[Show abstract][Hide abstract] ABSTRACT: Background:
Medicaid programs face growing pressure to control spending. Despite evidence of clinical harms, states continue to impose policies limiting the number of reimbursable prescriptions (caps). We examined the recent use of prescription caps by Medicaid programs and the impact of policy implementation on prescription utilization.
We identified Medicaid cap policies from 2001-2010. We classified caps as applying to all prescriptions (overall caps) or only branded prescriptions (brand caps). Using state-level, aggregate prescription data, we developed interrupted time-series analyses to evaluate the impact of implementing overall caps and brand caps in a subset of states with data available before and after cap initiation. For overall caps, we examined the use of essential medications, which were classified as preventive or as providing symptomatic benefit. For brand caps, we examined the use of all branded drugs as well as branded and generic medications among classes with available generic replacements.
The number of states with caps increased from 12 in 2001 to 20 in 2010. Overall cap implementation (n = 3) led to a 0.52 % (p < 0.001) annual decrease in the proportion of essential prescriptions but no change in cost. For preventive essential medications, overall caps led to a 1.12 % (p = 0.001) annual decrease in prescriptions (246,000 prescriptions annually) and a 1.20 % (p < 0.001) decrease in spending (-$12.2 million annually), but no decrease in symptomatic essential medication use. Brand cap implementation (n = 6) led to an immediate 2.29 % (p = 0.16) decrease in branded prescriptions and 1.26 % (p = 0.025) decrease in spending. For medication classes with generic replacements, the decrease in branded prescriptions (0.74 %, p = 0.003) approximately equaled the increase in generics (0.79 %, p = 0.009), with estimated savings of $17.4 million.
An increasing number of states are using prescription caps, with mixed results. Overall caps decreased the use of preventive but not symptomatic essential medications, suggesting that patients assign higher priority to agents providing symptomatic benefit when faced with reimbursement limits. Among medications with generic replacements, brand caps shifted usage from branded drugs to generics, with considerable savings. Future research should analyze the patient-level impact of these policies to measure clinical outcomes associated with these changes.
Preview · Article · Dec 2015 · BMC Health Services Research
[Show abstract][Hide abstract] ABSTRACT: Background
The 9th edition of the American College of Chest Physicians’ Antithrombotic Therapy and Prevention of Thrombosis guidelines emphasize the importance of considering the risk–benefit ratio of “patient-important” outcomes. However, little is known about patients’ perception and understanding regarding the different outcomes of antithrombotic treatment after orthopedic surgery, and the factors that influence their decision to use these treatments. Using a series of semi-structured interviews, we explored patients’ understanding and perception concerning the benefits and risks of antithrombotic treatment for the prevention of venous thromboembolism (VTE) after joint replacement surgery.
A series of semi-structured interviews were conducted with patients who had undergone knee or hip replacement surgery at a tertiary care hospital (Brigham and Women’s Hospital, Boston, MA) in 2014. Discussions were recorded and transcribed. Two investigators independently coded and analyzed the data to identify important themes and concepts using the constant comparative method.
Of 64 patients who were invited, 12 patients (19 %) completed the interviews. The majority of patients (92 %) were aware of the benefits of antithrombotic therapy for reducing the risk of blood clots, while less than half of them had a clear understanding of deep vein thrombosis and pulmonary embolism. While all patients were aware of risk of minor bleeding, only 6 patients (50 %) considered the risk of major bleeding as a possible side effect of antithrombotic treatment. Overall, patients perceived bleeding as a less important outcome than a thrombotic event. The lack of awareness about the risk of major bleeding, the assumption that a short-term exposure would not meaningfully affect bleeding risk, and the assumption that bleeding is a controllable event influenced their perception. Most patients (83 %) stated that their decision to use antithrombotic medications was mainly based on the trust in their physician’s expertise.
Patients perceived thrombotic events as more important outcomes than bleeding events. Patients’ understanding of thrombotic and bleeding events varies and may play a key role in their preferences. The majority of patients stated that trust in their physician’s expertise had a large influence on their decision to use antithrombotic medications.
Preview · Article · Oct 2015 · BMC Musculoskeletal Disorders
[Show abstract][Hide abstract] ABSTRACT: Objective:
The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product.
We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators.
We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators.
Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions.
