Interventions designed to improve the quality and efficiency of medication use in managed care: A critical review of the literature – 2001–2007

<p>Abstract</p> <p>Background</p> <p>Managed care organizations use a variety of strategies to reduce the cost and improve the quality of medication use. The effectiveness of such policies is not well understood. The objective of this research was to update a previous systematic review of interventions, published between 1966 and 2001, to improve the quality and efficiency of medication use in the US managed care setting.</p> <p>Methods</p> <p>We searched MEDLINE and EMBASE for publications from July 2001 to January 2007 describing interventions targeting drug use conducted in the US managed care setting. We categorized studies by intervention type and adequacy of research design using commonly accepted criteria. We summarized the outcomes of well-controlled strategies and documented the significance and magnitude of effects for key study outcomes.</p> <p>Results</p> <p>We identified 164 papers published during the six-year period. Predominant strategies were: educational interventions (n = 20, including dissemination of educational materials, and group or one-to-one educational outreach); monitoring and feedback (n = 22, including audit/feedback and computerized monitoring); formulary interventions (n = 66, including tiered formulary and patient copayment); collaborative care involving pharmacists (n = 15); and disease management with pharmacotherapy as a primary focus (n = 41, including care for depression, asthma, and peptic ulcer disease). Overall, 51 studies met minimum criteria for methodological adequacy. Effective interventions included one-to-one academic detailing, computerized alerts and reminders, pharmacist-led collaborative care, and multifaceted disease management. Further, changes in formulary tier-design and related increases in copayments were associated with reductions in medication use and increased out-of-pocket spending by patients. The dissemination of educational materials alone had little or no impact, while the impact of group education was inconclusive.</p> <p>Conclusion</p> <p>There is good evidence for the effectiveness of several strategies in changing drug use in the managed care environment. However, little is known about the cost-effectiveness of these interventions. Computerized alerts showed promise in improving short-term outcomes but little is known about longer-term outcomes. Few well-designed, published studies have assessed the potential negative clinical effects of formulary-related interventions despite their widespread use. However, some evidence suggests increases in cost sharing reduce access to essential medicines for chronic illness.</p

Giving formulary and drug cost information to providers and impact on medication cost and use: a longitudinal non-randomized study

BackgroundProviders wish to help patients with prescription costs but often lack drug cost information. We examined whether giving providers formulary and drug cost information was associated with changes in their diabetes patients' drug costs and use. We conducted a longitudinal non-randomized evaluation of the web-based Prescribing Guide ( www.PrescribingGuide.com ), a free resource available to Hawaii's providers since 2006, which summarizes the formularies and copayments of six health plans for drugs to treat 16 common health conditions. All adult primary care physicians in Hawaii were offered the Prescribing Guide, and providers who enrolled received a link to the website and regular hardcopy updates.MethodsWe analyzed prescription claims from a large health plan in Hawaii for 5,883 members with diabetes from 2007 (baseline) to 2009 (follow-up). Patients were linked to 299 "main prescribing" providers, who on average, accounted for &gt;88 % of patients' prescriptions and drug costs. We compared changes in drug costs and use for "study" patients whose main provider enrolled to receive the Prescribing Guide, versus "control" patients whose main provider did not enroll to receive the Prescribing Guide.ResultsIn multivariate analyses controlling for provider specialty and clustering of patients by providers, both patient groups experienced similar increases in number of prescriptions (+3.2 vs. +2.7 increase, p = 0.24), and days supply of medications (+141 vs. +129 increase, p = 0.40) averaged across all drugs. Total and out-of-pocket drug costs also increased for both control and study patients. However, control patients showed higher increases in yearly total drug costs of $208 per patient (+$792 vs. +$584 increase, p = 0.02) and in 30-day supply costs (+$9.40 vs. +$6.08 increase, p = 0.03). Both groups experienced similar changes in yearly out-of-pocket costs (+$41 vs + $31 increase, p = 0.36) and per 30-day supply (-$0.23 vs. -$0.19 decrease, p = 0.996).ConclusionGiving formulary and drug cost information to providers was associated with lower increases in total drug costs but not with lower out-of-pocket costs or greater medication use. Insurers and health information technology businesses should continue to increase providers' access to formulary and drug cost information at the point of care

Systematic review on quality control for drug management programs: Is quality reported in the literature?

