Time is now for nonopioid pain modalities

The Time Is Now for Nonopioid Pain Modalities

Alexandria, Va.—Our health care system needs to look beyond modalities such as virtual physical therprescribing opioid medications for pain to consider a range of modalities based on patient preferences, speakers said at the apy. The goal would be to determine whether such treatments could help improve patient outcomes and result in 130 2020 Opioid Management Summit. less opioid use among those enrolled. The specifics are still being discussed, Dr. Americans “We’re not saying you can’t take opioids,” said Cheri Lattimer, RN, BSN, as a recommended approach to manage low back pain (2018;391[10137].doi. Sherman said, but could be particularly helpful during the COVID-19 pandemic die every day the executive director of the National Transitions of Care Coalition, a nonorg/10.1016/S0140-6736(18)30725-6). Another paper in JAMA Network Open with people staying home. The insurer also is looking into exercises to promote mindfrom an opioid profit organization dedicated to raising awareness about transitions of (2018;1[1]:e180105) demonstrated that chiropractic care, when added to usual fulness to improve how people cope with pain, conducting trainings for some memoverdose. care among health care professionals. medical care, resulted in moderate shortbers and employees, and making lessons “When you have a catastrophic injury or cancer, where pain has to be controlled by medications, we don’t want to take that away. But how can we give more options to individuals, whether the patient is an adolescent with a sports injury, a veteran or a senior?”

On average, 130 Americans die every day from an opioid overdose, Ms. Lattimer said, citing CDC statistics (bit.ly/39G5YxW). This includes both prescription opioids and illicit drugs, she said. Part of the problem stems from a lack of education, and U.S. patients believing they should not have any pain.

The fastest-growing population taking opioids is adults aged 65 years and older, Ms. Lattimer added, and most seniors are largely unaware of their options for pain management beyond what their doctors suggest.

Providers need to alter their management of pain to factor in patient preferences, social determinants of health, behavioral health and additional modalities, Payors and providers are encouraging the use of a variety of nonopioid pain treatments, she said. Complicating the including physical and occupational therapy, electrical stimulation, chiropractic manipulations issue, nonopioid therapy and phonopherosis, which uses electrical currents to deliver topical medication through the skin. options may be outside bundled payments, resulting in higher patient term improvements in low back pain available virtually. It is also studying a offer a discount to a network of procopays—or not covered at all. intensity and disability among active duty biofeedback device that may help people viders offering acupuncture, tai chi,

CDC guidelines and the National Pain military personnel. Specifically, adjusted alter how they respond to pain. massage and other alternative theraStrategy are very open to nonpharmamean differences in scores at week 6 “There is very much a willingness to pies, or cover trigger point injections cologic care to help address the overwere statistically significant in favor of look at these kinds of new approaches,” to treat painful areas of muscle, Dr. use of opioids, said chiropractor Sherry usual medical care plus chiropractic care Dr. Sherman said. DeLeo said in a phone interview. In McAllister, MS (Ed), DC, the executive compared with usual medical care alone addition, the network includes pain vice president of the Foundation for for low back pain intensity (mean differPlan Covers Wide Range management centers of excellence Chiropractic Progress. Complementary ence, –1.1; 95% CI, –1.4 to –0.7), disability Of Alternative Therapies where some members are referred for pain therapies include spinal manipula(mean difference, –2.2; 95% CI, –3.1 to Highmark Health, an integrated delivnerve blocks, behavioral therapy and tions by chiropractors, yoga, massage, –1.2), and satisfaction (mean difference, ery network in the Pittsburgh area, covother treatments. acupuncture and physical therapy. 2.5; 95% CI, 2.1-2.8). ers a range of modalities for pain manIn other tactics, the company has

“The Joint Commission, American Health plans are becoming increasingly agement among its different plans, said promoted CDC guidelines for safe prePain Society and American College of interested in alternative pain paths, comCaesar DeLeo, MD, the company’s scribing of opioids, set prior authoPhysicians all want us to go with nonmented Michael Sherman, MD, MBA, executive medical director and vice rization limits for initial duration of pharmacological options of pain conthe senior vice president and chief medipresident of strategic initiatives. These opioid prescriptions, and encouraged trol if possible, and to have discussions cal officer for Harvard Pilgrim Health include physical and occupational therparents to talk to oral surgeons before with patients,” Dr. McAllister said. Care in New England. “We’re very interapy, electrical stimulation and transtheir children are prescribed opioids

Emerging research is demonstrating ested in some of the newer modalities cutaneous electrical nerve stimulation for wisdom tooth extraction, he said. the benefits of some of these therapies in of treating pain, specifically [modalities] therapy, chiropractic manipulations, pain management, she said, including a that are nonopioid,” he said. and phonophoresis, which uses electri—Karen Blum three-part series published in the Lancet For example, his company is exploring cal currents to deliver topical medica(www.thelancet.com/series/low-backthe launch of a trial of a mobile app that tion through the skin. The sources reported no relevant pain), suggesting spinal manipulation would educate patients about nonopioid Some plans cover acupuncture or fi nancial relationships.

Digital Therapeutics

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their care, said Theresa Juday, RPh, the director of specialty product for CVS Health, during a webinar on understanding this emerging product class.

“All of us in managed care pharmacy are really focused on” considering a patient’s unique needs to personalize their care, Ms. Juday said. “Digital therapeutics can help accomplish that in a number of ways, such as providing care based on the patient’s schedule and in their setting.” These remote therapies “are critically important in today’s COVID-19 world, when patients can’t get to a physician’s office,” she stressed.

