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3a. Access: Initiatives to Improve Equity in Medicines Access
Social Disparities in the Use of Prescription Medications: A Population-Based Approach
1University of Chicago, United States of America; 2Brown University, United States of America
Problem statement: Social disparities in the use of prescription medication may be an important, yet overlooked, contributor to persistent social disparities in health. The majority of existing data sources for which prescription medication use measures are derived, however, are not population-based and therefore disproportionately exclude data on the most socially disadvantaged populations (including racial/ethnic minorities) that may experience limited access to prescription medications. Thus, information on social disparities in the use of prescription medications is incomplete. This information is particularly important for the development of pharmaceutical policies intended to improve access to prescribed medications in these populations.
Objectives: This study will use population-based medication data to describe patterns in the use of prescription medications by socioeconomic status and race/ethnicity and to identify social and health care factors associated with racial/ethnic disparities in the use of prescription medications.
Design, setting, and study population: In-home interviews were administered between June 2005 and March 2006 to 3005 community-residing individuals, aged 57–85 years, drawn from a cross-sectional, population-based sample of the United States. Prescription medication use was defined as the use of at least 1 prescription medication. Multistage, multivariable logistic regression models were developed to examine the social and health care factors associated with racial/ethnic disparities in the use of prescription medications.
Outcome measures: Prevalence of prescription medication use by socioeconomic status and race/ethnicity
Results: Individuals living in poverty were 60% less likely to use prescription medications in comparison to their non-poor counterparts (OR 0.40 [CI 0.24, 0.68]). After adjusting for differences in age and health status, Black and Hispanic minorities were 40% and 45% less likely, respectively, to use prescription medications in comparison to their Caucasian counterparts. Racial/ethnic differences in the use of prescription medications are reduced after the introduction of factors representing poverty and access to primary care. In contrast to previous studies, insurance status and educational attainment did not explain racial/ethnic disparities in the use of prescription medications.
Conclusions: This study provides population-based evidence of social disparities in the use of prescription medications among older adults in the United States. These findings suggest that policy efforts to improve access to prescription medications in minority communities need to address factors beyond insurance-centered affordability, including barriers associated with poverty (e.g., geographic access to pharmacies) and access to primary health care. In addition, social disparities in access to prescription medications should be incorporated into models examining social determinants of health in the US and globally.
Funding source: Information not provided
Differences in the Availability of Medicines Used for Noncommunicable and Communicable Conditions in the Public and Private Sectors of Developing Countries
1Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland; 2Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; 3Health Action International - Global, Amsterdam, the Netherlands
Problem statement: Studies have found that low availability, high prices, and poor affordability are impediments to access to medicines in low- and middle-income countries.
Objective: To investigate whether, in these countries, differences exist in the availability of medicines used for noncommunicable diseases (NCDs) compared to those used for communicable conditions
Design: A secondary analysis of medicine availability in 40 developing countries was conducted using data from surveys of public and private sector medicine outlets collected with a standard methodology. Availability was compared for 30 commonly surveyed medicines: 15 used for communicable conditions and 15 used for NCDs. The primary outcome measure was the difference in mean availability between the two baskets of medicines (communicable and noncommunicable). In addition, to investigate whether the availability of NCD medicines differed by indication, the mean availability of each therapeutic class represented in the NCD medicines basket was compared to the mean availability of the 15 medicines in the communicable basket. The ratio of the availability of the communicable medicines basket to the noncommunicable medicines basket was also calculated on a country-by-country basis and analysed by World Bank Income Group and WHO Region.
Setting: Cameroon, Chad, China, Colombia, Congo, El Salvador, Ethiopia, Fiji, Ghana, India, Indonesia, Iran, Jordan, Kazakhstan, Keya, Kuwait, Kyrgyzstan, Lebanon, Malaysia, Mali, Mongolia, Morocco, Nigeria, Oman, Pakistan, Peru, Philippines, São Tomé and Principe, South Africa, Sudan, Syria, Tajikistan, Tanzania, Thailand, Tunisia, Uganda, Ukraine, United Arab Emirates, Uzbekistan, Yemen.
Results: Across the countries studied, generic medicines used for NCDs have significantly lower availability than those used for communicable conditions in both the public sector (36.0% versus 53.5%, p=0.001) and private sector (54.7% versus 66.2%, p=0.007). In the public sector, the lower the country’s income level, the larger the gap in availability between the two treatment types. In lower-middle and low-income countries medicines for communicable conditions are >4 times more available than NCD medicines. In African countries, medicines for communicable conditions are nearly 9 times more available. A similar trend is not observed in the private sector, where results are constant across income groups and regions. In both public and private sectors, antiasthmatics, antiepileptics, and antidepressants had similar low availability (28–30% and 40–45% in the public and private sectors, respectively) and showed the largest difference in availability with the basket of communicable medicines.
Conclusions: Given that NCDs account for 40% of mortality in low-income countries and 25% of mortality in Africa, the observed gaps in public sector availability of medicines for these conditions cannot be justified by current disease patterns. Governments should give greater priority to the supply of medicines for NCDs through the public health system to ensure that those needing treatment are not unduly disadvantaged. International agencies, governments and other stakeholders should also work together to raise the profile of NCDs on health and development agendas.
Funding source(s): None.
Jumping into the Pool: Is It the Shallow or the Deep End?
1Duke University, United States of America; 2Drugs for Neglected Diseases Initiative, Switzerland
Problem Statement: Pooling can lower the transaction costs of accessing building blocks of knowledge, thereby facilitating and accelerating R&D for new health products. But for neglected diseases, benefits from such pooling may be restricted by tiering policies that place limits on such access for specific market segments defined by disease or geography.
