The Emerging Science of Prophylactic Therapies for Migraine. Interim Outcomes Report. Lilly USA, LLC Grant ID: A 19557

Transcription

1 The Emerging Science of Prophylactic Therapies for Migraine Interim Outcomes Report Lilly USA, LLC Grant ID: A 19557

2 Program Information Overview: This enduring webcast shares highlights from a live presentation, which took place in Scottsdale in November 2016 as part of the 46 th annual Scottsdale Headache Symposium, in conjunction with the American Headache Society. Featuring Dr. David Dodick, Dr. Deborah Friedman, and Dr. Stewart Tepper, this activity reviews complicated patient cases and up to date information on targeted and specific therapies for the treatment of migraines. Intended Audience: This activity was designed for clinicians involved in the care and treatment of patients with migraine pain. Release/Expiration Date: December 29, 2016/December 29, 2017 Credit: 1.0 AMA PRA Category 1 Credit Sponsored By: The Academy for Continued Healthcare Learning (ACHL) Funding: Supported by an educational grant from Lilly USA, LLC

3 Executive Summary Impact 1565 Learners (2,000 Guaranteed by activity expiration) 661 Certificates (350 Guaranteed guarantee exceeded) Professions Reached 33% Physicians 32% Physician Assistants 30% NP/Nurses 5% Other Patient Impact Up to 16,508 patients will be impacted per month Icon made by FreePik from

4 Executive Summary Satisfaction All faculty were very highly rated with an average rating of 3.58/4.0 Learning Objectives 99% of participants strongly agree that they are better able to meet the learning objectives after completing the activity Impact 96% of learners will change their practice based on this activity 51% of learners will seek to address barriers to patient access to therapies Patient Impact Patient outcomes will be positively impacted as a result of this activity according to 88% of learners Icon made by FreePik from

5 Executive Summary 75% 49% 57% The average post test score on questions regarding pharmacokinetics and MOA of CGRP mabs. Post activity, clinicians are aware of how these agents differ from currently approved therapies, and the advantages they offer specific patient subsets. After participating in this activity, Learners PLAN TO: More frequently assess their migraine patients for changes in disability Engage in patient education Discuss nonpharmacological strategies which patients can use to help control their pain Clinicians, post activity, are more open to using quantifiable scales (ie, HIT 6, MIDAS) to assess the impact of migraine on patients lives 96% These numbers demonstrate that clinicians not only received education on this new class of migraine drugs, but started to understand how to UTILIZE them in a clinical setting. More importantly, following the activity, nearly all participants (96%) are instituting practice based changes to positively impact patient care and outcomes.

6 Executive Summary Future Educational Opportunities Improve management of side effects, comorbidities, and pain through a comparison of the adverse events associated with current and emerging therapies Provide educational tools to facilitate better communication with patients to increase shared decision making Educate clinicians on the science of approved and emerging therapies to increase personalized therapy Icon made by FreePik from

7 Faculty CHAIR David Dodick, MD, FAHS, FRCPC, FACP Professor of Neurology Mayo Clinic Phoenix, AZ FACULTY Deborah I. Friedman, MD, MPH, FAHS Professor, Neurology and Neurotherapeutics and Ophthalmology University of Texas Southwestern Medical Center Dallas, TX Stewart J. Tepper, MD, FAHS Geisel School of Medicine at Dartmouth Professor of Neurology Hanover, NH

8 Level 1: Participation Practicing Type Physician 33% Physician Assistant 32% Nurse Practitioner Nurse 8% 22% Total Participants Certificates Awarded Other HCP 5% 0% 5% 10% 15% 20% 25% 30% 35% 40% N=661

9 Level 1: Specialty Specialty Family/General Practice 37% Internal Medicine 12% Emergency Medicine Neurology 9% 9% Pediatrics Surgery Psychiatry 6% 6% 5% Clinical (unspecified) 17% 0% 5% 10% 15% 20% 25% 30% 35% 40% N=661

