McKesson : How to Get Your Specialty Practice Ready for CAR-T Cell Therapies

Chimeric antigen receptor (CAR) -T cell therapies can give your community specialty practice promising new treatment options for patients with cancer and other diseases. Today, most patients get CAR-T therapy in a hospital. Soon, many CAR-T therapies will be available to patients from specialty providers in outpatient settings.

If your specialty practice hopes to take advantage of that shift in settings, the time to think about it is now. You need to consider a handful of threshold issues before deciding. You need to prepare. And you need technical support to help you and your patients get the most out of these new treatments.

What does your specialty practice need to offer CAR-T cell therapy?

Before your specialty practice decides to offer CAR-T therapy, you need three things:

1. Access to an apheresis provider. CAR-T therapies involve collecting a patient's blood and sending it to a lab. The lab genetically alters white blood cells to kill cancer or other diseased cells. Apheresis is the process of collecting blood from a patient, separating out parts of the blood you want, and then infusing the unused parts of the blood back into the patient. If your specialty practice wants to offer CAR-T therapies, you'll need an apheresis provider nearby.

2. Access to a qualified hospital. After your specialty practice infuses genetically altered white blood cells back into your patients, there can be serious side effects. Each CAR-T therapy alters different white blood cells. This means each therapy has different side effects. You will need to know the specific side effects for the CAR-T therapy you offer. Equally important is access to a hospital that can treat CAR-T therapy patients and any side effects. A hospital that is accredited by The Foundation for the Accreditation of Cellular Therapy (FACT) indicates a level of specialization to care for these patients.

3. Clinical competency. Your specialty practice must have the clinical competencies to successfully give CAR-T therapies to patients. You should know how these genetically engineered cells work and how they affect the body. It's not just your physicians who need to know. It's your nurses and anyone who comes in regular contact with the patient. Every person who interacts with the patient must be able to recognize side effects and respond quickly and appropriately.

You also need competencies beyond clinical skills. Specialty providers must be good at:

• Team-based care
• Communication with other specialty providers
• Care coordination across settings

How do you prepare your specialty practice for CAR-T cell therapy?

Let's start with the most basic requirements:

• Housing. It may take the lab several weeks to genetically alter the white blood cells before they are infused back into the patient. If the patient is not local, they and their family may need temporary housing.
• Transportation. Patients may need transportation to your practice for the therapy itself and for follow-up appointments. Attending follow-up visits will be mandatory for your CAR-T therapy patients.
• Space. Your specialty practice will need space to store CAR-T therapies after the lab delivers them. You'll also need infusion center space to administer the therapy to patients. Delivery of the modified cells is coordinated with the patient's return to the center so infusion can occur soon after delivery.

What protocols for CAR-T cell therapies do you need to follow?

Next are protocols, policies and procedures. Your specialty practice will need:

• A biosafety committee
• Standard operating procedures for CAR-T therapy administration and management of patients
• Risk evaluation and mitigation strategies (REMs program)
• Certification from the CAR-T therapy manufacturer as a designated provider

The most important part of your specialty practice's preparation is patient and caregiver education. Tell your patients and caregivers about the therapy protocols. That includes recognizing the signs of potential treatment toxicities and side effects. It also includes explaining that your practice will track the effects of their therapy for an extended period. Patient navigators can be very helpful in preparation for and following therapy.

You should also discuss the financial implications of their CAR-T therapy. Financial counseling will be needed to help the patient and family understand the patient's benefit plan. A financial counselor can help them access manufacturers' patient assistance programs.

How to map your patient's CAR-T cell therapy journey

Your specialty practice should map your patients' CAR-T therapy journey as part of your educational process. Knowing what to do before it happens is critical to patient safety.

After receiving their CAR-T therapy, patients will require 24/7 access to clinicians who can diagnose and begin early treatment for any side effects. Your patients should have access to on-call physicians who know how to care for them. Don't send them to an answering service or to doctors who are unfamiliar with the side effects of CAR-T therapy.

If one of your patients is having serious side effects, they may require admission to a hospital. You don't want the patient going unannounced to a hospital emergency room. You need the patient to go to a hospital, ideally one with FACT accreditation, bed access, and clinicians trained to treat CAR-T therapy patients. These arrangements need to be made ahead of time.

That also means having specific medical specialists available for your patients. These include oncologists, neurologists and possibly intensivists. Your designated hospital should have the right drugs and pharmaceutical support to care for patients with serious side effects.

How can technology simplify CAR-T processes?

CAR-T therapies are as complex as the diseases they're designed to fight. They can also make some of your practice's routine processes more complex.

One process is prior authorization to get a patient's health insurance plan to approve a CAR-T therapy. CAR-T therapy comes with a high price tag. For many patients, enrollment in a CAR-T therapy program comes only after other treatments have failed. Getting pre-approval and navigating payment can take time. You can track both with software applications for specialty providers.

Technology can also help with monitoring. Your specialty practice will watch your CAR-T patients for a long time after treatment. You will collect data on treatment effectiveness, disease recurrence, and anticipated and unexpected side effects. You will report that data to manufacturers and disease registries. You will therefore need an EHR system with those capabilities.

Your community specialty practice will also need technology to measure the two indicators of CAR-T cell therapy success: patient outcomes and patient experience. With the right preparation and execution, your practice can score well on both.