Practice Forms and Documents

Find the enrollment forms you'll need to help patients access LUCENTIS 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 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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LUCENTIS Access Solutions Enrollment Forms

LUCENTIS Access Solutions can help your patients better understand their coverage, find financial assistance options, learn how to get LUCENTIS and know which specialty pharmacy their health insurance plan requires.


Prescriber Service Form

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


Patient Consent Form 

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


Formulario de Consentimiento del Paciente

A version of the Patient Consent Form for your Spanish-speaking patients.


Genentech Patient Foundation Enrollment Forms

The Genentech Patient Foundation provides free LUCENTIS 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

Includes patient, insurance and prescription information. Page two must be completed and submitted by the prescriber.


Patient Consent Form

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


Formulario de Consentimiento del Paciente

A version of the Patient Consent Form for your Spanish-speaking patients.


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.

Appeal Letter

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

Additional Information to Enclose in Your Letter

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

INDICATIONS
Macular edema following retinal vein occlusion (RVO)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).

Myopic choroidal neovascularization (mCNV)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with myopic choroidal neovascularization (mCNV).

Wet age-related macular degeneration (wAMD)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD).

Diabetic retinopathy (DR)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with diabetic retinopathy (DR).

Diabetic macular edema (DME)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with diabetic macular edema (DME).

CONTRAINDICATIONS

LUCENTIS is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with LUCENTIS. Monitor intraocular pressure prior to and following intravitreal injection with LUCENTIS and manage appropriately.

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS 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).

Neovascular (wet) age-related macular degeneration

The ATE rate in the 3 controlled neovascular AMD studies during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of LUCENTIS-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the study during the first year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3.

In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2, and a study of LUCENTIS used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg LUCENTIS compared to 1.1% (5 of 435) in patients in the control arms (odds ratio 2.2 [95% confidence interval (0.8-7.1)]).

Macular edema following retinal vein occlusion

The ATE rate in the 2 controlled RVO studies during the first 6 months was 0.8% in both the LUCENTIS and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of LUCENTIS-treated patients compared to 0.4% (1 of 260) in the control arms.

Diabetic macular edema and Diabetic Retinopathy

In a pooled analysis of Studies DME-1 and DME-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg LUCENTIS, 5.6% (14 of 250) with 0.3 mg LUCENTIS, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg LUCENTIS, 1.2% (3 of 250) with 0.3 mg LUCENTIS, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg LUCENTIS and 10.8% (27 of 250) with 0.3 mg LUCENTIS; the stroke rate was 4.8% (12 of 249) with 0.5 mg LUCENTIS and 2.0% (5 of 250) with 0.3 mg LUCENTIS.

Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with LUCENTIS compared with control. A pooled analysis of Studies D-1 and D-2, showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg LUCENTIS, in 2.8% (7 of 250) of patients treated with 0.3 mg LUCENTIS, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg LUCENTIS and in 4.4% (11 of 250) of patients treated with 0.3 mg LUCENTIS. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.

ADVERSE EVENTS

Serious adverse events related to the injection procedure that occurred in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.

In the LUCENTIS Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough.

As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time.

FOR ADDITIONAL SAFETY INFORMATION, PLEASE SEE LUCENTIS FULL PRESCRIBING INFORMATION.

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.

    • LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.

      LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.

    • Campochiaro PA, et al; BRAVO Investigators. Ophthalmology. 2010;117:1102-1112.

      Campochiaro PA, et al; BRAVO Investigators. Ophthalmology. 2010;117:1102-1112.

    • Data on file. South San Francisco, CA: Genentech, Inc.

      Data on file. South San Francisco, CA: Genentech, Inc.

    • Brown DM, et al; CRUISE Investigators. Ophthalmology. 2010;117:1124-1133.

       

      Brown DM, et al; CRUISE Investigators. Ophthalmology. 2010;117:1124-1133.