novartis cellchain™ platform: ctl019 ordering process and ... · doc no.: cllchn_tm_417_01_lta...

Novartis CellChain™ Platform: CTL019 Ordering Process and Online Product Request Form

Novartis Oncology

Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0

Updated 08/2018


Updated 08/2018

Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.

This material is provided for background and educational

purposes by Novartis Pharma AG.

This material is for the sole use of the intended recipient

and may not be altered or further disseminated in any

fashion by the recipient for further use.

Business Use Only2


Updated 08/2018


Training Objective

Business Use Only3

To provide Treatment Center staff an overview of the ordering process for CTL019 in CellChain™,

the online platform used to support this process

If you have questions after training,please contact your Novartis Cell Therapy Network Manager or

the CTL019 Service Center at +800 100 10 100 or [email protected]

mailto:[email protected]


Updated 08/2018


In this training, you will gain information about:

• “Patient to Patient” Chain of Identity

• Centralized Novartis Ordering process for CTL019

• CellChain™ Online Platform

• Online Product Request Form

• Product Cancellation/Replacement/Credit

• Support available from the CTL019 Service Center

Business Use Only4


Updated 08/2018


CTL019 “Patient to Patient” Chain of Identity road map

• Patients must always sign the Patient Consent form, indicating that Novartis can use their T-cells to manufacture KYMRIAH. In some countries, patients must also sign a Data Privacy form.

Business Use Only5

Patient

Apheresis facility

(cell collection)

Cell processing

(cryopreservation) Transport

to Novartis

Cell processing

(preparation for infusion)Transport to EU

Distribution Hub

Manufacturing at Novartis

Transport

to Site

Name, DOB,Batch ID

Name, DOB,Batch ID, DIN/APH ID



––––––––––––––

Only Batch ID passed to Manufacturing


––––––––––––––

On FinalProduct Label



DOB, date of birth; EU, European Union; ID, identification; NPC, Novartis Pharmaceuticals Corporation; NPhAG, Novartis Pharma AG.


Updated 08/2018


CTL019 Centralized Order Process

Novartis Oncology – Region Europe

• Manages Overall Onboarding Processand Regional Infrastructure

• Manages Product Ordering Process with the Novartis Technical Operations organization through the CTL019 Service Center

• Coordinates with Novartis’ local organizationsto supply the product at country level

Business Use Only6

CellChain™ Online

Order Process


Updated 08/2018


CTL019 Order Process Overview

Business Use Only7

CTL019 Service Center +800 100 10 100

[email protected]

Order Status in CellChain™

Dashboard

CellChain™ Online

Order Process


CellChain™ Online Ordering Platform Overview

Novartis Oncology


Updated 08/2018


Updated 08/2018



Business Use Only9

Final Product Shipped to

hospital cell lab,

who confirms

receipt

InvoiceNovartis invoices

hospital after

hospital cell lab

receives product

Step 1 Step 2 Step 3 Step 4

ProductRequest

PatientIdentification

Apheresis

• Product Request submitted

• Batch ID assigned by Novartis

(initiates Chain of Identity)

• Product Request approved

• Apheresis request generated by

Novartis and sent to network site

• Apheresis Data Form submitted

• Apheresis Data Form approved

• Collected cells (Apheresis

Material) are cryopreserved and

shipped to Novartis

Manufacturing begins after the following are

received:

• Product Request• Patient Cells/

Cryopreserved Apheresis

Manufacturing is on a first-in,

first-manufactured basis


Updated 08/2018


Apheresis


(continued)

Business Use Only10

Step 2

Product Request

Pharmacists

CAR-T/Transplant

Coordinator

Treating Physicians

Apheresis

CenterCell Lab Staff

CellChain™ Online Ordering system


Updated 08/2018


CTL019 Order Process Overview(continued)

Business Use Only11

Step 2

*Apheresis and cryopreservation must occur prior to completion of the Apheresis Data Form. Cryopreserved

Apheresis Material may be collected up to 30 months before the start of manufacturing.