10 Level 2: Learning Objectives Please rate the following objectives to indicate if you are better able to: Illustrate how to factor multiple patient specific characteristics into the treatment plan when managing migraines Examine and discuss the emerging science associated with calcitonin gene related peptide (CGRP) monoclonal antibodies (mabs) and their role in migraine prevention. Highlight strategies and tools to assess the impact of migraine on daily functioning and quality of life in order to generate a more personalized and inclusive treatment plan. Analysis of Respondents Rating Scale: 4 = Strongly Agree 1 = Strongly Disagree % of learners strongly agree or agree that all learning objectives were met. N=645

11 Level 2: Satisfaction Faculty Ratings Rating Scale: 4=Excellent, 1=Poor Ability to effectively convey the subject matter Expertise on the subject matter David Dodick, MD, FAHS, FRCPC, FAPC Deborah Friedman, MD, MPH, FAHS Stewart Tepper, MD, FAHS All faculty were highly rated across all areas, with an average rating of 3.58/4. Overall Evaluation Analysis of Respondents 4 = Excellent, 1 = Poor Quality of educational content 3.53 Level of instruction % of learners rated all aspects of the activity as excellent or good! N=645

12 Level 2: Objectivity & Bias Did You Perceive Any Bias? 100% 80% 90% 60% 40% 20% 0% 10% Yes No Activity was perceived as objective, balanced, and non biased. N=645

13 Levels 3 & 4: Pre/Post test Overview Overview of correct responses: 100% 75% 50% 25% 0% 12% 86% 85% 64% 50% 39% Topic Question Pre Post % Change Understanding PK of CGRP mabs 1 12% 64% 433% CGRP mabs MOA 2 39% 86% 121% Migraine triggers/patient education 3 50% 85% 70% 208% Average percent change from pre to post test Learners knowledge and competence increased regarding efficacy and metabolism of CGRP monoclonal antibodies and how they can be used to solve some of the existing issues seen with approved therapies as well as with respect to strategies for patient education and patient control of migraine triggers

14 Levels 3 & 4: Pre test vs. Post test Which of the following is true? A. CGRP monoclonal antibodies (mabs) have an average half life of up to 24 hours B. CGRP mabs are cleared by the reticuloendothelial system C. CGRP small molecule antagonists have shown efficacy in reducing the frequency of headache days in episodic migraine D. CGRP mabs target CGRP, amylin, and their receptors 75% 50% 25% 21% 11% Pre (N=861) 12% 64% Post (N=661) 57% 15% 11% 10% 0% A B C D The number of participants correctly answering the post test question increased by 433% over the pre test, demonstrating that participants were more knowledgeable regarding the pharmacokinetic properties of this drug class. Indicating that participants understand how this new, emerging class of migraine therapies is cleared from the body which may be especially relevant when tailoring therapy for patients who have pre existing conditions such as renal or liver impairments.

15 Levels 3 & 4: Pre test vs. Post test Which of the following CGRP antagonists target the CGRP receptor? A. Fremenezumab (TEV 48125) B. Erenumab (AMG 334) C. ALD 403 D. Galcanezumab (LY ) 100% 75% 50% 25% 0% Pre (N=861) Post (N=661) 86% 39% 25% 17% 19% 6% 5% 3% A B C D As a result of this activity learners were more knowledgeable regarding the differences between the mabs and how they act to inhibit CGRP and eventually, to reduce the frequency of episodic/chronic migraines. These learnings support recently released preclinical data which have also highlighted differences among fremenezumab, ALD 403, and galcanezumab regarding their respective times to bind and dissociate from the ligand which may contribute to differences drug effect duration.

16 Levels 3 & 4: Pre test vs. Post test Linda M is a 38 year old female who suffers from episodic migraines about five times a month. She takes a triptan and uses OTC medication to relieve her pain. Because of a project at work, she has been getting less sleep, is stressed, and has noticed that the number of her migraines has increased. What is the best course of action for this patient? A. Prescribe a sleep aid and remind her not to take too many triptans (>2 a day) B. Remind the patient about the factors that she can control and which will allow her to feel less stressed(ie, exercise, meditation, small breaks, eating well, staying hydrated) C. Consider transitioning her to preventive therapy such as amitriptyline or a beta blocker D. Consider transitioning her to preventive therapy such as onabotulinumtoxina or topiramate. 100% 75% 50% 25% 0% Pre (N=861) Post (N=661) 85% 50% 24% 12% 14% 3% 7% 5% A B C D Learners selected the correct answer 70% more often on the post test compared to pre test. Certain factors such as sleep, specific foods, and caffeine can trigger a migraine; however, these are factors which patients can help to control. Patient education can increase awareness of how patients can modify and minimize migraine triggers.

