Comments due by September 11, 2020
The Society for Immunotherapy of Cancer (SITC) announced a public comment period on its upcoming clinical practice guideline, The Society for Immunotherapy of Cancer consensus statement on immune effector cell-related adverse events. Comments are due by the end of September 11, 2020.
This manuscript is part of the SITC Cancer Immunotherapy Guidelines program, which is a collection of clinical practice guidelines available in the open-access, peer-reviewed online journal, Journal for ImmunoTherapy of Cancer (JITC). It was written by an expert panel that included representatives from the American Society of Hematology (ASH), the American Society for Transplantation and Cellular Therapy (ASTCT), and the Foundation for the Accreditation of Cellular Therapy (FACT).
The United States Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for CAR T-cell Therapy for Cancers on August 7, 2019. Among other changes, the decision no longer requires Coverage with Evidence Development (CED) and now allows coverage for indications on FDA-approved indications and uses recommended by a citation in CMS-approved compendia. FACT appreciates CMS’s consideration of our comments and of those submitted by several of our stakeholders. Many of the changes will promote patient access to CAR T-cell therapy.
The American Society for Transplantation and Cellular Therapy (ASTCT), one of FACT’s parent organizations, indicated that it is also pleased with many of the changes from the proposed decision memo and responded with a comment letter about suggestions for continuing to improve reimbursement for this therapy.
We believe in the utility of FACT Standards to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals. We will continue to work with all of these stakeholders to do our part to promote patient access.
CAR T cell therapy is considered one of the most promising new treatments for patients battling relapsed and refractory leukemia, lymphoma and other forms of cancer. The assessment and grading of CRS and ICANS have varied considerably across clinical trials, academic studies, and commercial products, which has made it difficult to compare the safety and measure toxicity across all of these settings. This also has hindered the ability of researchers to develop the best strategies to manage these toxicities. Join Drs. Stephan Grupp and Sattva Neelapu on October 2, 2019, at 2:30 pm CT, for an ASTCT webinar discussing the new definitions and grading for CRS and neurotoxicity that more accurately categorize the severity of these toxicities.
The American Society of Gene & Cell Therapy (ASGCT) has partnered with FACT and the American Society for Transplantation and Cellular Therapy (ASTCT) to bring you the two-part webinar series, “Centers’ Experience with Implementing Commercial CAR T-cell Products.”
The first webinar will be on Thursday, July 25, 2019 at 11:00 am ET. Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in this process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.
Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:
- Agreements with Manufacturers
- FACT accreditation
By Sherry Adkins, RN, MSN, ANP-C and Kara Wacker, MBA, RAC
The CARTOX Mobile App for iPhone and Android, created by MD Anderson Cancer Center, is now available to assist clinicians with accurate and timely grading and treatment of toxicities associated with immune effector cellular therapy (IEC). The app is intended for physicians, nurse practitioners, physician assistants, nurses, and pharmacists who treat patients receiving IECs.
Sherry Adkins, RN, MSN, ANP-C, Advanced Practice Provider Supervisor, Lymphoma Research at the MD Anderson Cancer Center developed the idea of an app to allow for safer and more efficient care of the rapidly expanding population of patients receiving IECs. “We recognize that the app has helped our group improve the safety and efficiency of care for this group of patients,” explains Adkins. “We hope it will help other clinicians, particularly those who are just beginning to administer this therapy.”
Ms. Adkins led the implementation strategy with coding assistance from Darren Skeete and his team from the center’s Informational Technology (IT) department. Members of the MD Anderson CARTOX Committee, including Drs. Sattva Neelapu and Elizabeth Shpall, reviewed and tested the app. The process started in the Fall of 2017, and MD Anderson clinicians had access by August of 2018.
The app is based on published guidelines, and will continue to be updated as science evolves to reflect the most current practice guidelines. The initial version of toxicity grading was based on the MD Anderson’s CARTOX program guidelines, but has since been updated to reflect the ASTCT (formerly known as ASBMT) consensus grading. (Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25. Review.)