[Show abstract][Hide abstract] ABSTRACT: Background:
Among patients with type 2 diabetes, insulin intensification to achieve glycemic targets occurs less often than clinically indicated. Barriers to intensification are not well understood. We present patients' baseline characteristics from MOSAIc, a study investigating patient-, physician-, and healthcare environment-based factors affecting insulin intensification and subsequent health outcomes.
MOSAIc is a longitudinal, observational study following patients' diabetes care in 18 countries: United Arab Emirates (UAE), Argentina, Brazil, Canada, China, Germany, India, Israel, Italy, Japan, Mexico, Russia, Saudi Arabia, South Korea, Spain, Turkey, United Kingdom, United States. Eligible patients are age ≥18, have type 2 diabetes, and have used insulin for ≥3 months with/without other antidiabetic medications. Extensive baseline demographic, clinical, and psychosocial data are collected at baseline and regular intervals during the 24-month follow-up. We conducted descriptive analyses of baseline data.
Four thousand three hundred forty one patients met eligibility criteria. Patients received their type 2 diabetes diagnosis 12 ± 8 years prior to baseline visit, yet patients in developing countries were younger than in developed countries (e.g., UAE, 55 ± 10; Germany = 70 ± 10). Saudi Arabians had the highest HbA1c values (9.0 ± 2.2) and Germany (7.5 ± 1.4) among the lowest. Most patients in 5 (28 %) of the 18 countries did not use an oral antidiabetic drug. Over half of patients in fourteen (78 %) countries exclusively used basal insulin; most Indian and Chinese patients exclusively used mixed insulin.
MOSAIc's baseline data highlight differences in patient characteristics across countries. These patterns, along with physician and healthcare environment differences, may contribute to the likelihood of insulin intensification and subsequent clinical outcomes.
[Show abstract][Hide abstract] ABSTRACT: One-quarter of U.S. patients do not have a primary care provider or do not have complete access to one. Work and personal responsibilities also compete with finding convenient, accessible care. Telehealth services facilitate patients' access to care, but whether patients are satisfied with telehealth is unclear.
We assessed patients' satisfaction with and preference for telehealth visits in a telehealth program at CVS MinuteClinics.
Cross-sectional patient satisfaction survey.
Patients were aged ≥18 years, presented at a MinuteClinic offering telehealth in January-September 2014, had symptoms suitable for telehealth consultation, and agreed to a telehealth visit when the on-site practitioner was busy.
Patients reported their age, gender, and whether they had health insurance and/or a primary care provider. Patients rated their satisfaction with seeing diagnostic images, hearing and seeing the remote practitioner, the assisting on-site nurse's capability, quality of care, convenience, and overall understanding. Patients ranked telehealth visits compared to traditional ones: better (defined as preferring telehealth), just as good (defined as liking telehealth), or worse. Predictors of preferring or liking telehealth were assessed via multivariate logistic regression.
In total, 1734 (54 %) of 3303 patients completed the survey: 70 % were women, and 41 % had no usual place of care. Between 94 and 99 % reported being "very satisfied" with all telehealth attributes. One-third preferred a telehealth visit to a traditional in-person visit. An additional 57 % liked telehealth. Lack of medical insurance increased the odds of preferring telehealth (OR = 0.83, 95 % CI, 0.72-0.97). Predictors of liking telehealth were female gender (OR = 1.68, 1.04-2.72) and being very satisfied with their overall understanding of telehealth (OR = 2.76, 1.84-4.15), quality of care received (OR = 2.34, 1.42-3.87), and telehealth's convenience (OR = 2.87, 1.09-7.94) CONCLUSIONS: Patients reported high satisfaction with their telehealth experience. Convenience and perceived quality of care were important to patients, suggesting that telehealth may facilitate access to care.
No preview · Article · Aug 2015 · Journal of General Internal Medicine
[Show abstract][Hide abstract] ABSTRACT: Several small studies have reported inconsistent findings about the safety of selective serotonin reuptake inhibitors (SSRIs) among patients undergoing coronary artery bypass grafting (CABG). We sought to investigate post-CABG bleeding and mortality outcomes related to antidepressant exposure.
We identified patients who underwent CABG between 2004 and 2008 in the Premier Perspective Comparative Database. We determined whether they received SSRIs, other antidepressants, or no antidepressants on any pre-CABG hospital day and used Cox proportional hazards models to compare bleeding and mortality rates among the exposure groups while adjusting for potential confounders based on administrative data, pre-CABG charge codes, and discharge diagnosis codes.
