Kenneth Komorny, PharmD, BCPS, was a co-lead on development of National Comprehensive Cancer Network (NCCN) recommendations for biosimilar management. He explains some of the positions the NCCN has taken.
The Center for Biosimilars® (CFB): I'm Tony Hagen, senior editor for The Center for Biosimilars®. Biosimilars are valuable tools for saving money and improving access to care. But using them requires care in storage, records management, payer interactions and procurement. To help pharmacy teams get this process right, the NCCN [National Comprehensive Cancer Network] Pharmacy Directors Forum put together a set of recommendations on safe and efficient use of biosimilars in the clinical setting. The NCCN forum also called for bringing an end to single biosimilar payer policies, which they feel are too restrictive. We spoke to a co-lead on the paper, Kenneth Komorny, the chief of pharmacy at Moffitt Cancer Center. Dr Komorny worked with a team of 10 others, including Ryan Roux, vice president of pharmacy at the University of Texas MD Anderson Cancer Center.
CfB:When talking about the risks of using biosimilars, in the NCCN paper, you say that you don't mean to discourage the use of these products. More specifically, you want to emphasize the need for attention to detail for doing things carefully. Can you elaborate on that thought?
Komorny: That's absolutely true. By no means did we intend to discourage those products. All of the members on the workgroup support the clinical use of biosimilars with careful attention, as you said, to some of the major risk points that we highlighted. Unfortunately, there's a misperception that no additional work is needed in using biosimilars and that there are really no risks from an operational standpoint of utilizing multiple biosimilars. As highlighted in our paper, that couldn't be further from the truth. There are many moving parts. There's an awareness of those risk points. It's important to establish a solid strategy around those risks to avoid process failures and really to ensure a best practice. So, that was our intention with the paper.
CfB: The pharmacy directors team at the NCCN believes that a legislative solution may be the best answer to payer single-biosimilar policies. Can you explain?
Komorny: Sure. The need to process different brands of the same medication to different patients on the same day leads to risks, as we discussed in the article. When a payer selects only 1 of many biosimilars and they only will pay for that one, and then another payer selects a different biosimilar of that same medication, that truly serves as the root cause to that problem. We have very strong relationships with some of our payers and we negotiate and collaborate on initiatives that are important to them. At the same time, they work with us to assure that we can provide that care in a safe manner. But other times, honestly, there's less interest in collaboration. In those cases, legislation may be necessary to intervene on potentially unsafe policies. So, I guess I wouldn't say that it's the best answer in all situations, but it may be the only answer in certain circumstances.
CfB: How prevalent is single-biosimilar policy in the payer world?
Komorny: So, I can tell you from our perspective, from Moffitt's standpoint, at this point with our major commercial payers of all the medications that have biosimilars, we have 1 mismatch currently between our default formulary biosimilar and all of our payers. I feel like we've done a good job at balancing that. I'll also say that a vast majority of our payers have more than 1 biosimilar that they will allow for payment. That gives health systems the flexibility of picking and choosing those biosimilars that we can use consistently across our patients, regardless of which payer they have.
CfB: If you were to design legislation that would alleviate this bottleneck and make more biosimilars available for providers to work with, how would that legislation read?
Komorny: I think at its core, really, the highest likelihood for an error is when we're processing different biosimilars for different patients, as I just described. I think the prevention of single sourcing, where payers only pay for 1 biosimilar of a medication, has to be critical to any legislation that would come forward, because again, that is the root cause to those variances in process and procedure that we have that lead to errors.
CfB: Do payers appear not to be able to negotiate or resolve this issue without some sort of legislative mandate?
Komorny: Yes. I think that would be that would be the last alternative, right? If we were able to work with one another to mitigate some of those risks—and that's what we do. We take every effort to try to work with our payers to sort out a resolution that's good for them and good for us, because our primary interest is the care of the patients and assuring that we're treating them the way they need to be treated at that highest level. I think that's what the white paper does. It establishes what some of those best practices look like and how we can provide the highest level of care for our patients.
CfB: What are some of your other recommendations for enabling health care institutions to get the biosimilars they want to the head of the queue?
Komorny: Well, I think it rests on a robust formulary management system That's critical to optimizing medication use and medication safety within a health system. The formulary review needs to be thoughtful and involve safety, clinical, and economic considerations. But with the biosimilars, it also requires close payer coverage assessments. So, I think, as illustrated in the paper, an upfront as well as an ongoing payer policy coverage review is essential. What we look for in the core of our formulary processes [is] to identify those biosimilars that are covered by the greatest number of major payers to maximize consistency and create the least number of variations in the process. As I mentioned, today, we have 1 mismatch between 1 of our payers and 1 of the medications that has a biosimilar. And although we need to treat that as an exception, which is a convoluted process and we have to spend extra attention to detail to assure that mistakes are not made. That's manageable.
CfB: When you say it's a mismatch, you mean the payers' formulary does not permit the biosimilar that you prefer?
