Prior Authorization Policies and Preferred Drug Lists in Medicaid Plans: Stakeholder Perspectives on the Implications for Youth with ADHD.

This qualitative study describes how Medicaid policies create challenges for the delivery and receipt of mental health treatment for low-income youth in Georgia. We conducted focus groups with caregivers of Medicaid-enrolled children with ADHD and semi-structured interviews with providers and administrators at four safety net clinics that provided mental health care to these youth. Stakeholders reported that prior authorization policies for psychosocial services, restrictiveness of preferred drug lists, and changes in preferred drug lists in Medicaid plans created barriers to treatment continuity and quality for youth with ADHD and led to more administrative burden for safety-net clinics serving these youth.

Managing costs and care for chronic idiopathic constipation.

For decades, chronic idiopathic constipation (CIC) has been one of the most common chronic functional gastrointestinal disorders encountered by clinicians. Common comorbidities include depression, diabetes, functional dyspepsia, hypothyroidism, overweight, obesity, and neurological disorders. CIC imposes a large economic burden on the American healthcare system with estimated costs of $1912 to $7522 in 2007 US dollars per patient per year. Individuals affected by CIC indicate significant rates of absenteeism and presenteeism at work. Those with constipation have poorer general health, mental health, and social functioning compared with healthy controls. The average patient with CIC tries approximately 4 over-the-counter (OTC) and 2 prescription medications before finding an effective treatment. Guideline-directed treatment generally recommends moving from lifestyle modifications to OTC products and prescription laxatives. Most patients report that the relief they receive is unacceptable. Reliable evidence indicates that newer prescription drugs offer greater relief of symptoms than those of traditional approaches. Appropriate formulary management of CIC offers opportunities to impact patient care in 3 major areas: clinical, economic, and humanistic outcomes. Plans will need to be flexible, especially because patient dissatisfaction with treatment is prevalent in CIC.

Association between FDA black box warnings and Medicare formulary coverage changes.

OBJECTIVES: To assess whether Medicare formularies restrict access to drugs receiving new FDA black box warnings for which safer drug alternatives are available. STUDY DESIGN: A retrospective analysis using Medicare Prescription Drug Plan Formulary files to determine formulary changes for drugs receiving FDA black box warnings between 2007 and 2013. METHODS: We identified all FDA-approved medications available in tablet or capsule formulation that received a black box warning between 2007 and 2013 related to death and/or cardiovascular risk. We then determined formulary coverage of these drugs pre-black box warning, 1 year after, and 2 years after. For each formulary, we identified formulary restrictiveness, defined as: unrestrictive coverage (no prior authorization or step therapy), restrictive coverage (prior authorization or step therapy required), or no coverage. RESULTS: Nine drugs with at least 1 FDA-approved safer drug alternative received 10 new black box warnings for death and/or cardiovascular risk between 2007 and 2013. In response to FDA black box warnings, overall formulary restrictiveness increased for 40% (n = 4) of drugs at 1 year, and for 50% (n = 5) at 2 years. However, for the majority of drugs (n = 7), most formularies remained unrestrictive 2 years after a new black box warning. CONCLUSIONS: Medicare formularies became more restrictive for half of the drugs that recently received new FDA black box warnings for death and/or cardiovascular risk and for which safer drug alternatives are available. However, a substantial proportion of formularies remained unrestrictive, suggesting inconsistent responses to new safety information to curtail the use of these medications.

Computational health economics for identification of unprofitable health care enrollees.

Health insurers may attempt to design their health plans to attract profitable enrollees while deterring unprofitable ones. Such insurers would not be delivering socially efficient levels of care by providing health plans that maximize societal benefit, but rather intentionally distorting plan benefits to avoid high-cost enrollees, potentially to the detriment of health and efficiency. In this work, we focus on a specific component of health plan design at risk for health insurer distortion in the Health Insurance Marketplaces: the prescription drug formulary. We introduce an ensembled machine learning function to determine whether drug utilization variables are predictive of a new measure of enrollee unprofitability we derive, and thus vulnerable to distortions by insurers. Our implementation also contains a unique application-specific variable selection tool. This study demonstrates that super learning is effective in extracting the relevant signal for this prediction problem, and that a small number of drug variables can be used to identify unprofitable enrollees. The results are both encouraging and concerning. While risk adjustment appears to have been reasonably successful at weakening the relationship between therapeutic-class-specific drug utilization and unprofitability, some classes remain predictive of insurer losses. The vulnerable enrollees whose prescription drug regimens include drugs in these classes may need special protection from regulators in health insurance market design.

