Medical Policies - Medicine


Sphenopalatine Ganglion Block for Headaches or Facial Pain

Number:MED205.039

Effective Date:06-01-2018

Coverage:

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Sphenopalatine ganglion (SPG) blocks, using anesthetics (e.g., marcaine, or naropin), with or without steroid(s), are considered experimental, investigational and/or unproven for all indications, including, but not limited to the treatment of migraines, non-migraine headaches, or facial pain.

Description:

Chronic migraine and severe headaches are common conditions and the available treatments are not universally effective. When headaches occur 3 or more times monthly, preventive treatment is usually recommended. 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 (FDA) are available for the SPG blocking procedure.

Background

Headaches are common neurologic disorders and are among the top reasons that patients 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. (1) The 2 most common types of headache are tension-type headaches and migraines. Tension headaches have a prevalence of approximately 40%. (2) Diagnostic criteria include the presence of at least 2 of the following characteristics: bilateral headache location, non-pulsating pain, mild-to-moderate intensity, and headache not aggravated by physical activity. (3) Migraines are the second-most common headache disorder, with a 1-year migraine prevalence of approximately 12% in the U.S. (2) They are characterized by severe pain on 1 or both sides of the head, gastrointestinal complaints, 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. (3)

Cluster headaches are less common than tension or migraine headaches, with an estimated prevalence of 0.1% of the population. (2) 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).

Treatment

A variety of medications are used to treat acute migraine episodes. They include medications taken at the onset of an attack to abort the attack (triptans, ergotamines) and medications to treat the pain and other symptoms of migraines once they are established (nonsteroidal anti-inflammatory drugs [NSAIDS], antiemetics). Prophylactic medication therapy may be appropriate for people with migraines that occur more than 2 days per week. In addition to medication, behavioral treatments (e.g., relaxation, cognitive therapy, biofeedback) are used to manage migraine headache. Botulinum toxin type A injections are a FDA?approved treatment for chronic migraine.

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, patients may seek emergency treatment. Tension-type headaches are generally treated with over the counter pain medication.

Local anesthetic blocks (discussed below) and neurostimulation have been used in a variety of ways in the management of facial/neck neuralgias (e.g., sphenopalatine, trigeminal, herpes zoster). (14, 15) This includes subcutaneous injections of lidocaine or marcaine (bupivacaine) to the peripheral nerves (e.g., greater occipital nerve, lesser occipital nerve, supraorbital nerves, SPG, and facet joints of the upper cervical spine) as additional forms of therapy. (14, 15) Although the effect of each block is limited in duration, a series of subcutaneous injections may provide some sustained relief. (14, 15)

Sphenopalatine Ganglion Block

SPG blocks are a proposed treatment option for chronic migraines, some severe non-migraine headaches, and facial pain. 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. SPG 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.

Trans-nasal topical application of anesthetic to the SPG has been considered the simplest method to establish a blockade for relief of headache and facial pain and has been utilized according to medical literature since 1902. The anesthetic drops are instilled deep into the nares through a variety of methods.

The proposed procedure for SPG blockade is to insert intranasally a 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. Some form of SPG blocking procedure has been used for many years. 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. Another variation is to insert a needle into the cheek and inject local anesthetic but this no longer appears to be used because it is more invasive and can be painful. Neurostimulation of the SPG and SPG blockade with radiofrequency (RF) lesioning have been used outside of the U.S., (4) but these treatments are not cleared or approved by FDA.

Three catheter devices are commercially available in the U.S. for performing SPG blocks. The catheters have somewhat different designs but all are attached to syringes that contain 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 SpenoCath®, Allevio™), patients are positioned on their back with their nose pointed vertically and their head turned to the side. With the Tx360® device, patients remain seated. (5)

The company marketing the Tx360® Nasal Applicator device proposes its use in the context of the MiRx™ protocol. (6) This 2-part protocol includes a medical component for immediate pain relief and a physical component to reduce headache recurrences. The medical component involves clinical evaluation and, if the patient is considered eligible, an SPG block procedure. The physical component can include any of a number of approaches such as physical therapy, ergonomic modifications, massage, and dietary recommendations.

