FDA Approves First New Weight Loss Drug Since 2014, Issues EUA for COVID-19 Antibody

FDA Approves Wegovy for Weight Loss

The FDA approved Wegovy (semaglutide) weekly injections for chronic weight management in adults with obesity or overweight with at least one weight-related condition – such as high blood pressure, type 2 diabetes, or high cholesterol – for use in addition to a reduced calorie diet and increased physical activity.

In the FDA’s announcement, they state that losing 5-10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in patients with obesity or overweight. Because this drug can assist with weight loss, it has the potential to reduce the impact that comorbid conditions have on a workers’ comp claim, helping to better facilitate recovery in injured worker patients.

However, considering the number of common side effects and special warnings with this drug, if a patient receives Wegovy, their drug regimen should be carefully monitored to avoid drug-drug or drug-disease interactions.

The approved drug label features several warning and precautions, including those tied to:

  • Thyroid C-cell tumors
  • Acute pancreatitis
  • Acute gallbladder disease
  • Hypoglycemia
  • Acute kidney injury
  • Hypersensitivity
  • Diabetic retinopathy complications in patients with type 2 diabetes
  • Heart rate increase
  • Suicidal behavior and ideation

Common side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with type 2 diabetes, flatulence (gas buildup), gastroenteritis (an intestinal infection) and gastroesophageal reflux disease (a type of digestive disorder).

Wegovy should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal products. Wegovy has not been studied in patients with a history of pancreatitis.

Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FDA Issues EUA for Sotrovimab for COVID-19

The FDA issued a new emergency use authorization (EUA) for the use of sotrovimab – an investigational monoclonal antibody – for the treatment of mild-to-moderate COVID-19 in adults weighing at least 40 kilograms (about 88 pounds) who are at high risk of progression to severe COVID-19.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.

Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. This treatment has not shown benefit in patients hospitalized due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation.

An EUA is not the same as an FDA approval. With an EUA, the FDA evaluates available evidence and carefully balances any known or potential risks with known or potential benefits for use during an emergency.

Data supporting this EUA for sotrovimab are based on an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild-to-moderate COVID-19 symptoms.


Tags: FDA, approval, Wegovy, semaglutide, weight loss, weight management, EUA, sotrovimab, COVID-19


Empowering the Patient as a Mitigator of Claims Complexity

Managing the complexities of claims is more important than ever – but as we continue to peel back the layers of what drives the duration, cost, and patient safety concerns associated with complex claims,1 in some ways it is becoming more challenging than ever. And as we as an industry continually develop new and innovative tools to help address these challenges, there is one asset that can perhaps be leveraged more optimally as a mitigator of claim complexity – the injured worker patient.

Even as workers’ compensation programs have been moving towards a more patient-centric approach to managed care, injured worker patients themselves may not always be positioned as equal stakeholders. To some extent, they move through the claims process as the object in Newton’s third law of motion, upon which the forces of the system, however well-designed or intentioned, are applied.

INJURED WORKER INFLUENCE

The challenge with this? Patients as a stakeholder hold the greatest individual level of influence over the outcomes of their care – for better, or for worse. In the instance of catastrophic injuries, this may also include supporting family members or partners who may be assisting with caretaking. Specific to more complex claims, this influence is typically seen to worsen complexities. In a research study conducted by Healthesystems, two-thirds of workers’ compensation professionals felt that the injured worker often does not play enough of a role in mitigating complexities, but rather, contributes to them.1

This may lend some insight into why aspects of the claims process may involve the injured worker in a unidirectional fashion, delivering information without a structure or process in place that invites patient input.

But what if more aspects of the claims process were built to better accommodate the flow of information in both directions? Consider one example where the injured worker is involved in their claims journey from a bidirectional standpoint in their own claims experience – the initial reporting of an injury.

Continue reading the article in full at RxInformer.


Tags: RxInformer, claims complexity, patient


Interstate Variation and Trends in Workers’ Comp Drug Payments

The Workers’ Compensation Research Institute (WCRI) published a new flash report on Interstate Variation and Trends in Workers’ Compensation Drug Payments from Q1 of 2017 to Q1 of 2020.

