year and a half, before Medicare coverage could be guaranteed.

So, right now it's a catch-22. ACIP has made the recommendation. The data are there, the vaccine is efficacious, seniors can benefit from it, but Medicare will only routinely pay for one vaccination. Retail cost of PPSV23 is about $80. Cost of PCV13 is more than twice that: about $170. Make sure your patients understand the benefits of pneumococcal vaccination, but also make sure that they understand that they may be out of pocket for the cost of the second one.

For Medicine Matters, I'm Dr Sandra Fryhofer.

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