Migraine Prevention and Treatment © 2016 Conduent Business Services, LLC. All rights reserved.
Educational RetroDUR Mailing
Initial Study
Follow – up /Restudy
Executive Summary
Purpose: To improve the pharmacotherapy of migraine headache by promoting clinically appropriate and cost-effective therapy for headache prevention and acute treatment.
Why Issue was Selected: It is estimated that 28 million people in the United States are affected by migraine headaches, although many remain undiagnosed. The prevalence of migraine is highest from ages 25 to 55 years for both men and women. Migraine is responsible for at least $13 billion in lost productivity annually and at least $2.5 billion in direct medical costs. This disorder is not only chronic, but at times a chronic progressive disorder. Migraines interfere with the activities of daily living; they decrease physical activity and appetite, cause fatigue, and increase sensitivity to light and sound. Migraine takes an enormous social and economic toll on the individual and on society as a whole.1 Treatment includes establishing a comprehensive plan targeting identification and avoidance of triggers, extensive patient education, behavioral management strategies, and development of a pharmacological treatment plan for prevention and acute treatment.1,2
Program Specific Information:
Performance Indicators Exceptions
(<18 Years) FFS (<18 Years) MCO
Overutilization of acute therapy (2) 20 (45) 1,474
Underutilization of preventive therapy
(0) 12 (0) 681
Nonadherence with preventive therapy
(0) 3 (0) 593
Increased risk of drug interactions and adverse drug events associated with acute therapy
(0) 30 (70) 2,872
Increased risk of serotonin syndrome (3) 8 (77) 714
Setting & Population: All patients with a history of migraines either documented in medical claims or inferred diagnosis, through the presence of triptan or ergotamine therapy, in the last 2 years.
Types of Intervention: Cover letter with dosage chart and modified profiles
Texas Medicaid Migraine Prevention and Treatment
2 Migraine Prevention and Treatment © 2016 Conduent Business Services, LLC. All rights reserved.
Main Outcome Measures: The performance indicators in this proposal will be remeasured.
Anticipated Results: Increased utilization and adherence with preventive migraine therapy Reduced overutilization of acute migraine therapy Decreased risk of acute migraine therapy drug interactions and adverse
events
Performance Indicator #1: Overutilization of Acute Therapy
Why has this indicator been selected?
Acute migraine therapy consists of a variety of pharmacologic classes of therapy. If acute therapy is overused, ( i.e., if the duration of use exceeds a specified number of days for the drug class) the patient may experience severe adverse effects or medication-overuse headaches and/or rebound headaches.2,3
How will the patients be selected?
Candidates (denominator): All patients with a history of migraine (documented or inferred) in the last 2 years receiving acute migraine therapy (e.g. triptans, ergot derivatives, ergot/caffeine compounds, butorphanol, and multi-ingredient analgesic compounds such as Midrin and Fioricet) in the last 60 days.
Exception criteria (numerator):
Candidates who received acute therapy at dosages that exceeded treating 4 migraine headaches per month based on quantities submitted in the last 60 days (unless the package insert stated a different number of headaches/months that could be treated safely; 5 for sumatriptan/naproxen, 3 for zolmitriptan oral/eletriptan). See Appendices A and B for maximum monthly limit for two months.
Performance Indicator #2: Underutilization of Preventive Therapy
Why has this indicator been selected?
Preventive therapy for patients with migraines can reduce the frequency, intensity and/or duration of acute migraine attacks. These improvements may lead to an improved patient quality of life. Indications for preventive migraine therapy include: two or more migraine episodes per month that produce disability lasting > 3 days per month, use of acute migraine therapies more than twice per week, contraindications to, or treatment failures with acute migraine therapies, and the presence of uncommon migraine conditions. Additionally, some medications used to treat other disease states, such as depression, hypertension, or seizure disorders, are also effective for preventing migraine headaches, and should be considered when preventive therapy is initiated.4
How will the patients be selected?
Candidates (denominator): All patients with a history of migraine (documented or inferred) in the last 2 years receiving acute migraine therapy within the last 30 days.
Exception criteria (numerator):
Candidates without preventive migraine therapy in the last 90 days that qualify for preventive migraine therapy based on quantities submitted in the last 90 days (average of treating more than 3 headaches per month). See Appendix C, D and E. Candidates with history of a comorbid condition (depression/ insomnia/bipolar disorder/hypertension/asthma/seizure disorder) in the last year which could influence the choice of preventive therapy will be identified if data is available.
Performance Indicator #3: Nonadherence with Preventive Therapy
Why has this indicator been selected?
Since clinical benefit from preventative therapy can take up to 3 months, patients may perceive their prescribed preventive migraine therapy is ineffective leading to nonadherence.4 This may increase the frequency of acute attacks or can erroneously lead the clinician to believe that the patient requires a higher dose or change in therapy to achieve adequate symptom control.
How will the patients be selected?
3 Migraine Prevention and Treatment © 2016 Conduent Business Services, LLC. All rights reserved.
Candidates (denominator): All patients with a history of migraine (documented or inferred) in the last 2 years receiving preventive migraine therapy will be identified. See Appendix C. A 90 day window will be examined for gaps in therapy. To eliminate from consideration patients who stopped therapy, and/or switched to another drug, patients who did not receive the study drug in the 45 day window before and after the 90 day window will be excluded from analysis.
Exception criteria (numerator):
Candidates who received < 60 days supply of the preventive medication during a 90 day period.
Performance Indicator #4: Increased Risk of Drug Interactions and Adverse Drug Events Associated with Acute Therapy
Why has this indicator been selected?
For patients with migraine receiving acute therapy, quality of care issues such as drug interactions and risk of adverse drug events should be monitored to promote optimal use of medications and to ensure patient safety.2
How will the patients be selected?
Candidates (denominator): All patients with a history of migraine (documented or inferred) in the last 2 years receiving acute migraine therapy (e.g. triptans, ergot derivatives, ergot/caffeine compounds and multi-ingredient analgesic compound such as Midrin and Fioricet) in the last 45 days.
