Max Access Solutions Guidelines

Contents

SECTION 1: BACKGROUND

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].

SECTION 2: GOVERNANCE

Governance

  1. As an INGO and non-profit organization in the State of Washington, The Max Foundation is governed by a Board of Directors
  • The Board of Directors maintain a set of bylaws;
  • Bylaws are reviewed and updated on a regular basis, as determined to be adequate by the Board of Directors;
  • Each member of the Board of Directors completes a conflict of interest form to ensure participation on the Board does not present a conflict

Finance

  1. The Max Foundation complies with Generally Accepted Accounting Principles (GAAP) and
  • Files an IRS 990 tax return in the US;
  • Generates a financial statement that is audited annually
  1. Product donated to the organization is valued based on Wholesale Acquisition Cost (WAC) as determined at the start of each calendar year
  1. All product donations are recorded as revenue and expense based on product value, inventory, and record of end-use transfer

Gift-in-kind Policies

  1. The Max Foundation accepts product donations in furtherance of the organization’s mission and for which there is a specific programmatic need
  1. The Max Foundation only accepts products of confirmed quality and with adequate shelf life of at least 12 months at time of product donation
  1. Product is distributed in low- and middle-income countries (LMIC) through a third party logistics provider (3PL)
  • A 3PL is selected following a bid process and review by the Chief Executive Officer (CEO) and Board of Directors;
  • The Max Foundation, with its 3PL, monitors key performance indicators as agreed upon contractually

Organizational Evaluation

  1. The Max Foundation is guided by the organization’s strategic plan when developing criteria to evaluate the effectiveness of programs that integrate gift-in-kind

Information Systems

  1. The Max Foundation utilizes a proprietary, information data system, referred to as Patient Access Tracking System (PATS), that tracks an individual patient’s treatment life cycle and integrates physician-driven treatment decisions with business processes

Local Partners Assessment

Country and Regional Assessment

  1. The Max Foundation reviews the World Bank’s Country and Lending Groups, as well as local access channels for each specific product, when assessing country eligibility for product donations
  1. Countries are selected jointly with the Donor company donating product to The Max Foundation

Clinic or Institution Assessment

  1. Clinics and institutions are reviewed to confirm its authority to handle product in accordance with donation guidelines

Physician Assessment

  1. The Max Foundation reviews medical licenses to ensure that health care providers (HCP) new to the organization are authorized to prescribe donated product in the countries where patients are being treated
  1. The Max Foundation enters into collaboration agreements with HCPs to
  • Ensure that patient care is managed in accordance with donation guidelines, including prescribing and managing treatment in accordance with the product label, and reporting adverse events as per local health regulations
  • Ensure that product is maintained in accordance with donation guidelines, including storage, dispensing, and as needed, destruction of unused product
  1. HCPs are verified through this process and enlisted into a Max Network of approved health care providers

Patient Assessment

  1. The Max Foundation ensures the right patient receives the right treatment at the right time by screening all new patients to ensure eligibility

Patient Verification

  1. Patient identity and country of residence is confirmed through the collection of relevant documentation

Medical Eligibility

  1. Each patient is confirmed to be under the care of a verified HCP in the Max Network of approved providers
  1. For initial approval of product donation, The Max Foundation follows product label indication
  • If the product is registered locally, The Max Foundation follows the local product label as a reference document
  • If the product is not registered locally, The Max Foundation follows the product label of the country where Max receives the product donation
  1. For ongoing approval of product donation, The Max Foundation confirms treatment continuation with the HCP

Financial Eligibility

  1. The Max Foundation reviews the insurance status of patients to determine their ability to access product through social security, health insurance, reimbursement, or other access scheme
  • Patients who have access to the product through insurance or similar are not eligible for product donation under MAS
  • Every effort is made to help patients sign up for and navigate existing channels of access, as applicable
  1. The Max Foundation performs a financial review of patients and their ability to afford the product in countries where product is commercially available
  • To determine affordability, the patient’s annual household income is compared against the annual, local purchase price of the product; should the purchase price constitute more than 5% of the total household income, the patient is eligible for product donation
  • In countries where a government issued ration or below poverty level (BPL) card is available, these patients are eligible for product donation and no other means test is applied

Privacy & Consent

  1. Each patient under consideration for a product donation receives a consent form regarding the use of patient information and program expectations
  • By signing the consent form, the patient permits collection of confidential, patient information, and if approved for product donation, agrees to abide by program rules
  1. The Max Foundation does not share patient names or individual patient information with Donor companies
  • Aggregate data is reported periodically to Donor companies and to the public at large

Adverse Event Reporting

  1. The Max Foundation monitors the safety of patients receiving donated product and notifies donor companies of any Adverse Event which come to the attention of any team member, agent, or subcontractor involved in an access solution for as long as donated product is available
  1. The Max Foundation reports all adverse events, special scenarios, and product complaints that we become aware of directly to the Donor company within one business day and no more than three calendar days in the event of weekends or national holidays
  1. All team members involved in the administration of a gift-in-kind program complete safety reporting training at program start and on an annual basis thereafter
  1. HCPs in the Max Network of approved health care providers are expected to report adverse events as per local health regulations
  1. All adverse event reports and related source documents are maintained indefinitely
  1. Adverse event reports to the Donor company are reconciled internally on a daily basis
  1. The Max Foundation performs quality checks of adverse event reports on no less than a monthly basis

Case Closure

  1. Product donation is discontinued on a patient-by-patient basis in the event of death, lost contact, ability to access, changes in affordability, and/or for reasons specified by the HCP
  1. If a representative of The Max Foundation is unable to perform annual verification with a patient or HCP to confirm ongoing treatment, product donation is discontinued on a patient-by-patient basis

SECTION 3: DEFINITIONS

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/

[iii] Partnership for Quality Medical Donations, “PQMD Guidelines for Quality Medical Product Donations”. http://www.pqmd.org/programs/donation-guidelines/

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