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Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Real-world refill rate equivalent for select preventive migraine medications¹

The following data/information is obtained from real-world evidence (RWE) studies. RWE differs from evidence derived from clinical trials in terms of study design and methodology, patient population, the way in which treatments are assigned (random vs non-random), outcomes assessed, and source of data. Results from RWE are not intended for direct comparison to clinical trial results and should be viewed as complementary information.

In an analysis, these data represent the proportion of patients newly treated with select preventive migraine medications who refilled the equivalent of a second or fourth prescription for that medication¹

CGRP=calcitonin gene-related peptide.

Summary of Ranges

Second month refill equivalent percent ranges for products within the class were: antiepileptics (63%-69%); beta-blockers (56%-77%); injectable CGRP antibodies (excluding Emgality) (81.5%-82.2%); antidepressants (66%-74%).

Fourth month refill equivalent percent ranges for products within the class were: antiepileptics (41%-47%); beta-blockers (12%-61%); injectable CGRP antibodies (excluding Emgality) (65%-67%); antidepressants (43%-55%).

These data make no representation or conclusions as to factors contributing to patients refilling prescriptions a second or fourth time.

Inclusion of a product or therapeutic class in this chart does not establish clinical comparability of the product/classes for any or all indications and should not be seen as making any claim regarding efficacy or safety.

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Hypersensitivity Reactions
Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

Real-world refill rate equivalent* analysis design¹

Internal analysis derived from the use of information under license from the following IQVIA information service: Longitudinal Access and Adjudication Data (LAAD)^® for the period January 2010 to March 2020, during which patient eligibility was determined. IQVIA expressly reserves all rights, including rights of copying, distribution, and republication. New-to-product patient cohorts were determined during the time frame of April 2019 to September 2019 for 2nd fill equivalent and from January 2019 to June 2019 for 4th fill equivalent. The look forward period for all patients lasted until March 2020.¹

Fill is based on total days of supply and not on absolute count of fills. All prescriptions less than 30 days of supply were rounded to 30 days for all products.¹

*One of the following scenarios must be true for a patient to be considered as having received the equivalent of a 2nd refill¹:

• The patient receives ≥60 days of supply with first prescription
• The gap between the start date of the prescription where the patient received at least 60 days of supply and the end date of the immediate previous script is ≤60 days. This scenario applies to situations in which patients filled multiple scripts to reach 60 days of supply

One of the following scenarios must be true for a patient to be considered as having received the equivalent of a 4th refill¹:

• The patient receives ≥120 days of supply with first prescription
• The gap between the start date of the script where the patient received at least 120 days of supply and the end date of the immediate previous script is ≤60 days. This scenario would apply to situations in which patients filled multiple scripts to reach 120 days of supply

Inclusion criteria¹

• Included patients from the United States who were ≥18 years of age with a migraine diagnosis, using ICD-10 Diagnosis Codes for Migraine: G43.0xx (Migraine without aura), G43.1xx (Migraine with aura), G43.7xx (Chronic migraine without aura), G43.8xx (Other migraine), G43.9xx (Migraine, unspecified) from June 2015 to March 2020
• The analyses included medications listed within American Headache Society (AHS)/American Academy of Neurology (AAN)’s evidence-based recommendations for the preventive treatment of migraine headache. All medications are considered by the AHS to be “Established” (Level A evidence: divalproex sodium, topiramate, metoprolol, propranolol, timolol) or “Probably” effective (Level B evidence: amitriptyline, venlafaxine, atenolol, nadolol) treatments for the prevention of migraine
• Included all CGRP antibody injectables indicated for the preventive treatment of migraine: Emgality, Aimovig^®, Ajovy^®
• For the 2nd month fill equivalent analysis, patients were new-to-product based on a two-year lookback and had at least 1 new prescription fill for any of the included products between April 1, 2019 and September 30, 2019
• For the 4th month fill equivalent analysis, patients included were new-to-product based on a two-year lookback and filled at least 1 new prescription for 1 of the included products between January 1, 2019 and June 30, 2019

Exclusion criteria¹

• Excluded patients with an epilepsy diagnosis (345.x or G40.x codes) and patients with an episodic cluster headache diagnosis (339.0x, 339.01, 339.02, G44.0, G44.00x, G44.01x, or G44.02x codes), spanning ICD-9 or ICD-10 codes between January 1, 2010 and March 31, 2020
• Excluded patients who filled, or attempted to fill, an Emgality 300 mg prescription
• Excluded data related to pediatric, dental, veterinary, and other unrelated prescriber specialties

Sample size¹

• For 2nd month fill equivalent data (April 2019-September 2019), the following total patients met the inclusion criteria: 135,646 (antiepileptics); 141,718 (beta-blockers); 58,627 (injectable calcitonin-gene related peptide [CGRP] antibodies [excluding Emgality]); 122,187 (antidepressants); and 41,466 (Emgality)
• For 4th month fill equivalent data (January 2019-June 2019), the following total patients met the inclusion criteria: 137,808 (antiepileptics); 148,388 (beta-blockers); 68,908 (injectable CGRP antibodies [excluding Emgality]); 125,127 (antidepressants); and 35,492 (Emgality)

Analysis design¹

• Eligible patients included all payer segments including but not limited to cash, commercial, Medicare and Medicaid beneficiaries. No exclusions were made based on payer segment
• Second or fourth month fill equivalent rates were calculated individually for each product within a class
• Analyses had a follow-up period until March 31, 2020
• Class average percentages are a weighted average of new brand starts, calculated by aggregating patient counts across products within the respective class

Limitations¹

• Some products included in analyses can be used to treat diseases other than migraine. Therefore, all patients included in analyses required a migraine diagnosis
• Any products excluded from analyses were only excluded if data limitations existed (eg low volume that increased risk of misrepresentation)
• Patients included in the analyses were not matched for potential confounders
• Patients could have previously tried another preventive, including another injectable CGRP antibody
• Data assessment for 2nd fill equivalent (April 2019-September 2019) and 4th fill equivalent (January 2019-June 2019) included different measurement periods to ensure longer look-forward period for 4th fill analysis
• Source data is based on prescription fill behavior for reporting entities which does not contain information related to insurance coverage independent of the prescription data, and so continuous enrollment was not applied

Antiepileptics: divalproex, topiramate; beta-blockers: atenolol, metoprolol, nadolol, propranolol, timolol; injectable CGRP antibodies (excluding Emgality): Aimovig^®, Ajovy^®; antidepressants: amitriptyline, venlafaxine.¹

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Adverse Reactions
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.