Benefits of Using 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

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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

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: We talked about some of the potential benefits not only in the treatment course of therapy, but also that it’s an oral [medication], so it’s convenient for patients and those are some of the differences compared to traditional chemotherapy. Dr Vidula, when you’re thinking about the potential benefits of oral SERDs [selective estrogen receptor degraders] even over other endocrine therapies for metastatic breast cancer, what are some of those potential benefits that are worth differentiating between the 2?

Neelima Vidula, MD: As you mentioned, it’s a good selling point for patients that they have another oral targeted therapy. It’s also important to note that this is a genomically-driven therapy. As Dr Lu was discussing previously, the benefit that was seen with elacestrant in the EMERALD study was heightened in patients who have ESR1 [estrogen receptor 1] mutations, which may develop in a good fraction of patients who have been treated with a prior aromatase inhibitor. And I think that patients will find that appealing as well because it’s a targeted therapy and one that has the potential to overcome that hormone resistance.

Ryan Haumschild, PharmD, MS, MBA: I feel [targeted therapies] are so important, especially as we’re rolling out our precision medicine panels. It’s really nice to have a conversation with patients to say, “Hey, this therapy is really going to express itself well in you and here’s why.” I know our payer colleagues who are also tuning into the American Journal Managed Care® are also very considerate of making sure that if we have a companion diagnostic and we have good predictability of benefit, it’s a good match, especially in patients that are most eligible. Dr Lu, a question for you, as we think about oral SERDs and compliance, a lot of times one of the things I think about is the dosing schedule. For many unfamiliar with the dosing schedule, maybe you could give an overview of the dosing schedule for SERDs and how that impacts the treatment of metastatic breast cancer.

Janice Lu, MD: The dosing schedule, I believe, is pretty straightforward. It’s a 345-mg daily dose for patients, so it’s 1 pill a day. In the EMERALD trial [NCT03778931], the dose reduction was minimal. Only 3% of patients had dose reduction. Just to echo what Dr Vidula said, it was well tolerated and then there was an overall benefit with the oral SERD for patients who needed treatment for endocrine-sensitive disease.

Ryan Haumschild, PharmD, MS, MBA: Excellent. When I’m looking at compliance with a patient, I know a lot of times that pill burden may have an impact on a patient, the frequency of the medication, and one of the things you describe with these oral SERDs is that it’s once a day. So for a lot of patients, if we can achieve a good proportion of days covered, then a lot of times we can see the same results we saw in a clinical trial. Because, therefore, we can keep patients motivated on therapy and they can follow through. And if we manage the GI [gastrointestinal] toxicities appropriately, the patient will ultimately, hopefully, be very successful on therapy.From a payer’s perspective, I know a lot of times when we’re also covering a therapeutic, we want to make sure that patients are taking it appropriately. When you hear a new oral SERD coming to the market or being utilized that has once-a-day dosing, what is your real thought process when you’re making coverage decisions? How does dose frequency come into play when you’re evaluating the whole value proposition of a new therapeutic?

Lucy R. Langer, MD, MSHS: The once-a-day dosing makes this drug very appealing. Of course, there are all of the other elements that go into the consideration for coverage, but the once-a-day dosing says to me, this patient may be more likely to have a very nice response because they’re actually going to get the dose that’s intended. I think that another consideration is that the adverse effects of this medication cannot be brushed aside, the nausea, and the previously described adverse effects. And I think ensuring that there’s a good support mechanism in place, either in the physician’s clinic or through the payer, or through other organizations that provide support, that help these members manage [and] navigate their adverse effects, and be proactive about them, as you said, also will help them to achieve their goals of having an optimal response.

Transcript edited for clarity.