Treatment Cost and Psychological Impact of Burkitt Lymphoma on Ghanaian Families and Caregivers.

OBJECTIVE: Before June 2022, the treatment cost of Burkitt lymphoma (BL) in Ghana was mainly borne by the child's family or caregiver. We determined the treatment cost of BL in children and its psychological impact on parents and caregivers. METHOD: This prospective observational study assessed the direct medical and nonmedical costs (US dollars [USD]) incurred during the treatment of a child with BL for 6 consecutive months using a cost diary. Productivity losses and the psychological impact on parents and caregivers were assessed using a self-administered questionnaire and the Caregiver Quality of Life Index-Cancer (CQOLC). RESULTS: Of the 25 participants, 7 abandoned the treatment of their children, and 4 withdrew because the children passed away. The median (Q1, Q3) cost for treating BL per child for caregivers/parents (N = 12) was USD 947.42 (USD 763.03, USD 1953.05). Direct medical costs formed 71% (USD 11 458.97) of total treatment costs. Working hours of parents before the child's cancer diagnosis decreased from a median (Q1, Q3) of 44.00 (20.00, 66.00) hours to 1.50 (0, 20.00) hours after the diagnosis. The mean (SD) CQOLC score was 107.92 (15.89), with higher scores in men (111.00 [17.26]), married participants (111.26 [17.29]), Higher National Diploma certificate holders (113.00 [1.41]), and participants earning a monthly income more than USD 84.60. CONCLUSION: Treatment costs reduced the overall household income of 5 families. Parents and caregivers experienced reduced work hours and loss of employment. CQOLC scores were higher in married participants, those with a higher educational background, and those with higher income.

Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.

Introduction: National regulatory systems in Southern Africa reflect various stages of maturity, and pharmacovigilance (PV) practices are not aligned. In the absence of guidance for formulating PV guidelines in Southern African Development Community (SADC) countries, this study aimed to create a checklist that may be used to assess the rigour of PV guidelines in this region and provide guidance for the National Medicines Regulatory Agency (NMRA) authors. Methods: A document analysis was performed based on harmonised international guidelines (n = 22) that prescribed methods of PV regulation to identify themes and items to incorporate into a checklist. The contextualisation of the checklist to the African pharmaceutical environment was accomplished by referencing peer-reviewed journal articles (n = 7). The checklist was subjected to face and content validation by non-experts and PV experts. Results: The document review yielded 5 themes, 18 sub-themes, and 73 items structured into the checklist. Themes encompassed PV systems, definitions, individual case safety reporting, aggregate reporting, and risk management. Under PV systems, aspects of the quality management system were outlined, that is, the legal basis for PV, a description of the marketing authorisation holder's (MAH's) PV system, archiving of data, contracting of PV tasks, and the duties of the person responsible for the MAH's PV obligations. Definitions of the key terms and major stakeholders were identified. Reporting of individual case safety reports (ICSRs) was explicated by considering the criteria for reporting, categories of reportable information, expedited reporting requirements, reporting timelines, and ICSR reporting format. Aggregate report submission during the development and post-marketing phases was addressed. Risk management encompassed signal detection, re-evaluation of the benefit-risk ratio, the safety decision-making process, risk management planning, risk minimisation and safety communication. Conclusion: The developed checklist can contribute towards assisting SADC NMRAs to formulate national PV guidelines that reflect current international practice, with local context incorporated. Plain Language Summary: Developing a checklist for the evaluation of medicine safety guidelines in Southern Africa Introduction: In Southern African Development Community (SADC) countries, the guidelines for medicine safety [pharmacovigilance (PV)] that marketing authorisation holders (MAHs) and healthcare professionals need to adhere to, are not aligned. We saw the need to develop a checklist that can be used to evaluate these guidelines.Methods: We studied international documents issued by the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Council for International Organizations of Medical Sciences (CIOMS) and the European Medicines Agency (EMA). On the organisational websites, we obtained 22 documents and identified 73 checklist items. All the items were arranged under 5 themes and 18 sub-themes to create the checklist. We adapted the checklist to the local context by using seven journal articles addressing PV concerns in Africa. Experts checked the content and usability of the checklist.Results: The themes were PV systems, definitions, individual case safety reporting (ICSR), combined reporting and risk management. PV systems had six sub-themes: legal structure, description of the MAH's PV system, contractual agreements, information storage, the qualified person responsible for PV (QPPV) and where the QPPV is located. We included the definitions of keywords and role-players. The ICSR theme had five sub-themes, i.e. criteria for reporting, categories of reportable information, expedited reporting, reporting timelines, and reporting format. Submission of summary reports comprised an overview of the safety profile of a medicine once it is approved by regulators, as well as during clinical trials. Risk management included signal detection, re-evaluation of the benefit-risk ratio, safety decision-making process, risk management planning, risk minimisation, and safety communication. The checklist is applied by allocating yes/no scoring per item.Conclusion: The checklist may be used by regulators within SADC to assess their PV guidelines for alignment with international standards and suitability to the local environment.