Exception criteria (numerator):
Candidates with a history of: 1) Comorbid condition that places them at increased risk of a serious adverse
drug event in the last 2 years (with the exception of uncontrolled hypertension in the last year). See Appendix F.
2) One day overlapping therapy with an interacting drug in the last 45 days. See Appendix G.
Performance Indicator #5: Increased Risk of Serotonin Syndrome
Why has this indicator been selected?
Serotonin syndrome is a potentially fatal adverse reaction that may result from a drug-induced excess of serotonin activity. It is a predictable consequence of excess serotonin activity most often induced by a combination of agents that increase serotonin activity by different mechanisms. Patients taking triptan or ergotamine derivatives are at increased risk since these medications possess serotonergic properties.5,6
How will the patients be selected?
Candidates (denominator): All patients receiving therapy with a triptan or ergotamine derivative in the last 45 days.
Exception criteria (numerator):
Candidates concomitantly receiving any of the following medications with one or more days of overlap:
Monoamine oxidase inhibitor Selegiline Rasagiline Selective Serotonin Reuptake Inhibitor Selective Serotonin/Norepinephrine Reuptake Inhibitor
References:
1. Lipton RB, Bigal ME. Migraine: Epidemiology, impact and risk factors. Headache 2005; 45 [Suppl 1]:S3-S13. 2. Marmura MJ, Silberstein SD, and Schwedt TJ. American Headache Society Evidence Assessment: The Acute
Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Headache 2015;55:3-20
3. Goadsby PJ, Lipton RB, Ferrari MD. Migraine-current understanding and treatment. N Engl J Med 2002;346(4):257-270.
4. Silberstein SD, Holland S, Freitag D, et al. Evidenced-based guideline update: pharmacologic treatment for episodic migraine prevention in adults. Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012;78:1337-45.
4 Migraine Prevention and Treatment © 2016 Conduent Business Services, LLC. All rights reserved.
5. Boyer EW and Shannon M. The Serotonin Syndrome. N Engl J Med 2005;352(11):1112-20. 6. Food and Drug Administration. Potentially life-threatening serotonin syndrome with combined use of SSRIs and
SNRIs and triptan medications. Available on line at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm Accessed September 25, 2017.
Appendices Appendix A: Triptan Quantity Limit*
Product Available dosages
Maximum Daily Dosage
Maximum Monthly Quantity*
Maximum Monthlylimit x 2 months
Sumatriptan Injection (Imitrex Inj®, Zembrace™ SymTouch, Alsuma™, Sumavel®)
4mg, 6mg stat dose pen cartridge, Dose Pro 3mg/0.5mL pre-filled auto injector 6mg/0.5ml vials
12mg 4 x 3mg inj 2 x 6mg injections (1ml)
48mg (4ml): 8 x 4mg pen cartridges 8 x 6mg pen cartridges 8 x 6mg/0.5ml vials
8 ml 16 x 4mg pen cartridges 16 x 6mg pen cartridges 16 x 6mg/0.5ml vials
Sumatriptan Tablets (Imitrex®)
25mg 50mg, 100mg
200mg
800 mg: 32 x 25mg tabs 16 x 50mg tabs 8 x 100mg tabs
64 x 25mg tabs 32 x 50mg tabs 16 x 100mg tabs
Sumatriptan Nasal Spray (Imitrex® Nasal Spray)
5mg and 20mg unit of use
40mg 160mg: 32 x 5mg 8 x 20mg
64 x 5mg units 16 x 20mg units
Sumatriptan Internasal Powder (Onzetra® Xsail)
11mg 44mg 176 mg: 16 x 11mg
32 x 11mg
Naratriptan (Amerge®)
1mg, 2.5mg 5mg
20mg: 20 x 1mg 8 x 2.5mg
40 x 1mg tabs 16 x 2.5mg tabs
Zolmitriptan Tablets (Zomig®)
5mg, 2.5mg 10mg 30mg: 12 x 2.5mg tabs 6 x 5mg tabs
24 x 2.5mg tabs 12 x 5 mg tabs
Zolmitriptan ODT (Zomig®-ZMT)
2.5 mg 10mg 30mg: 12 x 2.5mg tabs
24 x 2.5mg tabs
Zolmitriptan Nasal (Zomig® Nasal Spray)
5mg unit of use 10mg 40mg: 8 x 5mg units
16 x 5mg units
Rizatriptan benzoate (Maxalt®, Maxalt®-MLT)
5mg, 10mg 30mg 120mg: 24 x 5mg tabs 12 x 10mg tabs
48 x 5mg tabs 24 x 10mg tabs
Almotriptan (Axert®)
6.25mg, 12.5mg
25mg 100mg: 16 x 6.25mg tabs 8 x 12.5mg tabs
32 x 6.25mg tabs 16 x 12.5mg tabs
Frovatriptan (Frova®)
2.5mg 7.5mg 30mg: 12 x 2.5 mg tabs
24 x 2.5 mg tabs
Eletriptan (Relpax®)
20mg 40mg
80mg 240mg: 12 x 20mg tabs 6 x 40mg tabs
24 x 20 mg tabs 12 x 40 mg tabs
Sumatriptan/Naproxen (Treximet®)
85mg/500mg 170/1000mg 850/5000mg: 10 x 85mg/500mg tabs
20 x 85mg/500mg tabs
* Official Prescribing Information. Available at: http://www.fda.gov/cder/ [last accessed 9/25/17]. The safety of treating an average of more than 4 migraine attacks in a 30 day period has not been established for all triptans except eletriptan, zolmitriptan tablets and sumatriptan/naproxen. The package inserts for eletriptan (Relpax) and zolmitriptan tablets (Zomig and Zomig-ZMT) state that the
5 Migraine Prevention and Treatment © 2016 Conduent Business Services, LLC. All rights reserved.
safety of treating an average of more than 3 migraine attacks in a 30 day period has not been established. The package insert for sumatriptan/naproxen (Treximet) state that the safety of treating an average of more than 5 migraine attacks in a 30 day period has not been established. Zembrace, Alsuma and Sumavel do not provide any guidance.
