Summary

Prior authorization requirements and specialty pharmacy steering by payors delay the start of oral anticancer therapy, interrupt established treatment and worsen adherence. Integrated specialty pharmacies with oncology expertise can visibly shorten these delays. Pharmacists and advanced practice providers have led much of the research in the area of oncology medication access, and they have the potential to make a substantial impact on healthcare policy and patients’ access to therapy by participating in advocacy activities and engaging with their legislators.

Key Takeaways

  • Oral anticancer therapy often carries high copayments and separate insurance processes from infusions, and income limits can exclude patients from assistance.

  • A new prior authorization requirement on an established oral anticancer drug increased time to next fill by 9.7 days and raised the odds of treatment discontinuation within 120 days.

  • External specialty pharmacy fills delayed treatment initiation by four to six days and were associated with worse adherence in retrospective studies.

  • Integrated specialty pharmacies and embedded pharmacists reduce delays, and APPs and pharmacists have led much of the supporting research in this area.

  • Advocacy through professional societies and sharing patient stories through legislator contact can make a difference for our patients.

A Patient Who Is Relieved, Then Worried About Cost

A 68-year-old retiree was diagnosed with myeloma at a local oncologist's office and has now come to an academic medical center. He is fit and transplant eligible, and quadruplet induction is recommended. He and his wife are relieved to have a plan, but they are worried about its cost. His insurance covers the infusions given in clinic, but the oral component of the regimen carries a substantial copayment, even though he has prescription coverage. They live on a fixed income and fear that they cannot begin or continue treatment while paying their other expenses.

Manufacturer copay and financial assistance are the obvious first steps, but eligibility is complicated by his insurance status and household income, and clinicians often see patients above the income limits for support whose copayment is still beyond their ability to pay. The specialty pharmacy then reports that his insurance may delay the start of treatment because of prior authorization and step therapy rules.

What the Data Show About Prior Authorization

Prior authorization requirements increase the probability of delayed and discontinued care. A 2024 study of Medicare patients already receiving an oral anticancer agent found that introducing a new prior authorization requirement increased the time to their next fill by 9.7 days and raised the odds that they discontinued treatment within 120 days. A survey-based study of patients with experience of prior authorization in their cancer care found that 22% did not receive the care their team recommended. Of those with delays, 73% reported a delay of more than two weeks, and most patients had to get personally involved in the process. As a result of their experiences, 83% of patients reported that they trusted the health care system less.

What the Data Show About Specialty Pharmacy Restrictions

Specialty pharmacy restrictions, in which payors steer patients from an internal specialty pharmacy to an external one, are associated with longer time to treatment and poorer adherence. In a single-center study from 2024, time to treatment initiation was six days longer for patients whose specialty medications had to be filled externally than for those using an integrated health system specialty pharmacy. Another retrospective study comparing internal and external fills found a four-day delay, along with statistically significantly worse adherence among patients who filled oral anticancer medications at an external pharmacy.

Panel Perspectives on Access in Practice

Infusion and Oral Therapy Take Separate Paths

An APP on the panel described the frustration of getting the infusion portion of a chemotherapy regimen approved through the medical benefit while the oral agent runs through the pharmacy benefit, because the systems do not talk to each other. A comprehensive plan sent to the insurer may be approved in part, but the two components are processed differently, with little visibility. The center sends everything to its specialty pharmacy first, and if the pharmacy is not contracted to fill an oral medication, specialists embedded there identify who can fill it and often transfer the prescription. For clinics without such resources, the effort of tracking all the pieces is considerable. After the infusion, the oral script is sent, and the question becomes how to confirm that the patient received it and started it, especially when a ramp-up or labs are planned for a particular day.

An Integrated Pharmacy Fixes Problems That Distance Creates

A pharmacist on the panel described the single biggest frustration with oral chemotherapy medication access as being unable to use the institution's integrated specialty pharmacy, because with the internal pharmacy, a call or a walk down the hall can fix the problem. When a patient reports one pill left and the supply must come from a pharmacy in another state, options narrow. Different sources of medication also disrupt timing for regimens that were studied as combinations started simultaneously or in a precise sequence. At some institutions, every oral specialty medication goes to a queue and is reviewed by a medication access team, even if the prescription goes outside. Site-of-care rules add another issue: because all infusion centers are hospital-based, even injectable medications raise questions about clear bagging to avoid the hospital-based facility fee.

What Internal Specialty Pharmacies and Pharmacist-Led Oral Chemotherapy Clinics Can Achieve

Many institutions have embedded pharmacist-driven oral chemotherapy clinics, while other institutions’ internal specialty pharmacies set a standard, providing care and follow-up beyond what would be expected, including when prescriptions must be filled externally: the team knows when the patient receives the drug and when treatment starts. The panel agreed that every institution should have an internal specialty pharmacy and oral chemotherapy clinics, and that APPs and pharmacists, who led many of the studies cited, should continue to lead this research to make the case nationally.

A Call to Advocacy

The speaker's closing challenge was that this is the best time to engage, because these issues are being debated. Congress held a hearing on oral chemotherapy last month, the Cancer Drug Parity Act is written and under discussion with bipartisan support, and legislators are also talking about modernizing clinical trial access and patient steering, which is what happens when prescriptions are sent externally.

Practical steps include joining organizations with advocacy councils, among them JADPRO, HOPA, ASH, ASTCT, and ACCC; subscribing to their newsletters; following legislators' updates; and writing, meeting with, and telling patient stories to lawmakers, because legislators often cite the stories that clinicians told them. Colleagues can also help by supporting someone else to attend advocacy days if one is not comfortable speaking, and institutions should prioritize sending APPs and pharmacists to these events. A panelist added that the real win is not getting Patient A the drug that day, but rather identifying the barriers overcome with significant effort and removing them so they do not recur. That is why advocacy matters in the long run.

Why Access Barriers Matter for Cellular and Bispecific Therapy

The earlier discussion of cellular therapy raised the same issues: manufacturers fund travel and housing for many CAR-T products, yet panelists stressed that staff, lodging support, and financial navigation must be funded before the need arises. The access barriers described for oral agents are therefore part of the broader gap between a therapy's approval and a patient's ability to receive it, and pharmacists and APPs are positioned to document it, teach it, and advocate for change.

For Patients

Cancer treatment can be expensive even when you have insurance. Infusions given in the clinic are often covered differently from pills you take at home, and a pill may carry a large copayment. Insurers may also require approval before a medicine is covered, which can delay the start of treatment or interrupt treatment that has already begun, and they may require you to fill prescriptions at an outside pharmacy instead of an embedded pharmacy where you receive the rest of your cancer care, which in studies led to later starts to treatment and more missed doses.

Tell your team right away if cost worries you. Pharmacists, social workers, and financial counselors can look for manufacturer assistance, foundation grants, and alternatives, and some can help you track your prescription so that you do not run out.

Ask your team who is handling approval, how you will know when your medicine ships, and who to call if you have one pill left. Share your experiences with your medical team as well as your legislators: your story can make a difference!

References

  1. Prior authorization and association with delayed or discontinued prescription fills. J Clin Oncol. 2024;42(8):951-960. doi:10.1200/JCO.23.01693

  2. Society for Immunotherapy of Cancer and Association of Community Cancer Centers. Expanding access to cellular and bispecific therapies: workshop report. https://www.sitcancer.org/get-involved/policy/expanding-access-to-cellular-and-bispecific-therapies

  3. Real-world implementation of bispecific antibody delivery in community oncology: overcoming operational barriers through partnerships and interprofessional education. Blood. 2025. https://www.sciencedirect.com/science/article/pii/S0006497125073951