<p>Abstract</p> <p>Background</p> <p>Maintaining quality of care while managing limited healthcare resources is an ongoing challenge in healthcare. The objective of this study was to evaluate how the impact of drug management programs is reported in the literature and to identify potentially existing quality standards.</p> <p>Methods</p> <p>This analysis relates to the published research on the impact of drug management on economic, clinical, or humanistic outcomes in managed care, indemnity insurance, VA, or Medicaid in the USA published between 1996 and 2007. Included articles were systematically analyzed for study objective, study endpoints, and drug management type. They were further categorized by drug management tool, primary objective, and study endpoints.</p> <p>Results</p> <p>None of the 76 included publications assessed the overall quality of drug management tools. The impact of 9 different drug management tools used alone or in combination was studied in pharmacy claims, medical claims, electronic medical records or survey data from either patient, plan or provider perspective using an average of 2.1 of 11 possible endpoints. A total of 68% of the studies reported the impact on plan focused endpoints, while the clinical, the patient or the provider perspective were studied to a much lower degree (45%, 42% and 12% of the studies). Health outcomes were only accounted for in 9.2% of the studies.</p> <p>Conclusion</p> <p>Comprehensive assessment of quality considering plan, patient and clinical outcomes is not yet applied. There is no defined quality standard. Benchmarks including health outcomes should be determined and used to improve the overall clinical and economic effectiveness of drug management programs.</p

Cost Containment Strategies for Prescription Drugs: Assessing the Evidence in the Literature

Outlines various options for addressing prescription drug spending growth, including a description of each cost containment strategy, its use by private or public payers, and a discussion of known evidence about its effectiveness or cost saving potential

Policy options: Towards making a universal prescription drug policy for Canada

A universal prescription drug coverage policy remains an unfinished business of Canadian healthcare system with over sixty year long historical roots. Since national medicare doesn’t provide prescription drugs outside of hospitals, provinces and territories have independently developed public drug insurance programs (primarily for seniors and the poorest on social assistance) under various eligibility and patient cost-sharing arrangements. The absence of universal public coverage inevitably created a large role for private financing of prescription drugs by means of a variety of costly private insurance plans and out-of-pocket payments that many Canadians cannot afford. This situation has by now driven the system to a crisis point where the phenomenon of fast-rising costs of medically necessary drugs has added further adverse effects on public health, in terms of reduced equity of access and lost socio-economic wellbeing. It costs the health system billions of dollars downstream by requiring additional visits to physicians and resulting hospitalizations as patient health conditions deteriorate due to cost-related non-adherence to prescriptions. In the past a number of attempts towards making a national pharmacare failed and the status quo with a confusing patchwork prevailed. Of late, the federal government has taken a sincere initiative to implement a universal drug coverage plan inclusive of some measure of user-charge. This study evaluates the likely impact of different types of patient charges in a public system of prescription drug coverage for Canada. Employing qualitative and quantitative methods of analysis, it examines both primary and secondary data to evaluate the three policy options considered in this study. Taking all aspects into account, reasonable policy recommendations are made to make an affordable and efficient prescription drug coverage for all Canadians with the aim of reducing cost-related non-adherence to prescriptions, providing improved access to medications and, in the end, to achieve better health outcomes

The effect of a health-system real-time prescription benefit tool on primary medication adherence: an interrupted time series study

