The Pharmacy and Therapeutics Committee Revisited: Transparency in Focus

The American Journal of Pharmacy Benefits, September/October 2016, Volume 8, Issue 5

The role of Pharmacy and Therapeutic committees in formulary creations raises concerns.

I usually catch up on my reading during airlines trips. It is a time I am not disrupted and can concentrate. During a recent flight, I came upon an August 2016 article talking about Pharmacy and Therapeutic (P & T) committees and their role in formulary creation.

Throughout my career, I have lead P & T committees for 3 organizations. Because of my past experience and my ongoing consulting roles that focus on pharmacy, I took particular interest in this article. I found several intriguing points associated with the article and thought that it was a good time for us to take an updated look at these committees and their role in today’s pharmacy decision making process.

What Is the Committee and What Does It Do?

I assume that most people reading The American Journal of Pharmacy Benefits

®

know what a P & T committee is. Regardless, let’s take a moment and set the foundation. At a high level, all of these organizations do similar things: they evaluate medications and help to create a drug list that will be utilized by an organization.

There are some nuances and differences that can be found across committees depending on a number of things, such as who the hosting organization is (hospital, provider group, health plan, or pharmacy benefit manager) and the population they are deciding on behalf of (Medicare, Medicaid, or commercial). The size of the P & T committee and the credentials of those on the committee also vary.

Who Is on the Committee?

One of the biggest controversies associated with a P & T committee is whether there should be transparency associated with its membership. In the early 1990s when I initially sat on, and then lead, the P & T committee for a health plan, all the members of the committee where known by those outside of the committee.

There was full transparency of the membership and each member’s affiliation. At that time, members of the committee were regularly contacted by a number of special interest groups trying to persuade them to decide in favor of their products. This was very disruptive to the individuals and created concerns over potentially inappropriate relationships between the decision makers on the committee and the manufacturers.

Over the years, transparency of membership within the P & T committee has changed. Today, for the most part, the membership names and affiliation are shielded by others outside the committee. This was the bone of contention found in the article that I was reading and had recently being voiced by a number of individuals and organizations.

The belief of those asking for full membership disclosure is that these are people making important decisions that affect millions of lives, and they believe that people should know who is making these decisions, as well as their credentials, giving themselves assurances that there is no bias involved in their decision making.

You may wonder, “Why the secrecy”? I can understand why people may ask that question, especially those that do not have all of the facts or understand the historical experiences that have occurred. There is actually very good reason for the identities of the committee to be guarded. Through my past experience, as well as the experience of others, when P & T committee members’ names are made public, manufacturers, advocacy organizations, and others market and lobby these people on a regular basis. All of us are looking for thoughtful decision making, free from pressure of those that may have any number of biases.

In fact, the need for withholding names achieves the goals of those who are asking for transparency. What I would suggest is that P & T membership be transparent in terms of credentials. This could help the public, and anyone that cares to know, that the individuals making the decisions regarding drug formularies come with broad-based expertise. I would also suggest that an ethics expert and someone representing the consumer be included on all P & T Committees.

How Does the Committee Make Decisions?

This article that I read asked not only for membership transparency, but also for transparency of the process used by the P & T Committee to make its formulary decisions. This is an area in which I agree with the article. The need to keep the membership of the P & T committee helps to assure a fair and balanced decision-making process, just as long as the process itself is fair.

Committees making formulary decisions for Medicare Part D plans have a process they need to follow, as set out by regulation. I believe that this model is one that should be utilized regardless of population that is served. Historically, members of P & T committees focused on the safety and efficacy of the medications they were reviewing. However, over the last several years, many committees have begun to look at cost and value in addition to the clinical attributes of a drug. I don’t have a problem with this just as long as the models are well articulated.

I think that we would all agree that drug formularies can have a significant effect on the populations they cover. Therefore, who makes the decisions, and how those decisions are made, becomes very important. I know that it does not help those that are asking for greater transparency on all parts of the process, but I will say that the organization where I led the P & T committee for 10 years was one that I had a great deal of faith in.

The membership was diverse and we had an ethicist and a decision making model that was replicated across our Medicare, Medicaid, and commercial populations. As someone who was covered by this formulary, I can say that I felt safe that everything was done right. A report by the National Association of Insurance Commissioners expressed the desire for state commissioners to examine the P & T Committees within their states and identify issues surrounding transparency, conflicts of interest, and written documentation of decision-making process. In theory, this should not be an issue.

My concern is that consistency in process does not necessarily occur nationally if the regulations or decisions are at a state level. I think we need to stop for a minute, take a step back and ask the following: what are we looking to accomplish? Is it to have all medications available to all consumers or is it to have medications that have been shown to be safe, effective, and of value?

We are entering a time where we are more and more focused on value. I believe it is time for value to be part of the formulary decision-making process. That is where the transparency model needs to focus.

What do you think?