At the first annual conference of the Institute for Clinical Immuno-Oncology on October 1, 2015, in Philadelphia, the discussion revolved around integrating immuno-oncology into clinical practice and programs that assist with patient access to these treatments.
Who Pays for Immuno-Oncology?
Immuno-oncology clinical trials have transformed the cancer treatment landscape. Nearly every week we hear about improved trial outcomes across a broad range of tumor types. However, challenges remain with clinical integration of these revolutionary agents into mainstream cancer care. To discuss existing challenges and possible solutions, the Association of Community Cancer Centers hosted the first annual conference of the Institute for Clinical Immuno-Oncology (ICLIO) on October 1, 2015, in Philadelphia. ICLIO launched as an immuno-oncology resource for community oncologists earlier this year.1
Among the sessions was a presentation by Niesha Griffith, MS, RPh, FASHP, administrator of Oncology Pharmacy and Infusion Services at the James Cancer Hospital, Ohio State University. Griffith provided insight into administrative challenges with immuno-oncology agents, existing coverage policies, and reimbursement concerns. She ended with suggestions on the best practices for successfully using these agents in practice.
The primary challenges for her as an administrator, said Griffith, included:
1. Patient and staff education. Identify a point person to be a resource for immuno-oncology and a core group to manage patient education. This requires proactive staff education on immuno-oncology updates.
2. Patient triage, especially with respect to unfamiliar adverse events. Staff attending patient phone calls should be aware of potential adverse effects that demand immediate attention. Develop protocols for patient triage/management.
3. Navigating financial challenges for these high dollar agents.
4. Reimbursement concerns with new-to-market agents. Assign a dedicated financial or reimbursement staffer—familiar with manufacturer programs, co-pay foundations, and patient assistance programs—to focus on immuno-oncology agents.
5. Off-label use may cause reimbursement concerns. Each institution needs a policy in place to ensure best practices with off-label use, with patients being kept well-informed on financial challenges with reimbursing off-label use.
Griffith pointed out that her cancer center moved reimbursement specialists to the pharmacy department to handle high-dollar approvals, and also developed a work flow to ensure a smooth process for both on-label and off-label immuno-oncology agent use—a staff-intense process that would need additional hands on board. Several oncologists attending the session pointed out that this would be a difficult proposition for an already resource-stretched community oncology practice.
“Payers need to keep up with accelerating evidence-based new indications,” said Griffith. She believes that as marketplace competition increases, payers may include step therapy in precertification requirements to specify preferred agents.
During a subsequent panel discussion, Spencer Green, MS, MBA, business operations manager, Bozeman Deaconess Cancer Center, said, “By entering into an alliance with organizations like the ACCC, community centers can gain access to experts for the necessary information on these novel treatment options. Company sales representatives are an additional resource to understand the program—it can help avoid back-end issues with billing and reimbursement.” This can also prevent delays in patient access to care, he added.
Steve D’Amato, BS Pharm, BCOP, executive director, New England Cancer Specialists, and current president of ACCC, insisted on including payers in the conversation. “We have a good relation with our payers,” he said. “We have shared some of our data with Anthem on new therapies, cost implications, and what we are doing as beneficiaries. Both Aetna and Anthem have been quite supportive of the programs in place at our clinic with these agents.” Keeping payers informed on policies being developed at our institutions and clinics can have a huge impact on reimbursement, and can also help payers understand the challenges we face with using these agents, added D’Amato.
1. Institute for Clinical Immuno-Oncology: a community centered on transformative care. Institute for Clinical Immuno-Oncology website. http://accc-iclio.org/. Accessed November 17, 2015.
Patient Assistance Programs Ensure Affordable and Quality Cancer Care
Oncologists are increasingly aware of the hardships patients face as they choose newer oncolytic agents that promise better outcomes. The financial toxicity of healthcare, particularly in oncology, is not lost on anyone, and drug companies have renewed their efforts with patient assistance programs, ensuring that physicians,as well as patient support groups,are aware of the financial resources that patients can access. “We work extensively to provide clarity around our programs to clinicians,” shared Frank Marra, executive director, Patient Affordability and Executive Services at Bristol Myers Squibb.
Marra was part of a panel discussion at the first national meeting of the Institute for Clinical Immuno-Oncology, an initiative of the Association of Community Cancer Centers, held October 2, 2015, in Philadelphia. The panel followed a presentation by Linda House, RN, BSN, MSM, president, Cancer Support Community (CSC). According to House, the patients open up to CSC more than they do with their oncologists. “We try to work on psychosocial aspects of the patient’s care,” she said. In an 8000-patient registry, CSC has observed that 75% of cancer patients follow their clinician’s advice when making health decisions. So with respect to newer, more expensive immuno-oncology agents, the quality of patient care is closely associated with reimbursement. And to be able to afford this expensive care, patients and their families sacrifice vacations, social events, and skimp on groceries, House said.
“Many live with chronic toxicities, and need follow-up care; 36% do not return to work.” Mental health conditions are an important sideeffect associated with their suffering and “depression in cancer patients is estimated to cost about $8400 per patient,” said House, adding that the pharmaceutical industry is actively partnering with organizations like CSC to understand the needs of patients and to provide improved support. “We have 1-800 helplines at CSC, with mental health counselors on call,” and CSC’s partnership with Onyx Pharmaceuticals allows their support line to transfer callers to CSC’s helpline.
During the subsequent panel, Delali Attiogbe, site manager for BioOncology Managed Markets, Genentech, said that her company understands that patients do hold financial conversations with their treating physician, and so her company is ensuring physician awareness on patient support programs. “We are also partnering with groups like CSC, arranging warm transfers of patients. There are dedicated groups within the company to help the process,” said Attiogbe.
Charles Lynch, program coordinator of the Oncology Medical Assistance Program at Yale-New Haven Hospital, said “We have a support system at Yale that various health service providers are involved in, including clinicians, nurses, and social workers.” After the treatment clinic works out a treatment plan, his department calculates the patient’s out-of-pocket expenses and also evaluates the available alternatives on drug lists, Lynch explained. “We explore PAN [Patient Access Network] and PAF [Patient Advocate Foundation] foundation grants and co-pay cards…all the information is assessed to support care.”
When asked if the newer immuno-oncology agents have created unique challenges for patient assistance programs, Marra said that while similar challenges have persisted over the years, newer products have only amplified the problem. “We work extensively to provide clarity around our programs to clinicians and we are striving to enroll every patient in the program. Each patient is different and the program tries to adapt around their needs,” said Marra.