This report presents data on prescriptions paid in workers’ comp for key therapeutic groups by quarter and across 28 states. These groups represent the large majority of all prescription payments in workers’ comp, including:

  • Anticonvulsants
  • Antidepressants
  • Compounds
  • Dermatological agents
  • Musculoskeletal therapy agents
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Opioids

This study provides a high-level view of changing costs of prescription drugs in workers’ compensation across 28 states, demonstrating where workers’ comp prescribing dollars are being spent and whether spending for those groups of drugs is going up or down.

Overall, quarterly prescription payments per claim decreased 15% or more in 20 states from 2017-2020. However, quarterly prescription payments varied widely in Q1 of 2020, ranging from an average low of $24-$25 in states like California, Minnesota, and Wisconsin, to as high as $206 in Louisiana. Interestingly, Connecticut saw a 30% increase in quarterly prescription payments during the study period

WCRI found that in most states, dermatological agents and NSAIDs are more important than other drug groups as a share of total prescription payments. In a median of the 28 study states, these drugs accounted for 20% of total prescription payments in Q1 of 2020. Payments for these drugs rose, while payments for opioids, compounds, and anticonvulsants decreased overall.

Per-claim payments for dermatological agents varied from $7 per claim in Iowa to $190 in Louisiana, while per-claim payments for NSAIDs varied from $21-22 in Delaware and Massachusetts to $126 in Louisiana.

Anticonvulsants made up the third highest share of total prescription payments, though anticonvulsants experienced a decrease in payments between Q2-Q3 of 2019, due to the availability of new generic formulations of Lyrica.

Musculoskeletal therapy agents made up the fourth largest share of prescription payments. Musculoskeletal therapy agents saw very little changes across the nation, other than 30-65% decreases in utilization in five states.

Opioids made up the fifth largest share of prescription payments, with prescribing continuing to decline across the nation at an average of 56%. Trends varied across states; in Louisiana, opioid prescribing dropped 40%, and in California it decreased 81%.

Additional key highlights from the study include:

  • In Q1 of 2020, 50% or more of prescription payments in Florida, Georgia, Illinois, and Maryland were for physician-dispensed drugs
  • Antidepressant payment shares were stable in most states, though increases ranging from 8-10% were seen in Iowa and Minnesota
  • Compounds now make up a small percent of payments in all 28 states
  • Other drug groups – including anticoagulants, antiemetics, antiretrovirals, antibiotics, and ulcer drugs – account for 26% of prescription payments as of Q1 of 2020, an increase of 7% since Q1 of 2017

Tags: WCRI, drug trends, prescribing trends, prescription data, drug data, NSAID, anticonvulsant, opioid


Mental Health Injuries Gain Momentum in Workers’ Comp

Nebraska Governor Pete Ricketts recently signed Legislative Bill 407 into law, providing workers’ comp coverage for mental injuries and mental illness among correctional employees.

The state previously enacted legislation establishing workers’ comp coverage for first responders for “mental-only” injuries that do not include a physical injury, and this new law extends those same rights to additional occupations.

Across the nation, more and more states are debating whether or not to cover mental health claims, and if so, if they should cover claims that do not include a corresponding physical injury.

Healthesystems has previously reported on how first responders – a population vulnerable to mental health concerns due to a high likelihood of encountering traumatic events on the job – are gaining coverage for post-traumatic stress disorder (PTSD), but now it seems the coverage of mental health concerns may be expanding.

Earlier this year when covering top legislative issues for 2021, NCCI reported that at least 40 bills were in motion this year surrounding compensation for mental injuries, with more than 30 of those bills specifically mentioning PTSD, though states are unique in how they define mental injuries.

Currently, two major bills making progress are taking place in Connecticut and New York.

The Connecticut General Assembly introduced Senate Bill 660, which would expand workers’ comp benefits for certain mental or emotional impairments suffered by healthcare providers in connection with COVID-19.

This bill would apply to activities substantially dedicated to mitigating or responding to the COVID-19 pandemic, including but not limited to witnessing the death of a person due to COVID-19 and treating patients with COVID-19. The list of healthcare professionals this bill would cover is wide, including persons employed at:

  • Doctors’ offices, healthcare centers, hospitals or clinics
  • Medical schools
  • Local health departments
  • Nursing facilities, retirement facilities, nursing homes, or group homes
  • Home healthcare providers
  • Any facility that performs laboratory or medical testing
  • Pharmacies or any similar institution
  • Any other location where the employee must provide personal care assistance

This bill has passed the House and Senate and now sits with the Governor. If enacted, it could help set precedent for expanding mental injury claims to healthcare workers beyond the scope of the pandemic, as healthcare workers frequently experience traumatic events on the job.

