Proposed Project Scope. OPTIMAL USE OnabotulinumtoxinA for the Prevention of Chronic Migraine Clinical Evidence, Policies and Practice

Transcription

1 Proposed Project Scope OPTIMAL USE OnabotulinumtoxinA for the Prevention of Chronic Migraine Clinical Evidence, Policies and Practice May 2018

2 1. BACKGROUND AND RATIONALE Migraine is a common, debilitating neurological disorder characterized by recurrent headaches accompanied by nausea, vomiting, and sensitivity to light and to sound. An episode may last from four to 72 hours and may be preceded by an aura (a visual or auditory disturbance). There are two subtypes of migraine, episodic migraine (EM) and chronic migraine (CM), which are differentiated by the frequency of headache occurrence. 1 EM is characterised by headaches on less than 15 days per month and affects approximately 12% of adults while CM is associated with 15 days or more headache days per month for at least 3 months and is experienced by approximately 1% of adults of Western countries. 2,3 Migraines are costly in terms of health care resources, lost productivity, and impact on quality of life. 3,4 In 2016, the Global Burden of Disease Study estimated migraine to be the second leading cause of years lived with disability in the world. 5 Migraine management includes treating acute attacks and using prophylactic drug therapy to reduce attack frequency or severity. Acute attacks can be treated with acetaminophen, NSAIDs (ASA, ibuprofen or naproxen), and triptans. 4 Prophylactic medications are usually considered for patients experiencing more than four attacks per month. 6 These medications include a variant of the botulinum toxin (onabotulinumtoxina), beta-blockers (propranolol, metoprolol, or atenolol), serotonin antagonist (pizotifen), tricyclic antidepressants (amitriptyline or nortriptyline), serotoninnorepinephrine reuptake inhibitors (venlafaxine), antiepileptic (topiramate or valproate), angiotensin inhibitor (candersartan), and calcium channel blockers (flunarazine). Natural products such as riboflavin, magnesium, butterbur extract and coenzyme Q10 are also use for migraine prophylaxis. 7 In clinical practice, patients on migraine prophylaxis frequently discontinue or switch treatments due to lack of efficacy or tolerability. 8,9 Policy Issue Due to its disabling, pervasive nature and the scarcity of safe and effective preventive therapies, migraine prophylaxis represents a significant unmet clinical need globally. Currently in Canada, two drugs are approved to prevent CM: onabotulinumtoxina (Botox) and topiramate (Topamax) a. In May 2014, CDEC recommended that onabotulinumtoxina not be reimbursed for the management of chronic migraine. 10 Since then, drug plans from only three Canadian jurisdictions (AB, ON, Veterans Affairs Canada) have reimbursed onabotulinumtoxina for chronic migraine, with strict eligibility criteria in the latter two. According to CADTH-participating drug plans, the unmet clinical need and evolving evidence call for a reassessment of onabotulinumtoxina for chronic migraine in patients who have failed previous preventive therapies. In light of the identified needs, CADTH is planning a review of the recent clinical evidence, policies, and practice guidelines surrounding the use onabotulinumtoxina for the prevention of chronic migraine. Table I: Policy Question Should onabotulinumtoxina be reimbursed for the prevention of chronic migraine in patients who have failed other types of therapies? a Topiramate is indicated for the prevention of any type of migraine 2

3 Table II: Products Available in Canada Product (Trade name) Manufacturer Drugs indicated for chronic migraine prevention Topiramate (Topamax) a Janssen, generics 25, 100 and 200 mg tablets; recommended 100 mg/day OnabotulinumtoxinA (Botox) Allergan 155 U administered intramuscularly (IM) as 0.1 ml (5 U) injections to 31 sites, every 12 weeks Comparator drugs used off-label for chronic migraine prevention (sample) Amitriptyline (Elavil) AA Pharma, generics Nortriptyline (Aventyl) AA Pharma, generics Propanolol (Inderal LA) Pfizer, generics a Topiramate is indicated for migraine prophylaxis irrespective of type (episodic or chronic) 2. PROJECT DESCRIPTION The proposed review will assess onabotulinumtoxina for the prevention of chronic migraine in adult patients experiencing 15 or more days of headache per month. Special focus will be given to its use and value in patients who have failed previous oral therapies due to unmet benefits or intolerance. Attention will also be given to subgroups of patients with or without medication overuse headache. The purpose of the review is to address the uncertainty in the relative value and place in therapy of onabotulinumtoxina and inform formulary listing by Canadian public drug plans. Results from the review will be used to investigate a potential reassessment of onabotulinumtoxina by the Canadian Drug Expert Committee. Please note that at this time, no decision regarding a reassessment of onabotulinumtoxina through the CADTH Common Drug Review (CDR) process has been made. The project scope elements to be included in the review can be found in Table III and IV below. Table III: Project Scope Clinical Review Population: Adults with CM as defined as 15 or more headache days per month or fulfilling the ICHD-III criteria (see Appendix 1). Outpatient or long term care settings Subgroup: patients who have failed or did not tolerate therapy with three or more prophylactic drugs for migraine. Subgroup: patients who overuse analgesic medication Intervention: OnabotulinumtoxinA Comparators: Placebo Best supportive care (including use of acute analgesics and abortive medication) No comparator Outcomes: Effectiveness - Frequency, intensity, and duration of migraine events. - Pain 3

