Aetna considers standard and heptavalent pneumococcal conjugate vaccines medically necessary according to the recommendations of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP).

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Standard Pneumococcal Vaccine:

Aetna considers standard 23-valent pneumococcal polysaccharide vaccine (PPV23, e.g., Pneumovax, Pnu-immune) medically necessary for all individuals aged 65 years or older.

Aetna considers standard pneumococcal vaccine medically necessary for persons over 2 years of age with any of the following conditions:

1. Chronic cardiovascular disease
2. Chronic pulmonary disease
3. Diabetes mellitus
4. Asplenia (functional or anatomic)
5. Persons living in special environments or social settings with an identified increased risk of pneumococcal disease (e.g., certain Native American and Alaska Native populations)
6. Alcoholism (adults)
7. Chronic liver disease (including cirrhosis)
8. Chronic renal failure or nephrotic syndrome
9. Sickle cell disease
10. Multiple myeloma (adults)
11. Metastatic or hematologic malignancies
12. Acquired or congenital immunodeficiency (including HIV infection)
13. Other conditions associated with immunosuppression (such as organ transplantation, bone marrow transplantation, and persons on immunosuppressive chemotherapy (including corticosteroids))
14. Cerebrospinal fluid leaks
15. Persons who have or are planning to receive a cochlear implant (see CPB 013 - Cochlear Implants and Auditory Brainstem Implants).

Aetna considers standard pneumococcal vaccine experimental and investigational for other indications.

Routine re-vaccination is not recommended by the CDC.  In accordance with the CDC’s recommendations, Aetna considers re-vaccination medically necessary only for the following groups:

• Persons aged 65 years or older if they received vaccine 5 or more years previously and was less than 65 years of age at the time of vaccination,
• Persons aged 2-64 years with asplenia. If member is more than 10 years of age, a single re-vaccination is considered medically necessary 5 or more years after previous dose; if member is aged 10 or younger, re-vaccination is considered medically necessary 3 years after previous dose,
• Immunocompromised persons 2 years of age or older. A single re-vaccination is considered medically necessary if 5 or more years have elapsed since receipt of the first dose; if the member is 10 years of age or younger, re-vaccination is considered medically necessary 3 years after previous dose.

In addition, re-vaccination with the 23-valent pneumococcal polysaccharide vaccine is considered medically necessary for high-risk individuals who received the 14-valent polysaccharide vaccine, which was in use prior to 1983.

Re-vaccination has no proven value for other groups.

Heptavalent Pneumococcal Conjugate Vaccine:

According to the recommendations of the CDC’s Advisory Committee on Immunization Practices , Aetna considers heptavalent pneumococcal conjugate vaccine (PCV7, e.g., Prevnar, Prevenar) medically necessary for all children under 2 years of age, and high-risk children between the ages of 2 and 5 years.  High-risk groups include children with:

• Sickle-cell disease and other sickle cell hemoglobinopathies, congenital or acquired asplenia, or splenic dysfunction
• Infection with human immunodeficiency virus
• Immunocompromising conditions, including
• Congenital immunodeficiencies: B- (humoral) or T-lymphocyte deficiency; complement deficiencies, particularly c1, c2, c3, and c4 deficiency; and phagocytic disorders, excluding chronic granulomatous disease
• Renal failure and nephrotic syndrome
• Diseases associated with immunosuppressive therapy or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin’s disease; or solid organ transplantation,

• Chronic illnesses, including

  • Chronic cardiac disease, particularly cyanotic congenital heart disease and cardiac failure
  • Chronic pulmonary disease, excluding asthma unless on high dose corticosteroid therapy
  • Cerebrospinal fluid leaks
  • Diabetes mellitus
  • Children who have or are planning to receive a cochlear implant (see CPB 013 - Cochlear Implants and Auditory Brainstem Implants).

Based on the ACIP’s recommendations, Aetna considers heptavalent pneumococcal conjugate vaccination medically necessary for all other children aged 24-59 months, including the following populations identified by ACIP as a priority:

• Children aged 24-35 months
• Children of Alaska Native or American Indian descent
• Children of African-American descent
• Children who attend group day care centers (defined as a setting outside the home where a child regularly spends over 4 hours per week with more than 2 unrelated children under adult supervision).

Aetna considers heptavalent pneumococcal conjugate vaccine experimental and investigational for other groups.