17 Levels 3 & 4: Pre test vs. Post test There are several tools and strategies clinicians can use to better understand the impact of migraine on patients lives as well as aid in increasing the understanding of both parties of how to effectively control migraine. From the list below, please identify one tool or strategy which you CURRENTLY USE/PLAN TO USE in order to better understand how migraine impacts your patients: A. Patient headache diaries B. Assess disability via scale such as HIT 6 or MIDAS C. Discuss the management of existing comorbidities so as to minimize other factors complicating migraine treatment D. Review patients treatment plans with them; discuss goals of migraine treatment, frequently 60% 50% 40% 30% 20% Currently Use (N=861) 47% 39% 22% 14% Plan to Use (N=645) 19% 20% 20% 18% 10% 0% A B C D An increase of 57% was seen post activity in learners who were open to using HIT 6 or MIDAS scales. These scales are composed of 5 6 questions which can be quickly administered in an office setting and completed by the patient. Use of these scales may provide a compliance advantage over a patient diary and are a quick way for clinicians to gather information on migraine disability.

18 Level 4: Impact of Activity This activity will improve my performance: Yes, how? Yes: 58% No: 11% Validated Practice: 31% Awareness of CGRP receptor antagonist and good review of beta blocker use Encourage lifestyle changes for patients and keeping headache diary I now better understand the emerging therapies and am reassured on the state of existing therapies as it relates to my practice experience New prescription medications/headache outcome resources to use (patient reported outcome tools) Better manage patients with migraines using tools provided i.e. MIDAS and HIT 6 Use scales for assessment and prescribe prophylaxis when indicated Utilize new tools to assess migraine headaches and current RXs in the TX of Migraine H/As Will place more emphasis on patient disability for prophylaxis This activity will improve my patient outcomes: Yes, how? Yes: 52% No: 12% Validated Practice: 36% I now know of other management therapies for chronic and episodic migraines Increased research leading to increased prophylactic treatment So often refer patients to neuro; may now be more likely to counsel, try preventives. Will start prophylaxis sooner N=645 This activity was highly effective, with 58% indicating it will impact performance and 52% indicating it will impact their patients outcomes.

19 Level 4: Impact of Activity Please identify how you will change your practice as a result of attending this activity (select all that apply): Change the management and/or treatment of my patients by more frequently assessing disability caused by headache, taking time for patient education, and/or discussing nonpharmacological strategies that patients can use to help control their pain. 49% Create/revise protocols, policies, and/or procedures. 24% Other changes. 31% This activity validated my current practice, no changes will be made. 4% 0% 20% 40% 60% 96% of learners will change their practice! N=645

20 Level 4: Impact of Changes on Patient Care Number of patients with migraines you see each month: >21 7% % % 0 14% 0% 20% 40% 60% 80% Changes will impact between 5,710 and 16,508 patients each month. This assumes the data above is representative of all participating healthcare professionals (1,582), who indicated they would change their practice as a result of this activity (96%). N=645

21 Level 4: Confidence After participating in this activity, how confident are you in describing the emerging targets under investigation for the prevention of migraine? A. Extremely confident B. Very confident C. Somewhat confident D. Not very confident E. Not at all confident 50% 25% 0% 47% 35% 11% 7% 0% A B C D E 46% of participants described themselves as being extremely or very confident in their ability to describe some properties of emerging agents for migraine prevention. Future Education Opportunity: 47% of participants categorized themselves as only somewhat confident potentially representing an audience who would be receptive to further education in this area.

