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MIRVASO

Rosacea Redness

Savings

IMPORTANT SAFETY
INFORMATION

Terms & Conditions

Mobile Program

By agreeing to these Terms of the Mirvaso (brimondine) topical gel, .033% Mobile Program (“Program”), you consent to receive autodialed text messages on behalf of Galderma Laboratories, L.P. (“Galderma”).

Consent is not a condition of purchase or use of any Galderma product. The Program is valid with most major US carriers. There is no fee payable to Galderma to receive text messages; however, your carrier’s message and data rates may apply. Data obtained from you in connection with your registration for, and use of, this service may include your phone number, related carrier information, and elements of pharmacy claim information which will be used to administer this program and to provide program benefits such as savings offers, information about your prescription, refill reminders, as well as program updates and alerts. Galderma reserves the right to rescind, revoke or amend the Program without notice at any time.

Participants may receive an average of 6 messages per month during the course of this program. You may unsubscribe from the Program at any time by texting STOP. For help, text HELP or contact your mobile carrier. Patients with questions about the Program or Savings offer should call 1-844.492.9817.


Eligible insured patients whose coverage includes their prescription may pay no more than $50 for a 30-gram tube of Mirvaso Gel. Patients whose insurance does not cover Mirvaso Gel may pay no more than $80 for their prescription. Maximum benefit to eligible patients will not exceed $200. Offer not available to cash paying patients. The Savings Card provides savings on out-of-pocket expenses for up to 6 uses for which you have a valid prescription. You may use the Savings Card at any participating pharmacy located in the United States.

The Savings Card: (a) may not be combined with any savings, discount, free trial, or other similar offer for the same prescription; (b) is not transferable; (c) is void if reproduced; and (d) is not health insurance. Limit one (1) Savings Card per patient. The Savings Card has no cash value and will not be accepted outside of participating pharmacies in the United States. This offer expires 12/31/2015, unless this offer is earlier terminated by Galderma. This offer may be subject to limitations imposed by state or federal law, or by your health insurer. The Savings Card is not valid where prohibited by law or by your health insurer.

Eligibility

By using this Savings Card, you acknowledge that you currently meet the following eligibility criteria: (a) you have a valid prescription for Mirvaso Gel; (b) are subject to a private insurance co-pay requirement for your prescription; (c) you are not enrolled in Medicare Part D, Medicaid, Medigap, VA, DoD, TRICARE®, or any other government-run or government-sponsored health care program with a pharmacy benefit; and (d) you reside in the United States. No purchase is necessary and there are no membership fees. The selling, purchasing, trading or counterfeiting of this Savings Card is prohibited by law. By using this Savings Card, you acknowledge and demonstrate that you understand and agree to comply with the terms and conditions of this offer as set forth herein. Actual payment for Mirvaso Gel will depend upon individual insurance coverage.

Patient Instructions

Present the Savings Card to your pharmacist along with an eligible prescription for Mirvaso Gel each time you fill your prescription. The prescriber ID# must be identified on the prescription. It is important to make sure that you comply with your health insurer’s policies about Savings Cards. Therefore, if you have health insurance, you agree that you will disclose your use of this offer to your private insurer and will use this Savings Card consistent with your health insurer’s policies, including not seeking reimbursement from your insurer for any amount that Galderma provides toward your co-pay. You are responsible for any applicable taxes. If you have any questions about the Mirvaso Gel Savings offer, please call 1-844-492-9817.

Pharmacist Instructions

When you apply for this offer, you certify that you will: (a) not use the Savings Card to promote the services of your pharmacy; (b) comply with the policies of the patient’s insurer and not use the offer when prohibited by the patient’s insurer or by applicable law; (c) inform insurers about use of the Savings Card as required; (d) not use the Savings Card for any patient enrolled in a Medicare Part D, Medicaid, Medigap, VA, DoD, TRICARE®, or any other government-run or government-sponsored health care program with a pharmacy benefit; and (e) not seek reimbursement from a patient or health insurer for amounts provided by Galderma toward the patient’s co-pay. Galderma will deny payment if you do not comply with the terms of this offer.

For Insurance/Covered Patients

Submit the claim to the primary Third-Party Payer first, then submit the balance due to Therapy First Plus as a Secondary Payer COB (coordination of benefits) with patient responsibility amount and a valid Other Coverage Code (eg, 8). This will reduce the patient's co-pay to $50. Valid Other Coverage Code required. For any questions regarding Therapy First Plus online processing, please call the Help Desk at 1-800-422-5604.

For Insured/Not Covered Patients

Submit the claim to the primary Third-Party Payer first, if the primary claim submission shows a managed care restriction (step-edit, prior authorization or NDC block), continue the claim adjudication process and submit the balance due to Therapy First Plus as a Secondary Payer COB with patient responsibility amount and a valid Other Coverage Code of 3. This will reduce patients co-pay to $80. Valid Other Coverage Code required.

GALDERMA RESERVES THE RIGHT TO RESCIND, REVOKE OR AMEND THIS SAVINGS OFFER WITHOUT NOTICE AT ANY TIME.

Important Safety Information
Indication:  MIRVASO® (brimonidine) topical gel, 0.33%* is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. Adverse Events:  In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin burning sensation and contact dermatitis. Warnings/Precautions:  MIRVASO Gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. MIRVASO Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of MIRVASO Gel by children have been reported. Keep MIRVASO Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

MIRVASO Cost Reduction Card Program Information

1. This offer is not valid if prescriptions are paid by any state or other federally funded programs, including, but not limited to Medicare or Medicaid, Medigap, VA, DOD or TRICARE®. 2. This card is good for use only with a MIRVASO® (brimonidine) topical gel, 0.33%* prescription at the time the prescription is filled by the pharmacist and dispensed to the patient. 3. Offer good only in the USA at participating retail pharmacies and cannot be redeemed at government-subsidized clinics. 4. Galderma Laboratories, L.P. reserves the right to rescind, revoke, or amend this offer without notice at any time. 5. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. 6. Cash value is 1/100th of 1¢. 7. By using this card, you demonstrate that you understand and agree to comply with the terms and conditions of this offer as set forth on this card. 8. Actual payment for product will depend on individual insurance coverage.

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

Study Designs

Two 4-week pivotal studies

The safety and efficacy of MIRVASO® (brimonidine) topical gel, 0.33%* was evaluated in 2 identical, randomized, vehicle-controlled trials with 553 patients aged 18 years and older. Study participants were randomized 1:1 to receive either MIRVASO or vehicle gel once daily for 4 weeks. The primary endpoint for both studies was 2-grade composite success at hours 3, 6, 9, and 12 on day 29. The secondary endpoint was 1-grade composite success at 30 minutes on day 1. Composite success was defined as improvement on both the Clinician Erythema Assessment and Patient Self-Assessment.1

Long-term, open-label study

The long-term safety and efficacy of MIRVASO was studied in a 52-week, multicenter, open-label, non-comparative study with 449 patients with moderate to severe facial erythema of rosacea. The primary objective of the study was to evaluate the long-term safety of MIRVASO applied once daily for up to 12 months. The secondary objective of the study was to evaluate the long-term efficacy of MIRVASO applied once daily for up to 12 months.2

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

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Important Safety Information
Indication:  MIRVASO® (brimonidine) topical gel, 0.33%* is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. Adverse Events:  In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin burning sensation and contact dermatitis. Warnings/Precautions:  MIRVASO Gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. MIRVASO Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of MIRVASO Gel by children have been reported. Keep MIRVASO Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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