mp-748
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Remote Electrical Neuromodulation for Migraines

Policy Number: MP-748

Latest Review Date: May 2022

Category: Surgery                                                  

POLICY:

Remote electrical neuromodulation for acute migraine is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Migraine

Migraine is a neurologic disease categorized by recurrent moderate to severe headaches with associated symptoms that can consist of aura, photophobia, nausea and/or vomiting. Overall migraine prevalence in the United States is about 15 percent but varies according to population group. Prevalence is higher in women (21%), among American Indian/Alaska Natives (22%) and among 18- to 44-year-olds (19%). Social determinants including low education level (18%), use of Medicaid (27%), high poverty level (23%) and being unemployed (22%) are also associated with higher rates of migraine.

Migraine is categorized as episodic or chronic depending on the frequency of attacks. Generally, episodic migraine is characterized by 14 or fewer headache days per month and chronic migraine is characterized by 15 days or more headache days per month. Specific International Classification of Headache Disorders diagnostic criteria is as follows:

  • Episodic migraine:
    1. Untreated or unsuccessfully treated headache lasting 4 to 72 hours
    2. Headache has at least two of the following characteristics:
      1. Unilateral location
      2. Pulsating quality
      3. Moderate or severe pain intensity
      4. Aggravation by or causing avoidance of routine physical activity
    3. At least one of the following during headache:
      1. Nausea and/or vomiting
      2. Photophobia or phonophobia
  • Chronic migraine:
    1. Migraine-like or tension-type headache on 15 or more days per month for more than 3 months
    2. At least 5 headache attacks without aura meet episodic migraine criteria 1-3, and/or at least 5 headache attacks with aura meet episodic migraine criteria 2-3
    3. On more than 8 days per month for more than 3 months, fulfilling any of the following criteria:
      1. For migraine without aura, episodic migraine criteria 2 and 3
      2. For migraine with aura, episodic migraine criteria 1 and 2
      3.  Believed by the patient to be migraine at onset and relieved by
        a triptan or ergot derivative

Migraine attacks, whether due to episodic or chronic migraine, call for acute management. The goal of acute treatment is to provide pain and symptom relief as quickly as possible while minimizing adverse effects, with the intent of timely return to normal function. Pharmacologic interventions for treatment of acute migraine vary according to migraine severity. First-line therapy for an acute episode of mild or moderate migraine includes oral non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen. Moderate to severe migraine can be treated with triptans or an NSAID-triptan combination. Antiemetic’s can be added for migraine accompanied by nausea or vomiting, though certain antiemetic medications used as monotherapy can also provide migraine relief. Other pharmacologic interventions used to treat acute migraine include calcitonin-gene related peptide antagonists, which can be used in patients with insufficient response or contraindications to triptans, lasmiditan, and dihydroergotamine. Migraine can be managed at home, although acute migraine is a frequently cited reason for primary care and emergency department visits. Regular use of pharmacologic interventions can result in medication overuse, which in turn could lead to rebound headache and increased risk of progression from episodic to chronic migraine.

Remote electrical neuromodulation (REN) may possibly offer an alternative to pharmacologic interventions for patients with acute migraine or it may reduce the use of abortive medications and the risk of medication-overuse to treat acute migraines. The only currently available REN device (Nerivio™) cleared for use by the FDA is worn on the upper arm and stimulates the peripheral nerves to induce conditioned pain modulation (CPM). The conditioned pain in the arm induced by the Nerivio REN device is believed to decrease the perceived migraine pain intensity. Control of the REN device is accomplished through Bluetooth communication between the device and the patient's smartphone or tablet. At onset of migraine or aura and no later than within one hour of onset, the user initiates use of the device through their mobile application. Patient-controlled stimulation intensity ranges from 0 to 100 percent, corresponding to 0 to 40 mill amperes (mA) of electrical current. Patients are instructed to set the device to the strongest stimulation intensity that is just below their perceived pain level. The device provides stimulation for up to 45 minutes before turning off automatically. The Nerivio manufacturer specifies that the device can be used instead of or in combination with medication.

KEY POINTS:

This evidence review was created in March 2022 with a search of the PubMed database. The most recent literature update was performed through March 22, 2022.

SUMMARY OF EVIDENCE

For individuals with acute migraine due to episodic or chronic migraine who receive remote electrical neuromodulation (REN), the evidence includes two RCTs and nonrandomized, uncontrolled studies. Relevant outcomes are symptoms, functional outcomes, quality of life and treatment-related morbidity. Use of an active REN device resulted in more patients with improved pain and symptoms at 2-hour follow-up compared with a sham device based on two small (total N=212) RCTs with numerous relevance limitations. Based on the existing evidence, it is unclear how Nerivio would fit into the current acute migraine management pathways. The specific intended-use (e.g., treatment naive, those with contraindications to medication, or those who have failed pharmacologic treatment); and associated empirically documented recommended REN regimen(s) (e.g., a clinically relevant effective device intensity threshold) must be specified in order to adequately evaluate net health benefit. Additionally, functional outcomes and quality of life must be evaluated in well-designed and well-conducted studies in well-defined populations using well-defined and documented Nerivio regimens. The evidence is        insufficient to determine that the technology results in an improvement in the net health outcome.        

Practice Guidelines and Position Statements

American Headache Society

In 2021, the American Headache Society (AHS) issued guidance on the integration of new migraine treatments, including REN, into clinical practice. The AHS addressed the use of neuromodulatory devices as a group that included electrical trigeminal nerve stimulation, noninvasive vagus nerve stimulation, single-pulse transcranial magnetic stimulation and REN; no guidance specific to REN use was issued.