In April, the FDA issued guidance to more readily allow the distribution of computerized behavioral therapy and other digital therapeutic devices for psychiatric and mental health disorders during the pandemic (bit. ly/34Y0VrS). The use of these tools “may improve mental health and wellbeing of patients with psychiatric conditions during periods of shelter-inplace, isolation, and quarantine,” the FDA wrote in its guidance (box). The technology, the agency added, has the potential to facilitate social distancing and ease the burden on hospitals and care providers.

Several companies, such as Akili Interactive, jumped at the opportunity. Shortly after the FDA guidance was issued, the firm released Endeavor, a digital attention treatment for children with attention deficit hyperactivity disorder delivered via a video game. Akili is offering it free for a limited time to qualifying families, said Jeff Abraham, MBA, the company’s vice president for market access and trade, at a virtual press briefing on digital therapeutics.

In a company trial, Akili gave AKL-T01 or a similar tablet-based game that used different stimuli to 348 children aged 8 to 12 years old. After four weeks, patients using AKL-T01 showed improvements based on an attention performance index, which was the study’s primary end point (P=0.006).

“Because of the pandemic situation and we don’t know the future, there is a need for us to find alternatives to what our traditional medical system was using,” Mr. Abraham said. “We may not be getting back to that anytime soon.”

Addiction Medicine

Yuri Maricich, MD, the chief medical officer at Pear Therapeutics, said some digital therapeutics provide an option for patients who otherwise may not have a solution. For example, products offered by his firm manage addiction to cannabis, cocaine and other stimulants “for which there are no therapies approved,” he said. “The only option they have now is a prescription digital therapy.” Usage records reviewed by his company indicate patients are using the therapies for addiction around the clock as they need them, not just during 9-to-5 office hours. “That’s a really unique thing right now in the time of COVID,” Dr. Maricich said.

Defining value, making sure all stakeholders are educated on proper use of the therapies, and evaluating the technologies present ongoing challenges, speakers noted.

“This is basically a new way of providing medicine, and evaluating that can be challenging,” Mr. Abraham said. “For some of these products, there’s not going to be a comparator.”

The digital therapeutics space is “exciting, but also chaotic, because there are hundreds of thousands of solutions available for patients and payors today,” said Mark Bini, MBA, the chief patient experience officer at the pharmacy benefit manager Express Scripts, during the press briefing. “This poses a problem for [determining] what works and what doesn’t.”

Last December, the company launched a digital health formulary, which works like a drug formulary, to help its clients

Digital Devices Are FDAApproved for 8 Mental Health Conditions

1. Obsessive-compulsive disorder 2. Generalized anxiety disorder 3. Insomnia disorder

4. Major depressive disorder 5. Substance use disorder

6. Post-traumatic stress disorder

Akili Interactive’s AKL-T01 digital medicine program uses the same storytelling and reward mechanisms as standard video games—but adds algorithms that dial the level of stimuli up or down to meet the needs of the patient.

evaluate digital health solutions based on their clinical effectiveness and usability, and negotiate value and return on investment. The first cohort of products includes solutions for diabetes, pulmonary conditions, cardiovascular and behavioral health, with plans to expand to women’s health, oncology, inflammatory conditions and musculoskeletal disorders.

“People confined to their homes during the COVID-19 pandemic can really benefit from having a solution in the palm of their hand,” Mr. Bini said.

An Express Scripts review of its mental health claims data showed a 21% or higher increase in usage of antidepressants, antianxiety and insomnia medications from mid-February to mid-March 2020, Mr. Bini said. “While there are medications that can help treat these conditions, we also believe there are digital solutions we can put in the hands of people to help manage these conditions, as well.”

Start Where You Are

There is no need to reinvent the wheel when evaluating these products, said Patty Taddei-Allen, PharmD, the senior director of clinical analytics at WellDyne, a pharmacy benefit manager. “We already have processes in place to evaluate premarket medications, so a similar framework should be applied when framework shou evaluating digital therapeutics,” she evaluating dig said during a webinar. said during a Important factors to consider Important include safety and efficacy, Dr. include safe Taddei-Allen said. There may Taddei-Alle not be a randomized controlled not be a ra trial, but there should be peertrial, but reviewed literature that review evaluates products based on evaluat these parameters. Also conthese p sider benefit coverage, which sider be may require conversations may req with a client on improving with a c or altering their benefit plan or alterin design. Finally, patient access design. Fin and usability must be considered, along and usability must with product safety and security. with product safety

Companies can employ comparative effectiveness research methods when evaluating digital therapeutics, Dr. Taddei-Allen noted. Online tools are available to help synthesize a body of evidence that exists for a particular product. In addition, managed care organizations may have extensive access to medical and administrative claims to allow them to conduct ongoing observations of how a digital therapeutic is working.

Digital therapeutics face an additional hurdle: There is not yet a formulary evaluation framework that is widely accepted by most organizations. “In fact, they may not have a process in place to evaluate these products or even know they exist,” Dr. Taddei-Allen said. Decisions also need to be made whether to place the products under the medical or pharmacy benefit, which may affect beneficiaries’ share of the cost.

In addition, many organizations lack the infrastructure to collect clinical outcomes associated with digital therapeutics. Ongoing evaluation is key for these therapeutics, Dr. Taddei-Allen said.

“Postmarket surveillance is required, but there are not many reports of that occurring,” she said. “If possible, organizations should collect and review clinical outcomes and determine if the outcome is due to the digital therapeutic or any other confounding variables. It takes a lot of education. There’s a lack of understanding among providers, patients and plan sponsors on where digital therapeutics fit in the care of patients.” —Karen Blum

Ms. Juday’s presentation was supported by an unrestricted educational grant from Novo Nordisk, Inc. The remaining sources reported no relevant fi nancial relationships other than their stated employment.