This policy is based on the recommendations of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, the U.S. Preventive Services Task Force, the American Academy of Pediatrics Committee on Infectious Diseases, the American College of Physicians Task Force on Adult Immunization, and the Infectious Diseases Society of America.

Pneumococcal disease is an infection with the bacteria Streptococcus pneumoniae, which causes pneumonia, bacteremia, and meningitis. Pneumococcal disease is a significant cause of morbidity and mortality in the United States. Population-based surveillance studies have reported annual invasive pneumococcal disease rates of at least 15-19/100,000 population and pneumococcal meningitis rates of 0.3-1.2/100,000. Significantly higher incidence rates are reported for persons less than 5 years of age or over age 65; African Americans, Native Americans, and Alaska Natives; nursing home residents; alcoholics; and those with chronic medical or immunodeficient conditions.

Pneumococcal disease accounts for about 15% of severe community-acquired pneumonia, which has a case-fatality rate (proportion of cases resulting in death) of 9-26%. Pneumococcal bacteremia and meningitis are also associated with high case-fatality rates. The highest case-fatality rates from invasive pneumococcal infection occur in elderly persons (30-43%) and patients with co-morbid conditions (25-27%).

Standard pneumococcal vaccine:

Standard (unconjugated) pneumococcal polysaccharide vaccine (Pneumovax, Pnu-Immune) contains 23 purified capsular polysaccharide antigens of S. pneumoniae, and is protective against 88% of the strains of S. pneumoniae causing bacteremic pneumococcal disease reported in the United States. The six serotypes that most frequently cause invasive drug-resistant pneumococcal infection in the United States are represented in the 23-valent vaccine. These vaccines were licensed in the United States in 1983 and replaced an earlier 14-valent formulation that was licensed in 1977.

Clinical studies have demonstrated the effectiveness of standard pneumococcal vaccine in reducing the incidence of pneumococcal pneumonia in the elderly and in immunocompetent high-risk groups. A meta-analysis combining the most recent trials reported that vaccinated individuals had 11 fewer episodes of definitive pneumococcal pneumonia and 25 fewer episodes of presumptive pneumococcal pneumonia per 1,000 subjects (Fine, 1994). Case-control studies and indirect cohort studies support the protective value of vaccine in immunocompetent recipients, with vaccine efficacy estimates of 60-75% reported, but not in severely or relatively immunocompromised individuals, including those with alcoholism, chronic renal failure, immunoglobulin deficiency, nephrotic syndrome, sickle cell disease, multiple myeloma, metastatic or hematologic malignancies, or systemic lupus erythematosus. For some of these disorders, efficacy point estimates suggest a benefit but the confidence intervals are wide and include the possibility of no benefit.

The U.S. Preventive Services Task Force (USPSTF) concluded that there is insufficient evidence to recommend for or against pneumococcal vaccine as an efficacious vaccine for immunocompromised individuals, but noted that recommendations for vaccinating these persons may be made on other grounds, including high incidence and case-fatality rates of pneumococcal disease and minimal adverse effects from vaccine.

Immunocompromised conditions associated with high risk for pneumococcal disease include alcoholism, cirrhosis, chronic renal failure, nephrotic syndrome, sickle cell disease, multiple myeloma, metastatic or hematologic malignancies, acquired or congenital immunodeficiencies (including HIV infection), and other conditions associated with immunosuppression, such as organ transplant.

For most individuals, accepted guidelines suggest a single vaccination is sufficient. The CDC and UPSPTF do not recommend routine revaccination, but state that it may be appropriate to consider revaccination in certain immunocompetent individuals at highest risk for morbidity and mortality from pneumococcal disease who were vaccinated more than 5 years previously. These authorities also state that it may be appropriate to consider periodic revaccination of certain high-risk immunocompromised patients, who are likely to have poor initial antibody response and rapid decline of antibodies after vaccination. In addition, revaccination with the 23-valent pneumococcal polysaccharide vaccine may be appropriate for high-risk individuals who received the 14-valent polysaccharide vaccine, which was in use prior to 1983.

Standard pneumococcal vaccine may be given with other vaccines. No data indicate that administration of pneumococcal vaccine with DTP, poliovirus, influenza, or other vaccines increases the severity of reactions or diminishes the responses.

Standard pneumococcal vaccine is not indicated in the prophylaxis of otitis media in children. The safety of pneumococcal vaccine in pregnancy has not been evaluated.