Background: Real-time prescription benefit (RTPB) tools are intended to provide accurate outpatient medication cost information to providers at the point of prescribing. This may allow for meaningful affordability discussions between providers and patients. While becoming more widespread, there is limited evidence on the effectiveness of this functionality on clinical and economic outcomes. Objective: To evaluate the effect of an integrated RTPB module on primary medication adherence and medication costs. Methods: This single-site, uncontrolled, interrupted time series analysis utilized case-level retrospective medication order and dispensing data from a large integrated delivery network (IDN) in Texas (2018-2022). Eligible outpatient medication orders (for branded diabetes medications, respiratory maintenance inhalers, and attention deficit/hyperactivity disorder [ADHD] medications) electronically prescribed for dispensing at the health system pharmacy network were examined for sales within 30 days of the order date (primary medication adherence). Segmented generalized linear regression models were used to model the association between RTPB functionality on instantaneous and durable changes in primary medication adherence rates and secondary medication cost outcomes. Results: A total of 54,328 medication orders met all study criteria (pre-intervention, N=27,425; post-intervention, N=26,903). In the post-intervention period, 67.3% of orders triggered an RTPB alert; however, only 0.5% of these were proactively initiated by the prescriber. Overall, the RTPB module was associated with an instantaneous decrease (23.6%; 95% CI; 14.7-31.6%) in odds and a monthly decrease (3.0%; 95% CI; 2.3-3.7%) in odds of 30-day primary medication adherence. This was consistent in analyses of respiratory inhaler and ADHD subsets. There was no association between RTPB functionality and out-of-pocket costs, except for an instantaneous decrease (25.0%; 95% CI; 5.4-40.4%) in the inhaler subset. Lastly, the RTPB module was associated with an instantaneous increase (7.2%; 95% CI; 3.0-11.7%) and a monthly increase (1.2%; 95% CI; 0.8-1.6%) in total medication costs, but medication subset analyses were conflicting. Conclusion: While evidence of a benefit from RTPB functionality was mixed, there was evidence of time-varying confounding that was not accounted for due to lack of a control group. Notably, while response rates of the RTPB module were high, there is minimal use of the more proactive component of the tool.Pharmaceutical Science

Prescription Trends in Branded Versus Generic Glatiramer Acetate Utilization Among Insurers for the Treatment of Multiple Sclerosis in the United States

Purpose: Multiple Sclerosis (MS) is a chronic condition managed by disease modifying pharmaceutical therapies (DMTs). Health care cost is increasing due to high prescription drug spending. The high cost of branded DMTs highlights the potential value of lower cost generic therapies. Using generic DMTs could reduce the spending in the prescription drug sector. Recently, generic glatiramer acetate (GA) that treats relapsing remitting multiple sclerosis has become available. Appropriate insurer policies and practices are imperative to promote the use and utilization of generics like GA. Notably, no study has specifically evaluated the differences in utilization uptake of branded vs generic GA among the major insurer categories. The purpose of this study is to establish whether insurer type affects the rate of utilization uptake of branded vs generic GA. Methods: Prescription claims data for branded or generic glatiramer acetate for Commercially insured patients, Medicare beneficiaries with supplemental insurance, and Medicaid patients were extracted from Symphony Health Integrated Dataverse® data set from Oct 2014 – Jan 2019. Patient claim cohorts were identified through branded Copaxone® 20 mg or 40 mg, generic Glatopa® 20 mg or 40 mg, and generic Mylan Glatiramer Acetate 20 mg or 40 mg national drug codes. Data was limited to 52 months of claims data inclusive of FDA post-approval of generic glatiramer acetate options. Projected glatiramer acetate utilization rates were estimated using exponential regression modeling. Patient out of pocket costs were captured as pharmacy transactional level insights from the patient’s primary plan pay setting of the initial co-pay amount and additional plan pay from third-party utilization of copay cards subsidizing the prescription. Results: From October 2014 to January 2019, 111,906 patients with multiple sclerosis were prescribed glatiramer acetate by Neurologists (80%) and had 1,624,159 approved dispensed claims primarily through specialty mail (87%) and categorized by payment type as 63.2% Commercial, 25.4% Medicare, and 11.8% Medicaid. The market trend showed a consistent decline in branded glatiramer acetate claims offset by a rapid uptake in generic glatiramer acetate with its initial market entry but remained relatively flat until launch of an additional generic market entrant. Generic market share has continued to grow reaching an approximate 30% share of claims. Over the 52 months brand glatiramer acetate utilization has declined more than half at 56%, while generic claim volume has grown 155% over the past 16 months. Among the payer types, Medicare has observed the greatest brand decline at 70% and the second highest generic utilization uptake at a 28% share. Commercial insurers have the greatest category claim volume and greatest generic growth to a 26% share, while the brand has declined by 44%. Medicaid has had the lowest utilization volume and the greatest ratio of generic utilization among insurers at 45%. Patient out of pocket costs are highest with branded use across all insurer types, while Medicaid has the lowest patient out-of-pocket costs. Across all payment types, generics offer approximately a 20% discount to the brand in patient out of pocket costs. Conclusion: The study revealed that generic glatiramer acetate adoption or utilization has been slow among insurers but increasing over the past sixteen months with additional generic GA entrants and increased price competition. The greatest trend in generic utilization is occurring within the Commercial channel followed by Medicare and Medicaid, which has had the lowest growth trend. The results indicate that barriers to generic glatiramer acetate may vary by insurer and influenced by prescriber or patient choice. Generic uptake is projected to increase across all insurer types reflective of trends during 2019 open enrollment and healthcare benefit design change associated with a new health insurance cycle. Lower patient out-of-pocket costs and generic preferred formulary positioning will influence utilization rates, especially in beneficiaries or enrollees with the greatest financial cost shift risk

