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Abbott's (ABT) CGM Device Gets MHLW Nod for Expanded Coverage

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Abbott Laboratories (ABT - Free Report) has gained approval from the Japanese Ministry of Health, Labour and Welfare (“MHLW”) to expand the reimbursement coverage for its FreeStyle Libre system to include all people with diabetes who require insulin at least once a day. The reimbursement expansion for the continuous glucose monitoring (CGM) system is anticipated to take effect on Apr 1, 2022.

The expanded reimbursement coverage was granted based on the overall value proposition of FreeStyle Libre, which considered ease-of-use and scientific evidence demonstrating the clinical benefits of utilizing the FreeStyle Libre system among patients taking self-injections of insulin. With the expanded coverage, more diabetes patients will get the glucose data required to manage their condition without using the routine fingersticks related to traditional blood glucose monitoring.

The latest MHLW approval of the expanded coverage for the FreeStyle Libre system is likely to bolster Abbott's diabetes care business.

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The expanded reimbursement coverage for the FreeStyle Libre system will provide healthcare professionals with CGM information and actionable insights for diabetes patients. Previously, these data and insights were available to only a limited number of patients requiring multiple daily insulin injections. This would help patients form a better understanding and control of their diabetes based on glucose fluctuation through continuous monitoring, leading to better management of their overall condition and lowering the risks of diabetes-related complications.

 

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Per management, the FreeStyle Libre system has been designed with access and affordability in mind. The FreeStyle Libre systems provide a complete and comprehensive glucose picture, eliminating the need for routine fingersticks. The technology helps facilitate behavior change, allowing people to live better and more fulfilling lives.

Industry Prospects

Per a report published in Allied Market research, the global continuous glucose monitoring systems’ market size is expected to see a CAGR of 22% by 2027. Factors, including a surge in the geriatric population and the increasing prevalence of diabetes, are expected to fuel market growth.

Given the substantial market prospects, the expanded coverage for the FreeStyle Libre system comes at an opportune time.

Other Notable Developments

In February 2022, Abbott gained FDA approval for an expanded indication for its CardioMEMS HF System to support the care of heart failure patients. The CardioMEMS sensor acts as an early warning system for doctors, enabling them to treat worsening heart failure. It has been found to reduce hospitalizations for patients with later-stage heart disease when utilized in monitoring for signs of worsening heart failure.

In January 2022, the company announced the receipt of the FDA clearance for the EnSite X EP System with EnSite Omnipolar Technology. The new system is available in the United States and across Europe, and is intended to assist physicians in better treating cardiac arrhythmias. It offers a highly detailed three-dimensional maps of the heart to aid physicians in detecting and treating areas of the heart where abnormal rhythms originate.

In the same month, the company received FDA approval with its Proclaim XR spinal cord stimulation system for people with chronic pain. This time, the regulatory body has approved an expanded magnetic resonance imaging compatibility for the Proclaim XR platform with Octrode leads. The approval will augment Abbott’s Neuromodulation arm.

Share Price Performance

The stock has outperformed its industry over the past year. It has declined 2.7% against the industry’s 16.8% fall.

Zacks Rank and Key Picks

Currently, Abbott carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space are Henry Schein, Inc. (HSIC - Free Report) , AMN Healthcare Services, Inc. (AMN - Free Report) and McKesson Corporation (MCK - Free Report) .

Henry Schein has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.5%. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Henry Schein has outperformed the industry over the past year. HSIC has gained 26% compared with the industry’s 7.6% rise over the past year.

AMN Healthcare has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average. It currently flaunts a Zacks Rank #1.

AMN Healthcare has outperformed its industry in the past year. AMN has gained 38.5% versus the 53.5% industry decline.

McKesson has a long-term earnings growth rate of 11.8%. McKesson’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 20.6%, on average. It presently carries a Zacks Rank #2 (Buy).

McKesson has outperformed the industry over the past year. MCK has gained 58.4% in the said period compared with 7.6% growth of the industry.

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