Appendix B: Non-Triptan Quantity Limits
Product Available dosages
Maximum Daily Dosage*
Maximum Monthly Quantity**
Maximum Monthly
limit x 2 months Ergotamine: SL tab† 2mg 2 tablet 8 x 2mg tablets 16 x 2mg tablets
Ergotamine/Caffeine: Oral tablet 1mg/100mg 6 tablet 24 x 1mg/100mg
tablets 48 x 6mg/100mg
tablets Ergotamine/Caffeine: Rectal suppository
2mg/100mg 2 supp 8 x 2mg/100mg
supp 16 x 2mg/100mg
supp Dihydroergotamine: Nasal‡ 4 mg/ml 1 ampule 4 ampules (1 kit) 8 ampules (1 kit)
Dihydroergotamine: Inj§ 1mg/ml ampule
3mg 12 x 1mg/ml
ampules 24 x 1 mg/ml
ampules Isometheptene/Dichlorophenazone/ APAP (e.g., Midrin)¶
1 cap 5 capsules 20 capsules 40 capsules
Butalbital Products (Fiorinal/Fioricet products)
1 tablet 6 tablets 24 tablets 48 tablets
Butorphanol: Nasal†† 10mg/ml 2.5ml bottle 4mg (4 sprays)
(16 mg/16 sprays) or
2 bottles (5 ml)
(36 mg/36 sprays) or
3 bottles (7.5 ml) * Official Prescribing Information. Available at: http://www.fda.gov/cder/ [last accessed 9/25/17] ** Based on treating 4 headaches/month † Not to exceed 2 tablets in any 24-hour period for migraine ‡ Studies have not shown additional benefit from acute doses >2 mg for a single migraine administration. Discard ampule after use. 8 ampules per kit § Max dose (IM/SC) = 3mg in a 24-hour period. 1mg/ml ampules ¶ Up to 5 capsules within a 12-hour period †† 1 mg/1 spray in 1 nostril. May repeat 1mg dose within 60 to 90 minutes. The initial 2 dose sequence may be repeated in 3 to 4 hours as needed. One bottle (2.5ml)=14-15 sprays Appendix C: Pharmacologic Therapy for Migraine Prevention4 Antiepileptic Drugs Divalproex sodium
Sodium valproate Topiramate
Beta Blockers Metoprolol Propranolol Timolol
Triptans Frovatriptan (menstrually-associated migraine) * These medications are classified by the American Academy of Neurology as having established for prevention of episodic migraine headaches (Level A).
Appendix D: Non-Triptan Acute Migraine Therapy: Thresholds for Use of Preventive Therapy
Product Dosage per HA* Number of Units for
3 HA/month Number of Units for 3 HA/Month x 3 months
Ergotamine: SL (2mg/tab)† 2 tabs 6 tabs 18 tabs Ergotamine/Caffeine: Oral (1mg/100mg)
6 tabs 18 tabs 54 tabs
Ergotamine/Caffeine: Rectal (2mg/100mg)
2 suppositories 6 suppositories 18 suppositories
Dihydroergotamine: Nasal (4mg/ml)‡ 4 sprays (2 mg/0.5ml)
or 1 ampule 3 ampules or
1 kit 9 ampules or
2 kits Dihydroergotamine: Inj (1mg/ml)§ 3mg/3ml 9 ml 27 ml Isometheptene/Dichlorophenazone/ APAP (e.g., Midrin)¶
5 caps max/12 hours 15 caps 45 caps
Butalbital Products 6 tabs max/d 18 tabs 54 tabs
Butorphanol: Nasal†† Up to 4mg (4 sprays) (12 mg/12 sprays) or
1 bottle (2.5 ml) (36 mg/36 sprays) or
3 bottles (7.5 ml) * Official Prescribing Information. Available at: http://www.fda.gov/cder/ [last accessed 9/25/17] † Not to exceed 2 tablets in any 24-hour period for migraine
6 Migraine Prevention and Treatment © 2016 Conduent Business Services, LLC. All rights reserved.
‡ Studies have not shown additional benefit from acute doses > 2 mg for a single migraine administration. Discard ampule after use. 8 ampules per kit § Max dose (IM/SC) = 3mg in a 24-hour period ¶ Up to 5 capsules within a 12-hour period †† 1 mg/1 spray in 1 nostril. May repeat 1mg dose within 60 to 90 minutes. The initial 2 dose sequence may be repeated in 3 to 4 hours as needed. One bottle (2.5ml)=14-15 sprays Appendix E: Triptan Therapy: Thresholds for Use of Preventive Therapy*
Product Available dosages
Maximum MG Daily Dosage
Maximum MG Monthly Dosage┼
Number of Units for 3 HA/month‡
Number of Units for 3 HA/month x 3 months
Sumatriptan Injection 4mg/0.5ml 6mg/0.5ml
12mg (1ml) 48mg 3ml 9ml
SumatriptanTablets 25mg, 50mg,
100mg 200mg 800 mg 9 27
Sumatriptan Nasal Spray
5mg and 20mg unit of use
40mg 160mg 6 18
Sumatriptan Nasal Powder (Onzetra®)
11mg 44mg 176mg 16 48
Naratriptan (Amerge®) Tablets
1mg, 2.5mg 5mg 20mg 9 27
Zolmitriptan (Zomig®, Zomig® ODT) tablets
5mg, 2.5mg 10mg 30mg 6 18
Zolmitriptan Nasal Spray
5mg unit of use 10mg 40mg 6 18
Rizatriptan benzoate (Maxalt®, Maxalt®-MLT)
tablets 5mg, 10mg 30mg 120mg 6 18
Almotriptan (Axert®) Tablets
6.25mg, 12.5mg 25mg 100mg 6 18
Frovatriptan (Frova®) Tablets
2.5mg 7.5mg 30mg 9 27
Eletriptan (Relpax®) Tablets
20mg, 40mg 80mg 240mg 6 18
Sumatriptan/Naproxen (Treximet®) Tablet
85mg/500mg 170mg/1000mg 850mg/5000mg 9 27
* Official Prescribing Information. Available at: http://www.fda.gov/cder/ [last accessed 9/25/17] ┼ Based on established safety data in the package insert for treating the average number of headaches in a 30 day period ‡ Also takes into account number of tablets in original container size The Official Prescribing Information does not provide guidance on the average number of headaches to treat in a 30 day period for Zembrace, Alsuma and Sumavel.
