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Conference Agenda

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Session Overview
Session
3f. Malaria: Prices and Affordability of ACT in the Private Sector
Time: Wednesday, 16/Nov/2011: 10:15am - 11:15am
Session Moderator: Hoda Atta, WHO/EMRO, Egypt
Session Moderator: Catherine E. Vialle-Valentin, Harvard Medical School, United States of America
Session Rapporteur: Charles C Ezenduka, Health Policy Research Group, Nigeria
Location: Lal 1-2

Presentations

Cost Analysis of Management of Malaria Using ACT in the Private Sector of Zimbabwe: A Regulatory Implication

Travor Mabugu1, Tendai Matsatsa2

1University of Zimbabwe, Zimbabwe; 2Kenlink Pharmacy, Harare, Zimbabwe

Problem statement: The development of antimalarial drug resistance has led to increasing calls for the introduction of artemisinin-based combination therapy (ACT). Zimbabwe adopted ACTs as first-line management of malaria with 62% of malaria patients traditionally being managed in the private sector; however, of importance was the issue of accessibility. The previous first-line therapy of chloroquine plus sulfadoxine and pyrimethamine (CQ-SP)was easily accessible with limited financial barriers. ACTs are expensive and have an additional condition to access them. Medicines Control Authority of Zimbabwe (MCAZ) regulation can affect access by changing the category of these regimens from prescription preparation (PP) to household remedy (HR). It is expected that any category chosen by MCAZ has implications for out-of-pocket expenditure per malaria case managed from a patient’s perspective. This study aimed at elucidating the variation in costs of management of malaria using ACTs from patient’s perspective. Specifically, patient costs associated with different categories from PP, pharmacist initiated medicine (PIM), pharmacy (P), and HR.

Objectives: To determine the costs associated with management of a single adult case of uncomplicated malaria using ACTs with ACTs assuming different categories in Zimbabwe (HR, P, PIM, and PP) from a patient’s perspective; to determine the costs associated with management of a single adult case of uncomplicated malaria using CQ-SP in Zimbabwe, from a patient’s perspective; and to compare these costs and make appropriate recommendations from an economic perspective

Design: An activity-based costing (ABC) approach was instituted in this study. The three major activities involved included consultation, diagnosis, and drug treatment, which are major indicators of the out-of-pocket expenditure from the patient perspective. Three possible scenarios for consultation could be assumed depending on the category of the ACT: (1) no consultation required (if a drug is categorized as HR or P), (2) pharmacists’ consultation if it is a PIM, and (3) doctor’s consultation if it is a PP. Diagnosis has two major routes—either optic microscopy or through rapid diagnostic tests based on lateral flow immuno-chromatography (commonly known as RDTs). Drug treatment could only be equivalent to the drug price of either ACT or CQ-SP. We developed case scenarios for malarial patients in need of malaria health services using various possible routes. These possible routes were valued using market rates in the private sector. All costs were reported in 2010 base year.

Setting: Private patient case scenarios were developed to depict the stages of malaria service provision is this sector.

Study population: All patients with susceptible malaria episodes who access their services in the private sector (estimated to be 62% of all malaria cases in Zimbabwe)

Intervention(s): The intervention of interest was an adult case of malaria managed in the private health sector of Zimbabwe.

Policies: Introduction of ACTs, followed by regulatory framework, which required mandatory confirmation by malaria test before commencement of treatment. Furthermore, a requirement of categorization of ACTs was also pending.

Outcome measure(s): The extent of variation in financial barriers to access of malarial service in the private health sector of Zimbabwe as approximated by out-of-pocket expenditure on consultation, diagnosis, and drug treatment.

Results: The study determined that the decision of how to categorize ACTs has huge implications for access of malarial services in the private health sector of Zimbabwe. Initially, there was no consultation required with the use of CQ-SP in malaria management. Because these medicines were HR category, they could be accessed in supermarkets. Their cost per adult course was only 2.67 U.S. dollars (USD) (range 2–4USD). If categorized as HR or P, however, ACTs will lead to a total cost per case managed of 15.98 USD (range 12–17USD). If categorized as PIM, an initial consultation will average 1USD (range 0–3USD) plus the diagnosis using RDT of approximately 5USD (range 4–6USD) with additional drug cost averaging 13.48USD. It was also determined that the cost of management of malaria if ACT are categorized as PP will increase to (1) consultation fee of 20USD (range 15–30USD), (2) diagnosis costs of 5USD for RDTs or 12.22USD for laboratory (optic microscopy), and (3) 13.48USD for drug treatment.