The Tx360® is used in adults to deliver small amounts of fluid via aerosol spray to the nasal pathway, including to the area of the sphenopalatine foramen. The anesthetic is loaded into the Tx360®, placed in the patient’s nares, and applied by spraying the posterior floor of the nose. (16) Treatment time is as little as 10 seconds, with relief felt within 15 minutes. The applicator is a one-time use only. The anesthetic most often used is marcaine or naropin (ropivacaine), with or without a steroid (dexamethasone), and can be administered in a medical office, pain clinic or emergency department setting. A randomized controlled trial (RCT) has described a course of treatment for migraines consisting of SPG blocks twice a week for 6 weeks (total, 12 treatments). Sustained pain relief has been experienced for as long as 28 days. Although, the optimal number and frequency of SPG treatments remains unclear. Information from the American Migraine Foundation suggests that the procedure can be repeated as often as needed to control pain. (5)

SGB blocks are proposed for both short- and long-term treatment of headaches and migraines. When used in the emergency setting in patients with severe acute headaches, the goal of treatment is to abort the current headache while the patient is in the emergency department. In the RCT 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.

Regulatory Status

The Tx360® Nasal Applicator (Tian Medical), the Allevio™ SPG Nerve Block Catheter (JET Medical), and the SpenoCath® (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 to the FDA prior to marketing. All 3 devices are used to apply numbing medication intranasally. For the Tx360®, the FDA classified the device as a manual pump nebulizer to instill droplets, but the intended use is not for treatments as a nebulizer. FDA Product Code: EPN.

Rationale:

The policy was created in 2015 and based on searches of MedLine database for peer-reviewed, published scientific literature of randomized controlled clinical trials. The most recent search was completed on April 9, 2018. The following is a summary of the key literature.

Assessment of efficacy for therapeutic interventions involves a determination of whether the intervention improves health outcomes. The optimal study design for this purpose is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases such as noncomparability of treatment groups, placebo effect, and variable natural history of the condition.

Because the placebo response rate is typically high in patients with headache, assessment of the evidence for this medical policy focuses on randomized, placebo-controlled trials.

Chronic Migraine

The published literature on sphenopalatine ganglion (SPG) blocks to treat chronic migraine consists of 1 double-blind, placebo-controlled randomized trial (7, 8) and a case report with 3 patients. (9)

Findings from the RCT were published in two 2015 publications by Cady et al. The first publication (7) reported on the primary outcome measure and key secondary outcomes, and the subsequent publication (8) reported on supplemental secondary outcomes and longer-term follow-up. The trial included patients who met International Classification of Headache Disorders-II diagnostic criteria for chronic migraine (10) and had a chronic migraine for at least 3 months. Patients could use concomitant headache medication, but had to agree not to change medication use during the study period. Following an initial 28-day baseline period to confirm the diagnosis of chronic migraine, patients were randomized 2:1 to receive treatment with bupivacaine 0.5% or saline (placebo) applied using the Tx360® device. Patients received a series of 12 treatments - 2 treatments a week for 6 weeks. The primary outcome was change in pain severity, measured using a 0-to-10 numeric rating scale (NRS). Pain severity was assessed 15 minutes, 30 minutes, and 24 hours after each treatment. Key secondary outcome measures were the Patient’s Global Impression of Change (PGIC), the Headache Impact Test (HIT-6) questionnaire, and patient satisfaction with treatment. In addition, patients kept headache diaries throughout the study.

Forty-one patients met eligibility criteria and had chronic migraine diagnoses confirmed during the baseline period. These patients were randomized to bupivacaine (n=27) or to placebo (n=13). Mean baseline scores on the NRS were 4.8 in the bupivacaine group and 4.5 in the placebo group. When findings for all treatments were pooled, patients in the bupivacaine group reported a significantly greater reduction in NRS scores than the placebo group at 15 minutes, 30 minutes, and 24 hours after treatment. Bupivacaine-treated patients also had significantly lower PGIC scores than saline-treated patients at 30 minutes and 24 hours post-treatment. No statistically significant between-group differences were found in HIT-6 scores or in average acute mediation use. Only 1 serious adverse event was reported and it was not treatment-related.