Adherence and clinical outcomes of HIV patients switching to a fixed-dose combination regimen.

Background: The efficacy of antiretroviral therapy (ART) is monitored using clinical markers such as viral load (VL) and CD4 counts. Adherence to ART has been associated with viral suppression and improved clinical outcomes. Objectives: To determine the relationship between adherence status with multiple-tablet regimens (MTR) and fixed-dose combination (FDC) regimens, to weight, CD4 count and VL of patients living with HIV. Method: An observational, descriptive study was conducted on a closed cohort of patients living with HIV and attending a primary health care clinic in Northern Cape in South Africa between 01 January 2013 and 31 December 2015. Patients were on an MTR and changed to an FDC regimen. Adherence was measured using the medicine possession ratio (MPR). Results: Statistically significant differences exist between the mean MPR of the 30-day (p = 0.0308) and 28-day supply (p < 0.0001) of the MTR when compared to FDC regimen. No statistically significant differences could be found between adherence and clinical outcomes such as weight, CD4 count and VL for either MTR or FDC regimens. The suppressed VL values measured for MTR were n = 299 (89.25%) and n = 415 (93.05%) for FDC regimen. Conclusion: Adherence improved when patients were switched to FDC, but no statistically significant differences in clinical outcomes measured as weight, CD4 count and VL between adherence status and regimen type could be found. Contribution: This study contributes to much-needed information about ART adherence and clinical outcomes (such as weight, CD4 count and VL) of adult HIV-positive patients in a public healthcare clinic in the Northern Cape, South Africa.

Coexisting Conditions among Children and Adolescents with Cancer in a Section of the South African Private Health Sector: Perspectives from Drug Utilization Data.

Coexisting conditions are relatively common in children with cancer, however, there is a paucity of information on the prevalence of coexisting conditions in children with cancer in South Africa. This cross-sectional study aimed at investigating the common coexisting conditions occurring in children and adolescents younger than 19 years undergoing cancer chemotherapy in a section of the South African private health sector. Medicine claims data from 1 January 2008 to 31 December 2017 were queried to identify coexisting conditions using the International Classification of Diseases, Tenth Revision (ICD-10) codes indicated on reimbursed claims. Where ICD-10 codes per claim were non-specific, the pharmacological drug classes of non-cytotoxic medications claimed alongside these codes were categorized using the Monthly Index of Medical Specialties (MIMS) classification system and analyzed using the drug utilization 90% (DU90%) principle. Analysis of sub-pharmacologic drug classes was stratified according to gender and age groups. The reimbursement category of these medicines was noted. Data were analyzed descriptively. A total of 173 participants were included in the study. ICD-10 codes were available for 13.65% (N = 2631) of medicine claims. Diseases of the respiratory system (J00-J99, 7.15%), gastrointestinal tract (K00-K95, 1.60%), and skin disorders (L00-L99, 0.95%) were the most prevalent specific diagnoses identified. Non-specific ICD-10 codes were recorded on 86.35% (n = 2272) of non-cytotoxic medicine claims. The most frequently utilized pharmacological classes of medications included antimicrobial agents (17.40%), respiratory system agents (13.91%), and analgesics (10.64%). As determined from ICD-10 codes and medication claimed on reimbursed claims, children and adolescents being treated for cancers mostly suffered from acute conditions, in particular, microbial infections and diseases of the respiratory system. This indicates the need for the integration of antimicrobial surveillance programs into childhood and adolescent cancer care to curb antimicrobial infections.

