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Operations & Effective Practices in Immuno-Oncology:

Practical Pearls

Apr 21, 2017

Since 2011, the U.S. Food and Drug Administration (FDA) has approved five checkpoint inhibitors (ipilimumab, pembrolizumab, nivolumab, atezolizumab, and avelumab) for treating patients with various advanced malignancies.1-5 Several anti-PD-1 and anti-PD-L1 trials are ongoing, as are trials that combine different immunotherapy agents, and immunotherapy agents with other treatment modalities such as chemotherapy.

As these treatment modalities become established therapy in the community setting, it will become ever more important to build operational capacity. This article provides an overview of strategies for building capacity to support information dissemination, timely reimbursement, and care coordination within the multidisciplinary care team.

Information Dissemination

New immuno-oncology (I-O) approvals are typically accompanied by a tsunami of indication information. Clinicians and non-clinical support staff need to be aware of this information to support treatment planning, billing and reimbursement, and patient education. Steven L. D’Amato, BSPharm, Executive Director, New England Cancer Specialists, suggests the following strategies to support this awareness:

  1. Appoint an I-O champion to be the “point person” for I-O product questions. This champion—for instance a physician or pharmacist—needs to know where to get up-to-date information about I-O therapies and how to coordinate staff education. An I-O champion can also be charged with proactively updating practice protocols that may be impacted by the addition of I-O therapies, integrating manufacturer-provided resources, such as on-site training and education, and archiving materials so that new staff can be quickly on-boarded to your practice’s approach to I-O.

  1. Create an I-O Pharmacy and Therapeutics (P&T) Subcommittee to evaluate new formulary medication requests. Regularly and proactively update staff via this P&T Subcommittee, which can also support on-site training and on-boarding new staff.

 

P&T Immuno-Oncology Subcommittee Roles

  • Educate medical staff and administrators about the safe and appropriate use of medications

  • Develop and implement policies and procedures regarding medication use

  • Monitor adverse drug events and reporting

  • Work to reduce medication errors

  • Assist in developing clinical care plans and guidelines

  • Keep HCPs abreast of evolving and new indications, e.g., combination therapies



  1. Provide administrators with data that demonstrate the value of I‑O to patients, as well as the value of being able to offer advanced treatment strategies. Communicating this information can help administrators understand how to best support an I-O program, for instance, by providing funding for technology and staff.

Formulary Management and Reimbursement

It is no secret that I-O treatment is costly. High demand for expanded indication use of new products may lead to additional reimbursement complexity and financial overhead, as may the development of new combinations of I-O drugs with new or existing therapies. There are many strategies that oncology practices can use to limit their financial risk.

  1. Ensure that pharmacy services have the resources they need to manage the drug formulary addition process, drug procurement, and order set development. Pharmacy can also help to educate staff about new drug information (e.g., immune-related adverse events [irAEs], monitoring, administration, preparation) and provide information about infusion drug preparation/dispensing.

  1. Reimbursement and billing specialists are essential to ensure accurate coding that is aligned with current drug indications. Identify a point person from within existing financial or reimbursement staff to focus on I-O. This person should have expertise in the nuances of various manufacturer patient assistance programs, co-pay foundations, and other patient assistance programs to optimize reimbursement and patient support. For instance, Sanford Health has trained pharmacy technicians—who have intimate knowledge of therapies—to ensure preauthorization and benefit verification prior to treatment.

 

Reimbursement Checklist

  • Consider enrolling all patients in manufacturer-provided patient assistance programs for benefits investigation and copay support.

  • Discuss the costs of high-dollar medications upfront with patients – make them partners in the financial conversation.

  • Track reimbursement claims.

  • Identify core staff with clinical skills as reimbursement specialists for I-O claims.

  • Require patients to sign an Advanced Beneficiary Notice or Notice of Non-Coverage.

  • Identify a clinical specialist pharmacist at the point of care to support and engage the clinical team.



  1. Compassionate dispensing of these drugs may be available for indications that are outside the FDA-approved label.4 Reimbursement specialists can liaise with pharmaceutical companies concerning drug replacement and financial assistance.3

  1. Develop an expanded indication policy for I-O therapies, that includes upfront pre-authorizations with patients to make patients aware of the clinical and financial risks and benefits of therapy, and that predetermines all expanded indication requests.

Patient Financial Support

The potential for financial toxicity continues to be a challenge for patients receiving I‑O therapy. Treatment itself is costly, and the financial burden for patients is increased by co-pays and deductibles.

