New Drug Developments Impacting Comp

FDA Approves Biosimilar for Humira

The FDA recently approved Abrilada (adalimumab-afzb) a biosimilar for Humira® (adalimumab), indicated for the treatment of:

  • Rheumatoid arthritis
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Adult Crohn’s Disease
  • Ulcerative colitis
  • Plaque psoriasis

In various industries, workers may develop osteoarthritis by experiencing cumulative or acute trauma, resulting in the prescription of osteoarthritis drugs. This has led to certain specialty medications for inflammatory conditions appearing in workers' comp claims, with drugs for other arthritis conditions being prescribed off-label. Furthermore, it is possible for occupational injury to aggravate pre-existing inflammatory joint disease that may have been previously mild.

For these reasons, specialty arthritis injections like Humira, and now Abrilada, may be seen in workers’ compensation claims. As specialty drugs often come with high costs, the presence of biosimilars can reduce those costs when utilized in appropriate populations, assuming the medication is prescribed for the appropriate indications.

FDA Approves RediTrex for Rheumatoid Arthritis

The FDA has also approved once-weekly RediTrex (methotrexate) subcutaneous injections for the management of severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and symptomatic control of disabling psoriasis.

Once more, arthritis drugs may be prescribed off-label in workers’ compensation for the treatment of occupational osteoarthritis resulting from cumulative or acute trauma, or when a pre-existing inflammatory joint disease is aggravated by occupational injury, meaning this drug could potentially appear in workers’ comp claims.

RediTrex is available in varying dosages, depending on which condition it is meant to treat. Common adverse reactions include nausea, abdominal pain, dyspepsia, mouth sores, rash, nasopharyngitis, diarrhea, vomiting, headache, dizziness, and more.

RediTrex is contraindicated with pregnancy, alcoholism or liver disease, preexisting blood dyscrasias, and more. For further information, read the FDA-approved label.

FDA Approves Xcopri for Partial-Onset Seizures

The FDA has also approved Xcopri (cenobamate tablets) for oral use in the treatment of partial-onset seizures.

Various seizure drugs are common in workers’ comp, as head injuries from falls and other traumas can lead to seizure disorders, including traumatic brain disorder (TBI). For this reason, it is possible the Xcopri could eventually make its way into workers’ comp claims.

According to the FDA-approved label, adverse reactions for Xcopri include somnolence, dizziness, fatigue, diplopia, and headache. Xcopri is pending controlled substance schedule, meaning the drug may require close monitoring. Xocpri will be available in various strengths, ranging from 12.5 mg to 200 mg.

FDA Fast Tracks a New PTSD Drug

In other news, the FDA has granted Fast Track designation to BNC210, a drug currently in development from Bionomics Limited, created for the treatment of post-traumatic stress disorder (PTSD) and other trauma-related and stressor-related disorders, including anxiety disorders, comorbid anxiety and depression.

As legislation across the country continues to expand workers’ comp coverage for PTSD to first responders, understanding the therapies available for PTSD, be they pharmacologic or not, is important to managing claims, and any new drugs for PTSD could make a serious impact in workers’ comp.

Bionomics Limited claims BNC210 does not cause sedation, memory or motor impairment, and is not addictive, unlike other antianxiety drugs, such as benzodiazepines.

A Phase 2, 12-week, double-blind, placebo-controlled study of 193 patients found that BNC210 did not significantly improve symptoms, but a dose-response relationship predicted to meet the primary endpoint was established based on this trial data.

These findings were enough to spur the FDA into granting BNC210 Fast Track designation, which increases communication between drug developers and the FDA. With Fast Track drugs, the FDA reviews portions of the New Drug Application (NDA) ahead of submission of the completed application, which can significantly help manufacturers in improving their NDAs, increasing their likelihood of approval.


Tags: FDA, approval, biosimilar, osteoarthritis, arthritis, Abrilada, adalimumab, Humira, injection, specialty drug, Fast Track, Phase 2, PTSD, anxiety


Questioning Costs: A Field Guide to Fee Schedules

There’s high demand to control ever-rising healthcare costs, and fees for professional services and medical equipment continue to climb. While drug prices may dominate headlines, stakeholders across the healthcare spectrum know that a multi-pronged approach that touches on other high-cost aspects of healthcare is necessary to reduce overall medical costs.

Costs for ancillary products and services do not face nearly as much scrutiny as drug prices, and it is important to remember that whenever healthcare costs are reduced in one line of service, stakeholders have historically found ways to make up for lost revenue elsewhere, making the unraveling of fee schedules more important than ever.

Learn how fee schedules are created, how payers can influence the rulemaking process, and how to understand when fee schedules are inappropriately adjusted for financial gain.

Read the full article online at RxInformer clinical journal.


Tags: Fee schedule, RxInformer


How Declining Opioid Use Impacts Claims and Outcomes

The California Workers’ Compensation Institute (CWCI) recently published The Impact of Declining Opioid Use on Lost-Time Claim Development & Outcomes in California Workers’ Compensation.

This report utilized the CWCI’s Industry Research Information System (IRIS) to look at 237,000 lost-time claims from 2008-2017, with payment and prescription data through 2018, to answer three questions:

  • What are the trends in both the frequency and intensity of claims with acute and chronic opioid use?
  • To what extent has decreased opioid use driven changes in medical and indemnity cost trends?
  • What is the impact of declining opioid use on benefit payments, temporary disability (TD) days, and systemwide costs?

The study found that the proportion of injured workers receiving opioids declined 51% over the last decade, from a point where 49% of injured workers received opioids, down to 24%. In fact, the prevalence of claims with chronic opioid use (three or more prescriptions within four consecutive months) fell from 13% of all claims to 3%, while the prevalence of claims with acute opioid use declined from 36% of claims to 21%.