Childhood cancers in a section of the South African private health sector: Analysis of medicines claims data.

BACKGROUND: Although childhood cancers are rare, increases in incidence have been observed in recent times. There is a paucity of data on the current incidence of childhood cancers in South Africa. AIM: This study described the epidemiology of childhood cancers in a section of the private health sector of South Africa, using medicines claims data. SETTING: This study was designed on a nationally representative medicine claims database. METHOD: A longitudinal open-cohort study employing children younger than 19 years and diagnosed with cancers between 2008 and 2017 was conducted using medicine claims data from a South African Pharmaceutical Benefit Management company. Cases were identified using International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes C00 to C97, together with a medicine claim reimbursed from oncology benefits. Crude incidence rates were calculated per million persons younger than 19 years on the database and standardised using the Segi 1960 world population. Temporal trends in incidence rates, analysed using the joinpoint regression, were reported as annual percentage changes (APCs). RESULTS: Overall, 173 new cases of childhood cancers were identified in the database, translating into an age-standardised incidence rate (ASR) of 82.3 per million. Annual incidence of cancer decreased from 76.7 per million in 2008 to 58.2 per million in 2017. More incident cases were identified in males (68.8%). The highest proportion of incident cases was recorded for leukaemias (39.9%), the 5-9 year age group (34.1%) and the Gauteng Province (49.7%). CONCLUSION: The incidence of childhood cancers decreased over time in the section of the private health sector studied. Leukaemias were the major drivers of childhood cancer incidence.

Childhood cancers in a section of the South African private health sector: Analysis of medicines claims data

Background: Although childhood cancers are rare, increases in incidence have been observed in recent times. There is a paucity of data on the current incidence of childhood cancers in South Africa.Aim: This study described the epidemiology of childhood cancers in a section of the private health sector of South Africa, using medicines claims data.Setting: This study was designed on a nationally representative medicine claims database. Method: A longitudinal open-cohort study employing children younger than 19 years and diagnosed with cancers between 2008 and 2017 was conducted using medicine claims data from a South African Pharmaceutical Benefit Management company. Cases were identified using International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes C00 to C97, together with a medicine claim reimbursed from oncology benefits. Crude incidence rates were calculated per million persons younger than 19 years on the database and standardised using the Segi 1960 world population. Temporal trends in incidence rates, analysed using the joinpoint regression, were reported as annual percentage changes (APCs). Results: Overall, 173 new cases of childhood cancers were identified in the database, translating into an age-standardised incidence rate (ASR) of 82.3 per million. Annual incidence of cancer decreased from 76.7 per million in 2008 to 58.2 per million in 2017. More incident cases were identified in males (68.8%). The highest proportion of incident cases was recorded for leukaemias (39.9%), the 5­9 year age group (34.1%) and the Gauteng Province (49.7%).Conclusion: The incidence of childhood cancers decreased over time in the section of the private health sector studied. Leukaemias were the major drivers of childhood cancer incidence

Methylphenidate and atomoxetine prescribing trends in children in the Western Cape Province of South Africa, 2005-2013.

