Pharmacy and Therapeutics - January 2008 - (Page 38) Advances in Vaccine Technology as well as the future role of genomics, the traditional model of medical coverage may need to evolve. The questions of how these innovations will be funded and who will fund them may become more fluid. In the past, the question of whether different vaccines created an equivalent reduction in morbidity and mortality for the same cost was not asked; however, this question needs to be addressed. Many payment and reimbursement structures— ranging from universal coverage, effective from the first dollar, to differing levels of reimbursement, such as a standard coverage (100%) versus a nonstandard benefit (a 20% plan member copayment)—will be analyzed and reviewed by those responsible for funding these advances. Again, documented clinical and financial outcomes and targeted disease states will be playing a significant role in determining how health plans approach the placement of vaccine products. The role of activism and the Advisory Committee on Immunization Practices (ACIP) guidelines will remain important variables. This is because many health plans routinely follow the ACIP’s recommendations; if this reviewing body begins to cover certain vaccines or populations, many plans will probably follow those guidelines. reimbursement policies for vaccines, and this approach is considered to offer a good return on investment. As we mentioned earlier, this traditional approach may be re-examined in some areas, with many alternative options to be explored. With most of these alternatives, one goal remains: making sure that the best vaccines reach the right patients with few impediments. For physicians, the introduction of newer vaccines has led to a greater number of nontraditional vaccinators, such as pharmacies and businesses traditionally outside the health care system that are now becoming acquainted with, and challenged by, the financial implications. Expectations about reimbursement levels and profitability may need to be addressed to ensure that all parties involved—health plans, physicians, employers, and patients—feel their contribution is significant. In 2007, the immunization schedule for children was already crowded; 15 different vaccines were recommended for children from birth to six years of age, and 14 were recommended for older children, seven to 18 years of age. Many of these vaccines are administered multiple times, and adults may need additional boosters. The development and approval of new vaccines against infectious diseases, as well as other potential uses for them, are likely to exacerbate this problem. A desire to simplify the regimen is fueling a trend toward combination vaccines. Although many combined vaccines have been used historically (e.g., diphtheria, pertussis, and tetanus), new combinations are being approved for children (e.g., pentavalent vaccines such as GSK’s Pediarix [diphtheria, acellular pertussis, tetanus, hepatitis B, and inactivated polio vaccine]) and for adults (e.g., GSK’s Twinrix for hepatitis A and B). The main challenge will be to balance immunogenicity in the newer formulations while maintaining their benefits of easier administration and lower costs. In this regard, adherence is likely to be a key issue in the future. If it can be shown that a product improves compliance and clinical outcomes while reducing costs, that vaccine may benefit from preferential positioning by health plans. For instance, Happe et al., using data from SelectHealth, retrospectively compared children receiving the HEDIS Combination 2 vaccine series with those receiving each vaccine series individually. 34 By two years of age, children in the combination cohort were more likely to have been fully vaccinated, and vaccinated within the recommended age ranges, than children receiving each series individually (86.9% vs. 74.1%, P < 0.001; 45.2% vs. 37.5%, P = 0.001 respectively). Additional studies with data indicating improved compliance rates and outcomes support the value of this technological advancement. FUTURE TRENDS The success of vaccines against childhood diseases has created enthusiasm for researching additional targets. Merck’s Gardasil was the first vaccine licensed with a primary indication to prevent cervical cancer. A second HPV vaccine, Cervarix is being considered for licensure in the U.S. Other preventive cancer vaccines are also in development, many of which are in clinical trials,12 and therapeutic vaccines designed to treat or ameliorate different types of cancer after it has occurred are also being pursued. Therapeutic vaccines for chronic infectious diseases such as hepatitis B, HIV, and cytomegalovirus are being studied, as are vaccines designed to halt or reverse the progression of Alzheimer’s disease.12,32 Even with these new goals and with the trend of therapeutic vaccines moving toward targeting morbidity rather than mortality, we must still ask: How should efficacy be analyzed? Although 100% efficacy is rarely seen, products with the greatest clinical impact on the broadest population have been favored. With some of the newer agents, this criterion might not remain as important. For instance, if a vaccine works in a portion of the population and that segment can be identified, an MCO might direct the product’s use to ensure its appropriateness for that segment. If a screening tool or a laboratory value can narrow the pool of patients to those who are most likely to benefit from a vaccine, an MCO might use controls (e.g., prior authorizations) to ensure that the most appropriate patients are being targeted with that tool or lab value, thereby resulting in improved success and in protection of the company’s financial investment. As more costly vaccines enter the market, the financial implications for health plans and physicians will become more pronounced. The debate over who will pay and how much will be paid will only intensify. Vaccines remain the single best investment in health care,33 but the costs associated with the increasing options are beginning to strain both public and private systems. Most health plans have liberal coverage and COMMENTARY Vaccines exemplify the premise behind managed care to promote wellness and prevent disease while also avoiding unnecessary treatment-related costs. The benefits of childhood vaccines in reducing mortality alone are undeniable.1 However, the cost–benefit relationship for the new generation of vaccines that can target reductions in morbidity or prevent rare and costly illnesses such as cancer is less clear. The promise of a brighter future is motivation up to a point; eventually, however, continued on page 41 38 P&T® • January 2008 • Vol. 33 No. 1
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