This Week in Managed Care: February 22, 2019

CMS offers a plan to cover chimeric antigen receptor (CAR) T-cell therapy, a study faults FDA’s handling of fentanyl oversight, and breast surgeons call for genetic testing in all breast cancer patients. Welcome to This Week in Managed Care, I’m Samantha DiGrande.

Coverage for CAR T-Cell Therapy

After months of speculation, CMS has a plan to pay for CAR T-cell therapy, but there’s a catch: Every patient would have to be enrolled in a registry or a clinical trial and followed for at least 2 years. The Coverage with Evidence Development model would generate data that CMS would use for a broader model that would not require patients to enroll in registries.

Said CMS Administrator Seema Verma, “[This] proposed coverage decision would improve access to this therapy while deepening CMS’s understanding of how patients in Medicare respond to it, so the agency can ensure that it is paying for CAR T-cell therapy for cases in which the benefits outweigh the risks.”

But Joseph Alvarnas, MD, vice president of government affairs and senior medical director for employer strategy​ at City of Hope; editor-in-chief of Evidence-Based Oncology™, told AJMC^® that while the data will be useful, the documentation requirements could affect patient access. Said Alvarnas, “It adds to the burden, and anything that adds to the burden increases the risk of disenfranchising some patients.”

For more, visit ajmc.com.

Oversight of Rapid-Release Fentanyl

FDA’s program to block inappropriate use of fentanyl failed to prevent off-label use or keep it away from patients who were not already using opioids, a study reported this week. A study in JAMA and an accompanying editorial called for reforms of FDA’s Risk Evaluation and Mitigation Strategy, known as REMS.

JAMA authors also criticized FDA for a five-year effort to block researchers from gaining access to data and said despite, weaknesses in REMS, the agency did nothing to fix the program. Five years after the program began to monitor transmucosal immediate release fentanyl, researchers found the following:

• 39% of physicians reported prescribing the fentanyl class for chronic noncancer pain
• Claims showed that 34.6% to 55.4% of patients getting the fentanyl class were opioid nontolerant, even though the class is contraindicated.

Authors suggested several reforms, including making a third party in charge of REMS.

Genetic Testing for All Patients With Breast Cancer

Guidelines issued last week by the American Society of Breast Surgeons call for giving every patient diagnosed with breast cancer a genetic test with a multigene panel. The consensus statement from the society’s board of directors has 5 elements:

• Breast surgeons, genetic counselors, and other knowledgeable professionals can provide education and counseling, make recommendations and arrange testing.
• Genetic testing should be available to all patients with a personal history of breast cancer. Testing should include BRCA1/2, PALB2, and other genes consistent with family history.
• Patients who had genetic testing may benefit from updated testing.
• Genetic testing should be made available to those without a history of breast cancer who meet the National Comprehensive Cancer Network guidelines.
• Variants of uncertain significance are DNA sequences that are not clinically actionable. This type of result must be considered inconclusive.

The statement is supported by a study published last year in the Journal of Clinical Oncology. Some payers have required genetic counseling with testing to avoid unnecessary surgeries.

For more, visit ajmc.com.

Diet Drink Consumption and Stroke Risk

Diet soda is not as healthy as it seems, according to findings from the Women’s Health Initiative. A study that tracked 81,000 women for an average of nearly 12 years found that those who drank two or more artificially sweetened drinks per day had a 23% higher risk of having any type of stroke, and a 31% higher risk of having a stroke to a blood clot in the brain, compared with women who drank fewer than 1 beverage a week. Risk increased even for women with no prior history of cardiovascular disease or diabetes.

Said study author Yasmin Mossavar-Rahmani, PhD, associate professor of clinical epidemiology and population health at Albert Einstein College of Medicine: “Our research and other observational studies have shown that artificially sweetened beverages may not be harmless and high consumption is associated with a higher risk of stroke and heart disease.”

Advancing Quality Oncology Care

Finally, join us in Dallas March 7 when The American Journal of Managed Care^® will hold its next session of the Institute for Value-Based Medicine: Advancing Quality Oncology Care in the Evolving Value-Based Care Landscape. The session begins at 5:30 pm at the Four Seasons Las Colinas and features:

• Ray Page, DO, PhD, FACOI, president & director of research; and Barry Russo, chief executive officer of the Center for Cancer and Blood Disorders
• Lance Spivey, president of StratiFi Health
• Kashyap Patel, MD, chairman of Carolina Blood and Cancer Center
• John Cox, DO, MBA, FASCO, professor at UT Southwestern Medical Center

For all of us at the Managed Markets News Network, I’m Samantha DiGrande, thanks for joining us.