Toxicity management is based on the CARTOX program’s guidelines, which were developed by a multidisciplinary, multi-institutional group of clinicians (Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19. Review). Toxicity management guidelines are currently being updated and the mobile APP will be updated to reflect those changes in the near future.
To download the app, search for CARTOX in the Apple Store or Google Play.
This month we recognize and celebrate June as the 7th Annual Cancer Immunotherapy Month™ hosted by the Cancer Research Institute. Patients, caregivers, advocacy organizations, health care professionals and industry partners, unite to raise awareness of the lifesaving potential of cancer immunotherapies. Every day, so many work to transform T-cell therapy including researchers who have helped pioneer this research and continue to make seminal advances in this growing field. This month is not only termed to promote general awareness, but also to provide educational growth and professional development opportunities for clinicians, researchers, and patients.
Below are some of the benefits of cancer immunotherapy: (Benefits of Immunotherapy (n.d.). Retrieved from: http://www.cancerresearch.org/immunotherapy/why-immunotherapy).
Cancer immunotherapy can work on many different types of cancer
- Immunotherapy enables the immune system to recognize and target cancer cells, making it a universal answer to cancer.
- The list of cancers that are currently treated using immunotherapy is extensive. See the full list of Immunotherapies by cancer type.
- Immunotherapy has been an effective treatment for patients with certain types of cancer that have been resistant to chemotherapy and radiation treatment
Cancer immunotherapy offers the possibility for long-term cancer remission
- Immunotherapy can “train” the immune system to remember cancer cells. This “immunomemory” may result in longer-lasting remissions.
- Clinical studies on long-term overall survival have shown that the beneficial responses to cancer immunotherapy treatment are durable—that is, they can be maintained even after treatment is completed.
Cancer immunotherapy may not cause the same side effects as chemotherapy and radiation
- Cancer immunotherapy is focused on the immune system and is often more targeted than conventional cancer treatments such as chemotherapy or radiation.
- Both chemotherapy and radiation damage healthy cells, leading to common side effects such as hair loss and nausea/vomiting. These side effects may be less likely with immunotherapy.
- Side effects of cancer immunotherapy will vary depending on which type of immunotherapy is used. They are usually related to stimulation of the immune system and can range from minor symptoms of inflammation (e.g., fever) to major conditions similar to autoimmune disorders.
To learn more about Immunotherapy visit: http://www.cancerresearch.org/immunotherapy/what-is-immunotherapy
FACT Submits Comments to CMS Regarding Proposed National Coverage Determination for CAR T-Cell Therapies for Cancer
By: Kara Wacker, MBA, FACT Strategic Planning Administrator
The United States Centers for Medicare & Medicaid Services (CMS) released a proposed decision memo that outlines coverage for CAR T-cell therapies for cancer using a National Coverage Determination (NCD) with Coverage with Evidence Development (CED). FACT responded to this proposal on March 15, 2019. Comments were a result of input from a variety of stakeholders, including the FACT Board of Directors and Immune Effector Cell Task Force, FACT-accredited programs, FACT inspectors, professional societies, data registries, manufacturers, and payers. We commend the cellular therapy field for its collaborative efforts to provide feedback that would be helpful to CMS as it seeks to provide beneficiaries access to CAR T-cells, and we appreciated this opportunity to provide feedback.
Highlights of FACT’s comments include:
- Suggestion that coverage is provided based on Food and Drug Administration (FDA)-approved product labels to allow coverage as therapies advance.
- Support for the use of the Center for International Blood and Marrow Transplant Research (CIBMTR) as the data registry, and suggestion to certify the registry prior to finalization of the proposed decision memo.
- Request for clarification on the utility of quality of life data for the stated purposes.
- Clarification regarding the scope of various sets of FACT Standards.
- Agreement that hospitals should meet FACT requirements to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals.