This Week in Managed Care: March 22, 2019

New primary prevention guidelines could increase the use of some diabetes drugs, the FDA expands criteria for which patients can take part in clinical trials, and a summit on Value-Based Insurance Design shows the need for tough conversations with stakeholders.

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

Cardiovascular Prevention in Diabetes

Last weekend’s annual meeting of the American College of Cardiology (ACC) brought an updated set of primary prevention guidelines, released with the American Heart Association.

The guidelines say 2 newer classes of type 2 diabetes drugs, the SGLT2 inhibitors and the GLP-1 receptor agonists, can be prescribed to prevent long-term complications, such as heart failure.

The guidelines also recommend limiting the use of aspirin in primary prevention and for clinicians to investigate social determinants of health.

Other headlines from the ACC meeting included:

• A large study involving Apple Watch found it can capture atrial fibrillation, and Johnson & Johnson now plans to use the watch in a randomized clinical trial
• New results from the DECLARE trial found that dapagliflozin offers benefits for diabetes patients with heart failure
• New results from the REDUCE-IT trial show a high dose of an omega-3 fatty acid component, sold as Vascepa, cuts the total of cardiovascular events by 30%

Read full coverage of the ACC Scientific Session.

Patient Inclusion Criteria for Trials

Both the FDA and the research community have discussed the challenge of getting more patients in clinical trials—especially study patients who reflect the real-world population.

With this in mind, FDA last week issued 4 draft guidance proposals and 1 final guidance to get more children and more patients with comorbidities into cancer trials.

Said FDA Commissioner Scott Gottlieb, MD, “In trials testing treatments for cancer, some eligibility criteria have become commonly accepted over time or used as a template across trials without a clear scientific or clinical rationale or justification. In other cases, eligibility criteria can be deliberately restrictive, even though it is not clinically merited. As a result, cancer patients are often unnecessarily restricted from participating in trials.”

The final guidance gives criteria for enrolling teenagers in adult oncology trials. The adolescent and young adult age group has been underrepresented in clinical trials, and survival rates in this age group have stalled.

The proposed guidance documents address the following:

• Minimum age requirements for pediatric patients
• When studies can enroll patients with HIV, hepatitis B, or hepatitis C
• When studies can enroll patients who had pre-existing organ dysfunction
• The criteria for enrolling patients with brain metastases

In a recent interview with The American Journal of Managed Care^® (AJMC^®), Janice Mehnert, MD, of Rutgers Cancer Institute of New Jersey discusses when trials should be open to patients with comorbidities.

Watch the video.

Discussing Low-Value Care

There’s plenty of discussion about the need to reduce low-value services in healthcare, but actually making those cuts requires tough conversations. That was one of the lessons from this year’s Value-Based Insurance Design Summit, held at the University of Michigan in Ann Arbor.

Gwen Darien, of the National Patient Advocate Foundation, said the language used when describing the need to eliminate low-value services is critical.

Said Darien: “A lot of the ways that we’ve talked about reducing low-value services has had to do with waste and waste in the system. People do not want to hear that anything that their doctor is prescribing for them is wasteful.”

Instead, it’s important for payers to frame the conversation about the harms of unnecessary services.

Check out full coverage of the V-BID summit.

Increasing Awareness of PrEP

Gay and bisexual men who participated in community groups had greater awareness of pre-exposure prophylaxis, or PrEP, than those who did not, a new study has found. With 70% of new HIV infections occurring among gay and bisexual men, getting this group to take PrEP is a crucial step to reducing infection rates.

The study in PLoS One, which was conducted in New Orleans, a city with a high HIV infection rate, found the following:

• Men in the target population who took part in community groups were 40% more likely to be aware of PrEP than those who did not.
• 47% of gay and bisexual men were aware of PrEP.
• 60% of participants would be willing to use it.

Conference Coverage

AJMC^® will be on the road again this week, covering the 45th Annual Meeting and Cancer Center Business Summit of the Association of Community Cancer Centers (ACCC), which takes place in Washington, DC.

From there, we head to Orlando, Florida, for the annual conference of the National Comprehensive Cancer Network.

Sign up for coverage from major meetings,

Read all our conference coverage from ACCC and NCCN.

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