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The United States Department of Health and Human Services charged The Lewin Group with the task of elucidating the mechanisms that affect the extent to which Americans receive the most up-to-date pharmacotherapies for the treatment of mental illness. In examining this problem, we determined that this question is made up of two separate components that work together to affect whether a particular drug is used widely in the health care system. These two components may be described as Access and Utilization. Access refers to structural issues (e.g. coverage and benefit) within the health care benefit system that determine whether a health care service is available for use. Utilization is a more subjective concept and reflects the degree to which services that are available are actually used by the consumer. In turn, each of these components is influenced by several factors.
Simply stated, "Access" to a particular health care service may be defined as the set of factors that affect the potential ability of an individual or a group to acquire timely and appropriate use of that service. Traditionally, access to health care services has been limited by race, gender, age, and class.7 These factors cannot be controlled by the design of the health care system. Health care payers have more direct control over access via the design of their benefit programs. Among these, four principal factors affect access to pharmaceuticals. These include:
Benefit design is the primary mechanism that influences access to newer pharmaceuticals. Some health plans do not cover pharmaceutical benefits at all (e.g., Medicare), while others place restrictions on the number of prescriptions a given beneficiary may receive each month (e.g., several State Medicaid programs). Furthermore, coordination of benefits between inpatient and outpatient, access to specialty psychiatric care, and payment responsibility represent three ways in which benefit design can affect access. Based on our review of the literature and on previous research, we identified the following issues as factors that primarily impact benefit design:
The most basic drug formulary is a descriptive list of medications available in a given health care setting. Early formularies were lists of all medications available in a hospital pharmacy. Eventually, some formularies began to limit the availability of unlisted agents, thereby serving a regulatory function. These "restrictive" formularies have been adopted by many health care payers as a method of containing costs by restricting access to expensive medications.
The use of formularies to control costs has been questioned on both scientific and policy grounds. Levy and Cocks extensively reviewed the literature on the effects of restrictive formularies on overall health care costs.8 The authors conclude that although drug costs decreased in categories where restrictions were imposed (16 of 27 published case studies), the predominant effect of these restrictions was to shift costs by increasing utilization of either non-restricted drugs or other health care services (13 of 16 studies). The authors conclude that none of the studies clearly showed an association between drug restrictions and reduced costs in other health service categories.
In a 1992 study, Moore and Newman found that while implementation of a restricted formulary could reduce a State's Medicaid drug expenditures, these savings are more than offset by spending increases caused by service substitution elsewhere in the system. This study included estimates for effects on spending for mental health services specifically, although particular pharmaceuticals were not mentioned.9
Horn and co-workers found that restricted formularies tended to increase utilization of other health care resources for patients with diagnoses of arthritis, asthma, epigastric pain/ulcer, hypertension, and otitis media.10,11 Because this study has encountered stringent criticism for methodological flaws, these results should be interpreted with caution.12
More recently, Streja and coworkers compared the outcomes of patients from an HMO in California that designated a single "preferred" SSRI agent (paroxetine) with the outcomes of patients enrolled in an HMO that designated two agents as preferred (paroxetine, fluoxetine). Patients were treated by the same group of 22 board-certified primary care physicians. These researchers found that patients from the HMO with a single preferred SSRI were 80% less likely to complete therapy than were patients from the HMO that had 2 preferred agents. Although differences in completion rates varied with the choice of first-line agent (paroxetine, fluoxetine, or sertraline), the formulary effect was independent of the initial drug used to treat the patient. This study is the first of its kind to show a direct impact of a limited formulary including newer antidepressants on outcomes, independent of the agent chosen for therapy.13
Prior authorization (PA) is a gatekeeping mechanism put in place in some health care programs whereby a patient or provider must obtain special approval prior to the dispensing of a particular set of drugs. Individuals within the health care payer organization approve or deny a particular prescription request based on a defined set of criteria. PA requirements have been criticized for creating a physician "hassle factor," that is to say, the documentation required to get a PA drug approved is too burdensome for most physicians to be willing to pursue.
The rationale for using PA is based on several assumptions. These may include:
Under step care programs, physicians are required to attempt to treat a patient with a designated first-line drug and document treatment failure or patient intolerance prior to using another "reserved" agent. In general it is thought that the designated first-line drug is an older, often cheaper, and perhaps less effective drug than the reserved drug. Alternatively, patients may be required to try a new-generation, formulary drug before being given reimbursement for another non-formulary, new-generation drug. Step care programs are similar to prior authorization programs in that they often serve to control prescribing practices.
Utilization is defined as the use of a health care service, procedure, device, or pharmaceutical. Utilization is influenced by access, although the actual utilization of a given pharmaceutical may not reach the maximum level expected given a specified level of "access." Utilization can be recorded in a number of ways: per capita, hospital length of stay, physician office visits, or number prescriptions. With regard to utilization of pharmaceuticals, four principal factors affect utilization:
Ultimately, a pharmaceutical agent can only be used as often as physicians are willing to prescribe it. Therefore, physician preferences, perceptions, and prescribing habits play a significant role in determining the extent to which a new technology is utilized in the health care system. Factors that influence physician preference, perceptions, and prescribing habits include awareness of newer agents, the length of time an agent as been on the market, the clinical profile of the agents, and the physician's education or treatment philosophy.
