GUARDING THE SUPPLY OF LIFESAVING DRUGS

Angels for Change has launched an innovative program – Project GOLD (Generic Oncology Lifesaving Drugs) – with the assistance of its founding pilot members Cencora, McKesson and Fresenius Kabi.

Phase 1 of this program is a pilot designed to protect cancer patients in the near term and allow sufficient runway for more complex long-term solutions to be developed. The short-term goal of Project GOLD is not just modest; it is crucial.

It is centered around Guardianship—guarding the supply of lifesaving cancer therapies vulnerable to shortage through increased stakeholder collaboration, transparency, a commitment to improving safety stock inventories, and safe and timely distribution of patient-level emergency supplies for those generic injectable oncology drugs at risk.

Drug shortages are not just a problem; they are a significant crisis for our nation's patients, hospitals, physicians, and pharmacists. 99% of hospital pharmacists navigate at least one essential medicine shortage daily. Over the last 20 years, the marketplace has struggled to predict and consistently meet the demand for commonly used generic injectable oncology drugs.

More recently, the problem has been exacerbated from a 10-year high in drug shortages. Cancer patients have suffered because the current market dynamics do not enable a sufficient supply of these life saving therapies.

It is essential to incorporate sustainability, reliability, and patient-centric design into the pharmaceutical generic supply chain to address drug shortages. The potential impact of these measures is significant, and we can only achieve this by the active participation of all stakeholders through an enhanced and more collaborative approach.

We must rethink our practices for the collective good, ensuring equal access to essential medicines for all patients.

Together, we can work towards a future where every patient can access the vital medicines they need. By implementing innovative and proactive measures, such as establishing redundant production for use in times of shortage, we can strengthen the supply chain and provide security and confidence in the solution. We welcome others from across the supply chain to join us by reaching out to see how to become involved in Project GOLD!

This program could not be possible without the support of our partners and founding pilot members:

FREQUENTLY ASKED QUESTIONS:

What is Project GOLD?

1. Angels for Change and our founding pilot members Cencora, McKesson, and  Fresenius Kabi USA have come together to launch an innovative program, Project GOLD (Generic Oncology Lifesaving Drugs). This program is a testament to our stakeholders' crucial role in the pharmaceutical industry. Phase 1 of this program pilot is designed to protect cancer patients from harm through an extended runway of buffer inventory for six vulnerable to shortage oncology medicines.

2. A proactive process for sharing and distributing the drugs to patients in need without care disruption through the angels for change Drug Shortage Hotline. 

3. Utilizing buffer stock of these oncology products for exclusive use by Angels for Change for disparity free emergent patient care.

4. GOLD is a new mitigation strategy that increases "just in case supply" by adding a buffer inventory of lifesaving cancer therapies vulnerable to the shortage.

5. Angels for Change Drug Shortage Hotline (DSH) is the nation’s only place for patients, physicians, pharmacists, facilities and hospitals to gain access to emergency supplies during a scarce event. Our DSH is 98% effective in ensuring emergency supply access to patients in an Oncologic Drug Shortage.

Why Project GOLD?

1. Sustainability and reliability must be built into the supply chain to achieve an enduring solution to end drug shortages—a commitment of pilot members to proactively increase the buffer supply of the vulnerable to shortage oncology medicines, a place to call for help, a mechanism to move supply, and facilitation is needed to achieve this goal

2. We are starting with Oncologic medicines because oncology patients are the most vulnerable to life-saving generic injectable shortages. They rely on these medicines for care. There are often no suitable alternatives to treatment and generic injectable medicines are the most vulnerable to shortage.

