Forms and Documents

LUCENTIS Access Solutions Enrollment Forms

The SMN and PAN are required for enrollment in LUCENTIS Access Solutions.

Other Important Documents

Considerations for Composing a 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. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for LUCENTIS

 

Considerations for Composing a Sample Appeal Letter

This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for LUCENTIS

 

Enrolling in the Genentech Patient Foundation

The Genentech Patient Foundation gives free medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.

 

Fax Cover Letter

Use this cover sheet when faxing documents to LUCENTIS Access Solutions.

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

SMN=Statement of Medical Necessity.

Important Safety Information & Indication

Indications

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with:

  • Neovascular (wet) age-related macular degeneration (wAMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy (DR)
  • Myopic choroidal neovascularization (mCNV)

Important Safety Information

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.

Increases in intraocular pressure have been noted both pre-injection and post-injection with LUCENTIS.

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).

Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with LUCENTIS compared with control. 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.

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.

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.