INTRODUCTION
Prescription drug costs are an important contributor to increasing vigour care costs for aged and disabled folks. Medicaid's drug expenditures have grown at double-digit inflation rates since 2000 (Baugh et al., 2004). Although prescription drug coverage for dually eligible beneficiaries transitioned to the Medicare Part D drug benefit on January 1, 2006, the guide of rising prescription drug costs for dually eligible Medicaid recipients is probable to continue to affect public expenditures within a similar manner. In fiscal year 2000, the aged- and blind/disabled-eligibility groups accounted for 14.3 and 24.8 percent, respectively, of Medicaid enrollment but 26.8 and 58.1 percent, respectively, of Medicaid prescription drug expenditures (Baugh et al., 2004). Blind and disabled enrollees own seen the sharpest increases in payments for prescription medication since 1990, growing at an annual rate of 20.1 percent compared to 13.5 percent for the elderly (Baugh et al., 2004).
Previously, we assessed the cost contributions of newer pharmaceuticals to growing prescription expenditures for Kansas Medicaid's aged enrollees during a 3-year period (Shireman et al., 2005). Although newer pharmaceuticals accounted for more than 50 percent of prescriptions within four of eight therapeutic classes, they accounted for a disproportionately greater rate of expenditures for five of those classes. Mean prescription prices rose during the 3 years primarily due to the adoption of newer pharmaceuticals as the newer products were at smallest twice as expensive as older option in six of eight classes.
Little have been reported around the specific patterns of medication use among Medicaid's disabled enrollees. Since they constitute the most expensive Medicaid Program and own even more extreme medication expenditures than the elderly, we performed a similar analysis of newer versus elder medication use patterns to oblige inform State policy makers. It is all right to assume that this analysis will identify future areas of research into conception medication use in a importantly medicated population.
We analyzed Kansas Medicaid data to describe trends within medication use patterns for seven medical drug classes across 3 years. We limited the analysis to disabled those between the ages of 18 and 65 who qualified for Social Security Income (SSI) benefits or were medically dependent. We excluded other disabled groups who may have received Medicaid benefits, such as those awaiting SSI determination (MediKan). Our exploration be limited to the types of medication commonly used by this population. In particular, we evaluated the impact on Medicaid's expenditures of shifts from elder, less expensive medication to newer, more costly options inwardly the same drug class.
METHODS
Study Design
The study design be a retrospective cross-sectional analysis reflecting three sequential, 1-year time periods. Due to the timing of the background extraction, the third time period just included 11 months of prescription claims. The methods were nearly the same to those applied in the analysis of newer medication adoption surrounded by an older Medicaid cohort (Shireman et al., 2005). The single difference was the catalogue of therapeutic classes included in the analysis that follows.
Sample Selection
The sampling frame consisted of people enrolled at lowest possible 1 month between May 1999 and April 2002 in Kansas Medicaid's SSI or medically dependent disabled programs. The Department of Social and
Rehabilitation Services (SRS) provided a 10-percent random indication (n = 6,256) of the sampling frame (n = 62,651) to represent the study population. We eliminated 38 cases beside dates of disappearance prior to May 1999, leaving a final baseline cohort of 6,218 folks. Persons enrolled contained by managed contemplation were excluded as their claims information would not be complete.
Data Extraction
Using the beneficiary identification numbers, an SRS programmer extracted adjectives paid and crossover claims from institutions, outpatient service providers, pharmacies, and nursing homes for services rendered during the three study period. The beneficiary-based claims files contained detailed information regarding services provided, including date of service; diagnosis codes; procedures conducted or medications dispensed; billing provider information; and expenditure amounts for Medicare, other third party payers, and Medicaid. The programmer also cleaned the claims background by removing reversals and duplicates and accounting for adjustments. In adding together to the claims data, the programmer created an eligibility directory that contained beneficiary information such as date of birth, date of death, see and ethnic class, sex, and monthly enrollment indicators for each month during the spell that the beneficiary was actively enrol in Medicaid.
We determined dual eligibility for Medicaid and Medicare by analyzing Medicaid's inpatient and outpatient claims for Medicare payments. We pooled diagnosis codes from institutional, outpatient service, and nursing home claims for respectively individual, and determined the presence of major medical and mental strength conditions through comorbidity flags based on diagnosis codes (Centers for Disease Control and Prevention, 2007) from the International Classification of Diseases, Ninth Revision, Clinical Modification.