Validating pharmaceutical product claims: questions a formulary committee should ask.

Claims, justifying the acceptance and placement of new products on health system formularies, are all too often presented in terms that are either unverifiable or only verifiable in a timeframe that is of no practical benefit to formulary committees. One solution is for formulary committees to request that (i) all predictive claims made should be capable of empirical testing and (ii) manufacturers in making submissions should be asked to submit a protocol that details how their claims are to be assessed. Evaluation of claims can provide not only a significant input to ongoing disease area and therapeutic reviews, but can also provide a needed link to comparative effectiveness research and value-based healthcare. This paper presents a set of protocol standards (PROST) together will questions that should be addressed in a protocol review.

Antenatal corticosteroids for management of preterm birth: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth complications are the leading cause of deaths for children under five years. Antenatal corticosteroids (ACS) are effective at reducing mortality and serious morbidity amongst infants born at <34 weeks gestation. WHO guidelines strongly recommend use of ACS for women at risk of imminent preterm birth where gestational age, imminent preterm birth, and risk of maternal infection can be assessed, and appropriate maternal/newborn care provided. However, coverage remains low in high-burden countries for reasons not previously systematically investigated. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for ACS. RESULTS: Eleven out of twelve countries provided data in response to the ACS questionnaire. Health system building blocks most frequently reported as having significant or very major bottlenecks were health information systems (11 countries), essential medical products and technologies (9 out of 11 countries) and health service delivery (9 out of 11 countries). Bottlenecks included absence of coverage data, poor gestational age metrics, lack of national essential medicines listing, discrepancies between prescribing authority and provider cadres managing care, delays due to referral, and lack of supervision, mentoring and quality improvement systems. CONCLUSIONS: Analysis centred on health system building blocks in which 9 or more countries (>75%) reported very major or significant bottlenecks. Health information systems should include improved gestational age assessment and track ACS coverage, use and outcomes. Better health service delivery requires clarified policy assigning roles by level of care and cadre of provider, dependent on capability to assess gestational age and risk of preterm birth, and the implementation of guidelines with adequate supervision, mentoring and quality improvement systems, including audit and feedback. National essential medicines lists should include dexamethasone for antenatal use, and dexamethasone should be integrated into supply logistics.

Planning a pharmacy-led medical mission trip, part 1: focus on medication acquisition.

Pharmacists can be involved in many functions of the medical mission team. Particularly, they can play a large role in formulary development, acquisition of medications, and organization of medications before and during the mission trip. Important factors for consideration in formulary development and logistical planning include the group's budget; importation laws and regulations of the country being visited; transportation and storage of medications and supplies; disease states anticipated; whether controlled substances will be included; whether medical or surgical procedures will be provided; age distribution and languages of the population to be treated; whether sample medications will be used; handling of unused medications and supplies after the trip; and considerations of the population's cultural beliefs. Various organizations are available to provide medications for medical mission efforts at little to no cost, and knowledge of these organizations will help to facilitate the process of medication acquisition. Additionally, pharmacists can provide insight regarding the logistical set-up and workflow considerations during the mission experience.

An application of a proposed framework for formulary listing in low-income countries: the case of Côte d'Ivoire.

BACKGROUND: The General Mutual Benefit Fund for Civil Servants and State Employees of Côte d'Ivoire (MUGEFCI; Mutuelle Générale des Fonctionnaires et Agents de l'État de Côte d'Ivoire) is a health mutual fund providing coverage (medical consultations, laboratory tests and treatment) for its enrolees (government officials and agents). This organization aims to improve its current drug reimbursement process because of budgetary constraints. One method of achieving this is to implement a formulary-listing framework specifically developed for low-income countries. OBJECTIVE: The aim of this study was to evaluate the feasibility of developing a new formulary for the MUGEFCI in Côte d'Ivoire, by implementing a formulary-listing framework specifically designed for under-researched settings. METHODS: The application of this formulary-listing framework (based on multi-criteria decision analysis [MCDA]) consisted of four steps. First, relevant formulary-listing criteria and their levels of variation were identified and weighted according to their importance in the decision making around drug reimbursement. Second, a set of priority treatments to be assessed was determined. Once the treatments eligible for reimbursement were determined, scores were assigned to these treatments according to their performance on the formulary-listing criteria levels. Finally, a composite league table (weighted matrix) was constructed to rank the set of treatments by priority order of reimbursement. A budget-impact analysis (BIA) was also conducted to appraise the economic implications of the new composite drugs league table. The extent to which the new priority list of reimbursable drugs was affordable for the MUGEFCI was then measured. RESULTS: Policy makers in Côte d'Ivoire considered severity of disease and cost effectiveness of treatment to be the most significant criteria for priority reimbursement of drugs. This translated into a general preference for antimalarials, treatments for asthma and antibacterials for urinary tract infection. Moreover, the results of the BIA suggest that the new priority list of reimbursable drugs would be affordable if the real economic impact of drugs per member is less than $US66. Over this threshold, the MUGEFCI would have to select reimbursable drugs according to their rank in the priority list and their respective budget impact per patient (cost per patient). This selection would start from the first treatment, going down the list until the $US66 per patient is exhausted. CONCLUSION: It was possible to use MCDA to simultaneously consider different decision criteria for drug reimbursement in Côte d'Ivoire; therefore, it is feasible to use MCDA to establish a formulary for low-income countries. The application of this method is a step towards transparency in policy making.