22 Pharmacotherapy Considerations Which of the following factors do you give the most consideration to when adopting a new to market pharmacotherapy? Ease of patient compliance 30% Cost to the patient 44% Science underlying the new therapy 24% Other 2% 0% 10% 20% 30% 40% 50% 60% N=652

23 Pharmacotherapy Considerations When these therapies are approved for use in the US, which factor will determine if you will use them in the appropriate patient populations? Cost 58% Frequency of administration 11% Duration of effect 15% Ease of side effect mangement 15% 0% 10% 20% 30% 40% 50% 60% Cost was by far the largest determinant of use for clinicians. Whether this represents costs to the practice to acquire the drug or the cost to the patient even with insurance is unclear. However, both factors would potentially drive access and use. N=652

24 Level 4: Barriers Please indicate any barriers you perceive in implementing these changes: Select all that apply: Level 4: Perceived Barriers To Implementing A. Current migraine therapies do not offer adequate 30% Changes 23% 24% 27% pain relief B. Patient reluctance to see HCP regarding their headaches C. Lack of consensus or professional guidelines D. Lack of time to assess/counsel patients E. Cost F. Lack of administrative support G. Reimbursement/insurance issues H. Lack of opportunity (patients) I. Lack of resources (equipment) J. Patient compliance issues K. No barriers L. Other barriers 20% 10% 0% 11% 19% 5% 18% 7% 5% 24% 24% A B C D E F G H I J K L Participants indicated cost (27%) as the most common barrier to implementing change in their practice. Other barriers included patient compliance (24%) and patient reluctance to see HCPs regarding headaches (24%). Also, 23% indicated current migraine therapies do not offer adequate pain relief. 2% N=645

25 Level 4: Barriers Will you attempt to address these barriers in order to implement changes in your performance, and/or patients outcomes? Yes: 51% No: 18% N/A No barriers identified: 31% Yes, how? Assist my patients and contact pharmaceutical companies when insurance will not pay for the drug prescribed. Address efficacy at outset of treatment and give treatments more time before changes are made Cost vs benefit will be discussed Discuss with patient the importance of compliance Encourage patients to be an active participant in their healthcare Follow the changing guidelines Increased patient assessment, education and reevaluations Set collaborative goals with patient and find cost effective solutions No, why not? Very difficult to overcome breakdown in medical care system It is hard to get approval for these types of medications Because I can't prescribe anything more than a triptan and toradol in an urgent care setting. This was informative for me to educate people about what is out there. These barriers are not easily addressed in a resource poor country where I practice N=591 51% of learners are interested in addressing barriers, primarily through patient education, liaising with pharmaceutical companies to obtain lower patient medication costs, and even by engaging with insurers to approve a drug for a patient. Additional strategies that practitioners are open to using include: periodic re evaluations of disease status, severity, and impact, and employing personalized treatments at the outset.

26 Topics of Interest What topic areas would you most like to see in future activities? Managing neuropsychiatric comorbidities and migraine 31% Managing side effects of multiple migraine medications 36% Differentially diagnosing headache subtypes 33% 0% 20% 40% Clinicians indicate interest in all three topics provided, however this outcomes report demonstrates clinicians are most in need of strategies to help manage the side effects seen with current migraine treatments as well as managing comorbidities in migraine patients. N=645

27 Key Takeaways What is one pearl you took away as a result of your participation? Always consider what changes in life occurred that could be causing increase in migraines or any other morbidity (seizures, HF) I was surprised by how few chronic migraine sufferers receive effective treatment Better understanding of pathophysiology of how some migraine medications work Candasartan use as: prophylaxil instead of beta blockers in the treatment of episodic migraines CGRP AB's have long half life; antibodies are promising Consider alternatives to triptans Consider HA effect in psychiatric disorders Current available treatments are poorly utilized and not highly effective with significant adverse effects Did not realize how poorly available treatments are and how patients do not take them Emerging use of CNS stimulator devices Frequency of migraine/poor success rates of tx Gabapentin is essentially worthless for migraine prevention; ineffective for migraine prophylaxis High discontinuation rate among those treated prophylactically Monoclonal antibodies can be effective in prevention; appear to be very promising as prevention of migraine Level of disability and medication overuse Statistical significance is not same as clinical significance Use migraine assessment tools to measure nature and effects of migraine Newer migraine medications and biologics MABs How much testing is done on the emerging drugs I am excited about CGRP and hope to use it one day! Importance of reducing stress and other triggers Importance of spending time evaluating/counseling Important to assess non pharmacological treatments Managing comorbidities for migraine sufferers New therapies/medications can be helpful for patients who suffer from migraines that don't generally respond to triptan/ergots Vast amount of pts untreated for migraine headache Use migraine assessment tools to measure nature and effects of migraine Multiple treatment modalities must be investigated; new and advancing treatment strategies for control of migraines are underway New medication for acute headaches that doesn't cause vasoconstriction New research coming out on the physiology and treatment of migraine Metoprolol, propranolol, and timolol are established as effective and should be offered for migraine prevention if patients physiology can tolerate it Start prophylaxis sooner post 8+ headaches/month Patient compliance of prevention medication is poor Patients with migraines are not adequately assessed, diagnosed or treated Non invasive devices showing promise, awaiting FDA Non pharmacological management has an important role in pt care

