Latest Review Date: November 2024

Category: Medical                                         

POLICY:

Sphenopalatine ganglion blocks are considered investigational for all headache indications, including but not limited to the treatment of migraines and non-migraine headaches.

DESCRIPTION OF PROCEDURE OR SERVICE:

Chronic migraine and severe headaches are common conditions, and the available treatments are not universally effective. A proposed treatment option is blocking the sphenopalatine ganglion (SPG) nerve by applying topical anesthetic intranasally. Several catheters approved by the U.S. Food and Drug Administration are available for the SPG blocking procedure.

Headaches and Headache Treatments

Headaches are common neurologic disorders and are among the top reasons why individuals seek medical care. Headaches affect approximately 50% of the general population in a given year and over 90% of people have a lifetime history of headache. The 2 most common types of headaches are migraines and tension-type headaches.

Migraines are the second-most common headache disorder, with a 1-year migraine prevalence of approximately 12% in the United States. Migraines are characterized by severe pain on 1 or both sides of the head, nausea, and, at times, disturbed vision. Migraines can be categorized by headache frequency, and by the presence or absence of aura. Chronic migraine is defined as attacks on at least 15 days per month for more than 3 months, with features of migraine on at least 8 days per month.

Tension-type headaches have a prevalence of approximately 40%. Diagnostic criteria include the presence of at least 2 of the following 4 characteristics: bilateral headache location, non-pulsating pain, mild-to-moderate intensity, and headache not aggravated by physical activity; lasting between 30 minutes and 7 days; and not accompanied by nausea, vomiting, photophobia, or phonophobia.

Cluster headaches are less common than tension or migraine headaches, with an estimated prevalence of 0.1% of the population. They are characterized by severe unilateral orbital, supraorbital, and/or temporal pain that also includes other symptoms in the eye and/or nose on the same side (e.g., rhinorrhea, eyelid edema or drooping).

Postdural puncture headache (PDPH), is a common complication of lumbar puncture. This headache also occurs with low cerebrospinal fluid volume from a leak at the site of the dural puncture, resulting in low cerebrospinal pressure and intracranial hypotension. Individuals undergoing epidural anesthesia are also at risk for PDPH due to unintended dural puncture, which has been reported to occur in <1% to 6% of obstetric individuals. PDPH is characterized by a bilateral frontal or occipital headache that worsens with sitting or standing and is relieved in the supine position. Associated symptoms may include nausea, neck stiffness, low back pain, tinnitus, and visual disturbances. The reported incidence of PDPH as a complication of lumbar puncture is variable, ranging from 10% to 40% of lumbar puncture procedures. Incidence may be as low as 2% when small gauge, non-cutting needles are used.

A variety of medications are used to treat acute migraine episodes. These include medications taken at the onset to abort the attack (e.g., triptans, ergotamines, lasmiditan, calcitonin-gene related peptide antagonists) and medications to treat the pain and other symptoms of migraines once they are established (e.g., nonsteroidal anti-inflammatory drugs, antiemetics). Prophylactic medication therapy may be appropriate for people with migraines that occur more than 2 days per week. Botulinum toxin type A injections are a U.S. Food and Drug Administration (FDA) approved prophylactic treatment for chronic migraine. Several calcitonin-gene related peptide antagonists are available as FDA-approved treatment options for acute and prophylactic treatment of migraine. In addition to medication, behavioral treatments (e.g., relaxation, cognitive therapy) are used to manage migraine headache.

Severe acute cluster headaches may be treated with abortive therapy, including breathing 100% oxygen and triptan medications. Other medications used to treat cluster headaches include steroids, calcium channel blockers, and nerve pain medications. Due to the severity of pain associated with cluster headaches, individuals may seek emergency treatment. Tension-type headaches are generally treated with over-the-counter pain medication.

Sphenopalatine Ganglion Block

Sphenopalatine ganglion (SPG) blocks are a proposed treatment option for chronic migraines and some severe non-migraine headaches. The SPG is a group of nerve cells located behind the bony structures of the nose. The nerve bundle is linked to the trigeminal nerve, the primary nerve involved in headache disorders. The SPG has both autonomic nerves, which in this case are

associated with functions such as tearing and nasal congestion, and sensory nerves, associated with pain perception. These blocks involve topical application of local anesthetic to mucosa overlying the SPG. The rationale for using SPG blocks to treat headaches is that local anesthetics in low concentrations could block the sensory fibers and thereby reduce pain while maintaining autonomic function.

