Mary Caffrey

Former FDA Commissioner Scott Gottlieb, MD, who has returned to the American Enterprise Institute, left FDA in April after 2 whirlwind years that saw a record pace of approvals and policy actions that covered everything from high drug prices to teen vaping. He spoke Friday in Philadelphia at Patient-Centered Oncology Care®, the annual meeting of oncology reimbursement stakeholders held by The American Journal of Managed Care®.

Hypertrophic cardiomyopathy is often an inherited condition and patients may not show symptoms, or those symptoms may be vague, such as fatigue or shortness of breath. The condition can cause varied levels of risk and can result in sudden cardiac death.

Oncology care groups have praised the multipayer Oncology Care Model (OCM) for transforming cancer care through greater focus on care navigation, palliative care, survivorship, and keeping patients out of the emergency department. But there are complaints that practices can be penalized for elements beyond their control—notably, the soaring cost of state-of-the-art immunotherapies that were not on the market when the OCM was conceived.

Researchers at the University of Alabama at Birmingham first isolated the kinase HIPK2 from among hundreds of potential targets by using bioinformatics to hone in on the protein kinase as a target for study.

Oral semgalutide’s price, along with its potential for adverse events, caused ICER to give empagliflozin the edge in cost effectiveness as physicians and health plans evaluate which type 2 diabetes therapy should be given after metformin.

There has been much speculation among the 175 practices still taking part in the OCM what will happen when the 5-year model expires in 2021. The RFI document states that the Oncology Care First model would start in January 2021, “when no new episodes would be initiating in OCM.”

Authors led by Justin Carrico of RTI Health Solutions compared 9 different biologics and the oral drug apremilast in treatment of psoriasis; their anaylsis, “from a US health plan’s perspective,” involved both base cost and cost-effectiveness models that included adverse events.

Rising rates of obesity and diabetes have raised concerns that more people could be headed for end-stage renal disease (ESRD); thus, Medicare has been seeking ways to reduce the cost of care and to improve the quality of life for people on dialysis. Scientists are focusing on whether more patients with early-stage type 2 diabetes should take sodium glucose co-transporter 2 inhibitors, which have been shown to slow renal decline.

The 19 signers of the letter to HHS Secretary Alex Azar and CMS Administrator Seema Verma include Senate Finance Committee members and lawmakers from states with high rates of diabetes and obesity.

Proposed changes to the Stark Law that would make collaboration easier have purposely excluded pharmaceutical manufacturers, according to speakers at the Community Oncology Alliance Payer Exchange Summit.

The Oncology Care Model is a leading innovation in the move from fee-for-service to value-based reimbursement in large part because CMS has made adjustments based on physician feedback, according to an agency official who addressed the Community Oncology Alliance Payer Exchange Summit.

What would a successor to the Oncology Care Model (OCM) look like? Community oncologists discuss at the Payer Exchange Summit sponsored by the Community Oncology Alliance.

Heading into 2019, the idea that oncology practices would fully embrace financial responsibility for clinical decisions still seemed far-fetched for many. And yet, when it was time to make the call, moving to 2-sided risk proved a “simple” decision, said Travis Brewer of Texas Oncology, who took part in a panel offering an update on the Oncology Care Model (OCM) at the start of the Community Oncology Alliance (COA) Payer Exchange Summit, which opened Monday in Tyson’s Corner, Virginia.

The idea that obesity is linked to mood disorders has been posited since at least 2004.

The advantage of empagliflozin, and the sodium glucose cotransporter 2 class generally, is that its unique mechanism expels excess glucose through the urine, thus offering the possibility of reducing glucose variability—eliminating the “roller coaster” effect that many with type 1 diabetes experience that can cause long-term microvascular damage.

A Colorado-based company, SonderMind, seeks to take on the financial risk associated with reimbursement for mental healthcare so that therapists will be more willing to see patients using their insurance coverage.

Results are based on the DECLARE-TIMI 58 cardiovascular outcomes trial, presented last year at the American Heart Association Scientific Sessions.

The trial, led by a team from the University of Edinburgh, used the troponin blood test to detect heart attacks, but with separate thresholds for men and women.

The global blood shortage is unevenly distributed: Out of 195 countries examined in the study, 119 had unmet need totaling more than 102 million units, the equivalent of 1849 per 100,000 population worldwide.

Although results of other recent studies have noted the rise in the rate of obesity-related cancers among younger adults, this is the first study to also find a concurrent decrease in the rate of new cancer cases among patients 65 years and older.

Omada Health, a longtime leader in digital health coaching for diabetes prevention and type 2 diabetes (T2D) care, and Abbott, maker of the FreeStyle Libre, said the partnership will “create a new paradigm” in T2D management.

A medical affairs official with Janssen said physicians may not bring up the option of a long-acting injectable for fear of disrupting the doctor-patient relationship.

The authors say their findings align with other analyses showing the cost-effectiveness of sodium glucose co-transporter 2 (SGLT2) inhibitors.

Previous work has linked psoriasis and nonalcoholic fatty liver disease, but this is one of the first studies to tie together the severity of the 2 conditions.

The findings have implications for survivorship care, as more patients are living longer due to the availability of immunotherapies.

Women who enter menopause before age 50 are substantially more likely to have a nonfatal cardiovascular event before they turn 60, and the risk grows the younger the women are when menstruation ends, according to a recent analysis.

More than 2 years after the FDA derailed the trajectory of its novel treatment system for type 2 diabetes (T2D), Intarcia Therapeutics today announced that regulators have accepted a resubmitted new drug application for the mini pump that delivers a continuous dose of exenatide.

A study last year pointed to empagliflozin as the best choice for patients who have type 2 diabetes and non-alcoholic fatty liver disease.

The mechanism studied affects a broad range of physiological responses and is now the focus of intense study by the pharmaceutical industry.

Diagnosis of hypertension was based on guidelines updated by the American College of Cardiology and the American Heart Association in 2017.