28 Next Steps Final outcomes report to be provided 90 days post activity expiration (March 2018) For questions, please contact: Brittany Puster Director, Education Development Academy for Continued Healthcare Learning (ACHL) E: P: ext. 134

29 Appendix All text based responses

30 Level 4: Activity Impact If you indicated this activity will improve your performance, please specify: Addressing lifestyle changes as well as medication therapy Advances in migraine tx Assess patterns degree of disability Aware of current offered therapies and assessment tools. Awareness of CGRP receptor antagonist. Good review of beta blocker use. Better and more tx options Better assessment of HAs in patients Better evaluation of monthly headache patterns, potential for overuse. Better insight to plan of care Better knowledge of newer therapies/prevention. Better management of migraine Better patient education Better under of pathophysiology and possible treatments. Better understanding of current treatments and new treatments on the horizon Better understanding of effective treatment modalities. Broaden how I treat my patient's with migraines and understanding emerging treatments that will be available to them in the future. Change in monitoring and prescribing Change my treatment strategies. Understand and describe emerging treatments. Consider new treatments and continue to watch for new FDA approved options Consider short comings of some preventatives Consideration of over use HAv more often Discuss migraine modalities with pt Discussing impact and frequency of migraines Educate patients on availability of new treatment strategies Encourage lifestyle changes for patients and keeping headache diary Evaluate and assess migraines better with the different tools. Exposed me to latest therapeutic strategies on how to TX and how to best monitory therapeutic goals. Help me to better understand treatment modalities How is screen patients I am aware of new treatment options available to patients. I will try to use questionnaires mentioned in this activity to assess how my patients are doing. I experience chronic migraine myself and if I can decrease my frequency of migraines I will be better able to assist patients/veterans who I treat/serve I know which medications are first line and then second line. Know efficacy of various drugs and patient compliance challenges. I now better understand the emerging therapies and am reassured on the state of existing therapies as it relates to my practice experience

31 Level 4: Activity Impact If you indicated this activity will improve your performance, please specify: I understand the various meds, side effects of the newer & future drugs. I was unaware of this new drug class I will encourage patients to keep headache diaries to help ID possible helpful lifestyle changes. identify pts that need more than Tripans or Ergots. Inquire more thoroughly about current treatment & symptoms Know which long term medications are effective/preferable learning about pharmacology Made me more aware of treatment options which always is helpful to a nurse Make patients more involved in making their treatments plans May help to use medicines more wisely and according to guidelines and evidence based More aggressive diagnosis and treatment of migraines More focus on preventative measures More prepared for the new agents (CGRP) when they come out. More selective in choosing treatment for migraine headache New prescription medications to consider and headache outcome resources (patient reported outcome tools). Offer patients more choice for prevention Prior to this lecture, I was unaware of all the treatment options in development for migraines Pts in hospital environments can have exacerbations of migraines and often need special interventions to self manage Put into consideration the efficacy and side effects of current treatment Specific, current knowledge gained on migraine prevention and treatment This activity will help me manage patients with migraine better using the tools provided I.e. MIDAS and HIT 6. To better assess patient holistically in regards to migraine in setting of other comorbidities Understanding meds for proper usage. Use of newer therapies when available Use scales for assessment and prescribe prophylaxis when indicated Utilize new tools to assess migraine headaches and current RXs in the TX of Migraine H/As We don't currently have any patients on prophylactic therapy for chronic migraines, but I believe some of my patients would benefit from it. Will place more emphasis on patient disability for prophylaxis work in Residential Treatment Centers where headaches are among the most common complaints

