Regulatory News
All those whose lives are touched by CLL are affected by the pharmaceutical industry, insurance coverage, and government regulations. Which medications are available for which indications, where new ones are in the approval process, what they cost, who can access them, and what resources are available to help with equitable access, are controlled by the FDA, the CDC, federal and state authorities, the drug manufacturers, as well as insurance providers, including Medicare and Medicaid. CLL Society keeps you up to date on that news in this section.
4 Action Steps to Take Right Now
Step One
Start by researching which medications you think you might need on your CLL / SLL journey, then checking to see if they are part of your insurance plan’s formulary. Lists of covered medications are often published by insurance plans. You can also call the insurance company’s helpline or even your pharmacy. Find out if it is possible to access drugs that are not on the formulary or consider participating in plans that do offer coverage for the medications you need.
Step Two
Learn as much as you can about those new drugs that might be helpful in your circumstances, then monitor their progress as they come close to FDA approval by following CLL Society’s clinical trial and regulatory news.
Step Three
Find out which drugs or clinical trials are on hold or have been withdrawn from use.
Step Four
Be aware of how legislation and government policies can affect affordable and equitable access to necessary treatments. CLL Society works hard on your behalf to bring about improved availability and controlled costs for the community we serve.
Step One
Start by researching which medications you think you might need on your CLL / SLL journey, then checking to see if they are part of your insurance plan’s formulary. Lists of covered medications are often published by insurance plans. You can also call the insurance company’s helpline or even your pharmacy. Find out if it is possible to access drugs that are not on the formulary or consider participating in plans that do offer coverage for the medications you need.
Step Two
Learn as much as you can about those new drugs that might be helpful in your circumstances, then monitor their progress as they come close to FDA approval by following CLL Society’s clinical trial and regulatory news.
Step Three
Find out which drugs or clinical trials are on hold or have been withdrawn from use.
Step Four
Be aware of how legislation and government policies can affect affordable and equitable access to necessary treatments. CLL Society works hard on your behalf to bring about improved availability and controlled costs for the community we serve.
FEATURE
FDA Approves Liso-cel, the First and Only CAR-T for CLL / SLL
3/14/24: FDA approved lisocabtagene maraleucel, the first CAR-T for relapsed / refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Brand-named Breyanzi and commonly known as liso-cel, it is the first and only chimeric antigen receptor (CAR) T or CAR-T cell therapy available for CLL / SLL patients. Its accelerated approval is for patients who have been previously exposed to a BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) and a BCL-2 inhibitor (venetoclax).
ADDITIONAL READING
