Feature

Association of American Cancer Institutes launches initiative to advance CAR T-cell therapies

Joseph McGuirk, DO
Joseph McGuirk

Association of American Cancer Institutes launched a national initiative to advance the use of chimeric antigen receptor T-cell therapies.

The association — which includes 98 academic and freestanding cancer research centers in the United States and Canada —established a working group last year to discuss common challenges associated with CAR T-cell therapy.

Upon learning that many of AACI’s members were facing similar challenges with CAR T-cell implementation, group members saw the potential to expand its activities into an initiative that would allow for greater member engagement and educational opportunities.

“We are convening CAR T-cell experts across the country to identify obstacles and enhance opportunities for centers offering these therapies,” Joseph McGuirk, DO, medical director for blood and marrow transplant at The University of Kansas Cancer Center and chair of Association of American Cancer Institutes’ (AACI) CAR T steering committee, said in a press release. “In 2018 alone, nearly 8,500 patients should have been able to access CAR T-cell therapies while only a small fraction of that number utilized them. This underscores the need for AACI’s CAR T Initiative to allow AACI cancer centers to ensure access to these therapies to eligible patients.”

HemOnc Today spoke with McGuirk about how this initiative came about, how it will be structured, who will be involved, and the potential impact it may have for patients.

Question: How did this initiative come about?

Answer: The new president of AACI — Roy Jensen, MD, director of the NCI-designated cancer center at The University of Kansas — determined along with the association’s administration and its most recent past president, Stanton L. Gerson, MD, that CAR T-cell therapy and cellular therapy in general are critically important advances in medicine. However, there are significant toxicities associated with many of the CAR T-cell therapies that have been pursued. Understanding the biology of this was clearly an important undertaking so that we could ameliorate it. In addition, building more potent and consistent CAR T cells to more reliably kill cancer cells and potentially cause less toxicity was essential. Also, there was a clear need to harmonize and standardize toxicity grading. We felt AACI could take a leadership role to support these initiatives on a national level.

Finally, the two FDA-approved CAR T-cell therapies — axicabtagene ciloleucel (Yescarta; Kite Pharma, Gilead) and tisagenlecleucel (Kymriah, Novartis) — are very costly. Axicabtagene ciloleucel has a list price of $373,000, and tisagenlecleucel has a list price of $475,000. This does not include patient preparation for treatment, nor potential hospitalization or ICU stay, which many patients require after receiving these therapies.

There were some challenges with rolling out the therapy because there were no codes for CAR T-cell therapy billing. These issues had not been worked out before the FDA approved tisagenlecleucel, so we had an FDA-approved therapy on the market but no well-established ways to ensure it would be appropriately paid for without causing substantial financial devastation for institutions or patients and their families.

AACI, in collaboration with other professional organizations around the nation, lobbied locally, statewide and nationally for improvement in the payment models for Medicare. There has been some progress, but we still have quite a long way to go.

Q: What is the aim of the initiative?

A: We have an important role at AACI to help educate our legislators at the local and national levels — as well as our colleagues in hematology, oncology and general practice — about the importance of these therapies. Only a small fraction of patients for whom these therapies are recommended are able to access them. There are a number of reasons for this, including barriers related to finances, Medicare and Medicaid, and an overall lack of education about the logistics of referral. We need to reach out to our communities and ensure that our physicians, colleagues and community centers are aware of who should be referred, when they should be referred and what the outcomes are. Communication is critically important. Through this initiative, AACI has an opportunity to facilitate communication across its membership.

Q: Who is included in the initiative?

A: AACI focuses on enhancing the impact of North America’s leading academic cancer centers by keeping pace with the changing landscape in science, technology and health care. AACI provides a national platform for us to support and carry out the mission to improve access for our patients, but also to educate our colleagues in health care so patients are able to access this therapy. The AACI board of directors approved the CAR T-cell initiative, which includes three working groups. The first will tackle reimbursement issues. The second will be challenged with best practices in the United States — what we expect and how to harmonize this across the nation so that patients will receive the same care no matter where they are treated. The third is our clinical research group that will look at how we can make CAR T-cell therapy work better for our patients and mitigate toxicities.

Q: How might the initiative expand?

A: In addition to facilitating education and communication, this initiative provides a forum for us to standardize how we report on toxicities and outcomes for patients and partner with other entities that are working on this.

Q: Is there anything else that you would like to mention?

A: It is absolutely astonishing where we are now vs. where we were a decade ago. This speaks to the great promise of this technology. We are truly in the midst of a revolution in cancer therapeutics, and this is one part of the revolution that is unfolding in cancer therapeutics. Building better constructs to allow for broader access and expanding these therapeutics into other cancers with this initiative shows great promise. – by Jennifer Southall

For more information:

Joseph McGuirk , DO, can be reached at The University of Kansas Cancer Center, 3901 Rainbow Blvd, Kansas City, KS 66160; email:jmcguirk@kumc.edu. For more information about the initiative, go to www.aaci-cancer.org/car-t.

Disclosure: McGuirk reports research funding from Kite Pharma and Novartis; a speakers role with Kite Pharma; and consultant/advisory board roles with Kite Pharma and Juno Therapeutics.

