Global Health Challenges Spur Vaccine Development - Pharmaceutical Technology

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Global Health Challenges Spur Vaccine Development
Manufacturers fund research and reduce prices to tackle diseases.

Pharmaceutical Technology
Volume 35, Issue 10, pp. 28-36

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.

GAVI will have the funds to purchase these more affordable products because the Gates Foundation and major donor nations pledged $4.3 billion in June to support its international immunization program. The UK led the list with a $1.3 billion pledge, followed by Gates, Norway, the US, and several other countries. Japan and Brazil gave for the first time this year. This support helped GAVI fend off criticism from international relief organizations that it does not do enough to negotiate lower prices for vaccines, allegedly because of too-close ties to big vaccine makers. GAVI also responded by appointing Seth Berkley to head the organization, a prominent AIDS vaccine researcher who has campaigned for years to make all vaccines equally available to children throughout the world.

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 utilization 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 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.


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