Medical Policy: 02.01.52
Original Effective Date: December 2013
Reviewed: July 2021
Revised: July 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Acute/chronic migraine and acute/chronic non-migraine headaches are common conditions and available treatments are not always effective. A proposed treatment options include blocking the sphenopalatine ganglion (SPG) nerve by applying an intranasal topical anesthetic or peripheral nerve injections/nerve blocks may also be used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches
As many as 90% of all primary headaches fall under a few categories including migraine, tension-type, and cluster headache. While episodic tension-type headache (TTH) is the most frequent headache type in population-based studies, migraine is the most common diagnosis in patients. Cluster headache typically leads to significant disability and most of these patients will seek medical attention.
Chronic daily headache (CDH) is a descriptive term that encompasses several different specific headache diagnoses characterized by frequent headaches. Primary CDH subtypes of long duration (i.e., four hours or more) include chronic migraine and chronic tension-type headache. Primary headache types of shorter duration that can be chronic and occur daily are chronic cluster headache, chronic paroxysmal hemicrania and primary headache disorders such as cervicogenic headache.
A variety of medications are used to treat acute/chronic 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, 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 (eg, relaxation, cognitive therapy) are used to manage migraine headache. Botulinum toxin type A injections are FDA-approved treatment for chronic migraine.
Severe acute/chronic 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.
The purpose of sphenopalatine ganglion (SPG) block(s) in patients who have chronic headaches (chronic migraine, chronic tension type headache, chronic cluster headache and cervicogenic headache (primary headache disorder) is to provide a treatment option that is an alternative to or an improvement to existing therapies.
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 which are associated with the 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.
The proposed procedure for SPG block 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, reaching the SPG. Three catheter devices are commercially available for performing SPG blocks: SpenoCath, Allevio SPG Nerve Block Catheter and Tx360 Nasal Applicator device. The company marketing Tx360 Nasal Applicator device proposes its use in the context of the MiRX protocol. This is a two- part protocol which 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 number of treatment approaches such as physical therapy, ergonomic modifications, message, and dietary recommendations.
The optimal number and frequency of SPG blocks is unclear. Randomized controlled trials have described a course of treatment for migraines consisting of SPG blocks twice a week for 6 weeks, for a total of 12 treatments.
Peripheral nerve injections/nerve blocks may also be used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches
Although clinicians commonly utilize these peripheral nerve injections/nerve blocks to manage headaches the procedure has yet to be standardized for this indication.
The relevant population of interest is individuals with acute/chronic headaches (chronic migraine, chronic tension type headache, chronic cluster headache and cervicogenic headache (primary headache disorder).
The therapy being considered is Sphenopalatine ganglion (SPG) block(s) and peripheral nerve injections/ nerve blocks.
SPG block(s) are proposed for both short and long- term treatment of chronic headaches and chronic migraines. When used in the emergency department 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 setting.
Peripheral nerve injections/nerve blocks may also be used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches.
The following therapies and practices are currently being used to treat chronic headaches (chronic migraine, chronic tension type headache, chronic cluster headache and cervicogenic headache (primary headache disorder): medications, self-management [exercise, relaxation/message], physical therapy, ergonomic modifications and dietary recommendations).
The general outcomes of interest are reductions in headache frequency, intensity, and medication use. Treatment-related adverse events are minor. A series of injections may be given over several weeks, with follow-up over months to monitor for treatment effect and durability.
Based on review of the peer reviewed medical literature regarding the use of sphenopalatine ganglion (SPG) block(s) for the treatment of migraine and non-migraine headaches the evidence includes randomized controlled trials (RCTs) and case series. Sphenopalatine blocks are being proposed as preventative for chronic migraines and evidence demonstrating reduced migraine frequency, severity or other objective outcomes from robust trails are still needed. For non-migraine headaches additional studies preferably randomized controlled trials (RCTs) are needed to evaluate SPG blocks for this indication. The evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.
Based on review of the peer reviewed medical literature regarding peripheral nerve injections/nerve blocks used at various locations around the face and neck (occipital nerve, trigeminal nerve, supraorbital nerve and stellate ganglion) to reduce pain and inflammation using injectable anesthetic, steroids or other agents to manage headaches (migraine or non-migraine headaches) is limited. There is considerable variability among clinicians as to injection site(s) and medication selection, indicating a substantial gap in the literature to guide practice and supports the need for further research (controlled clinical trials) in this area. The evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.
In 2019, the European Headache Foundation issued an update: Aides to management of headache in primary care (2nd edition) and this updated management guide does not mention the use sphenopalatine ganglion nerve block or any other types of nerve blocks in the treatment of headaches or trigeminal neuralgia.
The American Headache Society (AHS) Special Interest Section for Peripheral Nerve Blocks and Other Interventional Procedures cited the paucity of evidence for treatment of most headache disorders and cranial neuralgias, excluding cluster headaches.
The Institute for Clinical Systems Improvement’s clinical guideline on “Diagnosis and treatment of headache” (2013) did not mention trigeminal nerve block as a therapeutic option.
An updated consensus statement for treating migraine was released in December 2018 by the American Headache Society.
Use evidence-based treatment at the first sign of a migraine attack. Use NSAIDs (including aspirin), nonopioid analgesics, acetaminophen, or caffeinated analgesic combinations for mild-to-moderate attacks and migraine-specific agents (triptans, dihydroergotamine) for moderate or severe attacks and mild-to-moderate attacks that respond poorly to NSAIDs or caffeinated combinations.
Use a nonoral option for select patients, including those with nausea or vomiting or those who have trouble swallowing.
Options for outpatient rescue include SC sumatriptan, DHE injection or intranasal spray, or corticosteroids. Inpatient options may include parenteral formulations of triptans, DHE, antiemetics, NSAIDs, anticonvulsants (eg, valproate sodium and topiramate, except in women of childbearing age who are not using reliable birth control), corticosteroids, and magnesium sulfate.
The Tx360 Nasal Applicator Device (Tian Medical, the Allevio SPG Nerve Block Catheter (JET Medical), and the SpenoCath (Dolor Technologies) are considered class I devices by the U.S. Food and Drug Administration (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 local anesthetic intranasally.
See Related Medical Policies
Sphenopalatine ganglion (SPG) block(s) are considered investigational for the treatment of migraines and non-migraine headaches because the evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.
Nerve block(s)/injection therapy of local anesthetic steroids or other agents to the stellate ganglion, supraorbital nerve, occipital nerve, or trigeminal nerve is considered investigational for the treatment of migraines and non-migraine headaches because the evidence is insufficient to support a conclusion concerning the net health outcomes or benefits associated with this procedure.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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