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Video Transcript: Risk and Reward: Navigating REMS pitfalls to position brands for success

Webisode transcriptions completed by third-party vendor. AmerisourceBergen Specialty Group assumes no liability for the accuracy of the content.

Gina: Best practices for REMS implementation. Elements to Assure Safe Use. Impact on utilization management strategies. What should pharmaceutical manufacturers keep in mind as they work to launch—or optimize—their REMS programs? What impact can a successful REMS program have on a product’s viability? Join us to find out. “In the Know” starts now.

Hello and welcome to “In the Know,” your source for insight and analysis on the issues that matter to specialty pharma. I’m your host, Gina Clark.

Today, we turn our attention to Risk Evaluation and Mitigation Strategies and the importance they have in the future of several specialty pharmaceutical products. We’ll examine the evolving FDA requirements, manufacturer preparedness for these changes and the effect REMS might have on appropriate access to products.

Joining us today is Peyton Howell, president for AmerisourceBergen Consulting Services; as well as Terri Madison, vice president for Xcenda, and leader of the company’s epidemiology and risk management consulting practice.

Thanks to you both for being with us today.

Peyton: Thank you Gina.
Terri: Thanks Gina, It’s a pleasure to be here.

When REMS were first mentioned as replacement programs for the old risk maps, there was quite a bit of anxiety in the pharma community about what that might entail. To a certain degree, it seems like the requirements have not been as stringent as many manufacturers feared. So is this much to do about nothing or are there still areas related to REMS that pharma needs to watch closely?

Terri: I do think the observations of a lot of manufacturers were a concern that REMS would be more stringent is definitely born out with our consulting experience. We’ve worked with several customers who have actually submitted drafts for REMS proposals that have ended up to be much more stringent then what the FDA ultimately approved for their products. However, saying that, I do think that there are a few trends that we do need to keep our eyes on.  The first one is that big difference between REMS and risk maps, is that REMS require formal assessments.  Its simple assessments of the effectiveness of the communication materials, as well as more formal assessments of is the REMS achieving its desired objectives in minimizing the safety issues of concern. So I think as we start to see those REMS assessments come in, the first wave should be coming in sometime this year, we’ll probably start to see some changes in futures REMS requirements as the FDA starts incorporating those learning’s in their future requirements.

Peyton: and related to that one important piece to is the fact that right now these REMS really are different for each product. So I think that’s created a lot of anxiety for manufacturers because products can be very similar in their needs, but the products feel different to the manufactures, kind of like starting from scratch. But that’s very different for patients and prescribers.

Terry: Yes, that’s a great point. I think right now there’s very few class wide REMS out there. Although, if you actually look at the REMS that are approved, there’s several products that are not officially on a class wide REM, but actually appear to be a class wide REMS. A great example would be the floraclinarhymes, where there’s over six out there on the market all with REMS to look at Akeley’s tendon rupture, but they’re not considered a class wide REMS. So I think more and more, as we start to see some standardization in there, that’s definitely something the provider community’s been asking for.

Peyton: Standardization is definitely an opportunity.

How are manufacturers and regulatory organizations like the FDA, measure the effects of most of REMS programs? What does success look like from program to program?

Terri: So, they’re certainly with the REMS requirements. These require formal assessments that are required. And these assessments can vary from a simple survey that assesses a patient’s receipt of and understanding of a medication guide to very formal pharmaco epidemiologic studies that look at the effectiveness of the actual REMS and achieving its desired objectives and reducing the incidents of certain adverse events. I think that as we move forward, again with these REM assessments, the data that’s going to come out of those is going to drive future decisions for the FDA requirements.

Peyton: That’s a good point, so we might see the REMS change and evolve after this first load of assessments comes through.

Terri: Absolutely.

Let’s focus on those REMS programs that do require the elements to ensure safe use. What does this entail?

Terri: So the elements to ensure safe use are described over several pages of the REMS guidance that is out there. But in essence, the elements fall into three basic categories. The first is that health care providers and particular prescribers have had some special training or certification before they can prescribe a product. The second is that a product may only be used in certain health care settings. So for example, there was a concern about anaphylaxis. But the prescription can only be administered in a setting that can treat a patient if there is an anaphylactic reaction. The third area is looking at patients, and in particular documenting that patients are eligible to receive certain product and that they’ve got certain safety conditions present. So when the laboratory monitoring and negative pregnancy tests, those are the different elements to ensure safe use or ETA use.