Appendix F: Increased Risk of Adverse Effect*┼
Acute Migraine Therapy Medical Condition Butalbital Products Porphyria Ergotamine Derivatives Ischemic Heart Disease
Hemiplegic Migraine Hepatic Impairment Peripheral Vascular Disease Renal Impairment Uncontrolled Hypertension
Isometheptene Products Closed Angle Glaucoma Hepatic Impairment Ischemic Heart Disease Renal Impairment Uncontrolled Hypertension
7 Migraine Prevention and Treatment © 2016 Conduent Business Services, LLC. All rights reserved.
Triptans (all) Cerebrovascular Event (hemorrhagic and ischemic) Ischemic Heart Disease Hemiplegic Migraine Peripheral Vascular Disease Uncontrolled Hypertension
Eletriptan Naratripan Sumatriptan Sumatriptan/Naproxen
Hepatic Impairment
Naratriptan Renal Impairment * Official Prescribing Information. Available at: http://www.fda.gov/cder/ [last accessed 9/25/17]
┼ Level 1 Drug-Disease State Interactions. First DataBank. Inc, San Francisco, CA Appendix G: Acute Migraine Therapy Drug-Drug Interactions*┼
Acute Migraine Therapy Interacting DrugButalbital Products Monoamine oxidase inhibitors
Ergotamine Derivatives
Beta-blockers Clarithromycin-containing products Delaviradine Efavirenz-containing products Erythromycin Itraconazole Ketoconazole Nitrates Macrolides Monoamine oxidase inhibitors Protease inhibitors Sibutramine Triptans
Isometheptene Products Bromocriptine Monoamine oxidase inhibitors
Triptans Ergotamine derivatives Monoamine oxidase inhibitors (except almotriptan, eletriptan, frovatriptan, naratriptan)
* Official Prescribing Information. Available at: http://www.fda.gov/cder/ [last accessed 9/25/17] ┼ Level 1 Drug-Disease State Interactions. First DataBank, Inc., San Francisco, CA
<<Date>> <<Name>> <<Address>> <<Address>>
RE: Caring for Your Patients with Migraine Headaches
Dear Dr. <<NAME>>:
The goal of this quality management program is to assist you in caring for your patients with migraine headaches. This program is based on recommendations from the American Headache Society and the American Academy of Neurology.1,2 These recommendations are designed to assist you in maximizing outcomes and promoting the safe use of medications in your patients with migraine headaches.
American Headache Society Evidence Assessment. The Acute Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Available at:
http://onlinelibrary.wiley.com/doi/10.1111/head.12499/epdf
American Academy of Neurology Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults. Available at:
http://www.neurology.org/content/78/17/1337.full.pdf+html
Claims data indicates in the Texas Fee-For-Service Program there are approximately 2,602 individuals with a diagnosis of migraine headaches. This treatment included 1,204 prescriptions for acute migraine medications in a recent 365 day period at the total cost of $112,965
Total Texas Medicaid Fee-For-Service Specific Data
Migraine Management Indicator Summary Number of Patients with
Opportunities*
<18 Years > 18 Years
Identify patients that may be overutilizing acute migraine therapy 2 20
Underutilization of preventive therapy 0 12
Promote the use of and encourage adherence with migraine preventive therapy
0 3
Promote safe and effective use of medications through identification of potential drug-drug interactions and adverse drug events associated with migraine therapy
0 30
Identify patients on medication combinations that put them at risk for serotonin syndrome
3 8
*Based on data 7/21/17 The enclosed patient profiles reflect one or more of the above issues and are provided as a medical record reminder for when your patients return for their next appointments.
We acknowledge that there may be clinical variables influencing an individual patient’s management that are not apparent in claims data. However, we believe the issues identified may assist you in caring for your patient(s). It is possible that your license number may have been inadvertently assigned to the claim as an error at the pharmacy during the billing process. Also, some prescribed medications as well as some recommended laboratory monitoring or physical examinations may not appear on the patient’s profile because they may have been privately purchased or were not billable to Medicaid Services. We thank you for reviewing this information and caring for Texas Medicaid patients, and we welcome the opportunity to discuss any comments or concerns you may have about our quality management program. Please feel free to call our office at 1-866-923-7208 with questions or concerns. If your mailing address is incorrect, it must be updated through the Texas Medical Board online at http://www.tmb.state.tx.us/page/change-address. Sincerely, Medicaid Drug Use Review Board Vendor Drug Program H-630 P.O. Box 85200 Austin, TX 78708-5200
Migraine Management Indicator Summary
o Identify patients that may be overutilizing acute migraine therapy. Acute migraine therapy consists of a variety of pharmacologic classes of therapy including 5-HT1B/1D agonists (triptans), ergotamine derivatives, butorphanol, and multi-ingredient analgesic compounds (Midrin®, Fioricet®, Fiorinal®). If acute therapy is overused ( i.e., if the duration of use exceeds a specified number of days for the drug class) patients may experience severe adverse effects or medication-overuse headaches and/or rebound headaches.1
o Promote the use of migraine preventive therapy. Preventive therapy for patients with migraines can reduce the frequency, intensity and/or duration of acute migraine attacks. Preventive therapy is generally recommended for patients experiencing two or more migraines per month, particularly if their migraines cause substantial disability and are not adequately relieved using acute migraine therapies, and if contraindications to abortive therapies are present. Additionally, some medications used to treat other disease states, such as depression, hypertension, or seizure disorders, are also effective for preventing migraine headaches, and should be considered when preventive therapy is initiated.2
o Encourage adherence with preventive therapy. Since clinical benefit from preventive therapy can take up to three months, patients may perceive their prescribed preventive medication is ineffective leading to non-adherence. This may increase the frequency of acute attacks or can erroneously lead the clinician to believe that the patient requires a higher dose or change in therapy to achieve adequate symptom control.1
o Promote safe and effective use of medications through identification of potential drug-drug interactions and adverse drug events associated with migraine therapy. Several potential drug-drug and drug-disease state interactions with acute migraine therapies have been identified. Drug-drug and drug-disease state interactions that are contraindicated in the prescribing information or are drug combinations that should not be dispensed or administered to the same patient are identified.
