Authors: Shu-wen Tran, B.S., UMKC PharmD Candidate 2020 and Diana Tamer, B.S., Pharm.D., BCOP
How is it possible that patients with certain metastatic cancers are still treated with traditional chemotherapy when targeted precision medicine is available for them as first line agents? While sequencing the whole genome led to having technologies today to sequence each patient’s tumor DNA, and finding targeted therapies for tumorigenesis driving mutations; these therapies are costly and not affordable to most patients—even those with insurance coverage. Is there any way to drive down the cost of oncolytic agents? Let’s explore some avenues.
Targeted therapy, otherwise known as precision medicine, are medications designed to specifically target driving mutation(s) that is/are causing the cancer type. Targeted therapy differs from traditional therapy in that they act on a specific pathway or gene mutation related to the cancer type instead of acting systemically, affecting all normal and abnormal cells. Over the past 10 years, the FDA has approved more than 80 targeted oncolytic therapies, with more than half of them approved for oral administration.1 It is important to understand that traditional chemotherapies remain the standard of care in early stages of cancer, while targeted drug therapies are options for patients with metastatic disease—if they harbor a particular mutation. That is also partly because as new drugs are studied in clinical trials for cancer patients, they start testing them in patients that have no other options and are at more advanced stages of their disease. That being said, as these drugs gain approval, clinical trials in earlier stages of the disease are underway; which will lead to maybe more use of these agents at all stages of cancer.
Disparities in insurance plan coverage for cancer treatment is one of the most challenging aspects patients are facing. Patients are faced with a financial burden when their plan coverage diverges (medical versus pharmacy benefit), and their oral cancer drug therapy treatment is submitted through their pharmacy benefit, instead of their medical benefit. Often times a set-back in cancer treatment occurs because they are unable to afford therapy. So why is this happening?
“Medical benefits often require patients to pay a flat copayment (perhaps $20 to $50 per visit) for care in an outpatient setting, which can include administration of intravenous medications. Pharmacy benefits, by contrast, often have a tiered copayment structure and other provisions that increase cost sharing for more expensive medications. Pharmacy benefits may include coinsurance (in which patients are responsible for a percentage of the medication cost), high overall deductibles, and caps on annual drug benefits.”2 Most insurance plans place oral cancer agents into a “specialty tier” or “fourth tier,” which may require a cost-sharing responsibility for the patient of anywhere from 25 to 33 percent of the cost of the drug, leading to copays which can range from$150-$7,000 per month. And these medications are taken chronically, typically on a daily basis, until disease progression, unacceptable toxicity, or death. And a common question that patient ask in clinic is: “What would I do when I can no longer afford this treatment?”
In 2013, the Cancer Drug Parity Act3 was first introduced to Congress. The purpose of this bill is to help ensure that patients will not pay more for oral chemotherapy agents under their pharmacy benefit than they would for an intravenous chemotherapy agent under their medical benefit. One might wonder, don’t we have something like this in effect? Well, yes—in 43 states. Since 2007, many states have passed their own oral parity law, but it only applies to state health plans, leaving out patients under self-funded and fully insured health plans. If Congress approves this bill, the new federal legislation will require all health plans, including the remaining seven states to adopt this cancer drug parity act. Currently, seven states have yet to adopt this cancer drug parity act: Alabama, Idaho, Michigan, Montana, North Carolina, South Carolina, and Tennessee4.
In a retrospective claims analysis published by Dr. Dusetzina and colleagues5, authors found that oral chemotherapy parity laws showed only “modest” financial benefit for patients. Their analysis encompassed 63,780 patients from three nationwide insurers (Aetna, Humana, and UnitedHealthcare), comparing effects before and after oral chemotherapy parity laws. Patients that were studied lived in one of 16 states that had implemented oral chemotherapy parity laws from July 2008 to July 2012, and who were receiving chemotherapy treatment. Results showed an increase in patient out-of-pocket (OOP) spend of more than $100 per month in plans subject to parity versus a slight decline in plans not subject to parity (8.4% to 11.1% vs. 12.0% to 11.7%, p=0.004). Monthly patient OOP spend on oral chemotherapy agents showed a decline in plans subject to parity in the 25th-, 50th-, and 75th percentile ($19.44, $32.13, $10.83, p<0.001), but saw an increase at the 90th- and 95th percentile ($37.19, $143.25, p<0.001). Dr. Dusetzina and colleagues conclude that “these laws alone may be insufficient to ensure that patients are protected from high out-of-pocket costs.”
So what should we do? As more and more precision, targeted therapies are being pumped into the market, cancer patients should not have to pay any less for their oral cancer drug treatment under their pharmacy benefit than they would under their medical benefit. It is currently unclear exactly how many patients will benefit from this bill. This federal act is a start to help patients gain access to precision medicine. The underlying issue may be the price of the agents themselves. But that’s another article for another time.