Peyton: and once concern we have about elements to ensure safe use from a supply chain perspective, is that they’re often oriented towards the prescribers setting.  Which then can lead to requirements of a more restricted distribution, other types of systems for accessing the product. You know, that’s a concern because is there an option to consider looking at either the prescriber or the site so that we don’t add new costs into the system, unless its absolutely necessary from a safety perspective.

Right, so from what you’ve seen, how prepared are manufacturers when it comes to implementing these elements? How much of an impact might ETASU’s have on a products success? Either positive or negative, depending on the manufacturers level of preparedness.

Terri: I think most manufacturers are very well prepared to deal with the more simple REMS.  Those REMS that require just a medication guide or communication practices out to health care providers that might prescribe. However, when it comes to the more restricted distributions and the patients’ registries, our experiences have been that they’re not very well prepared. In fact, a lot of the companies, where there’s a large company or a start up company, are coming to look for service providers to help them. Especially, because they’ve not been very well integrated in the actual day to day supply chain of distribution and drug administration.

Peyton: and Terri is being humble.  She’s been extremely busy and it’s been a really challenging time, and some times, the manufactures moving forward and thought they were prepared for REMS but then got different guidance. Sometimes, a less restricted REMS, and they need to be prepared in a different way. So, it’s been very very busy opportunity for her consulting practice. But I think manufacturers are trying to respond to this new environment in a positive way.

Terri: Yes, I think another component with the elements to ensure safe use is people are a lot of the time focused on the negatives of a restricted distribution. But if you look at product like InteReg, that has a very restricted distribution in a hospital, that product probably wouldn’t have been approved without a REMS, so here is a case where the REMS actually does an excellent job with minimizing the risks for those patients, and the products out there on the market for the patients that need it, But probably otherwise would not have been approved.

Peyton: And some of the REMS we work on, there’s an opportunity to build other services around that REMS or at least do it in a conducive way so that your not adding on what feels like a lot of additional burden on to health care providers, be that hospitals, physicians, and their staff.

In early May, the FDA announced that REMS for opiod Products are in the final stages of development, and could be ready this summer. How might this effect how these products are prescribed?  And for the companies that make these products, what plans of action could they be deploying right now to address this?

Terri: So the opiods, Are interesting, because there were actually suppose to be a class wide REMS issued last October and there was a huge outcry from state coulters. Predominately, patient advocacy groups and prescribers to say “We need to think about this?” and what is the ETASU in terms of registration and restricted access going to do to allow us to give these products to our patients without disrupting our relationships with these patients and their confidentiality. So what’s been going on for the last year, the FDA has been getting a lot of state coulter feedback, especially from the patient advocacy groups and the prescribers so they have a better idea of how to implement the elements to ensure safe use without disrupting that beneficial access to patients who do need opiods For example for cancer pay management.

Peyton: The cancer patients are a real concern of ours. AmerisourceBergen was on a recent steering Committee, apart of NCCN, and both Terri and I were actually at that meeting just a week ago. It’s a palpable level of concern, in terms of implementing that classified REMS and its impact for cancer patients, which is so different than all the other patients that would utilize those types of treatments and what type of flexibility will be available?

Terri: I think the key is really going to be with a lot of REMS, but particularly the opiods To get that state coulter feedback and make sure that whatever the final program looks like, that its not creating unnecessary barriers.

Peyton: So we may not see anything on this for a little bit. Although it’s expected this summer, it could be later, I don’t know, what do you think?

Terri: Yes, I think their official plan is next October; there was a delay of 12 months.

Gina: For those manufacturers, who know that REMS requirements are in their upcoming products future, what should they be doing to prepare, as their products approach this approval?

Terri: I think there’s a lot of things they can be doing to prepare. Certainly, in the planning stages, even before they’ve submitted their new drug application. They can be trying to prepare for their global risk management plan, and the risk mitigation strategies, and discussing those with the regulatory authorities to harmonize their strategies throughout the world. I think the other thing on the implementation side, is if they have a pretty good idea that they’re going to need a REMS, to start talking with people about the implementation, in terms of things that may effect distribution etc.

Peyton: Absolutely, because the sooner we can begin talking to a manufacturers about their needs, then the more creative we can be together to develop a solution, that may even enhances the product in the market place.

What about when a safety concern emerges for an existing product and the FDA determines that a REMS will be needed? How can these manufacturers ensure a smooth REMS implementation for their product?  Especially, given the potential changes in the steps required to complete a prescription.