o Identify patients on medication combinations that put them at risk for serotonin syndrome. Both the triptans and ergotamine derivatives possess serotonergic activity. If they are used in combination with other medications that also increase serotonin activity, patients are at risk for serotonin syndrome. Mild presentations of this potentially fatal reaction are relatively easy to miss clinically.3
o Botox for prophylaxis of adults with chronic migraine defined as an attack >15 days per month and lasting 4 hours a day or longer. The American Academy of Neurology guidelines state that onabotulinumtoxinA (Botox®) is effective and should be offered to increase headache-free days (Level A) and is probably effective and should be considered to improve health-related quality of life (Level B) in chronic migraine.4
References: 1. Marmura MJ, Silberstein SD, and Schwedt TJ. American Headache Society Evidence Assessment: The
Acute Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Headache 2015;55:3-20.
2. Silberstein SD, Holland S, Freitag D, et al. Evidenced-based guideline update: pharmacologic treatment for episodic migraine prevention in adults. Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012;78:1337-45.
3. Boyer EW, Shannon M. The Serotonin Syndrome. N Engl J Med 2005; 352:1112-20. 4. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for
the treatment of blepharospasm, cervical dystonia, and adult spasticity, and headache. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2016; 86:1-9.
Template: MIGRAINE 2017
External Messages
3200003373 Page: 1
129 # Candidates
367 DDI: Ergots-Macrolides Drug-drug interaction-ergot and macrolide: According to submitted pharmacy claims data,
it appears that your patient is receiving an ergotamine derivative (ergotamine, D.H.E.) and a
macrolide antibiotic (erythromycin, clarithromycin) concurrently. This combination
is contraindicated due to the increased risk of severe and/or life-threatening
reactions such as acute ergot toxicity characterized by vasospasm and ischemia of the
extremities and other tissues. Since your patient may have only been on the antibiotic for a
limited time, this may not currently be an issue. Please consider alternative therapy in the
future should the condition being treated arise again.
566 # Candidates-B
1379 Migraine: Overutilization Ergots Potential overutilization of ergot derivative: According to submitted pharmacy claims data,
it appears that your patient may be using an ergotamine derivative (ergotamine, D.H.E.)
excessively for migraine headache relief. This type of utilization can increase the risk
of adverse drug events and may lead to rebound or worsening of headaches. Please review
the use of this acute migraine therapy with your patient, discuss avoidance of migraine triggers,
and consider the addition or optimization of migraine preventive therapy.
1381 Migraine: IADE: Concomitant Use of 5-HT Duplicate triptan therapy: According to submitted pharmacy claims data, it appears
that your patient is using more than one triptan product. Use of more than
one triptan is generally not recognized as synergistic and is usually not indicated. Using this
combination may increase the risk of adverse drug events and may decrease overall
compliance. Please review the need for this combination of medications, and if you have
not already done so, verify that your patient has discontinued the appropriate agent(s).
1382 Incr ADE: 5-HT Agonists and Ergots Drug-drug interaction-triptan and ergot: According to submitted pharmacy claims data,
your patient received a triptan and an ergotamine derivative (ergotamine, D.H.E.) concurrently.
Concurrent use can result in additive vasoconstrictive effects and a prolonged vasospastic
reaction. Ergotamine derivative and triptan use within 24 hours of each other is contraindicated.
Please advise patients accordingly and monitor for signs and symptoms of
this interaction.
1384 DDI: 5HT Agonists with MAOIs Drug-drug interaction-triptan and MAOI: According to submitted pharmacy claims data, it
appears that your patient is receiving a triptan and a monoamine oxidase inhibitor (MAOI)
concurrently. MAOIs can decrease the clearance and increase the systemic exposure to
triptans. Concurrent use or use of a triptan within 2 weeks of discontinuation of a MAOI is
contraindicated. Please advise your patient accordingly and select alternative therapy.
1385 Incr ADE: 5-HT Agonists and Ischemic Heart Disease Drug-disease contraindication-triptan and ischemic heart disease: According to submitted
pharmacy and medical claims data, it appears that your patient has ischemic heart
disease and has received a triptan. Use of triptans is contraindicated in patients with
ischemic heart disease due to the increased risk of coronary vasospasm. Please review
the need for this medication and select an alternative agent.
Flag Internal Messages External Messages
Template: MIGRAINE 2017
External Messages
3200003373 Page: 2
1386 Incr ADE: 5-HT Agonists and Hypertension, Uncontrolled Drug-disease contraindication-triptan and uncontrolled hypertension: According to submitted
pharmacy and medical claims data, it appears that your patient has hypertension and has
received a triptan. Use of triptans is contraindicated in patients with uncontrolled hypertension
because these drugs may cause a transient increase in blood pressure. If your patient's
blood pressure is uncontrolled, please consider an alternative agent.
1387 Incr ADE: 5-HT and cerebrovascular disease Drug-disease contraindication-triptan and cerebrovascular disease: According to submitted
pharmacy and medical claims data, it appears that your patient has cerebrovascular disease
and has received a triptan. Use of triptans is contraindicated in patients with cerebrovascular
disease because they may increase the risk of cerebral hemorrhage, subarachnoid
hemorrhage, stroke, and other cerebrovascular events. Please review the need for this
medication and select an alternative agent.
