Michael E. Chernew, PhD
Pertuzumab, a new HER2-positive breast cancer drug, is being launched at a 31% premium to the price of trastuzumab. This is an aggressive strategy that will substantially increase the cost of treating patients with metastatic HER2-positive breast cancer, while also aiming to deliver the best outcomes for patients.
Pertuzumab will be used as an add-on to trastuzumab to treat patients. Progression-free survival was boosted by 6.1 months when the drugs were used in combination in the CLEOPATRA study.
With payers already anxious about the rising costs in oncology, an 18-month course of the combination treatment is estimated to reach more than $180,000. This cost sets the bar high for the future, as expensive targeted drugs are expected to be used increasingly in combination to deliver the best outcomes.
To examine these treatment benefits, cost concerns, and potential insurance coverage strategies, Michael E. Chernew, PhD, professor, Department of Healthcare Policy, Harvard Medical School, moderated a panel discussion with Lee Newcomer, MD, MHA, senior vice president, Oncology, UnitedHealthcare, and Sandra M. Swain, MD, medical director, Washington Cancer Institute, Medstar Washington Hospital Center.Chernew: Dr Swain, I am interested in the current treatment landscape for patients with breast cancer. Can you discuss how physicians choose breast cancer treatments for their patients?
There are a lot of different treatment paradigms for breast cancer and it really depends on if you are talking about early stage disease or metastatic disease. Let’s start with metastatic disease. Unfortunately, even with some of our very effective treatments, we really don’t affect survival in a lot of cases of metastatic breast cancer. However, breast cancer has really been categorized now into different kinds of breast cancer—ER-positive breast cancer, triple negative breast cancer [meaning there is no estrogen receptor or HER2], and HER2-positive breast cancer [in which patients have the HER2 oncogene that is overexpressed]. So, it’s very complex; you can’t just answer that with one answer. The way an oncologist would choose is to look at the biology of the tumor [to see] if it has the receptors or not. For example, if the tumor had the HER receptor with metastatic disease and it was first line you would choose trastuzumab. And, with the recent data in the CLEOPATRA study showing that the addition of pertuzumab to trastuzumab plus docetaxel actually has a large benefit, oncologists would consider this also at this point.
So, can you provide a brief overview of the CLEOPATRA trial?
Sandra M. Swain, MD
The CLEOPATRA trial was a prospective, phase III, randomized study in patients who had not received any chemotherapy for metastatic HER2-positive breast cancer. The study included 808 patients and they were randomized to either receive placebo plus trastuzumab plus docetaxel [control group] or pertuzumab plus trastuzumab plus docetaxel [pertuzumab group]. It was firstline treatment, and the endpoint of the study was to look at an independently assessed progression-free survival. It really had a spectacular result in my opinion. It was a progression-free survival advantage of 6 months. This was actually a placebo-controlled study, so even though progression-free survival can be a difficult endpoint, it was clear in this study that there really was a benefit to the addition of the drug pertuzumab. The interim analysis of survival showed a trend in favor of pertuzumab in the initial report that we released at the San Antonio Breast Cancer Symposium and published in The New England Journal of Medicine
in December 2011, but most recently we’ve reanalyzed the survival and, actually, a press release came out this past June showing that there was a survival benefit also with the addition of pertuzumab.As a first-line treatment, how many breast cancer patients would be eligible? Just the patients who would have the HER2 target?
ï»¿The patients with HER2-positive overexpression are approximately 15% to 20% of breast cancer. The indication is only for patients who have not had previous chemotherapy. It wouldn’t be for someone who’s had trastuzumab or other drugs or second-, third-, or fourthline treatments. It’s only for first-line treatment.
That would be approximately 15% or less because of the exclusions?
Swain: Maybe a little less than [the general population of patients with breast cancer]. Per year, it would be 15%, but of the patients now, it’s certainly going to be less because a lot of patients now would have had other treatments.