Mary Caffrey

Officials with GlaxoSmithKline said COLUMBA is the first long-term study for an anti-IL5 biologic to treat severe asthma that has been reported.

Attendees at the American Thoracic Society 2018 International Conference, meeting in San Diego, California, heard details that led to FDA's recent expansion of the indication for GlaxoSmithKline's Trelegy Ellipta, including findings that the once-daily combination also provides significant mortality benefits over a dual therapy that is often the combination patients with chronic obstructive pulmonary disease (COPD) are taking when triple therapy is recommended.

The study comes as FDA is moving to bring more order to the area of mobile health. It is in the midst of a pilot for a precertifcation process that involves well-known companies such as Apple, Verily, and diabetes-specific companies like Tidepool.

Organizers of the project said it aims to build a better set of data on hypoglycemia that will help researchers and clinicians understand the condition, predict it, and gauge its cost.

The HHS secretary took on critics who said the plan went too easy on pharma and touted provisions that he said would change incentives that have worked in favor of companies and against patients.

Out-of-pocket costs for consumers and targeting the complex pharmaceutical rebating system were the high points of a presentation that began in the Rose Garden and ended with HHS Secretary Alex Azar's details in the White House press room.

In testimony before a Senate committee, the chief scientific and medical officer said no single stakeholder is at fault, but the entire system of insulin delivery must be examined to make things better for consumers.

FDA Commissioner Scott Gottlieb, MD, has embraced the calorie counts at restaurants a year after his agency put them hold on the eve of his arrival. A Nutrition Facts label update is delayed but not scuttled, in contrast with the reversal of school lunch changes from the Obama administration.

Authors report theirs is the first real-world study comparing the 2 SGLT2 inhibitors.

This week's announcement comes after cardiologists have spent several years sharing accounts of their difficulty gaining access to PCSK9 inhibitors for their patients.

CMS Administrator Seema Verma called on qualified providers of the National Diabetes Prevention Program to become Medicare suppliers. But in last year's rulemaking process, commenters warned that the program CMS had designed was too bureaucatic and did not pay enough upfront to attract small, community-based providers.

While precise pricing information was not released, net pricing will be within the cost-effective ranges set by the Institute for Clinical and Economic Review.

Even though her final stretch at the helm of Planned Parenthood was not easy, Cecile Richards told the nation's obstetricians she is optimistic because of the activism she sees among women and girls at the grassroots level. "Women are on fire," she said.

Clinicians in the audience attending the annual meeting of the American College of Obstetricians and Gynecologists said patients and payers may only see the headlines about the US Preventive Services Task Force (USPSTF) ratings and don't pay attention to finer points about recommendations for subgroups.

The drug's sponsor filed for FDA approval earlier this week under breakthrough therapy status.

Women face many barriers to treatment for postpartum depression, but obstetricians are well-positioned to help overcome them.

One study revealed that 40% of residents in the South report financial barriers that prevent them from giving patients long-acting reversible contraception, including lack of insurance coverage and the cost of the device, which prevents it from being stocked.

The president's panel at the American College of Obstetricians and Gynecologists' 2018 Annual Clinical and Scientific Meeting in Austin, Texas, discussed how to make postpartum care more value-based as women give birth at older ages and need team-based care.

Guidance for primary care physicians prescribing type 2 diabetes therapies comes at an opportune time. A major rift over guidelines for glycemic control has opened between the American College of Physicians, a professional association of internists, and diabetes specialists, including endocrinologists and diabetes educators.

If most practices excel at the same clinical practice measures, then small differences in performances could lead to significant financial differences, a speaker warned.

The analysis comes a few weeks after FDA approved a label change that reflects a study showing insulin degludec was associated with a 40% drop in hypoglycemia.

Researchers found that cost-effectiveness calculations shifted dramatically when they assumed people with diabetes used continuous glucose monitoring (CGM) sensors for 10 days instead of 7 days. This is significant because Dexcom just received approval for a next-generation CGM system with a factory-calibrated 10-day sensor.

AJMC® Convenes the First Gathering of the Institute for Value-Based Medicine to Share Best Practices in New Payment Models in Cancer Care

President and CEO Kevin Sayer said the company will file for Medicare coverage of the G6, while it continues to work out an issue that prevents beneficiaries from using a feature that lets data be displayed or shared on cell phones.

The insurer's chief medical officer reports that the CDC metric is proving useful over time.

Some Medicare Advantage plans may not be fully ready for the requirements of this history-making preventive service.

After taking recommendations from providers, Mississippi lawmakers pass a bill that would end caps on prescription drugs and office visits in Medicaid.

At the Society of Gynecologic Oncology’s 2018 Annual Meeting on Women’s Cancer, 1 abstract found Patient-Centered Oncology Payment model would yield savings if hospitalizations were reduced, while another abstract piloted a scoring system for financial toxicity in gynecological cancers.

The lead researcher said the study could lead to women being given a statin as soon as they are diagnosed with endometrial cancer.

Much about using PARP inhibitors is open to debate, starting with what kind of genetic test to give before using them. Combination therapies are the next frontier, according to an expert panel.