BACKGROUND: There is paucity of data on methylphenidate and atomoxetine prescribing patterns in South African children. AIM: To describe the prescribing trends of these agents in children residing in the Western Cape Province. SETTING: South African private health sector. METHODS: Longitudinal drug utilisation study on medicine claims data from 2005-2013, focussing on the number of patients and prescriptions per patient. RESULTS: The total number of patients increased by 29.5% from 2005 to 2013. The majority were boys (male:female ratio, 3.5:1), and between the ages of > 6 and ≤12 years in 2005 and >12 and ≤18 years in 2013. More than 75% of patients received methylphenidate or atomoxetine in the City of Cape Town Metropolitan municipality. Prescriptions for methylphenidate and atomoxetine increased by 45.5% overall from 2005 to 2013 (p < 0.001), with that for methylphenidate and atomoxetine increasing by 36.0% and 314.5%, respectively. The average number of annual methylphenidate prescriptions per patient increased from 3.96 ± 2.92 (95% CI, 3.69-4.23) in 2005 to 4.38 ± 2.85 (95% CI, 4.14-4.61) in 2013 (Cohen's d = 0.14) and for atomoxetine from 2.58 ± 1.86 (95% CI, 1.80-3.37) in 2005 to 4.85 ± 3.66 (95% CI, 3.84-5.86) in 2013 (Cohen's d = 0.62). CONCLUSION: Although the total number of patients and prescribing of methylphenidate and atomoxetine increased significantly from 2005 to 2013, a slight downward trend was observed in the mean number of prescriptions per patient per year from 2008 onwards. These prescribing patterns warrant further research.

Surveillance of antibiotic use in the private sector in Namibia using sales and claims data.

INTRODUCTION: Antibiotics are among the most commonly used therapeutic agents for humans globally, and their use has been associated with the development of resistance. The objective of this study was to identify sources for quantifying antibiotic usage patterns and to assess such use in ambulatory patients in the private health sector of Namibia. METHODOLOGY: A retrospective analysis of prescription claims data and sales data for the period 2008 to 2011 was conducted. Antibiotic use was expressed in the number of antibiotic-containing prescriptions and volume of units sold and then standardized using defined daily dose per 1,000 inhabitants per day. RESULTS: Antibiotic usage was highest in females (53%), in people 18-45 years of age (41%), and in Windhoek (34%). Overall, wholesale data showed higher antibiotic use than prescription claims data. However, both sources showed similar patterns of antibiotic use. Penicillins were the most used pharmacological group, with amoxicillin/clavulanic acid combination being the most used of the agents. CONCLUSION: Antibiotic use in the private sector of Namibia is comparable to that of high-consuming European countries such as Italy. A trend observed in this study was the decrease in the use of narrow-spectrum antibiotics in favour of broad-spectrum and newer antibiotics. Since this was the first study to assess antibiotic use in the private sector of Namibia, it could serve as a starting point for continued monitoring of antibiotic use in the whole of Namibia in the context of the World Health Organization's Global Action Plan to contain antibiotic resistance.

Medicine possession ratio as proxy for adherence to antiepileptic drugs: prevalence, associations, and cost implications.

OBJECTIVE: To determine the adherence status to antiepileptic drugs (AEDs) among epilepsy patients; to observe the association between adherence status and age, sex, active ingredient prescribed, treatment period, and number of comorbidities; and to determine the effect of nonadherence on direct medicine treatment cost of AEDs. METHODS: A retrospective study analyzing medicine claims data obtained from a South African pharmaceutical benefit management company was performed. Patients of all ages (N=19,168), who received more than one prescription for an AED, were observed from 2008 to 2013. The modified medicine possession ratio (MPRm) was used as proxy to determine the adherence status to AED treatment. The MPRm was considered acceptable (adherent) if the calculated value was ≥80%, but ≤110%, whereas an MPRm of <80% (unacceptably low) or >110% (unacceptably high) was considered nonadherent. Direct medicine treatment cost was calculated by summing the medical scheme contribution and patient co-payment associated with each AED prescription. RESULTS: Only 55% of AEDs prescribed to 19,168 patients during the study period had an acceptable MPRm. MPRm categories depended on the treatment period (P>0.0001; Cramer's V=0.208) but were independent of sex (P<0.182; Cramer's V=0.009). Age group (P<0.0001; Cramer's V=0.067), active ingredient (P<0.0001; Cramer's V=0.071), and number of comor-bidities (P<0.0001; Cramer's V=0.050) were statistically but not practically significantly associated with MPRm categories. AEDs with an unacceptably high MPRm contributed to 3.74% (US$736,376.23) of the total direct cost of all AEDs included in the study, whereas those with an unacceptably low MPRm amounted to US$3,227,894.85 (16.38%). CONCLUSION: Nonadherence to antiepileptic treatment is a major problem, encompassing ~20% of cost in our study. Adherence, however, is likely to improve with the treatment period. Further research is needed to determine the factors influencing epileptic patients' prescription refill adherence.