The second publication by Cady et al. reported on 1- and 6- month follow-up results and on supplemental secondary end points. (8) To control for multiple comparisons, the cutoff for statistical significance for the supplemental secondary end points was p less than 0.01. There were no statistically significant differences between groups in the reported supplementary secondary outcomes. These outcomes included the number of headache days per month, the mean pain score, and quality of life measures. A post-hoc power analysis revealed that the trial was underpowered to detect significant differences in secondary outcomes. Some results were suggestive of a long-term effect. For example, the bupivacaine group had a lower, albeit nonsignificant number of headache days in the month posttreatment (17 days) than the placebo group (23 days). However, a trial with a larger sample size would be needed to confirm whether 1- or 6-month results are significantly better after bupivacaine than after placebo treatment.

The objective of one 2013 case series from Candidio et al. was to evaluate the U.S. Food and Drug Administration (FDA) cleared Tx360® device to deliver medication to the SPG located at the posterior aspect of the middle nasal turbinate. (9) Three patients were evaluated with the following presenting conditions: trigeminal neuralgia, chronic migraine, and post-herpetic neuralgia. The nasal applicator delivered a combined solution of ropivacaine and dexamethasone for the SPG blockade. Post-procedural assessments were done at 15 and 30 minutes, and on days 1, 7, 14, 21, and 28. All 3 patients were followed for 1 year, with some of the 3 having as many as 10 SPG blocks after the initial 28 days. All patients reported pain relief within 15 minutes after the topical spray application. For 2 of the 3, sustained pain relief was encountered throughout the initial 28-day period. All patients reported pain relief with additional SPG blocks over the span of the first year. The authors concluded that controlled double blind studies with higher number of patients are needed to validate the conclusions of this one small case series that included treatment of trigeminal neuralgia, chronic migraine, and post-herpetic neuralgia.

Section Summary: Chronic Migraine

One small case series of 3 patients was the basis for the FDA clearance of 1 device. The sampling was small and limited to testing the 1 device. Additionally, not all 3 patients had chronic migraine, 2 of which had neuralgia causing facial pain. One double-blind, placebo-controlled, randomized trial has evaluated trans-nasal SPG blocks for chronic migraine. The trial found a significantly greater short-term (up to 24 hours) reduction in pain severity after active treatment versus placebo. However, there were no significant longer-term effects on other outcomes (i.e., 1 and 6 months after 12 treatments over 6 weeks). The trial was underpowered to detect outcomes at 1 and 6 months. It had some risks of bias due to a high rate of dropouts. Additional adequately powered trials are needed to determine the impact of SPG blocks on health outcomes.

Severe Acute Headache Treated in the Emergency Setting

The published literature on SPG blocks to treat severe acute headache consists of 1 double-blind, placebo-controlled, randomized trial (2015) from Schaffer et al. (11) The trial included patients between the ages of 18 and 65 who presented to the emergency department (ED) with a frontal-based crescendo-onset headache and a negative neurologic examination. The trial focused on frontal-based headaches because they are considered most likely to respond to SPG blocks. Headaches were not classified into specific types but patients with sudden-onset headache were excluded. Ninety-three patients met eligibility criteria and were randomized 1:1 to treatment with bupivacaine 0.5% (n=45) or to a saline placebo (n=48) applied using the Tx360® device. The intervention consisted of 1 treatment session. The primary outcome was a 50% absolute pain reduction on a 100-mm visual analog scale (VAS) 15 minutes post-treatment. Four patients, 2 in each group, withdrew before receiving the intervention and 2 were deemed ineligible after randomization. Thus, 41 patients in the bupivacaine group and 46 in the placebo group were included in the primary analysis.

For the primary outcome, 20 (49%) patients in the bupivacaine group and 19 (41%) patients in the placebo group had at least a 50% reduction in the mean VAS score. The difference between groups (7.5%) did not differ statistically (95% confidence interval, -13% to 27%). Secondary outcomes, including at least a 19-mm reduction in VAS score, percentage of patients who were headache-free 15 minutes post-intervention, and percentage of patients who were nausea-free 15 minutes post-intervention, also did not differ significantly between groups. Seventy-six (88%) patients were available for follow-up after 24 hours. The percentage of patients headache-free at 24 hours was significantly higher in the bupivacaine group (n=26 [72%]) than in the placebo group (n=19 [48%]; difference, 25%; 95% CI, 2.6% to 44%). No serious adverse events were reported in either group. The trialists stated that, in retrospect, outcome assessment at 1 hour after treatment would have been useful because headache relief at 1 hour, but not at 24 hours, is clinically relevant for ED headache patients.

