Ensuring Access to Oral SERDs

EP: 1.Differences Between SERDs and Other Therapies

EP: 2.Efficacy of Oral SERDs in the EMERALD Trial

EP: 3.Safety Concerns Associated With Oral SERDs

EP: 4.Benefits of Using Oral SERDs

EP: 5.Progression-Free Survival of Oral SERDs in Clinical Practice

EP: 6.Role of Oral SERDs in Treatment of ER+/HER2- in Metastatic Breast Cancer

EP: 7.ESR1 Mutation Confirmation With Oral SERDs

EP: 8.Coverage Considerations for Oral SERDs

EP: 9.Clinical Impact of Oral SERDs

EP: 10.Treatment Failure and Resistance Before Oral SERDs

EP: 11.Cardiovascular Risk and Menopausal Symptoms Associated With Oral SERDs

EP: 12.Monitoring and Managing Adverse Effects With Oral SERDs

EP: 13.Payer Perspectives on SERDs

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EP: 14.Ensuring Access to Oral SERDs

EP: 15.How Patient Advocates Can Help the Newly Diagnosed

EP: 16.Empowering Patients With Metastatic Breast Cancer

EP: 17.Helping Patients With Metastatic Breast Cancer Enroll in Clinical Trials

EP: 18.Guiding Patients Through Complex Treatment Decisions

EP: 19.Patient Advocate's Role in Shared Decision Making

EP: 20.Helping Patients Overcome Health Disparities as a Patient Advocate

Ryan Haumschild, PharmD, MS, MBA: Dr Langer, how can physicians, providers, and practitioners who are utilizing these therapies make sure they get access to these new oral SERDs [selective estrogen receptor degraders] from a managed care perspective?

Lucy R. Langer, MD, MSHS: I think in general in the market, the big thrust should be on clinical trials. We should be enrolling patients in clinical trials so we can develop the data that will prove the efficacy of these drugs. Once they’ve been proven efficacious, they will be in the NCCN [National Comprehensive Cancer Network] guidelines, [and] there will be coverage. I think the bigger question is do enough physicians know about these newer agents? When something has accelerated approval, how do you get the word out? How do you educate physicians about it and make sure it’s not just at the academic centers, but also pervasive in the community? And you have to address issues of access inequity, social determinants of health, [and] social drivers of health. Does the patient have access to a medical center where they are aware of the advanced therapies? We have lots of work to do ahead of us for sure to ensure access. But I think driving the data, clinical trial enrollment, and broad education are key.

Ryan Haumschild, PharmD, MS, MBA: Thanks to all of you for this rich and informative discussion. Before we conclude, I’d like to get final thoughts from each of our panelists. If we could start with you first, Dr Langer.

Lucy R. Langer, MD, MSHS: From the perspective of a payer and also as a practicing oncologist, I think this is a very exciting time. These SERDs are exciting drugs. The more we are learning about them, the more exciting it gets. I think we need to continue to drive clinical trial enrollment, drive the data development, drive experience with these drugs, and then take very seriously how they get positioned in the NCCN guidelines so that we can ensure access and ensure that they’re used appropriately and that patients can experience the benefit of the drugs.

Ryan Haumschild, PharmD, MS, MBA: I think data and access, and even a lot of populations that are underrepresented in clinical trials, it’s our goal to increase the diversity of trials, get more data, so we can make concrete decisions moving forward.Dr Vidula, how about final thoughts from you?

Neelima Vidula, MD: I think it’s a very exciting time for the management of ER+[estrogen receptor-positive]/HER2- metastatic breast cancer. We’re in the era of targeted therapies. We have a number of drug approvals that are targeted therapies, including oral SERDs, and there are likely more to come in the coming years. That said, I think it’s really important to offer patients who have advanced ER+/HER2- breast cancer the opportunity to undergo a cell-free DNA test or to have tumor tissue genotyping sent on a biopsy from a metastatic site lesion. That can potentially identify actionable mutations that might open up opportunities for that patient to either participate on a clinical trial of a targeted agent or benefit from an approved targeted agent, such as elacestrant if they have an ESR1 mutation that’s detected. I think it’s also important for us as a field to ensure that we have equitable access to these types of genomic tests. That’s where our payers’ assistance would certainly help because we want to make sure that patients who come from diverse backgrounds have access to these novel agents and can benefit from them as well.

Ryan Haumschild, PharmD, MS, MBA: Excellent, thank you. I love the comment about molecular testing and the strong and important role it plays in treatment selection, as we heard earlier in this discussion. Dr Lu, I’m going to leave you with our final thoughts from this discussion.

Janice Lu, MD: We have so many great options for patients with ER+/HER2- disease at this point. As a practicing physician, my focus is to improve progression-free survival for patients, overall survival, as well as the quality of life. I want to discuss with patients [and] my colleagues constantly, provide them with information about what’s available, what’s the best option for now, how to do the best sequencing, and how to prolong their life as the ultimate goal. As Dr Vidula mentioned, it’s the time of precision medicine and genomics testing; there are so many markers we need to look for. ESR1 is the one for oral SERDs, and I definitely want to remind myself constantly and colleagues I work with, to provide patients with the best options. Thank you.

Ryan Haumschild, PharmD, MS, MBA: Absolutely. Shared decision-making with the patient sets them up for success, and when we set them up for success, it enables them to achieve the best responses possible, and you did a great job summarizing that.

Thank you again, and to our viewing audience, we hope you found this AJMC^® Peer Exchange to be useful and informative.

Transcript edited for clarity.