Alignment in the registration, selection, procurement and reimbursement of essential medicines for childhood cancers in South Africa.

The effectiveness of a health system in providing access to medicines is in part determined by the alignment of several core pharmaceutical processes. For South Africa's public health sector, these include the registration of medicines, selection and subsequent procurement through national tenders. Registration, selection and reimbursement are key processes in the private sector. This study assessed the alignment of forementioned processes for essential paediatric oncology medicines in South Africa. A selection of priority chemotherapeutics, antiemetics and analgesics in the treatment of five prevalent childhood cancers in South Africa was compared with those listed in 1) the WHO Essential Medicines List for Children (WHO EMLc) 2021, 2) the registered health products database of South Africa, 3) the relevant South African National Essential Medicines Lists (NEML), 4) bid packs and awarded tenders for oncology medicines for 2020 and 2022 and 5) oncology formularies from the leading Independent Clinical Oncology Network (ICON) and two private sector medical aid schemes. Consistency between these sources was assessed descriptively. There was full alignment for 25 priority chemotherapeutics for children between the NEML, the products registered in South Africa and those included on tender. Due to unsuccessful procurement, access to seven chemotherapeutics was potentially constrained. For antiemetics and analgesics, eight of nine active ingredients included on the WHO EMLc were also registered in South Africa and on its NEML. An exploratory assessment of private sector formularies showed many gaps in ICON's formulary and two medical scheme formularies (listing 33% and 24% of the chemotherapeutics, respectively). Despite good alignment in public sector pharmaceutical processes, access constraints to essential chemotherapeutics for children may stem from unsuccessful tenders. Private sector formularies show major gaps; however, it is unclear how this translates to access in clinical practice.

Joosse IR ，van den Ham HA ，Mantel-Teeuwisse AK ，Suleman F ... -  《BMJ Global Health》

Understanding the decision making process of selection of medicines in the private sector in South Africa - lessons for low-middle income countries.

The affordability of essential medicines is a challenge in achieving Universal Health Coverage (UHC). One of The Lancet Commission's recommendations on financing of essential medicines is to ensure governments and national health systems include essential medicines in the benefit packages provided by public and private healthcare sectors. Currently in South Africa (SA), there is a dearth of information on the processes for medicines selection for private sector medical scheme formularies. This study aimed to improve the understanding of how formulary managers of selected medical schemes made decisions for the selection of medicines for their formularies. This paper described their opinions obtained from in-depth interviews. Qualitative in-depth interviews were conducted with 10 individuals from 7 private sector medical schemes and administrators in SA. All participants interviewed were involved in formulary development and management. Interviews were conducted from June 2013 - January 2015. Interviews were guided by a discussion guide and audio recorded. Recorded interviews were transcribed verbatim. Transcripts were coded by the first author, corroborated by the second author, reconciled, and imported into NVIVO for data analysis. Schemes and administrators had similar formulary decision making and management committees in place (viz. Clinical and Therapeutics committees). The process of and criteria for medicines selection and evidence based review of formularies were also similar. Selection of medicines was inherent in the formulary review process. Medicine price was important in the decision taken to list medicines. Most schemes expressed a difficulty with lack of information to support pharmacoeconomic evaluations of medicines for inclusion on the formulary. This together with the basic monitoring of use of medicines by patients for most schemes left room for improvement in the decision making process for those schemes. This is one of the first studies in SA describing interviews with private sector medical scheme Formulary managers. It contributes to an increased understanding of how decisions are taken to include/exclude medicines on private sector medical scheme formularies. It provides insight into the medicine selection and review processes, including processes on monitoring and evaluation of medicines use by the private sector which serve as lessons for Low-Middle income countries moving towards UHC.

Perumal-Pillay VA ，Suleman F 《-》

Understanding medicine access strategies for innovator medicines registered in South Africa.

South Africa is composed of a two-tier healthcare system. One tier is a private healthcare system that is funded through medical insurance, and comprised of people who can afford to make monthly payments towards their medical insurance. Second tier is a government-funded public healthcare system, which covers the majority of the population. This study explored the perceived barriers and current strategies being utilised by the pharmaceutical industry to increase access to innovator medicines. The objectives of the study were to: (1) quantify and classify innovator medicines registered between 2010 and 2020 by the South African Health Products Regulatory Authority (SAHPRA); (2) identify barriers to accessing innovator medicines in South Africa through interviews with market access managers from innovator companies; and (3) explore the current market access strategies used by the pharmaceutical industry. This study employed a quantitative and qualitative methodology. Whereby the former involved the extraction of a list of innovator medicines from the regulator database, and the latter involved 9 semi structured interviews. Purposive sampling was conducted through pharmaceutical association member companies. The interviews included seven market access managers and two medicine managers from one of the payers in South Africa. Thematic analysis was used to interpret the data collected from the study. According to the regulator database during the review period, 238 innovator medicines were registered. Only 14.77% were available in the public sector in the form of tenders, whereas in the private sector (based on the products having a SEP), 76.92% were available. From the interviews six themes emerged: reimbursement of medicines, types of reimbursement, partnerships, technology, legislative challenges, and other factors (e.g., real-world evidence). Access to innovator medicines in South Africa is a challenge, as the price of these therapies is high. Therefore, various stakeholders in the health sector must collaborate to identify and implement solutions that are locally relevant. The government needs to proactively update policies that would allow for alternative reimbursement methods to be explored.

Jama TNQ ，Suleman F 《-》

Formulary Management Activities and Practice Implications Among Public Sector Hospital Pharmaceutical and Therapeutics Committees in a South African Province.

The World Health Organization identified Pharmaceutical and Therapeutics Committees (PTCs) at district and hospital levels as one of the pivotal models to promote rational use of medicines (RUM). This is endorsed by the Government in South Africa. Formulary development and management is one of the main functions of PTCs. This study aimed to describe the formulary management activities among PTCs in public hospitals in Gauteng Province, South Africa, following initiatives to promote RUM in South Africa. Qualitative, nonparticipatory, observational study, observing 26 PTC meetings. Data were coded and categorized using NVivo9® qualitative data analysis software. Themes and sub-themes were developed. The themes and sub-themes on formulary management are the principal focus of this paper. More than half of the observed PTCs reviewed their formulary lists. There was variation in the review process among institutions providing different levels of care. Various aspects were considered for formulary management especially requests for medicines to be added. These included cost considerations (mainly focusing on acquisition costs), evidence-based evaluation of clinical trials, patient safety, clinical experience and changes in the National Essential Medicines List (NEML). The tertiary PTCs mostly dealt with applications for new non-EML medicines, while PTCs in the other hospitals mainly requested removal or addition of EML medicines to the list. This is the first study from Gauteng Province, South Africa, reporting on how decisions are actually taken to include or exclude medicines onto formularies within public sector hospitals providing different levels of care. Various approaches are adopted at different levels of care when adding to- or removing medicines from the formulary lists. Future programs should strengthen PTCs in specialized aspects of formulary management. A more structured approach to formulary review at the local PTC level should be encouraged in line with the national approach when reviewing possible additions to the NEML.

Matlala M ，Gous AGS ，Meyer JC ，Godman B ... -  《Frontiers in Pharmacology》

Assessing the prices and affordability of oncology medicines for three common cancers within the private sector of South Africa.

Mattila PO ，Babar ZU ，Suleman F 《-》