We identified 132,686 eligible patients: 7112 exposed to SSRIs, 1905 exposed to other antidepressants, and 123,668 unexposed. As compared with no exposure, neither SSRIs (hazard ratio [HR] 0.98; 95 % confidence interval [CI] 0.90-1.07) nor other antidepressants (HR 1.11; 95 % CI 0.96-1.28) increased major bleeds, and neither SSRIs (HR 0.93; 95 % CI 0.80-1.07) nor other antidepressants (HR 0.84; 95 % CI 0.62-1.14) increased mortality. Both SSRIs (HR 1.14; 95 % CI 1.10-1.18) and other antidepressants (HR 1.11; 95 % CI 1.03-1.19) were associated with a slight increase in receipt of one or more packed red blood cell (pRBC) units, but neither were associated with substantial increases in receipt of three or more pRBC units (HR 1.06; 95 % CI 0.96-1.17 for SSRIs; HR 1.09; 95 % CI 0.91-1.31 for other antidepressants).
In this large cohort study, neither SSRIs nor other antidepressants were associated with elevated rates of major bleed, or in-hospital mortality.
[Show abstract][Hide abstract] ABSTRACT: With so much recent change in the healthcare system, it is easy to forget that Medicare Part D was only implemented in 2006. At the time, it represented the largest expansion in coverage for seniors since the introduction of Medicare in 1965. For the first time, seniors could voluntarily enroll in a government-subsidized, privately offered insurance program to make medications affordable, and 37 million of our most vulnerable Americans have enrolled to date.1 The program is widely acknowledged as a great success, expanding access to treatment, helping to improve health outcomes, and likely even reducing the overall costs to Medicare by improving patient health and reducing the need for other, more expensive health care services.2-5 As many of our most common chronic conditions can now be managed entirely with highly effective and low-cost generic medications,6 there may be no more cost-effective way to enhance coverage that will meaningfully improve health and, at the same time, bend t ...
No preview · Article · Apr 2015 · Journal of General Internal Medicine
[Show abstract][Hide abstract] ABSTRACT: Generic drugs are approved on the basis of pharmaceutical equivalence and bioequivalence. Some drug products have unique structural or functional attributes, necessitating modified approaches to bioequivalence determinations.
The aim of this systematic review was to identify studies that evaluated laboratory or clinical outcomes of six drugs approved via modified bioequivalence approaches.
We conducted a systematic review of articles published through February 2014 in MEDLINE, EMBASE, and International Pharmaceutical Abstracts related to six recent drugs subject to modified regulatory approaches: venlafaxine extended release tablet (Effexor XR), acarbose (Precose), enoxaparin (Lovenox), vancomycin capsules (Vancocin), sodium ferric gluconate (Ferrlecit), and calcitonin salmon nasal spray (Miacalcin NS). We included all empirical evaluations (whether in vivo or in vitro) and excluded case studies, qualitative analyses, and pharmacoeconomic evaluations. Studies were summarized and evaluated on their methodological quality and assessed for bias using the Cochrane Risk of Bias Assessment Tool. Articles were divided into studies of US FDA-approved generics and non-FDA-approved generics available in non-US locations.
We extracted drug(s) studied, study design, setting, sample size, population characteristics, study endpoints and results, and source of funding.
After retrieving 1408 articles and searching through the full text of 106 articles, we found 26 articles that met our inclusion criteria-8 examining FDA-approved versions and 18 examining non-FDA-approved versions. Among FDA-approved generics, five studies of enoxaparin showed minor variations in biologic activities of unclear clinical importance, and no publications involved acarbose, venlafaxine ER, or vancomycin capsules. Among non-FDA-approved generics, nine studies of enoxaparin supported generic bioequivalence, despite three showing minor variations in drug activity. Four of six studies of venlafaxine ER supported generic bioequivalence, while two found a lack of bioequivalence with a Canadian generic version of the drug. Most studies were either highly susceptible to bias (12/26) or were not able to be assessed for bias (13/26), in part because eight studies were abstracts/posters without full reports.
Pharmaceutical manufacturers sometimes raise scientific concerns related to potential generic versions of their drugs; however, in the six cases we reviewed, these companies did not follow up the pre-approval concerns they raised with any methodologically rigorous post-approval testing using clinical endpoints. Despite their pre-approval controversy, experience with these generic drugs provides reassurance of their clinical interchangeability. Systematized post-approval study of certain generic drug bioequivalence determinations is needed.
