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President and chief executive officer of the National Psoriasis Foundation (NPF) Leah M. Howard discusses her article “Pharmacy benefit manager reform vs. direct drug plans.” Leah analyzes the recent emergence of direct-purchase drug programs and argues that while innovative thinking is welcome, it cannot replace the need for deep systemic change. She advocates for bipartisan legislative solutions such as the Safe Step Act to address the root causes of high costs in the U.S. health care system rather than relying on siloed fixes that may not help everyone. The conversation emphasizes that true relief for patients with chronic diseases requires transparent pharmacy benefit manager reform and a move away from profit-driven incentives that punish the sick. Join us to learn how we can push for lasting policies that prioritize patient health over corporate profits.

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Transcript

Kevin Pho: Hi. Welcome to the show. Subscribe at KevinMD.com/podcast. Today, we welcome Leah Howard. She is the president and chief executive officer of the National Psoriasis Foundation. Today’s KevinMD article is “Pharmacy benefit manager reform versus direct drug plans.” Leah, welcome to the show.

Leah Howard: Thanks for having me, Kevin.

Kevin Pho: All right. Tell us briefly a little bit about yourself and then the events that led you to write this article in the first place.

Leah Howard: Sure. As you said, I am Leah Howard, president and CEO of the National Psoriasis Foundation. I have been with the organization since 2012. The NPF is a really fascinating organization. We were started in the late 1960s in Portland, Oregon, by a woman who lived with severe psoriasis. At the time, there was no internet and no way for patients to connect with other people sharing the same challenges they were. She felt very alone and isolated. As a gift to her for her 30th birthday, her husband put a tiny ad in The Oregonian that just invited people to call this number to share information. From that, she got a hundred phone calls in the first week and realized there was a real need to connect people living with psoriasis and psoriatic arthritis to one another.

Fast forward nearly 60 years, and we are the largest nonprofit supporting psoriatic disease, really driving progress on behalf of this community of about 8 million people. I have enjoyed the opportunity to do that for many years. I am a lawyer by background and came here actually to head up our government affairs team. This article and this work that we are doing to really push for change on behalf of this community is work that is near and dear to my heart. It is really a key part of our current strategic plan, which has two goals: finding a cure for psoriasis and psoriatic arthritis, and optimizing the health of our community today.

Kevin Pho: Your KevinMD article is “Pharmacy benefit manager reform versus direct drug plans.” For those who didn’t get a chance to read your article, tell us what it is about.

Leah Howard: For about a decade, the National Psoriasis Foundation has been leading an effort across the country to improve access to therapies, in part through legislation that puts guardrails around step therapy. This is a very frustrating practice probably for both your clinician listeners as well as the patients they serve. For many people, the frustration of step therapy really comes from the fact that it is driving patients toward a therapy that might not be the most appropriate for them and might not be the one that their clinician thinks, based on their personal health history, they really should be using.

What we have been working to do in partnership with others is to bring this common-sense reform first at the state level and now at the federal level to patients. Through that legislation, we want to put some guardrails, an exception process, and some timelines around the use of step therapy. The legislation at both the state and federal levels doesn’t ban the practices but really gives both patients and providers the guidance on how to work within a step therapy protocol to get the patient on whatever therapy they think is best.

We have been pushing that work at the state level for about 10 years and at the federal level now for the last several. We had a lot of really good progress last year. That legislation actually got folded into the Senate version of pharmacy benefit manager reform, which was exciting to see. But of course, we got to the end of the Congress and the end of the calendar year, and that bill didn’t pass. So we have gotten the legislation reintroduced, and our advocate network, which includes both patients and providers, has been working to share information about the value of this bill with federal and state policymakers.

What caused me to write this article was that earlier this fall we also started seeing some discussion, both by individual pharmaceutical companies as well as the current administration, around making more products available directly to consumers. From our perspective, anytime there are barriers standing between patients and providers that actually prevent them from getting patients on whatever treatment they think is best, that is frustrating. We started watching the conversation that was happening nationally around these direct-to-consumer offerings and noted that there really weren’t any patient voices that were a part of that process or speaking out on this topic. I thought this was a really hot issue, and this should be something that the patient voice is represented in. I saw an opportunity here to both comment on these offerings as well as just remind people that as we consider new solutions like this, there are other solutions out there that have been studied and talked about for the last several years that ought not to be forgotten.

