Patient Cost-Sharing in Oncology and the Patient Access Network Foundation

The Patient Access Network (PAN) Foundation is a charitable organization that provides underinsured patients with the financial support they need to meet cost-sharing requirements for breakthrough therapies and other costly cancer treatments. PAN was established more than 10 years ago, partially in response to the development of the Medicare Part D prescription drug benefit. Since then, PAN has evolved with the Part D program and the trend among public and private payers to develop separate benefit approaches for specialty drugs, including the use of limited distribution channels and higher cost-sharing requirements.

With nearly 60 disease-specific funds, including 25 for oncology, PAN provides cost-sharing assistance for therapies that are used to treat 2 tumor types for which the FDA has approved distinct immuno-oncology agents: 1) for hormone-refractory prostate cancer, the therapeutic cancer vaccine sipuleucel-T, marketed as Provenge; 2) for metastatic melanoma, the T-cell potentiating anti-CTLA-4 monoclonal antibody, ipilimumab, marketed as Yervoy. In addition, PAN provides assistance for 2 other immunotherapies approved for metastatic melanoma: pembrolizumab, marketed as Keytruda; and nivolumab, marketed as Opdivo.

More broadly, the foundation focuses on helping the underinsured meet the high cost-sharing requirements for critical, prescribed therapies. As such, PAN responds to the reality of current policy and market conditions, while trying to anticipate how future trends could impact its mission and operations. For example, after the Affordable Care Act (ACA) passed in 2010, PAN anticipated the change in the timing of when patients would need financial support; in particular, the start of manufacturers’ discounts for brand name drugs, as well as other provisions that will close the Medicare Part D coverage gap by 2020.

Recently, PAN has been witnessing a growing need for patient financial assistance, as more Medicare Part D plans and commercial insurers are requiring a high percentage (25%-33%) of coinsurance for specialty drugs. While the higher coinsurance cost allows Part D enrollees to qualify for catastrophic coverage earlier in their treatment cycle, this benefit design change has the potential to limit access to and decrease adherence to current cancer therapies—and likely will have the same effect on new immuno-oncology therapies.

EVOLVING WITH MEDICAL PROGRESS

PAN continually evaluates trends in research and development (R&D), regulatory actions for therapies in the R&D pipeline, and government policy and market developments that affect patient access to important treatments for cancer, rare diseases, and chronic conditions. The foundation has followed—with great interest— the development of immunotherapy, a new paradigm in oncology care and an important therapeutic advance that complements current approaches using chemotherapy, small molecule—targeted therapies, radiation, and surgery.

Immuno-oncology presents new challenges that span the regulatory spectrum: from FDA approval of therapies and related biomarkers to a broad range of challenges affecting patient access, including coverage decisions of government programs and private payers, and increased cost-sharing requirements for specialty drugs. Currently approved immuno-oncology therapies and those under development will fall in the specialty category.

Biomarkers, a critical part of the immuno- oncology framework, play an important role in the development of more personalized approaches to drug therapies, and are increasingly included in national clinical guidelines and on FDA labels.¹ In the 10 years since the Human Genome Project ended, medications that include pharmacogenomic information on the FDA-approved label have doubled.² Characterizing biomarkers helps physicans identify positive or negative responders to a certain therapy.³ Because the cost burden for these tests may fall on patients, PAN may need to expand the scope of its cancer funds to provide assistance for patients who face high out-of-pocket (OOP) costs for molecular testing.

ADDRESSING THE COST-SHARING BURDEN

In addition to the high cost-sharing burden associated with traditional, and more time-limited, types of cancer treatment, some newer oncology treatments are prescribed as maintenance therapies over lengthier periods of time. As a result, patients face increasing financial pressures long after the initial oncology treatment has ended.

PAN provides vital assistance to help patients who might otherwise forgo critical therapies prescribed by their physicians. Researchers have quantified the importance of financial assistance by linking patients’ adherence to prescribed treatment to their ability to pay their cost-sharing amounts. Significant evidence has demonstrated the inverse relationship between patient adherence to a prescribed treatment and the level of financial hardship that a cost-sharing percentage represents, based on their income. A study from Prime Therapeutics found that 1 in 6 cancer patients with high OOP costs abandon their medication at the pharmacy. In fact, patients with OOP costs greater than $200 were at least 3 times more likely to not fill their prescriptions than those with OOP costs of $100 or less.⁴ By providing financial grants to cover some or all of a patient’s costsharing amounts, PAN is able to eliminate or reduce cost-sharing as a barrier to that patient’s ability to initiate and adhere to important therapies, including those in the immuno-oncology group.

UNDERSCORING THE ISSUE OF UNDERINSURANCE

Figure

The magnitude of underinsurance as a barrier to cancer care is increasing as the level of health coverage increases (see for more details). The tax subsidies for coverage obtained through the state and federal marketplaces authorized by the ACA are benchmarked to the premium for a defined Silver plan, which has an actuarial value of 70%; that is, 30% of the average annual costs for the covered group, including the high coinsurance rates applied to specialty drugs, will be paid out of patients’ own pockets. The trends in the marketplaces are consistent with those of employer health plans, the leading source of private health insurance coverage.

For example, for 2015, most exchange plans have set the maximum out-ofpocket (MOOP) cost limit lower than the maximum of $6600 for individual plans and $13,200 for plans offered to families. The average deductible for Silver plans, which accounted for about two-thirds of 2014 marketplace enrollment, increased by 7% for 2015 to $2658 (or 45% of the MOOP cost limit). The average deductible for Bronze plans increased to $5249 (or 82% of the MOOP cost limit).⁵

More than half of the individuals helped by PAN had incomes at or below 200% of the federal poverty level. The majority of patients (85%) who have been helped by PAN also are Medicare beneficiaries who cannot afford therapies,6 some of which may be covered as a Part B benefit or a Part D benefit. The other 15% are insured by a private health plan.

LOOKING FORWARD

As a charitable organization, PAN is guided by a board of directors that provides overall policy direction to staff regarding the Foundation’s operations. Most of PAN’s revenue is in the form of donations from interested stakeholders, primarily specialty drug manufacturers. Most of PAN’s expenses are associated with the cost-sharing grants that it provides to patients, along with the necessary administrative costs required to meet the needs of patients in a responsible manner, consistent with all of the regulatory requirements of charitable foundations that provide financial assistance to underinsured patients.

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PAN has continually evolved its programs to respond to the changing needs created by new therapeutic approaches, such as immuno-oncology; legislative changes, such as the ACA provisions that provide health coverage for millions of Americans; and the Medicare Part D changes, including closing the coverage gap and regulatory review of Part D plans’ use of specialty cost-sharing tiers. The Foundation appreciates the role that Evidence-Based Oncology plays in encouraging discussions between providers, payers, and patients on the quality and cost of cancer care. PAN welcomes the chance to participate in discussions about how the new paradigm represented by immuno-oncology will impact the need for the patient financial assistance that PAN provides and how to broaden the range of resources required to provide this important resource for patients.

Dan Klein is president and chief executive officer of the Patient Access Network Foundation.References

framework: enabling a new era of cancer

therapy. Oncoimmunology. 2012;1(3):334-339.

1. Hoos A, Britten C. The immuno-oncology

Genome Project. National Human Genome

Research Institute website. http://www.genome.

gov/27553526. Published April 12, 2013.

Accessed January 13, 2015.

2. NHGRI celebrates 10th anniversary of the Human

Medicine Coalition website. http://www

.personalizedmedicinecoalition.org/Userfiles/

PMC-Corporate/file/pmc_case_for_personalized_