Clinical Overview: Steps to Implementation of Rebyota for Recurrent C difficile Infection

Recurrent Clostridioides difficile infection (rCDI) is a clinical challenge, with disease recurrences occurring in up to 25% of index cases and of these patient’s subsequent recurrences can occur as often as 60%. These recurrent episodes occur despite treatment with antibiotics, oral vancomycin and fidaxomicin, given as per the IDSA guidelines.

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Recently, the FDA approved the live biotherapeutic product Rebyota. This is a new product unfamiliar to many pharmacists and other health care providers with different steps in the eventual process.

These steps include:

1. Acquisition. It is at this stage that insurance status needs to be verified. Determine whether the patient has coverage through Medicare, Medicaid, or commercial insurance. Many insurances will require prior authorization for the product so this will need to be obtained prior to ordering Rebyota. Once approval is received, information on how to order the product.
2. Delivery and storage. What to do when it arrives in the pharmacy.
3. Reimbursement. What are the coverage, insurance, reimbursement and payment steps.
4. Administration. When to bring the patient into the site for administration and how the product is to be administered.
5. Follow-up. What is needed post administration.

The decision to prescribe Rebyota is often made by either the gastroenterology or infectious diseases physician, or a mid-level provider. The product should be given 1-3 days after the completion of antibiotics but no longer than 72 hours.

As such, good communication between the pharmacy, patients, and caregivers is important. Additionally, feedback to the physician and nurses/health care providers is also critical to a successful outcome.

Acquisition

Once a prior authorization for Rebyota is received (if required), the product may need to be ordered unless it is in stock. As with any live product, there are defined times to place an order, Monday-Friday and special requests can be made over the weekend.

There are specialty distributors and pharmacies through which orders can be placed. Orders require an account to be established, but this is a simple and straightforward process.

Delivery Storage

Rebyota will arrive in a large orange temperature-controlled frozen shipper box as the product is stored in dry ice. The orange box should be returned using AEROSAFE 1-2 days after administration by calling 585-328-2140.

Alternatively, any FedEx driver will take this product back once the dry ice has evaporated or been removed. Instructions for Rebyota storage and thawing are provided. On receipt, the Rebyota carton needs to be stored in the ultracold freezer (between -60 and -90 degrees C) for future use, or in a refrigerator in which it is stable for up to 5 days (2-8 degrees C). Rebyota should not be refrozen once thawed.

Prior to use, Rebyota must be completely thawed by placing the carton in the fridge for at least 24 hours prior to administration. An alternate option is to leave the Rebyota carton in the sealed orange box, which serves to refrigerate the LBP, and keeps it stable for up to 5 days from the date on the orange box.

If the product has been thawed and the patient does not show up for whatever reason, Ferring will replace Rebyota free of charge.

Reimbursement

Many insurances will require authorization for Rebyota so this will need to be obtained prior to administering. It is also important to know that until a J code is given for this product, the payment status from insurance is going to need more attention including copies of acquisition cost, justification for treatment through medical necessity letters and clinical documentation.

Because CDI tends to affect the older patient it is important to know that Rebyota is covered and reimbursed under Medicare Part B with no prior authorizations using the J code for patients over 50 years of age. The miscellaneous biologic J code J3590/C 9399 are applied. An administration code of G0455 is used in the hospital setting and G0455 and CPT07082.

If the product is being used for an FDA-approved indication, Rebyota will be covered. Reimbursement for each site should be checked individually based on site contracting/purchase agreements.

Buy and bill product acquisition is required for Medicare Part B. Additionally, the product must be obtained through a special distributor network.

Administration

It is important to ensure that the patient completed their antibiotics 1-3 days before their appointment. Any health care provider can administer Rebyota as it is rectally delivered. The process is straightforward.

Request the patient empty their bladder and if possible, bowel before Rebyota administration. Place the patient in the preferred position, either on left side or knee to chest position. Lubricate and insert the administration tube about 5 inches pointing slightly toward the navel. Hold the administration tube, with other hand pinch the clamp.

Gradually raise the bag and allow the product to flow via gravity into the patient. Upon completion, withdraw the tube while keeping the patient in position for about 15 minutes to reduce potential cramping and/or leakage.

There is no required cleaning as the product itself is not infectious. If the patient is not able to retain the enema and there is leakage in the room, consider cleaning that room properly based on terminal cleaning standards. If there is no leakage, that room should not be considered contaminated and normal cleaning procedures would apply. Because Rebyota is a small volume LBP of 150 mL, significant leakage is not expected. Similar cleaning precautions should be considered if the patient uses the restroom prior to leaving your facility.

Note that the procedure does not require an endoscopy suite, the patient does not need anesthesia nor bowel preparation.

Follow-up

Following the procedure it is important to check in on the patient. After LBP administration, the patient is free to leave, use the restroom as needed, and conduct their activities of daily living. Patients should be instructed to contact their provider if they experience any serious adverse events (AEs), keeping in mind that mild gastrointestinal AEs may occur, such as abdominal pain, diarrhea, and abdominal distension.