1388 Incr ADE: 5-HT Agonists and Peripheral Vascular Syndromes Drug-disease contraindication-triptan and peripheral vascular disease: According to submitted
pharmacy and medical claims data, it appears that your patient has peripheral vascular
disease and has received a triptan. Use of these agents is contraindicated in patients with
peripheral vascular syndromes. Please review the need for this medication and
select an alternative agent.
1422 Migraine: Dx= Insomnia &/or Depression Migraine diagnosis with insomnia and/or depression: According to submitted pharmacy and medical
claims data, it appears that your patient has a history of migraine and insomnia and/or depression.
Please consider comorbidity if prescribing preventive migraine therapy (e.g., consider the use of
an antidepressant such as amitriptyline, if appropriate).
1424 Migraine: Dx = Hypertension Migraine diagnosis with hypertension: According to submitted pharmacy and medical claims data, it
appears that your patient has a history of migraine and hypertension. Please consider comorbidity
if prescribing preventive migraine therapy (e.g., consider the use of an antihypertensive such as
a beta-blocker, if appropriate).
1425 Migraine: Dx= Reactive Airway Disease Migraine diagnosis with reactive airway disease: According to submitted pharmacy and medical claims
data, it appears that your patient has a history of migraine and reactive airway disease. Please
consider comorbidity if prescribing preventive migraine therapy (e.g., avoid the use of
non-cardioselective beta-blockers).
1426 Migraine: Dx= Seizures &/or Bipolar Disorder Migraine diagnosis with seizure and/or bipolar disorder: According to submitted pharmacy and
medical claims data, it appears that your patient has a history of migraine and seizure and/or
bipolar disorder. Please consider comorbidity if prescribing preventive migraine therapy (e.g.,
consider the use of divalproex in patients with bipolar disorder and divalproex or topiramate
in patients with seizures, if appropriate).
1753 Incr ADE: Ergots-Nitrates Drug-drug interaction-ergot and nitrate: According to submitted pharmacy claims data,
it appears that your patient has received an ergotamine derivative (ergotamine, D.H.E.) and
a nitrate concurrently. When these agents are used concurrently, the antianginal
effects of the nitrate may be decreased and blood pressure may increase. Please
monitor your patient for signs and symptoms of worsening angina and increased
blood pressure and consider alternative therapy.
Flag Internal Messages External Messages
Template: MIGRAINE 2017
External Messages
3200003373 Page: 3
1755 Incr ADE: Ergots-Beta Blockers Drug-drug interaction-ergot and beta-blocker: According to submitted pharmacy claims
data, it appears that your patient has received a beta-blocker and an ergotamine derivative
(ergotamine, D.H.E.) concurrently. Beta-blockers can increase the vasoconstrictive effects
of ergotamine derivatives leading to peripheral ischemia. Please consider if an
alternative to these medications can be prescribed. If not, peripheral ischemic effects
should be monitored.
1756 Incr ADE: Ergots & Peripheral Vascular Syndromes Drug-disease contraindication-ergot and peripheral vascular disease: According to submitted
pharmacy and medical claims data, it appears that your patient has peripheral vascular disease
and has received an ergotamine derivative (ergotamine, D.H.E.). Ergotamine derivatives are
contraindicated in patients with peripheral vascular disease.
Please review the need for this medication and select alternative therapy.
1757 Incr ADE: Ergots & Hypertension (uncontrolled) Drug-disease contraindication-ergot and uncontrolled hypertension: According to submitted
pharmacy and medical claims data, it appears that your patient has hypertension and has
received an ergotamine derivative (ergotamine, D.H.E.). Ergotamine derivatives may
cause an increase in blood pressure and should be used with caution in patients with
hypertension. If the patient's hypertension is uncontrolled, please consider an alternative
agent, as ergotamine derivatives are contraindicated in patients with this condition.
1758 Incr ADE: Ergots & Ischemic Heart Disease Drug-disease contraindication-ergot and ischemic heart disease: According to submitted
pharmacy and medical claims data, it appears that your patient has ischemic heart disease
and has received an ergotamine derivative (ergotamine, D.H.E.). Ergotamine
derivatives are contraindicated in patients with ischemic heart disease since they have a direct
vasoconstrictive effect on vascular smooth muscle. Please review the need for this medication
and select alternative therapy.
1759 Incr ADE: Ergots & Renal Impairment Drug-disease interaction-ergot and renal impairment: According to submitted pharmacy and
medical claims data, it appears that your patient has renal impairment and has received an
ergotamine derivative (ergotamine, D.H.E.). Ergotamine derivatives are contraindicated in
patients with severe renal impairment. Please use with caution in your patient or consider
alternative therapy.
1760 Incr ADE: Ergots & Hepatic Impairment Drug-disease interaction-ergot and hepatic impairment: According to submitted
pharmacy and medical claims data, it appears that your patient has hepatic impairment and
has received an ergotamine derivative (ergotamine, D.H.E.). Ergotamine derivatives are
contraindicated in patients with severe hepatic impairment. Please use with caution in
your patient or consider alternative therapy.
1763 Incr ADE: Butalbital-Porphyria Drug-disease contraindication-butalbital and porphyria: According to submitted pharmacy
and medical claims data, it appears that your patient has porphyria and has received
butalbital. The use of butalbital is contraindicated in patients with porphyria because
it may precipitate the disease (by inducing cytochrome P-450 isoenzymes), thus
increasing the demand for heme synthesis. Please review the need for this
medication and consider an alternative agent.
Flag Internal Messages External Messages
Template: MIGRAINE 2017
External Messages
3200003373 Page: 4
1764 Incr ADE: Butalbital-MAOI Drug-drug interaction-butalbital and MAOI: According to submitted pharmacy claims
data, it appears that your patient may have received butalbital and a monoamine
oxidase inhibitor (MAOI) concurrently. MAOIs may enhance the CNS depressant effects
of butalbital by inhibiting its metabolism. Please monitor for signs and symptoms of CNS
depression (i.e., dizziness, drowsiness, and lightheadedness), and consider if an
alternative agent can be prescribed.
