A strategic framework for access to medicines
We have created a practical framework to increase sustainable access to our medicines that includes innovative affordability programs and initiatives that help to build sustainable capacity across the entire patient journey through:
- End-to-end patient access throughout the life cycle of Takeda’s assets, starting from development to post- approval access for our highly innovative medicines and, potentially, our dengue vaccine candidate.
- Innovative programs that increase sustainable access to our medicines.
- Building sustainable health care capacity at every stage of the patient journey from diagnosis to ongoing patient support.
- Strategic engagement and collaboration with policymakers and experts from NGOs, patient organizations and governments.
Early patient access to treatments
Providing patients with early and uninterrupted access to lifesaving treatments is an important component of our Access to Medicines strategy. We have a number of mechanisms to help to achieve this:
- Post-Trial Access (PTA) allows continued treatment for eligible clinical trial participants who require access to the investigational medicine after a clinical trial has completed. Takeda provides PTA through a variety of mechanisms. Recent examples are rollover protocols for vedolizumab (Entyvio), which treats Crohn’s disease, and ixazomib (Ninlaro), which treats multiple myeloma, that were designed specifically to allow continued access to patients deriving benefits from study treatment until approval is received for reimbursement in the patient’s country for the patient’s indication and clinical scenario.
- Named Patient Programs (NPP) and Individual Patient Requests (IPR) give patients in need of novel treatments access to safe, tested treatments before they are approved and available in their country. We provided pre-approval access via NPP and IPR to more than 7,300 patients to date across multiple disease areas, including patients in Brazil, China, Egypt, Kenya, Pakistan and Ukraine, among others.
- We’ve partnered with cancer nonprofit The Max Foundation to provide early patient access to Iclusig. The Max Access Solution Iclusig, is a kinase inhibitor targeting an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The Iclusig access pathway is specifically designed to help patients who live in regions where the medicine is not available commercially, significant access hurdles exist or local market initiatives cannot enable access to the therapy. The Max Access Solution Iclusig program had 125 active patients in 16 low- and middle-income countries as of March 31, 2020, and is open to patients in a wide range of low- and middle-income countries.