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 AHFS Oncology Expert Committee members are required to complete disclosure forms listing direct and indirect financial interests that are relevant to matters considered by the Committee for themselves, their spouse, and any minor children upon appointment to the Committee and at least every 3 years thereafter. In addition, prior to each off-label use review, those Committee members selected to participate in the review are required to update this disclosure information 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, as well as any outside experts (consultants) used to facilitate understanding and decision-making of the voting Committee members, 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. Committee members are selected on a rotating basis to participate in reviews of off-label oncology uses. However, at the discretion of the AHFS staff, specific individuals may be selected based on their area of expertise. Prior to each off-label use review, the AHFS staff screens Committee members’ current disclosure information and selects individuals who do not have direct or indirect conflicts of interest involving themselves, their spouse, or minor children that relate to the specific off-label use being reviewed. When the disclosures are evaluated for potential conflicts, interests or affiliations involving the sponsor of the drug under consideration, a potential competitor, or an affected firm or organization are all considered. An interest is considered relevant if the Committee’s decision on medical acceptance of the off-label use has the potential to result in a direct and predictable impact on the interest.
- Committee members are not allowed to participate in the off-label determination process if they have disclosed relevant direct or indirect financial interests involving themselves, their spouse, or any minor child that have a combined value exceeding $50,000.
- Committee members who have disclosed relevant direct or indirect financial interests involving themselves, their spouse, or any minor child that have a combined value of less than $50,000 are not asked to serve as reviewers. However, if the Committee member’s expertise is deemed to be required, the AHFS staff determines the merits of using the Committee member in an advisory capacity to provide expert review of the subject matter. The AHFS staff may decide to grant a waiver permitting the Committee member to participate in an advisory capacity, but the Committee member is not permitted to participate in the review of clinical materials or in the voting process.
- Committee members who have affiliations with a sponsor or organization (i.e., consultant, speakers bureau) that are relevant to the 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. If the Committee member’s expertise is deemed to be required, the AHFS staff determines the merits of using the Committee member in an advisory capacity to provide expert review of the subject matter. The AHFS staff may decide to grant a waiver permitting the Committee member to participate in an advisory capacity, but the Committee member is not permitted to participate in the review of clinical materials or in the voting process.
- AHFS may choose to use an outside expert (consultant) to facilitate understanding and decision-making of the voting Committee members, especially in cases where there is a lack of expertise amongst the existing Committee members. Consultants do not participate in either the review of clinical materials or in the voting process.
- Availability of Information on Financial Disclosures and Conflicts of Interest
- 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 participate in the development, review, or disposition of an off-label oncology determination of medical acceptance is published in the Final Determination report for that off-label use.
- If no direct or indirect conflicts of interest 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 or a relevant affiliation (see Process for Selection of Committee Member Reviewers and Experts) and the individual was granted a waiver permitting participation in an advisory capacity, the nature of the conflict is summarized in the Final Determination.
- If the expertise of an outside consultant is required, the nature of any relevant conflict 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.
