New Formulary Decision Making Tool Shows Promise in Study; Falls Short in Real World
By Mia Burns
The National Pharmaceutical Council has released a study that details new work in in developing, testing and piloting a more structured approach to formulary decision making. Transparency in Evidence Evaluation and Formulary Decision-Making discusses efforts to increase the clarity, consistency, and transparency of how evidence is applied by payers during the formulary decision making process. During the project, the new approach was evaluated in a pharmacy and therapeutics, also known as P&T setting.
Pfizer sponsored the project in part, and NPC conducted and completed it with Cerner Research and other research experts in three phases. The first step was leveraging a panel to create an evidence assessment tool based on the core elements of formulary decision-making: safety, efficacy, cost, and certainty of evidence. Next, the evidence assessment tool was validated by surveying a larger group of medical and pharmacy directors. Finally, the tool was piloted in a real-world pharmacy and therapeutics environment.
Although the survey responses from the validation process with medical and pharmacy directors indicated that the tool could increase clarity, consistency, and transparency in formulary decision making, the tool did not hold up during real-world pilot testing. Participants in the pilot testing portion of the project indicated that the tool did not capture the dynamic and complex variables involved in the formulary decision making process, and therefore would not be suitable for more sophisticated organizations.
“There are two theories,” says Chief Science Officer, Robert Dubois, MD, PhD, National Pharmaceutical Council, who is also a study co-author. “First, the tool was not sophisticated enough to incorporate all of the issues payers need to make a decision. Perhaps the inclusion of additional factors to the tool might address that concern, and an enhanced tool might lead to greater clarity, consistency, and transparency of formulary decision making. A second theory suggests that no formal tool would be acceptable because they do not wish to precisely define what drove the decision (e.g., the factors, their relative weights, and the distribution of views among the committee). We do not know which theory is most operative.”
Dr. Dubois also told Med Ad News Daily, “Some organizations develop their own drug summaries based upon literature reviews that they perform. Large national payers or PBMs have sufficient staff and expertise to conduct them. These would be the more sophisticated groups. Other organizations that don’t conduct their own assessments may contract this support service to others, utilize materials developed by others, or have less available staff or expertise. This latter group has less sophistication in this arena.”
A bit of “black box” currently exists around the decision making process, according to Dr. Dubois, and this has led to decisions about treatment access being unpredictable to patients, providers, and biopharmaceutical manufacturers. The researchers set out to identify ways to clarify the process.
“Formulary committees may not want to make public the factors that drove their decision to include/exclude a drug on formulary, or the rationale for the tiering, or the need for other medical management oversight,” Dr. Dubois told Med Ad News Daily. “To our knowledge, most all P&T committees in the non-governmental space hold closed meetings and detailed proceedings, or transcripts are not made available to the public.”
In addition to its previous research on how payers assess evidence, NPC is continuing to explore ways to enhance the processes used to evaluate evidence. Specifically, NPC is working with the Academy of Managed Care Pharmacy and the International Society for Pharmacoeconomics and Outcomes Research on a joint project called the CER Collaborative Initiative to provide greater uniformity and transparency in the evaluation and use of evidence for coverage and healthcare decision making. The CER Collaborative is developing a user-friendly toolkit and training materials to help increase decision makers’ awareness, understanding, and confidence in their abilities to critically appraise individual studies and synthesize the evidence from a variety of study methods to guide formulary decisions.
Posted: August 2013