Pharmaceutical supply chain in China: current issues and implications for health system reform.

OBJECTIVE: This article discusses the performance and distortions of pharmaceutical market in China and provides some reflections and policy implications for currently implemented reform. METHODS: This study is based on literature review and publicly available data by searching electronic databases and official web pages of the Chinese government on the internet. RESULTS: China's economic transition and the incremental and piecemeal nature of health care reform have created a pharmaceutical market with a number of deficiencies, including ineffective supervision, mark-up price pattern, distortion of the price schedule, and lack of authoritative drug formulary. CONCLUSIONS: We conclude that the root cause of the market and government failures is that higher-than-cost drugs preferred by all suppliers. New drug pricing mechanism is the key to the current pharmaceutical reform and should be implemented in coordination with other health system reforms.

Family physician attitudes about prescribing using a drug formulary.

BACKGROUND: Drug formularies have been created by third party payers to control prescription drug usage and manage costs. Physicians try to provide the best care for their patients. This research examines family physicians' attitudes regarding prescription reimbursement criteria, prescribing and advocacy for patients experiencing reimbursement barriers. METHODS: Focus groups were used to collect qualitative data on family physicians' prescribing decisions related to drug reimbursement guidelines. Forty-eight family physicians from four Ontario cities participated. Ethics approval for this study was received from the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board at McMaster University. Four clinical scenarios were used to situate and initiate focus group discussions about prescribing decisions. Open-ended questions were used to probe physicians' experiences and attitudes and responses were audio recorded. NVivo software was used to assist in data analysis. RESULTS: Most physicians reported that drug reimbursement guidelines complicated their prescribing process and can require lengthy interpretation and advocacy for patients who require medication that is subject to reimbursement restrictions. CONCLUSION: Physicians do not generally see their role as being cost-containment monitors and observed that cumbersome reimbursement guidelines influence medication choice beyond the clinical needs of the patient, and produce unequal access to medication. They observed that frustration, discouragement, fatigue, and lack of appreciation can often contribute to family physicians' failure to advocate more for patients. Physicians argue cumbersome reimbursement regulations contribute to lower quality care and misuse of physicians' time increasing overall health care costs by adding unnecessary visits to family physicians, specialists, and emergency rooms.

Drug quality in South Africa: perceptions of key players involved in medicines distribution.

PURPOSE: Substandard medicines contribute to poor public health and affect development, especially in the developing world. However knowledge of how manufacturers, distributors and providers understand the concept of drug quality and what strategies they adopt to ensure drug quality is limited, particularly in the developing world. The purpose of this paper is to explore pharmaceutical manufacturers', distributors' and providers' perceptions of drug quality in South Africa and how they ensure the quality of drugs during the distribution process. DESIGN/METHODOLOGY/APPROACH: The approach taken was qualitative data collection through key informant interviews using a semi-structured interview guide. Transcripts were analysed thematically in Johannesburg, Pretoria and Durban, South Africa. Participants were recruited purposefully from a South African pharmaceutical manufacturer, SA subsidiaries of international manufacturers, national distribution companies, national wholesaler, public and private sector pharmacists, and a dispensing doctor. In total, ten interviews were conducted. FINDINGS: Participants described drug quality in terms of the product and the processes involved in manufacturing and handling the product. Participants identified purchasing registered medicines from licensed suppliers, use of standard operating procedures, and audits between manufacturer and distributor and/or provider as key strategies employed to protect medicine quality. Effective communication amongst all stakeholders, especially in terms of providing feedback regarding complaints about medicine quality, appears as a potential area of concern, which would benefit from further research. ORIGINALITY/VALUE: The paper hightlights that ensuring medicine quality should be a shared responsibility amongst all involved in the distribution process to prevent medicines moving from one distribution system (public) into another (private).