Conclusions: It is evident from the results that making the ACTs a PP will yield a total out-of-pocket expenditure of approximately 56USD, which is about 4 times greater than a case with ACT categorized as a HR. This results in enormous financial barriers to access. It is therefore paramount for the regulator (MCAZ) to consider these cost implications if universal access to malaria treatment and care is to be realized. These results, however, need to be weighed in line with other factors such as drug resistance associated with unlimited access, misuse of limited resources associated with uncontrolled access and unconfirmed cases, and training of the public on use of RDTs.

Funding source(s): Health Economics, Research and Information Trust

189-Mabugu-_b.ppt
189-Mabugu-_c.pdf

Cost-Effectiveness of Treating Malaria Following Three Methods of Diagnosis: Implications for Scaling-Up Use of Rapid Diagnostic Tests in Uganda

Vincent Batwala1, Pascal Magnussen2, Fred Nuwaha3

1Mbarara University of Science & Technology, P. O. Box 1410, Mbarara, Uganda; 2Centre for Health Research and Development, Faculty of Life Sciences, Copenhagen University, Thorvaldsensvej 57, DK1871 Frederiksberg C, Denmark; 3Disease Control and Environmental Health, Makerere University School of Public Health, P. O. Box 7072, Kampala, Uganda

Problem statement: The use of high-cost artemisinin-based combination therapy (ACT) as first-line treatment for uncomplicated malaria stimulated the interest in reassessing the diagnostic practices in sub-Saharan Africa. Clinical (presumptive) diagnosis of malaria as it is now performed in remote settings leads to considerable drug expenditure on inappropriate treatment of patients free of parasitaemia.

Objectives: To compare the cost-effectiveness of treating malaria with artemether-lumefantrine based on microscopy, rapid diagnostic test (RDT), and presumptive diagnosis in different transmission settings.

Design: A cost-effectiveness trial with two intervention arms and one control arm.

Setting: Three public primary health care centers (HCs) located in a district of low transmission intensity in western Uganda and three in a high transmission setting in the eastern part of the country were involved.

Study population: Some 22,052 consenting outpatients weighing ≥5kg, with suspected uncomplicated malaria were consecutively enrolled from March 2010 to February 2011. Of these, a random sample of 1,627 was selected to measure additional socioeconomic characteristics.

Intervention: Three HCs were randomized to three diagnostic arms (microscopy, RDT and presumptive diagnosis) in each study district. In intervention arms (microscopy and RDT), finger-prick blood was examined before receiving treatment. Patients were treated basing on test results and clinician judgement. Socio-demographics, symptoms, and cost data were directly collected from patients and service providers. Costing was performed following both the standard step-down cost allocation method and the ingredients approach. Essential features of policy change that were evaluated included cost-effectiveness of the diagnostic strategies to appropriately target antimalarial drugs in peripheral government HCs and to improve the management of non-malarial febrile illness.

Outcome measures: Proportion of outpatients correctly diagnosed and treated; average cost-effectiveness ratios (ACERs) and incremental cost-effectiveness ratios (ICERs).

Results: RDT was more effective (87.7%) than microscopy (79.7%) and presumptive diagnosis (64.3%). The superior effectiveness of RDT was maintained when data was stratified by transmission intensity. Overall RDT was cost-effective with lowest ACER 5.95 US dollars (USD)and ICER USD5.0 compared to microscopy ACER 6.94 and ICER USD 9.61 per case correctly diagnosed and treated. The difference in ICERs between RDT and microscopy was greater in the high transmission area (USD 8.90) than in low transmission setting (USD 1.78).

Conclusion: RTD was cost-effective in both low and high transmission settings. Adherence to test results is essential to benefit from use of RDTs and with a global campaign to reduce the cost of artemether-lumefantrine, the Malaria Control Program and stakeholders need a strategy for malaria diagnosis because as the cost of the drug decreases, presumptive treatment is likely to become attractive.

Funding Source: TARGETS Makerere University School of Public Health/ Department for International Development project; Center for Health Research and Development, Copenhagen University, Denmark; and the Belgian Technical Cooperation local grant.

1095-Batwala-_b.ppt
1095-Batwala-_c.pdf

Evaluating the Impact of Subsidized Artemether-Lumefantrine in the Retail Sector on Coverage of Prompt Effective Treatment of Children Under Five in Kenya- A Cluster Randomized Controlled Trial

Beth B. Pamba Kangwana1, Sarah V. Kedenge1, Abdisalan M. Noor1,7, Victor A. Alegana1, Andrew J. Nyandigisi2, Jayesh Pandit3, Mbogo Bunyi4, Manya Andrews5, Greg W. Fegan1,7, Simon Brooker1,6, Robert Snow1,7, Catherine A. Goodman1,6

1KEMRI-Wellcome Trust Research Programme, Kenya; 2Division of Malaria Control, Kenya; 3Pharmacy and Poisons Board, Kenya; 4Population Services International, Kenya; 5M*Power Consulting, Kenya; 6London School of Hygiene and Tropical Medicine, United Kingdom; 7Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, CCVTM, Oxford, United Kingdom

Problem statement: Despite public sector distribution of the artemisinin-based combination therapy (ACT) artemether-lumefantrine (AL) for the treatment of uncomplicated malaria in Kenya since 2006, access still remains low, with the country being far from achieving the Roll Back Malaria (RBM) target of 80% of malaria cases treated with effective treatment within 24 hours.