[Show abstract][Hide abstract] ABSTRACT: Background:
With proliferating treatment options for anticoagulant therapy, physicians and patients must choose among them based on their benefits and risks. Using a Discrete Choice Experiment, we elicited patients' relative preferences for specific benefits and risks of anticoagulant therapy.
Methods and results:
We selected a sample of US patients with cardiovascular disease from an online panel and elicited their preferences for benefits and risks of anticoagulant therapy: nonfatal stroke, nonfatal myocardial infarction, cardiovascular death, minor bleeding, major bleeding, bleeding death, and need for monitoring. These attributes were used to design scenarios describing hypothetical treatments that were labeled as new drug, old drug, or no drug. Latent class analysis was used to identify groups of patients with similar preferences. A total of 341 patients completed all Discrete Choice Experiment questions. On average, patients valued a 1% increased risk of a fatal bleeding event the same as a 2% increase in nonfatal myocardial infarction, a 3% increase in nonfatal stroke, a 3% increase in cardiovascular death, a 6% increase in major bleeding, and a 16% increase in minor bleeding. The odds of choosing no drug or old drug versus new drug were 0.72 (95% confidence interval, 0.61-0.84) and 0.86 (95% confidence interval, 0.81-0.93), respectively. Previous stroke or myocardial infarction was associated with membership in the class with larger negative preferences for these outcomes.
Patients' preferences for various outcomes of anticoagulant therapy vary and depend on their previous experiences with myocardial infarction or stroke. Incorporating these preferences into benefit risk calculation and treatment decisions can enhance patient-centered care.
Preview · Article · Nov 2014 · Circulation Cardiovascular Quality and Outcomes
[Show abstract][Hide abstract] ABSTRACT: Objective:
Disease-modifying antirheumatic drugs (DMARDs) are recommended for all patients with rheumatoid arthritis (RA). Some estimate that approximately one-half of patients with RA do not receive DMARDs. We hypothesized that patients with RA living farther from rheumatologists would be less likely to receive RA diagnoses and to receive DMARDs.
US-based Medicare patients ages >65 years were study eligible. We calculated driving distance from patients' homes to the nearest rheumatologist. Using multivariable logistic regression, we assessed relationships between driving distance and RA diagnosis and between driving distance and DMARD receipt. In one set of analyses, distance was divided into quartiles: 0-2, 2.1-5, 5.1-15.9, and ≥16 miles. In a second set of analyses, we used predefined categories: 0-15, 15.1-30, 30.1-60, and >60 miles.
Among 59,426 Medicare beneficiaries, 918 had diagnosed RA. Compared to the first quartile, increased distance was associated with decreased odds of RA diagnosis (odds ratio [OR] 0.96 [95% confidence interval (95% CI) 0.80-1.16] in second quartile, OR 0.88 [95% CI 0.72-1.07] in third quartile, and OR 0.72 [95% CI 0.56-0.93] in fourth quartile; P < 0.01 for trend). Similar results were observed using predefined categories. Among those with RA, increased distance was associated with increased odds of DMARD receipt across quartiles (OR 1.15 [95% CI 1.06-1.25] in second quartile, OR 1.41 [95% CI 1.29-1.54] in third quartile, and OR 1.32 [95% CI 1.18-1.46] in fourth quartile; P = 0.001 for trend). There was no relationship between predefined categories and DMARD receipt (P = 0.45 for trend).
Increased driving distance to rheumatologists was associated with decreased odds of RA diagnosis. Among those with diagnosed RA, the odds of DMARD receipt rose as distance increased from <2 to 16 miles, but not beyond. Urban residents living closer to rheumatologists may have barriers to DMARD use besides geographic access.
[Show abstract][Hide abstract] ABSTRACT: Background: Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them. Objective: To determine whether patients are more adherent to generic statins versus brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes. Design: Observational, propensity score-matched, new-user cohort study. Setting: Linked electronic data from medical and pharmacy claims. Participants: Medicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008. Intervention: Initiation of a generic or brand-name statin. Measurements: Adherence to statin therapy (measured as the proportion of days covered [PDC] up to 1 year) and a composite outcome comprising hospitalization for an acute coronary syndrome or stroke and all-cause mortality. Hazard ratios (HRs) and absolute rate differences were estimated. Results: A total of 90 111 patients who initiated a statin during the study was identified; 83 731 (93%) initiated a generic drug, and 6380 (7%) initiated a brand-name drug. The mean age of patients was 75.6 years, and most (61%) were female. The average PDC was 77% for patients in the generic group and 71% for those in the brand-name group (P < 0.001). An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group (HR, 0.92 [95% CI, 0.86 to 0.99]). The absolute difference was -1.53 events per 100 person-years (CI, -2.69 to -0.19 events per 100 person-years). Limitation: Results may not be generalizable to other populations with different incomes or drug benefit structures. Conclusion: Compared with those initiating brand-name statins, patients initiating generic statins were more likely to adhere and had a lower rate of a composite clinical outcome.
