This Week in Managed Care: December 20, 2019

A federal appeals court overturns the individual mandate, the Trump administration unveils a plan to import low-cost drugs, and FDA approves a popular fish oil pill to prevent heart attacks and strokes.

Welcome to This Week in Managed Care, I’m Christina Mattina.

Federal Appeals Court Strikes Down Individual Mandate

A federal appeals court has found the individual mandate unconstitutional, creating more doubt about the centerpiece of the Affordable Care Act (ACA) ahead of the 2020 presidential election.

In a 2-1 ruling, the 5th Circuit found that a Texas District Court judge went too far in finding the entire ACA unconstitutional and remanded most of the case back for review. The panel told the Texas court to take a “finer-toothed comb” in ruling whether loss of the individual mandate would also dismantle requirements that health plans cover pre-existing conditions or that young adults can stay on parents’ plans through age 26.

The panel wrote, “We do not hold forth on just how fine-toothed that comb should be—the district court may use its best judgment to determine how best to break the ACA down into constituent groupings, segments, or provisions to be analyzed. Nor do we make any comment on whether the district court should take into account the government’s new posture on appeal or what the ultimate outcome of the severability analysis should be.”

President Trump’s response noted that nothing happens to the healthcare system for now: “Today’s decision … confirms what I have said all along: that the individual mandate, by far the worst element of Obamacare, is unconstitutional. This decision will not alter the current healthcare system. … The radical healthcare changes being proposed by the far left would strip Americans of their current coverage. I will not let this happen. Providing affordable, high-quality healthcare will always be my priority.”

However, the administration’s shifting position in the case means it has sided with states that seek to overturn the ACA while relying on some of its provisions to create new payment models in oncology and kidney care and to find solutions for high drug prices.

For more, visit ajmc.com.

US Unveils Proposed Rules to Allow Some Canadian Drug Imports

FDA and HHS jointly presented a plan Wednesday to allow certain drugs imported from Canada—one that may not cover some specialty medications and costly therapies for chronic disease.

The plan comes in 2 parts:

• First, a notice of proposed rulemaking would let states import small molecule brand-name drugs sold at retail pharmacies—typically drugs with rebates.
• Second, a draft guidance for industry would let manufacturers seek a National Drug Code for FDA-approved drugs now sold in foreign countries and import these drugs to the United States.

The plan for states leaves out controlled substances, intravenous or infused drugs, biologics, or drugs with risk evaluation and mitigation strategies.

The plan appears to be a middle ground between eliminating rebates, which Azar sought, but President Donald Trump ultimately rejected.

Said HHS Secretary Alex Azar, “These are historic actions by HHS and the FDA, and they represent the bold nature of President Trump’s agenda for lowering drug costs. The President has recognized the opportunity to lower costs for American patients through safe importation, and we at HHS and FDA are delivering on that possibility through a safe, commonsense approach.”

Former FDA Commissioner Dr. Scott Gottlieb, who has opposed drug imports due to safety concerns, tweeted, “On close review [the proposed rule] places stringent conditions on the importation of drugs. While it may sharply limit Canadian drugs under this framework, it maintains critical FDA safeguards to protect consumers.”

The plan is opposed by pharmaceutical industries in both the United States and Canada.

For more, visit ajmc.com.

FDA Approves Vascepa as Add-on Therapy to Reduce CV Risk

The FDA has approved the purified omega-3 fatty acid Vascepa as an add-on as a way to reduce the risk of heart attacks and strokes.

The fish oil derivative, first approved to treat triglycerides, has been shown in studies to reduce the risk of a first cardiovascular event by 25%.

Said study author Dr Deepak Bhatt, “The FDA approval [of Vascepa] as an addition to statin therapy to reduce the risk of cardiovascular events is a major milestone in cardiovascular prevention. Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statins nearly 3 decades ago. Many patients will benefit from this historic advance in care.”

The label change covers patients with triglycerides of at least 150 mg/dL. Patients must have established cardiovascular disease or diabetes with 2 additional risk factors.

Government-Insured Patients With Breast Cancer Face a Higher Risk of Death

Patients with breast cancer who have government insurance face a higher risk of death, according to a retrospective study presented at the San Antonio Breast Cancer Symposium.

The study by the ECOG-ACRIN group examined 9800 women who took part in separate clinical trials for 2 different treatments. Overall, women in Medicaid and Medicare were much less likely to take part in clinical trials.

Said the study’s lead author, Dr Samilia Obeng-Gyasi, “Having insurance in and of itself was not enough to ensure access to a clinical trial or a good clinical outcome. … With continued changes to insurance at the federal and state levels, physicians and policy makers would benefit from having more data such as what we produced in our study.”

For more, visit ajmc.com.

Evidence-Based Oncology™

The proposed cancer care model Oncology Care First gets extensive coverage in the new issue of Evidence-Based Oncology™, which features interviews with leading oncologists Dr Kashyap Patel and Dr Stephen Schleicher and a commentary from Keely Macmillan of Archway Health.

For the full issue, visit ajmc.com.

For all of us at AJMC^®, I’m Christina Mattina. Thanks for joining us.