Let’s Talk Step Therapy

Shiva: My name is Shiva Mozaffarian and today we’re here for a discussion about the current state of step therapy reform. Step therapy can be a factor in obtaining treatment choices for psoriasis and psoriatic arthritis. Leading this discussion will be guest moderator, Jason Harris, Vice President of Government Relations and Advocacy here at the NPF who oversees both federal and state advocacy activities. Jason will be joined by Sam Cox, our State Government Relations Manager who addresses policy change in 17 states in the Central Region of the United States, along with Sarah Buchanan, Director of Federal Government Relations and Health Policy. Welcome all and thank you all so much for being here today. Jason, if you’d like to start the discussion?

Jason: Absolutely. Thank you and thank you to Sarah and Sam for joining us today to talk all things step therapy. So we're just gonna jump right into it. Sam, why don't you give us a good definition, a good baseline of what is step therapy?

Sam: That's a good question, Jason. Step therapy is an insurance protocol that requires patients to try and fail treatments selected by an insurance company before granting coverage for the treatment that was originally selected by the patient and the provider.

Jason: Alright, thank you, Sam. So sometimes it's getting in the way of getting care or treatment to the people that need it. And Sarah, so this has been going on for the better part of a decade, almost, I think when we date back to it. As we look back and then we'll get to where we are now, what were some of those initial efforts on step therapy reform like and how did they begin?

Sarah: Yeah, so the NPF worked with a couple organizations to start the step therapy reform campaigns in states. Started off pretty slowly with a couple states here and there. But then over time, I think it gained a lot of momentum. State lawmakers saw a lot of value in these bills and honestly, the number of insurers practicing step therapy increased as well. Ultimately the patient community and the provider community have come around and aligned on model legislation and now we have a pretty sophisticated operation going where patients and providers are working together to try to pass the state laws in every state.

Jason: Excellent. So it really started with a few states and it's bubbled up to the point where we are now. We have federal legislation which we'll get to in a little bit. But first, Sam you focus a lot on our state advocacy program and working these bills across the country. So what do some of these state-based step therapy reform laws do? What are we advocating for here?

Sam: First, let me point out that these state-level bills are not bans on step therapy protocols, instead they place guardrails or parameters in which those protocols must be based. Also, it's important to note that there is significant variation in the state bills, but generally the ideal law does 3 important things. First, it establishes clinical review criteria or clinical practice guidelines upon which any step therapy protocols must be based. This is what the intention that any protocols are rooted in some scientific or medical reason. Secondly, it establishes an exceptions process. These are sometimes referred to as overrides or exemptions, but the exceptions process outlines the circumstances in which an exception should be granted. Those again can vary from state to state, but generally include if a drug is contraindicated, if it's expected to be ineffective, if the patient has tried and failed it, if it's not in the best interest of the patient, or if the patient is already stable on that. And then finally, it sets a time period in which the exception requests must be granted or denied. Generally speaking, that’s 72 hours or 24 hours in an emergency situation or circumstance. And that's an overview of what these state bills do to help people get to the medicine that their providers recommended.

Jason: All right, so we're not banning step therapy, common sense guardrails, reasonable exception, process for time. That all sounds really good. So where are we, how many states have passed some type of step therapy reform over the last 6 to 10 years?

Sam: Yeah, so the first bill passed in Kentucky in 2011 or 2012. We’re up to 36 states. Last year, we added Tennessee, which was a big win, as well as Colorado, and Massachusetts. So 36 and obviously a goal to get all states.

Jason: And you mentioned Kentucky because that's where you're from as the first one.

Sam: Well, I will say this, it is where I'm from. It also had the first bill and last year there was actually a bill that strengthened the existing original law that makes it one of the strongest in the country. So it's worth noting.

Jason: Alright, shout out Kentucky. Well, switching gears to federal, so Sarah, you live and breathe this every day. You lead a coalition of more than 260 organizations, I believe with the Safe Step Ad Hoc Coalition, is that right?

Sarah: 215 organizations but we'll get to 260.

