Some promising news to kick off Blood Cancer Awareness Month – on September 1, 2020, the U.S. Food and Drug Administration approved a new oral maintenance treatment for certain adult patients with acute myeloid leukemia (AML).
CC-486 (Onureg®) is now approved for the continued treatment of adult patients with AML who achieved first complete remission (CR) or CR with incomplete blood count recovery (Cri) following intensive induction chemotherapy and who are not able to undergo intensive curative therapy, such as hematopoietic stem cell transplant.
CC-486 is a new oral formulation of azacitidine, an existing therapy that is administered via infusion or injected subcutaneously at a clinic or hospital. This approval establishes an important new maintenance treatment for AML patients in remission that can be taken once daily as a pill.
The approval is based on data from the QUAZAR AML-001 study, which showed that the therapy resulted in a statistically significant and clinically meaningful improvement in overall survival of nearly 10 months, compared to placebo.
The Leukemia & Lymphoma Society (LLS) helped laid the foundation for this advance, supporting early proof-of-concept work through our research grants portfolio. We continue to lead the charge against AML through our groundbreaking Beat AML Master Clinical Trial – the first collaborative precision medicine clinical trial in a blood cancer – and our investment in the most cutting-edge AML research around the globe, which you can learn more about here.
LLS helped advance 55 of the 65 blood cancer treatment options approved by the U.S. Food and Drug Administration since 2017.
430,000 people – it’s a huge number. It’s the population of Minneapolis. Nine straight days of sell-out crowds at Yankee Stadium. Nearly the entire enrollment of the Southeastern Conference. And it’s the number of people who, in the last six weeks, have become newly eligible for Medicaid, thanks to successful ballot initiatives this summer in Oklahoma and Missouri. LLS, our staff, and our volunteers are proud to have played a role in this major win for patients.
Those victories couldn’t have come at a more important time, with patients navigating both COVID-19, which directly threatens their health, and the recession, which threatens their ability to obtain insurance and afford healthcare. Medicaid is a critical lifeline for low-income cancer patients, and we know that millions of Americans have lost their health insurance during the recession. Expanding Medicaid helps ensure low-income families and individuals can access healthcare.
In both Oklahoma and Missouri, our Office of Public Policy mobilized advocates through emails, texts and social media, urging them to vote for Medicaid expansion and pointing them toward information on how to register to vote and cast their ballots. LLS also worked closely with other patient organizations as part of a coalition, highlighting how Medicaid expansion would support patients in their time of need.
LLS continues its advocacy work on behalf of patients at the federal level as well. Recently, Senate Republicans introduced their latest COVID-19 relief bill, and House Democrats introduced theirs in May. As you’ve likely seen, relief talks have come to a standstill. While the future of supplemental unemployment benefits, which ended in July, is in the spotlight, LLS’s policy priorities are focused on other issues impacting patients directly.
We’re urging lawmakers to:
Provide additional funding for Medicaid, which many cancer patients depend on
Create an open enrollment period on HealthCare.gov, allowing anyone who wants to buy health insurance to purchase it right now
End surprise medical bills – which can discourage people from getting medical treatment and cause financial devastation
Provide federal subsidies for COBRA coverage, allowing those who lost their jobs amid the recession to continue to afford health insurance
Extend paid leave for workers to reduce the spread of COVID-19
LLS led the drafting of a recent letter to Congressional leaders on behalf of nearly 30 patient organizations that elaborates on each of these needs. Additionally, LLS signed onto a statement with other nonprofits and patient organizations, calling for programs in the next federal COVID-19 package that will address the financial needs of nonprofits so they can keep serving their communities.
So far, our network of online volunteers has shared more than 12,000 letters with Congress urging lawmakers to take important steps to protect the health and safety of blood cancer patients. We’re in an unprecedented time. That’s why LLS’s Office of Public Policy – experts in lobbying, public policy, advocacy and communications – continues to work to ensure our country is doing everything possible to protect blood cancer patients.
Want to raise your voice for patients? Sign up to be an advocate today.
As an LLS Clinical Trial Nurse Navigator, Ashley Giacobbi works tirelessly to connect the right patient with the right clinical trial – work that has become increasingly complicated in the COVID-19 era.
But recently, she went the extra mile to ensure a patient – a young healthcare worker whose AML had relapsed several times – could access a trial that offered a promising treatment option.
The patient had reached out to LLS seeking a trial back in May. Giacobbi identified about 15 options that were close to the patient’s home and seemed like a good fit. She shared them with the patient, who in turn discussed them with her physician.
Then, Giacobbi said, she heard nothing – until a few months later when she got a call from the medical director of the patient’s insurance company. The patient had submitted to her insurer a list of eligible trials provided by LLS and a request to receive a consultation at a large academic medical center, where three of the trials were being conducted. But the insurer had denied her request.
Unfortunately, these denials are common, Giacobbi says. But it’s unusual for a medical director to contact LLS’s Clinical Trial Nurse Navigators after a denial. In this case, the medical director sought more information about trials and how they’re typically covered by Medicare. Many commercial insurers follow Medicare’s positions as a guide to their own coverage decisions. Giacobbi shared that information, along with information about LLS’s Clinical Trial Support Center (CTSC).
The medical director suggested that she believed the denial was an error and said there was some “wiggle room” in the decision. Eventually, she called Giacobbi back and shared the good news: the insurer decided to reverse its denial. Thanks to the information that LLS provided, the patient’s insurance would cover the care associated with her participation in the clinical trial. “It’s exciting to know that the patient had the option to move forward with the trial she feels is best for her,” Giacobbi says.
That wasn’t all. The medical director added that she planned to have her company reevaluate its policies around clinical trials and provide education to staff about how to handle claims involving trials.
For cancer patients, clinical trials represent hope – but unfortunately, obstacles often stand in the way for those seeking access to these lifelines.
LLS’s Office of Public Policy is working to ensure every patient’s insurance coverage includes coverage for care associated with clinical trials, explains Brian Connell, LLS’s executive director of federal government affairs. “In theory, the Affordable Care Act provides that – but in practice, there are a lot of holes,” Connell says.
In some cases, insurers may not even be following their own rules when it comes to clinical trial coverage – which may have been the case for the initial denial Giacobbi helped address.
Fixing those problems doesn’t just help patients get access to medical care. It helps advance research. “We hear all the time from researchers who say patients can’t come to their trials because of their insurance coverage,” Connell says. “But it’s supposed to be covered, according to the Affordable Care Act. Part of our detective work is figuring out exactly what’s going on.”
LLS is working to do exactly that as part of an effort with a working group of other patient organizations studying barriers to clinical trial coverage. Alissa Gentile, director of the CTSC, leads that work for LLS.
Of course, insurance coverage isn’t the only barrier to trials. In most cases, a patient enrolled in a clinical trial must make repeated visits to an academic medical center – not just for treatments, but for blood samples, imaging and other monitoring. But those trips can pose a hurdle to some patients, who may not have the time or resources to make repeated visits to those facilities if they are far from home. A more creative approach might allow patients to get imaging and lab work done at more conveniently located facilities, with treatment administered at the academic centers. Some of these changes are happening already as a response to COVID-19.
LLS is working to break down barriers like these to ensure patients who are eligible for clinical trials can participate. “If you make clinical trials more accessible, you’ll have more people in your trials, more diversity in your trials – and ultimately, you get more accurate results,” Connell says.
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