1765 Incr ADE: Isometheptene & Glaucoma Drug-disease contraindication-isometheptene and glaucoma: According to submitted
pharmacy and medical claims data, it appears that your patient has glaucoma and has
received isometheptene. The use of isometheptene, a sympathomimetic amine,
is contraindicated in patients with glaucoma because it constricts dilated cranial and
cerebral arterioles, which may exacerbate glaucoma. Please select alternative therapy.
1766 Incr ADE: Isometheptene & Renal Impairment Drug-disease contraindication-isometheptene and renal impairment: According
to submitted pharmacy and medical claims data, it appears that your patient has renal
impairment and has received isometheptene. Its use is contraindicated in severe
cases of renal disease. Please use with caution in patients with renal impairment
or consider alternative therapy.
1767 Incr ADE: Isometheptene & Hypertension (uncontrolled) Drug-disease contraindication-isometheptene and uncontrolled hypertension: According
to submitted pharmacy and medical claims data, it appears that your patient has hypertension
and has received isometheptene. The use of this drug is contraindicated in patients with
uncontrolled hypertension because it can cause vasoconstriction and may exacerbate
existing hypertension. If your patient's blood pressure is uncontrolled, please consider
alternative therapy.
1768 Incr ADE: Isometheptene & Hepatic Impairment Drug-disease contraindication-isometheptene and hepatic impairment: According to
submitted pharmacy and medical claims data, it appears that your patient has hepatic
impairment and has received isometheptene. Isometheptene is contraindicated for
use in patients with hepatic impairment. Please select alternative therapy.
1769 Incr ADE: Isometheptene & Ischemic Heart Disease Drug-disease contraindication-isometheptene and ischemic heart disease: According
to submitted pharmacy and medical claims data, it appears that your patient has ischemic
heart disease and has received isometheptene. The use of isometheptene is
contraindicated in patients with ischemic heart disease because it can cause
vasoconstriction and may exacerbate existing ischemic heart disease. Please select
alternative therapy.
1770 DDI: Isometheptene-Bromocriptine Drug-drug interaction-isometheptene and bromocriptine: According to submitted pharmacy
claims data, it appears that your patient may have received isometheptene and bromocriptine
concurrently. It has been reported that concurrent use may cause hypertension and
ventricular tachycardia. The combination may also result in vasospasm, probably as a
result of combined pharmacodynamic effects, and should be avoided. Please consider if
an alternative agent can be prescribed.
1771 DDI: Isometheptene-MAOI Drug-drug interaction-isometheptene and MAOI: According to submitted pharmacy claims data,
Flag Internal Messages External Messages
Template: MIGRAINE 2017
External Messages
3200003373 Page: 5
it appears that your patient has received an isometheptene-containing product and
a monoamine oxidase inhibitor (MAOI). Because isometheptene has sympathomimetic
properties, concurrent use with an MAOI may result in hypertensive crisis. Please review
the need for these medications and select alternative therapy.
2096 Nonadherence: Prophylaxis Migraine Meds Nonadherence-preventive migraine meds: Your patient may be nonadherent with a
medication used for migraine prevention. From prescription data, it appears that your patient
received < 60 days of maintenance therapy in a recent 90-day period. Please review this
information to determine the best course of action for your patient.
4761 Migraine: Overutilization of butalbital products Potential overutilization of butalbital product: According to submitted pharmacy claims
data, it appears that your patient may be using a butalbital product excessively for
migraine headache relief. This type of utilization can increase the risk of adverse drug
events and may lead to rebound or worsening of headaches. Please review the use of
this acute migraine therapy with your patient, discuss avoidance of migraine triggers, and
consider the addition or optimization of migraine preventive therapy.
4762 Migraine: Overutilization Triptan Therapy Potential overutilization of triptan therapy: According to submitted pharmacy claims, it appears
that your patient may be using a triptan excessively for migraine headache relief. This type
of utilization can increase the risk of adverse drug events and may lead to rebound or worsening
of headaches. Please review the use of this acute migraine therapy with your patient, discuss
avoidance of migraine triggers, and consider the addition or optimization of migraine preventive
therapy.
4859 Migraine: Overutilization of isometheptene Potential overutilization of isometheptene: According to submitted pharmacy claims
data, it appears that your patient may be using an isometheptene product excessively for
migraine headache relief. This type of utilization can increase the risk of adverse drug
events and may lead to rebound or worsening of headaches. Please review the use
of this acute migraine therapy with your patient, discuss avoidance of migraine triggers,
and consider the addition or optimization of migraine preventive therapy.
5282 DDI: Ergots-Protease Inhibitors Drug-drug interaction-ergot and protease inhibitor: According to submitted pharmacy claims
data, it appears that your patient has received an ergotamine derivative (ergotamine, D.H.E.)
and a protease inhibitor concurrently. Concomitant use of ergotamine derivatives and
protease inhibitors may result in ergotism (acute ergot toxicity) characterized by vasospasm
and/or ischemia of the extremities. Concurrent use of these medications is contraindicated.
Please select alternative therapy.
6915 Incr. ADE: Eletrip/Naratrip/Sumatriptan w/Hepatic Impairment Drug-disease contraindication-selected triptan and hepatic impairment: According
to submitted pharmacy and medical claims data, it appears that your patient has
hepatic impairment and has received eletriptan, naratriptan, or sumatriptan. These
drugs are contraindicated in patients with severe hepatic disease due to decreased
clearance of the drug, and should be used with caution, in lower doses, in patients
with mild to moderate hepatic impairment. Please review the use of triptan therapy
in your patient and consider if a dose reduction is necessary.
Flag Internal Messages External Messages
Template: MIGRAINE 2017
External Messages
3200003373 Page: 6
6916 Incr. ADE: Naratriptan w/Renal Impairment Drug-disease contraindication-naratriptan and renal impairment: According to submitted
pharmacy and medical claims data, it appears that your patient has renal impairment
and has received naratriptan. This drug is contraindicated in patients with severe renal
impairment due to decreased clearance of the drug, and should be used with caution, in lower
doses, in patients with mild to moderate renal impairment. Please review the use of this
drug in your patient and consider if a dose reduction of naratriptan is necessary.
