Neurostimulation for Primary Headache Disorders: Part 2

Relative Cost Analysis

Cost analysis is not the primary concern when considering potential treatment modalities for a disabled and suffering patient who has been refractory to medical management. The efficacy and safety of possible invasive procedures is the first consideration. The financial cost of a given procedure must then be considered both when advocating an approach for a given patient and when considering the impact of individual therapy on health care resources. The latter requires weighing the cumulative cost of treatment against the economic burden of disease on society without the given treatment.

Regardless of treatment type used, the economic impact of primary headache disorders is vast. The economic burden of migraine has been well studied. Within the USA, epidemiological studies estimate the total economic burden of migraine at over $13 billion annually.^[41] The American Productivity Audit estimated this cost at $20 billion.^[42] In Europe, the yearly cost attributable to migraine is estimated at $27 billion.^[43] The American Migraine Prevalence and Prevention (AMPP) study estimated the annual cost of CM at $7750 per person per year.^[44]

Ohio costs for a Medicare reimbursement for the placement of a peripheral stimulator, including all fees and the cost of the device in February, 2011 is $26,578. The generator itself accounted for the majority of this cost at $17,090. Given the previously documented cost of CM, the cost of these interventions seems reasonable if the stimulation is utilized in a severe and disabled patient, is effective, and is continued for approximately 3 years.

The most costly neurostimulatory procedure is DBS. Given its application for CCH, the cost of the condition has been evaluated with and without this procedure. The individual cost of DBS has been estimated by the British National Health Service in 2007.^[45] The total cost including evaluation, the surgical procedure and equipment was approximately 35,000 Euros per patient. An additional 150,000 Euros in operative equipment is needed to perform the procedure. This equipment has a 3-year lifespan and would be used to treat multiple patients. Use of 3 sumatriptan injections per week, inhaled oxygen, and 200 mg of topiramate per day was estimated to cost 46,000 Euros over the course of a decade. These figures demonstrate a relative cost benefit of DBS for CCH compared with the cost of medical management if DBS is used for enough years and enough DBS are implanted over the life span of the surgical equipment. Approximate figures would be DBS use for 10 years with at least 5 DBS devices implanted per year.

The cost of medical management for an individual with CCH has been recorded and published in Germany in 2010.^[46] Over 1 decade this patient experienced 5447 attacks with a cost of 47,030 Euros.

Leone and colleagues have compared the difference in cost of sumatriptan injection pre and post DBS with the cost of the procedure itself in 19 patients in 2009 in Italy.^[47] The patients were followed over 4 to 9 years post-procedure. When averaged per patient, the cost saving post-procedure was 149,901 Euros per patient with DBS because of a reduction in sumatriptan use alone.

A cost comparison of other less invasive and less costly procedures has not been produced. Given the relative efficacy of various procedures, it seems reasonable to assume that similar or even greater savings might result from other less invasive neurostimulatory procedures for severe and refractory cases of primary chronic headache. Regarding ONS in particular, it is important to note that continued lead migration over time requiring further operations will increase the long-term cost of the procedure. However, there is some consensus that certain neurosurgical techniques in ONS placement can eliminate or greatly reduce lead migration, which may reduce future costs.

Cite this: Neurostimulation for Primary Headache Disorders: Part 2 - Medscape - Oct 01, 2011.

Table 1. Treatment Modality: Vagal Nerve Stimulation
Author	Diagnosis	Number Treated	Efficacy	Significant Adverse Effects
Hord et al³	EM	4	75% had >50% decreased frequency or severity	None reported
Mauskop et al⁴	CM	4	25% had >50% decreased frequency	25% could not tolerate
Cecchini et al⁵	CM	4	50% had >50% decreased frequency	None reported
Mauskop et al⁴	CCH	2	100% had significant MIDAS decrease	None reported
Total number treated regardless of condition			14
Number responding			8
Percentage of responders			57%

CCH = chronic cluster headache; CM = chronic migraine; EM = episodic migraine; MIDAS = Migraine Disability Assessment Score.

Table 2. Treatment Modality: Deep Brain Stimulation
Author	Diagnosis	Number Treated	Efficacy	Significant Adverse Effects
Leone et al†¹³	CH	16	81% had pain freedom or only sporadic attacks	1 subclinical hemorrhage
Schoenen et al¹⁴	CH	6	50% had pain freedom or >50% decreased frequency	1 intra-operative hypertension followed by aneurysm rupture and death, 1 intra-operative panic attack with autonomic features
Black et al¹⁵	CH	2	100% had >50% decreased frequency	None reported
Starr/Sillay et al†^16,17	CH	5	60% >50% decreased frequency or intensity	Intra-operative TIA
Bartsch et al¹⁸	CH	6	50% had >50% decreased frequency	None reported
Fontaine et al‡⁹	CH	11	55% had >50% decreased frequency	1 subcutaneous infection, 1 transient loss of consciousness and hemiparesis with severe micturition syncope
Benabid et al¹⁹	CH	1	100% "responded"	Not reported
D'Andrea²⁰	CH	3	66% "responded"	Not reported
Mateos et al²¹	CH	2	50% "responded"	Not reported
Leone et al²²	CH	108 attacks	23% had >50% decreased intensity of attacks	None reported
Walcott et al²³	PH	1	Initial relief, follow-up pending	None reported
Leone et al†²⁴	SUNCT	1	100% had pain freedom	None reported
Lyons et al²⁵	SUNCT	1	100% had >50% decreased frequency	Erectile dysfunction
Total number treated regardless of condition			55
Number responding			36
Percentage of responders			65%

† Stimulation interruption resulted in recurrence.
‡Double blinded placebo controlled.
CH = cluster headache; PH = paroxysmal hemicrania; SUNCT = short-lasting unilateral neuralgiform headaches with conjunctival tearing and injection; TIA = transient ischemic attack.

Table 3. Treatment Modality: Deep Brain Stimulation Followed by Vagal Nerve Stimulation
Author	Diagnosis	Number Treated	Efficacy	Significant Adverse Effects
Franzini et al²⁶	CCH	1	100% had <50% decreased frequency	None reported

CCH = chronic cluster headache.

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