FDA Approves Elyxyb Oral Solution for Migraines

The FDA has approved Elyxyb (celecoxib) oral solution for the acute treatment of migraine with or without aura. This drug is a nonsteroidal anti-inflammatory drug and is not indicated for the preventive treatment of migraine.

According to the FDA-approved drug label, the recommended and maximum dose of Elyxyb is 120 mg taken orally, with or without food. Elyxyb should be used for the fewest number of days possible per month on an as-needed basis.

Like all NSAIDs, Elyxyb can cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. These risks can increase with duration of use.

Furthermore, as an NSAID, Elyxyb may cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach of intestines, which can be fatal. These events can occur at anytime during use and without warning symptoms. Elderly patients and patients with a history of GI disorders are at greater risk of serious GI events.

For further information, read the FDA-approved drug label.

Tags: FDA, drug approval, Elyxyb, oral solution, celecoxib, NSAID, migraine

Live Better, Heal Better: Employee Wellness in Workers' Comp

Workers’ comp continues to grow more complex as the scope of care expands to a greater, more holistic view of patient wellness. Health concerns outside of a claim can significantly impact a patient’s recovery from a workplace injury, and addressing these concerns has the potential to lead to greater claims outcomes and cost savings.

Among many insights pulled from a 2020 workers’ comp industry survey conducted by Healthesystems, claims professionals ranked comorbidities and poor worker health the number one program challenge facing the industry, and the third biggest challenge overall. Specific to health risks, comorbidities ranked second, while mental health ranked third.1

These findings are consistent with industry research; PricewaterhouseCoopers claims 80% of a person’s health is attributable to health behaviors related to physical environment and socioeconomic conditions,2 and the Journal of Occupational and Environmental Medicine (JOEM) posits that mental health, physical health, job characteristics, and support from work organizations were the most significant determinants of an employee’s productivity.

This article explores how comorbidities, fatigue, and mental health impact claims management.

Read the full article online at RxInformer clinical journal.

Tags: RxInformer, employee wellness, wellness, employee, mental health, comorbidity, fatigue

Remdesivir a Potential Treatment for COVID-19?

With drug researchers and developers working hard to establish treatments for COVID-19, one medication is seeing promising buzz.

Remdesivir, an investigational antiviral medication that inhibits viral RNA synthesis, was created by Gilead Sciences in 2009 as a potential treatment for hepatitis C. While remdesivir did not work as initially hoped as an HCV treatment, it later showed promise during the height of the Ebola outbreak when scientists explored which antivirals could help patients.

Due to its status as an antiviral, initial tests were conducted to gauge remdesivir’s potential to treat COVID-19, and so far the results are positive enough that the FDA issued an emergency use authorization (EUA) allowing doctors to use remdisiver to treat hospitalized COVID-19 patients. An EUA is a declaration that circumstances exist to justify the emergency use of drugs and biological products that have not been FDA-approved, particularly when no other effective alternatives are available, assuming the benefits appear to outweigh the risks.

This EUA was based on review of topline data from a randomized, double-blind, placebo-controlled trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institute of Health (NIH), and from a Gilead-sponsored open-label trial that evaluated different durations of remdesivir.

The NIAID trial involved 1,063 hospitalized patients with advanced COVID-19 and lung involvement. Those who received remdesivir recovered 31% faster than similar patients who received placebo, with an 11-day recovery time versus a 15-day recovery time. Results also suggested a survival benefit with a mortality rate of 8% for the remdesivir group versus an 11.6% mortality rate with the placebo group.

The Gilead-sponsored trials included two Phase 3 studies to evaluate the safety and efficacy of remdesivir for COVID-19. Both trials were randomized, open-label, multicenter studies, each assessing different dosing durations delivered intravenously. The first study involved 400 patients with severe COVID-19 who received five or 10 days of remdesivr, while the other study involved 600 patients with moderate COVID-19 who received five or 10 days of remdesivir.

It was found that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course. Furthermore, no new safety signals were identified with remdesivir across either treatment group, and patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms.

Gilead claims that if a five-day regimen is as effective as a 10-day regimen, then they could significantly expand the number of patients who could be treated with remdesivir.

These initial trials have since been backed by other clinical studies.

The New England Journal of Medicine published a study on the compassionate use of remdesivir for patients hospitalized with COVID-19. Approximately 53 patients with COVID-19 were analyzed after receiving a 10-day course of the drug delivered intravenously at a dosage of 200 mg on the first day, followed by 100 mg every following day. Eighteen days after treatment, clinical improvement was seen in 36 patients.

Furthermore, the Journal of the American Medical Association (JAMA) published a review of pharmacologic treatments for COVID-19, finding remdesivir to be the most promising therapy for COVID-19 due to its potent in vitro activity against the virus. Furthermore, within lung infection models, remdesivir prevented lung hemorrhage and reduced viral lung titers more than comparator agents.

However, not all research bodes well. The Lancet published trial information on a randomized, double-blind, placebo-controlled, multicenter trial across 10 hospitals in Hubei, China, where 237 patients received either remdesivir or placebo for 10 days. In this trial, remdesivir use was not associated with a difference in time to clinical improvement.

But while most of the initial research is positive, there is still not enough data to definitely show that remdesivir is an effective treatment for COVID-19. The FDA’s decision to grant remdesivir an EUA to treat COVID-19 is not the same as FDA approval; the EUA is for emergency use in the face of a crisis.

According to the FDA’s remdesivir fact sheet, remdesivir is investigational because it is still being studied and more information could soon come to light. However, it is believed remdesivir may shorten the time to recovery for some people. Remdesivir may help decrease the amount of coronavirus in the body, potentially speeding recovery. Possible side effects may include infusion related-reactions, as this EUA is for IV administration once a day for up to 10 days, and increases in levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver.

