PRICE AND ACCESS
Vaccine development generates tension among companies regarding how to make R&D profitable enough to encourage private-sector
investment while also being able to offer sufficiently low prices to make products available to poor nations. While public
health officials admit that the most cost-effective vaccine is one that's free, the stated goal is to provide emerging markets
with vaccines that cost less than $5 per dose. UNICEF is supporting this effort by publishing the prices it pays individual
manufacturers for immunizations as a way to encourage competition in vaccine pricing for developing nations. In response,
manufacturers are cutting prices significantly on vaccines for developing nations. At a June 2011 meeting in London to secure
donor funding for the Global Alliance for Vaccines and Immunization (GAVI), India-based manufacturers promised a record low
$1.75 per dose price for pentavalent vaccines that protect against five diseases: diphtheria, tetanus, pertussis, hepatitis
B, and Haemophilus influenzae type b (HIB). GSK and Merck reduced rates on rotavirus and HPV vaccines, and other leading manufacturers
announced similar moves.
Even in the US, high prices appear to limit vaccine utilization. Sales have been sluggish for Dendreon's Provenge despite
a positive national coverage decision from Medicare that has prompted insurer coverage. Full treatment still costs more than
$100,000 due to a complex regimen that involves manipulation of a patient's own immune cells. Physicians appear reluctant
to prescribe Provenge because of tight insurer requirements, high copays, and limited evidence of effectiveness.
Price may be a factor in slow vaccination rates for the HPV vaccine as well. A 2010 CDC analysis found that more teens received
vaccines to protect against meningitis (63%) and tetanus-diphtheria-pertussis (69%), but only 49% of young girls received
one dose of the HPV vaccine, and only 32% received the full three-dose regimen. "Our progress is stagnating," complained Anne
Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases. "Now that we have the tools to prevent
most cervical cancers, it is critical that we use them." The CDC report noted lower HPV immunization rates among poor and
minority teens, a sign that the $400-price tag for the full course of treatment probably is a problem. Moreover, some parents
have raised concerns about side effects linked to Merck's Gardasil, and that some teenagers may regard vaccination as a green
light for premarital sex.
Merck's efforts to expand Gardasil's label to include male protection from anal cancer also has run into opposition due to
cost and effectiveness issues. An analysis for CDC's Advisory Committee for Immunization Practices (ACIP) indicates a much
higher cost for vaccinating boys and men in order to prevent cancer and death, due to much lower incidence of the male disease.
Although cost issues may limit utilization of some vaccines, adult immunization has gained support from health reform legislation.
President Obama's Affordable Care Act requires insurers to cover all recommended vaccines for adults, with no copays or deductibles,
as part of efforts to expand preventive care. The policy applies now to new group and individual health plans, but is expected
to affect all coverage over time.