Physicians may be influenced somewhat by the publication of treatment guidelines. These may either come from a nationally recognized expert source, such as the American Psychiatric Association, or may be produced in-house by a health plan. These guidelines may play a role in influencing physician-prescribing decisions to a greater or lesser degree.
Perhaps the most fundamental driver of pharmaceutical utilization is the clinical trial history of a particular drug. A pharmaceutical is approved for use by the FDA for a particular indication based on the clinical trials submitted by the manufacturer. The labeling therefore reflects only the evidence presented by the manufacturer in the filing. A drug may be effective in many more indications than that for which it is approved for marketing by the FDA. Examples include fluvoxamine, an SSRI approved for marketing in the US only for the treatment of Obsessive-Compulsive Disorder, although it is widely used as an antidepressant in Europe. Similarly, atypical antipsychotics are used with some frequency for the treatment of bipolar disorder and the treatment of behavioral disturbances in dementia patients, even though these medications are only approved for use in schizophrenia and related illnesses. Health care payers are therefore often placed in a difficult situation: is it proper to reimburse a drug used to treat an indication for which it is not approved, even if such use is commonplace?
Post-approval, pharmaceutical marketing plays an important role in influencing physician and consumer awareness of current therapies. This influence comes partially through physician education: pharmaceutical representatives distribute literature (approved by the FDA) documenting the appropriate use and efficacy of the agents they represent. In addition, the industry sponsors numerous physician education symposia and programs that qualify for continuing medical education (CME) credit either at a local level or at national meetings. Furthermore, marketing to physicians often involves the distribution of pharmaceutical samples, the availability of which may have an influence on which agent within a particular class of similar drugs is chosen by the physician for an individual patient. In 1997, the pharmaceutical industry spent approximately $7.0 billion on marketing (i.e. "detailing") to health care professionals.14 In addition to direct detailing of health care professionals, the pharmaceutical industry places advertisements in clinical and trade journals to promote products. Recently, antidepressants have led other classes of drugs in spending for journal-based advertising. In 1999, citalopram, the antidepressant co-marketed by Forest and Parke-Davis, was the most-advertised product in this class, followed closely by Eli Lilly's fluoxetine.15
In recent years, Direct-to-Consumer (DTC) marketing has become more prevalent. The 10 drugs most heavily advertised to consumers in 1998 accounted for $9.3 billion (or approximately 22%) of the total increase in drug spending between 1993 and 1998.16 During the first 10 months of 1998, pharmaceutical companies spent $1.1 billion on DTC ads, compared with $1.0 billion in 1997. The only psychotherapeutic entering the top five drugs in DTC spending was Glaxo Wellcome's Zyban, a version of bupropion approved as a smoking-cessation aid, that totaled $5.7 million in advertising expenditures.17
Utilization management and review (DUR) are programs utilized by many payers to promote patient safety and manage costs by an increased review and awareness of outpatient prescribed drugs. The theory behind utilization review is that more careful scrutiny of drug prescribing and dispensing patterns should help avoid unfavorable drug-drug interactions, drug-disease interactions, therapeutic duplication and over-prescribing by providers. DUR programs may be administered either prospectively or retrospectively. As a result of OBRA 1990, States were encouraged by enhanced federal funding to design and install point-of-sale electronic claims management systems that interface with their information systems operations to facilitate review of pharmaceutical utilization in real-time.
Several studies have shown that PRODUR programs have had a positive effect on patient safety, provider prescribing habits and dollars saved. For example, a GAO report examined the PRODUR systems of five States (Maryland, Missouri, New Mexico, Oregon, Pennsylvania) to evaluate their effect on patient safety and cost savings. During a 12-month period, the systems alerted pharmacists to over 6 million prescriptions that had the potential causing unfavorable medical events due to drug-drug interactions, overutilization, and pregnancy. Approximately 10% of these alerts resulted in canceling prescriptions due to possible risks to patients. These cancellations resulted in savings of over $5 million to these five States.18
Faced with rising health care costs and limited resources health care providers seek new ways to provide high-quality, cost-efficient care, especially for patients with chronic illnesses such as depression and schizophrenia. Several years ago, disease management emerged as a promising innovation with the potential to achieve this goal. The Boston Consulting Group first used the phrase "disease management" in its current sense in a 1993 report. Since that time, disease management techniques have been adopted and applied in a variety of delivery settings in the private sector and in Medicaid primary care case management.
Disease management is a term used to define various systematic, integrated approaches to the complete management of a disease state. In contrast to the compartmentalized delivery of health care that has traditionally been the norm in the United States, disease management uses a patient-centered approach to provide all components of care, and focuses on both quality and total cost. This approach includes coordination of physician care (e.g., primary care, specialty care) with pharmaceutical care and institutional care as well as various components of a disease state (e.g., co-morbidities of diabetes mellitus such as hyperlipidemia and renal disease). In addition to emphasizing continuity of care and a multidisciplinary approach, disease management also promotes patient empowerment through health education and encourages compliance with successful treatment programs, including medication.
Although formal disease management programs appear to be more common for physical illnesses such as diabetes and asthma, the utility of these programs in the treatment of severe mental illnesses such as depression and schizophrenia should not be overlooked.
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Last updated August 20, 2000