A Critical Link: What Medical Communicators Should Know about Preparing AMCP Dossiers

What role do medical communicators play in the world of health care reimbursement? 

In the United States, health care reimbursement and access is a complex process that involves multiple parties known as payers (or payors): insurers, national health entities, and other decision-makers. The goal is to provide effective health care to patients while also weighing the costs of drugs, devices, and procedures in order to develop plans for formularies.

Before making a determination on which products will be the most effective and provide the best value, payers often request Academy of Managed Care Pharmacy (AMCP) dossiers. These documents help weigh the clinical evidence and economic factors that determine which health care products will provide the greatest value. 

In addition, AMCP dossiers can be especially important for coverage of orphan drugs used to treat rare diseases.

Medical communicators play a role in this process by participating at various points, including preparing AMCP dossiers, which are the industry standard.

“Although writing and editing regulatory documents and publications are established roles for medical writers in the pharmaceutical industry, preparation of AMCP dossiers and other payer-related documents offers a new opportunity in medical communications,” write authors Linda L. Rice, PhD, and Jessie Wolfe Galson, PhD, in an AMWA Journal article.

What are AMCP dossiers? And what is the role of medical communicators in creating these important documents? 

The AMCP Dossier

The AMCP is a national society of managed-care pharmacists and other health care professionals in the United States. The organization developed the AMCP dossier as a nationally recognized guideline for structuring and organizing health care information. The format was developed to provide a high standard of objectivity and credibility to facilitate an open communication process between manufacturers and health care decision makers (HCDMs).

In the AMCP’s guiding document, The AMCP Format for Formulary Submissions, the organization describes the goals of creating a standardized format for dossiers. 

“First, it is intended to improve the timeliness, scope, quality, and relevance of clinical and economic information provided by manufacturers to HCDMs. Further, by assessing the health care system impact of using a product, the evidence requested can improve the HCDM’s ability to compare the effects of formulary alternatives on clinical outcomes, value, and economic consequences for the entire health care system. Second, the AMCP format streamlines the evidence acquisition and review process for HCDMs and health care system staff. By clearly specifying the standards of evidence implicit in the existing formulary process, the format furnishes pharmaceutical manufacturers with consistent direction concerning the nature and format of information that is expected. In addition, the standardized format allows health care system staff to formally evaluate the completeness of submissions received and to easily add the results of the HCDM’s own systematic literature reviews and analysis.”

AMCP dossiers are complicated and lengthy documents that can run between 30 and 100 pages, requiring literature evidence in most sections, including the disease description. Knowledge of data analysis is also needed to prepare the models.

The AMCP lists the following elements as content that may be included in a dossier for products before FDA approval:

• Clinical trial information from Phase 1, Phase 2, and Phase 3 studies 

• Peer-reviewed publications 

• Medical congress abstracts, posters, presentations

• Medical information or medical communication departments’ response letters

• Information from clinicaltrials.gov

• Preclinical studies

• Data on file per manufacturer’s discretion

• Disease state information, eg, disease description, epidemiology, clinical presentation, currently available therapies, clinical practice guidelines, etc.

• Pipeline product information, eg, proposed mechanism of action 

• Any other information that a manufacturer deems relevant to the request and allowable according to the manufacturer’s policies and procedures

• Some manufacturers may consider providing certain information under a confidentiality agreement 

Note: This does not preclude other information being included.

3 Types of Dossiers

The AMCP breaks down the dossier into 3 different types. 

1. An Unapproved Product Dossier compiles information on a pipeline product where a manufacturer is seeking, or plans to seek, FDA approval. 

2. An Approved Product Dossier includes information about a marketed product that has received FDA approval. It includes information on on-label and off-label uses of the product.

3. An Unapproved Use Dossier includes information about an unapproved use of an approved product. 

Why Is a Dossier Important?

The AMCP dossiers provide the information that payers need to decide which products are going to be most effective and cost-effective. Payers need dossiers to evaluate new drugs and to determine if or where they fit into their formularies. The dossiers tell the story of the products’ value, compiling the clinical evidence from trials on the products, the disease information, and their economic value. 

Creating an Excellent Dossier

In a presentation on AMCP dossiers at the 2023 AMWA-MAC Annual Conference, Iris Tam, PharD, FAMCP, spelled out considerations for creating a dossier that meets the needs of all parties. 

For example, it is important to identify consistent and citable sources of data, to determine which clinical trials to include, and to know and understand the science. Medical writers need to know the difference between good and bad studies. They should be able to critically analyze study design, data groups, and statistical tests, and capture the nuances of how data is represented in studies.

Dossiers often have page limits and format considerations. They require a clear, concise scientific writing style that mirrors a clinical publication. They should be written using a factual, objective tone, avoiding promotional or branding language. Writers should stick to the key points in the summaries. 

Here are some of the components of a good dossier, according to Tam.

• Accurate, relevant, and timely

• Comprehensive yet concise and user friendly

• Transparent with full disclosures

• Has logical structure and flow for the scientific and clinical audience

• Fully referenced using credible sources

• Uses scientific writing style and tone but avoids too much jargon because not all people who will read the dossier are scientists or physicians

• Has a neutral and objective writing tone 

• Includes the right number and type of high-quality references to build a compelling case for the product 

• Contains succinct summaries that let the data speak for themselves

• Highlights the main points of each study used

The Role of Medical Communicators

Medical communicators participate in creating AMCP dossiers by undertaking literature reviews, identifying and analyzing the quality and evidence and data for the content, drafting according to format, revising documents, and incorporating reviewers’ comments.

By bringing sound editorial judgment and scientific rigor to the complex system of reimbursement and access, medical communicators are helping address the challenges of providing effective medical treatments to patients who need them.