9377 Incr ADE: Migraine Med/Serotonin Antidepressant (SS) Increased risk of adverse event-migraine med with SSRI/SNRI: According to pharmacy
claims data, it appears that your patient has received migraine therapy with a selective serotonin
reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor. This combination places
patients at risk for developing serotonin syndrome (SS). SS may occur when 2 or more
serotonergic agents are taken together. While SS appears to be relatively uncommon, it is
likely underreported in mild cases. Signs and symptoms include: mental status & behavioral
changes (confusion, agitation), altered muscle tone (tremor, hyperreflexia, myoclonus), fluctuating
vital signs & diarrhea. Please evaluate the need for continued use of these multiple
serotonergic medications. Otherwise monitor your patients for subtle signs/symptoms of SS.
9378 Incr ADE: Migraine Med/MAOI Med (SS) Increased risk of adverse event-migraine med with MAOI: According to pharmacy claims data,
it appears that your patient has received migraine therapy with a monoamine oxidase inhibitor.
This combination places patients at risk for developing serotonin syndrome (SS). SS may occur
when 2 or more serotonergic agents are taken together. While SS appears to be relatively
uncommon, it is likely underreported in mild cases. Signs and symptoms include: mental status
& behavioral changes (confusion, agitation), altered muscle tone (tremor, hyperreflexia,
myoclonus), fluctuating vital signs & diarrhea. Please evaluate the need for continued use of
these multiple serotonergic medications. Otherwise monitor your patients for subtle signs/
symptoms of SS.
11836 Incr ADE: Ergots-Hemiplegic migraine Drug-disease contraindication-ergot and hemiplegic migraine: According to submitted
pharmacy and medical claims data, it appears that your patient is receiving an ergotamine
derivative (ergotamine, D.H.E.) and has a history of hemiplegic migraine. Due
to their vasoconstrictive properties, ergotamine derivatives are contraindicated for use
in patients with hemiplegic migraine. Please review the use of ergotamine derivatives in
your patient and select alternative therapy.
11837 Incr ADE: 5-HT agonists and Hemiplegic migraine Drug-disease contraindication-triptan and hemiplegic migraine: According to submitted
pharmacy and medical claims data, it appears that your patient is receiving triptan therapy and
has a history of hemiplegic migraine. Due to their vasoconstrictive properties, triptans are
contraindicated for use in patients with hemiplegic migraine. Please review the use of triptans
in your patient and select alternative therapy.
11838 DDI: Ergots-Azole antifungal Drug-drug interaction-ergot and azole antifungal: According to submitted pharmacy
claims data, your patient has taken an ergotamine derivative (ergotamine, D.H.E.) and an azole
antifungal (itraconazole, ketoconazole, posaconazole, or voriconazole) concurrently. This
combination is contraindicated due to the increased risk of severe and/or life-threatening
reactions such as acute ergot toxicity characterized by vasospasm and ischemia of
Flag Internal Messages External Messages
Template: MIGRAINE 2017
External Messages
3200003373 Page: 7
the extremities and other tissues. Since your patient may have only been on the antifungal
for a limited time, this may not currently be an issue. Please consider alternative antifungal
therapy in the future should the condition being treated arise again.
11839 DDI: Ergots-Efavirenz containing product Drug-drug interaction-ergot and efavirenz-containing product: According to submitted
pharmacy claims data, your patient is taking an ergotamine derivative (ergotamine, D.H.E.)
and an efavirenz-containing product (Sustiva, Atripla) concurrently. This combination is
contraindicated due to the increased risk of severe and/or life-threatening reactions including
acute ergot toxicity characterized by vasospasm and ischemia of the extremities and
other tissues. Please select alternative therapy.
11840 DDI: Ergots-delaviridine Drug-drug interaction-ergot and delaviridine: According to submitted pharmacy claims
data, your patient is currently taking an ergotamine derivative (ergotamine, D.H.E.) and
delaviridine (Rescriptor) concurrently. This combination is contraindicated due to the
increased risk of severe and/or life-threatening reactions such as acute ergot toxicity
characterized by vasospasm and ischemia of the extremities and other tissues. Please
select alternative therapy.
11879 Migraine: Overutilization of Butorphanol NS Potential overutilization of butorphanol nasal spray: According to submitted
pharmacy claims data, it appears that your patient may be using butorphanol nasal
spray (Stadol NS) excessively for migraine headache relief. This type of
utilization can increase the risk of adverse drug events and may lead to rebound
or worsening of headaches. Please review the use of this acute migraine therapy
with your patient, discuss avoidance of migraine triggers and consider the addition or
optimization of migraine preventive therapy.
14742 Migraine: Underutilization of preventive trt Underutilization of Preventive Migraine Therapy: According to submitted pharmacy claims, it
appears your patient's utilization of acute migraine therapies may reflect the need for preventive
therapy. Additionally, they are not currently receiving preventive migraine therapy or therapy
that is recognized by the American Academy of Neurology as having established or probable
efficacy (Level A or B evidence). Preventive therapy is generally recommended for patients
experiencing two or more migraines per month, especially if their migraines cause substantial
disability and are not adequately relieved by acute migraine therapies, or if contraindications
to acute therapies exist. Please review your patient's utilization of their acute migraine
therapies and consider the addition of preventive therapy if appropriate.
14767 Migraine: Valproate use & pregnancy Increased Risk of Adverse Drug Event: Valproate use in Migraine with Pregnancy: According
to submitted pharmacy and medical claims, it appears your patient with migraine headaches
is receiving a valproate analogue (i.e., valproic acid, divalproex sodium, valproate sodium)
and may be pregnant. These drugs are contraindicated for use during pregnancy when used for
prevention of migraine headaches due to decreased IQ scores in children exposed to
these drugs while their mothers were pregnant. Please review your patient's migraine
therapies, and consider alternative preventive therapy.
Flag Internal Messages External Messages