This Week in Managed Care: April 19, 2019

A landmark study finds a diabetes drug prevents kidney failure, FDA approves a new treatment for metastatic bladder cancer, and nearly half of all cancer deaths are due to modifiable risk factors.

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

Canagliflozin Cuts Risk of Renal Failure, Death

A highly anticipated study this week found that the type 2 diabetes drug canagliflozin cut the risk of renal failure or renal death by 30%, a finding that should be hugely important to policy makers. End-stage renal disease already accounts for 7% of spending in Medicare, and kidney failure is rising along with obesity.

Results for the CREDENCE study, presented in Melbourne, Australia, showed the following:

• Canagliflozin easily met a primary endpoint of reducing the risk of dialysis, a need for kidney transplant, doubling of serum creatinine, or renal or cardiovascular death.
• Compared with placebo, patients taking canagliflozin had fewer heart attacks and strokes, although these results may have been affected because the study ended early.
• CREDENCE showed no signs of increased amputation risk seen in an earlier study of canagliflozin.

Janssen, which sells the drug as Invokana, is expected to ask FDA to remove a boxed warning to reflect this new data. The company has already filed for a new indication based on the CREDENCE results.

Said the study’s lead author, Vlado Perkovic, MBBS, PhD, FASN, FRACP, of The George Institute, “Canagliflozin is the first medical breakthrough in nearly 20 years proven to slow the progression of chronic kidney disease in patients with diabetes at high risk of developing kidney failure. These impressive results…have significant clinical implications for preventing kidney failure and improving health for millions of people living with chronic kidney disease and type 2 diabetes.”

CREDENCE is the first of a wave of renal outcomes studies in the SGLT2 inhibitor class, which have already been shown to have multiple benefits beyond lowering blood glucose.

For more, visit ajmc.com.

FDA Approves Erdafitinib for Metastatic Bladder Cancer

FDA last week approved the first targeted therapy for bladder cancer. Erdafitinib, sold as Balversa, is approved for treatment of adults with locally advanced or metastatic bladder cancer with certain fibroblast growth factor receptor mutations (FGFR), if their cancer has progressed on platinum-based chemotherapy. Treatment with the therapy brought an overall response rate of 32.2%, with a median duration of 5.4 months. FDA also approved a companion diagnostic test to identify patients who will benefit from the drug.

Said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research: “We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. Today’s approval represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.”

Modifiable Risk Factors Account for Approximately Half of Cancer Deaths

Nearly half of all cancer deaths can be tied to a modifiable risk factors, such as smoking, being obese, or alcohol use. While cancer death continues to decline overall, 45% of the 607,000 deaths in 2019 will be tied to behavioral factors or things like failure to improve cancer screening. The findings are based on an evaluation of two surveys that are conducted by the CDC, with results published in the journal Cancer Epidemiology, Biomarkers, and Prevention. The study captured data through 2017.

The authors found that death rates varied significantly by race and by education level, adding to the evidence that social determinants of health play an important role in health outcomes.

The authors wrote: “Reducing these modifiable cancer risk factors and improving cancer screening will require broad implementation of national, state, and local policies, social/community efforts, as well as individual behavioral interventions. Many of these strategies have been proven to be effective, but their application has been suboptimal, especially in socioeconomically deprived populations.”

Perspective on the Unstable Future of Genetic Testing Reimbursement

A panel discussion at a meeting last week of Florida oncologists included the surprise announcement that CMS may reopen the National Coverage Determination for Foundation Medicine. During the meeting of the Florida Society of Clinical Oncology in Kissimmee, Florida, Dr. James Almas of LabCorp, previously a medical officer at CMS, said that the federal agency would soon announce a reopening of the coverage determination because it does not allow the same test to be used more than once, with one exception.

A representative from Foundation Medicine said that Medicare’s coverage for the company’s next-generation sequencing test is fairly broad, but she did not dispute Almas’ account.

Rapid advances in testing are making their way into clinical guidelines, as more therapies rely on genetic testing to ensure the right patients are receiving expensive cancer treatments. However, testing now occurs at multiple points during cancer treatment, and reimbursement policy has not always kept pace.

Said Michael Kolodziej, MD, of ADVI Health, “When an NCD is reopened, it’s dangerous. In reality, it’s a threat to Foundation Medicine.”

For full coverage of the FLASCO meeting, visit ajmc.com.

Understanding the Relationship Between Inappropriate Opioid Prescribing and Mortality

Finally, a new study in The American Journal of Managed Care^® shows a strong connection between inappropriate opioid prescribing practices and deaths. The study drew on data from Georgia Medicaid pharmacy claims from 2009 to 2014, as the opioid crisis was escalating. It showed that the odds of death were 76% higher for patients who experienced at least one inappropriate prescribing practice—and deaths were much higher among fee-for-service patients than those in managed care.

The authors wrote: “Being in managed care Medicaid decreased the odds of experiencing death by 69% for opioid users compared with being in fee-for-service Medicaid.”

For the full study, visit ajmc.com.

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