Drug Benefit Plan Research Articles

Medication Assessments by Care Managers Reveal Potential Safety Issues in Homebound Older Adults

Over-the-counter (OTC) medications, benzodiazepines, and barbiturates are not covered under many Medicare drug benefit plans; hence, their use by homebound older adults is largely unreported. Furthermore, the tiered design of Medicare drug formularies may in fact promote the use of older but potentially inappropriate medications. Little is known about the use of these medications in the homebound older adult population. To determine the prevalence of the use by homebound older adults of OTC drugs, dietary supplements (vitamins, minerals, and herbal products), Part D-excluded medications (benzodiazepines and barbiturates), and potentially inappropriate medications (according to Beers criteria). Patients were enrollees in a home and community-based Medicaid waiver provider. All clients were older than 65 and were dually eligible for Medicare and Medicaid. All clients met Florida Medicaid's medical and financial criteria for nursing home placement. The medication list was obtained by geriatric care managers during a home assessment. A total of 3911 older adults (mean [SD] age 83.6 [8.0] years) were taking an average of 9.9 [4.8] drugs. Of these individuals, 74.5% were using an OTC medication, 41.9% were using a dietary supplement, 29.6% were using a benzodiazepine or barbiturate, and 25.2% were using at least 1 potentially inappropriate medication. Based on data gathered by a geriatric care management assessment, we found that most of the homebound older adults enrolled in our study used medications not included in their Medicare drug benefit. The use of potentially inappropriate medications was also common in this population. Future drug safety initiatives involving the elderly will benefit from engaging care managers in identifying and addressing the potential hazards posed by commonly used prescribed and nonprescribed medications.

A Proposed Framework for Formulary Listing in Low-Income Countries

Formularies of reimbursed drugs are widely adopted tools in healthcare systems. However, little is known about the selection process of drugs that appear on these formularies. The aim of this paper was to shed light on this process by reviewing the way selected public Drug Benefit Plans in high-, middle- and low-income countries, including Canada, the US, UK, France, Germany, Brazil, South Korea and Ghana, manage the formulary listing process. Common steps and challenges are identified and this information used to make recommendations for developing a framework for formulary listing in low-income countries. We found that all DBPs studied used a formulary to list reimbursable drugs and the selection criteria utilized to determine which drugs should be listed were similar between plans, although weighting of individual criterion differs and the composition of the committee (i.e. physician vs economist) is likely to have an impact. The WHO model list of essential medicines plays a bigger role in formulary selection in middle-income countries than in high-income countries. In low-income countries, the focus is on the prioritization of health interventions and improving access to healthcare. On the basis of our review and an appraisal of the health needs of low-income countries, we have proposed four steps that are the pillars of our framework for formulary conception in low-income countries. These steps are the identification and weighting of relevant formulary listing criteria (combining both literature review and qualitative research approaches), the determination of priority diagnostics/treatments to be assessed, the criteria scoring and the treatment ranking by priority order of reimbursement. Finally, for the purpose of developing a formulary, we recommend use of the multicriteria decision analysis approach to guide priority drug ranking.

