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The Pharmacoeconomics of Oral and Self-Administered Cancer Treatments
Oral and patient-administered forms of chemotherapy have come a long way since the 1950s , when mercaptopurine and methotrexate were first approved by the U . S . Food and Drug Administration ( FDA ). Several oral anticancer medications ( OAMs ) have since gained regulatory approval and , increasingly , these agents are joining the ranks of standard-of-care for the treatment of hematologic malignancies and other cancers .
OAMs have been embraced because of their convenience , efficacy , and safety but , because insurers cover them differently than intravenous drugs , prescribing OAMs can impose burdensome levels of cost-sharing on patients . And it ’ s easy to see how : with list prices often exceeding $ 100,000 per year , almost any level of proportional cost-sharing could be prohibitive . 1
This disparity in coverage between OAMs and intravenous drugs places hematologists in a medical and ethical predicament , according to Alan Rosmarin , MD , professor of medicine at University of Massachusetts Medical School and chief mission officer of the Samuel Waxman Cancer Research Foundation in New York .
“ As hematologists , we want our patients to have the most effective drugs – those that improve their lives ,” explained Dr . Rosmarin , who also is chair of the American Society of Hematology ’ s ( ASH ’ s ) Committee on Government Affairs . “ We don ’ t care about what form the drug is in , but we don ’ t want to give a second-class treatment because cost is an issue for the patient – especially when costs are due just to idiosyncrasies in insurance-plan design .”
“ Oral parity ” is the proposed legislative solution that could alleviate coverage discrepancies between oral and intravenous anti-cancer medications . Advocates for oral parity laws also want to bring financial relief to patients who are shouldering unmanageable drug costs . Here , ASH Clinical News examines the advantages and disadvantages of OAMs and the efforts underway to address financial issues associated with their use , as well as those of other anti-cancer drugs .
America ’ s Byzantine Insurance Structure
OAMs are used across a large and growing range of cancer types and constitute the first choice of treatment for remission induction and maintenance in certain hematologic malignancies . In chronic myeloid leukemia ( CML ), for example , firstline treatment involves an oral tyrosine kinase inhibitor .
“ To give anything but a tyrosine kinase inhibitor these days if these drugs are available would be malpractice , unless that person was going to get a transplant for some reason ,” Dr . Rosmarin said . Nevertheless , he and other oncologists regularly encounter patients with limited access to OAMs because of unmanageable out-of-pocket ( OOP ) costs .
Most insured cancer patients in the U . S . contribute financially to their medications . When the treatment is an infused anti-cancer agent , the payment is usually covered under the health plan ’ s “ medical benefit ;” patients pay a standard , flat co-payment for an office visit that may include outpatient intravenous medications .
However , patient-administered anti-cancer drugs ( mostly oral agents , but self-injected drugs also are included in this classification ) generally are covered under the patient ’ s “ pharmacy benefit .” Oral and self-injected drugs tend to appear on separate specialty tiers , which may have higher co-payments than intravenous drugs . Covered drugs might also have high deductibles and annual benefit caps , all of which result in proportionally higher cost-sharing than what is required for parenteral drugs administered in a clinic or hospital setting – even if the actual costs of the drugs are similar .
And , if patients can ’ t afford their medications , they can ’ t benefit from them . Research has shown that sticker shock impacts treatment adherence . A study of claims data from more than 38,000 people who received a new prescription for one of 38 OAMs from 2014 to 2015 found that , as OOP costs rose , fewer patients filled their prescriptions . 2
When the required co-pay was less than $ 10 , only 10 percent of patients failed to pick up their prescriptions . This figure jumped to 32 percent for patients whose OOP costs were between $ 100 and $ 500 , and to 41 percent when OOP costs were between $ 500 and $ 2,000 . When the OOP costs exceeded $ 2,000 , nearly half of patients ( 49 %) never filled their prescriptions .
Delayed initiation of treatment was also significantly higher for those with higher cost-sharing burdens .
“ Patients in our study were facing a new cancer diagnosis or a change in their disease that required a new treatment . Imagine leaving your doctor ’ s office with a plan , ready to start treatment , only to find you can ’ t afford it ,” lead author Jalpa A . Doshi , PhD , from the Perelman School of Medicine at the University of Pennsylvania , said in an accompanying press release . Approximately one in eight patients identified in the retrospective study had OOP costs above $ 2,000 and , even more sobering ,
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