Legislation Aims to Ease Patient Access to Oral Oncolytics

During the past decade, as traditional intravenous (IV) chemotherapies have given way to more targeted oral medications, the administration of cancer treatments has gradually shifted  from the clinic to the home. Oral oncolytics have empowered many patients to reclaim control of their lives by enabling them to spend less time in infusion clinics and more time enjoying their own pursuits. For many immunocompromised patients—particularly during the ongoing COVID-19 pandemic—oral therapies have removed the burden of transportation, a significant barrier to treatment for some.  

But due to inequities in access to self-administered oral oncolytics (compared to traditional infusion drugs), patients prescribed these medications can experience significantly higher cost-sharing. The enormous out-of-pocket cost difference between well-covered traditional chemotherapies and often-uncovered oral oncolytics can result in levels of financial toxicity from which many patients struggle to return. For some patients, a monthly prescription can cost thousands of dollars in out-of-pocket costs—the result of insurer pay structures that disadvantage patients on oral oncolytics. 

Reducing Cost-Sharing 

The medical benefit portion of group plans is usually informed by standardized amounts for coinsurance and copays. Insurers allow providers to bill IV therapies as medical benefits, which are covered at a much higher rate than oral medications, which are typically covered under drug benefits. Most drug benefits classify prescription medications within a tiered system, which can result in wide-ranging out-of-pocket costs.  

Insurers categorize many new and costly medications as “non-preferred,” which can result in significant copays for patients prescribed these drugs. For example, it is not unusual for a group plan to require a 20 percent coinsurance for an IV therapy, and, under the same policy, require a 50 percent coinsurance for an oral oncolytic on the plan’s non-preferred drug list. This results in oral therapies carrying a much higher cost burden than traditional infusion drugs.  

These cost-sharing disparities have resulted in treatment non-adherence and unnecessary treatment delays as patients struggle with coinsurance and copay amounts. Patients negatively affected by significant cost-sharing burdens have shared their stories, raising awareness about the issue and promoting conversations about equal access.  

Promoting Cancer Parity 

To address this issue, the U.S. House of Representatives has this year reintroduced the Cancer Parity Act (H. R. 4385), which seeks to resolve unequal cost-sharing for oral oncolytics as part of the Biden administration’s commitment to “end cancer as we know it.” The proposed legislation, which enjoys bipartisan support, was introduced by Rep. Brian Higgins (D-NY-26) on July 9 and is co-sponsored by four additional Democratic and Republican representatives. “Cancer patients should have access to whichever treatment gives them the best chance to fully recover,” said Rep. Gus Bilirakis (R-FL-12), a co-sponsor of the bill.  

By “requiring health plans that cover anticancer medications administered by a health provider to provide no less favorable cost-sharing for the patient-administered anticancer medications,” the proposed law would result in enormous savings for patients with cancer who are prescribed oral oncolytics. The Cancer Parity Act would apply to medications that are: approved by the FDA; medically necessary for the cancer treatment; and clinically appropriate in terms of type, frequency, extent site, and duration. To accomplish this, the bill seeks to prevent unequal coverage of oral and infusion drugs by amending ERISA (the Employee Retirement Income Security Act of 1974), which regulates group health plans—the most common types of insurance plans in the U.S.  

Eliminating Delays 

Dispensing oral oncolytics also differs from dispensing traditional IV therapies in terms of wait times for patients. Prescriptions for oral therapies often require prior authorization from insurers, which can delay treatment as clinical and office staff struggle to navigate the often-bureaucratic requirements necessary for approval. Then, if an insurer requires that a specific drug be dispensed by an external specialty pharmacy, there may be additional delays as clinics coordinate the delivery of the drug. These built-in delays can mean that patients start their therapies weeks after they are prescribed. 

Introduced in May 2021, the Timely Access to Cancer Treatment (TACT) Act (H.R.3258) addresses the wait time for fulfilling oral oncolytic prescriptions. At its core, the legislation aims to reform the practices of health insurers and pharmacy benefit managers (PBMs). The bureaucratic systems that PBMs engender can systematically undermine the provider/patient relationship by hampering timely access to prescribed medications.  

“The TACT Act is a simple, commonsense solution that would remove unnecessary roadblocks and empower doctors to get their patients the critical care that they need in a timely manner,” said Terri Sewell (D-AL-7), the bill’s sponsor. If enacted, the law will: 1) improve timely patient access to oral oncolytics by eliminating bureaucratic red tape, 2) impose a 72-hour turnaround for medication dispensing, 3) require pharmacies to alert providers within 24 hours if they cannot fill prescribed medications within the proposed time limit, and 4) give providers and patients the authority to pick an alternative pharmacy of their choice if they do not receive their medication in a timely manner.  

Taken together, these two bills aim to compel insurers to treat all cancer therapies equally, thus easing patient access to life-saving oral oncolytics. ACCC will continue to advocate for and monitor the Cancer Drug Parity Act and the TACT Act.

For more information:

• ACCC Oncology Pharmacy Education Network (OPEN)
• Integrating Oral Oncolytics into Pharmacy Practice
• Oral Parity: When Modern Medicine Outpaces Policy