Prescribing patterns of non-steroidal anti-inflammatory drugs in chronic kidney disease patients in the South African private sector.

Background Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used pharmaceutical agents worldwide. NSAIDs are considered nephrotoxic and should therefore be used with caution or be avoided completely in high risk patients, such as chronic kidney disease (CKD) patients. Objective This study aimed to investigate the prescribing of NSAIDs in CKD patients in order to generate awareness and improve the outcome of these patients. Setting The study was conducted using medicine claims data in the private health sector of South Africa. Method A descriptive, quantitative study was performed, using retrospective data obtained from a Pharmaceutical Benefit Management company. Data from 1 January 2009 to 31 December 2013 were analysed. The study population consisted of all patients with an ICD-10 code for a CKD (N18), in association with a paid claim for an NSAID. Main outcome measure The stratification of NSAID prescribing volume among the CKD population in terms of gender, age, NSAID type, dosage and prescriber type. Results The prescribing of NSAIDs in CKD patients varied between 26 and 40 % over the 5 year study period. No association between gender and CKD patients who received NSAIDs versus those who did not was found, with p > 0.05 and Cramer's V < 0.1 for each year of the study. The association between age groups and CKD patients who received NSAIDs versus those who did not was statistically significant, but practically weak (p < 0.05; Cramer's V ≥ 0.1). Most NSAID prescriptions (52-63 %) were for patients aged 35-64 years. Diclofenac (34.25 %) was the single most frequently prescribed NSAID, but the COX-2-inhibitors (celecoxib, meloxicam and etoricoxib) were the preferred NSAID class to be prescribed. The majority (61.6 %) of the NSAIDs were prescribed by general medical practitioners in dosages meeting and even exceeding the recommended daily dosage of patients with normal kidney function. Conclusions Even though NSAIDs are regarded as nephrotoxic drugs, they are still being prescribed to at-risk CKD patients, in particular, the elderly.

The impact of HIV/AIDS on compliance with antidepressant treatment in major depressive disorder: A prospective study in a South African private healthcare cohort.

BACKGROUND: MDD and HIV/AIDS have a high prevalence worldwide with severe consequences for patients. In both conditions, compliance with treatment is key to successfully treat these disorders. In the current study, we examine the effect of MDD on the compliance with ADs in patients diagnosed with co-morbid HIV/AIDS and how different classes of ADs influence compliance in this group of patients. METHODS: A prospective, cohort study design was used to analyse nationally representative medicine claims data submitted to a privately-owned South African Pharmaceutical Benefit Management (PBM) company. Two groups were distinguished in the database, namely patients with only MDD and patients with both MDD and HIV/AIDS, over a six-year study period. The study population was determined by the following inclusion criteria: patients older than 18 years, MDD should be diagnosed by a psychiatrist supported by an appropriate ICD-10 code, and all patients have to be on combination antiretroviral treatment (cARV) treatment. The medicine possession ratio (MPR) was used as proxy to determine patient compliance with AD medication. RESULTS: 127 patients (i.e. 0.24%) met the criteria of co-morbid MDD and HIV/AIDS. Females have a significantly higher prevalence of MDD and HIV/AIDS when compared to males. Patients diagnosed with both HIV/AIDS and MDD (74.43. ± 32.03, 95% Cl: 71.51-77.34) have a statistical significantly (p < 0.0001) lower compliance with AD treatment vs. MDD patients (80.94% ± 29.44, 95% Cl: 80.56-81.33), but the practical significance thereof, is low (Cohen's d = 0.2255). In this group only 26.83% of TCA had acceptable compliance compared to the 58.57% of SNRIs. Noteworthy observations were that 75% (p < 0.0217; Cramer's V = 0.0388) of venlafaxine and 28.6% (p < 0.0197; Cramer's V = -0.0705) of the paroxetine items were compliant in patients diagnosed with both HIV/AIDS and MDD. CONCLUSIONS: AD compliance is statistical significantly lower in depressed HIV/AIDS vs. depressed non-HIV/AIDS patients. However, these differences is of low practical or clinical significance, meaning that depressed HIV/AIDS patients would have missed approximately two AD doses (6.5% of a 30-day treatment period) more than the non-HIV/AIDS depressed patient over the same treatment period.

