Dr Langer explores how payers think about the authorization process for DEXA scans and other surveillance activities that would be required for selective estrogen receptor degraders (SERDs) and how oral SERDs affect quality of life.
Ryan Haumschild, PharmD, MS, MBA: As we talk about payers and managed care executives, Dr Langer, you’ve been a great participant, and we really rely on your expertise as well. Some of the comments earlier had to do with bone health and the preservation of bone health. How do we make sure that we’re engaging our payers in coverage decisions? How do payers think about the authorization process for DEXA [dual energy x-ray absorptiometry] scans and other surveillance activities that may be required for SERDs [selective estrogen receptor degraders]?
Lucy R. Langer, MD, MSHS: Medical societies, professional organizations, ASCO [American Society of Clinical Oncology], and NCCN [National Comprehensive Cancer Network], have put out guidelines about the frequency and periodicity of follow-up scans and imaging. And of course, payers will follow that for their coverage decisions. When it comes to things like DEXA scans, individuals who are on aromatase inhibitors, SERMs [selective estrogen receptor modulators], SERDs, anything that will alter the hormonal milieu that might alter then the bone health, that will be covered. I think it’s a pretty easy question for me because our coverage is pretty broad in that regard.
Ryan Haumschild, PharmD, MS, MBA: It sounds like SERDs would be included in the authorization criteria, mainly mechanistically, by the way they act within the body, and would allow patients to have access to that if needed.
Lucy R. Langer, MD, MSHS: That’s true. And not just the basic studies, but I think for the advanced bone imaging studies as well, if you fall into one of these higher risk categories, that will be covered.
Ryan Haumschild, PharmD, MS, MBA: Excellent. When we talk about oral SERDs, we’re doing a great job setting the patient up for success, and we’re thinking about the patient through the entire spectrum of care. But another thing that we need to be thoughtful about is patient-reported outcomes [PROs] and quality of life. That’s something that we know in the Enhancing Oncology Model within Medicare, that they’re really going to be focusing on. A lot of value-based contracts are also going to be looking at what is the quality of life for that patient. A lot of employers who are letting an insurer manage their benefits want to know, is this patient going to be able to show up to work? Are they going to have a high functionality of life and good mental health? So in the context of those considerations, Dr Lu, how do oral SERDs affect the quality of life for patients with ER+[estrogen receptor-positive]/,HER2- [human epidermal growth factor receptor 2–negative] breast cancer?
Janice Lu, MD: I’m really happy you brought up this question. In fact, Javier Cortes [MD, PhD,] presented data at ESMO [European Society for Medical Oncology] Breast Cancer 2023 last month in Berlin, [Germany] and I wish I were there. The data showed that there were no additional adverse events compared to the standard of care, so that was impressive. At the same time, we can avoid combination therapy and next step chemotherapy as Dr Vidula mentioned. So [we can] sequence the patient step-by-step and then try to use the best treatment with the highest progression-free survival, hopefully, overall survival, as well as least toxicity. Combination therapy quite often will have more adverse effects, and chemotherapy [will] definitely have a lot more adverse effects. Back to your question about overall quality of life, there were no additional adverse events compared with the standard of care from the PRO presentation last month.
Ryan Haumschild, PharmD, MS, MBA: Excellent. It sounds like to me, one of the key considerations is we need a mantra of quality of life, just as we have been [doing]. There are no additional considerations, but always want to set ourselves up for success, making sure we’re getting that feedback from patients and continue to adjust as needed.
Dr Langer, we couldn’t discuss the management of breast cancer and oral therapies without a discussion sometimes of the management strategies that our payer colleagues utilize. Their ultimate goal is to ensure the appropriateness of use and to make sure that sequencing is appropriate and matches the clinical data as well as the NCCN guidelines. When we think about utilization management strategies such as prior authorizations and step therapy, how are payers in the market viewing these newer therapies in terms of prior authorizations?
Lucy R. Langer, MD, MSHS: We constantly have our ears to the ground. We’re looking at the emerging data, and we’re thinking about our pathways program, we’re thinking about prior [authorization], we’re thinking about step therapy. All of these that I mentioned start first with the data. We look at the data. Do the data demonstrate superiority or noninferiority? What are the adverse effects? What’s the adverse effect profile? Is it better, is it worse, or is it the same as what the patient could have as an alternative? For step therapy, especially if there are alternatives or equivalent drugs, we want to position the drugs appropriately so that the system, and more importantly the patient, have less of a financial burden. That’s the way we’re thinking about it. It’s data first above all else.
Ryan Haumschild, PharmD, MS, MBA: Data first, making sure patients are on the right therapy. Throughout this entire discussion I’ve learned a lot, and we’ve been able to share so much great information around best practices, what the emerging data look like, and how oral SERDs fit into the treatment continuum. One of the main things we need to continue to keep our eyes focused on is getting access for our patients. If we’re not able to get our patients access, unfortunately, they’re not going to be able to achieve the clinical benefits we’re looking for.
Transcript edited for clarity.