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Methods 2: Pharmacoeconomic Methods for Deciding on the Value of Medicines
Role of Pharmacoeconomics in a Developing Country Context
National Department of Health, South Africa
Problem statement: There are various measures that countries can apply to contain the costs of medicines. Developing countries have limited resources; therefore, it is important that they identify the interventions that would have the greatest effect.
Objectives: The objectives are to (1) identify the role of pharmacoeconomics relative to other interventions as a cost-containment measure, and (2) propose a pharmacoeconomics implementation plan in a developing country context.
Design: This is a policy evaluation based on a literature review.
Setting: Developing country context
Interventions: There are various measures to control the costs of medicines. These include a pro-generics policy (fast track registration, substitution), regulation of manufacturer prices (control rebates/discounts, internal and external reference pricing), regulation of supply chain costs (wholesaler fees, dispensing fees, tariffs, and taxes), price transparency, application of TRIPS flexibilities, and pharmacoeconomics.
Results: The application of pharmacoeconomics as a cost-containment measure would have a margin impact on cost containment relative to other interventions—progenerics policy, price regulation and price transparency. The implementation of pharmacoeconomics requires specific expertise (pharmacoepidemiology, biostatistics, evidence-based medicine) and resources which is not abundantly available in a developing country. The requirements to submit a pharmacoeconomics analysis is usually for the purposes of reimbursement and is stipulated in legislation. Economic analyses are usually required where the manufacturer claims that there is a clinical benefit/lower adverse event incidence with a new chemical entity. Economic analyses are rarely required for generic drugs since reference pricing is the more effective policy instrument. Economic analyses are prepared by the manufacturer with a view to convince the purchaser (usually government) that the price premium for the new drug offers value for money when the benefits are considered. The application process includes a detailed guideline of how to prepare an economic analysis submission and the criteria that are used in decision making. A positive evaluation of an economic analysis usually results in a recommendation that the drug should be reimbursed for a specific disease stage which is linked to a treatment guideline.
Conclusion: Pharmacoeconomic analyses are not the most effective cost-containment tool relative to other interventions that should be first implemented in a developing country setting. The implementation of a pro-generics policy and price regulation are more effective in containing costs. When pharmacoeconomic analyses is considered as a policy option, it use to be restricted to specific high cost new chemical entities that claim a significant price premium due to a “clinical benefit.”
Funding source: Information not provided
Cost-Effectiveness of Treating Malaria Following Three Methods of Diagnosis: Implications for Scaling-Up Use of Rapid Diagnostic Tests in Uganda
Mbarara University of Science & Technology, Uganda
See poster number 1095.
Enabling Continuity of a Public Health ARV Treatment Program in a Resource-Limited Setting: The Case of the Transition of the African Comprehensive HIV/AIDS Partnerships (ACHAP) Support to the National ART Program to the Government of Botswana
1African Comprehensive HIV/AIDS Partnerships, Botswana; 2Department of HIV/AIDS Prevention and Care, Ministry of Health, Botswana
Problem Statement: The African Comprehensive HIV/AIDS Partnerships (ACHAP), a public-private partnership between the Government of Botswana, Merck & Co., Inc./The Merck Company Foundation, and the Bill & Melinda Gates Foundation, was formed in 2000 to provide comprehensive support to Botswana's HIV/AIDS response. HIV prevalence among pregnant women aged 15–49 years was about 36.2% and hospitals were overburdened with 60% of medical beds occupied by patients with HIV-related illnesses. Adult mortality increased almost fourfold between 1990 and 2000 and antiretroviral therapy (ART) was available to only 5% of the estimated 110,000 patients in need.
Design: With funding and technical support from ACHAP, leveraging the Government's own significant resource input, Botswana initiated its national ART program in 2002, the first in sub-Saharan Africa. ACHAP support included infrastructure, laboratory, and human resource development through training and recruitment, generation of strategic HIV and AIDS information, as well as donation of ARV medicines by Merck. Long-term challenges with provision of support across such a wide spectrum include sustainability and maintenance of program quality following transition.
