Pain Management, Lessons from Pear Therapeutics & a Path Forward-The HSB Blog 7/14/23
Our Take:
The integration of digital health technologies holds great promise in revolutionizing nonopioid pain management offering both innovative solutions for pain relief and improved patient care. While opioids have historically been used for relief of chronic and severe acute pain, for approximately the last 20 years the U.S. has been experiencing an opioid epidemic creating an urgent need for effective nonopioid alternatives for pain management. Opioids are associated with various adverse effects, ranging from respiratory depression to dependence/addiction, overdose, and death.
By providing personalized monitoring, nonpharmacological interventions, educational resources, and remote access to care, digital health can enhance patient outcomes, reduce opioid reliance, and contribute to a safer and more effective approach to pain management.
Key Takeaways:
U.S. healthcare spending, spending on musculoskeletal disorders cost an estimated $380 billion and the prevalence of low back pain, neck pain, and other joint-related conditions grew over 60% on average between 1996-2016 (Harvard Business Review)
People who live with chronic pain are four times more likely to suffer from depression or anxiety (World Health Organization)
Over 80 million Americans report chronic non-cancer pain, defined as non-malignant pain that lasts longer than three months, not associated with end of life (BMC Health Services Research)
Access to the diagnosis, treatment and management of pain is highly unequal globally, with almost half the world's population is not able to access essential health services (BMC Medicine)
The Problem:
Non Opioid pain management refers to a range of strategies and treatments aimed at relieving pain without the use of opioid medications. These approaches include nonpharmacological interventions such as digital therapeutics or DTx (typically apps are prescribed by a physician and used by a patient on their digital device), utilizing augmented reality and virtual reality technologies to provide immersive experiences and cognitive-behavioral therapy, among others.. For example, one method highlighted in “Pain Control Technology Embraces the Challenge to Reduce or Eliminate Opioids'', describes “COOLIEF* Cooled Radiofrequency (RF) a non-opioid, minimally invasive, non-surgical outpatient procedure providing long-lasting relief for chronic pain patients.” However, while non-opioid pain management has gained recognition as a safer and more sustainable option for addressing chronic and acute pain it has struggled to gain payer acceptance with many payers still viewing treatments as investigational, despite several drugs receiving FDA approval.
The continuous monitoring enabled by digital substance use disorder (SUD) tools empowers personalized and remote monitoring of patients' pain levels, timely communication with care teams, adjustments to pain management plans and even interventions if necessary. As highlighted in “Pain Control Technology Embraces the Challenge to Reduce or Eliminate Opioids”, the industry has wholeheartedly embraced the challenge put to it by the FDA which was “intended to spur the development of medical devices, diagnostic tests, and digital health technologies (mobile health applications included) to aid in the fight against the opioid crisis and achieve the prevention and treatment of opioid use disorder (OUD).”
Non-opioid pain management strategies offer a safer alternative to opioid-based treatments, but their effective implementation and widespread adoption can be hindered by factors related to digital health bringing about specific challenges that providers must overcome when trying to integrate digital health technologies into nonopioid pain management approaches.
First and foremost, digital health tools and platforms may not be easily accessible or affordable for all patients. Factors such as cost of devices, internet connectivity, and technical literacy can create barriers, particularly for individuals from low-income backgrounds or who reside in underserved areas.
For example, in Telehealth for management of chronic non-cancer pain and opioid use disorder in safety net primary care, the authors point out that "research indicates that among patients with opioid use disorder, use of telehealth can increase patient engagement over time, yet telehealth’s role in expanding access to care, improving medication recall, and increasing patients’ level of attendance is not well understood, especially in urban settings." Undoubtedly, accessibility issues like this hamper the equitable implementation of digital health solutions for nonopioid pain management.