Joseph McGuirk, DO
Joseph McGuirk

Association of American Cancer Institutes launched a national initiative to advance the use of chimeric antigen receptor T-cell therapies.

The association — which includes 98 academic and freestanding cancer research centers in the United States and Canada —established a working group last year to discuss common challenges associated with CAR T-cell therapy.

Upon learning that many of AACI’s members were facing similar challenges with CAR T-cell implementation, group members saw the potential to expand its activities into an initiative that would allow for greater member engagement and educational opportunities.

“We are convening CAR T-cell experts across the country to identify obstacles and enhance opportunities for centers offering these therapies,” Joseph McGuirk, DO, medical director for blood and marrow transplant at The University of Kansas Cancer Center and chair of Association of American Cancer Institutes’ (AACI) CAR T steering committee, said in a press release. “In 2018 alone, nearly 8,500 patients should have been able to access CAR T-cell therapies while only a small fraction of that number utilized them. This underscores the need for AACI’s CAR T Initiative to allow AACI cancer centers to ensure access to these therapies to eligible patients.”

HemOnc Today spoke with McGuirk about how this initiative came about, how it will be structured, who will be involved, and the potential impact it may have for patients.

Question: How did this initiative come about?

Answer: The new president of AACI — Roy Jensen, MD, director of the NCI-designated cancer center at The University of Kansas — determined along with the association’s administration and its most recent past president, Stanton L. Gerson, MD, that CAR T-cell therapy and cellular therapy in general are critically important advances in medicine. However, there are significant toxicities associated with many of the CAR T-cell therapies that have been pursued. Understanding the biology of this was clearly an important undertaking so that we could ameliorate it. In addition, building more potent and consistent CAR T cells to more reliably kill cancer cells and potentially cause less toxicity was essential. Also, there was a clear need to harmonize and standardize toxicity grading. We felt AACI could take a leadership role to support these initiatives on a national level.

Finally, the two FDA-approved CAR T-cell therapies — axicabtagene ciloleucel (Yescarta; Kite Pharma, Gilead) and tisagenlecleucel (Kymriah, Novartis) — are very costly. Axicabtagene ciloleucel has a list price of $373,000, and tisagenlecleucel has a list price of $475,000. This does not include patient preparation for treatment, nor potential hospitalization or ICU stay, which many patients require after receiving these therapies.

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There were some challenges with rolling out the therapy because there were no codes for CAR T-cell therapy billing. These issues had not been worked out before the FDA approved tisagenlecleucel, so we had an FDA-approved therapy on the market but no well-established ways to ensure it would be appropriately paid for without causing substantial financial devastation for institutions or patients and their families.

AACI, in collaboration with other professional organizations around the nation, lobbied locally, statewide and nationally for improvement in the payment models for Medicare. There has been some progress, but we still have quite a long way to go.

Q: What is the aim of the initiative?

A: We have an important role at AACI to help educate our legislators at the local and national levels — as well as our colleagues in hematology, oncology and general practice — about the importance of these therapies. Only a small fraction of patients for whom these therapies are recommended are able to access them. There are a number of reasons for this, including barriers related to finances, Medicare and Medicaid, and an overall lack of education about the logistics of referral. We need to reach out to our communities and ensure that our physicians, colleagues and community centers are aware of who should be referred, when they should be referred and what the outcomes are. Communication is critically important. Through this initiative, AACI has an opportunity to facilitate communication across its membership.

Q: Who is included in the initiative?

A: AACI focuses on enhancing the impact of North America’s leading academic cancer centers by keeping pace with the changing landscape in science, technology and health care. AACI provides a national platform for us to support and carry out the mission to improve access for our patients, but also to educate our colleagues in health care so patients are able to access this therapy. The AACI board of directors approved the CAR T-cell initiative, which includes three working groups. The first will tackle reimbursement issues. The second will be challenged with best practices in the United States — what we expect and how to harmonize this across the nation so that patients will receive the same care no matter where they are treated. The third is our clinical research group that will look at how we can make CAR T-cell therapy work better for our patients and mitigate toxicities.

PAGE BREAK

Q: How might the initiative expand?

A: In addition to facilitating education and communication, this initiative provides a forum for us to standardize how we report on toxicities and outcomes for patients and partner with other entities that are working on this.

Q: Is there anything else that you would like to mention?

A: It is absolutely astonishing where we are now vs. where we were a decade ago. This speaks to the great promise of this technology. We are truly in the midst of a revolution in cancer therapeutics, and this is one part of the revolution that is unfolding in cancer therapeutics. Building better constructs to allow for broader access and expanding these therapeutics into other cancers with this initiative shows great promise. – by Jennifer Southall

For more information:

Joseph McGuirk , DO, can be reached at The University of Kansas Cancer Center, 3901 Rainbow Blvd, Kansas City, KS 66160; email:jmcguirk@kumc.edu. For more information about the initiative, go to www.aaci-cancer.org/car-t.

Disclosure: McGuirk reports research funding from Kite Pharma and Novartis; a speakers role with Kite Pharma; and consultant/advisory board roles with Kite Pharma and Juno Therapeutics.

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