Olinvo (oliceridine) Completes Phase III Clinical Trials

Healthesystems continues to monitor drugs in development that can potentially impact workers’ comp, and recent completion of phase III trials for the investigational opioid Olinvo (oliceridine) warrants attention.

Olinvo, also previously known as TRV130, is an intravenous analgesic developed to treat moderate-to-severe acute pain with a reduced frequency of opioid-related adverse effects when compared to intravenous morphine.

In 2016, the drug was previously granted breakthrough therapy status by the Food and Drug Administration (FDA), in the hopes that it could provide pain relief with fewer side effects than other opioids.

Olinvo met primary efficacy endpoints in phase III trials, demonstrating significant pain relief qualities. However, the secondary endpoints which measure rates of respiratory depression, nausea and vomiting when compared to morphine were only significant at lower drug doses. This indicates that stronger drug doses may lack the increased safety benefits drug developers hoped the product would offer.

Publication of the phase III trial results are still pending. For further information, read Trevena’s press release.


Tags: Opioid, Drug Updates, Oliceridine, Olinvo


Dr. Robert Goldberg Comments on Virtual Reality in Workers’ Comp

Risk & Insurance recently published an article on the potential use of virtual reality (VR) in workers’ comp, diving into VR applications for rehab settings. This includes helping patients cope with pain, improved motor learning and mobility, and better patient engagement with rehabilitation programs.

The publication asked industry leaders, including Healthesystems Chief Medical Officer, Dr. Robert Goldberg, their perspective on this technology.

Dr. Goldberg believes that there is much promise in VR technology, but notes that clinicians are still years away from developing strong guidelines on the proper implementation of VR technology.

Understanding what kind of VR technology to use on certain medical conditions, and for what length and for what expected outcomes, is still unclear. In light of a current absence in guidelines, Dr. Goldberg expects payers to decide potential uses of VR on an individual, case-by-case basis.

Read the full article at Risk & Insurance.


Tags: Virtual Reality, clinical guidelines


Formularies Continue to Gain Steam

With the coming implementation of a formulary in California this year, and with New York and Florida expressing interest in formularies at the end of last year, 2017 seems to be the year where formularies make progress nationwide. At the moment, three additional states are reviewing legislation that aims to establish workers’ comp formularies.

Nebraska introduced Legislative Bill 408, which calls for the adoption of an evidence-based drug formulary that would apply to claims with a date of injury on or after January 1st of 2018, impacting all schedule II-V medications. This is the second time Nebraska legislators have introduced a bill aiming for a workers’ compensation formulary.

LB 408 specifies that drugs which are approved in the formulary would require no prior authorization, while non-approved drugs and drugs not appearing in the formulary would be subject to pre-authorization by the carrier. Furthermore, the bill allows for any party to request an independent medical examiner to determine if a non-formulary drug is appropriate for use and should be covered by insurers.

Kentucky introduced HB 296, which would require the commissioner of the Department of Workers' Claims to develop, adopt, and implement treatment guidelines and a pharmaceutical formulary on or before December 31, 2018. This bill would also incorporate urine drug testing requirements along with other controls for patients on opioids.

HB 296 has already passed the House and will soon be reviewed by the Senate.

Pennsylvania introduced House Bill 18, which would require the state to select a nationally recognized, evidence-based prescription drug formulary for the treatment of work-related injuries. If passed, a public commenting period would take place before selecting a formulary, lasting between 30 to 90 days, after which a decision would be made, which would then go into effect 30 days later.


Tags: Formulary, Formularies, Legislation


ACP Releases Guideline for Chronic Low Back Pain

The American College of Physicians (ACP) has developed Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain, a series of guidelines that emphasize non-pharmacologic treatments.

The release of these guidelines is another example of an ongoing clinical shift in the treatment of pain. In 2016, the Centers for Disease Control and Prevention released their opioid guideline, urging prescribers to practice more caution when using opioids to treat pain. The ACP’s low-back pain guideline was recently preceded by the American College of Occupational and Environmental Medicine’s (ACOEM) update to their guidelines for low-back pain, which also shift focus away from prescription pain medicines and towards alternative therapies.

The ACP guideline joins the ranks of evidence-based guidelines aiming to increase patient safety and yield improved patient outcomes. The guideline is based on a large-scale systematic review, composed of randomized controlled trials and an assortment of smaller-scale systematic reviews of noninvasive pharmacologic and non-pharmacologic treatments for low back pain.

The ACP guideline reviews the potential harm of certain pharmacologic therapies, demonstrating the low levels of effectiveness these drugs have in treating low back pain, while also emphasizing the potential benefits of non-pharmacologic treatments. The alternative therapies include: superficial heat, massage, acupuncture, spinal manipulation, exercise, multidisciplinary rehabilitation, mindfulness-based stress relief, tai chi, yoga, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, and more.

With low-back pain being one of the most common reasons for physician visits in the United States, the implementation of these guidelines could have a great impact on workers’ compensation claims, possibly steering treatment away from potentially harmful drugs like opioids.

For further information, read the guidelines in full.


Tags: Pain, Chronic Bain, Clinical Guidelines


Focus On: Opioid Overdose and Dependence Therapies

There have been many developments in the fight against opioids, including the expansion of access to drugs that combat opioid dependence and overdose. Claims professionals could see these medications appear more frequently in patient profiles, especially as state and federal legislation make these drugs more readily available. It is important that claims professionals understand the appropriate use of these drugs, as well as the reasons for use in certain patient populations, the differences between formulations, and appropriate precautions to consider when these drugs are prescribed to patients.

NALOXONE – THE OPIOID OVERDOSE ANTIDOTE

Naloxone blocks or reverses the effects of opioids and is used to counteract an opioid overdose. The presence of naloxone in a patient’s profile is concerning and warrants a closer look into the patient’s current opioid therapy. However, naloxone may be prescribed for various reasons.

NALOXONE FORMULATIONS

Commercially, naloxone is available as Evzio® auto-injector and Narcan® nasal spray. Both products consist of naloxone hydrochloride and work within minutes of administration.

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Continue reading the complete article in the latest issue of our RxInformer clinical journal.


Tags: Opioid overdose, opioid dependence, naloxone, Evzio, Narcan, buprenorphine