Almost four years after it was commissioned by the National Institute of Allergy and Infectious Diseases (NIAID), the Institute of Medicine (IOM), a branch of the National Academy of Sciences, has released a report analyzing which vaccines give the best return per R&D investment dollar. It concludes that vaccines for cytomegalovirus, influenza, insulin-dependent diabetes, multiple sclerosis, rheumatoid arthritis, group B streptococcus and Streptococcus pneumoniae—classified as Level I vaccines—have the best all-round R&D investment value.
"NIAID asked us to look into the future of where science will lead us, and to estimate costs of vaccine development, implementation and cost savings of premature morbidity and mortality," explains chair of the IOM Committee to Study Priorities for Vaccine Development, Robert Lawrence, Johns Hopkins School of Hygiene and Public Health.
The report, "Vaccines for the 21st Century: A Tool for Decisionmaking," stratifies 26 vaccines into four levels based on development cost versus the quality-adjusted life years (QALY) saved. This quantitative model operates within a computer spreadsheet and can be adapted to any candidate vaccine. It can be obtained free of charge from the IOM in Washington D.C.
Under its congressional mandate, the committee was restricted to evaluating vaccines of importance to the US rather than those that are beneficial on a worldwide scale: "We would have liked to examine disease burden in the developing world as well, but diseases such as schistosomiasis and malaria were off limits," says Lawrence.
Also off limits was an assessment of the value of developing an HIV/AIDS vaccine. Apparently the panel was not to appraise this type of vaccine because NIAID has already made substantial commitment to HIV vaccine research. However, Lawrence expects somebody outside the committee will quickly determine its cost-effectiveness now that the software for the model is in the public domain.
According to Adis International's R&D Insight drug development database, the National Institutes of Health (NIH) is presently involved in at least 50 vaccine development programs, most of which have a Level II ranking (for example, melanoma, herpes simplex, gonorrhea and hepatitis C vaccines that cost less than $10,000 to develop per QALY saved) or Level III ranking (for example, rotavirus and streptococcal A vaccines that cost between $10,000 and $100,000 per QALY saved). As a rule of thumb, explains Lawrence, "a therapy under $100,000 is usually a good buy in the US healthcare environment, so commitment to vaccines in all three of the first levels is justified."
The NIH is also working on at least three of the less favorable Level IV vaccines, which cost more than $100,000 per QALY saved. These include shigella and Escherichia coli vaccines. A summary of the report is available at http://www2.nas.edu/hpdp