Apheresis Data Form submitted

Apheresis Data Form approved

Cryopreserved collected cells

(Apheresis Material)* are shipped to Novartis

Apheresis request

generated by Novartis and sent

to network site

Batch ID assigned by

Novartis (initiates Chain of Identity)

Treatment

Center

submits a

Product

Request

Product Request details verified


Updated 08/2018


Apheresis

CTL019 Order Process Overview(continued)

Business Use Only12

Step 2

Product Request

Pharmacists

CAR-T/Transplant

Coordinator

Treating Physicians

Apheresis


CellChain™ Online Ordering system


Product Request Submission in CellChain™


Updated 08/2018


Updated 08/2018


Product Request Platform: CellChain™

Product Requests can be submitted using the Novartis online ordering platform, CellChain

• Novartis will accept Product Requests only from authorized personnel at CTL019 Treatment Centers who are qualified to prescribe CTL019

• A second-person (for example, a pharmacist) review at the Treatment Center is required to verify the accuracy of information in the product request and confirm the product order

• Order approval must be performed by a Treatment Center staff member other than the prescriber who initiated the order

• Multiple staff members should be trained, so a second-person review can be completed without delay

14 Business Use Only


Updated 08/2018


Product Request Process Overview

15

Submit Product

Request in

CellChain™

E-mail Notification

Sent to Verify Order

Verify/Approve

Order in CellChain

1 2

Business Use Only


Updated 08/2018


CellChain™ Access

The CellChain system will permit access only to authorized individuals with a personal username and password.

To receive access, you need to:

1. Complete this training

2. Submit a completed CellChain Access Request Form to Novartis

3. Read and acknowledge the Data Privacy Policy that is provided along with the Access Request Form

You will receive an e-mail from [[email protected]] with the subject line “Welcome to CellChain” that will contain your Username and a link to access the application. Follow the directions to set up your account.

CellChain is supported by

Microsoft Internet Explorer

versions 9-11 and Apple Safari version

11.x. Current versions of Microsoft Edge,

Mozilla Firefox, and

Google Chrome are also compatible.

[email protected]

[email protected]




Updated 08/2018


CellChain™ Account: Reset Your Password on First Login

The first time you log in to CellChain™, you

will be prompted to change your password

Notice the specified password length and

complexity requirements

[email protected]



Updated 08/2018


CellChain™ Account: Accept Novartis’ Privacy Policy on First Login

The first time you log in to CellChain™, you will be

prompted to accept Novartis’ CellChain Website

Privacy Policy

You can view details of the Privacy Policy by accessing the

provided link

Click I Accept to continue



Updated 08/2018


Logging in to CellChain™

Please note:

• Navigate to CellChain via the link received by

e-mail from [email protected]

• After five login attempts with an incorrect

password, the system will lock you out for

30 minutes

• If you are locked out of the application, please call

the CTL019 Service Center at +800 100 10 100

• The system will automatically log out users after

15 idle minutes


Login Screen



Updated 08/2018


Adding a New Product Request in CellChain™

• After you log in, the Dashboard will be displayed

• The Dashboard is a single location for you to:

– Add new requests

– Track the status of pending requests

– Track existing orders from your site

Click Add a

new request



Updated 08/2018


City Center Hospital

Entering a Product Request in CellChain™

Treatment Information

In the Indication/Clinical Trial

section, from the drop-down

menu, select the appropriate

disease state for the

identified patient

In the Prescriber section,

from the drop-down menu,

select the prescriber who

is treating the identified

patient


QUALIFIED PRESCRIBER


Updated 08/2018



Patient Information

Enter the patient’s

name, using care

to ensure correct

spelling

Note that for a

Clinical Trial, the

form will update to

require only the

patient initials to be

entered

Enter patient date

of birth in the

DD/MMM/YYYY

format

Enter patient weight, in kilograms, at

the time of the Product Request


Enter the hospital

patient ID, which is

the unique identifier

used by your

institution to track

your patient. Use of

this identifier can

help lookup the

patient record

Note that this field

will only be visible if

your hospital

requested for it

during the

onboarding

process


Updated 08/2018


City Center Cancer InstituteNorth Street 101, 12345 City Center, Germany

North Street 105, 12345 City Center, GermanyCity Center Cancer Institute


Leukapheresis Collection Information

Enter the estimated date (in your time zone)