Section Summary: Severe Acute Headache Treated in the Emergency Setting

One double-blind, placebo-controlled, randomized trial has evaluated a single trans-nasal SPG block for treating patients with acute headache presenting to an ED. The authors did not find a statistically significant benefit for active treatment compared with placebo 15 minutes post-intervention. Significantly more patients were headache-free at 24 hours in the active treatment than in the placebo group, but, in the absence of short-term pain relief, SPG blocks would not be a clinically useful treatment in the emergency setting. Future studies conducted in the emergency setting should assess outcomes for an intermediate time period (e.g., 1 or 2 hours post-treatment).

Cluster Headache

No RCTs or nonrandomized controlled studies were identified that evaluated intranasal SPG blocks for treating cluster headache. Two case series in patients with chronic drug-resistant cluster headache were published by a research group in Italy. (12, 13) Both studies used a needle (20-gauge in 1 study, 18-gauge in the other) under endoscopic control to inject a mixture of local anesthetics and steroid as close as possible to the SPG. The mixture consisted of triamcinolone acetonide (40 mg), 1% bupivacaine (4 mL), and 2% mepivacaine with 1/100,000 adrenaline (2 mL). The earlier study, published in 2006 by Felisati et al., included 21 patients who received between 2 and 4 total treatment sessions, provided 1 week apart. (12) Including 1 patient in whom the treatment could not be applied, 9 (45%) experienced no efficacy, 3 (15%) experienced a partial benefit, and 8 (40%) experienced a complete temporary benefit. In the 8 patients who had complete disappearance of attacks, the benefit lasted 2 to 4 weeks in 3 patients, 3 to 6 months in 3 patients, and 12 to 24 months in 2 patients. Four (19%) patients experienced treatment-related complications, which consisted of 1 case of marked nasal epistaxis 3 days after the procedure and 3 cases of temporary diplopia.

In 2010, Pipolo et al. reported on 15 patients who received 3 SPG block treatments a mean of 3 days apart. (13) Eight (53%) of the 15 patients experienced complete remission of cluster headache symptoms. Three (20%) of these continued to be in remission at last follow-up (mean, 18 months). One (7%) patient experienced partial benefit and 6 (40%) reported either no benefit or a benefit for less than 2 weeks. Three (20%) patients experienced complications, including 2 cases of severe epistaxis and 1 of reduced buccal opening that resolved after 5 months.

Section Summary: Cluster Headache

The literature includes 2 case series, both of which were published by the same research group in Italy. The approach to treatment was similar in the 2 studies but differed in terms of medication and application technique currently used in the United States. It is unclear how the safety or efficacy of the procedure used in the case series differs from an intranasal SPG block applying local anesthetics and using an FDA cleared device. In these series, 40% to 50% of patients experienced complete symptom relief for a variable length of time and about 20% had treatment-related complications. These studies had small sample sizes and lacked a sham treatment or alternative therapy for treating cluster headache.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this policy are listed in Table 1.

Table 1. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02365909

Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Post-Dural Puncture Headaches (PDPH)

30

Dec 2017

NCT02090998

Sphenopalatine Ganglion Nerve Block versus Elavil for Treatment of Transformed Migraines

200

May 2018

Table Key:

NCT: National Clinical Trial.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

Summary of Evidence

For individuals who have chronic migraine or facial pain resulting from neuralgias (e.g., sphenopalatine, trigeminal, herpes zoster) 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 longer-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 migraines and facial neuralgias, evidence demonstrating reduced migraine or pain frequency, severity, or other objective outcomes from robust trials is still needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have severe acute headache treated in the emergency setting who receive SPG block(s), the evidence includes 1 RCT. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The randomized, double-blind, placebo-controlled trial was 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 again data until 24 hours post-treatment, at which time significantly more patients 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 the effects of the technology on health outcomes.