By looking at claims with the same injury type but comparing claims with and without opioid use at 12 months and 120-month intervals, the study found:

  • Average benefit payments were 29.7% lower for claims without opioid use at 12 months, and 37% lower at 120 months
  • Claims without opioid use had 25.2% fewer TD days at 12 months, and 30.2% fewer TD days at 120 months
  • Average benefit payment at 12 months on a claim with acute opioid use were 28.1% lower that claims with chronic opioid use, and 35.9% lower payments at 120 months
  • Acute opioid use claims averaged 27.6% fewer TD days at 12 months than chronic opioid use claims, and 31.3% fewer TD days at 120 months
  • Systemwide savings from the decline in opioid use are projected to reach 16.5% for 2017 claims at 10 years of development
  • Cumulative savings from the decline in opioids are projected at $6.5 billion for 2010-2017 claims
  • 68% of non-opioid claims closed within 24 months, but it took twice as long to reach a similar closure rate for opioid claims

The study concludes that opioid utilization may continue to drop, depending on advances in evidence-based medicine, research, formularies, treatment guidelines, the behavior of medical providers, the adoption of alternative pain management protocols, regulatory developments, and various other factors.


Tags: CWCI, California, opioid, opioid utilization, payment


Minnesota Proposes PTSD Treatment Guidelines

The Minnesota Department of Labor and Industry’s Workers’ Compensation Division recently proposed rules to establish criteria for the treatment of post-traumatic stress disorder (PTSD) for first responders.

Legislation across the country continues to expand workers’ comp coverage for PTSD to first responders, but these proposed rules are perhaps the first to dictate how workers’ comp professionals must manage the care of PTSD for first responders, providing a great level of detail.

The rules state that a PTSD diagnosis must be made by a licensed psychologist or psychiatrist according to the most recently published edition of the Diagnostics and Statistical Manual (DSM) of Mental Disorders by the American Psychiatric Association.

Furthermore, a mental healthcare provider must complete an initial evaluation that includes a determination of:

  • The patient’s functional status
  • The patient’s relevant family history
  • The patient’s history of mental health conditions and treatment
  • If the patient will harm themselves or others, and/or requires hospitalization
  • Whether the patient has any comorbid physical or psychiatric disorders

Regarding treatment planning, the guideline establishes that prior to providing psychotherapy, providers must engage and collaborate with the patient to create a plan for treatment that:

  • Specifies treatment modalities
  • Determines if telemedicine will be utilized
  • Assesses a patient’s current level of symptoms and functional status
  • Develops goals based on symptoms status, which adhere to a timetable within the prescribed number of psychotherapy sessions
  • Addresses the patient’s plan to return to work, including any necessary restrictions

The guideline also details which trauma-focused psychotherapies are indicated for the treatment of PTSD, listing several acceptable therapies, while also accepting any other treatment modality recommended by the treating mental health provider which is an evidence-based, trauma-focused psychotherapy that meets key legislative requirements

Additionally, the guidelines dictate which medications are indicated for the treatment of PTSD, and they also establish a 16-week duration of psychotherapy treatment, at which point a patient is reevaluated. This reevaluation determines if additional therapy is required, though exceptions to the 16-week duration are also listed. And finally, the guideline also covers documentation requirements, requirements for providers notifying payers, and much more.

Public commentary on these proposed rules was gathered through December 12th, and updated rules may available in the near future.


Tags: Minnesota, PTSD, treatment guideline, evaluation, psychotherapy


Healthe in the Media

Several media outlets have recently reported on Healthesystems’ content, while also reaching out to our clinical leaders for their insight on these developing matters.

Risk & Insurance magazine covered a presentation delivered by Silvia Sacalis, BS, PharmD, VP of Clinical Services at Healthesystems, and Adam Seidner, MD, MPH, Chief Medical Officer at The Hartford, at the National Workers’ Compensation and Disability Conference (NWCDC), titled Medical and Pharmacy Insights for a Successful Return to Work.

The writeup from Risk & Insurance summarizes the presentation, paying special attention to real-world case studies that Drs. Seidner and Sacalis’ utilized to illustrate medication interactions, psychosocial considerations, areas of improved patient engagement, and intervention opportunities.

Risk & Insurance later followed up on this story with an in-depth interview with Dr. Sacalis that provided greater detail on return-to-work considerations, exploring topics such as comorbidities, drug interactions and side effects, gender, age, the pharmacokinetics of drugs, and the need for a holistic understanding of patients in order to best develop effective treatment plans.

Meanwhile, WorkCompCentral covered a recent RxInformer article from Healthesystems, titled When Demand Exceeds Supply: Older Patients and Fewer Physicians in Workers’ Comp. WorkCompCentral focused on the looming doctor shortage explored in Healthesystems’ publication, declaring it a hot topic for the future of workers’ comp, along with other noteworthy items.

And on the subject of RxInformer clinical journal, WorkCompWire highlighted the publication of the Winter 2019/2020 edition of RxInformer, detailing several of the articles which are now available online, including topics such as metrics in physical medicine program, cost-containment strategies for rising drug prices in workers’ comp, how to scrutinize fee schedules, and more.

Finally, Business Insurance published an article on the Department of Health and Human Services’ (HHS) new opioid tapering and discontinuation guideline. Healthesystems previously covered this development, and so Business Insurance reached out to Dr. Sacalis for her expertise on the matter.

Dr. Sacalis noted that the HHS’s slow, moderation-focused approach is favorable, as sustainable change occurs with moderation, focused on individual situations and customizations.


Tags: Risk & Insurance, Silvia Sacalis, NWCDC, return to work, medication, interaction, interview, patient engagement, WorkCompCentral, RxInformer, physician shortage, WorkCompWire