Healthcare workers are four times as likely to experience workplace violence than other workers, and 18% of nurses meet the criteria for PTSD.

Meanwhile, New York introduced Senate Bill 6373, which would expand to all workers the ability to receive PTSD coverage for extraordinary work-related stress incurred at work. Bill text specifies that factual findings must prove that stress was greater than that which usually occurs in the normal work environment.

This bill has already passed the Senate and now sits with the Assembly.


Tags: Nebraska, Connecticut, New York, healthcare workers, mental injury, mental health, mental-only, mental only


5 Ways We’re Innovating the Digital Experience for Claims Professionals

Healthe recently published a new featured article on WorkCompWire, which explores the importance of improving claims professionals’ digital experience to improve claims outcomes. The following content appears online at WorkCompWire.

Claims professionals have long been the frontline of claims management – this has not changed. What has changed is just about everything else.

Claims continue to grow in complexity – and therefore have become more complex to manage. The claims workforce is changing, too.

As we continue to try to attract talent to the industry, the bar becomes higher for what these new professionals expect. Better tools and a better experience. Humans are becoming increasingly hardwired for digital preferences and interactions. And with reason – with the right tools, there are tremendous efficiencies to be gained over historical methods. (Dozens of phone calls in a day? Let’s all pause for a reminiscent chuckle.)

And even as the tools and workflows employed to facilitate claims professionals’ jobs become increasingly more sophisticated – the tools themselves cannot appear more complex. The bar is set at nothing short of a streamlined, easy to use, one-stop experience.

It’s a big ask, but one that we’re driven to continually find new answers for. Here are five ways Healthe is leveraging technology, analytics, and insight to enhance claims professionals’ digital experience.

#1. Focus on the “Human” in Human-Computer Interaction

Part and parcel with technological design is the human element. How is the end user going to feel using the tool? What value are they going to derive from it?

When designing solutions meant to assist claims professionals, we start – and finish – by asking the prospective users what they think and what they need from these tools. These frontline users know just how many ways things can go wrong, or how often they run into the same hiccups in the claims process.

When captured effectively, claims professional insights can inform innovation in ways that improve productivity, deliver more informed interactions with injured workers, and make the process of claims management easier and more effective – while also improving claims staff satisfaction.

Here is where user research and user validation studies become valuable tools for understanding stakeholder preferences and pain points that can inform program enhancements and new services that meet the unique needs of different users – whether the day-to-day claims examiner, the nurse case manager, or claims leadership.

#2. Prioritize Visibility into Claim Information

Having the right information at their fingertips, at the time it is needed, is crucial to helping claims examiners make timely decisions that move a claim forward.

Effective information architecture brings greater visibility to important information across the claim lifecycle, while also removing the clutter. And an informed approach to information architecture includes applying research and data, including data on user behaviors within systems.

Research data helps to identify areas where visibility is lacking, prioritize the most and least valuable data elements that examiners wish to see in their claim tools, and ultimately creates an intuitive digital experience that includes step-by-step workflows and prepopulated data elements.

This ease-of-access and self-service visibility into key information has become even more important post-pandemic, where claims organizations continue to employ a remote workforce, reducing person-to-person interaction as a resource for claims examiners to help answer questions and troubleshoot problems.

Visit WorkCompWire to continue reading the article, which explores aligning technology preferences and needs, incorporating intelligent automation, and letting analytics drive claim and program management.


Tags: WorkCompWire, Healthesystems, analytics, technology preferences, automation, claims professional


Silvia Sacalis to Join Panel Presentation at FERMA 2021

The Florida Educational Risk Management Association (FERMA) 2021 Summer Conference will be held in-person in Sarasota from July 12-16th, and Healthe’s VP of Clinical Services, Silvia Sacalis, BS, PharmD, will join the panel presentation Care and Program Considerations for Under-Represented Populations.

This educational session will explore the diversity of today’s workforce, focusing on older workers, millennials, minorities, women, and first responders, presenting key takeaways for each population.

Dr. Sacalis will join Alice Wells, CWCL, AIC Director of TPA Operations at Johns Eastern, and Greg Nichols, P.T. President of SPNet Clinical Solutions.

The presentation will take place on July 15th at 9:00 AM EST.


Tags: Healthesystems, Silvia Sacalis, FERMA, conference, presentation, diversity, population management