Effects of restrictions on reimbursement for pharmaceutical drugs

Our review on restrictions to reimbursement by drug benefit plans (1) is part of an emerging series on pharmaceutical policies from the Cochrane Effective Practice and Organization of Care group (2–5). As expected, we found strong evidence that these restrictions do lead to lower spending on drugs but the more important question for us to answer was whether the savings associated with the restrictions can be obtained without unintended health consequences or shifting costs to other parts of the health care system. The answer is yes, but not always. The Cochrane Collaboration has taken up the challenge of Archie Cochrane’s vision of systematically reviewing the best available evidence in all areas of health care, to support clinical practice. We have a similar vision for a collection of reviews to support informed decision making on pharmaceutical policies. Many people are not aware of how much the science of pharmaceutical policy has advanced, with the availability of large administrative datasets and the ability of researchers to process anonymous data from millions of routine transactions. Our review is the fourth to be completed in the planned series of 13 Cochrane reviews of pharmaceutical policy. The other three completed reviews looked at reference pricing, copayments and caps, and physician incentives; and have all yielded insights that can be used to formulate better pharmaceutical policies. As we brought together the data for our review, we were surprised to find how much the results varied by drug class. In the 29 included studies, nine drug classes had been targeted for restriction. Most looked at policies restricting gastric acid suppressants and non steroidal anti inflammatory drugs, or NSAIDS. For these, there is good evidence that restrictive policies lead to savings without increasing the use of other health services. We also found evidence supporting restrictions for wet nebulizer respiratory drugs and fluroquinolone antimicrobials. However, second generation antipsychotic medications provided an exception to the generally positive findings. There was good evidence that restrictions for these were associated with treatment discontinuity and increased outpatient visits. This makes them poor targets for restrictive policies. We also found that the available evidence does not support restrictions for anti-platelets and angiotensin receptor blocker medications. The global nature of our review made us aware of European strategies to encourage the use of cost effective medications to prevent secondary complications of high blood pressure and blood cholesterol. We found a small but high quality body of evidence supporting the lifting or exemption of restrictions, when these drugs are used for secondary prevention. The evidence available for our review applies mostly to older or low income populations, because the research was conducted using data from publicly funded drug benefit plans. However, the policies are also used by employer or private insurance plans and our findings might be relevant in those settings. Spending on prescription medications has increased dramatically in recent years, while public funding has contracted, so the use of policies to control costs may be essential to ensure that drug benefit plans can be sustained. We are excited about our early steps in realizing the vision of providing policy makers with systematic reviews of pharmaceutical policy across all 13 major areas. These policies can have enormous ramifications for the health of populations and the sustainability of health systems. We will be moving on to investigate policies that determine which drugs are reimbursed but the body of research in this area is growing so quickly that we also need to develop strategies to ensure the regular updating of the existing reviews.

Registration for public drug benefits across areas of differing ethnic composition in British Columbia, Canada

BackgroundIn 2003, the government of British Columbia, Canada introduced a universal drug benefit plan to cover drug costs that are high relative to household income. Residents were required to register in order to be eligible for the income-based benefits. Given past research suggesting that registration processes may pose an access barrier to certain subpopulations, we aimed to determine whether registration rates varied across small geographic areas that differed in ethnic composition.MethodsUsing linked population-based administrative databases and census data, we conducted multivariate logistic regression analyses to determine whether the probability of registration for the public drug plan varied across areas of differing ethnic composition, controlling for household-level predisposing, enabling and needs factors.ResultsThe adjusted odds of registration did not differ across regions characterized by high concentrations (greater than 30%) of residents identifying as North American, British, French or other European. Households located in areas with concentrations of residents identifying as an Asian ethnicity had the highest odds of program registration: Chinese (OR = 1.21, CI: 1.19-1.23) and South Asian (OR = 1.19, CI: 1.16-1.22). Despite this positive finding, households residing in areas with relatively high concentrations of recent immigrants had slightly lower adjusted odds of registering for the program (OR = 0.97, CI: 0.95-0.98).ConclusionsThis study identified ethnic variation in registration for a new public drug benefit program in British Columbia. However, unlike previous studies, the variation observed did not indicate that areas with high concentrations of certain ethnicities experienced disadvantages. Potential explanations are discussed.

Ontario's law curbing the cost of generic drugs sparks changes for pharmacies and other Canadian buyers

Ontario shook up the world of generic drug pricing across the country 3 years ago when it passed Bill 102, the Transparent Drug System for Patients Act. In turn, the executive officer of Ontario’s $4-billion-a-year drug benefit plan saw her own life disrupted. In late April, Helen Stevenson was

Empirical Treatment of Community‐Acquired Pneumonia and the Development of Fluoroquinolone‐Resistant Tuberculosis

