This week, the top managed care stories included bipartisan proposals for fixing the Affordable Care Act (ACA); FDA approved a targeted therapy for patients with acute myeloid leukemia who have a rare genetic mutation; and a study found that more patients have gained access to clinical trials after the ACA was implemented.
A bipartisan group of House members try to fix Obamacare, FDA approves a new targeted therapy, and President Trump’s opioid commission wants to declare a state of emergency.
Welcome to This Week in Managed Care, I’m Laura Joszt.
Bipartisan Healthcare Reform
After Senator John McCain called on Congress to put aside partisanship to reform healthcare, a group in the House of Representatives is taking up the cause.
Calling themselves the Problem Solvers Caucus, the 43 Democrats and Republicans on Monday released a plan to stabilize the individual market in time for 2018 open enrollment. Co-chaired by Republican Tom Reed of New York (show photo) and Democrat Josh Gottheimer of New Jersey, (show photo) the group’s ideas include:
AML Drug Approved
FDA this week approved enasidenib, a targeted therapy to be sold as Idhifa, to treat patients with acute myeloid leukemia (AML) who have a rare genetic mutation. The approval came weeks ahead of the FDA’s deadline to act on the application.
The therapy, from Celgene and Agios Pharmaceuticals, was approved with a companion diagnostic for patients with an IDH2 mutation, whose leukemia has relapsed or resisted other treatment. Between 8% and 19% of AML patients have the mutation. The disease tends to strike older patients, starting in the bone marrow and progressing quickly. A trial showed that after six months on the therapy, 19 percent of patients had complete remission for an average of just over 8 months, and 4 percent of patients had complete remission for more than 9 months.
Celgene CEO Mark Alles praised FDA for acting quickly, and Agios’ CEO said there’s more to come. “The FDA approval of Idhifa just 4 years after entering the clinic is the first of what we expect to be multiple first-in-class precision medicines for patients with cancer and rare genetic diseases from our productive discovery engine.”
Cancer Trial Participation
A study based on data from MD Anderson Cancer Center in Houston, Texas, finds that the Affordable Care Act has made it easier for patients to gain access to clinical trials.
The study compared patients referred to a trial before and after the law took full effect in January 2014. Researchers found that patients referred after the effective date were five times more likely to be cleared by their insurer to participate.
Said MD Anderson’s David Hong, MD, “In a phase I trial, many patients are in a state of advanced disease, so a single day can matter a great deal to them. We are in a golden era of new drugs, but the only way to get them approved and available to patients is to get more people into clinical trials.”
Opioid National Emergency
President Donald Trump’s opioid commission has called on him to declare the addiction crisis a national emergency.
The panel, convened in March, wants to end a rule that limits how many Medicaid beneficiaries can get into residential treatment, and it called for greater access to medication to treat addiction. An emergency declaration would bring more awareness and more resources, commission members wrote in their report to the president.
“With approximately 142 Americans dying every day, America is enduring a death toll equal to September 11 every 3 weeks. Your declaration would empower your cabinet to take bold steps and would force Congress to focus on funding and empowering the executive branch even further to deal with this loss of life.”
Promoting Digital Health Innovation
The FDA knows digital health is coming and wants its rules to promote innovation, not hinder progress. That’s what FDA Commissioner Dr. Scott Gottlieb wrote in this week’s blog post that presented both the agency’s Digital Health Innovation Plan and its first piece, a software precertification program.
FDA will select 9 companies to test a new approach to software regulation, which will tailor rules toward a company’s overall track record, not individual products.
The goal is to let companies offer upgrades and collect data, with regulators looking at performance after the fact in most cases. Wrote Gottlieb, “We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”
Finally, the American Diabetes Association and the American Association of Diabetes Educators have updated their guidelines on diabetes self-management education and support, calling on payers to cover these services throughout a patient’s lifespan with the disease.
The AADE will meet hold its annual meeting this weekend in Indianapolis, and you can look for coverage on AJMC.com.
For all of us at the Managed Markets News Network, I’m Laura Joszt. Thanks for joining us.