SEE HOW!

Payer Management

Because of the high cost and complexity of CAR-T therapy, proper and effective management is key for payers. Foremost, communication is essential between all stakeholders — providers, payers, and patients — to ensure utilization is appropriate and safe.

As currently approved CAR-T therapies broaden their indications, and additional therapies move through the pipeline to expand CAR-T use into treatment of solid cancers, such as lung and breast cancer, and off-the-shelf CAR-T therapies become reality, this exciting opportunity and innovation will continue to create challenges and priorities for payers.22 Key to proper management in this space will be determining the appropriate patients for these therapies.22 Payers need to assess the full treatment landscape to properly identify which patients are CAR-T therapy candidates; deference to providers in these instances is important, but establishing appropriate policy will also be essential.22 Policies shifts may include medical necessity criteria in order to ensure these high cost therapies will be utilized by the appropriate patients. Key opinion leaders may also be a useful resource in providing second opinions in patient selection.

With currently available CAR-T therapies, organizations will typically coordinate payment by using customized agreements on a perpatient basis, making the billing and reimbursements for these therapies complicated and burdensome.23 Yet, as more CAR-T options become available, payers have been approving and allowing access to these therapies more expeditiously.23 However, payers will still need to take time to negotiate and customize these per-patient agreements in order to optimize management in this space.23

Continued strategizing and management will be required moving forward. Crafting policy that appropriately identifies populations and ensures access to new innovative therapies, whether on a patient-by-patient basis or through broader management, will be key to payers’ ability to effectively manage the cost burden of CAR-T therapy while ensuring access to the patients who may benefit most.

References

References (cont.)

3. Stanton, Dan. “CAR-T at the Crossroads: Is Allogeneic the Way to Go?” BioProcess International, 31 Jan. 2020, https://bioprocessintl. com/manufacturing/emerging-therapeutics-manufacturing/car-tcell-therapies-is-allogeneic-the-way-to-go/.

4. Depil, S., et al. “’Off-the-shelf’ allogeneic CAR T cells: development and challenges.” Nature Reviews Drug Discovery, Mar. 2020, https:// pubmed.ncbi.nlm.nih.gov/31900462.

5. Litchman, Manuel. “Autologous Vs. Allogeneic CAR-T Therapies: Time For A Second Look.” Cell & Gene, 14 Feb. 2022, https://www. cellandgene.com/doc/autologous-vs-allogeneic-car-t-therapiestime-for-a-second-look-0001.

6. “FDA D.I.S.C.O. Burst Edition: FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.” U.S. Food & Drug Administration, 30 Mar. 2022, https://www.fda.gov/drugs/resourcesinformation-approved-drugs/fda-disco-burst-edition-fda-approvalcarvykti-ciltacabtagene-autoleucel-treatment-adult-patients.

7. Berdeja, Jesus, et al. “Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study.” The Lancet, 24 June 2021, https://www.thelancet.com/journals/lancet/article/PIIS01406736(21)00933-8/fulltext.

8. “FDA D.I.S.C.O. Burst Edition: FDA approval Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.” U.S. Food & Drug Administration, 25 Apr. 2022, https://www.fda.gov/drugs/resourcesinformation-approved-drugs/fda-disco-burst-edition-fda-approvalyescarta-axicabtagene-ciloleucel-adult-patients-large-b-cell.

9. Locke, Frederick, et al. “Axicabtagene Ciloleucel as SecondLine Therapy for Large B-Cell Lymphoma.” The New England Journal of Medicine, 17 Feb. 2022, https://pubmed.ncbi.nlm.nih. gov/34891224/.

10. “FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma.” U.S. Food & Drug Administration, 18 Oct. 2017, https://www.fda.gov/news-events/press-announcements/ fda-approves-car-t-cell-therapy-treat-adults-certain-types-large-bcell-lymphoma.

11. “FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma.” U.S. Food & Drug Administration, 8 Mar. 2021, https://www.fda.gov/drugs/resourcesinformation-approved-drugs/fda-grants-accelerated-approvalaxicabtagene-ciloleucel-relapsed-or-refractory-follicular-lymphoma.

12. “FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma.” U.S. Food & Drug Administration, 31 May 2022, https:// www.fda.gov/drugs/resources-information-approved-drugs/fdaapproves-tisagenlecleucel-relapsed-or-refractory-follicular-lymphoma.

13. Fowler, Nathan Hale, et al. “Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial.” Nature Medicine, 17 Dec. 2021, https://www.nature.com/articles/s41591021-01622-0.

14. “FDA approves tisaganlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome.” U.S. Food & Drug Administration, 7 Sept. 2017, https://www.fda.gov/drugs/resources-information-approveddrugs/fda-approves-tisagenlecleucel-b-cell-all-and-tocilizumabcytokine-release-syndrome.

15. “FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma.” U.S. Food & Drug Administration, 3 May 2018, https://www.fda.gov/drugs/resources-informationapproved-drugs/fda-approves-tisagenlecleucel-adults-relapsed-orrefractory-large-b-cell-lymphoma.

16. “FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphoma.” U.S. Food & Drug Administration, 21 July 2022, https://www.fda.gov/drugs/resources-information-approved-drugs/ fda-disco-burst-edition-fda-approval-breyanzi-lisocabtagenemaraleucel-second-line-treatment-large-b.

17. Kamdar, Manali, et al. “Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, andomized, phase 3 trial.” The Lancet, 18 June 2022, https://www.thelancet.com/journals/lancet/ article/PIIS0140-6736(22)00662-6/fulltext.

18. Sehgal, Alison, et al. “Lisocabtagene maraleucel as secondline therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study.” The Lancet Oncology, Aug. 2022, https://pubmed.ncbi.nlm.nih.gov/35839786/.

19. “FDA Approves New Treatment For Adults with Relapsed or Refractory Large B-Cell Lymphoma.” U.S. Food & Drug Administration, 5 Feb. 2021, https://www.fda.gov/news-events/ press-announcements/fda-approves-new-treatment-adultsrelapsed-or-refractory-large-b-cell-lymphoma.

20. “Leukemia and Lymphoma: An assessment of CAR-T Therapies (tisagenlecleucel and axicabtagene ciloleucel).” Institute for Clinical and Economic Review, Mar. 2018, https://icer.org/assessment/ leukemia-and-lymphoma-2018.

21. “Anti B-Cell Maturation Antigen CAR T-cell and Antibody Drug Conjugate Therapy for Heavily Pre-Treated Relapsed and Refractory Multiple Myeloma.” Institute for Clinical and Economic Review, 11 May 2021, https://icer.org/wp-content/uploads/2020/10/ICER_ Multiple-Myeloma_Final-Report_Unredacted_112222.pdf.

22. Minemyer, Paige. “Optum: How payers can prepare now for wave of CAR-T therapies.” Fierce Healthcare, 22 Sept. 2020, https://www. fiercehealthcare.com/payer/optum-how-payers-can-prepare-nowfor-wave-car-t-therapies.

23. Cryts, Aline. “CAR T-cell Therapy: How Payers are Responding to Huge Price Tags.” Managed Healthcare Executive, 5 Nov. 2018, https://www.managedhealthcareexecutive.com/view/car-t-celltherapy-how-payers-are-responding-huge-price-tags.