Terri: So I present a sort of interesting angel on it, one thing that I think is a little bit of an advantage, is that if the product is already on the market, one of the big concerns with REMS is that manufacturers do not like to discuss REMS requirements before the FDA has come forward and said that a REMS is required with products that have not yet been launched. Once a product’s been launched, if they’re pretty sure they need a REMS, all of that guessing game is pretty much removed, and they can actually have good proactive discussions about what is needed in order to get the REMS out there. I think the big challenge is the timeline, because once the FDA has determined better REMS is required for a market of product, there is a timeline for implementation, and again I think that’s where service providers can really make a difference, especially if you’re working with an experienced provider that has experience putting together the REMS hub and the restricted distribution, has the connections with the pharmacies etc. can really make that timeline feasible for implementation.

Peyton: That’s a very important point, in terms of provider in put. Providers had their concern; they almost feel surprise by these REMS. So to practice on the market that ability to have them be participating in that process and have it be a more open dialogue with more providers, I think helps kind of take that black box feeling away.

What role does an issue like patient adherence and compliance play in this discussion? How can adherence programs integrate with well-designed REMS programs to create a differentiating point for a particular product?

Peyton: Well, that’s near and dear to my heart because I do think that’s one of the areas of opportunity when you think about the REMS program is that you have the opportunity to sometimes interact with patient. often times the prescriber, but depending  on the requirements of it. That might be the opportunity to enhance that patient education resources and access it, it really might facilitate patient adherence and compliance, which is a critical goal for everyone. So, when we look at a REMS type situation, we typically look the more expansive of REMS programs in terms of requirements. We try to identify elements such as adherence and compliance that add new value to the patients and the prescriber and the support and streamline that process.

Terri: Yes, I completely agree with Peyton. I think that patients, especially with some of the more complex chronic diseases are their own best advocates. When there are elements to ensure safe use such as monitoring, laboratory, ongoing symptoms and things like that, patients are in the position where they can actually escalate to the providers and receive that assistance from the nurses that are reaching out to them to make sure that they’re reminded to do that on a regular basis.

Peyton: Good point, it makes the REMS not sound so scary.

So how do you expect payers and PVMS to react to the upcoming REMS programs? Especially those with a more complex ETASU’s. How will REMS influence decisions around health plans utilization management strategies?

Terri: So it’s interesting because we just conducted a survey with our MCN network over the weekend.  And we particularly polled several of the payers on just these topics. What we learned is that, although most of the payers are familiar, anywhere from a little bit familiar to very very familiar with REMS, they are not seeing REMS, at least at this point, as something that’s much on their radar. Most of the payers that we talked to said they would not look at their prior authorization requirements and REMS with any types of modifications in their requirements for a restricted distribution REMS. They also said that they probably wont use products with REMS in any way to affect their formula or decision-making. So it’s sort of interesting. I think they’re kind of taking a wait and see approach.

Peyton: And it’s one of the pieces of frustration. You think about a REMS, so you kind of cleared the coverage and maybe really restricted use of a product but you don’t have a guarantee of coverage or a payment or really any preference in terms of co-payment. So this is one of the things we’ve heard both from oncology and cancer centers, but also prescribers in terms of any opportunity for the future to have the REMS at least be somewhat integrated to  coverage Policy.  Which will definitely help with the patient access perspective.

So what can manufacturers do to provide the right information to payers about the effectiveness of their programs?

Terri: I think there’s two things. One, first of all, is to get that state coulter feedback, especially when they’re designing their REMS and looking for barriers to access for patients and sharing that information with the payers so they can be in a better position to try to integrate and synergize some of those programs.

Peyton: Yes, I agree.  The opportunities to educate payers can happen at events like our manage care networks, and certainly all the contacts that they would normally do day to day with manage care is an opportunity to educate payers. They are not hearing about this piece of requirement and that means they are not using any of that information to their advantage and it’s very important.

So with all of this in mind, how will the future REMS effect appropriate patient access to vital medications?

Terri: I think all in all REMS are a good thing. It’s really modeling a changing paradigm of a lot of our products safety surveillance and the context. REMS are very proactive, the idea is to minimize or prevent risk rather than wait until there’s a risk and then react to it.  In that sense, I think that it is very good but, we’d really like to see, especially on the payer side, Is in the future a better synergy about the comparisons that are made and making payer decisions of looking not only at costs and looking at efficacy about also integrating risk into the equation.

That’s about all the time we have for today. Terri and Peyton, thank you so much for joining us.

Peyton: Thanks for having us.

Terri: Thanks a lot, Gina.

And thank you for joining us—we’ll be back soon with an all-new webisode. Until then, if it’s on your mind, it’s “In the Know.”

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