Objective: To evaluate to what extent the provision of prepackaged, subsidized AL delivered through private sector retailers would improve the coverage of prompt effective antimalarial treatment

Design: The evaluation employed a pre-post randomized cluster controlled design with 9 clusters (sub-locations) randomly allocated to each of the intervention and control arms groups. Cross-sectional household surveys were conducted before and 9 months after implementation in 3 randomly selected enumeration areas (EAs) per cluster.

Setting: 3 rural districts in Western Kenya which experience high levels of malaria transmission

Study population: About 43 homesteads were randomly selected per EA. All household heads and caregivers of children below 5 years resident in the homestead were interviewed.

Intervention: The 3 main components of the intervention were subsidized packs of pediatric AL under the brand name Tibamal® provided to retail outlets (drug and general stores), training of retail outlet staff, and community awareness activities. No interventions were implemented in the control sub-locations, and the policy of providing free AL at government facilities continued unchanged in both arms.

Outcome measure: The proportion of children under 5 years with fever in the past 2 weeks who began treatment with AL the same or following day of fever onset.

Results: Data were collected on 2,749 children aged 3–59 months at baseline and 2,662 at follow-up. On average, 29% of children experienced fever within 2 weeks prior to the interview. At follow-up, the percentage of children receiving AL on the same day of fever development or the following day had risen by 14.6% points in the control arm (from 5.3% [SD: 3.2] to 19.9% [SD: 10.0]) and 40.2% points in the intervention arm (from 4.7% [SD: 3.4] to 44.9% [SD: 11.7]). The percentage of children receiving AL in the intervention arm at follow-up was significantly greater than in the control, with a difference between arms of 25.0% points (95% CI: 14.1, 35.9; p = 0.0002). No significant differences were observed between arms in where caregivers sought treatment for their child’s fever or in the child’s adherence to AL (p > 0.05).

Conclusion: The pilot demonstrates that subsidizing ACT in the retail sector can significantly increase coverage of prompt effective treatment of malaria in rural areas. The increase in coverage observed in the control area probably reflected improved availability of AL in the public sector, highlighting that ensuring health facility AL stocks is also essential for improving AL access.

Funding source: The UK Department for International Development, the United States Agency for International Development and the Wellcome Trust.

712-Pamba Kangwana-_a.pdf
712-Pamba Kangwana-_b.pptx
712-Pamba Kangwana-_c.pdf

Retail Drug Market and the Prices of Antimalarial Medicines in Enugu Urban, Southeast Nigeria: Implications for Affordability and Access to Artemisinin-Based Combination Therapy

Charles C Ezenduka1, Mathew J Okonta2, Obinna I Ekwunife2

1Health Policy Research Group, University of Nigeria Enugu Campus; 2Dept of Clinical Pharmacy & Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria Nsukka

Problem statement: The majority of malaria services are provided through retail outlets in developing countries, yet limited information exists on the characteristics of the local market and its impact on the price, availability, and affordability of malaria medicines.

Objectives: Investigate the retail market to determine the influence on prices and affordability of malaria medicines in relation to the goals of malaria control measures and the use of ACTs and identify opportunities for improved coverage and access to quality malaria medicines

Design: Economic analyis; the study combined qualitative and quantitative methods, using an economic framework of structure-conduct-performance to explore the relationship between the local drug market and price and affordability of malaria medicines

Setting: Enugu urban, targeting retail drug outlets comprising private pharmacies and patent medicine vendors

Study population: Seven categories of antimalarials were surveyed in a sample of 38 out of 351 retail outlets. A stratified random sampling technique was adopted to survey the outlets by type and location. Data were collected by structured interviews, in-depth interviews, and retail audits from both the private and public sectors.