Kevin Pho: For those who aren’t familiar with psoriasis treatment and the various options, give us an example of what step therapy would be, and then give us some examples of some of these direct purchase drug programs that we are talking about. Just for those who aren’t familiar with the various medications and treatments we are talking about here.

Leah Howard: Absolutely. Psoriasis and psoriatic arthritis are chronic, systemic, immune-mediated diseases. When someone is diagnosed with one of those, that is a diagnosis that they will now live with for the rest of their lives. There are about 8 million people in the U.S. impacted by psoriatic disease. Because it is a disease that presents in different ways for different people, some people have more mild forms of psoriasis. For them, it may be appropriate to take a topical therapy. For those that have more disease coverage—more places on the skin, more prevalence of the disease, or disease in those harder-to-treat areas or more sensitive areas like the face, genitals, hands, or feet—a more aggressive agent would be appropriate. That would be something that would be consumed inside the body, either injected, infused, or ingested.

Those would be biologic agents, which are typically the most well-known systemic therapies. Most folks tell me they can’t turn on their TV and not see a commercial for a psoriasis or psoriatic arthritis drug. It is really amazing how far those therapies have come in the last 20 years since they were first approved. Typically what happens is a patient will work with their dermatologist or their rheumatologist to get that diagnosis of psoriasis or psoriatic arthritis. Then that specialist will say you really need to be on a systemic agent, something that can work from the inside of the body out to reduce that inflammation and prevent permanent joint damage, which does occur with psoriatic arthritis. So they would prescribe one of the more than a dozen biologics that are available in our space.

Typically what happens is that because of the business agreements between pharmaceutical companies and health insurance companies, that health insurer will come back to that physician and say: “These are the therapies that that patient may access that are preferred for that patient based on their health insurance plan.” The physician might want to go with one therapy, and the health insurance company is saying no, you need to use this other one instead. So they have to put that patient on that therapy and see how they do.

I think the challenge of this practice is that not every patient is the same, and not every treatment works the same. For a variety of reasons, a physician or a prescriber might think that one treatment is going to work better or be more appropriate for that patient based on their personal experience with the disease and their overall health history. What we have been doing with these step therapy bills is really working to put in those guardrails that enable the prescriber to work through the system if something, for whatever reason, does not make sense for that patient to take.

Over the last few months, a number of companies, as well as the federal government, have announced these direct-to-consumer options where patients will be able to work directly either through the company or through TrumpRx to purchase one of these therapies. I think there are still a lot of question marks as to how exactly that will work, how the patient’s provider will be kept in the loop, how their pharmacist will be aware of the patient taking that therapy, as well as how the cost-sharing will work for patients, which is always an issue. There are still a lot of question marks about that process that we will be waiting to see unfold in the coming months as those are rolled out.

Kevin Pho: Just so I am clear, what is proposed is that patients can now directly purchase some of these biologics, bypassing the drug plan and the physician. So presumably they would have to have a prescription from a physician, but they would be going outside of their plan and outside of the specialty pharmacy that has a contractual relationship with their health insurance company. From the perspective of the patient, what are some of the risks of that approach?

Leah Howard: We have been getting a lot of questions, not surprisingly, from our patient community about how these would work. I mentioned one of those questions: What will happen with my out-of-pocket costs? Will this count against my deductible? Those sorts of things. How will my pharmacist be kept in the loop? There is certainly a question about when people are taking two different therapies, how those therapies might work together inside that patient’s body. For our patient community that has a number of comorbidities, it is really important that they are sharing with both their health professional as well as their pharmacists all the different treatments that they are on so that there is no worry about contraindications or any adverse events because they are taking more than one therapy.

I think there are a lot of practical questions about how this will happen in practice. At the end of the day, our role is to really try to drive a conversation forward that is going to be about how we can support some of these system issues. While this is a big issue for our community, it is also going to impact many other chronic disease communities and is really emblematic of the fact that there are a number of challenges happening right now for patients living with chronic disease within this health care system. I think there is an opportunity for us to really put our heads together to think about better ways to deliver care.

Kevin Pho: Where are we legislatively in terms of that approach, and how likely is it to come to fruition?

Leah Howard: The Safe Step reform legislation that I mentioned has been reintroduced at the federal level earlier this year in both the House and Senate. I would encourage your listeners to contact their members of Congress and share more about their experiences with step therapy and how it has impacted their patient communities. We are hopeful that that legislation will move forward in this Congress. We have had unbelievable support over the last few years for that bill and have had that legislation passed in more than two-thirds of states at the state level.