In regard to these potential liver issues, healthcare providers must conduct blood tests to check the liver prior to administering remdesivir, and once daily while patients receive remdesivir.

According to the FDA’s EUA for remdesivir, the distribution of authorized remdesivir will be controlled by U.S. Government for use consistent with terms and conditions within the EUA.

Gilead will supply remdesivir to authorized distributors or directly to a U.S. Government agency, who will distribute to hospitals and other healthcare facilities.

Tags: COVID-19, remdesivir, coronavirus, FDA, clinical trials, JAMA, New England Journal of Medicine, Lancet, emergency use, EUA

IQVIA Reports on Healthcare Shifts in the COVID-19 Era

The IQVIA Institute for Human Data Science, a multinational health information technology and research company, published Shifts in Healthcare Demand, Delivery and Care During the COVID-19 Era, which utilizes longitudinal prescription data of over 4 billion prescriptions, medical claims data from CMS-1500 forms, and more, to understand how COVID-19 is impacting the healthcare system.

The report is broken up into sections that track the pandemic, explore patient use of health services, document the impact on medicine use, examine research activity for therapeutics and vaccines, and more.

Tracking the Pandemic

Based on the best public information available at the time of publication, IQVIA estimated that the modeled peak of active COVID-19 cases for the U.S. would be in early May with an estimation of 2 million confirmed cases, assuming current mitigation practices are maintained.

It should be noted that due to the fluidity of data available around COVID-19 cases, this data may have changed since publication of this report.

Furthermore, IQVIA found state-level profiles differ widely in number, timing, and rate of active cases, based on patterns of infection, to virus inactivity either through recovery or death, and social distancing practices. As of the publication of this report on April 29th, IQVIA estimated that per 100,000 population, the following states will experience these numbers of active cases:

  • New York – 1,200
  • New Jersey – 1,000
  • Massachusetts – 700
  • Louisiana – 500
  • Florida – 125
  • California – 100

Other significant points of note are:

  • States with higher per capita testing rates will have higher positive test ratios, meaning that testing levels are still not sufficient to accurately gauge infections
  • State testing levels vary widely in terms of number of tests relative to population and number of positive tests relative to the testing conducted. As of April 28, only one state tested more than 5% of their population
  • No state has achieved 14 consecutive days of any of the criteria areas set forth by federal plans for reopening the country
  • States with the highest mortality rate also tended to have higher utilization patterns of therapeutics associated with comorbidities

Patient Use of Health Services

Restricted movement orders issued across the country have resulted in a 70-80% reduction in the number of patient visits to doctors’ offices. However, telemedicine has offset some of these declines, as telemedicine consultations now account for 25% of consultations, as captured by insurance claims, with the highest shares in psychiatry and allergy/immunology.

The volume of lab tests has also decreased significantly as populations avoid healthcare settings for more minor concerns. Between the beginning of February to the end of March, lab tests initiated by emergency room visits fell more than 90%, while lab tests initiated by office visits and urgent care centers fell 75-80%.

It is believed that within the larger healthcare sphere, a lack of diagnostic testing will lead to delayed treatments and increased medical costs. Early signs indicate telehealth is not generating many lab orders.

Impact on Medicine Use

COVID-19’s impact on medicine use differs significantly by medicine type.

The use of drugs currently being investigated for COVID-19 treatment, including hydroxychloroquine, lopinavir + ritonavir (Kaletra), tocilizumab (Actemra) and sarilumab (Kevzara) has increased two-fold overall, with an eight-fold increase in hospitals. Note that this report did not include information on remdesivir.

Medicines used in hospitals to treat the symptoms of COVID-19, including respiratory treatments, sedatives, and pain medications, have seen increases between 100-700%.

Outside the hospital setting, 38 million more refills than normal were dispensed for chronic prescriptions in March in anticipation of restriction to access to pharmacies. However, this dynamic of stockpiling decreased after four weeks. It is unknown if this trend will resurge as social isolation measures continue. One note of interest is that between late March and early April, approximately 1 million fewer opioid prescriptions were filled than normal.

Research Activity for Therapeutics and Vaccines

At the time of publication, 182 drugs or regimens are in planned or active trials as therapeutics for COVID-19 or as vaccines. Over 900 trials are planned or underway, but 40% of those trials are not randomized, meaning results may be difficult to interpret.

For further insights, download the 30-page report.

Tags: COVID-19, IQVIA, trends, healthcare trends, drug trends, testing, diagnostic, lab

California Executive Order Greatly Expands COVID-19 Presumption

While many states have expanded workers’ comp coverage to provide benefits for COVID-19, these actions have primarily only applied to healthcare workers, first responders, and in some cases, certain essential front-line workers. However, California has issued a much broader policy.

California Governor Gavin Newsom signed Executive Order N-62-20 on May 6th, making COVID-19 a compensable occupational disease for employees who contract the virus on the job. This applies to all employees, not just those deemed essential by the state.

The order does clarify that to receive workers’ comp benefits that the employee must test positive for or be diagnosed with COVID-19 within 14 days after that the employee performed labor or services at the employee’s place of employment at the employer’s discretion; this only applies if the initial day of service was on or after March 19, 2020. Furthermore, the employer’s place of employment cannot be the employee’s home or residence.

However, the order states that if an employee has paid sick leave benefits specifically available in response to COVID-19, those benefits must be used and exhausted before any temporary disability benefits may be activated.

This order applies to all workers’ comp carriers in California, including self-insured employers, but insurers are free to adjust the costs of their polices.

This order is considered retroactive to the date of California’ stay-at-home order, issued on March 19th. The order is set to expire July 5, 2020.

Tags: COVID-19, California, presumption, coverage, compensability