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 of Professionally 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.
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.