Prescription Drug Analysis
We analyzed drug use pattern in the seven cathartic classes accounting for the largest expenditures for the Kansas Medicaid disabled population: (1) antibiotics, (2) antidepressants, (3) antipsychotics, (4) anticonvulsants, (5) anti-ulcer medications, (6) diabetes medication, and (7) analgesics. Due to differences in indications for use, we further divided analgesics into two category: opioids and non-steroidal anti-inflammatory drugs (NSAIDs). These therapeutic classes differed slightly from those examined in our prior analysis of aged Medicaid beneficiaries (Shireman et al., 2005).
Drugs in each beneficial class were separated into two subclasses, base on relative newness to the class at the time the medication be prescribed (Shireman et al., 2005). A physician and a clinical pharmacist independently classified the individual drugs within respectively class, with a second physician adjudicate disagreements. For most drug groups, newer and older designations be based on whether or not a generic form of the medication be available during the study timeframe. If the specific drug was available surrounded by generic form, then that drug be classified as old, regardless of whether a generic or brand term agent may have be ordered or dispensed. If only a trade-name agent be available during the study timeframe, then the medication be classified as new.
For most drug groups, this organization paralleled clinically relevant drug characteristics for grouping similar medications together. For example, antipsychotics be categorized as either elder, typical antipsychotics (e.g., chlorpromazine and haloperiodol) or newer, atypical antipsychotics (e.g., clozapine, risperidone, and olanzapine). Similarly, we classified the tricyclic amines (TCAs), trazodone, and maprotiline as older antidepressants: selective serotonin reuptake inhibitors (SSRIs), and other trade designation only antidepressants (e.g., venlafaxine and mirtazapine) constituted the newer antidepressants. For other curative classes, categories be derived based on clinically relevant distinctions, but which still paralleled elder and newer treatment options. For example, opioid analgesics be categorized into the long-acting opioids (e.g., MSContin, Oxycontin, and Fansdermal fentanyl) or shorter-acting agents. Anti-ulcer agents were categorized into H2 receptor antagonists (H2RA) or proton-pump inhibitors (PPI), after excluding antacids and misoprostol. The final adjudicate categories are shown within Table 1.
Overall Use and Price Changes
After selection and classification of the pertinent medication from the Medicaid pharmacy claims, we explored changes inside therapeutic classes over the three study period. First, we calculated utilization changes inwardly therapeutic category based on the number of prescriptions per person-years of watch. We determined person-years of observation using the months of eligibility inside each study interval for each beneficiary. This part of measure allowed us to document standard trends in the use of respectively class over time.
Secondly, we examined the mean prescription price for agents within the subclass during each time. We included only the amounts rewarded by Medicaid. Dollar amounts were accustomed for inflation using the U.S. city average consumer price index for all items next to 1999 as the base year (U.S. Department of Labor, 2007). Manufacturers' rebate were not considered surrounded by the prices since these were proprietary.
Market Share Analysis
The subsequent set of outcomes related to new versus elderly drug use. Drugs within the class designations be compared with respect to (1) the proportion of the marketplace, or market share, held by respectively subclass as a percent of total prescriptions for the class; and (2) the market share held by respectively subclass as a percent of total expenditures for the class.
RESULTS
In each study interval, the analysis included in excess of 4,000 disabled adults (Table 2). Just over one-half be female (55 percent respectively year). Over three-quarters (78 percent) were White those; Black persons be the most predominant minority group. The mean age be 43-44 years, and the highest proportion of enrollees (38 percent) be between the ages of 36 and 50. Nearly one-third of the cohort members (32 percent) be dually eligible for Medicaid and Medicare. Eighty percent or more were eligible for 10-12 months during respectively period, resulting in over 3,500 person-years of watch per period. The most prevalent conditions among the cohort be psychosis (40 percent), hypertension (20 percent), chronic lung diseases (16 percent), diabetes (12-13 percent), mental retardation (12-13 percent), and gastrointestinal disorders (11-12 percent), as shown in Table 2.
