Cost-containment balanced with appropriate patient access to commercially available medicines are key priorities for US managed care decision makers. Health plan drug formularies are designed to ensure that medicines available to their members are safe, effective and affordable. Management of drug formularies by Pharmacy and Therapeutics (P&T) or Formulary committees across health systems however vary based on the heterogeneous health care delivery models in which they serve, admittedly in a disparate and often fragmented system. The debate regarding inclusion of a drug on formulary can be contentious and will vary both within and across Formulary committees given packed agendas, limited time and limited resources. In fact, insufficient time and information have often led to “subjective, unsystematic, and incomplete” (Schiff et al, 2012) discussions at the P&T thus raising the question as to what the most efficient way is to provide the storyline and data to these committees.
Shortly after the FDA modernization act of 1997, the Academy of Managed Care Pharmacy (AMCP) introduced the AMCP dossier template to facilitate the exchange of information from manufacturers to payers. This included information beyond the label and later as a method to standardize a consistent process to respond to payers’ requests with the information they needed to evaluate products for formulary decisions as well as to educate prescribers and patients within the plans.
Clinical pharmacists within health plans are typically responsible for summarizing information and distilling the AMCP dossier into a brief monograph that is used for Formulary committee-level decision making. The AMCP dossier is one of the primary sources of information used to prepare the monograph that is used at the Formulary committee for policy setting. The process of distilling the AMCP dossier into a brief storyline (i.e., a brief monograph) to be discussed at the P&T can take days to weeks.
In a time and resource constrained environment a key question to consider is whether this is the most efficient mechanism for information exchange and decision making.
In an effort to answer this question, in-depth phone interviews with 10 US managed care representatives (6 Pharmacy Directors and 4 Medical Directors) (“payers”) were conducted with representation of national, regional and integrated health plans across the U.S. Importantly for exploration of this question, 9 of the 10 payers interviewed were Pharmacy and Therapeutics (P&T) committee members for their respective health plans. The current usefulness, benefits, and challenges of AMCP Dossiers in health plan decision making and explore unmet needs, gaps, and potential alternatives including a novel, interactive evidence dossier prototype as an alternative to the AMCP dossier were explored during the interviews.
Payers thought the current AMCP dossier contained too much information in some cases and was also missing key information in other cases. This, in and of itself, lends decision making difficult and time consuming at best.
There was a consistent message from the payers that the information they needed for decision making should be more comprehensive but at the same time there was a need for more ease of use. Finding new data or updates to data was also a key pain point for payer decision making using the current AMCP format. There was agreement across the payers that having the ability to quickly navigate to these updates would be useful during their review process.
If there was an avenue for effectively eliminating some of the review burden within the plans providing objective, systematic and complete tools for assessing medicines at the Formulary committee then limited resources could be better utilized. During the in-depth phone interviews, payers were presented with an interactive evidence dossier prototype designed to communicate content using integrated interactivity and multimedia capabilities to facilitate powerful scientific story-telling. Given their responses pertaining to the unmet needs with the current AMCP format, not surprisingly, all payers liked the interactive design of the prototype and the ability to easily find information and ultimately would provide an improved user experience.
The important point though is would this newer interactive dossier be more useful within the health plans.
All payers surveyed indicated that the interactive evidence dossier prototype was more useful than the AMCP dossier.
All payers interviewed stated that this new type of dossier would be useful in their plans given the ability to incorporate RWE and direct connection of publications from study information. Several payers noted the ability to find specific information easily and quickly was helpful. Others noted the ability to easily copy and paste tables, figures, and information into Formulary committee monograph templates as useful features.
The interactive evidence dossier alternative resonated with the payers surveyed due to its interactive design, functionality, and ability to easily find relevant information needed for Formulary reviews. One of the most important insights with the novel, interactive evidence dossier prototype was that it has potential to be used directly by Formulary committee members.
As a P&T committee member I rarely use the AMCP dossier directly, it is one of many resources used by clinical pharmacists to summarize evidence presented to P&T.
[Prototype] is a 21st century tool that I would welcome using as a direct resource.”– MD C
In a time and resource constrained environment, with a multitude of new therapies coming to market, the most efficient mechanism for information exchange with a storyline tailored for decision making is critical for Formulary committees. Having the ability to potentially bypass the internal processes of distillation of the AMCP dossier into a brief monograph but rather to go straight to Formulary committees may be the most efficient way to support robust decision making.
Schiff GD, Galanter WL, Duhig J, Koronkowski MJ, Lodolce AE, et al. (2012) A Prescription for Improving Drug Formulary Decision Making.
PLoS Med 9(5): e1001220. doi:10.1371/journal.pmed.1001220
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