Jason: Alright. Well, we can start with 260 by the time this comes out. So if we have passed reform in the states and Sam outlined what they do, why is it that we need a federal bill? Why is that so important?

Sarah: Yeah, that's a really good question. So the state bills apply to state-regulated insurance, which are usually the plans on the marketplaces. Employer plans are exempt from state laws. So even if you've passed a bill in a state like Kentucky, the people with employer insurance, which is a lot of Americans, don't have the protections in that state that Kentuckians with state-regulated insurance like individual or small group marketplace plans do. So we need to pass a federal bill to cover people in employer plans, which again are exempt from state laws. So the federal bill looks exactly like the state bills. It was based upon the model legislation that patients and providers came around to align behind. And so we're trying to pass that on the federal level. It's been introduced in both the House and the Senate, and we're doing our best to get it past the finish line.

Jason: Alright, thank you, Sarah. Yeah, we'll have some more updates too on current events as we continue to move forward. But back to you Sam. So when we're thinking about educating folks from our community and get them involved in this process whether that's passing a bill or now looking at what the implementation is like on bills that have been passed, what are some of the things you look for? What are some of the things that you do across the country?

Sam: Education is a substantial part of what we do. Educating advocates, educating legislators, and their staff. What is step therapy or utilization management overall? How it affects people and what they can do, passing a law about it to fix it. So our regional structures here at NPF are state teams divided into 3 regions. We have a great structure for regional advocacy committees, and those committees are robust. All are welcome. Great patient advocates that offers us the opportunity to talk about these policy issues in detail or the personal experiences of those patients with the step therapy protocols, which is all too common. So our education is about committee meetings, advocating, there's also always an appetite to speak with state legislators (state reps, state senators) and so there's education leading up to those communications about the legislative process as well as the step therapy reforms. So robust all around.

Jason: Community, bring them together and we'd be remiss if we didn't also mention individuals living with psoriatic disease and their family members, caregivers have been tremendous advocates, and we like to try and pair those with the provider perspective. So, dermatologist, rheumatologist, right. Anyone who has a stake in this process with respect to healthcare in general, but especially in step therapy reform.

So Sarah, kind of the same question to you, when you're looking at this from a federal perspective. What are some of the things you're looking for? We bring folks to Washington, DC for Capitol Hill Day. What are some of the things that you think are important?

Sarah: Well, first off, I like to say that any state-level advocate should participate in our federal advocacy as well, because we're tackling the same issues just for different sets of insurance plans. So anyone interested in advocacy that's operating on the state should definitely think about joining our federal work as well. When we're training advocates, we do try to make it easy for you just as Sam said to try to give them information, to have discussions with you, and teach you how to share your story. And I think a lot of patients teach us about these issues, patients, providers, and caregivers, by sharing their experiences and their stories with this as well. When we're working with advocates, that's really what we try to focus on. They don't have to be experts on the policy when they're talking with legislators. They don't even have to say everything perfectly. I never do. But having patients, caregivers and providers share their stories about how these issues impact them is really what I've seen as effective in getting legislators to cosponsor the bill, which means to publicly support the bill and try to get some committee attention to advance this legislation on the federal side.

Sam: Let me jump in on that Jason and just say that I agree with Sarah that any advocate who is just working with state should consider working on the federal and vice versa. I think the two really do prop each other up.

Sarah: Yeah.

Sam: There are several instances where a state delegation can be influenced by their federal counterparts and vice versa. So I think that is an important distinction that the two prop each other up and are equally important.

Jason: Absolutely. And as you both mentioned, the personal stories, the experiences that folks face when dealing with these problems are I'd say the highest percentage in what moves the legislator's mind or the staff's mind to end up really showing support for that issue. So no one has to be an expert on what those four or five exceptions are for step therapy reform. It's great to know, but that's not the point of what we do for advocacy or whether it's an individual or a doctor who's coming aboard to support this type of campaign. That's for Sarah and Sam to figure out and they can talk with the legislators. The important part is letting them know how this technique or this protocol is harming an individual or a health system like that.

So, Sarah, we've kind of gotten into a little bit about this, but how important are the state efforts and successes we've seen to current federal efforts underway?

