September 2012 Edition Vol.11, Issue 9

The Promise of Oral Anticancer Agents: Addressing Compliance and Affordability

The Promise of Oral Anticancer Agents: Addressing Compliance and Affordability (continued)

Patient Assistance Programs

PAPs (which may include free-drug programs), and commercial co-pay assistance and independent foundations provide financial assistance help to ensure that financial considerations do not interfere with medication prescribing, uptake, and persistence. PAPs are particularly important in cancer because cost sharing can be quite high, rendering a patient underinsured very quickly. 

In 2005, The Commonwealth Fund defined people as underinsured if they are insured all year but experience medical expenses that are at least 10% of their income (or at least 5% if their income is less than 200% of the federal poverty limit [FPL]) or whose deductibles are at least 5% of their income.[9] Efforts to update this definition will be challenging until all states have defined their essential health benefits, which may take until 2016 or longer.

PAPs may be provided directly by the manufacturer via a free-drug program or a cash-assistance program or indirectly via an independent charitable 501(c)3 disease foundation. The type of program appropriate for any given patient usually depends on income and insurance status (i.e., uninsured, federally insured, or commercially insured). 

Meanwhile, manufacturers typically provide direct assistance to uninsured patients who meet clinical and income eligibility requirements. Income requirements are usually calculated as an adjusted percentage of the FPL. For federally insured patients, the landscape is more complex due to Office of Inspector General (OIG) issues around beneficiary steering, anti-kickback, and false claims. 

Manufacturers cannot give cash assistance to federally insured patients to pay for co-payments or coinsurance or to help them through the donut hole. Instead manufacturers may set up disease funds or contribute to existing disease funds run by 501(c)3 foundations that provide financial assistance to income- and diagnosis-eligible underinsured patients. Donations to such funds are diagnosis-specific and cannot be allocated for a specific drug or class of drugs. Alternatively, a manufacturer may provide free drug for qualified patients who enter the donut hole under certain conditions. However, free drug does not move patients through the donut hole, but merely delays the issues presented by the donut hole for the next prescription. 

For commercially insured patients, manufacturers have more flexibility. While there is still concern over anti-kickback laws, the level of scrutiny is not as high as for patients with federally funded insurance. Manufacturers can set eligibility to account for drug characteristics (ie, oral vs IV), payer mix, and competitive landscape, regardless of income. However, most programs do have income thresholds to control costs.

Understanding the Insurance Mix

The insurance mix of patients who utilize PAPs does not reflect the insurance mix of people with cancer (Figure 2). Practice administrators in community practices estimate that 32% of patients who are in PAPs are commercially insured—an increase from 27% in 2010. The uninsured accounts for more than a quarter. Federally insured make up the remainder. 

Understanding the insurance mix of a product and the needs of each coverage segment will help manufacturers optimize the structure of a PAP as well as better understand how much support to provide. Additionally, the 32% of commercial patients receiving PAP support may not fully represent their need. There may be more commercial patients who applied to PAPs, but did not meet eligibility criteria or were unaware of the PAP offerings.

PAP Utilization in Practice: Commercially insured beneficiaries are the primary users of PAPs in community practices

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[9] The Commonwealth Fund Digest Archive. 61 Million Are Either Uninsured or Underinsured. Accessed August 21, 2012.


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