  1. To defray this toxicity, financial advocacy is emerging as a strategy to educate patients on financial resources and to provide navigation support through the direct and indirect costs associated with oncology treatment. Dan Sherman, MA, LPC, argues that financial advocates add value to community cancer programs, especially given the trend for expanded indication use of immunotherapy agents. Financial advocates can take the lead in proactively screening patients at the time of treatment planning to determine their out-of-pocket responsibilities, and, if necessary, develop strategies to diminish these costs. Conduct an inventory to determine whether your organization has a sufficient number of educated financial advocates. If not, consider hiring this staff category and/or participating in the Financial Advocacy Boot Camp offered by the Association of Community Cancer Centers (ACCC).

  1. Consider enrolling all patients being considered for I-O therapies in patient assistance programs (PAPs), regardless of whether the use is on-label or an expanded indication. Further, check all the applicable boxes on the patient assistance form, including prior authorization, appeal support, co-pay support, and manufacturer assistance/replacement medication. You can find a reimbursement administration tool

  1. While manufacturer co-pay programs may not be available for expanded indication uses, some manufacturer-sponsored programs may assist with benefits investigations, appeals, and general reimbursement questions. Reimbursement specialists should ask about such assistance.

  2. Patients may be willing to pay for I-O therapies out of pocket. Financial advocates should discuss this option with patients in addition to talking about their benefits and/or patient support programs. The Patient Access Network (PAN) Foundation is valuable source of information and resources to help patients overcome access to care barriers.

  1. Some private payers may send retrospective denials, particularly for expanded indication uses, even when there was a pre-determination in acceptance of the use. Ensure that your cancer program has written documentation of pre-approvals or pre-determinations when reimbursement may be in question.

   

Managing Immune-Related Adverse Events: Multidisciplinary Team Coordination and Education

It takes a village to coordinate care for patients treated with I-O agents. Notably, the side effect profile of checkpoint inhibitors is distinct and differs substantially from the side effects associated with chemotherapy.6 The types of irAEs observed may also vary with tumor type. Although clinicians cannot prevent common side effects (e.g., pruritus, arthralgia), the goal is to recognize them early and prevent escalation.

Therefore, education about irAEs needs to include all team members who are involved in the coordination of patient services related to I-O treatment, such as providers, pharmacists, financial case managers, nurses, schedulers, as well as multiple specialties beyond the cancer setting (i.e., emergency room or intensive care unit personnel, surgeons, house staff, endocrinologists, gastroenterologists, dermatologists, pulmonologists, neurologists, and radiologists). Steps that cancer programs can take to manage irAEs include:

  1. Infusion center staff need to be aware of and educated about irAEs so that they are comfortable administering and monitoring these new therapies. Education can include formal training and education programs for nursing staff—such as skills fairs that include mock drug reactions. Education events and materials should also include other specialists likely to come in contact with patients as they move across the treatment trajectory, including family medicine/primary care, nurse practitioners, and emergency room staff.

  1. As part of staff education, ensure that clinical and non-clinical staff understand and can identify the main potential adverse events associated with I-O products, and know when these events are potentially life-threatening and/or require immediate clinical attention. Update practice protocols regularly so that patients are triaged appropriately, particularly with regards to new or unfamiliar adverse events. The triage team needs to understand the uniqueness of immunotherapy, and how the response kinetics and side effect profile differ from chemotherapy.

  1. Establish a system that supports 24/7 patient access to providers who can respond to their questions about symptoms during treatment since any new symptom could indicate an irAE.

  1. When developing educational materials, be sure to include patients as part of the team—they want to learn about their diagnosis and treatment plan, including information about side effects and symptoms. Education materials should provide information about the goals and risks of the treatment plan and the impact of treatment on everyday life. Clinicians need to educate patients about side effects in very concrete terms that patients can understand, and in ways that provide reassurance about strategies for managing side effects, should they develop. Many pharmaceutical companies provide educational sheets and checklists that can be uploaded directly into an electronic medical record. Nurses can review these with patients at every visit.

  1. Patients need to understand what toxicities to report, when they should be reported, and to whom. Emphasize to patients that they must report new symptoms and ensure that they know how to contact the relevant point person at your cancer program. This education can also defray patient concerns that they will be taken off therapy.

  1. Consider providing patients on I-O therapies with information cards. Such cards provide drug names and the 24/7 emergency contact information for the oncology practice. This allows the oncologists to have one-on-one education with the staff seeing the patient. Emphasize to patients to ensure they always have their I-O card, so if they do have to go to the ER, they receive the necessary appropriate care.

 

References

  1. Bristol-Myers Squibb. Yervoy FDA Product Information. 2015.
  2. Merck & Co. Keytruda FDA Product Information. 2015.
  3. Bristol-Myers Squibb. Opdivo FDA Product Information. 2016.
  4. Genentech. FDA Tecentriq Product Information. 2016.
  5. USFDA. Avelumab (Bavencio). 2017.
  6. Haanen JB, Thienen H, Blank CU. Toxicity patterns with immunomodulating antibodies and their combinations. Semin Oncol. 2015;42(3):423-428.