BACKGROUND" Fluoroquinolone (FLQ) antibiotics are not uncommonly prescribed for community-acquired pneumonia that is later proven to be pulmonary tuberculosis (TB). Such FLQ monotherapy may result in FLQ-resistant pulmonary TB. To assess outpatient FLQ use by patients with culture-proven pulmonary TB before diagnosis, TB registries in Alberta and Saskatchewan, Canada, were linked with provincial and federal drug benefit plans. To assess FLQ resistance, a case-control study was performed. Of 428 patients with pulmonary TB who were covered by a drug benefit plan, 74 (17.3%) had received > or = 1 FLQ prescription during the 6 months immediately before receipt of the diagnosis. Older patients (age, >64 years) were more likely than younger patients (age, 15-64 years) to be prescribed an FLQ (P < .05). Patients who were prescribed an FLQ received a total of 103 prescriptions. Most (54 [73.0%] of 74) patients who were prescribed an FLQ received a single prescription. Most (69 [67.0%] of 103) FLQ prescriptions were written within 90 days before the diagnosis of pulmonary TB. Patients who were prescribed an FLQ were not statistically significantly more likely than matched patients who were not prescribed an FLQ (control subjects) to be infected with FLQ-resistant Mycobacterium tuberculosis. Of 148 isolates of M. tuberculosis from patients and control subjects, 3 were FLQ resistant; all of these isolates were from patients who had received multiple FLQ prescriptions. Patients who had received multiple FLQ prescriptions were more likely than patients who had received a single FLQ prescription to be infected with FLQ-resistant M. tuberculosis (15.0% vs. 0.0%; odds ratio, 11.4; P = .04). Outpatient FLQ use, ostensibly for community-acquired pneumonia, is not uncommon among patients with pulmonary TB, especially older patients. Single FLQ prescriptions were not associated with FLQ-resistant M. tuberculosis, whereas multiple FLQ prescriptions were associated with FLQ resistance.

A comparison of mail-service and retail community pharmacy claims in 5 prescription benefit plans

Background Little evidence has been presented to date that would either support or refute a widely held belief that mail-service pharmacy utilization routinely produces savings in drug benefit costs for prescription benefit plan sponsors. Objective To present a comparative analysis of mail-service and community pharmacy service drug benefit costs for 5 employer-sponsored prescription drug benefit plans. Methods A cross-sectional comparison of 17,725 matched transaction pairs of community and mail-service prescriptions from a data set comprised 484,987 prescription claims from a convenience sample of 5 employer-sponsored prescription benefit plans. Differences between community pharmacy and mail-service prescription transactions were examined at the per-unit level of analysis for drug ingredient costs, dispensing fees, co-payments, dollar amounts paid by plan sponsor, and total dollar amounts. Results Overall, the total cost of prescriptions was lower through mail-service pharmacies for all 5 plans studied. Two of 5 plans had co-payment incentives to use mail-service, yet plan sponsors paid more for mail-service drugs; respectively, 4.5% and 8.3% more overall, 25.0% and 21.4% more for generic medications; and 3.0% and 7.0% more for brand name medications. Mail-service co-payments were 48.9% and 51.7% lower. Mail-service utilization rates were 15.2% and 31.5% of the total number of prescriptions dispensed in the period studied. Three of 5 plans had no co-payment incentive to use mail-service and paid less for mail-service drugs; respectively, 18.7%, 6.6%, and 15.7% less overall; 17.4%, 15.6%, and 7.9% less for generic medications; and 18.8%, 5.2%, and 16.6% less for brand name medications. Mail-service co-payments were 10.5% more, 5.2% less, and 1.8% more than community pharmacy co-payments, respectively. Mail-service utilization rates were 0.8%, 1.2%, and 4.4%. Conclusion Co-payment incentives to use mail-service pharmacies instead of community pharmacies were associated with higher mail-service utilization rates and with higher costs to plan sponsors. Absence of a co-payment incentive to use mail-service pharmacies was associated with lower mail-service utilization rates and with lower costs to plan sponsors.

Cost-utility analysis of infliximab and adalimumab for refractory ulcerative colitis