Objectives: This study examines how the design of such pooling arrangements affects access to those in need, from bench to bedside. Specifically, what are the implications of tiering criteria on access to a pool’s resources?
Design: The study contrasts the approaches taken to design various pooling arrangements, from compound libraries and preclinical data upstream in the R&D pipeline to journal articles, clinical trial data, and patented drugs further downstream.
Setting: Pooling arrangements initiated in industrialized countries have significant implications on access in low- and middle-income countries.
Study Population: Examples of pooling arrangements were selected to illustrate the range of upstream and downstream R&D inputs that might be assembled to accelerate innovation for neglected diseases.
Intervention or Policy Change: Using publicly available data on pool criteria and components, the burden of selected neglected diseases, and intellectual property arrangements, the analysis examines the implications of pool tiering design on access.
Outcome Measures: Disability adjusted life-years (DALYs) and deaths for selected neglected diseases
Results: Various pools apply different eligibility criteria for accessing the R&D inputs assembled. For example, the Pool for Open Innovation for Neglected Tropical Diseases sets initial licensing to 16 diseases and to least developed countries (LDCs). By contrast, the Medicines Patent Pool strives to include both low- and middle-income countries. Looking at three neglected diseases, tiering limited to countries classified as least developed countries has significant coverage implications. By deaths and DALYs, nearly three-quarters of the burden of disease from trypanosomiasis falls in LDCs. For leishmaniasis, the reverse is true, and 80 percent or more of the DALYs or deaths occur in non-LDCs. For Chagas disease, the burden of disease almost exclusively falls outside of LDCs. Considered another way, those living under $2 a day in India exceed the entire populations of the 49 least developed countries combined.
Conclusions: Such tiering in pools has different implications for upstream or downstream R&D inputs. Upstream, noncommercial research fueled with public sector investment might go forward regardless of such tiering, but where private sector investment for scale-up is needed, the market of middle-income countries matters, and so does tiered access to these R&D inputs. Downstream, large segments of populations in need of the product may go without access. This calls for a more ambitious framework for neglected diseases R&D that ensures both innovation and access.
Funding Source: Drugs for Neglected Diseases Initiatives, the Open Society Institute, and the National Human Genome Research Institute
Assessing Global Health Financing and Policy: Potential Contribution of Pooled Funds
HLSP Institute, United Kingdom
Problem statement: There is growing interest in methods to accelerate the development of technologies for neglected diseases. Public and private groups have come together to conduct research and development (R&D) in these areas. However, some argue that funding flows inefficiently resulting in insufficient resources, funding volatility, poor resource allocation, and duplicated efforts. Also some believe that the current architecture could be reconfigured to better meet the needs of new donors who might prefer to fund a diversified “package” of product R&D efforts. In response, several pooled funding mechanisms have been proposed to address what proponents see as the key problem(s) in the current system: the Industry R&D Facilitation Fund (IRFF) originally proposed by the George Institute, the Fund for Research in Neglected Diseases (FRIND) proposed by Novartis, and the Product Development Partnership Financing Facility (PDP-FF) proposed by the International AIDS Vaccine Initiative (IAVI).
Objectives: We explored how these proposals would be expected to perform against two principal objectives—their capacity to raise additional money for neglected disease R&D and their capacity to improve the efficient allocation of the funding.
Design: We identified 7 avenues through which the proposals might be expected to deliver under the two principal objectives; these avenues became our criteria for assessing the proposals. For each criteria, we discuss the evidence for the extent of the problem, identify alternative options for resolving problems, and evaluate whether the proposal would be a superior method to resolve the problem, relative to the alternatives identified.
Results: (1) New Resource Generation? PDP-FF offers government donors a wider choice of funding modalities and could theoretically attract new government donors who are interested in innovative financing options. FRIND and IRFF would not be restricted to government donors and would theoretically have the best potential for attracting new donors. Interviews with donors who already support neglected disease R&D revealed limited interest in pooled funding participation; most of these donors’want to maintain a direct line of sight and control over their funds. Others were hesitant because of current financial pressures and/or lack of certainty over which problems are the most critical to solve. (2) Improved Resource Allocation? The PDP-FF model could provide more predictable funding to PDPs, although this would not necessarily result in a more predictable disbursement process or improve resource allocation decision-making. The PDP-FF would frontload R&D resources and may allow donors to recoup their investments, FRIND would be useful if one believes that milestone-based payments increase the overall performance of neglected disease research, there is potential for more research groups to participate in neglected disease outside of PDPs, and current resource allocation process across PDPs is suboptimal. FRIND’s overall complexity is reduced and effective portfolio management becomes more feasible if the fund focuses on late stage candidates only. There is also a theoretical fit between risk averse donors and a Phase III focused fund. IRFF could improve funding if current system problems relate to predictability of funding for PDPs and if the current portfolio management process pursued by PDPs is already sound. IRFF could allocate resources to PDPs in a predictable manner and with low transaction costs, keeping the PDP and funder interests aligned through partial reimbursement of expenditures.
Conclusions: Each proposal is designed to address a particular perceived problem(s) in the current system. This begs the question: which problems, if solved, would give us the highest leverage to accelerate R&D for neglected diseases? Through our interviews with over 50 experts, we found little consensus on the nature of the core problems or the relative importance of the problems.
Funding source: Bill & Melinda Gates Foundation through the Center for Global Health R&D Policy Assessment at the Results for Development Institute