American Academy Of Ophthalmology Responds To

Genentech Rebate Program For Lucentis Use

American Academy of Ophthalmology
12 / 27 / 2010
SAN FRANCISCO – Genentech (Hoffman – La Roche) manufactures two critically important pharmaceuticals,
Lucentis and Avastin, which are both used for treatment of several common eye diseases – including age-related
macular degeneration (AMD). Despite considerable clinical similarity, the price difference between these drugs is
substantial, with Lucentis generally costing up to 100 times the equivalent treatment with Avastin. A National
Institutes of Health (NIH) clinical trial titled, "Comparison of AMD Treatment Trials" (CATT), is currently under way to
compare the safety and efficacy of the two drugs, and the results may have far-reaching economic implications for
Genentech, patients, Medicare, and third party payors.
Genentech currently offers a rebate program for the top prescribers of Lucentis. The American Academy of
Ophthalmology (Academy) is aware that substantial incentives may influence decision-making in clinical care by
introducing a potential source of bias in the selection of drugs for AMD. In response to the disclosure about
Genentech's rebate program, the Academy, with the support of the American Society of Retina Specialists, the
Retina Society, and the Macula Society, is preparing an educational article for its monthly magazine, EyeNet.  It will
discuss the ethical ramifications of this and similar rebate programs having the potential to influence clinical care and
decision-making. The piece will also appear on the Academy's website for review by ophthalmologists worldwide. 
The educational article will reference the Academy's existing Ethics Advisory Opinion, Disclosure ofProfessionally
Related Commercial Relationships and Interests which requires physician disclosure of specific commercial
relationships to patients and other relevant parties. Also included will be reference to the Academy's existing
requirements under the Code of Ethics Rules 11, Commercial Relationships and Rule 15,Conflict of Interest.
Rule 11, Commercial Relationships, states, "An ophthalmologist's clinical judgment and practice must not be affected
by economic interest in, commitment to, or benefit from professionally related commercial enterprises."
Rule 15, Conflict of Interest, states, "A conflict of interest exists when professional judgment concerning the well-
being of the patient has a reasonable chance of being influenced by other interests of the provider. Disclosure of a
conflict of interest is required in communications to patients, the public, and colleagues." Violation of the Rules of the
Academy's Code of Ethics may results in sanctions imposed on a Fellow or Member by the Academy Board of
Trustees."  
Volume-based rebate programs or volume-based price discounting arrangements are common throughout virtually all
commercial enterprises.  Those that have no direct impact on patient care (copier paper or light bulbs for example)
are of no professional ethical concern and are considered a normal part of business practice.  Those that have the
potential to directly impact a physician's decision-making regarding patient care are far more problematic for
physicians from an ethical (and sometimes legal) perspective.  The Academy's hope is to assist its members in
understanding the issues involved.
Physician-industry collaboration produces important advances in medical care. Pricing incentives in the form of
rebates have long been part of the physician-industry relationship, and are legal under the Physicians Payment
Sunshine Act that was enacted as part of the Patient Protection and Affordable Care Act. That Act specifically
excludes rebates from the definition of a `payment or other transfer of value' that must be reported to the federal
government. In addition, a safe harbor to the federal anti-kickback statute protects certain rebates, but only if they are
properly structured.  Recently, rebate programs and other incentive programs have come under renewed scrutiny by
both physicians and the public because of their potential to damage the public's trust in physicians, and to
unnecessarily increase health care costs. Increasing awareness of potential conflicts of interest and the need to
disclose those conflicts to relevant parties serves the best interest of patients and the profession.
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About the American Academy of Ophthalmology's Ethics Program 

The mission of the Academy's Ethics Program is to advance ethical knowledge, skill, and behavior for
ophthalmologists and to administer the Academy Code of Ethics. The primary purpose of the Code is to protect
patients and educate Academy members about the ethical issues inherent in the profession of ophthalmology.
Cooperation with the Ethics Committee and compliance with the Code are conditions of continued Academy
membership.
The Academy's Code of Ethics first took effect Jan. 1, 1984. The Academy was the first, and remains the only
professional medical specialty organization to pursue and receive an advisory opinion from the Federal Trade
Commission (FTC), allowing the Academy to sanction members found to be in violation. Due process is essential to
the administration of the Code.
Academy Code of Ethics: http://www.aao.org/about/ethics/code_ethics.cfm
Academy Ethics Advisory Opinion, Disclosure of Professionally Related Commercial Relationships and
Interests: http://www.aao.org/about/ethics/upload/AO-Disclosures-of-Commercial-Interests-2010.pdf 

About the American Academy of Ophthalmology

AAO is the world's largest association of eye physicians and surgeons—Eye M.D.s—with more than 29,000 members
worldwide.  Eye health care is provided by the three "O's" – opticians, optometrists and ophthalmologists. It is the
ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. For more
information, visit the Academy's Web site at www.aao.org.