ObjectiveTo evaluate cost-utility of infliximab and adalimumab for the treatment of moderate-to-severe ulcerative colitis (UC) refractory to conventional therapies in Canada.MethodsA Markov model was constructed to evaluate incremental cost-utility ratios (ICUR) of 5 mg/kg and 10 mg/kg infliximab and adalimumab therapies compared to 'usual care' in treating a hypothetical cohort of patients (aged 40 years and weighing 80 kg) over a five-year time horizon from the perspective of a publicly-funded health care system. Clinical parameters were derived from the Active Ulcerative Colitis Trials 1 and 2. Costs were obtained through provincial drug benefit plans. ICUR was the main outcome measure and both deterministic and probabilistic sensitivity analyses were conducted.ResultsCompared to the strategy A ('usual care') in the base case analysis, the ICURs were CA$358,088/QALY for the strategy B ('5 mg/kg infliximab + adalimumab') and CA$575,540/QALY for the strategy C ('5 mg/kg and 10 mg/kg infliximab + adalimumab'). The results were sensitive to: the remission rates maintained in responders to 'usual care' and to 5 mg/kg infliximab, the rate of remission induced by adalimumab in non-responders to 5 mg/kg infliximab, early surgery rate, and utility values. When the willingness to pay (WTP) was less than CA$150,000/QALY, the probability of 'usual care' being the optimal strategy was 1.0. The probability of strategy B being optimal was 0.5 when the WTP approximated CA$400,000/QALY.ConclusionsThe ICURs of anti-TNF-α drugs were not satisfactory in treating patients with moderate-to-severe refractory UC. Future research could be aimed at the long-term clinical benefits of these drugs, especially adalimumab for patients intolerant or unresponsive to infliximab treatment.

Medication strategies used by Medicare beneficiaries who reach the Part D standard drug-benefit threshold

The mechanisms used by Medicare beneficiaries who reached their Part D drug-benefit threshold to cope with the costs of prescription drugs were evaluated. A retrospective review of integrated medical and pharmacy electronic records and a mail survey were utilized. Members of a Medicare Advantage plan continuously enrolled in 2006 in either a standard drug-benefit plan who reached their threshold by October 1, 2006 (study group) or a retiree drug subsidy plan without a threshold but by October 1, 2006, had reached the threshold in total drug spend (control group) were included. Data on members' cost-lowering medication strategies, demographics, and socioeconomic status were analyzed. Of the 1,472 questionnaires mailed, 622 (42%) were completed. Respondents in the study group were more likely than control respondents to be male, be married, own a home, report lower health status, and have a household income of <$30,000 (p < 0.05). There were no significant differences in age, race or ethnicity, and diagnoses between groups. Study group respondents were three times more likely than control group respondents to use a cost-lowering strategy (p < 0.001). Predictors of increased risk of using a medication cost-lowering strategy included study group assignment, age, health status, education, income, and purchase of a second-generation antipsychotic (p < 0.05). Respondents in the study group were three times more likely than respondents in the control group to report using a medication cost-lowering strategy. Respondents who were younger and had limited prescription drug coverage, lower household income, higher educational status, and poorer health status were at increased risk of adopting a cost-lowering strategy.

Improving Drug Benefits for Children with Asthma: Results of a Multi-stakeholder Workshop to Build a Research Agenda

Asthma is the most common chronic childhood disease, and evidence suggests that children underutilize inhaled corticosteroid ("controller") medications. Drug plans that provide benefits to children vary widely across Canada, and families may face high out-of-pocket costs. As an initial step in a knowledge exchange process aimed at motivating relevant research, a workshop was convened in March 2007 with diverse stakeholders to explore potential research topics within the theme of improving drug benefits for Canadian children with asthma. Six key challenges for further investigation were identified: (1) changing the perception of asthma from an episodic to a chronic disease, (2) improving diagnosis and management, (3) increasing intersectoral communication, (4) improving the quality of data, (5) developing better drug benefit plans and (6) practising more effective advocacy.

Effect of Cost-Sharing on Use of Asthma Medication in Children

To examine the effect of cost-sharing on the use of asthma medications in asthmatic children. According to asthma guidelines, children with asthma may require treatment with multiple medications, including controllers and relievers, to achieve optimal control. Although families may be enrolled in drug benefit plans, impediments to access persist in the form of cost-sharing. Population-based retrospective cohort study of children by analysis of administrative medication insurance claims data. Ontario, Canada. A cohort of 17 046 Ontario children with asthma enrolled in private drug plans. Main Exposure We used data on out-of-pocket expenses and reimbursement for medications to classify children as having zero, low (< 20%), or high (> or = 20%) levels of cost-sharing. We examined use of bronchodilators, inhaled corticosteroids, leukotriene receptor antagonists, oral corticosteroids, and combination agents. Multiple linear and logistic regressions compared medication use between cost-sharing groups, controlling for age and sex. The annual number of asthma medication claims per child was significantly lower in the high cost-sharing group (6.6) compared with the zero (7.0) and low (7.2) cost-sharing groups (P < .001). Children in the high cost-sharing group were less likely to purchase bronchodilators, inhaled corticosteroids, and leukotriene receptor antagonists compared with the low cost-sharing group (odds ratio, 0.76; 95% confidence interval, 0.67-0.86) and were less likely to purchase dual agents compared with the low cost-sharing group (odds ratio, 0.70; 95% confidence interval, 0.66-0.75). The cost-sharing level affected the use of asthma medication, with the highest cost-sharing group exhibiting significantly lower use of maintenance medications and newer dual agents.

