This Week in Managed Care: May 26, 2017

The CBO weighs in on the House healthcare bill, science and health groups are not happy about Trump’s new budget, and the FDA breaks new ground with a cancer drug approval.

Welcome to This Week in Managed Care, I’m Laura Joszt.

CBO Scores AHCA

This week, the Congressional Budget Office (CBO) gave a revised score for the American Health Care Act, which passed the House of Representatives on May 4th.

The new estimate finds 23 million people will lose coverage over 10 years, and that the bill will save $119 billion dollars. But CBO also found that a late change to the House bill, the MacArthur amendment, could lead to large premium disparities for those with chronic conditions, if they live in states that are likely to seek waivers from current rules that require community rating and coverage for essential health benefits.

The CBO found: “Over time, it would become more difficult for less healthy people (including people with preexisting medical conditions) in those states to purchase insurance because their premiums would continue to increase rapidly.”

A Senate working group is expected to write its own version of a replacement for the Affordable Care Act.

White House Reveals Budget

The Trump Administration released its budget for fiscal year 2018 this week, and White House Budget Director Mick Mulvaney said it was “the first time in a long time that an administration has written a budget through the eyes of the people who are actually paying the taxes.”

The budget contains several cuts to basic science and healthcare programs, including:

• $610 million to Medicaid over 10 years, on top of more than $800 million in cuts assumed by the AHCA
• $5.7 billion over 2 years to the Children’s Health Insurance Program
• $5.8 billion from the National Institutes of Health
• $1 billion from the CDC, which would harm the Diabetes Prevention Program scheduled to start in Medicare in January
• $855 million from the FDA, replaced with industry fees

Many groups called on Congress to reverse the cuts, including Daniel Hayes, MD, FACP, FASCO, president of the American Society of Clinical Oncology, who said: “Our biomedical research infrastructure is vital to sustaining the health and safety of our citizens. If allowed to crumble, it will take decades to rebuild. ASCO is ready to work with lawmakers to develop a budget that adequately funds cancer care and research infrastructure—and better serves the estimated 2.1 million Medicaid beneficiaries who have a cancer diagnosis or are cancer survivors.”

A First for FDA

FDA broke new ground in precision medicine this week, when it granted a drug approval based on a genetic marker, not a tumor location.

The approval given for pembrolizumab, sold as Keytruda, is for the treatment of adult and pediatric patients who have unresectable or metastatic, microsatellite, instability high or mismatch repair deficient solid tumors, that have progressed after treatment, or who have no other treatment options.

The drug was also approved for patients whose colorectal cancer has progressed after treatment with three other specific therapies. The new indication was granted under FDA’s accelerated approval process.

Health Economics Trends

AJMC traveled this week to Boston for the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research, known as ISPOR. We spoke with Dr. James Chambers, winner of the Bernie J. O’Brien New Investigator Award, about trends he sees coming in the next 5 years. Watch the interview.

See more coverage from ISPOR.

Gottlieb's Plan for the Opioid Crisis

Finally, in one of his first acts as FDA Commissioner, Scott Gottlieb, MD, outlined how he plans to tackle the nation’s opioid crisis.

In an open letter published on the FDA Voice blog, Gottlieb announced the creation of an Opioid Policy Steering Committee within FDA and listed 3 questions for the group;

• When should FDA require mandatory prescriber education?
• How can FDA ensure that prescribing is appropriate?
• What should be the standards for approving new opioid medications?

For all of us at the Managed Markets News Network, I’m Laura Joszt. Thanks for joining us.