The Washington Post is reporting on a story so craven you might want to bubble wrap your computer before reading it. A group of cancer doctors got together to see if there were any effective drugs on the market that would remain effective in treating cancer when taken at a lower dose. They were looking into finding ways to help lower the costs that cancer patients incur.
The science behind Imbruvica suggested that it could work at lower doses, and early clinical evidence indicated that patients with chronic lymphocytic leukemia might do just as well on one or two pills a day after completing an initial round of treatment at three pills per day.
The researchers at the Value in Cancer Care Consortium, a nonprofit focused on cutting treatment costs for some of the most expensive drugs, set out to test whether the lower dose was just as effective — and could save patients money.
The costs of taking Imbruvica for cancer patients are around $148,000 a year. So taking less of this drug might save you (and insurance companies) thousands of dollars every year. But big pharmaceutical companies don’t like losing money, no matter who has to die or go bankrupt; and Janssen and Pharmacyclics—two companies that have a joint venture in producing and selling the drug—came up with a nifty way around the potential loss of profits. The manufacturers decided to stop making a 140-milligram pill and begin making different strength pills that all cost $400 each. This literally triples the original price of the drug.
Doctors wrote about this infuriating turn of events in The Cancer Letter, published last week.
In order to ensure that all patients receive a single tablet rather than multiple 140 mg tablets, the manufacturer has priced all tablet strengths at the same price, so that a physician who wished to prescribe 420 mg as three 140 mg tablets would be unlikely to get payor approval to do so, since the cost would be 300% of the single 420 mg tablet. Furthermore, patients who have been on a daily dose of 140 mg now find that the cost of their 140 mg tablet is more than three-fold higher than the cost of their prior 140 mg capsule.
While flat pricing schemes are not uncommon, it is highly unusual to change from a linear (i.e., per mg) to flat pricing scheme after initial marketing approval, over an eight-fold range of daily dosages. Furthermore, this flat pricing scheme appears to have been motivated by the manufacturer’s awareness of the increasing interest in utilizing lower doses of ibrutinib off-label,[3] based on a study initiated at MD Anderson in June 2016 and recently presented at the 2017 meeting of the American Society of Hematology. In this small pilot study, the dose was lowered from 420 mg to 280 mg, then to 140 mg qd, without any apparent loss of biological efficacy, not surprising given the initial phase 1 study.
It’s important to point out that the viability of taking less of the drug Imbruvica to similar beneficial results has still not been resolved—and those patients taking the lower doses are now being gouged three times as much as they were when they started. The doctors also point out that the efficacy of these kinds of cancer treatments are further hindered by this insidious decision, because it includes a logistically idiotic buyback program that, while seemingly benign on paper, is potentially deadly to the patients.
Given the expected frequency of dose adjustments, the manufacturer (and/or its marketing partner) has developed the You&iTM program to allow patients to exchange their current tablets for those of a different strength. However, this program is inconsistent with rapid dose adjustments, since it requires completion of a form by the prescriber, signature of the form by a You&iTM pharmacist (only available from 8 am to 8 pm Eastern Time, Monday to Friday), shipping of the new strength to the patient, and the requirement for return of the patient’s prior tablets to the manufacturer. In the event of a temporary dose reduction (e.g., 14 day course of antibiotics), the process would need to occur again. This is critical because prior studies have demonstrated that a gap of a week or more without ibrutinib can impact survival.[9] Any putative convenience advantage of taking one pill a day is negated by the marked inconvenience to the patient of having to return pills every time there is a need for a dosage change. Furthermore, in the future, it is likely that many patients will be receiving combinations with other agents. Dosage adjustment in combination protocols is often much more complicated than for single agents.
It is worth comparing the prescribing information for ibrutinib with that of warfarin, which has been called “the most dangerous drug in America”.[10] Warfarin is formulated in nine strengths ranging from 1-10 mg daily. However, prescribers have complete discretion to select the dose strength most appropriate for each individual patient, and may choose to prescribe a 2 mg strength for a patient whose daily dosage requirement ranges from 4-6 mg daily. Prescribers also choose to use every other day dosing on occasion. Needless to say, it would be not be possible to safely use warfarin if the prescriber had to order a new tablet strength for each and every dosage change.
But don’t worry, everybody—Janssen and Pharmacyclics are just trying to make the world a better place!
In a statement, Janssen and Pharmacyclics said the companies began to develop the new single-tablet dosing regimen in 2015 “as a new innovation to provide patients with a convenient one pill, once-a-day dosing regimen and improved packaging, with the intent to improve adherence to this important therapy.” They called the studies on lower dosing “highly exploratory in nature” and noted that patients who take a higher dose of the drug will save money.
Any time you hear “improve packaging,” that’s some bullshit. Unless you are turning the capsule casing into magic, you are just doing industrial design work, while trying to cut costs on manufacturing. You do the research and you make the discovery and you get the big payout. That’s great. After that, trying to squeeze more and more money out of people going through the most difficult times of their and their families’ lives is evil. Only evil.