In a Cochrane review, Chang and colleagues (2007) assessed the effectiveness of pneumococcal vaccine as routine management in children and adults with bronchiectasis in reducing the severity and frequency of respiratory exacerbations and pulmonary decline. The authors concluded that currently there is a lack of reliable evidence to support or refute the routine use of pneumococcal vaccine as routine management in children and adults with bronchiectasis. Randomized controlled studies examining the effectiveness of this intervention using various vaccine types in different age groups are needed.

Heptavalent pneumococcal conjugate vaccine:

A seven-valent pneumococcal conjugate vaccine (Prevnar^TM, Prevenar^TM ) has been introduced by Wyeth Lederle for use in children. The FDA has approved of this protein-polysaccharide conjugate vaccine for prevention of invasive pneumococcal disease (meningitis and bacteremia) in infants and toddlers.

The American Academy of Pediatrics (AAP) and the CDC Advisory Committee on Immunization Practices (ACIP) recommended pneumococcal polyvalent vaccine for routine use in all children 2 and under, and for black, Alaskan Native, and Native American toddlers up to age five, as well as for those with sickle-cell anemia, HIV infection, or other immunodeficiency diseases. For infants, the AAP and ACIP recommends that the vaccine be given in four doses at 2, 4, 6, and 12 to 15 months; for children who are 7 to 11 months, three doses; for children who are 12 to 23 months, two doses; and for children 2 years or older, only one dose is needed. See table below.

Table: Numbers of doses of Prevnar recommended by the ACIP for average risk children in each age range:

Pneumococcus is the most frequent cause of otitis media, pneumonia, and bacteremia in children, as well as the principle cause of childhood bacterial meningitis. The most susceptible to pneumococcal diseases are children less than two years old. Standard pneumococcal polysaccharide vaccines are poorly immunogenic in this age group. The new protein-polysaccharide conjugate vaccine is immunogenic during infancy and is capable of providing long-term immunity.

Pneumococcal conjugate vaccine targets the seven serotypes (strains) of Streptococcus pneumonia that are responsible for 85% of bacterial pneumonia in children. The serotypes contained in the vaccine are also commonly associated with antibiotic resistance.

A 3-year, multicenter clinical trial involving 37,868 children reported that the pneumococcal conjugate vaccine was effective against invasive pneumococcal disease caused by seven prevalent serotypes of bacteria.  Pneumococcal conjugate vaccine had an efficacy rate of 97% against invasive pneumococcal disease with vaccine serotypes, and a 93% efficacy rate for disease with any serotype. Children who received the pneumococcal vaccine were one third less likely to develop x-ray confirmed pneumonia compared to children who received a conjugate meningococcal vaccine as a control. Children who received the vaccine were 73% less likely to have had severe pneumonia, and 89% less likely to develop pneumococcal meningitis and bacteremia. The results also suggested efficacy against frequent, recurrent otitis media; vaccinated children were 20% less likely to have otitis media severe enough to require drainage tubes.

Although preliminary evidence indicates that pneumococcal conjugate vaccine may be safely administered with other childhood vaccines, the ACIP has recommended that further studies be performed on the safety of vaccine co-administration.

The FDA cautions that the pneumococcal conjugate vaccine is not indicated for use in adults.

A phase III trial evaluating the efficacy of the pneumococcal conjugate vaccine against pneumococcal otitis media is ongoing in Finland.  Wyeth Lederle is planning a supplemental filing for the otitis media indication.

The Advisory Committee on Immunization Practices (ACIP) recommends pneumococcal vaccination for persons who have or are scheduled to receive a cochlear implant.  The ACIP recommends that children with cochlear implants aged less than 24 months should receive seven valent pneumococcal conjugate vaccine, as is universally recommended; children with a lapse in vaccination should be vaccinated according to the catch-up schedule.  The ACIP recommends that children aged 24 to 59 months with cochlear implants who have not received pneumococcal conjugate vaccine should be vaccinated according to the high-risk schedule; children with a lapse in vaccination should be vaccinated according to the catch-up schedule for persons at high risk.  Children who have completed the seven valent pneumococcal conjugate vaccine series should receive standard 23-valent pneumococcal vaccine more than 2 months after vaccination with seven valent pneumococcal vaccine.   Persons aged 5 to 64 years with cochlear implants should receive standard 23-valent pneumococcal vaccine according to the schedule used for persons with chronic illnesses; a single dose is indicated.  The ACIP advises that persons planning to receive a cochlear implant should be up-to-date on age-appropriate pneumococcal vaccination more than 2 weeks before surgery, if possible.