The application of pharmacoeconomic modelling to estimate a value-based price for new cancer drugs.

RATIONALE, AIMS AND OBJECTIVES: Value-based pricing has recently been discussed by international bodies as a means to estimate a drug price that is linked to the benefits it offers patients and society. The World Health Organization (WHO) has recommended using three times a country's per capita gross domestic product (GDP) as the threshold for economic value. Using the WHO criteria, pharmacoeconomic modelling was used to illustrate the application of value-based price towards bevacizumab, a relatively new drug that provides a 1.4-month survival benefit to patients with metastatic colorectal cancer (mCRC). METHODS: A decision model was developed to simulate outcomes in mCRC patients receiving chemotherapy ± bevacizumab. Clinical data were obtained from randomized trials and costs from Canadian cancer centres. Utility estimates were determined by interviewing 24 oncology nurses and pharmacists. A price per dose of bevacizumab was then estimated using a target threshold of $CAD117,000 per quality adjusted life year gained, which is three times the Canadian per capita GDP. RESULTS: For a 1.4-month survival benefit, a price of $CAD830 per dose would be considered cost-effective from the Canadian public health care perspective. If the drug were able to improve patient quality of life or survival from 1.4 to 3 months, the drug price could increase to $CAD1560 and $CAD2180 and still be considered cost-effective. DISCUSSION: The use of the WHO criteria for estimating a value-based price is feasible, but a balance between what patients/governments can afford to pay and the commercial viability of the product in the reference country would be required.

A pharmacoeconomic modeling approach to estimate a value-based price for new oncology drugs in Europe.

BACKGROUND: Several European governments have recently mandated price cuts in drugs to reduce health care spending. However, such measures without supportive evidence may compromise patient care because manufacturers may withdraw current products or not launch new agents. A value-based pricing scheme may be a better approach for determining a fair drug price and may be a medium for negotiations between the key stakeholders. To demonstrate this approach, pharmacoeconomic (PE) modeling was used from the Spanish health care system perspective to estimate a value-based price for bevacizumab, a drug that provides a 1.4-month survival benefit to patients with metastatic colorectal cancer (mCRC). The threshold used for economic value was three times the Spanish per capita GDP, as recommended by the World Health Organization (WHO). METHODS: A PE model was developed to simulate outcomes in mCRC patients receiving chemotherapy ± bevacizumab. Clinical data were obtained from randomized trials and costs from a Spanish hospital. Utility estimates were determined by interviewing 24 Spanish oncology nurses and pharmacists. A price per dose of bevacizumab was then estimated using a target threshold of € 78,300 per quality-adjusted life year gained, which is three times the Spanish per capita GDP. RESULTS: For a 1.4-month survival benefit, a price of € 342 per dose would be considered cost effective from the Spanish public health care perspective. The price may be increased to € 733 or € 843 per dose if the drug were able to improve patient quality of life or enhance survival from 1.4 to 3 months. CONCLUSIONS: This study demonstrated that a value-based pricing approach using PE modeling and the WHO criteria for economic value is feasible and perhaps a better alternative to government mandated price cuts. The former approach would be a good starting point for opening dialog between European government payers and the pharmaceutical industry.

