AHFS Conflict of Interest and Disclosure Policy

The mission of AHFS is to provide an evidence-based foundation for safe and effective drug therapy. Information published in the AHFS DI compendium, including specific information on off-label uses, helps to shape treatment decisions made by clinicians and influences public and private healthcare policy and decisions. As a result, it is important that the information be authoritative, objective, and free of undue influence from drug sponsors (e.g., pharmaceutical manufacturers, sellers), health insurers, pharmacy benefit managers, and other third parties who may seek to use the compendium to promote their own vested interests. Editorial decisions are evidence-based and made independent of third parties; final decisions are made solely by the AHFS Editorial Staff, taking into account the advice of expert reviewers. In the case of balloted determinations made by the AHFS Oncology Expert Committee, decisions made through this process will prevail and will not be overturned by the AHFS Staff.

Numerous experts, including physicians, pharmacists, and other professionally qualified individuals, participate in an extramural review process for AHFS. Participation is solicited but voluntary, and no honorarium or other benefit is provided. These experts must provide full disclosure of interest, including any affiliation they have with or financial involvement they have in the sponsor of the drug(s) under consideration and directly competitive products. In the case of balloted determinations made by the AHFS Oncology Expert Committee, conflict of interest disclosure policies follow the definition of a publicly transparent process for identifying potential conflicts of interest as established in Section 414.930(a) of the Code of Federal Regulations (CFR).

Disclosure of Interests by Individuals Substantively Involved in the Oncology Off-label Use Determination Process

All individuals who substantively participate in the development, review, or disposition of an off-label oncology determination of medical acceptance are required to disclose direct and indirect financial interests. All Committee members appointed to the AHFS Oncology Expert Committee are required to complete an initial disclosure form listing all direct and indirect financial interests for themselves, their spouse, and any minor children for the previous 12 months. Prior to each review, those Committee members selected to participate in a particular off-label review are required to update their disclosure information, as well as that of their spouse and any minor children, to identify any potential new conflicts of interests. AHFS staff members who substantively participate in the development, review, or disposition of a compendial recommendation for an off-label oncology use also are required to disclose their own direct and indirect financial interests as well as those of their spouse and any minor children.

Process for Selection of Committee Member Reviewers and Experts

Members of the AHFS Oncology Expert Committee have been identified as experts through their affiliated professional organizations, which include the American Society of Health-System Pharmacists (ASHP), Association of Community Cancer Centers (ACCC), American Society of Clinical Oncology (ASCO), Hematology and Oncology Pharmacist’s Association (HOPA), and Oncology Nursing Society (ONS), and review,by AHFS staff of submitted credentials. Individual Committee members are selected to participate in the review of an off-label use on a rotating basis. However, at the discretion of the AHFS staff, specific individuals may be selected based on their area of expertise. The AHFS staff screens all the initial disclosure information for the AHFS Oncology Expert Committee and selects those committee members who do not have any direct or indirect conflicts of interest of their own or involving their spouse or minor children related to the specific off-label use being reviewed. Conflicts of interest are evaluated by AHFS staff not only as they relate directly to the sponsor, organization, or affected firm, but also are considered in the context of the interests relating to a potential competitor. Relevant conflicts of interests are those with a potential to result in a direct and predictable impact on a financial interest as a result of a final determination of medical acceptance.

• Committee members who have disclosed direct or indirect financial interests involving themselves, their spouse, or any minor child in an amount exceeding $50,000 that are relevant to the particular off-label use under consideration are not allowed to participate in the determination process.
• Committee members who have disclosed direct or indirect financial interests involving themselves, their spouse, or any minor child in an amount less than $50,000 that are relevant to the particular off-label use under consideration are not routinely asked to serve as reviewers, but may be asked to serve in an advisory capacity if their expertise is required; however, they are not able to vote on the final ballot.
• Committee members who have affiliations with a sponsor or organization (i.e., consultant, speakers bureau) that are relevant to the particular off-label use under consideration, or whose spouse or any minor child has such affiliations, regardless of whether they receive any form of monetary compensation, are not asked to serve as reviewers, but may be asked to serve in an advisory capacity if their expertise is required; however, they are not able to vote on the final ballot.

If a Committee member has been identified as having a conflict of interest and it is determined that the particular member’s expertise is required, the AHFS staff determines the merits of using the Committee member in an advisory capacity to provide an expert review on the subject matter. The AHFS staff may elect to grant a waiver indicating the role of the Committee member in an advisory capacity, but will also indicate that there was no participation in the final review or vote by the particular Committee member.

AHFS may choose to use an outside expert in either a consulting role or on an ad-hoc basis to help facilitate the understanding as well as the decision-making of the voting Committee members, especially in cases where there is a lack of expertise amongst the existing Committee members. However, outside consultants do not participate in the review of materials or in the final vote. Outside consultants are required to complete the disclosure form to provide the same information that has been requested of the full Committee members.

Availability of Information on Financial Disclosures and Conflicts of Interests

In accordance with the need for transparency, a conflict of interest statement summarizing the management of recognized conflicts of interest for individuals (e.g., Committee members, consultants, AHFS staff) who substantively participated in the development, review, or disposition of an off-label oncology determination is published with each Final Determination Report.

• If no direct or indirect conflicts for individual committee members or their spouses or minor children have been identified during the screening and selection process, then this is so stated in the final determination.
• If a Committee member has disclosed a relevant financial interest of less than $50,000 involving self, spouse, or any minor child (see Process for Selection of Committee Member Reviewers and Experts) and is asked to participate in a review in an advisory capacity, the nature of the conflict is summarized in the final determination.
• If the expertise of an outside consultant is required to facilitate understanding and decision-making of the voting Committee members, the nature of any relevant conflict(s) involving the consultant or the consultant’s spouse or any minor child is summarized in the final determination.

Additional information pertaining to conflicts of interest for each final determination is maintained and made timely available in response to public requests for a period of not less than 5 years after initial publication of the determination.