on which the pick up of the cryopreserved

Leukapheresis material should be scheduled

If the autopopulated

addresses are

not correct, call

the CTL019 Service

Center at

+800 100 10 100

Select the

Leukapheresis

collection center

from the drop-

down menu

Select the

cryopreserved

Leukapheresis

pickup location

from the drop-

down menu



Updated 08/2018





Product Delivery Information

If the autopopulated

addresses are

not correct, call

the CTL019 Service

Center at

+800 100 10 100

Select the

infusion center

from the drop-

down menu

Select the

finished product

ship to location

from the drop-

down menu



Updated 08/2018


Click Browse to select the appropriate signed patient notice from your

computer, and then click Upload to upload it. A confirmation note will be

displayed after a successful upload

It is recommended to upload the signed patient notice for documentation

purposes in case of audits and inspections


Entering a Product Request in CellChain™ Patient Notice


Updated 08/2018


Select the step you want to take with this order:

• Save (return later to update/submit)

• Submit (send to Novartis)

• Cancel (delete all information)

I confirm that the patient notice for Kymriah was presented to the patient/legal guardian prior to submitting this order form,

the patient/legal guardian has been fully informed about the risks and procedures involved in receiving KYMRIAH and,

where needed, has provided consent to allow Novartis (1) to collect, process and keep certain personal data; and (2) to

process and store the patients T cells. We will store the signed original of the patient notice in the patient’s record at our

institution.

I confirm that we have, or will, provide the following materials to the patient/legal guardian prior to the infusion of KYMRIAH:

(1) Package Leaflet; (2) Patient Education Leaflet; and (3) Patient Alert Card.

Read and confirm the attestation by checking the box



AttestationPatients must always sign the Patient Consent form, indicating that Novartis can use their T-cells to manufacture KYMRIAH. In some countries, patients must also sign a Data Privacy form.


Updated 08/2018


When a product request does not include an uploaded patient notice

during submission, a warning will be displayed.

You can either return to upload the patient notice or continue to submit

the request without uploading the patient notice.



Patient Notice Reminder


Updated 08/2018


Product Request Status in CellChain™

After you submit the request, you will be returned to the dashboard.

Here, you can view and track the status of the new request and existing orders:

This flag indicates

the order has not

yet been approved

by a second person

at the ordering site

(The next section

discusses this step)



Updated 08/2018


Saved Product Requests in CellChain™

If you clicked the option to save your work, you will receive this confirmation:

Your work on this product request has been saved but not submitted.

You can access it again from the Dashboard

Return to Dashboard



Second-Person Approval of Product Request in CellChain™


Updated 08/2018


Updated 08/2018


Overview of Second-Person Approval in CellChain™

• After the product request is submitted, an e-mail alert will be sent to all Treatment Center staff with CellChain™ access to approve the product request

• To approve the product request, a trained CellChain user (other than the submitter) must click the hyperlink in the e-mail. Clarify whether the second-person approval will need to be conducted by a Pharmacist at your institution

• The hyperlink will take the user to the CellChain approval page

• The approver will review the request information and reenter the patient’s last name

• If all information is correct, approve the request. If anything is incorrect, reject the request


City Center Cancer InstituteCommercial – DLBCL - Description HCP_User_001

yes 14-Apr-1999 45.5


Updated 08/2018


Order Approved in CellChain™

• “Order: Approved” does not mean a manufacturing day or time is reserved

• Manufacturing will begin only after the cryopreserved Leukapheresis material is received by

Novartis

– After Novartis has confirmed receipt of the order, all Treatment Center CellChain users will receive

a confirmation e-mail

After approval, the

order status in

your dashboard

will now state

“Order: Approved”



Updated 08/2018


Rejecting a Product Request in CellChain™

If you Reject the product request, you will be

prompted to enter a reason for rejection

Please be as specific as possible (eg, incorrect

spelling of patient first name – should be “Jane”;

wrong ship-to address – should be 123 Street Road)

NOTE: Rejecting a Product Request is not considered a cancellation under the Cancellation Policy



Updated 08/2018


City Center Cancer Institute

Fixing a Rejected Product Request in CellChain™

Any qualified user at the

Treatment Center (including

the person who rejected it)

will be able to fix the error(s)

that caused the rejection

and resubmit for approval

The subsequent second-

person approver will need to

be a different individual from

the person who fixed the

error and resubmitted the

product request



CellChain™ Dashboard Overview


Updated 08/2018


Updated 08/2018


CellChain™ Dashboard View of Order Status

Draft order

(not yet submitted)

Order waiting for

second-person

approval

Flags show

current status



Updated 08/2018



(continued)

Product Request was

rejected (needs to be

fixed and resubmitted)

Product Request was

approved

Product Request

was approved,

and cryopreserved

apheresis was received

Flag shows

rejected status

This color indicates that action is needed to

proceed to next step.

