Contributions
Abstract: EP746
Type: E-Poster Presentation
Session title: Gene therapy, cellular immunotherapy and vaccination - Clinical
Background
Chimeric antigen receptor T-cell (CAR-T) therapies have demonstrated the potential to treat relapsed/refractory hematological malignancies1. First CAR-T therapy (Kymriah) was launched in 2017 and up to this day there are 3 approved therapies in the US for DLBCL, MCL and ALL.2 Kymriah and Yescarta, both are approved in the US, EU, Japan, and Australia.3-8 Despite having demonstrated strong efficacy data in clinical trials in multiple indications3-8, the commercial pick-up of these drugs hasn’t been great. As per some studies, there are two key challenges affecting the commercialization of CAR-Ts:9
- complex manufacturing and supply chain Reprogramming/CAR-T creation and expansion and Infusion
- high-touch commercial model: High cost to set up, certify, and scale sites
These challenges make it difficult for healthcare facilities to utilize CAR-T treatment for eligible patients. It is crucial to find out the facilities which has the potential infrastructure to make the treatment available. In this study, we have come up with solutions to address those challenges by identifying the eligible facilities and their referrals. The target of our study is Australia, as it has an untapped capacity to make the CAR-T treatment available for patients due to its improved healthcare system and high healthcare spending.
Aims
- Identify potential healthcare facilities which are eligible for CAR-T treatments and clinical research, using:
- Site/ Facility Identification;
- Accreditations for different CAR-T processes (leukapheresis, manufacturing, infusion)
Methods
Due to complexities involved in manufacturing and supply chain, having a centralized manufacturing facility becomes critical for CAR-T therapies. Many strategic decisions around marketing and clinical trials can be taken by identifying eligible healthcare facilities considering factors like capability to perform complex processes, patient potential, and clinical trial experience. To achieve this objective of identifying key facilities, we have used a proprietary approach as explained below:
- Site Identification was performed using top down drug consumption approach to obtain Relapsed/refractory Non-Hodgkin’s lymphoma (NHL) treating hospitals and their estimated patient potential
- A Referral network was established for the hospitals which have accreditations for all 3 processes, considering them the most eligible sites for treatment or clinical research
Results
There are a total of 82 hospitals in Australia, from which:
- Eight Hospitals are fully accredited for CAR-T and could potentially treat 17% of eligible R/R NHL patients;
- · 62% of hospitals are without any accreditation for CAR-T processes;
- · 28% of partially accredited (1 or 2 processes) hospitals could benefit from additional certification to grant them autonomy to perform CAR-T;
- · Around 18% of hospitals have experience in conducting CAR-T clinical trials
Conclusion
A limited number of hospitals in Australia are equipped with adequate facilities to process and provide the CAR-T treatment. Hospitals with 1 or 2 processes accreditation could benefit to further 50% of patients from additional certification to grant them autonomy to perform the treatment. Utilizing the referral network data, patients can be referred to fully accredited facilities expanding treatment access.
Keyword(s):
Abstract: EP746
Type: E-Poster Presentation
Session title: Gene therapy, cellular immunotherapy and vaccination - Clinical
Background
Chimeric antigen receptor T-cell (CAR-T) therapies have demonstrated the potential to treat relapsed/refractory hematological malignancies1. First CAR-T therapy (Kymriah) was launched in 2017 and up to this day there are 3 approved therapies in the US for DLBCL, MCL and ALL.2 Kymriah and Yescarta, both are approved in the US, EU, Japan, and Australia.3-8 Despite having demonstrated strong efficacy data in clinical trials in multiple indications3-8, the commercial pick-up of these drugs hasn’t been great. As per some studies, there are two key challenges affecting the commercialization of CAR-Ts:9
- complex manufacturing and supply chain Reprogramming/CAR-T creation and expansion and Infusion
- high-touch commercial model: High cost to set up, certify, and scale sites
These challenges make it difficult for healthcare facilities to utilize CAR-T treatment for eligible patients. It is crucial to find out the facilities which has the potential infrastructure to make the treatment available. In this study, we have come up with solutions to address those challenges by identifying the eligible facilities and their referrals. The target of our study is Australia, as it has an untapped capacity to make the CAR-T treatment available for patients due to its improved healthcare system and high healthcare spending.
Aims
- Identify potential healthcare facilities which are eligible for CAR-T treatments and clinical research, using:
- Site/ Facility Identification;
- Accreditations for different CAR-T processes (leukapheresis, manufacturing, infusion)
Methods
Due to complexities involved in manufacturing and supply chain, having a centralized manufacturing facility becomes critical for CAR-T therapies. Many strategic decisions around marketing and clinical trials can be taken by identifying eligible healthcare facilities considering factors like capability to perform complex processes, patient potential, and clinical trial experience. To achieve this objective of identifying key facilities, we have used a proprietary approach as explained below:
- Site Identification was performed using top down drug consumption approach to obtain Relapsed/refractory Non-Hodgkin’s lymphoma (NHL) treating hospitals and their estimated patient potential
- A Referral network was established for the hospitals which have accreditations for all 3 processes, considering them the most eligible sites for treatment or clinical research
Results
There are a total of 82 hospitals in Australia, from which:
- Eight Hospitals are fully accredited for CAR-T and could potentially treat 17% of eligible R/R NHL patients;
- · 62% of hospitals are without any accreditation for CAR-T processes;
- · 28% of partially accredited (1 or 2 processes) hospitals could benefit from additional certification to grant them autonomy to perform CAR-T;
- · Around 18% of hospitals have experience in conducting CAR-T clinical trials
Conclusion
A limited number of hospitals in Australia are equipped with adequate facilities to process and provide the CAR-T treatment. Hospitals with 1 or 2 processes accreditation could benefit to further 50% of patients from additional certification to grant them autonomy to perform the treatment. Utilizing the referral network data, patients can be referred to fully accredited facilities expanding treatment access.
Keyword(s):