Equitable Access and 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Find out which drugs or clinical trials are on hold or have been withdrawn from use.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.

Please consider helping CLL Society in its advocacy work.

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.

Please consider helping CLL Society in its advocacy work.

FEATURE

FDA Approval of Lymphoma Medicine Ukoniq (Umbralisib) Is Withdrawn Due to Safety Concerns

We have already covered the voluntary withdrawal by the TG Therapeutics of its application for use in CLL of umbralisib in combination with ublituximab (U2 combination) after the FDA made it very clear that it is not likely to be approved soon, if ever. Now its approvals in marginal zone lymphoma (MZL) and follicular lymphoma (FL) are being withdrawn by the FDA. Read more.

TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA (biologics license application/supplemental new drug application) for U2 to Treat Patients with CLL and SLL: The End of the Road for Any New PI3Ki for CLL/SLL?

TG Therapeutics, after a decade of development, is withdrawing its application for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

While they are real safety concerns, this is not good news for CLL/SLL patients. Read more.

ADDITIONAL READING

TG Therapeutics, after a decade of development, is withdrawing its application for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).