Capping patient assistance for specialty prescription drugs may lead to lower medication adherence, according to findings published in The American Journal of Managed Care® (AJMC®). In an accompanying editorial, AJMC®’s co-editor-in-chief calls for a “truce” between drug makers and payers so that cost does not prevent patients from accessing high-value therapies.
(CRANBURY, N.J.) -- Employers and their employees are grappling with the rising costs of specialty drugs. High-deductible health plans (HDHPs) are one way to manage costs, but they have received some negative attention for the possible impact they have on deterring people from seeking needed medical care. But another method—co-pay accumulator adjustment programs (CAAPs)—could be having the same effect, according to a new study published in the current issue of The American Journal of Managed Care® (AJMC®).
Until recently, co-pay assistance funds, typically in the form of co-pay cards or coupons offered by pharmaceutical companies for branded drugs, counted toward the patient share of payment due to the lack of an accounting process to separate patient out-of-pocket (OOP) payments from manufacturer subsidies. This assistance allowed HDHP enrollees to reach their deductible limit sooner, largely without using their own funds, and it also exacerbated employers’ concerns around increasing medical spending.
Through the use of CAAPs, pharmacy benefit managers ensure that any manufacturer subsidy for patients’ OOP medication cost is not credited toward their deductible. Under a CAAP, HDHP enrollees may see a sharp, sometimes unexpected, spike in OOP medication costs during treatment when manufacturer subsidy limits are reached but before they reach their deductible.
This is the first study to examine whether unanticipated OOP expenses may lower medication adherence and persistence. The authors examined autoimmune drugs, such as those used for gastrointestinal or arthritis-related autoimmune disorders, before and after a CAAP was implemented in an insurance exchange that managed patients enrolled in an HDHP paired with a health savings account (HSA) or a preferred provider organization (PPO). After CAAP implementation, adjusted trends in monthly fills per person for drugs like adalimumab and etanercept (sold under the brand names Humira and Enbrel, respectively) fell more rapidly, the risk of treatment discontinuation was significantly higher, and the proportion of days covered (PDC) was significantly lower for patients with the HSA versus the PPO. Ten months after the CAAP started, HSA patients had 233 fewer autoimmune drug fills per 1000 patients, 20 percentage points higher treatment discontinuation, and 12 percentage points lower PDC, compared with the period before the CAAP.
“In the face of growing healthcare affordability challenges, we question whether CAAPs are appropriate. Evidence suggests that although [specialty pharmaceutical] expenditures may fall because of reduced drug use, overall healthcare expenditures may increase,” the authors write.
Nonmedical switching for reasons of cost containment may negatively impact health outcomes, they write; although such techniques may cause other health costs to rise and hurt worker productivity, employers generally look at short-term results instead of long-term effects.
“While this analysis did not specifically evaluate the effect of household income on specialty drug adherence, our prior research would suggest that lower-income individuals are disproportionately negatively impacted by such unanticipated medical expenses. Our current study evaluating the impact of employee wage on specialty drug adherence and use of CAAPs will provide additional insights, hopefully leading to more value-driven and equitable benefit designs for the future,” said Bruce W. Sherman, MD, lead author of the study.
In an accompanying editorial, A. Mark Fendrick, MD, co-editor-in-chief of AJMC®, and Jason D. Buxbaum, MHSA, note, “The competing strategies of [patient assistance programs] and CAAPs create confusion and administrative burden for clinicians and patients, potentially reducing adherence to clinically indicated services and worsening patient outcomes.” They call for a “truce” in order to balance the needs between patient access and managing expenses through new, collaborative arrangements.
“For example, payers could limit CAAPs to low-value situations (such as when a brand name is requested but a chemically equivocal generic is available), and manufacturers could develop stricter guidelines on who receives cost-sharing assistance,” Fendrick said.
For the full study, click here.
For the full editorial, click here.
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