As "Me-Too" Options Expand, Cost, Side Effects Become Considerations, McCullough Explains
The proliferation of new cancer treatments has created a novel challenge for oncologists and hematologists in recent years, said Stacey McCullough, PharmD, the senior vice president for pharmacy at Tennessee Oncology. For the first time, they frequently must decide which of several essentially similar medications makes the most sense for a particular patient.
Comparisons can be difficult, McCullough explained during the 4th annual meeting of Patient-Centered Oncology Care, which took place November 19-20, 2015. However, careful consideration of factors such as safety, adherence, and cost can help drive good decisions. To illustrate the growth of me-too cancer medications, McCullough highlighted drug approvals that occurred between 2009 and 2013. Those years produced 51 new drugs, 24 of which featured novel mechanisms for attacking tumors. And, if anything, the trend is accelerating.
“We could look to the last few weeks, and 6 or 7 new drugs, I think, have been approved,” McCullough said. The most important criterion for choosing between similar drugs is efficacy, but it’s generally impossible to discern the most effective product in a given class. Head-to-head trials are rare, while comparing results from one trial to another is nearly impossible. Different trials of different medications don’t even share the same endpoint.
“If we look at the cohort of these drugs that were approved over the last 5 years, the endpoints were equally distributed,” McCullough said. “Progression free survival, overall survival, or overall response rates were all equal endpoints of these studies.”
The dearth of comparative evidence necessarily leads to broad guidelines. The National Comprehensive Cancer Network lists 3 tyrosine kinase inhibitors as first-line treatment options for chronic myelogenous leukemia (CML) and 17 sequence options (that use only 5 medications) for patients who eventually need 3 lines of therapy.
There are, however, strategies for caregivers who wish to use available information to establish preferences among apparently similar medications. For example, it is sometimes possible to compare safety and side-effect profiles and use those comparisons to decide which patients should get which medications. “Each of these molecules has distinctions that make them a little bit different,” she said. “They exhibit different side-effect profiles, so they can be tailored to individual patients based on their comorbid position.”
Choosing the medication that produces fewer side effects for the patient might actually increase its efficacy by increasing patient adherence to prescribed regimens. Choosing a medication that’s used on an easy-to-remember schedule could do the same, although McCullough believes caregivers must also give patients better counseling in order to raise adherence rates.
“Go through their daily activities with them,” she said. “Help them figure out when is the time that they can remember to take something once or twice a day. How do they need to take it in relationship to food? What about the other medications that they’re taking? How do they need to store it? It’s education on this level that’s going to make a difference for the outcome.”
McCullough also believes that cost comparisons can help caregivers make wise choices among otherwise similar medications. She noted that the total cost of the different CML medications can vary by $10,000 a month or $120,000 per year per patient. Multiply that by the 6000 new patients who will be diagnosed with the disease in any given year and systemic savings from consistently choosing the cheaper medication over the expensive alternative could reach $720 million.
McCullough urged caregivers to consider cost from the viewpoint of patient co-pays, as well. Co-pays can differ substantially among the various oral options, and there can also be substantial differences between any oral option and an intravenous treatment that’s given in the office. “The last factor, and certainly not the least important when we talk about these oral medications, is that they do have the patient incur a higher co-pay in many instances,” she said before warning about the dangers of prescribing oral medications that patients struggle to afford.
“Do they make concessions, split their doses, skip doses so that they can afford the next pill or so that the medication lasts a little bit longer?” McCullough asked. When the calendar turns to a new year, so can benefits, and providers should be mindful of this. “We can never take for granted that what a patient could afford yesterday is still affordable for them as we go forward.”