No preview · Article · Sep 2014 · Annals of internal medicine
[Show abstract][Hide abstract] ABSTRACT: Background Generalisability has been reported as a barrier to using evidence in policy making. Little data are available on whether US and Canadian based evidence on cost-sharing and medication adherence is generalizable to international populations. To explore external validity, we compared the impact of two similar cost sharing policies, one in the US and one in Ireland, on medication adherence.
Methods A repeated measures longitudinal study design was employed to measure individual drug adherence before and after the introduction of drug cost-sharing policies. The Irish policy introduced a 50 cent copayment/prescription item in a publicly insured population in 2010. A similar policy occurred in the Massachusetts Medicaid population in 2003. Prescription data were obtained from centrally held pharmacy claims databases; HSE-PCRS, in Ireland and Medicaid Analytical Extract in the US New users of anti-hypertensive, anti-hyperlipidaemic and anti-diabetes drugs entered the cohort 6 months prior to initiation of cost-sharing polices and were followed for 12 months post-policy change. Segmented regression with generalised estimating equations and an autoregressive correlation structure was used.
Results The Irish policy change resulted in a 3.9% (95% CI, 2.91%-5.02%) immediate drop in adherence to anti-hypertensive drugs in Ireland, whereas the US policy did not affect anti-hypertensive adherence. Relative to the US, the Irish population had a 5.3% (95% CI, 3.68% - 6.92%) additional decrease in adherence to anti-hypertensive drugs immediately after the policy change. Adherence to anti-hyperlipidaemic drugs was insignificantly reduced (-0.6235%, 95% CI, - 2.41%-1.16%) immediately post-policy change in the U. S. However, adherence to anti-hyperlipidaemics was reduced in Ireland by 3.4% (95% CI, 2.25%-4.62%). Compared to the US, Irish patients decreased their adherence to anti-hyperlipidaemics by 2.8% (95% CI, 0.673%-4.945%). Adherence to anti-diabetic drugs did not differ internationally post-policy change. There was no evidence for international differences in the long-term impact (12 months) of policy changes.
Conclusion Irish and US populations had different changes in adherence to anti-hypertensive and anti-hyperlipidaemic drugs directly after implementation of cost-sharing policies, with greater reductions in adherence in the Irish population. However, changes in adherence to anti-diabetic drugs were similar between the populations. This study suggests that North American and Canadian evidence may not be automatically internationally generalizable. Rather, the specific attributes of a setting should always be considered before applying evidence to policy. This novel study will be of interest to global policymakers as they seek to develop evidence based cost-sharing policies.
Preview · Article · Sep 2014 · Journal of Epidemiology & Community Health
[Show abstract][Hide abstract] ABSTRACT: Primary medication adherence occurs when a patient properly fills the first prescription for a new medication. Primary adherence
only occurs about three-quarters of the time for antihypertensive medications. We assessed patients’ barriers to primary adherence
and attributes of patient–provider discussions that might improve primary adherence for antihypertensives. In total, 26 patients
with incomplete primary adherence for an antihypertensive, identified using their retail pharmacy claims, participated in
four focus groups. Following a moderators’ guide developed a priori, moderators led patients in a discussion of patients’ attitudes and experiences with hypertension and receiving an antihypertensive
medication, barriers to primary adherence, and their preferences for shared decision making and communication with providers.
Three authors analysed and organized data into salient themes, including patients’ anger about and suspicion of their hypertension
diagnosis, the need for medication and providers’ credibility. A trusting patient–provider relationship, shared decision-making
support, full disclosure of side effects and cost sensitivity were attributes that might enhance primary adherence. Developing
decision support interventions that strengthen the patient–provider relationship by enhancing provider credibility and patient
trust prior to prescribing may provide more effective approaches for improving primary adherence.