The development of a value based pricing index for new drugs in metastatic colorectal cancer.

BACKGROUND: Worldwide, prices for cancer drugs have been under downward pressure where several governments have mandated price cuts of branded products. A better alternative to government mandated price cuts would be to estimate a final price based on drug performance, cost effectiveness and a country's ability to pay. We developed a global pricing index for new cancer drugs in patients with metastatic colorectal cancer (mCRC) that encompasses all of these attributes. METHODS: A pharmacoeconomic model was developed to simulate mCRC patients receiving chemotherapy plus a 'new drug' that improves survival by 1.4, 3 and 6months, respectively. Cost and utility data were obtained from cancer centres and oncology nurses (n=112) in Canada, Spain, India, South Africa and Malaysia. Multivariable analysis was then used to develop the pricing index, which considers survival benefit, per capita GDP and income dispersion (as measured by the Gini coefficient) as predictor variables. RESULTS: Higher survival benefits were associated with elevated drug prices, especially in higher income countries such as Canada. For Argentina with a per capita GDP of $15,000 and a Gini coefficient of 51, the index estimated that for a drug which provides a 4month survival benefit in mCRC, the value based price would be $US 630 per dose. In contrast, the same drug in a wealthier country like Norway (per capita GDP=$50,000) could command a price of $US 2,775 per dose. CONCLUSIONS: The application of this index to estimate a price based on cost effectiveness and the wealth of a nation would be important for opening dialogue between the key stakeholders and a better alternative to government mandated price cuts.

Improving patient access to cancer drugs in India: Using economic modeling to estimate a more affordable drug cost based on measures of societal value.

BACKGROUND: Using multiples of India's per capita gross domestic product (GDP) as the threshold for economic value as suggested by the World Health Organization (WHO), decision analysis modeling was used to estimate a more affordable monthly cost in India for a hypothetical new cancer drug that provides a 3-month survival benefit to Indian patients with metastatic colorectal cancer (mCRC). METHODS: A decision model was developed to simulate progression-free and overall survival in mCRC patients receiving chemotherapy with and without the new drug. Costs for chemotherapy and side-effects management were obtained from both public and private hospitals in India. Utility estimates measured as quality-adjusted life-years (QALY) were determined by interviewing twenty-four oncology nurses using the Time Trade-Off technique. The monthly cost of the new drug was then estimated using a target threshold of US$9,300 per QALY gained, which is three times the Indian per capita GDP. RESULTS: The base-case analysis suggested that a price of US$98.00 per dose would be considered cost-effective from the Indian public healthcare perspective. If the drug were able to improve patient quality of life above the standard of care or survival from 3 to 6 months, the price per dose could increase to US$170 and US$253 and offer the same value. CONCLUSIONS: The use of the WHO criteria for estimating the cost of a new drug based on economic value for a developing country like India is feasible and can be used to estimate a more affordable cost based on societal value thresholds.

Using pharmacoeconomic modelling to determine value-based pricing for new pharmaceuticals in malaysia.

BACKGROUND: Decision analysis (DA) is commonly used to perform economic evaluations of new pharmaceuticals. Using multiples of Malaysia's per capita 2010 gross domestic product (GDP) as the threshold for economic value as suggested by the World Health Organization (WHO), DA was used to estimate a price per dose for bevacizumab, a drug that provides a 1.4-month survival benefit in patients with metastatic colorectal cancer (mCRC). METHODS: A decision model was developed to simulate progression-free and overall survival in mCRC patients receiving chemotherapy with and without bevacizumab. Costs for chemotherapy and management of side effects were obtained from public and private hospitals in Malaysia. Utility estimates, measured as quality-adjusted life years (QALYs), were determined by interviewing 24 oncology nurses using the time trade-off technique. The price per dose was then estimated using a target threshold of US$44 400 per QALY gained, which is 3 times the Malaysian per capita GDP. RESULTS: A cost-effective price for bevacizumab could not be determined because the survival benefit provided was insufficient According to the WHO criteria, if the drug was able to improve survival from 1.4 to 3 or 6 months, the price per dose would be $567 and $1258, respectively. CONCLUSION: The use of decision modelling for estimating drug pricing is a powerful technique to ensure value for money. Such information is of value to drug manufacturers and formulary committees because it facilitates negotiations for value-based pricing in a given jurisdiction.

