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Taking On Too Much

This issue of Managed Care was billed as being about Medicaid managed care and vulnerable populations. But as grumpy editors often say, that’s a topic not a story. And it didn’t take us very long to discover that the story was social determinants of health. Lola Butcher, a regular contributor to…

FDA Green-Lights First Fully Interoperable Continuous Glucose Monitoring System

The FDA has permitted marketing of the Dexcom G6 (Dexcom, Inc.) integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in patients two years of age and older with diabetes. This is the first type of continuous glucose monitoring system permitted by the agency to…

HTX-011 Provided Postoperative Pain Relief, Reduced Need for Opioids in Phase 3 Trials

Positive topline results have been reported from the completed phase 3 studies of the investigational agent HTX-011 (Heron Therapeutics) in patients undergoing bunionectomy (Study 301/EPOCH1) and hernia repair (Study 302/EPOCH2). HTX-011 achieved all primary and key secondary endpoints in both phase…

New Test for Diagnosing Insulin Resistance Could Turn the Tide Against Diabetes

This article marks a milestone. My first Tomorrow’s Medicine column ran in the April 2003 issue of Managed Care. As I thought about what to write about for this column, I reflected back on the past 15 years. Since the beginning, Tomorrow’s Medicine has focused on cutting-edge, highly technical,…

Keytruda Scores Another Win in Phase 3 Lung Cancer Study

The pivotal, phase 3 KEYNOTE-042 trial evaluating pembrolizumab (Keytruda), Merck’s anti-programmed death-1 (PD-1) therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non–small-cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary…

Duobrii Produces Positive Phase 3 Results in Psoriasis Treatment

Positive first-time results have been published for Duobrii (halobetasol propionate and tazarotene lotion, Ortho Dermatologics) for the treatment of plaque psoriasis. The data appear in the Journal of the American Academy of Dermatology. Two phase 3, multicenter, randomized, double-blind clinical trials…

FDA Restricts Sale and Distribution of Essure Contraception Device

The FDA has issued an order to restrict the sale and distribution of the Essure permanent contraception device (Bayer) to ensure that all women considering use of the device are provided with adequate risk information so that they can make informed decisions. The agency is taking this step after becoming…

Researchers Propose New Alzheimer’s Definition Based on Biology

Alzheimer’s researchers have proposed a radical change in the way the disease is defined, focusing on biological changes in the body rather than clinical symptoms such as memory loss and cognitive decline, according to a Reuters report. The new research framework, released by the Alzheimer’s Association…

FDA OKs Second Ovarian Cancer Indication for PARP Inhibitor Rubraca

The FDA has approved rucaparib (Rubraca, Clovis Oncology, Inc.) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The agency granted regular approval…

Briefly Noted April 2018

The window of time between a stroke and effective thrombectomy may be as long as 16 hours in many cases, according to a study in the New England Journal of Medicine. But advanced brain imaging technology may give physicians an extra 10 hours or more to respond to treat some strokes. A study published…

Managed care rules in Medicaid

Thirty-nine states had contracts with comprehensive risk-based Medicaid managed care organizations and in 29 of those states, 75% or more of the Medicaid beneficiaries were enrolled in one of those organizations. A large majority (27 of 32) of the Medicaid expansion states used managed care organizations to cover newly eligibly adults.

FDA Approves Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

The FDA has permitted marketing of IDx-DR (IDx LLC)—the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood…

Pradaxa Reversal Agent Praxbind Receives Full FDA Approval

The FDA has provided full approval for idarucizumab (Praxbind, Boehringer Ingelheim), the specific reversal agent for dabigatran (Pradaxa, Boehringer Ingelheim). Idarucizumab is indicated for patients treated with dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency…

FDA Clears First Contact Lens With Light-Adaptive Technology

The FDA has cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology (Johnson & Johnson Vision Care, Inc.) are soft contact lenses indicated for daily use…

FDA Approves Opdivo Plus Yervoy Combination for Certain Renal Cell Carcinoma

The FDA has granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) in combination for the treatment of intermediate- or poor-risk, previously untreated advanced renal cell carcinoma (RCC). The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label…

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