Value in Cancer Care Consortium Leads the Charge Against Mounting Financial Toxicity
Journal of Clinical Pathways spoke with Allen Lichter, MD, FASCO, regarding the growing concern of financial toxicity among stakeholders in the cancer community and the efforts of the Value in Cancer Care Consortium to improve the access, affordability, and value of cancer therapies.
Mr Bessette: Can you explain the increasing financial toxicity that we’ve seen accompanied with efforts to de-escalate therapy?
Dr Lichter: Financial toxicity is now an important aspect of oncology care. When insurance schemes and concepts were created years ago with copays and deductibles and other things, it was happening at a time when drugs were relatively inexpensive. A drug that costs $100 was considered an expensive agent. Nowadays, with modern oral cancer therapies are in the $100,000-$150,000 range or more and we start to see combinations of these drugs coming out, prescriptions that will cost patients hundreds of thousands of dollars carry copays that are significant.
In Medicare Part D, once you get through the donut hole you are responsible for 5% of the drug cost. If you are dealing with drugs that cost $50, that is one thing. But when you are taking a drug like ibrutinib, which might cost $130,000 or $140,000 per year, a 5% copay is a huge sum. The median income for seniors in the United States of America is somewhere in the mid-$50,000 range, so when you are spending $6000 or $7000 on a copay for one drug you are putting people under tremendous stress. Therefore, it is incumbent upon us to figure out how we might deal with this.
Mr Bessette: Can you briefly describe the Value in Cancer Care Consortium? How do you hope it will benefit government and commercial payers, taxpayers, and patients and their families alike?
What we have done is establish a group called the Value in Cancer Care Consortium less than one year ago, whose goal is to do clinical research designed to reduce the cost of the therapies we give without decreasing their effectiveness and consequently, give patients at least some partial relief. We can do this because many of the drugs we use today for modern cancer therapy are given in doses that are well in excess of what is necessary to produce the effect. Once the company establishes the dose and the FDA label is established and the on-label dose is locked in, it is not in the company’s interest to start doing further research to see if the dose can be lowered. Instead, it is our responsibility to do that work and that is what the Value in Cancer Care Consortium intends to do.
Our first pilot study of the prostate drug, abiraterone, showed that 75% of the drug could be eliminated without changing the effectiveness of the agent. Our next study will be in a hematologic drug, ibrutinib, used for chronic lymphocytic leukemia and other lymphomas. In this case, we believe that approximately 66% of the drug is wasted in the standard dose of 420 mg. We believe the ideal dose is closer to 140 mg. Interestingly, the manufacturer changed the way the pills are sold and formulated.
Mr Bessette: Can you go into detail about this change?
Dr Lichter: When ibrutinib came out, the manufacturer’s own data showed that the target, which is a molecule called Bruton’s tyrosine kinase, was fully occupied at a dose that was quite low, but the company chose to test a dose of 420 mg. To this day, that dosage is on the label. About 33% of patients need dose reductions to 280 mg or 140 mg and the company produced the drug in a capsule of 140 mg. The label dose was three capsules per day, but if for side effect or drug interaction reasons, your physician could quickly and easily inform you to cut down to one or two capsules per day.
Then some studies were done, which the manufacturer participated in at the University of Texas MD Anderson, showing that the target was 98% occupied when patients received 420 mg, but also 98% occupied when they received 140 mg. Now, it is important to note that the manufacturer conducted those studies of target occupancy, so they understood what the issue was.
We had to do a clinical trial to show that the actual clinical outcomes were the same if you reduce the dose. But before we could do that trial, the company pulled the capsule from the market and came out with tablets: either 140 mg, 280 mg, or 420 mg. All of the tablets cost the same price. Therefore, if a patient takes a lower dose, our study shows that the lower dose is just as effective and there is no cost saving. In other words, if the 140 mg dose is, in fact, the proper dose, patients will pay three times as much for the tablet as they would for the capsule.
The manufacturer, of course, says that it is much more convenient for a patient to swallow one pill. But we are talking about a difference in cost of about $90,000 a year if you could end up with a lower dose. A good example to demonstrate this dilemma is the frequent use of Advil. I take Advil, sometimes two or three tablets at a time. It would be easier to take one, but would I pay $90,000 for that convenience? I absolutely would not. On this note, I doubt that the manufacturer convened focus groups of patients who would said, “The possibility of taking just one capsule rather than two is worth $90,000 to me.” As evidenced, changing the pill formulation was undoubtedly done to immunize the manufacturer against any revenue loss that they would suffer from conscientious physicians, such as those in the Value in Cancer Care Consortium who want to help patients through the financial struggles of cancer care.