Outline

A U.S. based pharmaceutical company was developing and commercializing an innovative immune-oncology product. If the product is successful in the market, it will serve as a new cancer treatment. While they were working on product development, Solem were contacted for assistance in creating a Budget Impact Model (BIM) and the Academy of Managed Care Pharmacy (AMCP) Dossier.

Introduction

AMCP dossiers are an essential component of US health plans.

They are one of the first and most impactful ways for a pharmaceutical company to demonstrate the medical benefit and economic impact to managed care payers in the United States.

Image credit: https://www.amcp.org/

The Challenge

The client’s product had already been submitted to the FDA for approval in the case of this collaboration. Within a very short timeframe, a BIM and AMCP dossier were to be developed in parallel with the FDA review.

Although formal guidelines for AMCP dossiers exist, healthcare decision-makers will seek specific information about the disease and technology involved. This level of detail and relevance is particularly important in the case of orphan indications, rare diseases, and therapies with novel mechanisms of action.

Payers in the United States expect section 2 of a dossier (Product Information and Disease Description) to contain accurate and relevant information about real-world comparator therapies.

In section 3 (Clinical Evidence), they seek outcome measures that have an impact on the bottom line of the health plan.

The most important information in section 4 (Economic Model) is on identifying major cost drivers.

Solution

Solem conducted a literature search to identify additional key sources that could support the dossier, alongside the data resources provided by the client (e.g., investigator brochures, Clinical Study Reports). In addition, all data for the budget impact model were identified and gathered from appropriate sources.

Following that, a sophisticated economic model was created. The input parameters used in this model were flexible, so while it provided a base case view, it could also be adapted to individual questions and the circumstances of individual health plans.

Results

Solem delivered a comprehensive AMCP dossier after four months and two review rounds. We also provided a graphical interface for the final budget impact model, which was combined with a technical report. All reporting and documentation were done in multi-user, flexible applications. This enabled the client to keep up with and communicate new developments and details, as well as apply the format to future projects.

Another feature that added significant value to the client was the inclusion of a user guide as well as company training on how to use the model to maximise value.

Our client was able to communicate the value of the product to US managed care payers in such a way that:

• was consistent with the global value proposition
• was aligned with the specific needs of U.S. payers
• presented the information in a user-friendly and accessible format
• complied with the most recent AMCP dossier format
• met FDA requirements for balanced information and product claims

Furthermore, significant sections of the dossier are now multifunctional and contribute to the development of the Global Value Dossier.

Because of the BIM’s flexibility, it can be easily adapted to other healthcare environments, such as European markets, saving future costs and valuable resources.

If your organization is up against a tight deadline or is considering your BIM or AMCP dossier, we’re here to help. Click here to contact us about an urgent or upcoming project. We’d love to chat.