Project GOLD  - Program Description

1. The short-term goal of Project GOLD is modest in scope (slightly increasing supply of 6 oncology medicines) and is centered around Guardianship—guarding the supply of lifesaving cancer therapies vulnerable to shortage through proactive increased stakeholder collaboration, transparency, a commitment to improve safety stock inventories, early warning practices, and safe distribution of patient-level emergency supplies for those generic injectable oncology drugs at risk. Our proactive approach is designed to instill confidence in the supply chain, pilot a new mitigation process that ensures patient care, enhance stakeholder coordination, build policies to navigate shortage without disparity, measure the success of the project, and activate for scalability.

Overall Program Goals & Objectives

1. Manage emergency supplies for patients proactively, ensuring access using the Angels for Change Drug Shortage Hotline.

2. Ensure patient continuum of care and eliminate patient access disparity during a shortage.

3. Promote supply chain resiliency through redundant supply of shortage vulnerable medicines.

4. Showcase the importance of proactive work, resiliency practices, and the critical roles of advocacy, manufacturing, and distribution in ending drug shortages. Our patient-centric design ensures that the needs of the patients are at the forefront of our efforts.

When is Project GOLD Starting?

1. Monday, August 12, 2024, with the initiation of 5 products, with a total of six products in Phase 1

Who & How - The Company's Roles / How is Project GOLD Going to Work?

1. Overall Program - Focus on patients experiencing a problem obtaining an oncology drug.

2. Angels for Change serves as the gatekeeper for pilot member entry into Project GOLD. A4C receives the initial correspondence from the Customer (Provider, Health System) or Patient experiencing a problem obtaining an oncology drug.

3. Distributor/Wholesaler — Will be responsible for performing inventory management services. They will implement the program to procure and manage inventory of critical drug products and distribute them to provider facilities as directed by Angels for Change. The distributor/wholesaler responsibilities also include safely distributing patient-level emergency supplies for those generic injectable oncology drugs at risk, ensuring that the medicines reach the patients promptly and securely. 

• Manage emergency supply for patients

• The buffer inventory of GOLD drugs will be stored by the distributor/wholesaler separately from the regular distributor/wholesaler inventory in a secure and controlled environment. 

• This buffer inventory ensures the safety and integrity of the drugs, as well as facilitates easy access when needed for distribution.

• Inventory for GOLD will be kept in one central location and shipped directly to the patient care facilities. 

• Product shipment will happen expediently, and the distributor/wholesaler will direct invoicing facilities/customers to them for payment.

• Distributors have the ability to select their own MFGs.

4. Manufacturer – Responsible for manufacturing and supplying drug products of the program. They will increase just in case capacity for distribution to increase supply. Additionally, they will increase additional patient emergency supply of the medicines for Angels for Change DSH to access in emergency by  committing to proactively increasing buffer supply of our most vulnerable to shortage oncology medicines.

Project GOLD – Products

Oncology Patients are Uniquely vulnerable to shortage. Their medicines are more vulnerable to shortage. Each product has had recent and ongoing shortage issues and has been further validated by the US Pharmacopeia Medicine Supply Map for supply chain risk. They are all life-saving and have no suitable treatment alternative. Pharmaceutical distributors and generic injectable manufacturers have supported the inclusion of these products in Project Gold for a pilot program to test a new buffer supply program. The utilization of these products is lower than other high use medicines. This allows the pilot to test all of its objectives with more modest people, patient and monetary resource risk.

1. Angels for Change selected these products using our 4 step Drug Shortage Product Selection Process. 

• Vulnerability: Is there a vulnerable patient population needing additional drug shortage support? Is the drug vulnerable to shortage?

• Patient Impact: Is the medicine Life Saving? Is there a suitable alternative

• Feasibility: Is there a model or process that can help these patients ensure access?

• Resource Allocation: Given limited resources and emergent crises, what is the best use of the resources to ensure supply?

2. Additional products will be considered for inclusion in Project GOLD after the first six months of the pilot and upon the consent of the relevant stakeholders. 

3. The first products targeted for inclusion in Project GOLD are:

• Azacitidine

• Dactinomycin

• Decitabine

• Docetaxel

• Leucovorin

• Levoleucovorin