Tanezumab Trials Yield Positive Results for Pain Management

Healthesystems has previously reported on tanezumab, an investigational, non-opioid biologic that selectively targets and inhibits nerve growth factor, an important mediator of pain. The drug received FDA Fast Track designation in 2017, expediting certain review procedures, due to the drug’s potential to offer significant pain relief without the risks of opioids.

In the last few months, Phase 3 clinical trials have yielded positive results for the use of tanezumab in chronic low-back pain and osteoarthritis, indicating that a new type of pain medication could soon be on the market.

Study A4091509, a randomized, double-blind, placebo and active controlled Phase 3 clinical trial, involved 1,800 patients suffering from chronic low-back pain for an average of 10 years with a documented history of inadequate treatment responses to other medications.

Trial results found that subcutaneous tanezumab injections, delivered seven times at eight-week intervals for 56 weeks, yielded a significant impact of pain on patients’ ability to function in everyday life, with tanezumab offering superior pain relief compared to placebo.

Meanwhile, Study A4091057, a randomized, double-blind, placebo-controlled trial of 810 patients experiencing osteoarthritis of the hip or knee, found that subcutaneous tanezumab injections, delivered every eight weeks for 24 weeks, resulted in a statistically significant improvement in pain and physical function when compared to placebo.

Both studies found tanezumab to be well-tolerated from a safety standpoint, and there are currently trials underway to see if tanezumab can help with pain resulting from bone cancer. If those trials also see positive results, it is possible that tanezumab could potentially see an even more diverse list of possible indications in the future, offering patients and providers more options in the treatment of pain.

Tags: tanezumab, FDA, clinical trial, pain, chronic pain, low-back pain, osteoarthritis

Opioid Imbalance: Risk Disparities Among Diverse Patient Populations

The wide-reaching concerns posed by opioids to patient safety and claim outcomes are well understood within workers’ compensation, and we have implemented many effective measures as an industry to tackle the opioid challenge. These efforts have been further bolstered by broad federal and state-based legislation that has occurred over the past several years, contributing to positive outcomes on a national level, including reduced prescribing rates and lower average morphine equivalent dose (MED).1

However, like most challenges facing our industry, there are nuances to consider that can lend further insight into our continued assessment of opioid utilization and risk among injured worker populations.

Diverse factors within populations such as patient race/ethnicity, socioeconomic status, geographic location, age and gender, mental health status, and even occupation bring forth differentiated findings as they relate to opioid prescribing behaviors and patient outcomes. Simply put, while opioids pose a risk in some form or fashion to all patients – this does not necessarily occur on an “equal opportunity” basis.

Diversity Factor: Race/Ethnicity

The relationship between race/ethnicity and opioids is complex and evolving. Historically, trends have shown racial disparities in pain management, and specifically in the opioid prescribing behaviors of doctors. Until recently, non-Hispanic white patients were more likely to be prescribed opioids and faced higher risk for prescription opioid overdose. However, a national trends study published in June indicates that the gap has closed between whites and blacks in regard to opioid prescribing for noncancer pain.2

While eliminating treatment disparity represents positive movement from a public health equality perspective, increased prescribing of opioids among black patients has created some negative consequences that include increased rates of opioid misuse within this population. While self-reported prescription opioid misuse remains highest among the white population at 4.5% nationally, other race/ethnic groups including Hispanic (4.2%), native Hawaiian or Pacific Islander (4.2%), and black (3.9%) populations are now proportionally very close from a risk perspective. However, non-Hispanic white individuals are still twice as likely to die from prescription opioid overdose compared with non-Hispanic black individuals.1

In addition to these shifting dynamics, interrelationships between race/ethnicity, socioeconomic status and geographic location add to the complexity when analyzing population-based risks.

Continue reading the full article online at RxInformer clinical journal.

Tags: Opioid, risk disparity, risk, patient population, diversity, socioeconomic, ethnicity, race, demographic, RxInformer

Tackling Topicals: Clinicians Takes Notice

The Annals of Internal Medicine recently published the results of a randomized controlled trial meant to determine the effectiveness of compounded topical pain creams. A total of 399 patients suffering from localized neuropathic pain (related to nerve damage) and/or localized nociceptive pain (caused by tissue injury) were given either one of two compounded pain creams or a placebo for the treatment of pain.

The study found no statistically significantly differences in pain reduction between patients using a compounded topical or a placebo, indicating that the topicals offered no clinical benefit, especially considering their high cost.

Topicals – in compounded forms and as private-labeled products – can inflate the cost of a claim while offering little-to-no clinical benefit for patients. However, as prescribing trends continue to shift, it appears topicals are seeing greater utilization.

Last month the California Workers Compensation Institute (CWCI) released a research update that looked at 5.75 million prescriptions dispensed in the California workers’ comp system from January 2009 to June 2018. Among many insights, the CWCI report found that prescription and private-labeled dermatological topicals saw a serious increase in spend. In 2009, these dermatological topicals made up 10.1% of drug spend, increasing to 17.6% in 2018, making it the drug class with the highest spend in 2018, surpassing opioids.

News outlets in the workers’ comp industry have covered these updates surrounding topical medications, including WorkCompCentral, who reached out to various industry professionals, including Healthesystems’ clinical experts.

Chief Medical Officer, Robert Goldberg, MD, FACOEM, discussed this shift in utilization and spend, stating that compound drug denials have lowered drug sales for certain entities, leading to a new focus in pushing private-labeled topicals to patients, despite high costs and a lack of clinical necessity. Meanwhile, Healthesystems Clinical Pharmacist, Dr. Regina Mears, noted that the results from the Annals of Internal Medicine confirmed what the Healthesystems clinical team has long continued to research, track, and manage via various compound utilization and cost management initiatives.