Influence Of Medicare Formulary Restrictions On Evidence-Based Prescribing Practices

Controlling the cost of prescription drugs is integral to improving health outcomes, and patient access and adherence to treatment. While prescription drugs can often provide essential therapeutic benefit, previous studies have suggested that inappropriate prescription drug use is a principal cause of adverse drug events as well as abuse and diversion of drugs. Thus, balancing the benefits and harms to promote appropriate prescription drug use is an essential component of healthcare delivery in the United States. There are multiple ways appropriate prescription drug use is promoted. Black-box warnings and drug labeling controlled by the FDA as well as guidelines released by the CDC, such as the 2013 guidelines released during the opioid epidemic, aim to promote appropriate prescription at a population level. At a patient-level, drug formularies have multiple strategies in place to promote safe and cost-effective prescribing of individual medications. The Center for Medicare & Medicaid Services (CMS) makes use of prescription drug formularies that are used for the coverage of around 17% of the US population. These formularies have uniformly adopted utilization management strategies, such as quantity limits, prior authorization, and step therapy, in order to promote safe, evidence-based and cost-effective prescribing. These strategies are in place to impact drug prescription rates as well as to incentivize use of biological or therapeutically interchangeable generics over brand-name drugs. Thus far, the implementation of utilization management strategies for commonly prescribed drugs has not been thoroughly studied. This study presents three main analyses conducted and published in the peer reviewed literature during my time in medical school. The first characterized the change in opioid prescription versus non-opioid analgesics in both the outpatient and emergency room setting in the context of the 2013 CDC guidelines encouraging prescription on non-opioid analgesic alternatives. We found that overall rates of pain medication prescribing were high and that opioid pain medication prescription increased in the outpatient setting only, whereas non-opioid pain medication prescribing increased in both the outpatient and ED settings, an area that has not been previously reported or well-investigated. The second study characterized how Medicare formulary restrictions were applied to opioid “potentiators”, which are commonly used in conjunction with opioids and increase patients’ risk of adverse events. We found that from 2013-2017, Medicare prescription drug plan formularies had relatively unchanged rates of benzodiazepine, non-benzodiazepine sedative-hypnotic, and gabapentinoid coverage with small increases in use of quantity limits, and that more than a quarter of formularies provided unrestrictive coverage of these potentially unsafe opioid potentiators in 2017. The third and final study herein presents a more global analysis of whether Medicare used formulary restrictions to promote prescription of therapeutically interchangeable generics over the top 100-grossing brand-name drugs in light of the 2020 CMS plans for an indication-based formulary design. We showed that a substantial portion of CMS formularies provided similarly restrictive coverage of brand-name drugs and their therapeutically interchangeable generics, including the same tier placement or utilization management, thereby missing opportunities to incentivize prescribing of less costly generics. Overall, the results of this comprehensive study on safe and cost-effective drug prescription showed that while current formulary design includes opportunities to reduce costly and potentially unsafe prescribing, the impact of these tools is sub-optimal. These results highlight the need for both physician and patient education on the utility of the formulary restriction strategies. On a larger scale, it suggests that these strategies alone may not be sufficient to reduce over-prescription of potentially unsafe drugs like opioid potentiators, or to incentivize prescription of cost-saving generics over brand-name drugs. The Center for Medicare & Medicaid Services (CMS) has proposed an indication-based formulary design starting in 2020, allowing Medicare Advantage and Part D prescription drug plans to cover drugs only for select indications, which could increase formulary negotiating power and secure more competitive pricing. This might be the change needed in order to ensure continued patient access to affordable and safe prescription drugs