Treatment Access at a Glance
At the center of our model is a patient who has been diagnosed with a certain cancer and prescribed a treatment for which no local access exists by one of our partner physicians. Working in collaboration with a robust network of leading cancer treating institutions and physicians, drug manufacturers, an international distributor, and local patient support organizations, we provide humanitarian access to the treatment with the aim that each required daily dose reaches the intended patient at the right time, while strengthening the local healthcare system.
The Max Foundation has extensive experience in managing patient access programs for oncology products. The Max Access Solutions model guidelines are the result of the best practices and expertise developed through this extensive experience. These guidelines are reviewed and updated periodically and shared externally with Donor Companies, Health Authorities, and other relevant stakeholders. They are meant to provide a foundation for the development of internal procedures for product requests under MAS. The guidelines further aim to align with World Health Organization (WHO) international guidelines for product donation as well as Partnership for Quality Medical Donations’ (PQMD) standards for international product donations.
The Max Foundation is an International Non-Governmental Organization (INGO) that believes all people living with cancer have the right to access the best treatment and support no matter where they live. To that end, our organization’s mission is to increase global access to treatment, care, and support for people living with cancer.
Furthermore, we believe that there is great societal value in establishing sustainable access solutions to high quality care. We understand the benefits of local governments supporting the good health and well-being of their own people, as per United Nations (UN) targets for sustainable development[i], and specifically that local governments support patients in need of cancer treatment. In the interim, in an effort to strengthen the local healthcare system and ensure immediate access to cancer treatment for those who need it today, The Max Foundation seeks to provide safe and controlled channels of access when local access does not exist.
Max Access Solutions (MAS) is The Max Foundation’s operational program through which donations of approved oncology products are channeled to patients in need based on guidelines outlined in this document and a country list determined in collaboration between The Max Foundation and each Donor company. MAS is meant to be a bridge for access to treatment specifically within low- and middle-income countries (LMICs) where the burden of disease is high and local government access programs may not be currently feasible.
Within MAS, companies donate product to The Max Foundation, and the organization channels product at its discretion to patients in need through their treating physician and within the scope of its collaboration agreements. Vetted health care providers (HCP) in LMICs initiate the product request and manage treatment of patients receiving product from The Max Foundation. The Max Foundation works through a third party logistics provider (3PL) who, as its agent, receives product from manufacturers and ships it to end users on the organization’s behalf.
The Max Foundation has extensive experience in managing patient access programs for oncology products. The MAS model guidelines are the result of the best practices and expertise developed through this extensive experience. These guidelines are reviewed and updated periodically and shared externally with Donor companies. They are meant to provide a foundation for the development of internal procedures for product requests under MAS. The guidelines further aim to align with World Health Organization (WHO) international guidelines for product donation[ii] as well as Partnership for Quality Medical Donations’ (PQMD) standards for international product donations[iii].
Adverse Event – Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Clinic or Institution – Refers to a hospital, brokerage, pharmacy, other dispenser, or warehouse in which product is received once it clears customs and is dispensed to an intermediary or end user
Donor Company – The pharmaceutical company or manufacturer that donates product to The Max Foundation for distribution to end users in LMIC
Gift-in-kind – Also referred to as in-kind product donations
Product – Refers to pharmaceuticals, such as targeted oral chemotherapy, and/or biotechnical devices that are used to treat patients or enable health care providers to make treatment decisions
Product Complaint – Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a medicinal product (including packaging and labeling) after it is released for distribution
Special Scenario – Includes exposure during pregnancy, exposure during breastfeeding, lack of efficacy, disease progression, interactions, medication errors, overdose, abuse or misuse, off-label use, and occupational exposure
Third party logistics provider (3PL) – a partnering organization that manages product throughout the supply chain until product reaches its ship-to recipient
[i] United Nations, “Transforming our world: the 2030 Agenda for Sustainable Development”. https://sustainabledevelopment.un.org/post2015/transformingourworld
[ii] World Health Organization, “Guidelines for Medicine Donations, Revised 2010”. http://www.who.int/medicines/publications/med_donationsguide2011/en/