Concept Foundation, Avenue de Sécheron 15, 1202, Geneva, Switzerland.
Reprod Health. 2020 Nov 4;17(1):171. doi: 10.1186/s12978-020-01012-8.
Understanding the price components of the mifepristone/misoprostol (combi-pack) for medical abortion to improve access is critical for identifying strategies to reduce product costs for quality-assured formulations and expanding its availability and use.
We constructed a cost of goods sold analysis using data collected from manufacturing companies in Bangladesh, China and India supported by publicly available information related to the product formulation, active pharmaceutical ingredients (API), manufacturing location, manufacturer profiles and other individual model components. Key model components were the active pharmaceutical ingredients (quality-assured or not), excipients, labour cost, operating cost and packaging.
Combi-pack direct production cost ranges from US$1.08 for finished products which are not quality assured to US$3.05 for products containing quality assured active pharmaceutical ingredients, which means that with a 30% administrative fee applied to those prices, it could be made available between US$1.40 and US$3.97 depending on location, manufacturer's profile, optimal market situation and the quality of the active pharmaceutical ingredients. The main model component impacting on the cost range is the purchase price of mifepristone active pharmaceutical ingredient and the current differential between quality-assured material supported by adequate documentation and API for which quality assurance cannot be demonstrated. Compared to India cost of goods sold is lower in Bangladesh primarily due to lower operating costs, including the cost of labour.
It is feasible to lower the cost of quality-assured combi-packs, through reducing mifepristone API cost and selection of the manufacturing location. However, manufacturers need to be incentivised to achieve WHO pre-qualification with a carefully built business case and require support in identifying and sourcing competitively priced material and manufacturing products to the necessary standard.
了解米非司酮/米索前列醇（组合包装）用于药物流产的价格构成对于提高可及性至关重要，这有助于确定降低合格制剂产品成本的策略，并扩大其供应和使用。
我们使用孟加拉国、中国和印度的制造公司收集的数据，并结合与产品配方、活性药物成分（API）、制造地点、制造商概况和其他个别模型组件相关的公开信息，构建了销售成本分析。关键模型组件是活性药物成分（合格或不合格）、赋形剂、劳动力成本、运营成本和包装。
组合包装的直接生产成本范围为 1.08 美元，适用于不合格的成品；3.05 美元，适用于包含合格活性药物成分的产品。这意味着，在对这些价格收取 30%的行政费用后，根据地点、制造商概况、最佳市场情况和活性药物成分的质量，其价格可能在 1.40 美元至 3.97 美元之间。影响成本范围的主要模型组件是米非司酮活性药物成分的采购价格，以及有充分文件支持的合格材料与无法证明质量保证的 API 之间的当前差价。与印度相比，孟加拉国的销售成本较低，主要原因是运营成本（包括劳动力成本）较低。
通过降低米非司酮 API 成本和选择制造地点，可以降低合格组合包装的成本。然而，制造商需要有动力通过精心制定的商业案例实现世卫组织预认证，并需要获得支持，以确定和采购具有竞争力价格的材料，并按照必要的标准生产产品。
