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For Patients and Caregivers

Practice Forms & Documents

Find the enrollment forms you'll need to help patients access VABYSMO after it's been prescribed, including for coverage, reimbursement and financial assistance services. There are also tips for composing a letter of medical necessity and an appeal letter.

To learn more about the resources available to help your practice, including information on benefits investigations and prior authorizations, go to Helpful Resources for Your Practice.

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Genentech Ophthalmology Access Solutions Enrollment Forms
Genentech Patient Foundation Enrollment Forms
Tips for Composing Letters of Medical Necessity and Appeal

Genentech Enrollment Forms

Genentech Ophthalmology Access Solutions can help your patients:

  • Get a better understanding of their coverage
  • Find financial assistance options
  • Learn how to get VABYSMO
  • Understand which specialty pharmacy their insurance plan uses
  • Reverify coverage if needed
  • Enroll in additional support options in the event of a coverage delay

Prescriber Service Form

This form is used to collect the patient’s health insurance and treatment information for enrollment in Genentech Ophthalmology Access Solutions.

Download the Prescriber Service Form

Patient Consent Form 

This form is signed and dated by your patient, giving written permission for Genentech to discuss their health information with you and the patient’s health insurance plan.

Download the Patient Consent Form (English)
Download the Patient Consent Form (Spanish)

Genentech Patient Foundation Enrollment Forms

The Genentech Patient Foundation provides free VABYSMO to people who don’t have insurance coverage or who have financial concerns and meet eligibility criteria.

The following forms are needed for applying for assistance from the Genentech Patient Foundation:

Learn more about the Genentech Patient Foundation and other resources programs.

Prescriber Foundation Form

This form is filled out by the healthcare provider and is used to collect the patient’s treatment information and determine eligibility for free Genentech medicine.

Download the Prescriber Foundation Form

Patient Consent Form

This form is signed and dated by your patient, giving written permission for Genentech to discuss their health information with you and the patient’s health insurance plan.

Download the Patient Consent Form (English)
Download the Patient Consent Form (Spanish)

Tips for Composing Letters of Medical Necessity and Appeal

Letter of Medical Necessity

This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference.

Tips for Drafting a Letter of Medical Necessity

Appeal Letter

This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference.

Tips for Drafting an Appeal Letter

Appeals

Use the links below to find additional information to enclose in your letter of medical necessity or appeal letter:

FDA Approval Letter
VABYSMO Prescribing Information
Sample Coding: Macular Edema Following Retinal Vein Occlusion (RVO)
Sample Appeal Letter for VABYSMO
Sample Avastin Step Back Appeal Letter for VABYSMO
NEXT: VABYSMO Access & Support

Important Safety Information & Indications


INDICATIONS
VABYSMO (faricimab-svoa) is a vascular endothelial growth factor (VEGF) inhibitor and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Macular Edema following Retinal Vein Occlusion (RVO).


IMPORTANT SAFETY INFORMATION

Contraindications
VABYSMO is contraindicated in patients with ocular or periocular infection, in patients with active intraocular inflammation, and in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

Warnings and Precautions
Endophthalmitis and Retinal Detachments
Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering VABYSMO. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Increase in Intraocular Pressure
Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with VABYSMO. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the VABYSMO clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

The incidence of reported ATEs in the nAMD studies during the first year was 1% (7 out of 664) in patients treated with VABYSMO compared with 1% (6 out of 662) in patients treated with aflibercept.

The incidence of reported ATEs in the DME studies from baseline to week 100 was 5% (64 out of 1,262) in patients treated with VABYSMO compared with 5% (32 out of 625) in patients treated with aflibercept.

The incidence of reported ATEs in the RVO studies during the first 6 months was 1.1% (7 out of 641) in patients treated with VABYSMO compared with 1.4% (9 out of 635) in patients treated with aflibercept.

Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of VABYSMO. Healthcare providers should discontinue treatment with VABYSMO in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Reactions
The most common adverse reactions (≥5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).

Pregnancy, Lactation, Females and Males of Reproductive Potential
Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VABYSMO and any potential adverse effects on the breastfed child from VABYSMO. Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment and for at least 3 months following the last dose of VABYSMO.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full VABYSMO Prescribing Information.

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      Fiedler U, et al. Trends Immunol. 2006;27(12):552–558.

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      Avery RL, et al. Presented at American Association of Ophthalmology (AAO) 2022. Sept 30–Oct 03 2022.

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      Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2022. Feb 11–12 2022.

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      Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2024. Feb 03 2024.

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      Heier JS, et al. Presented at American Academy of Ophthalmology Retina Subspecialty Day (AAO-SSD) 2021. Nov 12–13 2021.

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      Baumal CR, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022. May 1–4 2022.