Table 3 displays the trends in prescription utilization per person-year of observation for respectively of the drug classes. The classes with the superlative use were antidepressants (3.44 prescriptions per entity year, or RXs/PY), anticonvulsants (3.26 RXs/PY), opioids (2.95 RXs/PY), and antipsychotics (2.88 RXs/PY). Overall drug use increased in all classes except for antibiotics which saw a 4.7-percent decline in prescriptions per person year. Newer agents accounted for a clear majority of the increases: newer anticonvulsants increased by 72 percent, newer antidiabetic agents by 62 percent, newer anti-inflammatory agents by 58 percent, newer long-acting opioids by 46 percent, and newer antidepressants by 26 percent. The use of elder agents declined surrounded by six of the eight classes: antibiotics, antipsychotics, antidepressants, anticonvulsants, anti-ulcer medications, and anti-inflammatory agents. The most dramatic decline were see in the elder antipsychotics (24 percent), anti-ulcer medications (22 percent), and anti-inflammatory agents (21 percent).
Table 4 shows varying mean monthly prescription expenditures for respectively drug class, including increases for six of the eight classes. In contrast, mean monthly expenditures decline for antibiotics and anti-ulcer medications, near costs for both newer and older drugs contained by both of these classes decreasing. For example, mean monthly PPI expenditures decline from $130.90 to $118.04 per drug and mean monthly H2-antagonist prices decline from $60.46 to $28.05. This is likely due to generic version of omeprazole (a PPI) and ranitidine (an H2-antagonist) becoming available part-way through the study. The largest increase in prescription price occurred for the long-acting opioids where on earth mean monthly prices increased from $171.56 to $310.77, or 81 percent. Although prices for elder agents generally decline, they increased for short-acting opioids and antidiabetic agents.
In all classes, newer agents accounted for a complex percent of expenditures than the percentage of prescriptions as shown in Figure 1. (Additional information is available on request from the author.) Antibiotics and antidiabetic agents saw the tiniest change surrounded by the relative composition of newer and older agents. For adjectives other groups, newer medications contributed disproportionately to expenditures. For instance, newer anti-inflammatory agents accounted for 35 percent of the prescriptions in the class in the first term, but 54 percent of the expenditures. They grew to 52 percent of the prescriptions and 74 percent of the expenditures by the third period. Long-acting opioid use grew with the sole purpose slightly from 9 to 11-12 percent of prescriptions, but accounted for a marked increase in the proportion of expenditures (increasing from 43 to 64 percent). Newer antipsychotics, antidepressants, and anti-ulcer medication comprised over 70 percent of prescriptions and over 90 percent of expenditures in their respective market. Newer anticonvulsants grew from 18 to 28 percent of prescriptions accompanied by a transfer from 37 to 53 percent of expenditures.
[FIGURE 1 OMITTED]
DISCUSSION
Our purposes were to describe pattern of prescription drug use among the Kansas Medicaid disabled population and to examine the contribution to Medicaid's expenditures from shifts toward newer medications. We found mottled shifts toward newer medications over a 3-year time of year and disproportionate contributions of newer, more expensive medications to overall prescription costs for antipsychotics, antidepressants, anticonvulsants, anti-ulcer medication, anti-inflammatory agents, and opioids. These results are quite similar to those we reported for the aged Medicaid beneficiaries (Shireman et al., 2005).
The certainty that newer medications are commonly prescribed and that these agents are more expensive to purchase is a habituated theme for robustness care professionals, policymakers, and the public. However, this study quantify that pattern for specific, commonly used medication groups and describes the cost impact on Medicaid's pharmacy programs for disabled those, currently the most expensive Medicaid enrolled population. Other researchers own noted that rising prescription costs in Medicaid are attributable in part to the prescribing of newer, more expensive drugs when elder, less-expensive agents might often be equally effectual (Morden and Sullivan, 2005; Soumerai, 2004; Soumerai, Majumdar, and Lipton, 2000). Frank et al. (2005) explored this trend specifically among psychotropic drugs. They showed that growth in spending for antipsychotics be due to changes contained by the price and volume of newer drugs. Medicaid provides coverage for nearly 27 percent of all mental robustness expenditures (Mark and Buck, 2005), and since the disabled program includes persons beside severe mental illness, the present study, surrounded by part, reflect how those dollars are being spent beside respect to psychiatric medications. Further, in relation to Medicaid's overall spending on individual prescription products, they noted that newer antipsychotics ranked first, second, and eighth, against drugs that would be disproportionately used by the disabled Medicaid enrollees when compared to females, children, and the elderly. Indeed, the authors speculated that huge coverage by Medicaid and other insurance programs broadened the use of expensive medications and resulted within a greater willingness by physicians to prescribe them. Soumerai et al. (2000) noted, "... within is little doubt that the importance of suboptimal prescribing practice (both under- and overuse) vastly outweighs the costs of medication themselves." Recognizing this potential, several States are currently considering legislation that limits the skill of pharmaceutical sales representatives to gain data on physician prescribing practices. Such pains are intended to curb targeted outreach to certain physicians that can result within overprescription of new and expensive brand signature drugs (Saul, 2006).
