Based on previous reports and the 1998 trend analysis, a number of issues and factors had been identified that were used as an initial starting point to organize this research. The cost of newer medications has clearly been identified as a key issue. The increased costs associated with the development and use of the newer antidepressants and antipsychotics may pose significant barriers to their general and unrestricted use by consumers. From one perspective, the higher price of any new medication is justified as a means of recovering research and development costs. These costs include identifying a potential product and evaluating it through various required phases of pre-clinical and clinical testing that are needed to obtain formal approval of the drug from the Food and Drug Administration (FDA). This costly development and approval process typically takes several years, and no assurances exist that a marketable product will result. Even after FDA approval is obtained and the product is marketed, post-marketing issues may turn a profitable product into an unprofitable one.
Both public and private health care payers are also under considerable financial pressure, and may resist covering newer agents in an effort to control increasing prescription expenditures. Even if the clinical efficacy of a newer but more expensive medication is demonstrably superior to an older less costly medication, the cost-benefit decision point is not clear cut. Use of the less effective, but less expensive, medication may be defensible from the point of view that the added clinical value does not justify the higher cost of the newer medication on a routine basis.
However, the value of reduced or absent side effects and/or enhanced clinical efficacy may have cost implications that can counter-balance or offset the higher drug acquisition costs. Medications with fewer and/or more moderate side effects may improve patient compliance with therapy, which may lead to improved effectiveness when used in clinical practice. This improved real-world effectiveness may lead to improved day to day functioning while reducing other health care costs, such as those for physician or hospital visits.
While cost-savings and cost-effectiveness are often treated as equivalent, it is important to recognize that cost-savings do not accrue equally to all stakeholders. For example, health care payers reap the benefit of any savings in direct medical costs, while the consumer's interest lies in the most effective treatment with the mildest side effects, regardless of cost. Furthermore, the practice of administering budgets for individual health care sectors separately (e.g., pharmacy, psychiatric services, hospitals), often prevents health care payers from recognizing the overall net savings as individual service sectors struggle to manage their individual budgets.
Realistically, numerous factors affect the extent to which newer antidepressants and antipsychotics reach individuals who might benefit from them. Based on the 1998 trend analysis, it was thought that some of these factors would include:
- Physician (both primary care and psychiatrist) knowledge, attitude, and prescribing practices regarding newer psychotropic medications;
- Patient knowledge, attitudes and compliance with prescribed medication regimens;
- Drug benefit coverage decisions made by both private and public insurance plans, including
- Formulary acceptance,
- Patient cost-sharing requirements,
- Prior authorization requirements, and
- Requirements for a psychiatrist to prescribe psychotherapeutics;
- Formal or informal business arrangements between pharmaceutical companies, managed care organizations, and treatment facilities to promote or restrict access to and utilization of certain drugs;
- The extent and type of marketing efforts by pharmaceutical companies.
These factors are likely to vary by the kind of insurance coverage or health care system being considered, plan organization, and the type of health delivery model used.