Osteoporosis Improvement: A Large-Scale Randomized Controlled Trial of Patient and Primary Care Physician Education

We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. There was no difference in the probability of the primary composite endpoint (BMD test or osteoporosis medication) or in either of its components comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). Fractures from osteoporosis are associated with substantial morbidity, mortality, and cost. However, only a minority of at-risk older adults receives screening and/or treatment for this condition. We evaluated the effect of educational interventions for osteoporosis targeting at-risk patients, primary care physicians, or both. We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. The at-risk patients were women >or=65 yr of age, men and women >or=65 yr of age with a prior fracture, and men and women >or=65 yr of age who used oral glucocorticoids. The primary outcome studied was a composite of either undergoing a BMD test or initiating a medication used for osteoporosis. The secondary outcome was a hip, humerus, spine, or wrist fracture. We randomized 828 primary care physicians and their 13,455 eligible at-risk patients into four study arms. Physician and patient characteristics were very similar across all four groups. Across all four groups, the rate of the composite outcome was 10.3 per 100 person-years and did not differ between the usual care and the combined intervention groups (p = 0.5). In adjusted Cox proportional hazards models, there was no difference in the probability of the primary composite endpoint comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). There was also no difference in either of the components of the composite endpoint. The probability of fracture during follow-up was 4.2 per 100 person-years and did not differ by treatment assignment (p = 0.9). In this trial, a relatively brief program of patient and/or physician education did not work to improve the management of osteoporosis. More intensive efforts should be considered for future quality improvement programs for osteoporosis.

Estimating Medicare Part D's Impact on Medication Access Among Dually Eligible Beneficiaries With Mental Disorders

Medicare drug benefit (Part D) plans may restrict psychotropic medications more than state Medicaid programs do. This may have important implications for patients dually eligible for Medicare and Medicaid whose medications previously were covered under Medicaid. The objective of this study was to estimate rates of medication switching among dually eligible beneficiaries using antidepressants, antipsychotics, and mood stabilizers attributable to their enrollment in Medicare drug plans. Baseline data on medication usage patterns among 467 dually eligible beneficiaries with mental disorders from the Medicare Current Beneficiary Survey, formulary data from a sample of Medicare drug plans, and estimates of the utilization response to pharmacy management tools from the Medicaid literature were used to estimate the likelihood of switching medications conditional on use of drugs and assignment to particular Medicare drug plans. Restrictions on psychotropic medications were common among the drug plans studied. Estimated rates of medication switching attributable to Medicare Part D were 6%-10% among dually eligible beneficiaries using antipsychotics, 5%-7% among those using antidepressants, and 2%-4% among those using mood stabilizers. Switching rates varied substantially across plans. On average, relatively few dually eligible beneficiaries with mental disorders are likely to experience treatment disruptions because of formulary restrictions and utilization controls used by Medicare drug plans. However, beneficiaries in some plans will experience significant barriers to medication access. Given the substantial variation among Medicare drug plans' management of psychotropic medication use, clinicians and social service agencies should counsel their beneficiaries with mental disorders in navigating the complex Medicare drug plan market.

Estimating Medicare Part D's Impact on Medication Access Among Dually Eligible Beneficiaries With Mental Disorders