Advances in cancer therapeutics and patient access to new drugs.

Globally, there are approximately 7.4 million cancer deaths annually, approximately 13% of deaths from all causes. Cancer is a disease of older people and, as the population ages over the next 10-20 years, we can expect an increase in the cancer incidence. Encouragingly, cancer mortality has stabilized in many countries. Part of this success may be attributed to the development of new cancer agents, collectively called 'targeted therapies', that are more specific to key components of tumour growth. Worldwide, however, one of the main factors that limit patient access to these important new drugs is their cost, which is higher than traditional chemotherapy. In this review, the clinical and pharmacoeconomic data of selected targeted agents are discussed. In the second part of this article, the challenges faced by healthcare systems in making such drugs available to patients is reviewed. Current strategies used by many countries around the world to manage cancer drug budgets are presented, along with a proposed approach using pharmacoeconomic methodology that may increase patient access.

Analysis of possible drug-drug interactions between ritonavir and other antiretrovirals in a section of the private health care sector in South Africa

Background: The introduction of human immunodeficiency virus (HIV) protease inhibitors (PIs) has led to a dramatic decline in the morbidity and mortality associated with HIV infection. However; the concomitant use of PIs and other antiretrovirals (ARVs) can be complicated by drug-drug interactions (DDIs); adversely affecting levels of PIs. Methods: A quantitative; retrospective drug utilisation study was performed using data obtained from the medicine claims database of a pharmacy benefit management company during 2004; 2005 and 2006. The possible DDIs found among ARVS themselves were identified using the classification by Tatro.Results: The percentage of ARV prescriptions claimed of the total number of medicine items increased from 1.68(n = 43 482) during 2004 to 3.18(n = 51 613) during 2005; then to 4.74(n = 47 085) during 2006. A total of 1 326; 1 863 and 960 possible DDIs were identified among ARVs themselves for 2004; 2005 and 2006 respectively. Of these; ritonavir (unboosted or boosted) presented with the most possible DDIs; accounting for 74.28(n = 985) for 2004; 67.90(n = 1 265) for 2005; and 27.50(n = 264) for 2006. The highest prevalence of DDIs identified was between ritonavir (unboosted) and saquinavir (n = 974; 5) for 2005 and 2006; followed by indinavir (n = 490; 129; 155) for 2004 to 2006; and efavirenz (n = 274) for only 2004; then ritonavir (boosted); co-formulated as lopinavir/ritonavir; and efavirenz (n = 118; 88; 34) for 2004 to 2006; nevirapine (n = 49; 37) for 2004 and 2005; indinavir (n = 9) for 2004; and saquinavir (n = 22) for 2006.Conclusion: These findings indicate that concomitant use of PIs such as ritonavir; a potent cytochrome P450(CYP)3A4 enzyme inhibitor; and other ARVs is complicated by possible DDIs and therefore further studies need to be done on the ARV combinations and management of these DDIs. How to cite this article: Katende-Kyenda; N.L.; Lubbe; M.S.; Serfontein; J.H.P.; Truter; I. 2009. Analysis of possible drug-drug interactions between ritonavir and other antiretrovirals in a section of the private health care sector in South Africa. African Journal of Primary Health Care et Family Medicine; 1(1); Art. #21; 6 pages. DOI: 10.4102/ phcfm.v1i1.21