Financial Implications of Enzalutamide

Enzalutamide is indicated for second-line treatment for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).¹ There is no regulation over the setting of drug prices in the U.S. The monthly retail cost of treatment with enzalutamide is approximately $12,000, making it a “specialty drug.” The average price tag of the more than 300 medications that are considered specialty drugs is approximately $79,000 per year.² Medicare spent $32.8 billion on specialty drugs in 2015.³ With a mean treatment duration of 34 months,¹ the treatment costs for enzalutamide can be in the hundreds of thousands of dollars. This serves as a barrier to accessing treatment.

Table. Enzalutamide (Xtandi®): United HealthCare Medicare Advantage Choice Plan 1 (11203)

Current Structure

Pharmacy benefit managers (PBMs) are a third-party administrator of prescription drug programs for commercial plans, Medicare Part D and managed Medicaid prescription plans. They play a major role in the development and management of the medication formulary. PBMs have no legal obligation to act in the best interest of the consumer. As a result, manufacturers can influence PBMs’ formulary inclusion decisions through various financial incentives such as providing rebates for the PBMs.⁴ The out-of-pocket cost for specialty drugs includes premiums, medication deductibles and a co-pay (coinsurance), which vary based on the insurance plan. In a “specialty tier,” patients’ coinsurance exposure can be significant, in some instances as high as 25% to 33% of the drug price.³

For workers enrolled in employer-sponsored plans with 3 or more tiers, the average coinsurance rates are 18% for first-tier drugs, 25% for second-tier drugs and 37% for third-tier drugs. For single coverage in employer-sponsored plans, 62% of workers face an out-of-pocket maximum greater than $3,000, and 18% have an out-of-pocket maximum greater $6,000.⁵ This maximum is in addition to the premium and deductibles. We present a 58-year-old man with nmCRPC in Central Brooklyn with a salary of $64,658/year. His employer-sponsored plan is UnitedHealthcare^® Choice Plus Gold, which has no deductible for prescription drug coverage, but requires a 20% coinsurance with each prescription with a maximum of $150 co-pay/month for tier 3 specialty drugs. If this patient required second-line therapy with enzalutamide, his coinsurance cost would be $1,800 per year in addition to his insurance premiums.

Medicare Part D recipients constitute the largest nmCRPC patient segment. The percentage of Medicare enrollees who were in the 65- to 85-year age group in 2020 was 76%, while the median age for patients with nmCRPC in the PROSPER trial was 74 years.^1,6 Medicare Part D can be part of a Medicare Advantage plan, which provides complete health coverage, or as a stand-alone prescription plan. The table highlights the potential out-of-pocket cost exposure for a patient with nmCRPC in Brooklyn, New York with the UnitedHealthcare Medicare Advantage Choice Plan prescription drug plan using Medicare’s online Donut Hole calculator.

This Medicare Part D beneficiary in Central Brooklyn would have to pay over $10,000 for a year of enzalutamide. There is no limit on the total amount that Medicare Part D beneficiaries have to pay out of pocket each year unless they qualify for Part D Low Income Subsidies. When including Lupron^® (leuprolide), one of the most prescribed GnRH agonists in advanced prostate cancer, the total out-of-pocket cost for this patient for the year is approximately $11,078

Financial Assistance Programs

The Low Income Subsidies program offers financial support for annual deductibles, monthly premiums and co-payments associated with the Medicare drug prescription program. To qualify, beneficiaries must be enrolled in the Medicare Savings program, qualify for full Medicaid benefits and receive Supplemental Security Income. State Pharmaceutical Assistance Programs utilize state funds to pay for a portion of the prescription drug costs for state residents. They are usually directed at a defined population that meets specific enrollment criteria. Currently, there are only about 17 states with an operational State Pharmaceutical Assistance Program.⁷ Drug discount programs and charity patient assistance programs also help patients mitigate the cost of treatment. However, these organizations impose caps on the number of patients they can accept. For patients with nmCRPC, this is not a reliable option. Two such foundations, PAN Foundation and Patient Advocate Foundation Co-Pay Relief, offer a maximum yearly award level of $7,100 and $3,500, respectively. While providing a benefit to a subset of patients, many view this underwriting as a method to support the current retail pricing paradigm.⁸

Public/Private Sector Solutions

Public policy interventions would be disruptive to the status quo. Waxman et al identified major interventions with the potential to better control prescription drug prices.⁴ These interventions include allowing Health and Human Services via Centers for Medicare and Medicaid Services to negotiate directly with drug companies, stopping patent abuses, legislating abbreviated pathways in the U.S. for biosimilars for U.S. Food and Drug Administration approval, and requiring more transparency in the drug supply chain. Currently, contracts between manufacturers, PBMs and health plans are often designed to deter lower priced biosimilar products.⁴ Finally, as pharmaceutical research tends to be heavily subsidized by the federal government, ensuring public accountability in the drug development process is crucial in reducing prescription drug prices. Potential private sector solutions include the implementation of third-party financing for⁶ high-cost drugs via the well-established loan securitization model.⁹

Second-line treatment for nonmetastatic, hormone-resistant prostate cancer could have significant financial ramifications for patients. This is all largely based on the fallibility of the current health care paradigm; however, this is not the sole factor at play here. This financial toxicity also stems from the paucity of medical insurance literature and the demographic influences of these insurance consortiums, particularly when it comes to socioeconomically diverse communities. There is a salient disproportionality in health insurance literacy when it comes to this cohort of patients, especially Black and Hispanic patients.¹⁰ The importance of urologists’ understanding of the current financial structure surrounding specialty drugs cannot be overstated. By learning about the difficulties that patients encounter with increasing out-of-pocket costs, these providers can reduce the economic barriers that may disrupt their clinical management. The urologist must actively participate in facilitating patient access to the payment assistance programs previously discussed.