Sphenopalatine Ganglion Block for Headache

POLICY NUMBER

A.7.01.159

DESCRIPTION

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 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. The two most common types of headache are migraines and tension-type headaches.

Migraines are the second-most common headache disorder, with a one-year migraine prevalence of approximately 12% in the United States. Migraines are characterized by severe pain on one 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 two of the following four characteristics: bilateral headache location, nonpulsating 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 (eg, 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. Patients 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 patients. 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 two days per week. Botulinum toxin type A injections are a U.S. Food and Drug Administration-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 (eg, 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, patients 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 (eg, 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 two of the three commercially available catheters (the SpenoCath®, Allevio® Nerve Block Catheter), 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.

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 (RCT) 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 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 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.

The Tx360 Nasal Applicator (Tian Medical), the Allevio SPG Nerve Block Catheter (CureMed), and the Speno Cath (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 three devices are used to apply numbing medication intranasally.

POLICY

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

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/20/2017: Approved by Medical Policy Advisory Committee.

12/13/2019: Policy description updated. Policy statement unchanged.

01/19/2021: Policy description updated regarding post dural puncture headache. Policy statement unchanged.

02/01/2022: Policy description updated regarding tension-type headaches and medications. Policy statement unchanged.

10/24/2022: Policy description updated. Policy statement unchanged. Code Reference section updated to add CPT code 64400.

01/23/2023: Policy description updated. Policy statement updated to state that sphenopalatine ganglion blocks are considered investigational for all headache indications, including but not limited to the treatment of migraines and non-migraine headaches.

01/05/2024: Policy description updated regarding medications and devices. Policy statement unchanged.

01/31/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.159

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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