Call the CTL019 Service Center with questions



Updated 08/2018



(continued)

Manufacturing has started

Manufacturing is

completed; Product

now in QA testing

Manufacturing and QA

testing are completed

Estimated ship

dates* for final

products

*Estimated ship dates are subject to change and centers will be notified of the final shipment date.



Updated 08/2018


Final product has been delivered



(continued)


Updated 08/2018


ApheresisProduct Request

Pharmacists

CART/Transplant

Coordinator

Treating Physicians

Apheresis



Business Use Only40

Step 2

CellChain™ Online Ordering System


Cancellation, Product Replacement and Credit Requests


Updated 08/2018


Updated 08/2018


Cancellation, Product Replacement, and Credit Request

*Product received free of charge is not eligible for a credit.

Product Cancellation

Final Product Received by

Hospital

Unusable

Product

Replacement/

Credit Request*



Updated 08/2018


Product Cancellation

• To cancel an order, a Product Cancellation Form must be submitted to the CTL019 Service Center at [email protected] via secure e-mail

• The form must be signed by the CTL019 Treatment Center physician and pharmacist qualified to prescribe CTL019

• Cancellation is not complete until a confirmed CTL019 cancellation notice is received

• For full terms and conditions, please see the Cancellation, Unusable Product Replacement, and Credit Policy

• Note: during infusion center qualification, a Center ID will be assigned by Novartis and provided in the qualification confirmation letter

43

An order cannot be canceled after a CTL019 Treatment Center accepts

receipt of the CTL019 product

Business Use Only



Updated 08/2018


Unusable Product Replacement and Credit Request

• The Unusable Product Replacement and Credit Request Policy identifiessituations in which CTL019 may be considered unusable:

44

1. Qualified treatment site or cell lab human error, rendering CTL019 unusable

2. CTL019 temperature excursions at qualified treatment site or cell lab not covered under

site’s or cell lab’s insurance policy

3. CTL019 damaged during shipment but not recognized until after receipt

4. CTL019 temperature excursion during transportation but not recognized until after

receipt

5. Product quality issue identified during product thawing process and/or prior to infusion

6. CTL019 has expired (credit request must be submitted within 30 days of expiration)

7. Product cannot be used due to patient condition

Product

replacement

(if available)

or credit

Credit only*

When requesting a replacement or a credit, an Unusable Product

Replacement and Credit Request Form must be submitted

*Product received free of charge is not eligible for a credit.

Business Use Only


Updated 08/2018


Unusable Product Replacement and Credit Request (continued)

• To request a replacement dose (if one is available for the patient) or a credit, an Unusable Product Replacement and Credit Request Form must be submitted to the CTL019 Service Center at [email protected] via secure e-mail

• All requests must follow the replacement or credit process and satisfy the terms of the Cancellation, Unusable Product Replacement, and Credit Policy

• The form must be signed by the CTL019 Treatment Center physician and pharmacist qualified to prescribe CTL019

• Product received free of charge is not eligible for a credit

• Note: during infusion center qualification, a Center ID will be assigned by Novartis and provided in the qualification confirmation letter




Support available from the CTL019 Service Center


Updated 08/2018


Updated 08/2018


+800 100 10 100

[email protected]

Gettyimages/Epifantsev/467483388

Contact the CTL019 Service Center for Support

• The CTL019 Service Center is your first point of contact for CTL019 order help with:

• CTL019-related logistical questions

• CellChain™ user support (eg, new user, login help, data change support)

• PRF data entry support/case management

• Organization of pickup and delivery of apheresis material, finished product

Business Use Only47



Updated 08/2018


+800 100 10 100

[email protected]

Gettyimages/Epifantsev/467483388

Contact the CTL019 Service Center for Support

(continued)

• Updates on status of manufacturing process and expected delivery date

• Cancellation/Product replacement requests/Credit requests

• Product quality issues

• Printed RMP/other material requests

• General questions about CTL019 management

Business Use Only48



Thank you

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