Medicare drug benefit (Part D) plans may restrict psychotropic medications more than state Medicaid programs do. This may have important implications for patients dually eligible for Medicare and Medicaid whose medications previously were covered under Medicaid. The objective of this study was to estimate rates of medication switching among dually eligible beneficiaries using antidepressants, antipsychotics, and mood stabilizers attributable to their enrollment in Medicare drug plans.Baseline data on medication usage patterns among 467 dually eligible beneficiaries with mental disorders from the Medicare Current Beneficiary Survey, formulary data from a sample of Medicare drug plans, and estimates of the utilization response to pharmacy management tools from the Medicaid literature were used to estimate the likelihood of switching medications conditional on use of drugs and assignment to particular Medicare drug plans.Restrictions on psychotropic medications were common among the drug plans studied. Estimated rates of medication switching attributable to Medicare Part D were 6%-10% among dually eligible beneficiaries using antipsychotics, 5%-7% among those using antidepressants, and 2%-4% among those using mood stabilizers. Switching rates varied substantially across plans.On average, relatively few dually eligible beneficiaries with mental disorders are likely to experience treatment disruptions because of formulary restrictions and utilization controls used by Medicare drug plans. However, beneficiaries in some plans will experience significant barriers to medication access. Given the substantial variation among Medicare drug plans' management of psychotropic medication use, clinicians and social service agencies should counsel their beneficiaries with mental disorders in navigating the complex Medicare drug plan market.

Exploration of the Value of Health-Related Quality-of-Life Information From Clinical Research and Into Clinical Practice

Quality-of-life (QOL) instruments used in clinical research can provide important evidence to inform decisions about alternative treatments. This is particularly true when patients, such as those with cancer who are contemplating toxic chemotherapy, face tradeoffs between quantity of life and QOL or when the primary goal of therapy is to improve how patients feel. Surrogate measures (cardiac function, exercise capacity, bone density, tumor size) are inadequate substitutes for direct measurement of QOL. Quality-of-life measures will be most valuable when they comprehensively measure aspects of QOL that are both important to patients and likely to be influenced by therapy, when the QOL measurement instruments are valid (measuring what is intended) and responsive (able to detect all important changes, even if small), and when the results are readily interpretable (determining whether treatment-related changes are trivial, small but important, or large). Researchers are finding new, imaginative ways to help clinicians understand the magnitude of treatment impact on QOL. Additionally, QOL measures may be useful in clinical practice. Recent results from well-designed randomized controlled trials suggest that information on patient QOL provided to clinicians might, in some circumstances, result in benefits for these patients. Further investigation is warranted to confirm these observations and to define the particular combination of methods and settings most likely to yield important benefits.

The Medical License Number Accurately Identifies the Prescribing Physician in a Large Pharmacy Claims Database

Medical license numbers that identify physicians in pharmacy claims data are used increasingly for both research and quality improvement efforts; however, little is known about how well this information identifies the physician who wrote the prescription. We studied the accuracy of the medical license number in data from a state-run drug benefit plan by assessing its consistency with 2 external sources of data. We studied a cohort of new users of osteoporosis medications who participated in Medicare and a state-run pharmaceutical benefit program. The medical license number from the prescription data were merged with the American Medical Association's (AMA) Masterfile to determine if the physician on the pharmacy claim existed in the AMA directory and practiced in the area under study. The prescription data were then merged with Medicare Part B data to determine if the physician on the prescription had an outpatient visit with the patient who received the medication. Of the 40,002 index prescriptions, 38,671 (96.7%) were written by physicians or doctors of osteopathy. Of those, 38,618 (99.9%) could be matched to the AMA Masterfile of which 37,375 (98%) had a local address. Of the AMA-matched prescriptions with a valid Unique Physician Identification Number (UPIN), 28,888 (96.1%) could be matched to Medicare Part B data, indicating that the physician whose license number appeared on the prescription had at least 1 outpatient visit with the patient who received the medication. The state medical license number in the pharmacy claims dataset studied seems to identify the prescribing physician with a high degree of accuracy.