Outcome measures: Malaria drugs prices, availability, affordability

Results: The local market showed high availability, no concentration, high competition for antimalarial medicines comprising a wide range of products with very variable and competitive prices. SPs and the ACTs are the most dominant antimalarial agents together accounting for over 70% of market volume. SPs are the cheaper and most popular agents particularly in the PMVs and the ACTs have the widest range of brands and the most prescribed antimalarial agents dominant in pharmacies. Market segmentation was minimal with prices of antimalarials ranging from $0.13 to $7.52 per adult oral dose. ACTs were the most expensive antimalarials with a median price of $5.23 ($1.83 - $7.52) in a country where over 50% of the population lives below $2 a day, making them unaffordable for the majority of the low-income population. High prices were most likely to reduce the proportion of patients seeking care. High competition reduced the contribution of retail mark-up to about 20% of final prices, making procurement costs the most important factor contributing about 75% of the final prices of antimalarial medicines. The market is highly influenced by a large informal segment lacking in government regulation with implications for provision of quality malaria treatment.

Conclusions: Activities in the local market impact on the prices and affordability of quality antimalarial medicines and findings suggest measures to reduce procurement costs to enhance affordability of ACTs, such as government involvement in commercial distribution of antimalarial drugs as currently implemented in the public sector with reduced costs of medicines. Expansion into the private sector could be achieved through enhanced public-private partnership to reduce costs through subsidy and improve access to malaria medicines. Introduction of other financing mechanisms such as a social/community health insurance system is important to maximise access. Government regulation of the active market and education of providers and the public on appropriate use of antimalarials are crucial to ensure the provision of quality antimalarial medicines in Nigeria.

Funding source: The University of Nigeria

704-Ezenduka-_a.pdf
704-Ezenduka-_b.pptx
704-Ezenduka-_c.pdf

Improving Quality of Malaria Case Management Provided by Drug Shops in Uganda Through Accreditation and Regulation

Aziz Maija1, Saul Kidde1, Kate Kikule2, Dennis Mwesigwa2, Nasser Lubowa2, Martha Embrey1, Keith Johnson1

1Management Sciences for Health, Uganda; 2National Drug Authority

Problem Statement: In Uganda, most people in rural areas buy medicines from drug shops, which are often the only place nearby to do so. These shops may not be legally licensed or have staff that are trained or supervised. Drug shop customers typically do not receive instructions for medicine use, and often attendants sell the wrong medicines or the wrong dosages to treat common ailments, including malaria.

Objectives: To improve quality of uncomplicated malaria case management in the retail drug outlets through training, accreditation, and supportive supervision of drug sellers.

Design: A quantitative pre- and post-intervention design in two Ugandan districts: Kibaale as the intervention district and Mpigi as the control district. The baseline (2008) and endline (2010) studies measured quality of uncomplicated malaria case management using a mystery shopper scenario (malaria in a 5-year-old child).

Setting and Study Population: 45 Class C Drug Shops in Kibaale district; 43 in Mpigi district

Intervention: Attendants in existing Class C drug shops in Kibaale underwent training in good dispensing practices, uncomplicated malaria case management, record keeping, and patient communication as part of the transformation of the drug shops into Accredited Drug Shops. Training was supplemented by regular supportive supervision.

Outcome measures: Quality of uncomplicated malaria case management in a five year aged child as measured by (1) percentages of malaria encounters with appropriate malaria treatment (correct choice of treatment, dose, and treatment duration); (2) drug sellers stocking the recommended first-line antimalarials; (3) drug sellers asking about symptoms; and (4) drug sellers asking about prior medication given to the child and instructions for taking medicines.

Results: The percentage of malaria encounters with appropriate malaria treatment in Kibaale rose from 6% at baseline to 68% at endline. Mpigi drug shops also experienced increases from 5% to 47%. Availability of artemether-lumefantrine (AL) increased from 5-6% in both districts to over 85% (p = 0.291). However, there was a dramatic fall in the availability of chloroquine (from 80% to 2%) in Kibaale compared to a decrease from 73% to 32% in Mpigi (p<0.05). SP availability decreased from 100% to 7% in Kibaale while in Mpigi, it declined slightly from 100% to 85% (p < 0.05). The percentage of mystery shopper encounters where the drug seller (1) asked about symptoms rose from 56% to 64% in Kibaale and declined from 75% to 43% in Mpigi (p = 0.136); (2) asked about other medicines the child took—increased from 31% to 64% in Kibaale and remained unchanged in Mpigi; 40% at baseline and 43% at endline (p = 0.136); and (3) gave instructions for taking medicines—decreased slightly from 75% to 68% in Kibaale and also declined from 70% to 52% in Mpigi (p = 0.243).

Conclusions: Drug sellers play a complimentary public health role. Equipping these drug sellers with the necessary knowledge and skills as part of a government accreditation program can improve malaria case management.

Funding Source: Management Sciences for Health/East African Drug Seller Initiative, funded by a grant from the Bill & Melinda Gates Foundation

921-Maija-_a.pdf
921-Maija-_b.pptx
921-Maija-_c.pdf