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Next steps for you

Email or fax the signed prescription and then mail the signed original to ePharmacy

When you enrol a patient, the system autogenerates a prepopulated prescription. Check that all fields are correctly completed, and then print and sign the prescription.

Please email or fax the signed prescription to ePharmacy

Email: dispensary@epharmacy.com.au

Fax: 1300 363 879

After the prescription has been emailed or faxed, it is important to mail the original signed prescription to ePharmacy within five days. This is a legal requirement to ensure that ePharmacy can dispense ivosidenib when the request is approved. Mail the prescription in your own envelope, free of charge, to:

ePharmacy,
Reply Paid 612
Virginia BC
Queensland 4014

IMPORTANT: Please DO NOT give the original prescription to your patient.

A record of each patient you enrol will appear on your Manage Patients dashboard.

Next steps for your patient

When you submit the patient enrolment, HealthLaunch will automatically send the consent email, which you have already signed, to the patient for their signature.

This email details how the program works and includes the program Terms and Conditions and Privacy Statement. To complete their enrolment, your patient must READ and ACCEPT these by clicking the 'I ACCEPT' button towards the bottom of the email and e-signing the consent form.

If the application to supply ivosidenib for this patient is successful, they will receive a welcome email. This email provides:

An overview of the expedIDH Managed Access Program
A copy of the ivosidenib FDA Medication Guide or Tibsovo® (ivosidenib) Consumer Medicine Information
expedIDH Managed Access Program team contact details for questions

To register with the expedIDH Managed Access Program, please carefully read and accept all Terms and Conditions.

Therapeutic Goods Administration (TGA) access program Terms and Conditions

Understand that in Australia ivosidenib is only approved for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation after at least one prior line of systemic therapy. All other use is off-label.

I undertake to act in compliance with the regulations, customs, and the TGA requirements for Managed Access Programs in Australia.

I undertake to submit for each patient all the relevant forms to receive ivosidenib, and to provide a copy of relevant TGA forms to Servier.

Patient consent, safety and adverse event reporting, Terms and Conditions

I undertake to obtain written informed consent from all patients to be treated with ivosidenib. The signed informed consent form will be kept in the patient's medical file and made available if required.

I undertake to provide each patient with the available information on the use of ivosidenib: Australian Consumer Medicines Information and/or US FDA Medication Guide (Tibsovo).

I understand that this medication request will be clinically assessed by Servier for the use of ivosidenib on a named patient basis

For each patient, I will undertake an IDH1 analysis to confirm IDH1 R132 mutation and an ECG with QTc measurement prior to initiation of each treatment cycle with ivosidenib.

For each patient, I undertake to enter follow-up details in the event of treatment discontinuation.

I undertake to report to Servier all defects or deterioration of the medicinal products or their packaging and to notify Servier of all complaints set out by a patient (change of taste, appearance etc).

For each patient, I undertake to report all suspected adverse events/adverse drug reactions to Servier via this platform, irrespective of causal association, including the special situations below-whether associated with an adverse event or not-which occur during the treatment period with the supplied medicinal product, and within 30 calendar days after the last intake:

Exposure during pregnancy (maternal and/or transmission of a medicinal product via semen following paternal exposure) or breastfeeding
Overdose
Intentional abuse or misuse
Medication error including drug maladministration
Failure of expected pharmacological action (lack of therapeutic efficacy)
Occupational exposure
Suspected transmission via a medicinal product of an infectious agent

I undertake to provide Servier with adequate information in case of intake by a person other than the patient.

I undertake to immediately notify the above events on the same or next working day.

I will ensure that follow-up of each patient is appropriate to the nature of the event, and that it continues until resolution.

I accept that I must immediately notify Servier of any worsening of an already reported adverse event, including any change in terms of diagnosis, intensity, seriousness, measures taken, causality, or outcome regarding an adverse event.

If the patient follow-up is not done by me (hospitalisation, followed by a specialist or the patient's general practitioner, or other healthcare professional), I will do everything to establish/maintain contact with the person/department in charge of follow-up of the patient, in order to obtain additional information and to report it as an adverse event/adverse drug reaction/special situation.

I acknowledge that ivosidenib will be used exclusively for the patient for whom it has been prescribed. I undertake to dispose of all unused medicinal product (recovered from the patient in case of treatment discontinuation or not dispensed to the patient at the end of the treatment) in accordance with applicable laws and regulations and to either provide Servier with a destruction certificate or to return to Servier all unused medicinal product for destruction.

Data protection

I understand and agree:

That Les Laboratoires Servier (Data Controller) and Servier Laboratories (Aust.) Pty. Ltd. (Servier Australia)* are collecting and processing my personal information to manage this Managed Access Program. HealthLaunch, as the program coordinator of this Managed Access Program, will be collecting and processing my personal information on behalf of Servier Australia.
That the processing of my personal information is necessary for compliance with applicable legal and regulatory obligations within Europe, Australia and New Zealand and my personal information may be processed by the Data Controller, Servier Australia, other Servier entities, the relevant pharmacy processing and dispensing the prescription of ivosidenib, Therapeutic Goods Administration and other third parties who are assisting with the management of the Managed Access Program or confirming the validity of the data collected.
That it is not possible to manage the supply of ivosidenib without processing my personal information.
That other than as set out above, the patient’s identity during treatment will otherwise be coded, never disclosed and will be processed in accordance with Servier’s [privacy policy].
That my personal information is being collected and processed in a database for the management of Servier’s products internationally.
That my personal information may be transferred to recipients located inside or outside the European Economic Area (EEA).
That my personal information is being kept for 2 years after the end of the Managed Access Program and stored for 10 years after the end of the Managed Access Program or marketing of the product, whichever occurs last.
That I have the right of access, rectification and restriction of processing of my personal information. To exercise any of my rights, I should email dataprivacy@servier.com or contact my doctor, whichever is applicable.
That I may lodge a complaint regarding the protection of my personal information with the Office of the Australian Information Commissioner, GPO Box 5288, Sydney, NSW 2001. Tel: 1300 363 992.

*Data will be collected and stored by the program coordinator,HealthLaunch,on behalf of Servier.

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