The Promise of Oral Anticancer Agents: Addressing Compliance and Affordability
By Rhoda Dunn and Gordon Gochenauer
Sales of oral cancer drugs have more than tripled to $20.6 billion in five years and now account for 25.9% of total global oncology drug sales. Physicians and patients appreciate the targeted nature of most oral drugs, which tend to confer better tolerability than traditional chemotherapy combined with strong efficacy results (particularly in diseases such as CML, BRAF-mutated melanoma, and ALK-positive NSCLC for which a single protein is strongly correlated with the disease). Although most physicians can appreciate the convenience of oral cancer treatments for patients, it remains unclear whether prescribing and patient use of oral drugs has been optimized.
A 2012 Kantar Health survey of 150 oncologists showed that 48% of respondents would be more likely to prescribe an oral drug over an IV drug assuming clinical equivalence. This percentage is up from 40% two years ago. The reasons for the increased likelihood to prescribe an oral drug, in ranked order, are
the availability of specialty pharmacies to help with coverage and reimbursement issues, financial assistance, and patient compliance;
greater comfort with orals as familiarity has increased; and
However, concerns about patient compliance, safe handling, and affordability continue to place orals at a disadvantage relative to IV equivalents or alternatives. Based on these findings, there is room to improve oral drug utilization by addressing compliance and affordability concerns.
Drug affordability continues to challenge physician prescribing, prescription fulfillment, and patient compliance despite efforts to close the Medicare donut hole, neutralize the impact of out-of-pocket (OOP) burden on treatment choice through patient assistance programs (PAPs), and introducing oral parity legislation.
The issue of affordability may become even more acute in 2014, when the individual mandate requiring certain individuals to purchase health insurance or be subject to an additional tax is expected to go into effect, although some patients will benefit from a maximum OOP limit for oral drugs. Using healthcare reform in Massachusetts as a proxy for what might happen with national health reform, the Affordable Care Act (ACA) may simply replace uninsured patients with underinsured patients.
Although cost share for drugs at the point of service has generally decreased in Massachusetts, premiums and deductibles are rising and are front-loading costs such that patients may not be able to afford the care that would lead to a prescription.[3-5] Moreover, many patients who would otherwise have received free care, face cost sharing challenges for drugs alongside potential premiums and deductibles.[3-5] As a result, a growing share of Massachusetts residents spend a larger percentage of their incomes on total healthcare costs, and the number of residents facing medical debt and bankruptcy has not declined.[3-5]
In July 2012, it was announced that manufacturers will be allowed to offer co-pay assistance to commercially insured Massachusetts residents. Kantar Health speculates whether this change in stance is a consequence of growing underinsurance in the state. An increase in the number and degree of underinsured patients may require that manufacturers revisit the structure of free drug and co-pay assistance programs. A question for the lawyers is whether there is a point at which an “underinsured” patient can reasonably be reclassified as “uninsured.”