The proposed procedure for SPG blockade is to insert an intranasal catheter that is attached to a syringe carrying local anesthetic (e.g., lidocaine, bupivacaine). Once the catheter is in place, the local anesthetic is applied to the posterior wall of the nasal cavity and reaches the SPG. Originally, SPG blocks were done by inserting a cotton-tipped applicator dabbed with local anesthetic into the nose; this technique may be less accurate and effective than the currently proposed procedure. Neurostimulation of the SPG and SPG blockade with radiofrequency lesioning have been used outside of the United States, but these treatments are not cleared or approved by the FDA.

Three catheter devices are commercially available in the United States for performing SPG blocks. The catheters have somewhat different designs, but all are attached to syringes to deliver local anesthetic. The catheters are inserted intranasally and, once in place, the local anesthetic is applied through the catheter. With 2 of the 3 commercially available catheters (the SphenoCath®, Allevio® Nerve Block Catheter™), individuals are positioned on their back with their nose pointed vertically and their head turned to the side. With the Tx360® device, individuals remain seated.

The optimal number and frequency of SPG treatments is unclear. Information from the American Migraine Foundation suggests that the procedure can be repeated as often as needed to control pain. A randomized controlled trial has described a course of treatment for migraines consisting of SPG blocks twice a week for 6 weeks (total, 12 treatments).

Sphenopalatine ganglion blocks are proposed for both short- and long-term treatment of headaches and migraines. When used in the emergency setting in individuals with severe acute headaches, the goal of treatment is to abort the current headache while the patient is in the emergency department. In the randomized controlled trial that provided a 6-week course of treatment with SPG blocks for chronic migraine (mentioned above), short-term outcomes were assessed up to 24 hours after each treatment, and the duration and frequency of chronic migraines were assessed at 1 and 6 months after the course of treatment.

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through October 7, 2024.

Summary of Evidence:

For individuals who have chronic migraine who receive sphenopalatine ganglion (SPG) block(s), the evidence includes a randomized controlled trial (RCT) and a case report. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The randomized trial evaluated a regimen of 12 SPG blocks over 6 weeks and was double-blind and placebo controlled. The trial found significantly greater short-term (up to 24 hours) benefits from active treatment than from placebo. There were no significant long-term effects (i.e., 1 and 6 months after 12 treatments), although the trial was underpowered to detect longer term efficacy. Given that SPG blocks are being proposed as a preventive therapy for chronic migraine, evidence demonstrating reduced migraine frequency, severity, or other objective outcomes from robust trials is still needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have severe acute headache treated in the emergency setting who receive SPG block(s), the evidence includes single RCT. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The randomized, double-blind, placebo-controlled trial evaluated a single SPG block for severe acute headache of mixed etiologies. There was no statistically significant difference between active treatment and placebo for the primary outcome (pain reduction 15 minutes postintervention). The trialists did not collect pain data again until 24 hours posttreatment, at which time significantly more individuals were headache-free in the active treatment arm than in the placebo arm. Additional studies, preferably RCTs, are needed to determine whether SPG blocks are an effective treatment in the emergency setting. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have cluster headache who receive SPG block(s), the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two small case series, both of which evaluated an approach for intranasal SPG blocks that differs from the intervention currently available in the United States, were identified. In these series, 40% to 50% of individuals experienced complete symptom relief for a variable length of time and about 20% had treatment-related complications. However, it is not clear from these series the degree to which the procedures evaluated differ in safety and efficacy from an intranasal SPG block using a device cleared by the U.S. Food and Drug Administration. Additional studies, preferably RCTs, are needed to evaluate SPG blocks for treating cluster headaches. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have postdural puncture headache (PDPH) who receive SPG block(s), the evidence includes a systematic review of 9 RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review included 9 RCTs (N=381) comparing SPG blocks to various PDPH treatments or sham. The SPG block consists of various lidocaine concentrations (2% to 10%) with some studies combining lidocaine with ropivacaine, dexamethasone, or epinephrine. The primary outcome was the pooled assessment of the pain at various intervals. SPG blocks significantly improved pain compared with controls at 30 minutes, 1 hour, and 4 hours, but not at 2 hours, 6 hours, 8 hours, 12hours, or 24 hours. The use of rescue treatment was similar between groups. Limitations of the analysis include the variety of anesthetic strengths and combinations used for SPG, the open-label design of the majority of the studies, and the small sample size of the studies. Additional studies, preferably RCTs with larger sample sizes, are needed to evaluate SPG blocks for treating PDPH. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Pain Medicine

The American Academy of Pain Medicine (2021) conducted a systematic review to develop practice recommendations for use of percutaneous interventional strategies for the preventive treatment of migraine. Sphenopalatine ganglion blocks received a weak recommendation for chronic migraine prevention based on a very low certainty of evidence. The only therapy evaluated in the guideline that received a strong recommendation for chronic migraine prevention was onabotulinumtoxinA.