Cost-Effectiveness of Schizophrenia Pharmacotherapy

Back to table of contents Previous article Next article Letters to the EditorFull AccessCost-Effectiveness of Schizophrenia PharmacotherapySTEPHEN B. SOUMERAI Sc.D.MICHAEL R. LAW M.Sc.,STEPHEN B. SOUMERAI Sc.D.Search for more papers by this authorMICHAEL R. LAW M.Sc.Search for more papers by this author,Published Online:1 Apr 2007AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail To The Editor: The study by Robert A. Rosenheck, M.D. and colleagues represents a large and ambitious attempt to study the cost-effectiveness of pharmacotherapy for the treatment of schizophrenia (1) . The authors acknowledge the caveats for policy making. However, we are concerned that drug plan administrators will nonetheless use these results to promote prior authorization and step-therapy policies that restrict access to atypical antipsychotic medications. Such policies will be based on both the imperative to contain costs and the conclusions of this analysis, which are unwarranted based on limitations in the study design. The purpose of cost-effectiveness analysis is to compare the relative efficacy of interventions in order to aid decision making (2) . Thus, the study will be considered a commentary on policy options. However, the study deviates from the relevant policy choices in important ways. First, the trial was not limited to new episodes of schizophrenia. However, such patients are generally the only ones affected by Medicaid and Medicare policies, which largely grandfather currently treated patients. Second, it bases comparisons between typical and atypical medications on a select population—those both willing to switch antipsychotics and without tardive dyskinesia. The generalizability of this group is questionable, since those with tardive dyskinesia may benefit more from newer medications (3) . Further, it is telling that patients and their clinicians almost universally switched to another atypical antipsychotic agent, suggesting customization of individual treatment. To this end, the unique circumstances of a clinical trial limit generalizability. While trial participants were free to switch medications at any time, typical prior authorization policies are burdensome on provider time and have unknown impacts on medication adherence and clinical outcomes. Inclusion of these impacts and use of a societal perspective in the analysis might reveal quite different implications.The authors acknowledge that the results should not be used to limit treatment of patients to first-generation antipsychotics. However, their abstract—which is all many busy policymakers will ever read—states that perphenazine treatment “was less costly than treatment with second-generation antipsychotics with no significant differences in measures of effectiveness” (p. 2080) with no such caveat. Such statements will be all too alluring for pharmacy benefit managers struggling with costs. In fact, within 2 weeks of publication, we received requests for advice about proposed policies to provide typical agents without cost-sharing while charging high copayments for atypical medications in a large drug benefit plan. Consequently, we have serious concerns that this research will support potentially harmful access restrictions on effective medications for vulnerable patients.Boston, Mass.Dr. Soumerai reports a public-private partnership grant that includes funding from the Agency for Healthcare Research and Quality, Eli Lilly, the Harvard Pilgrim Health Care Foundation, and the Centers for Disease Control and Prevention. Mr. Law reports no competing interests.

Weighing in on the Medicare Prescription Drug Benefit Plan

The purpose of this analysis is to look at the Medicare Prescription Plan and determine how well it is performing, obstacles that it will face, and the potential longevity of the plan. The Medicare prescription plan will not be an easy fix as there are complex problems with few easy answers. The plan provides much needed drug coverage for millions of Americans and most agree it is the socially responsible thing for the government to do; however, the plan will face sustainability challenges in the future from controlling costs, an aging population, and technological advances in medicine. Medicare was in deep financial trouble before the addition of the new prescription plan. The addition has put a further cost burden on an already weakened system. The plan was not well thought out from a financial stand point and will not be able to endure into the future in its current state.

A Practical Physicians' Guide to the Medicare Drug Benefit Plan

Recent commentaries on Medicare Part D highlight both the early failings and the successes of the program. However, regardless of one's opinions about the program, Part D is a reality that millions of Medicare beneficiaries must address now and in the future. The ultimate economic, policy, and clinical success of the Medicare drug benefit plan depends on its transparency and ability to be navigated together by patients, physicians, and other parties. Although Medicare Part D is likely to evolve considerably in the future, it will continue to present elderly adults with numerous plan options and rules and therefore present persistent challenges for patients and physicians. By focusing on a few crucial aspects of Part D and taking advantage of available resources, physicians can simplify Part D for their patients, help them make informed decisions about enrollment and plan selection, and possibly help them save money with their current PDP. This may, in turn, reduce beneficiaries' out-of-pocket prescription costs, thereby improving patients' access to medications and possibly their medication adherence and health outcomes as well.

Using Pharmacoepidemiology To Inform Drug Coverage Policy: Initial Lessons From A Two-Province Collaborative

Prescription drug plan managers seek "real-world" evidence regarding the safety and effectiveness of drugs and drug coverage policies. University-based pharmacoepidemiologists with access to administrative health data can help meet these information needs and, by collaborating with other health plans, exploit variations in plan policy. Canada, with its universal health insurance, public drug benefit plans, and population-based linked health care databases, is an ideal setting for such research. Here we describe our initial experience in collaborating with researchers and drug plan managers in British Columbia and Ontario.