As we all know, health insurance is a little complicated regarding who has oversight of that. For marketplace plans, it is states that have that oversight. That is why it was important for us to pass the state bills. Now at the federal level, for folks that get health insurance through their employer, we would like to see those same protections extended to that community as well. That is why the federal bill is now pending.

Kevin Pho: For those who aren’t familiar with the Safe Step Act, just give us some of the highlights and specifics that the bill contains.

Leah Howard: Absolutely. The two most important things to know about the bill are first that it puts in place a set of exceptions. It outlines five exceptions that a provider can identify as appropriate for that patient to get around the step therapy protocols within their plan. Those could be things like the patient has already tried and failed on that therapy under another plan at another point in time, or that the required therapy is contraindicated for them, maybe because of other health history. So a set of five exceptions is the first part of the legislation.

The second part is the timeline. What it does is put in place a required timeline by which an insurance company will make a determination of whether that patient can get onto the requested treatment. So 72 hours in typical cases and 24 hours in emergency cases. This is important because, as I said, these are chronic diseases that are covered by these protocols, and it is critical that we not have a delay between when a patient is seen by a health care professional and when they are ultimately able to begin a treatment. That 72 or 24 hours ensures that that patient and provider have the opportunity to get that determination and make a decision about how to move forward.

Kevin Pho: So if this bill passes, in effect, it will allow the prescriber to directly prescribe biologics to those with psoriasis without getting any pushback saying, “Hey, you have to try this and this and this first.” Right?

Leah Howard: That is exactly right. And it is not specific to the psoriatic disease drugs. It really covers all of the therapies that a plan might be using these step therapy protocols in. That is why the NPF has been working in coalition with about 150 other organizations on these bills across the country over the last 10 years. I think there are a number of communities that are really challenged by these utilization management step therapy protocols. This would bring relief to many, many individuals living with chronic disease.

Kevin Pho: Where do you see the foreseeable future going forward? You have the potential passing of the Safe Step Act, and then concurrently you have these direct drug plan models. So what do you see the future hold when you have these two competing pathways going forward?

Leah Howard: We are incredibly optimistic about the future for our community and so many others living with chronic disease. I mentioned the amazing scientific progress that has happened over the last 20 years. When I talk to people in our community that were diagnosed with their psoriasis or psoriatic arthritis in the eighties or nineties, they talk about the frustration of not having options, not being able to manage their disease well, and really living with the shame and stigma associated with that.

In 2002, the first biologic was released in psoriatic disease, and it was a game changer. Now, more than 20 years later, these therapies are incredibly safe and effective and do amazing things for this community. In fact, for someone, almost regardless of how extensive their psoriasis is, they can get today to clear or almost clear skin, which is just phenomenal. Their psoriatic arthritis can be really well managed as well. So from a scientific standpoint, we are unbelievably hopeful about the future with patients being able to access and well manage their disease.

On the other side, I think our community really serves as a warning to other disease communities about the challenges of accessing treatments. All the scientific progress in the world doesn’t mean anything if at the end of the day people are not able to get on those therapies and use them. That is why our second goal focused on optimizing health is really centered around those barriers and those pain points that clinicians and patients face when it comes to getting individuals on these amazing life-changing therapies that are available today.

Kevin Pho: So it sounds like whether it is through the Safe Step plan or these direct purchase initiatives, it sounds like these biologics are going to be a little bit easier to access going forward for those with chronic conditions.

Leah Howard: We are certainly hopeful that is the aim of our organization and of the patients and clinicians that engage with us in our advocacy efforts. There should be no reason why all this great advancement is not ultimately available to the end consumer at the end of the day.

Kevin Pho: We are talking to Leah Howard. She is the president and chief executive officer of the National Psoriasis Foundation. Today’s KevinMD article is “Pharmacy benefit manager reform versus direct drug plans.” Leah, let’s have some takeaway messages that you want to leave with the KevinMD audience.

Leah Howard: The main thing that I would say is, as I said, it has been an amazing time of progress in psoriatic disease and so many other chronic diseases. If your listeners are not engaged in advocacy around these issues, or if they are not familiar with the success we have had at the state level in getting step therapy bills passed, I encourage you to visit psoriasis.org to learn more about our work and to get involved. We would love to have you engaged in our efforts.

Kevin Pho: Leah, thank you so much for sharing your perspective and insight. Thanks again for coming on the show.

Leah Howard: Thanks for having me.