Komorny: That's correct.
CfB: And how do you accommodate that?
Komorny: So, when we first experienced this a couple of years ago, we worked with our Process Excellence department here at Moffitt and we created a workflow process. There are 32 steps in that workflow process. It's a legal-size piece of paper that has the process for managing a mismatch of the drug to payer per patient. So, we have to walk through those steps, and it involves lots of different areas within our hospital involving IT [information technology], our financial clearance unit, managed care department, our pharmacy, our providers, and our nurses. We go through that checklist to ensure that we follow those steps properly. As I said, when it's 1 payer and 1 drug, is very time consuming—it’s worthwhile time spent—to prevent mistakes from happening, but it occupies a large part of our time working on that 1 patient. I just can't imagine if we had multiple mismatches across multiple different biosimilars. Again, that's why our recommendations are listed within the paper, to help mitigate some of that risk.
CfB: Earlier you described making sure you had a clear understanding within your institution which biosimilars were preferred and that you avoid mistakes. Is that something that the NCCN strongly recommends, making sure all process flows are clarified and that everybody is on the same page, and that they have access to systems that reveal the data necessary to make the right choices?
Komorny: That's exactly right, Tony. The work of the recommendations of meeting with your financial clearance unit, your revenue cycle departments, meeting regularly with managed care to identify policy changes, and working proactively with the payers as those changes come forth, those are critical to the success of best practice and operationalization of biosimilars. So, you hit the nail on the head there, yes.
CfB: So, in the biosimilar procurement process, I got the impression from the paper that there's a little bit of wasted effort. The NCCN was recommending a streamlining. Can you explain what was meant there?
Komorny: From the procurement standpoint, there was a lot of discussion in some of our early meetings, as we were talking about risk points from a procurement standpoint of not being able to receive the drug. And the context of that is when a drug is first available, it has to be stocked at the wholesaler and par levels have to be established.
So, at times, an institution may be ready to switch to a product or to start ordering a product and the wholesaler doesn't have it. There are other situations in which a wholesaler may stock that medication, but if 1 institution has been ordering that medication and now, 10 institutions are ordering that medication, they just don't have the stock on hand to be able to supply, and it could lead to a shortage-type situation. Those are usually fairly short term and those resolve over a period of time. Wholesalers figure out how much drug they need to keep on their shelves. So, short-term, it's certainly a risk, but for long-term, it's less of a risk. When we did the evaluation of the survey and the risk points, procurement really didn't receive discussion in the paper because of some of the other areas that we needed to focus on.
CfB: [In regard to] failure modes, you had a huge chart in your paper that explained the many ways that you could go wrong during the process. It seems very tricky. Can you elaborate on these issues and perhaps explain a bit more about how to get things right the first time and save money?
Komorny: A failure mode effects analysis [FMEA] is a wonderful tool for identifying what you should really focus on from a risk standpoint. The content expert that developed the FMEA that was in the paper from her institution identified various areas and scored those areas. So, when evaluating severity occurrence and detection of those risks, if the institution does that FMEA, they will have a clear picture of their first, second, and third areas to focus on from a risk standpoint. That was performed, as I said, at her institution, and that was consistent with the risk factors that were identified through the survey and that we focused on in our white paper. But I think the purpose of that failure mode effect analysis process is what we would recommend institutions to do to help find out at their institution what are some of the risk points that need to be identified first. So, that's part of our recommendation.
CfB: What's at stake if you don't follow these recommendations to the letter?
Komorny: The best practices that are described in this white paper will help minimize defects in the process for operationalizing biosimilars. Some of the primary failure points that we identified—medication errors, inefficiency, financial toxicity to both patients and to institutions—these best practices lead to less variation in the process, which will lead to less defects. When you're talking about defects in the process of high-risk oncology medications, [these] can lead to significant outcomes and they can be catastrophic for some patients.
So, our goal with this white paper is to share with other institutions how to design a process around biosimilars which will improve safety, improve efficiency, and decrease the financial toxicity to patients so that patients can be treated for their cancer in the best possible means. We feel that these recommendations are our best practice.
CfB: Tell us a bit more about the survey and how it was designed to get at the issues you thought were important in the use of biosimilars.
Komorny: Sure, Tony. This survey was developed by the Pharmacy Directors Forum Workgroup, a subgroup of the Pharmacy Director Forum through NCCN. The workgroup identified pharmacy leaders that evaluated different risk points at their institution. That feedback was then used to create a survey. There were 9 areas that were highlighted as potential risk points. And then, there was 1 free text box in that survey that allowed any other risk points to be highlighted if it was deemed appropriate. The survey was then sent to the entire NCCN Pharmacy Directors Forum and we had 14 out of 28 [respond to] that survey.
Based on the survey results, we prioritize the highest scoring risk factors, and that included payer restrictions, leveraging the HR [human resources], billing issues, storage issues and safety concerns. And then, that survey served as the foundation for the risk points that were highlighted throughout the paper.