American Headache Society

The American Headache Society guideline (ADH; 2016) on the treatment of cluster headache includes subcutaneous sumatriptan, zolmitriptan nasal spray, and high flow oxygen as Level A (established as effective) acute treatment recommendations. Sphenopalatine ganglion stimulation is rated as a Level B (probably effective) acute treatment recommendation. However, the recommendation for sphenopalatine ganglion stimulation was based on a single randomized controlled trial that evaluated an implanted, on-demand, acute electrical stimulation device of the SPG, rather than a catheter device used to apply local anesthetic. There are no Level A recommendations for reducing the frequency of cluster headaches in the guideline.

Multi-society International Working Group

A multi-society international working group with U.S representation published clinical practice guidelines on postdural puncture headache (PDPH) management. The guidelines state that "Evidence does not support routine use of SPGBs [sphenopalatine ganglion blocks) to treat PDPH". This was a Grade I level recommendation with a low level of certainty.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Sphenopalatine Ganglion (SPG), Sphenopalatine Ganglion Block, Tx360®, MiRx™ protocol, SpenoCath®, Allevio™

APPROVED BY GOVERNING BODIES:

The Tx360 Nasal Applicator (Tian Medical), the Allevio SPG Nerve Block Catheter (CureMed), and the SphenoCath (Dolor Technologies) are considered class I devices by the FDA and are exempt from 510(k) requirements. This classification does not require submission of clinical data on efficacy but only notification of FDA prior to marketing. All 3 devices are used to apply numbing medication intranasally.

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: 

CPT codes:   

REFERENCES:

1. American Migraine Foundation. Sphenopalatine Ganglion Blocks in Headache Disorders. 2016; americanmigrainefoundation.org/resource-library/sphenopalatine-ganglion-blocks/.
2. Barad M, Ailani J, Hakim SM, et al. Percutaneous Interventional Strategies for Migraine Prevention: A Systematic Review and Practice Guideline. Pain Med. Jan 03 2022; 23(1): 164-188.
3. Cady R, Saper J, Dexter K, et al. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360(®) as acute treatment for chronic migraine. Headache. Jan 2015; 55(1): 101-16.
4. Cady RK, Saper J, Dexter K, et al. Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine. Headache. Apr 2015; 55(4): 529-42.
5. Candido KD, Massey ST, Sauer R, et al. A novel revision to the classical transnasal topical sphenopalatine ganglion block for the treatment of headache and facial pain. Pain Physician. Nov-Dec 2013; 16(6):E769-778.
6. Dwivedi P, Singh P, Patel TK, et al. Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials. Braz J Anesthesiol. Jul 06 2023.
7. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. Jan 2018; 38(1): 1-211.
8. Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004; 24 Suppl 1: 9-160.
9. International Association for the Study of Pain (IASP). Global year against headache. www.iasp-pain.org/advocacy/global-year/headache/.
10. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
11. Plewa MC, McAllister RK. Postdural Puncture Headache (PDPH). In: StatPearls. Treasure Island (FL): StatPearlsPublishing; August 23, 2020.
12. Robbins MS, Starling AJ, Pringsheim TM, et al. Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines. Headache. Jul 2016; 56(7): 1093-106.
13. Schaffer JT, Hunter BR, Ball KM, et al. Noninvasive sphenopalatine ganglion block for acute headache in the emergency department: a randomized placebo-controlled trial. Ann Emerg Med. May 2015; 65(5): 503-10.
14. Schoenen J, Jensen RH, Lantéri-Minet M, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. Cephalalgia. Jul 2013; 33(10): 816-30.
15. Seebacher J, Ribeiro V, LeGuillou JL, et al. Epidural blood patch in the treatment of post dural puncture headache: a double-blind study. Headache. Nov 1989; 29(10): 630-2.
16. Singh A, Soares WE. Management strategies for acute headache in the emergency department. Emerg Med Pract. Jun2012; 14(6): 1-23; quiz 23-4.
17. Uppal V, Russell R, Sondekoppam RV, et al. Evidence-based clinical practice guidelines on postdural puncture headache: a consensus report from a multisociety international working group. Reg Anesth Pain Med. Jul 08 2024; 49(7): 471-501.

POLICY HISTORY:

Medical Policy Panel, November 2023

Medical Policy Group, December 2023 (6): New medical policy. Information regarding SGB transferred from MP 314 Occipital Neuralgia and Headache Treatment. Policy on Draft 1/1/24-2/15/2024.

MPAC, December 2023.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (9): Updates to Key Points, Practice Guidelines, and References.

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 illness, injury or disease.