Outcomes: With ACHAP as one of its key partners, Botswana’s ART program has achieved significant results in preventing deaths among adults and children. The public sector antiretroviral (ARV) program covers all districts in the country, treating almost 92% (156,581) of patients in need by end of July 2011, 61.9% being females and 38.2% males. It is estimated that between 2002 and 2007, the national ART programme with support from ACHAP and other partners has prevented deaths of about 53,000 Batswana living with HIV, helping them return to productive life, supporting their families, and contributing to the economy. The number of new childhood infections declined by 80% between 1999 and 2009 due to nearly complete coverage of an effective program to prevent mother-to-child transmission.
Results: Following the end in 2009 of ACHAP’s first phase, which focused on treatment, the partnership shifted to greater investment in the support of HIV prevention in its second phase from 2010 to 2014. To safeguard the gains of the national ART programme as well as enabling continued delivery of quality services beyond the second phase, ACHAP is transitioning programmatic support to the Government of Botswana by end of 2011, with the medicines donation continuing until December 2014. ACHAP has supported expansion of government treatment capacity by filling close to 200 positions, constructing 35 treatment facilities, and extending treatment capacity to primary clinic level through nurse training. The Botswana Government has absorbed over 90% of the ACHAP supported positions.
Conclusions: Joint management of this transition, effective monitoring of progress, continued government investment in cost-effective treatment, and prevention approaches will enhance capability to maintain programme quality, coverage., and access beyond the period of ACHAP support.
Funding Source: ACHAP.
Costs and Effects of a Multifaceted Intervention to Improve the Quality of Care of Children in District Hospitals in Kenya
KEMRI-Wellcome Trust, Kenya
See poster number 678
WelTel Kenya: Business Case for Using Mobile Phones as a Cost-Effective Health Intervention to Provide Care and Support HIV/AIDS Patients
1Simon Fraser University; 2British Columbia Centre Disease Columbia; 3University of British Columbia
Problem: The high prevalence of transmittable diseases coupled with limited resources hinders developing world countries’ ability to effectively treat their patients. The use of mobile phones and text (SMS) messages is proposed to be a cost-effective method for patients, health clinics, and entire health systems to provide patient-centered care. We recently reported in a multisite, randomized clinical trial that use of a simple cell phone patient-support intervention in Kenya improved adherence to ART and successful suppression of HIV viral load (The Lancet, 2010).
Objectives: We examined the resources, costs, and costs savings models required toscale-up WelTel Kenya1’s SMS intervention from the original 538 patients to a national and global example. The two examples used include: (1) 500,000 cohort of patients on ARTin Kenya; (2) 2,485 million cohort of patients on ART in globally funded PEPFAR programs.
Design: To estimate and analyze costs associated with scaling up SMS interventions to manage ARV patients. We developed both cost expenditures and cost savings models.
Setting: We looked at implementing the purposed program throughout Kenya and globally.
Study Population: Patients on ART who have access to a mobile phone.
Intervention: Analysis of programmatic implementation using a protocol of weekly SMS inquiries from a health provider to patients on ART. Patients are required to respond within 48 hours. Those indicating a problem or nonresponsive are followed up with a phone call to triage the problem and provided support as appropriate.
Policy: Enabling routine, structured cell phone communication with ART patients and provision of care via mobile phones are not currently the standard of care. As policy makers consider bringing mobile phone interventions to scale, these estimates provide insight into cost implications and costs savings.
Outcome Measures: Cost benefits analysis
Results: To estimate and analyze costs associated with scaling up SMS interventions to manage ARV patients, we looked at both cost expenditures and cost savings models. Cost expenditure models took several costs into account including: (1) cost of airtime for SMS and call-backs; (2) technological requirements (including computer, software, SMS gateway) at each health clinic or group of health clinics; and (3) human resources. Through a three-year strategy, SMS intervention costs between 10.21 to 11 US dollars (USD)/year. Cost saving models were used to predict health systems savings due to improvements in HIV treatment outcomes observed in WelTel Kenya1 (viral suppression and adherence). The following factors were taken into consideration: (1) preventing the need for second-line therapy; (2) preventing opportunistic infections; and (3) savings in health provider time. The potential costs savings for the Kenya cohort range from USD 1.6 to 19.4 million, and in the PEPFAR cohort range from USD 8.2 to 48.3 million from year 1 to 3. Costs saved do not take into account quality of life improvement factors to patients.
Conclusions: Using a weekly SMS protocol to deliver health services and provide support to ART patients provides both qualitative benefits and is anticipated to be a cost-effective way for a health system with limited resources to reach a large number of patients.
Funding Source: MBA thesis