4 - Other symptoms: nausea, vomiting, dizziness, and sensitivity to light, sound, smell, or touch - Cognitive functioning/impairment - Disability - Quality of life - Employment-related outcomes (e.g., unemployment, work productivity loss, absenteeism) - Use of rescue (abortive) therapies - Use of prescription analgesics - Number of ED and primary care visits Safety - Adherence/treatment discontinuation - Harms/adverse events such as (but not limited to) nausea, somnolence or dizziness Study designs: Randomized controlled trials Non randomized comparative studies Non-comparative studies Research Question 1. What is the clinical effectiveness and safety of onabotulinumtoxina for the prevention of chronic migraine? Table IV: Project Scope Environmental Scan Countries: Canada, USA, UK, France, Germany, Italy, Australia, New Zealand Organizations Public drug programs Clinical societies HTA agencies Patient population: Patients with chronic migraine Interventions OnabotulinumtoxinA injections Information: Clinical practice guideline recommendations (differentiate evidencebased guidelines from others) Place in therapy statements Public drug eligibility status Drug reimbursement criteria Research Questions 1. What are the guidelines regarding the use of onabotulinumtoxina in the prophylaxis of chronic migraine? 2. Which jurisdictions publically reimburse onabotulinumtoxina and according to what eligibility criteria? 3. KEY PROJECT COMPONENTS For this project, two research components will be developed in parallel and summarized in a final report for consideration by CADTH expert and advisory committees. 4

5 1) Clinical review. A rapid review of the efficacy and safety of prophylactic pharmacotherapy with onabotulinumtoxina for chronic migraine will be conducted according to the parameters listed previously. The review will be limited to evidence published after the 2014 CDR review on onabotulinumtoxina for migraine. Consideration will be given to potential confounding factors identified by CDEC in including headaches caused by chronic overuse of pain medication. Observational studies will be included to get a better understanding of the longterm, real-world effectiveness and safety of the therapy. 2) Environmental scan. A contextual analysis of the current or recent guidance on the use and management of the drug. The scan will summarize international evidence-based clinical practice guidelines, public policies and reimbursement criteria related to onabotulinumtoxina for the prevention of chronic migraine. 3) Optimal Use Policy Perspective. A narrative synthesis of key findings from previous components, including clinical evidence, policy options, combined with expert viewpoint on the place of onabotulinumtoxina in migraine care and in relation to the Canadian health system. 4. STATUS OF THE DOCUMENT This document will be posted on the CADTH website for public comments in May/June Stakeholder feedback will be accepted for ten (10) business days after the day of posting. Please submit all feedback to feedback@cadth.ca, referencing CADTH project number OP

6 5. REFERENCES 1. Classification Committee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition. In: London: International Headache Society; 2018: Accessed April 9, Bigal ME, Walter S, Rapoport AM. Therapeutic antibodies against CGRP or its receptor. Br J Clin Pharmacol. 2015;79(6): Mitsikostas DD, Rapoport AM. New players in the preventive treatment of migraine. BMC Med. 2015;13: Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015;61(8): Disease GBD, Injury I, Prevalence C. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, : a systematic analysis for the Global Burden of Disease Study Lancet. 2017;390(10100): Sinclair AJ, Sturrock A, Davies B, Matharu M. Headache management: pharmacological approaches. Pract Neurol. 2015;15(6): Pringsheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can J Neurol Sci. 2012;39(2 Suppl 2):S Ford JH, Jackson J, Milligan G, Cotton S, Ahl J, Aurora SK. A Real-world analysis of migraine: a cross-sectional study of disease burden and treatment patterns. Headache. 2017;57(10): Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20(1): CADTH. OnabotulinumtoxinA. 2013; Accessed March 20, Shamliyan TA, Kane RL, Taylor FR. AHRQ Comparative Effectiveness Reviews. In: Migraine in adults: preventive pharmacologic treatments. Rockville (MD): Agency for Healthcare Research and Quality Jackson JL, Kuriyama A, Hayashino Y. Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. JAMA. 2012;307(16): Jackson JL, Cogbill E, Santana-Davila R, et al. A comparative effectiveness metaanalysis of drugs for the prophylaxis of migraine headache. PLoS One. 2015;10(7):e

7 14. He A, Song D, Zhang L, Li C. Unveiling the relative efficacy, safety and tolerability of prophylactic medications for migraine: pairwise and network-meta analysis. J Headache Pain. 2017;18(1): Khan S, Olesen A, Ashina M. CGRP, a target for preventive therapy in migraine and cluster headache: Systematic review of clinical data. Cephalalgia. 2017: CADTH. Monoclonal antibodies to prevent migraine headaches. Ottawa (ON): CADTH; Calcitonin Gene-Related Peptide (CGRP) Inhibitors as Preventive Treatments for Patients with Episodic or Chronic Migraine: Effectiveness and Value (Draft Evidence Report). ICER

8 6. APPENDICES Appendix 1: ICHD-III diagnostic criteria for chronic migraine A. Headache (migraine-like or tension-type-like) on 15 days/month for >3 months, and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B D for Migraine without aura and/or criteria B and C for Migraine with aura C. On 8 days per month for >3 months, fulfilling any of the following: 1. Criteria C and D for Migraine without aura 2. Criteria B and C for Migraine with aura 3. Believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis International Headache Society Source: Classification Committee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition. London: International Headache Society; 2018: 3.org/1-migraine/1-3-chronic-migraine/. Accessed April 9,