Sarah: The state efforts are extremely important. First of all, the federal bill wouldn't exist without the state bills having been successful first. And like I said, the federal bill is really based upon our best learnings from the state efforts. Secondly, it's a lot easier to get legislators on the federal side to co-sponsor a bill if they know that their state passed a similar law, because they can look at that and see that they have a lot of support in their home districts and states for the federal bill because their state has already passed it. And then the third thing is a lot of implementation work on the state level raises awareness about these issues and the potential solution. And so those are all potential advocates and people that can then advocate their federal delegations to pass it too, so that these protections can be extended to people on the employer level. So I love my collaboration with Sam. He's an excellent colleague and I love seeing it when state and federal teams and state and federal advocates work together or even sometimes the same people, because that back and forth is so important.

Jason: Excellent.

Sarah: Sam, do you wanna talk about how great your collaboration is with me?

Sam: There's no better colleague than you, Sarah. I enjoy working with you, and I'm excited to see all the good stuff percolating on the federal level related to the bills you're working on. I think it's an exciting time.

Jason: Well, let's keep going with that. Sarah, why don't you give us a quick update? Where do we stand on the federal bill right now?

Sarah: So the federal bill was first introduced on the House side in 2017, introduced on the Senate side in 2019, both bills on the House and Senate side got reintroduced this year. The exciting thing that's happening this week and next week is the Senate HELP Committee announced a markup on May 2nd. I know that our champions are pushing to include the Safe Step Act and the HELP Copays Act in that markup. And so the patient and provider communities have teamed up and are going as hard as we can to try to advocate with our senators and get our grassroots going and our lobbyists emailing staff to try to be included in that markup. Just to back up real quickly, a markup is a meeting that the committee holds to edit and pass the bills out of committee and that's really the first step where these bills can start advancing. So once, if the Safe Step Act advances on May 2nd, that's a huge step for this bill. It's never had this kind of opportunity on the federal level before, so we're really gearing up for it and hoping we can be successful on May 2nd. But even if we're not, all these efforts have served a lot to raise awareness of the Safe Step Act among Help Committee members and Senate members. So if we're not included, we're still gonna try to do all the things, we're gonna try to get all the senators to co-sponsor the Safe Step Act. Same on the House side and keep pushing it through the process.

Jason: Appreciate that. So we will reconvene at some point to provide an update on where we are, although I'm sure all of our audience members are already signed up for our alerts and updates in advocacy anyway. But to that point, this is a bill that is truly bipartisan. We see that from who has supported it federally in the past. It's very even, Republicans and Democrats. More than half the country has passed legislation to reform step therapy. So just between those two kind of data points, you can see that this is something that really is bipartisan and it's nice to see in our climate today.

Sam, we're going to wrap up here just talking a little bit about the importance of involvement from our community, patient advocates, caregivers, and again, anyone who wants to help out is within our community. So I just wanted to get your perspective on how important they are to our success and then if anyone is listening and wants to get involved, how might they do that?

Sam: Yeah. Thanks, Jason. They are absolutely crucial to what we do and the success that we've had doing it. There's no question about it. A big part of what we do is to amplify the patient voice, to put it in the ears of legislators. That's the real communication and education that is needed to pass these bills. There are unfortunately several very strong and powerful stories about folks being caught in a problematic step therapy protocol and of course, this a all too common barrier to access can lead to under treatment, a delay in treatment, no treatment, and obviously that leads to all kinds of problems, irreversible progression of the disease, additional health issues, cost, quality of life concerns, etc. So these stories when we put them, when the advocate is willing, in front of a legislative committee, it is powerful and it does take notice. And to your point, Jason, I think that's a large reason why this has been bipartisan, not just at the federal level. All of the state legislation has been bipartisan. It’s Republicans and Democrats, not just in the legislature, but these laws are being implemented in Republican states and Democratic states. So it really is at the end of the day about our patient advocates. And to get involved, we would love to have them involved. They can obviously start by getting to know their state representatives and senators. All the people that I've spoken with that have done that have found that rewarding. They feel like they're involved. They feel like they're in the know, they feel heard - very important. But then also obviously contact us. Our website would be a good place. Our advocacy team would love to hear your story and would also love to help you throughout your journey. I know that we field many calls dealing with departments of insurance or insurance denials or anything like that. We would love to do everything that we can do to help connect patients with the treatments that they need.

