With a structured approach to developing access plans as early in clinical development as in pre-Phase II, Takeda demonstrates best practice in access planning for its R&D pipeline. For each R&D project, Takeda considers registration, non-exclusive voluntary licensing, patent waivers, equitable pricing, sufficiency of supply, WHO prequalification, product donations, access through clinical trials and an expanded access programme. 

In least developed countries and low-income countries (LICs), Takeda reports that it neither files patents nor enforces them, while it makes patent information available to the public upon request and participates in the Pat-INFORMED database. Where necessary, it supports voluntary licences and non-assertion declarations or clauses to improve patient access to medicines. It can consider granting licences to manufacturers under appropriate terms that can provide patients with low-cost access to their medicines on a selective basis. 

Takeda has strong project-specific access plans for some late-stage R&D projects. One such project is its dengue vaccine (TAK-003). Takeda intends to file for WHO prequalification for TAK-003 immediately after first regulatory approval. It has also initiated a vaccine distribution and logistics readiness (VD&L) project and is setting up a robust, flexible, sustainable, compliant and temperature-controlled global distribution network. 

Countries with the highest unmet need prioritised for the dengue vaccine

Takeda will launch the product with a primary focus on countries with the highest unmet medical need, mainly low- and middle-income countries. To allow faster access, it will strive to implement a global filing strategy, targeting countries with a high patient need and suitable health system infrastructures in parallel to a first major reference country approval. 

In middle-income countries where dengue is endemic, Takeda aims to expand access to its vaccine for two different population segments. One access approach for broader patient populations involves sustainable initiatives (supplemented by a financial sustainability model) to help patients who cannot afford the full vaccine price and are not covered by any government programmes. A second access approach, for vulnerable populations, involves the development of partnerships and programmes to create access for underserved communities which cannot afford to pay for healthcare. 

Beyond the dengue vaccine

Takeda states its aim to ensure the vaccine programmes are sustainable and is working on expanded access programmes through partnerships with institutions, funding organisations and NGOs. The company is also exploring access programmes for its products that treat life-threatening diseases such as cancer, planning to make these more swiftly available to patients.