Healthesystems has also reported on topicals in the page of RxInformer journal, addressing common myths surrounding private-labeled topicals, such as the belief that they are FDA-approved or superior to over-the-counter products, and the differences between private-labeled topicals and topical compounds.

Topical products, be they compounds or private-label products, should be investigated whenever found in a workers’ comp claim, as they do not offer any clinical advantages and serve to inflate claim costs.

Tags: Topical, private label, private-label topical, PLT, compound, topical compound, Annals of Internal Medicine, CWCI, WorkCompCentral, Goldberg, Regina Mears

The Drug Price Debate

The U.S. House of Representatives Energy and Commerce Committee met on March 13th to consider bills to lower drug prices, going over proposals that would punish drug manufacturers for employing tactics that delay the introduction of generic competition to the market.

This development is just the latest in a series of federal actions taken to address high drug prices, an issue that impacts healthcare professionals across the board, including those in the workers’ compensation industry.

Earlier in March, the United States Senate Special Committee on Aging held a hearing on the complex web of prescription drug prices, just weeks after the Senate Committee on Finance held the latest in a series of hearings on drug pricing in America. The Finance Committee called several pharmaceutical executives to testify and explain their pricing practices, with some CEOs agreeing that pricing reform is necessary as the current model is not sustainable.

Testifying executives had varying levels of agreement on how much government regulation is necessary to curb ever-increasing drug prices, and many executives favored rebate reforms proposed by the Trump Administration in a blueprint written last year to lower drug prices, along with initiatives targeting PBM practices, claiming that these initiatives would allow companies to pass on savings to payers and consumers. However, many have argued that this course of action does not directly require pharmaceutical companies to set lower initial prices, which could very well be the root of the problem.

Regardless, the issue of high drug prices is an incredibly complex problem, and while it seems federal regulators are taking a strong and even bipartisan approach to understanding and addressing the problem, there is currently no agreement on what measures must be taken.

Healthesystems previously addressed how the drug price debate will be a topic to watch in 2019, exploring the different types of initiatives proposed by varying parties, including:

  • Bills to bring generic drugs to market sooner
  • Allowing prescription drug imports from Canada
  • Permitting collective drug price negotiation by Medicare
  • Removing patents for drugs deemed “excessively priced” as determined by comparing U.S. prices to those in other countries and other criteria
  • Allowing government-controlled manufacturing of drugs
  • Ending the current patent-protection system for pharmaceuticals and replacing it with a government sponsored incentive system to develop needed drugs

With so many options for such a complex problem, it seems that carving a clear path forward may be difficult, requiring a multipronged approach made up of several initiatives, indicating that the future may see a flurry of different reforms, especially as different individual states propose their own solutions.

According to the National Academy for State Health Policy, there are currently 79 active bills in state legislatures across the country designed to lower pharmaceutical costs. And with many states currently operating or in the process of implementing formularies, we could see this issue managed in a diverse manner throughout the U.S.

But beyond reforms driven by lawmakers, some federal agencies are taking action where they can to lower drug prices; the FDA has enacted various initiatives over the last several months to help drug developers expedite the generic drug approval process, while back in January the Centers for Medicare & Medicaid Services (CMS) announced a new model to lower drug prices in Medicare Part D. This CMS action in particular could impact workers’ comp, as certain state fee schedules are based on CMS standards.

While it is not certain yet just how the drug price problem will be approached, from a workers’ comp perspective it should be noted that an effective way to reduce overall costs is to employ constructive clinical oversight and drug utilization management focused on outcomes, ensuring that drug use in a patient population is as efficient as possible to reduce unnecessary utilization and spending.

Tags: Drug price, drug pricing, FDA, CMS, federal, Senate, House of Representatives

FDA Establishes Guidance for Brain-Computer Interface Technologies

The FDA has announced steps to promote the development of brain-computer interface technologies (BCI), going so far as to issue draft guidance that provide thoughts on clinical and non-clinical testing for software, biocompatibility, electrical safety, and more.

But what is brain computer interface? BCI is the process of capturing electric activity in the brain, either through a surgically implanted electrode or special electrode cap, and sending that information to a computer system which translates that activity to a command for an external device.

BCI has the potential to help patients regain lost mobility, interact more functionally with prosthetics, restore communication, and much more. Healthesystems previously reported on BCI, noting various BCI breakthroughs, including:

But BCI technology still has a way to go before we see products flooding the market. Currently the only FDA-approved BCI technology is the NeuroPace chip from 2013, which scans the brain for electric activity related to seizures, short circuiting said activity. Furthermore, BCI devices must gain some semblance of portability and consumer-friendly maintenance functionality, which may be difficult as several BCI devices must be surgically implanted.

However, the FDA’s interest in BCI indicates that health professionals should begin taking this technology more seriously. Not only did the FDA provide initial thoughts on regulatory considerations for BCI technologies, but they also established a 15-person team of experts to study the BCI landscape and prepare future recommendations. Furthermore, the FDA may soon conduct public workshops to foster discussion of scientific and clinical considerations associated with the development of BCI devices.

And it isn’t just the FDA taking notice. The Journal of the American Medical Association just re-featured information from a November PLOS One paper that described how BCI was used to help quadriplegics with implanted electrodes control personal tablets and perform common tasks such as web browsing, sending emails, instant messaging, and texting.

As the field of BCI continues to make breakthroughs, it will only be a matter of time before such technologies make their way into workers’ comp.

Tags: FDA, brain-computer interface, brain computer interface, BCI, JAMA, PLOS One, paralysis, spinal, spinal cord, innovation, technology