No preview · Article · May 2014 · Health Education Research
[Show abstract][Hide abstract] ABSTRACT: Longitudinal healthcare claim databases are frequently used for studying the comparative safety and effectiveness of medications, but results from these studies may be biased due to residual confounding. It is unclear whether methods for confounding adjustment that have been shown to perform well in small, simple nonrandomized studies are applicable to the large, complex pharmacoepidemiologic studies created from secondary healthcare data. Ordinary simulation approaches for evaluating the performance of statistical methods do not capture important features of healthcare claims. A statistical framework for creating replicated simulation datasets from an empirical cohort study in electronic healthcare claims data is developed and validated. The approach relies on resampling from the observed covariate and exposure data without modification in all simulated datasets to preserve the associations among these variables. Repeated outcomes are simulated using a true treatment effect of the investigator’s choice and the baseline hazard function estimated from the empirical data. As an example, this framework is applied to a study of high versus low-intensity statin use and cardiovascular outcomes. Simulated data is based on real data drawn from Medicare Parts A and B linked with a prescription drug insurance claims database maintained by Caremark. Properties of the data simulated using this framework are compared with the empirical data on which the simulations were based. In addition, the simulated datasets are used to compare variable selection strategies for confounder adjustment via the propensity score, including high-dimensional approaches that could not be evaluated with ordinary simulation methods. The simulated datasets are found to closely resemble the observed complex data structure but have the advantage of an investigator-specified exposure effect.
No preview · Article · Apr 2014 · Computational Statistics & Data Analysis
[Show abstract][Hide abstract] ABSTRACT: Medication copayments can influence patient choices. We evaluated 2 copayment policies implemented by Massachusetts Medicaid incentivizing the use of selected generic medications.
In 2009, Massachusetts Medicaid copayments were $1 for generics and $3 for brands. On February 1, 2009, copayments for generic antihypertensives, antihyperlipidemics, and hypoglycemics (target medications) remained at $1, whereas copayments for all nontarget generics increased to $2 (policy #1) and $3 on July 1, 2010 (policy #2). Using state-level, aggregate prescription data, we developed interrupted time-series models with controls to evaluate the impact of these policies on use of target generics, target brands, and nontarget essential medications (defined as medications required for ongoing treatment of serious medical conditions).
After policy #1, target generic use increased by 0.93% (P<0.001) with a subsequent quarterly slope decrease of -0.16% (P<0.01); policy #2 led to a slope increase of 0.20% (P<0.01) for target generics; increase in target generics attributable to policy changes was 28,000 prescriptions per year. Neither policy affected target brand use. For nontarget essential generics, there was a -0.27% (P<0.001) quarterly slope decrease after policy #1 and a 0.32% (P<0.01) slope increase after policy #2 with total decrease attributable to policy changes of 127,300 prescriptions per year. For nontarget essential brands, there was a level increase of 0.91% (P<0.001) after policy #1 with increased use attributable to policy changes of 98,300 prescriptions per year.
Two copayment policies designed to encourage use of selected generic medications modestly increased their use; however, there was a shift in other essential medications from generics to brands, which could increase Medicaid costs. When adjusting copayments, careful consideration must be given to unintended consequences of specific policy structures.
[Show abstract][Hide abstract] ABSTRACT: Statin use has increased substantially in North America and Europe, with resultant reductions in cardiovascular mortality. However, little is known about statin use in lower-income countries. India is of interest because of its burden of cardiovascular disease, the unique nature of its prescription drug market, and the growing globalization of drug sales. We conducted an observational study using IMS Health data for the period February 2006-January 2010. During the period, monthly statin prescriptions increased from 45.8 to 84.1 per 1,000 patients with coronary heart disease-an increase of 0.80 prescriptions per month. The proportion of the Indian population receiving a defined daily statin dose increased from 3.35 percent to 7.78 percent. Nevertheless, only a fraction of those eligible for a statin appeared to receive the therapy, even though there were 259 distinct statin products available to Indian consumers in January 2010. Low rates of statin use in India may reflect problems with access to health care, affordability, underdiagnosis, and cultural beliefs. Because of the growing burden of cardiovascular disease in lower-income countries such as India, there is an urgent need to increase statin use and ensure access to safe products whose use is based on evidence. Policies are needed to expand insurance, increase medications' affordability, educate physicians and patients, and improve regulatory oversight.