Jason: Well said.

Sarah: Yeah, I'll plug it in our website psoriasis.org/advocacy. There's a really easy link if you wanna sign up and join us in advocating for these step therapy reform laws, both the state and federal ones. And I’ll echo what Sam said, it's so important to get community members involved. First of all, this bill is so strong because it's based off of stories and experiences that we heard from our community members. It resonates with a lot of community members because it came from the community. So having you speak up and share your story a) helps us navigate to make sure that we're advocating on things that actually impact you, but then b) your stories help to advance these bills as Sam was saying because it becomes a patient-centered issue which is really compelling to legislators. And I can talk to legislators until I'm blue in the face, but they're really not gonna take action until they hear from you, the people that live in their states and districts. So love to have you involved. We really view ourselves as representing you. You really make our work so much stronger and so much more effective and hopefully impactful.

Jason: Couldn't say it any better. Thank you, Sam and Sarah, for sharing your expertise on this specific issue and for all the work you're doing on the advocacy team. So just to sum it up, step therapy reform, we've made a lot of progress across the country. There's some federal action that we’ll give another update on about kind of where we are. But overall it is bipartisan, it is moving forward and we'd love to have your support and join us. So please reach out and hope you keep listening to future advocacy podcasts.

Jason: OK and it has been one second for you and one month for us. But here is the update on what happened, Sarah.

Sarah: Yeah, so we've been really excited about the progress on the Safe Step Act since we last recorded this podcast. The Senate HELP Committee, after some drama, did hold their markup on pharmacy benefit manager and included the Safe Step Act in that markup. It was added as an amendment and the amendment was voted nearly unanimously, 20 to one, so almost all members of the HELP committee voted for the amendment, except for Rand Paul. So with that unanimous support, we are now in the Senate HELP Committee’s version of their PBM reform. This is a great vehicle to be in. It's very promising and we're hopeful that the Senate will pass this vehicle later in the year. Right now, all eyes turn to the House side because we'd like to have similar progress in the relevant House committee, which is the Education and Workforce Committee. So we've been advocating with those members and generally speaking trying to increase the co-sponsors for the Safe Step Act on both the House and Senate, because if Congress does pass the pharmacy benefit manager package, it will require a lot of votes and making sure that the Safe Step Act stays in that package as a part of ours, it would be super helpful to have as many members of Congress supporting the bill as possible. So that's the update, Jason. And before I sign off and leave it to you, I just wanna pause and thank every advocate that's participated in this process. I know it's been several years down the road and you guys have done a lot to really raise awareness of the importance of this bill and gain support for it in Congress. So thank you and congratulations on this super important first step towards passage.

Jason: Absolutely. And just to reiterate before we close, this is the most progress this bill has ever made and it's been introduced in multiple editions of Congress. So really, really exciting, incredible work and we look forward to getting this across the finish line. And so I just wanted to thank all of our listeners for listening. And if you have any questions, you know where to find us. So thank you very much.

Shiva: Thank you Jason, Sam and Sarah for providing such an informative update about how NPF is addressing step therapy. I’m so glad you’re working on behalf of our community! In addition to your efforts, our successes in the states and momentum behind the Safe Step Act would not be possible without patient and provider advocates who share their stories. If you are currently experiencing step therapy, please contact our Patient Navigation Center by calling (800) 723-9166 or by emailing education@psoriasis.org. Not only do we want to hear your story, but a Patient Navigator will help you understand how to deal with insurance denials and identify programs that might help lower the cost of your treatments. To learn more about the progress of step therapy reforms visit steptherapy.com.

And finally thank you to our sponsor, Bristol Myers Squibb, who provided support on behalf of this Psound Bytes™ episode through an unrestricted educational grant.

Let’s Talk Step Therapy

Psound Bytes™ Transcript: Episode 197

Release date: Tuesday, June 13, 2023

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