Discipline of Pharmaceutical Sciences, School of Health Sciences, University of KwaZulu-Natal (Westville Campus), Private Bag X54001, Durban, KwaZulu- Natal, 4000, South Africa.
School of Health Sciences, University of KwaZulu-Natal (Westville Campus), Private Bag X54001, Durban, KwaZulu-Natal, 4000, South Africa.
BMC Health Serv Res. 2024 Oct 11;24(1):1220. doi: 10.1186/s12913-024-11696-4.
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.
南非由两级医疗保健系统组成。一个层级是通过医疗保险为其提供资金的私立医疗保健系统，由有能力支付医疗保险月费的人群组成。第二个层级是由政府提供资金的公立医疗保健系统，为大多数人提供服务。本研究探讨了制药行业为增加创新药物的可及性而感知到的障碍和当前所采用的策略。
本研究的目的是：（1）量化并分类南非卫生产品监管局（SAHPRA）在 2010 年至 2020 年间注册的创新药物；（2）通过采访创新型制药公司的市场准入经理，了解在南非获得创新药物的障碍；（3）探索制药行业目前采用的市场准入策略。
本研究采用了定量和定性的方法。前者涉及从监管机构数据库中提取创新药物清单，后者涉及 9 次半结构化访谈。通过制药协会成员公司进行了有针对性的抽样。访谈包括南非一家支付方的 7 位市场准入经理和 2 位药品经理。使用主题分析来解释从研究中收集的数据。
根据审查期间的监管机构数据库，共有 238 种创新药物注册。只有 14.77%的药物以招标的形式在公共部门供应，而在私人部门（基于产品具有特殊条件），有 76.92%的药物供应。从访谈中得出了六个主题：药品报销、报销类型、伙伴关系、技术、立法挑战和其他因素（如真实世界证据）。
南非获得创新药物存在挑战，因为这些疗法的价格很高。因此，卫生部门的各个利益相关者必须合作，确定并实施符合当地情况的解决方案。政府需要积极更新政策，以允许探索替代报销方法。