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 evaluate an approach for intranasal SPG blocks that differs from the intervention currently available in the U.S., were identified. In these series, 40% to 50% of patients 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 the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

This procedure is sometimes reported with CPT code 64505 (topical application of anesthetic agent to the sphenopalatine ganglion), but, in the absence of an actual injection, that code is incorrect. The American Medical Association recommends using an unlisted code 64999 to report this procedure.

This service is reported by some providers with CPT code 64505 along with the CPT code for trigeminal block 64400.

Anesthetic agents that may be used for this service are bupivacaine (S0020) or ropivacaine (J2795), with or without dexamethasone (J1094 or J1100).

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

64400, 64505, 64999

HCPCS Codes

J1094, J1100, J2795, S0020

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. IASP – Epidemiology of Headache (2011). Prepared by the International Association for the Study of Pain. Available at: <http://www.iasp-pain.org> (accessed April 9, 2018).

2. Singh A, Soares WE. Management strategies for acute headache in the emergency department. Emerg Med Pract. Jun 2012; 14(6):1-23; quiz 23-24. PMID 22830180

3. Headache Classification Committee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. Jul 2013; 33(9):629-808. PMID 23771276

4. Sanders M, Zuurmond WW. Efficacy of sphenopalatine ganglion blockade in 66 patients suffering from cluster headache: a 12- to 70-month follow-up evaluation. J Neurosurg. Dec 1997; 87(6):876-80. PMID 9384398

5. AMF – Sphenopalatine Ganglion Blocks in Headache Disorders (2016). Prepared by the American Migraine Foundation. Available at: <https://americanmigrainefoundation.org> (accessed April 9, 2018).

6. ITS – The MiRx™ Protocol (2013). Prepared by Innovative Treatment Solutions; Available at: <http://www.mirxprotocol.com> (accessed April 9, 2018).

7. 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. PMID 25338927

8. 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. PMID 25828648

9. 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):E769-78. PMID 24284858

10. Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004; 24 Suppl 1:9-160. PMID 14979299

11. 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. PMID 25577713

12. Felisati G, Arnone F, Lozza P, et al. Sphenopalatine endoscopic ganglion block: a revision of a traditional technique for cluster headache. Laryngoscope. Aug 2006; 116(8):1447-1450. PMID 16885751

13. Pipolo C, Bussone G, Leone M, et al. Sphenopalatine endoscopic ganglion block in cluster headache: a reevaluation of the procedure after 5 years. Neurol Sci. Jun 2010; 31 Suppl 1:S197-9. PMID 20464621

14. Bogduk N. Role of anesthesiologic blockade in headache management. Curr Pain Headache Rep. Oct 2004; 8(5):399-403. PMID 15361325

15. Levin M. Nerve blocks in the treatment of headache. Neurotherapeutics. Apr 2010; 7(2):197-203. PMID 20430319

16. Tx360® Nasal Applicator – Product Information. Lombard, Illinois: Tian Medical, Inc. (2011). Available at <http://tianmedical.com> (accessed February 26, 2015).

17. Sphenopalatine Ganglion Block for Headache. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 May) Surgery 7.01.159.

Policy History:

DateReason
6/1/2018 Document updated with literature review. Coverage statement rearranged to state, "for all indications, including, but not limited to the treatment of migraines, non-migraine headaches, or facial pain”. Description and Rationale rewritten and reorganized. References were reorganized, with 1-7, 10, 13-17, and 17 added; several references removed. Title changed from Topical Application Device for Anesthetic Treatment to the Sphenopalatine Ganglion for Headaches or Facial Pain to Sphenopalatine Ganglion Block for Headaches or Facial Pain.
2/15/2017 Document updated with literature review. Coverage unchanged.
2/15/2016 Reviewed. No changes.
9/1/2015 New medical document. Topical application of anesthetic (e.g., Marcaine, or Naropin), with or without steroid(s), to the sphenopalatine ganglion as a nerve block for headaches or facial pain using the Tx360® or similar device, is considered experimental, investigational and/or unproven.

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