On January 18, 2017, the FDA released two draft guidance documents regarding communications concerning medical products. The first draft guidance, entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers,” contains a number of frequently asked questions and their respective answers. FDA broke the questions down into the following categories:
- Communication of health care economic information (HCEI) to payors regarding approved drugs
- Communications to payors about investigational drugs and devices (investigational products)
Communication of HCEI by Firms to Payors Regarding Approved Drugs
In this section of the draft guidance, the FDA provides a list of 11 related questions that are frequently asked. Some of these questions include the following:
What is HCEI, and how can it be presented?
According to section 502(a) of the Federal Food, Drug, & Cosmetic (FD&C) Act, HCEI is “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.” Furthermore, HCEI pertains to the economic consequences associated with the clinical outcomes of treating, preventing, or diagnosing a disease.
There are several ways that this information may be presented. These include, but are not limited to:
- An event dossier
- A reprint of a publication from a peer-reviewed journal
- A software package comprising a model with a user manual
- A budget-impact model
How does FDA intend to implement this guidance for HCEI disseminated in accordance with section 502(a)?
The draft guidance states that the Agency does not plan to consider information false or misleading if a firm “disseminates to an appropriate audience HCEI that is the type of information within the scope of section 502(a).” In addition, the document states that the following information should be clearly and prominently stated in the HCEI:
- Study design and methodology
- Sensitivity analyses
- Information relevant to providing a balanced and complete presentation.
If HCEI contains material that is different from the FDA-approved labeling, “a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug” must also be included.
What are the Agency’s policies regarding risk-sharing and other value-based contracts between firms and payors?
According to the FDA, “this guidance addresses the communication of HCEI to payors, which may include communication of HCEI in the course of discussions between firms and payors related to risk-sharing and other value-based contracts.” However, as the FDA does not regulate the terms of contracts between firms and payors, the draft guidance is not intended to address the topic.
Communications by Firms to Payors Regarding Investigational Drugs and Devices
In some situations, sponsors may wish to provide payors with certain types of information regarding their investigational products. The draft guidance provides several frequently asked questions and the appropriate answers regarding this type of communication. The questions included in this section are:
What are the types of information covered by this section of the draft guidance and what is FDA’s approach with respect to firms that wish to provide such information prior to FDA approval or clearance of an investigational product?
As long as it is unbiased, factual, accurate, and non-misleading, the draft guidance states that the Agency will not object to the following types of information provided by firms to payors prior to receiving FDA-approval:
- “Product information (e.g., drug class, device design)
- Information about the indication sought, such as information from the clinical study protocol(s) about endpoint(s) being studied and the patient population under investigation (e.g., number of subjects enrolled, subject enrollment criteria, subject demographics)
- Factual presentations of results from clinical or preclinical studies (i.e., no characterizations or conclusions should be made regarding the safety or effectiveness of the product)
- Anticipated timeline for possible FDA approval/clearance
- Product pricing information
- Targeting/marketing strategies (e.g., outreach activities planned to generate prescriber awareness about the product)
- Product-related programs or services (e.g., patient support programs)”
What other information should firms provide to payors when communicating information about their investigational products?
Firms should provide the following information concerning investigational products:
- “A clear statement that the product is under investigation and that the safety or effectiveness of the product has not been established.”
- “Information related to the state of product development (e.g., the phase of clinical trial in which a product is being studied and how it relates to the overall product development plan).”
Additionally, the FDA recommends that firms provide payors with follow-up or updated information as any previously communicated information becomes outdated.
What types of information would be considered inappropriate to communicate to payors about investigational products?
“Communications between firms and payors that represent that an investigational product is FDA-approved/cleared or otherwise safe or effective for the purpose(s) for which it is under investigation would not be appropriate.”
The Agency’s draft guidance includes several other questions and the accompanying answers. For additional information, view the FDA’s full document.