Martie S. Lubbe

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.

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 Indias 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

Prevalence of possible drug-drug interactions between antiretroviral agents in different age groups in a section of the private health care sector setting in South Africa.

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

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

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

Antibiotic use in Namibia: prescriber practices for common community infections

170 and US

Initiative to progress research on medicine utilization in Africa: formation of the Medicines Utilization Research in Africa group

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.

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

Background:  The chronic nature of human immunodeficiency virus (HIV) infection requires lifelong highly active antiretroviral (ARV) therapy (HAART) to continuously suppress HIV‐1 viral replication, thus reducing morbidity and mortality. HAART is restricted by complex dosing, drug–drug interactions (DDIs) and toxicities.

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

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.

Assessment of the appropriateness of antibiotic prescriptions in Lesotho public hospitals: a novel methodology based on principles of antibiotic prescribing

Background: Despite the threat of resistance, the use of antibiotics globally is high and continues to increase. Much of this use is attributed to overprescribing by physicians. The objective of this study was to assess doctors’ management of common community-acquired infections in Namibia. Methodology: A cross-sectional survey based on a web-based self-administered questionnaire was conducted. Doctors belonging to the local professional associations comprised the study population. Data were collected from March to July 2014. Results: A 10% (n = 44) response rate was achieved. Respondents were from across the country and practised mainly in the private health sector. Both awareness of local antimicrobial sensitivity rates and ownership of national Standard Treatment Guidelines were poor (20% and 31% respectively). Common practice in managing common infections, with the exception of chronic otitis media, cystitis and pyelonephritis, is to treat empirically. The reported first-line antibiotics of choice were the combination of amoxicillin with clavulanic acid for upper respiratory tract infections and ciprofloxacin for urinary tract infections. Management of infections was the same across all socio-demographic factors and was not influenced by patient workload. Conclusion: This survey revealed that first-line antibiotic choices of doctors are not informed by the Namibia Standard Treatment Guidelines and the local and regional antimicrobial sensitivity data. Interventions to improve antibiotic prescribing in Namibia should include better dissemination of guidelines and information regarding local antimicrobial sensitivity rates as well as strategies for the implementation of guidelines.

The impact of appropriate antibiotic prescribing on treatment evaluation parameters

This two day meeting brought together drug utilisation researchers from across Africa. The purpose was to share current drug utilisation (DU) research findings to further DU research across Africa including the development of a medicines utilisation research group. This led to the formation of the MURIA (Medicine Utilisation Research in Africa) Group, with a tentative vision and mission as well as the first planned research methodology training course and a symposium in Botswana later in the year. Future research projects were also planned including studies on drug utilisation of ARVs in Botswana and across Africa as well as ways to enhance the appropriate use of antibiotics and increase generic utilisation.