32 Level 4: Activity Impact If you indicated this activity will improve your patients outcomes, please specify: Addressing morbidities will enlighten burdens After learning about emerging modalities, I will know which new treatments to recommend to my patients. As a provider in chronic pain medication, I will be able to better assist my patients via lifestyle modifications and other treatment options. I will be able to assess and refer patients with chronic migraines to the appropriate provider Being able to discuss emerging medications for the treatment of migraines. Better choice of agents will help them avoid more days of migraine per month. Better treatment choices should improve outcomes Better treatments (maybe) for headache sufferers Better under of pathophysiology and possible treatments. Can use new approaches when available and appropriate Different prevention methods of migraine and newer meds Due to the low patient adherence data, I will assess compliance at each appt. hopefully to decrease patients headache days I now know of other management therapies for chronic and episodic migraines Improved patient outcome from headache relief Improving patient outcomes by more effective treatment Increased knowledge of appropriate assessment tools as well as in depth knowledge of treatment options Increased research leading to increased prophylactic treatment More patients treated for chronic migraines More precise treatment plans Multimodal approach for the management of pain study. New considerations for therapy that may better help patients. Planning care and referral to specialist in a more timely manner Put into consideration Neuromodulation Rapid and sustained response Recognize the need for therapy So often refer Pts to neuro; may now be more likely to counsel, try preventives. Superb update on new medications and devices This will hopefully reduce overuse of abortive migraine medications. To provide alternative treatments from my current practice understanding the mechanics Utilizing current TX protocol to improves my patient's condition. Will start prophylaxis sooner Will use Triptans more for debilitating migraines. Know what alternatives exist.

33 Level 4: Activity Impact If you plan to change the management and/or treatment of your patients by more frequently assessing disability caused by headache, taking time for patient education, and/or discussing nonpharmacological strategies which patients can use to help control their pain OR create/revise protocols, policies, and/or procedures, please specify the changes you will make: Actively trying to prevent Ask for headache diaries, and discuss quality of life burden and their goals Asking more questions about how headaches affect my patient daily activities Better assessment with scales Better patient documentation of headaches By assessing the impact of migraines on patients' lives Getting involved in patient education Consider the MIDAS screening in addition to patient journals. Consider use of new drugs Diagnose and treat migraines more aggressively Diaries, lifestyle, to learn about new treatment options Disability assessment Discussing more ways to avoid triggers and nonpharmacological ways to control their migraines Discussing non pharm options Discussing nonpharmacological strategies which patients can use to help control their pain Encourage documentation of headaches and associated disabilities to help select more personalized treatment options Ensuring pts are permitted to self manage their resting periods as much as possible in a hospital setting Extend assessment time possibly with questionnaire Getting the HIT 6 tool to use Headache diaries, life style, stress factors, diet, sleep. Headache diaries, strict monitoring of all medications and supplements Headache diary I think both pharmacological and non pharmacological strategies are just as important I will counsel patients more on non pharmacological means to control migraines Implement more frequent use of assessment tools Include the tools mentioned in this program and the current RXs included Increasing follow up visits Insist on headache diaries Make the correct diagnosis with subsequent referral MIDAS More frequent follow up More frequently assessing disability caused by headache

34 Level 4: Activity Impact If you plan to change the management and/or treatment of your patients by more frequently assessing disability caused by headache, taking time for patient education, and/or discussing nonpharmacological strategies which patients can use to help control their pain OR create/revise protocols, policies, and/or procedures, please specify the changes you will make: More headache diaries More patient protocols More preventive plans More pt. discussion More referrals to neurology and recommending considering study participation More use of HA assessment tools. More use of HA diaries. Motivational interviewing to better understand patient desired outcomes Push patient and family education; provide hope and encouragement Revise protocols & instruct PA's. Take more time Taking time for patient Education That personal, mental and environmental factors have a great impact headache; Exercise; CBT Use MIDAS or HIT 6 Use MIDAS or HIT 6 to assess and monitor patients Use of diary Use rating scales Use the MIDAS Use the questionnaires to assess Using checklists and HA diaries Using described tools to assess when needed. Utilize PROS in evaluating migraine treatment MIDAS and HIT 6 scales Utilizing preventive medications in a more optimal fashion Will have support staff to meet with patients to reinforce use of non medication issues they can control at each appointment Working with and educating patients