The 1990 Omnibus Budget Reconciliation Act (OBRA) prevented State Medicaid Programs from imposing restrictive formularies and predetermined avenues for influencing drug utilization patterns. Many State Medicaid Programs enjoy tried to control their prescription drug costs through drug utilization review, monthly caps on numbers of prescriptions, prior authorization programs, and more just now, preferred drug lists, though these programs own had predetermined effectiveness (Crowley, Ashner, and Elam, 2005). Under Medicare Part D, CMS clearly expects prescription drug plans to implement utilization regulation and cost control tools, such as step therapy and beneficial interchange. The 2003 Medicare Prescription Drug, Improvement, and Modernization Act legislation and its regulations make clear that a high-ranking use of generic medications is a aim for the Part D program (Federal Register, 2005). Nationally, 2.5 million dually eligible disabled persons transitioned from Medicaid to Medicare Part D coverage for prescriptions on January 1, 2006. Generally, Part D prescription drug plans (PDPs) are required to cover all or substantially all of the drugs inside three of the classes studied here: antidepressants, antipsychotics, and anticonvulsants. For the other drug classes studied, PDPs are only required to cover at lowest possible two medications inwardly a pharmacologic class. The implications for expanding generic drug use and cost control are indefinite.
Several limitations of this study should be noted, including those that relate to the use of administrative claims data for research purposes. Although Medicaid pharmacy claims are widely considered to be reliable, the credentials of diagnosis codes in administrative notes may be more accurate for some conditions than for others. Expenditure data reflect only Medicaid's contribution and did not include costs borne by other payers. As previously noted, robustness outcomes, including quality of life span and adherence, associated with multiple prescribing options be not examined. The study sample reflect a wide breadth of types of condition conditions and disabilities: patterns among subgroups of beneficiaries next to particular diseases may come and go. Finally, these data come from a single Midwestern State beside a relatively open Medicaid formulary during the study extent and may not reflect the experience of other State Medicaid Programs or that of other payers.
It is also substantial to note that solely drug expenditures are reported here. For many of these medication classes, newer medication option may have potential benefits contained by terms of enhanced tolerability, reduced dosing frequency, better adherence, or other favorable clinical characteristics. Newer medications may also be advocate by current practice guidelines, consensus statements, and disease management algorithms, and thus be preferred by prescribers. Patients may also own strong preferences for newer medications that they believe may own better tolerability or outcomes. To the extent that clinical outcomes may be better with newer, more expensive medication than with elder, less expensive ones for indistinguishable condition, cost offsets may come about in other parts of the condition care system due to abort hospital admissions, a reduced amount of disease complications, or other laudable outcomes. For instance, the atypical antipsychotics were considered a through advance surrounded by psychiatry because of lower rates of extra-pyramidal side effects that were associated beside the older, typical antipsychotics. This predictable fueled the rapid adoption of atypical antipsychotics and the effective obsolescence of the typical antipsychotics and may have prevented tons untoward reactions among folks with severe mental bad health. More recent concerns about weightiness gain and subsequent development of diabetes coupled near trials demonstrating little therapeutic good thing associated with the atypical antipsychotics, however, own raised question about their relative cost value. It is reasonable to assume that spot on patients would benefit more from the use of atypical antipsychotics than other patients would. It is important to remember, however, that newer agents repeatedly are adopted outside the dogmatic scope of the populations surrounded by whom such clear cost effectiveness have been shown; the literature is replete beside examples of non-selective diffusion of innovation (Dai, Stafford, and Alexander, 2005). Because manufacturers single have to demonstrate efficacy relative to placebos, clinicians enjoy little guidance in select cost-effective therapy. Further work surrounded by evidence-based guidelines can help to inform clinicians.
The size and breadth of Part D will afford it power to inform drug benefit design and provide a rich database for postmarketing drug surveillance (Morden and Sullivan, 2005). With regard to the findings we present, the differential Part D formulary design requirements for some drug classes versus others may create a tryout of which cost control strategies are effective and appropriate. Carefully designed studies that examine the impact of varying Part D coverage of switch medication classes, such as those described here, and medication therapy organization services on patient outcomes would contribute substantially to our awareness of relative therapeutic cost usefulness.
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