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Background• Almost half of all Americans (approximately 133 million) suffer from at least
one chronic condition1
• Although medication adherence enhances health and reduces adverse health events, average compliance rates are just 50%2
• Because medication adherence increases pharmacy expenditures, payers and policymakers are interested in knowing whether lower medical costs from adherence offset these higher pharmacy costs
• If so, policies and programs to encourage medication adherence (e.g., value-based insurance design) may be well-worth their investment
• Despite the critical importance of estimating the value of medication adherence, the existing literature is surprisingly scant and methodologically challenged
1Centers for Disease Control and Prevention (CDC). Chronic disease overview [CDC website]. November 20, 2008. Available at: http://www.cdc.gov/NCCdphp/overview.htm. Accessed September 29, 2009.
2World Health Organization (WHO). Adherence to long-term therapies: evidence for action [World Health Organization website]. 2003. Available at: http://www.who.int/chp/knowledge/publications/adherence_report/en/index.html. Accessed September 29, 2009.
• To estimate the impact of medication adherence in four chronic vascular conditions (congestive heart failure (CHF), hypertension, diabetes, and dyslipidemia) on health services utilization and cost
• To examine whether adherence effects are different for seniors or by gender
Literature: Main Findings• Clinical trials routinely document drug cost-effectiveness usually via reduced
hospitalizations and emergency room (ER) visits, however, results may not be applicable to “real world” treatment settings
– Controlled environment likely different than eventual community-based settings– Provide treatment versus non-treatment and dose-response effect estimates– Individuals aren’t randomized to adherent versus non-adherent cohorts– Observational data more readily available and allows for hypothetical treatments
• Observational studies generally find higher adherence associated with– Increased pharmacy costs– Usually increased outpatient visits – Often lower ER use and hospitalization– But its impact on total healthcare costs is not always a net benefit
• Sokol et al. (2005) report non-seniors have total healthcare cost savings from adherence to CHF, diabetes, dyslipidemia, and hypertension drugs
Literature: Challenges• Potential endogeneity of adherence
– Findings from observational studies are questionable since unobserved characteristics may be the real cause, thereby leading to biased estimates
– Adherent individuals may engage in other healthy behaviors such as regular exercise that are unmeasured and correlated with health services utilization and cost (i.e., the “healthy user” effect)
• Cross sectional studies do not allow one to determine the direction of causality (i.e., individuals may become adherent as a result of an adverse medical event)
• It is also difficult to determine the timing and duration of adherence effects
Measuring AdherenceGoals:• Create a single adherence measure for each condition based on the
commonly used Medication Possession Ratio (MPR)• Considered adherence distribution and functional form of expected effect
– Using continuous MPR may not be clinically appropriate due to non-linear effects (i.e., is a movement from 0.10 to 0.30 clinically the same as 0.60 to 0.80?)
– Relatively arbitrary threshold of 0.80 generally referred to as “adherent”• Account for primary non-compliance
Steps followed:• For each of three 1-year observations• Calculated MPR by therapeutic class (TC)• Rolled up to condition-level as MPR mean, weighted by TC days’ supply• Created dichotomous measures of “optimally adherent” where MPR≥ 0.80• Time period started as of condition diagnosis date (i.e., MPR=0 for
Notes: Presented are marginal effect estimates from linear fixed effects models of health services utilization. All models included a weighted Charlson Comorbidity Index; two year indicator variables; dummy variables for senior, male, and adherent; and interaction terms for adherent with male and senior. Statistical significance based on robust Driscoll-Kraay standard errors denoted as follows: *** p<0.01; ** p<0.05; * p<0.10.
Notes: Presented are marginal effect estimates from linear fixed effects models of health services utilization. All models included a weighted Charlson Comorbidity Index; two year indicator variables; dummy variables for senior, male, and adherent; and interaction terms for adherent with male and senior. Statistical significance based on robust Driscoll-Kraay standard errors denoted as follows: *** p<0.01; ** p<0.05; * p<0.10.
Discussion• Optimal medication adherence in CHF, hypertension, diabetes, and
dyslipidemia was associated with:– Increases in gross pharmacy costs and physician office visits– Decreases in emergency department visits and inpatient hospital days
• Higher pharmacy costs were more than offset by lower medical costs
• Average benefit-cost ratios were:– 8:1 for CHF– 10:1 for hypertension– 7:1 for diabetes– 3:1 for dyslipidemia– Highest was 13:1 for seniors with hypertension– Lowest was 2:1 for non-seniors with dyslipidemia
• Adherence effects are more pronounced for the elderly
• Adherence effects did not significantly differ by gender
• Endogeneity still possible– Reverse causality– Time-variant unobservables correlated with adherence and utilization/cost
• Difficult to determine the timing and duration of adherence effects
• Non-linear, two-part models perhaps more appropriate– Probit / negative binomial for count measures– Probit / gamma-log link GLM for cost data
• However, linear models have some advantages:– Fixed effects estimation is easier (e.g., fixed effects gamma/log GLM)– More easily explainable to medical journal readers (e.g., Health Affairs)