Article Date: 7/1/2006

SPECIAL REPORT
The Lucentis Commitment – Access Made Simple
RONALD PARK, MD, MBA

As Peter K. Kaiser, MD, wrote in the previous article, ranibizumab is anticipated to add to the armamentarium of options for neovascular age-related macular degeneration (AMD). Genentech has worked for nearly a decade on ranibizumab and we are pleased to now be working alongside retinal specialists to make ranibizumab available to patients.

As ranibizumab enters the market, it is clear that the current healthcare system has a number of issues (patients without insurance and patients with inadequate insurance) that may create hurdles to accessing ranibizumab. Furthermore, dealing with these issues can take valuable time away from physicians and their staff. As someone who practiced medicine in Los Angeles in the 1990s, I personally know how frustrating this can be. Now, as an employee of Genentech, I am pleased to be part of a team introducing a suite of reimbursement and access support services to help address these hurdles for patients on ranibizumab. We call this the "Lucentis Commitment — Access Made Simple."

A HISTORY OF COMMITMENT TO HEALTH CARE

The Lucentis Commitment is built on Genentech's experience with a wide range of complex issues associated with office-injected or infused biologics. Since our founding 30 years ago, we have launched 14 biologic products in 8 different specialties, including human growth hormone in pediatrics (Nutropin), tissue-plasminogen activator in cardiology (Activase), anti-HER2 antibody in oncology (Herceptin), and anti-IgE antibody in allergic asthma (Xolair). With each of these drugs, we have gained experience in assisting our customers with reimbursement and access issues.

We have now taken that experience and tailored it to the retinal specialist community. To do so, we gathered input from retinal specialists and practice managers. We are thankful for their time, and we hope the result is a suite of services that will be helpful in addressing non-clinical hurdles for retinal specialists and their patients with wet AMD.

PROGRAM OBJECTIVES

The following description provides a brief overview of the three objectives of the Lucentis Commitment – Access Made Simple program. These objectives are to:

1. Maximize patient access
2. Minimize reimbursement hassle
3. Address office inventory concerns

Maximize Patient Access

Our primary objective is to ensure that all patients have access to our therapies. Given the wet AMD patient population insurance characteristics, we anticipate that primary and supplemental insurance will cover the majority of cost for most patients. However, we recognize there are 2 groups of patients who may have difficulty with access — the uninsured and those with high co-pays due to inadequate insurance.

Genentech has long recognized the needs of the uninsured and underinsured populations. For the last 20 years, we have provided free product through the Genentech Access to Care Foundation (GATCF) that provides assistance to eligible patients who are uninsured or rendered uninsured due to payer denial. Last year alone, GATCF helped 18 000 uninsured patients by providing approximately $200 million of free product. GATCF will be available to provide ranibizumab to eligible patients who meet its criteria (which include that the patient must have an annual adjusted gross income of less than $75 000). We have also worked to make the paperwork and forms as simple as possible for both physicians and patients. 

The other group of concern consists of underinsured patients, which may include those with high co-pay plans such as Medicare patients without supplemental insurance. For patients requesting assistance with their co-pays, we can help obtain information on and contact an independent public charity that may be able to provide the necessary financial assistance. Although the independent public charities ultimately make the decision regarding assistance, Genentech is committed to supporting the mission of these charities. Recently, Genentech donated more than $21 million to these charities for various disease states so that they could provide financial assistance to eligible patients who cannot access needed medical treatment due to high co-pay costs.

*At least until a permanent J-code is established.

Minimize Reimbursement Hassle

Genentech is committed to providing reimbursement assistance, thereby helping to reduce the time offices spend on reimbursement. To this end, Genentech has more than 100 people working on minimizing reimbursement hassle and facilitating patient access to ranibizumab.

Furthermore, access to these services is designed to be as simple as possible. One phone number is the gateway to the range of support services mentioned in this article. Our single point of contact number is 1-866-724-9394 and is available Monday through Friday, 9 am to 8 pm (EST). For those who prefer Web access, the same services can be accessed at www.lucentis.com.

Additionally, each retinal practice will have a dedicated, expert case manager to provide reimbursement support. This person can help you and your staff answer reimbursement questions, investigate patient insurance policy benefits, confirm payer coverage requirements, and assist as appropriate with coverage denials and appeals.

For certain accounts where in-office support would be appropriate, Genentech has a dedicated group of Retina Business Account Managers (RBAMs), who can work with your staff to provide patient-specific support with reimbursement, billing, coding, and patient assistance. RBAMs are local reimbursement experts who are not compensated on sales. Their goal is to simplify the distribution and reimbursement process for your office.

Address Office Inventory Concerns

We understand that holding and managing inventory of biologic drugs can be a challenge, and that many offices are concerned about this. It is a concern that we have found to be common for specialties that utilize office-injected/infused drugs.

To help address these issues, we have put in place a number of measures as part of the Lucentis Commitment — Access Made Simple Program. In particular, we have worked with our distributors to arrange 120-day invoice dating until a permanent J-code is established, so that you will have time to receive reimbursement after you use the drug. To minimize your inventory, all our distributors will offer overnight shipping, so you will not need to carry more product than you intend to use in the near-term. Finally, we offer a comprehensive spoilage program that will rapidly replace broken or spoiled vials that may result from shipping or refrigeration issues.

SUMMARY

We are very excited that ranibizumab will be available to retinal specialists and their patients with wet AMD. At the same time, we recognize the challenges posed by the non-clinical aspects of our healthcare system and how those challenges may impede your ability to provide ranibizumab to patients with wet AMD.

We hope you will find the Lucentis Commitment – Access Made Simple program will assist you in dealing with these challenges. Our goal for this program is to
help you spend your time caring for patients, and we hope this program provides a positive means toward this worthy end.

Ronald Park, MD, MBA, is a director of Managed Care and Customer Operations at Genentech in South San Francisco, Calif.



Retinal Physician, Issue: July 2006