The AHS determined that initiation of a neuromodulatory device is appropriate when all of the following criteria are met:

  • Prescribed/recommended by a licensed clinician
  • Patient is at least 18 years of age (the guidance noted that 3 devices, including REN, are approved for use in patients age 12 to 17 years)
  • Diagnosis of ICHD-3 migraine with aura, migraine without aura, or chronic migraine
  • Either of the following:
    • Contraindications to or inability to tolerate triptans
    • Inadequate response to two or more oral triptans, as determined by EITHER of the following:
      • Validated acute treatment patient-reported outcome questionnaire (Migraine Treatment Optimization Questionnaire, Patient Perception of Migraine Questionnaire-Revised, Functional Impairment Scale, Patient Global Impression of Change)
      • Clinician attestation

American Academy of Neurology/American Headache Society

A 2019 joint guideline issued by the American Academy of Neurology and the American Headache Society on the treatment of acute migraine in children and adolescents did not address the use of REN or other nonpharmacologic treatments.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

smartphone-controlled wireless transcutaneous electrical nerve stimulation device; Nerivio Migra; remote TENS unit; Remote electrical neuromodulation (REN); conditioned pain modulation (CPM); REN device; Nerivio®; Acute migraine treatment; Chronic migraine; Headache

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration (FDA), granted a de novo classification by (class II, special controls, product code: QGT) for Nerivio Migra (Theranica Bio-Electronics Ltd.) in May 2019. The new classification applied to this device and equivalent devices of this generic type. Nerivio Migra was initially cleared for treatment of acute migraine in adults who do not have chronic migraine.

The U.S. Food and Drug Administration (FDA) through the 510(k) process (K201824) cleared Nerivio for marketing in October 2020. The FDA determined that this device was equivalent to Nerivio Migra for use in adults. The device name changed to just “Nerivio” and the exclusion of chronic migraine patients was removed. The Nerivio device can provide more treatments than the predicate Nerivio Migra (12 treatments vs. eight treatments) and has a longer shelf life (24 months vs. 9 months). In January 2021, the Nerivio device was cleared for use in patients aged 12 to 17 years.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

K1023

Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm

REFERENCES:

  1. Ailani J, Rabany L, Tamir S, et al. Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Front Pain Res (Lausanne). 2021; 2: 753736.
  2. Ailani J, Burch RC, Robbins MS. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. Jul 2021; 61(7): 1021-1039.
  3. Burch RC, Loder S, Loder E, et al. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. Jan 2015; 55(1): 21-34.
  4. Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: Updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. Jan 2021; 61(1): 60-68.
  5. Diener HC, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. May 2019; 39(6): 687-710.
  6. Grosberg B, Rabany L, Lin T, et al. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. Nov-Dec 2021; 6(4): e966.
  7. Hershey AD, Irwin S, Rabany L, et al. Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis. Pain Med. Apr 08 2022; 23(4): 815-820.
  8. Hershey AD, Lin T, Gruper Y, et al. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. Feb 2021; 61(2): 310-317.
  9. Marmura MJ, Lin T, Harris D, et al. Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension Study. Front Neurol. 2020; 11: 226.
  10. Nierenburg H, Vieira JR, Lev N, et al. Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. Pain Ther. Dec 2020; 9(2): 531-543.
  11. Nierenburg H, Rabany L, Lin T, et al. Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability. Pain Ther. Dec 2021; 10(2):1245-1253.
  12. Nierenburg H, Stark-Inbar A. Nerivio (R) remote electrical neuromodulation for acute treatment of chronic migraine. Pain Manag. Apr 2022; 12(3): 267-281.
  13. Oskoui M, Pringsheim T, Holler-Managan Y, et al. Practice guideline update summary: Acute treatment of migraine in children and adolescents: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Headache Society. Headache. Sep 2019; 59(8): 1158-1173.
  14. Rapoport AM, Bonner JH, Lin T, et al. Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications. J Headache Pain. Jul 22 2019; 20(1): 83.
  15. Singh RBH, VanderPluym JH, Morrow AS, et al. Acute Treatments for Episodic Migraine. Rockville (MD): Agency for Healthcare Research and Quality (US); December 2020. Accessed April 5, 2022.
  16. Tassorelli C, Diener HC, Silberstein SD, et al. Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine. Cephalalgia. Oct 2021; 41(11-12): 1135-1151.
  17. Tepper SJ, Lin T, Montal T, et al. Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine. Pain Med. Dec 25 2020; 21(12): 3522-3529.
  18. U.S. Food and Drug Administration. De Novo Classification Request for Nerivio Migra. Accessed March 7, 2022.
  19. U.S. Food and Drug Administration. 501(k) Summary: Theranica Bio-Electronics LTDs Nerivio. Accessed March 31, 2022.
  20. U.S. Food and Drug Administration. 510(k) Summary: Nerivio Approval in Adolescents. Accessed March 8, 2022.
  21. VanderPluym JH, Halker Singh RB, Urtecho M, et al. Acute Treatments for Episodic Migraine in Adults: A Systematic Review and Meta-analysis. JAMA. Jun 15 2021; 325(23): 2357-2369.
  22. Yarnitsky D, Dodick DW, Grosberg BM, et al. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. Sep 2019; 59(8): 1240-1252.
  23. Yarnitsky D, Volokh L, Ironi A, et al. Nonpainful remote electrical stimulation alleviates episodic migraine pain. Neurology. Mar 28 2017; 88(13): 1250-1255.

POLICY HISTORY:

Medical Policy Panel, May 2022

Medical Policy Group, May 2022 (3): New medical policy. Policy created with literature review through March 22, 2022. Remote electrical neuromodulation for acute migraine is considered investigational. Available for comment June 1, 2022 through July 15, 2022.

Medical Policy Administration Committee, June 2022

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent 

      therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s ill