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American Academy Of Ophthalmology Responds ToGenentech Rebate Program For Lucentis UseAmerican 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 PaymentSunshine 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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