Pharmacy and Therapeutics - January 2008 - (Page 35) Advances in Vaccine Technology And Their Impact on Managed Care Jonathan A. McCullers, MD, and Jeffrey D. Dunn, PharmD, MBA ABSTRACT The discovery of vaccines has led to the near eradication of several important diseases and has had a tremendous impact on health for a relatively low cost. However, most vaccines in use today were developed by techniques that were pioneered more than 100 years ago and do not represent the full potential of the field. The introduction of genetic engineering has fueled rapid advances in vaccine technology and is now leading to the entry of new products in the marketplace. In the past, options for the utilization of vaccines in the area of managed care had been quite limited because of the historically straightforward application of immunizations. The growing number and type of vaccine targets, coupled with novel, more effective formulations, adjuvants, and routes of delivery for vaccines, will undoubtedly create new challenges. Although progress in vaccine technology has the potential to prevent illness and reduce the economic burden of diseases in the long term, thereby improving outcomes, ongoing problems remain in the short term. Who should and will pay for these anticipated improvements in health? How will this period of change be managed? This article describes the present “vaccine revolution” and attempts to answer these questions, which are becoming increasingly important in managed care. Key words: vaccine, genetic engineering, technology, managed care, adjuvant INTRODUCTION The advent of vaccines to prevent deadly childhood illnesses was one of the great success stories of the 20th century. Universal immunization against certain diseases has led to the eradication of smallpox and has almost completely eliminated many other infectious agents in the U.S., including those causing diphtheria, tetanus, poliomyelitis, measles, mumps, rubella, and Haemophilus influenzae type b invasive disease.1 However, many other diseases, including the three biggest killers— human immunodeficiency virus (HIV) infection, tuberculosis, and malaria—have not yet been adequately targeted by a vaccine effective enough to achieve a similar outcome. In addition, some common vaccine-preventable diseases such as influenza and pertussis continue to cause significant morbidity and mortality, primarily in adults, because of the underDr. McCullers is a physician and researcher in the Department of Infectious Diseases at St. Jude Children’s Research Hospital in Memphis, Tennessee. Dr. Dunn is Formulary and Contract Manager at SelectHealth in Salt Lake City, Utah. utilization or ineffectiveness of available vaccines.2,3 Recent advances in vaccine technology stemming from the application of genetic engineering are now providing an opportunity to target new diseases. The previous century’s successes in reducing the primary causes of mortality in childhood now include protecting against infectious agents that can result in significant morbidity. Scientific progress and these broadened applications will no doubt result in improved health-based outcomes, but progress often comes at a significant short-term cost. Although it is true that improved outcomes are the goal of health care technology and that preventing disease is preferable to treatment, thus reducing overall costs, confusion persists about the best course going forward. Given the current underutilization of vaccines (even when patients have no copayments) and the expanding use of vaccines to cover morbidity rather than mortality, managed care organizations (MCOs) are confronted with several questions, particularly in terms of benefits, reimbursement, and formulary management. To accept the newer vaccine technology, MCOs will require not only improved mortality data but also cost-efficacy data with long-term proven outcomes accompanied by lower medical and pharmacy expenses. For example, the use of new vaccines for human papillomavirus (HPV) must result in fewer cases of cervical cancer as well as in reduced cost savings in related medical expenses, such as for Pap smears and colposcopies. In this way, a manufacturer might be able to differentiate its product from a competing one. For several years, cost efficacy has been used to evaluate other classes of injectable vaccines, and it is a good method of comparing products when no head-to-head studies have been conducted. MCOs are beginning to analyze data involving comparisons of outlays for resources for specific outcomes, such as adverse events and hospitalizations. VACCINOLOGY: A RECENT HISTORY Most vaccines in use today were developed by one of two classic methods. In the 19th century, Salmon and Smith pioneered the inactivation of an organism and the injection of immunogenic components.4 The attenuation of live organisms, as first attempted by Louis Pasteur,5 was adapted to modern vaccine technology by Enders et al. in the 1950s.6 All but three vaccines in the currently recommended immunization schedule in the U.S.—those directed against hepatitis B virus, rotavirus, and HPV—are manufactured according to these techniques. In the 1970s, a pair of key discoveries—the expression of proteins in plasmids and the ability to sequence DNA—ushDisclosure. Dr. McCullers has served on the Speaker’s Bureau for MedImmune, Inc. (now AstraZeneca) and advisory boards for GlaxoSmithKline and MedImmune, Inc. Accepted for publication December 4, 2007. Vol. 33 No. 1 • January 2008 • P&T® 35
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