Addressing Unmet Medical Needs in Neuropathic Pain

The International Association for the Study of Pain defines neuropathic pain as “pain caused by a lesion or disease of the somatosensory system.” Although a common condition, attaining high-quality management in neuropathic pain can be challenging. Guidelines from the Special Interest Group on Neuropathic Pain (NeuPSIG) in 2015 acknowledged that more effective drug treatment for neuropathic pain remains an unmet medical need. Furthermore, Daiichi Sankyo’s 2016 Pain Trends Report identified improved management of neuropathic pain as an important trend over the next decade. First Report Managed Care spoke with stakeholders for their perspectives on this significant, hard-to-treat type of pain.

Pain Trends Report

To better understand current issues and trends in pain management, Daiichi Sankyo surveyed a broad cross-section of stakeholders to characterize and document unmet needs in pain management. Findings from the Pain Trends Report were presented during a Science & Innovation Theater at the recent AMCP Annual Meeting 2017. Although the report did not specifically focus on neuropathic pain, findings underscore several areas of concern with this type of pain.

Perhaps, one of report’s most important findings is that better management of neuropathic pain over the next 10 years is a trend that may be instrumental in shaping future policies and practices. 

“Neuropathic pain is an extremely common condition. Various estimates of the prevalence range from a low of about 3% to a high of over 12%, with most estimates settling at around 10%. That number is likely to grow as the population ages and the prevalence of type 2 diabetes increases. Coupling those numbers with a difficult to treat disease makes it an important and growing health issue,” Gary Owens, MD, president of Gary Owens Associates, said in an interview with
First Report Managed Care. Dr Owens, who is a member of the Editorial Board of Pain Trends Report, presented the report at AMCP.

Bob Twillman, PhD, FAPM, executive director of Academy of Integrative Pain Management (AIPM), agreed with the observation. 

“Neuropathic pain is frequently misdiagnosed, and even when it is diagnosed, it’s often not treated well. Add to that the fact that our best available treatments leave much to be desired in terms of both effectiveness and tolerability, and I think it’s fair to say that we have considerable opportunity for improvement,” he said.

Additionally, 78% of physician surveyed reported somewhat high to extremely high unmet needs for chronic neuropathic pain. For most payer organizations, pain treatment is among the largest drug categories for utilization and spending, however, 69% of payers surveyed were unaware of which type of pain (acute or chronic nociceptive, or chronic neuropathic) results in the most health care utilization. The report also pointed out large unmet needs in pharmacologic treatment for neuropathic pain.

Treatment

NeuPSIG conducted a systemic review and meta-analysis of studies of pharmacologic treatment for neuropathic pain published in Lancet Neurology in 2015, which resulted in its updated recommendations. The guidelines recommend tricyclic antidepressants, gabapentin, pregabalin, and serotonin-noradreline reuptake inhibitor as first-line therapies for neuropathic pain. Opioids were recommended as third-line treatment given its limited efficacy in neuropathic pain. 

Houman Danesh, MD, director of Integrative Pain Management at Mount Sinai, emphasized that individualized treatment for neuropathic pain is needed that “will incorporate some cutting-edge technology that has been studied as well as some alternative therapies such as acupuncture.” He continued, “[Neuropathic pain] can be very difficult to treat depending on the type [of neuropathic pain],” noting that a small number of medications can be used to treat this pain. “I am hopeful that new medications will come out soon that can really target the pain.” According to the Pain Trends Report, more than 20 new molecule entities for neuropathic pain have reached clinical development. The FDA is also gathering information to guide future drug development for this complex entity.

Multimodal therapy is another approach that can be part of step therapy for neuropathic pain. Individuals First Report Managed Care spoke with concurred this is an important strategy. “We have a large body of evidence, going back 30 years that demonstrates that the best treatment for chronic pain involves a multimodal, multidisciplinary approach. Using medications is fine, but they only go so far, and there are many other treatments that can be effective. Many of those treatments also involve increasing patient engagement, which is always a good thing,” said Dr Twillman.

“Treating pain is not just about giving medication. There is lifestyle, psychologic, and other physical factors that can be better managed to help alleviate chronic pain. Therefore, approaches that use physical therapists, mental health providers, pharmacists, nurses, and other professionals in addition to physicians is more likely to address this complex issue for patients,” said Dr Owens.

Dr Danesh added that with a multimodal approach “you get results with less side effects.”

Payer Priorities

Individuals with neuropathic pain are high consumers of health care resources. A study published in 2014 in ClinicoEconomics and Outcomes Research found that annualized direct medical costs to payers, direct costs to patients, and indirect costs per patient were $6016, $2219, and $19,000, respectively, with significant differences across pain severity levels. 

“I think that, because it ends up being undertreated, there is toxicity for patients (and their families and employers). There is toxicity for payers because many of the best treatments tend to be expensive, and the patient is likely to use those treatments indefinitely,” said Dr Twillman.

Payers are also an important stakeholder in neuropathic pain management. Dr Owens explained that payer priorities are to provide access to a range of medications uses to treat neuropathic pain, make sure the medications on the formulary are safe and effective, maintain the affordability of the benefit, and ensure that there are steps in place to manage abuse, misuses, and diversion of opioids if they are used.

“Payers get concerned when they see expensive treatments being used on a long-term basis with minimal evidence that those treatments are effective,” Dr Twillman explained. “This, I think, has been their view of some of the newer agents used to treat neuropathic pain, and as a result, they have implemented step therapy protocols that drive patients and prescribers to less expensive medications. These medications may be comparable in effectiveness, but they often produce more of a side effect burden for patients.” 

From a formulary perspective, there are only a few drugs specifically indicated for neuropathic pain, according to Ellen Drazen, communications manager at Express Scripts, noting that “neuropathic pain is not currently a major area of concern for our clinical and regulatory teams, or from payers.” In terms of pain, “clients are much
more focused on opioid utilization and cost,” she said.

Regulatory and Reimbursement Challenges

Clinicians treating pain, including neuropathic pain, continue to face regulatory and reimbursement hurdles. Dr Danesh has encountered reimbursement issues with certain procedures and medications. 

“Insurance companies will try and make it difficult to go down that path or not cover it all,” he said, citing acupuncture as procedure not usually covered. “It’s a process that requires a lot of effort not just in the diagnosis but then dealing with the insurance companies to try and get things approved.” 

According to Dr Twillman, on top of educating physicians on how to assess pain so they accurately identify neuropathic pain, and then use the most effective treatments.

“We have the challenge of making the most effective treatments available by means of having insurance cover them,” he said. “But the physician who misdiagnoses neuropathic pain and/or thinks that opioids are an effective treatment is making a mistake and actually making himself or herself more vulnerable from a regulatory standpoint.”

Stakeholders agreed that more education and understanding of proper management for neuropathic pain is needed, particularly for patients and physicians. 

“We need to better educate providers about how to diagnose it, because that is the first step in designing the right treatment. Then we need to teach about all the effective treatments and ways in which they can be combined to obtain the best results,” said Dr Twillman. 

To that end, AIPM provides content in its educational programs and publications on neuropathic pain, as well as presentations at its annual meeting and education courses available in the Pain Care Learning Center on AIPM’s website.