In addition, while these products need regulatory approval and patient acceptance, those are not always enough, as they need to have payers on board as well. For example, many in the industry point to Pear Therapeutics and its subsequent bankruptcy as both an example of a trailblazer in digital treatments for SUD as well as an example for what not to do. For example, as noted in “Pear Therapeutics: What Happened and What does this mean for DTx “Pear failed to secure widespread reimbursement for its solutions in the U.S. despite FDA clearance (more on Pear Therapeutics in “Backdrop”).
Moreover, seamlessly integrating digital health tools with existing healthcare systems and electronic health records (EHRs) is essential for effective non opioid pain management. As noted in “The Rise and Fall of Pear Therapeutics'', “the company relied heavily on third-party pharmacies, further complicating their operations,” As we have noted before, interoperability challenges between different platforms, lack of standardized data formats, and limited integration capabilities in healthcare are decided impediment to success. In the case of digital tools for pain management, where speed and accuracy of patient information is of paramount importance, this can impede the efficient exchange of information between and among clinicians and hinder the comprehensive management of a patient's pain.
The Backdrop:
As validated in “The Opioid Epidemic: A Geography in Two Phases”, “the United States has been experiencing a drug overdose mortality epidemic marked by the introduction and spread of opioids across rural and urban communities over the past 20 years and can be defined by two phases. In the first phase, beginning around 2000 and ending in the early 2010s, drug overdose mortality rates soared among middle-aged adults between 25-54 who became addicted to prescription opioid painkillers that drove the epidemic. In the second phase, which the authors refer to as “The Illicit Phase of the Epidemic”, since the early 2010s, opioid drug reformulation and declining prescription rates have resulted in ebbing mortality from prescription opioids. At the same time, illicit opioids such as heroin and, increasingly, fentanyl and related synthetic opioids rapidly entered the scene—causing a growing share of drug overdose deaths.
Currently, approximately, 4.8M adults in the US have a current or past opioid use disorder diagnosis, and over 80M report chronic non-cancer pain, defined as non-malignant pain that lasts longer than three months, not associated with end of life, according to “Telehealth for management of chronic non-cancer pain and opioid use disorder in safety net primary care”. The widespread use of opioids for this pain management has led to a significant increase in addiction, overdose, and mortality rates. This crisis has spurred a critical need for alternative approaches to pain management that reduce reliance on opioids.
However, as noted above, engaging patients in their own pain management, and ensuring compliance with nonopioid treatment plans can be challenging. In “Digital health in pain assessment, diagnosis, and management: Overview and perspectives'', the authors note that digital apps such as Pain Check can be helpful because of the subjectivity of pain assessment and the difficulty experienced when people cannot self-report pain as a result of being non-verbal or cognitively declined. As a result, while these digital health technologies offer opportunities for patient education, remote monitoring, and personalized interventions, ensuring patient motivation, adherence, and understanding of these tools becomes crucial for successful implementation.
Implications:
Digital health tools provide alternative strategies and interventions for pain relief, reducing the reliance on opioid medications. By offering non-pharmacological options such as virtual reality, augmented reality, mindfulness exercises, and physical therapy guidance, digital health can contribute to a decrease in opioid prescriptions and mitigate the risks associated with opioid use. These technologies, particularly telehealth services, enable patients to access specialized pain management care irrespective of their geographic location. This is particularly beneficial for individuals in rural or underserved areas who may have limited access to pain specialists which empowers improved access to care for earlier interventions, better pain management, and reduced healthcare disparities.
Despite the potential benefits, the implementation of digital health in nonopioid pain management faces challenges including accessibility, regulatory and reimbursement approval, data privacy and security, and interoperability. Digital health platforms generate vast amounts of data related to pain management, treatment outcomes, and patient experiences. Aggregating and analyzing this data can provide valuable insights into the effectiveness of nonopioid interventions, patient preferences, and trends in pain management but this data must be in a form that can be harnessed and analyzed by multiple systems. Nevertheless, the implications of incorporating digital health solutions in nonopioid pain management offer the potential for improved patient outcomes, reduced reliance on opioids, increased access to personalized care, and real-time monitoring, to name a few. In addition, there are other complementary therapies or digital treatments for SUD.
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