Decision

Pemigatinib: Treatment protocol: Information on the Pharmacovigilance System

Updated 21 January 2021

This decision was withdrawn on 9 April 2021

This page has been withdrawn as Pemigatinib has been granted a marketing authorisation.

Early Access to Medicines Scheme – Treatment protocol – Information on the pharmacovigilance system and requirements for reporting safety data

Introduction

The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed medicines and medicines used outside their licence, to UK patients that have a high unmet clinical need. The medicinal products included in the scheme are those that are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options.

The scientific opinion is based on assessment of the information supplied to the MHRA on the benefits and risks of the medicine. As such this is a scientific opinion and should not be regarded as a licensed indication or a future commitment by the MHRA to licence such a medicine, nor should it be regarded as an authorisation to sell or supply such a medicine. A positive scientific opinion is not a recommendation for use of the medicine and should not be interpreted as such. Under EAMS the risk and legal responsibility for prescribing the medicine remains with the physician, and the opinion and EAMS documentation published by the MHRA are intended only to inform physicians’ decision making and not to recommend use. An EAMS scientific opinion does not affect the civil liability of the manufacturer or any physician in relation to the product.

As the safety profile of the EAMS medicine may not yet be fully established it is particularly important that any harmful or unintended responses to EAMS medicines are reported. More information about the scheme.

Physicians should enroll any patients receiving EAMS medicines in the drug registry put in place by the pharmaceutical company to enable systematic collection of information on adverse events.

Suspected adverse drug reactions (ADRs) for any patients can also be reported directly to the MHRA via the Yellow Card scheme. When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates, outcome and results of any test results or investigations.

The information below is intended for healthcare professionals and is provided by the pharmaceutical company that manufactures the EAMS medicine. It summarises the requirements for clinical monitoring and reporting of adverse events with medicines used under the scheme.

Healthcare professionals should also consult the relevant detailed information provided by the company

EAMS Indication:

Pemigatinib monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.

Information on the Pharmacovigilance system:

A prescribing physician may request entry of their patients into the Early Access to Medicines Scheme (EAMS Protocol Number 42338/0002) by completing and submitting an Initial Application and Drug Supply Request Form. Upon review of the individual request and fulfilment of the eligibility criteria, Incyte will provide EAMS materials which will include information on the collection and reporting of adverse events.

All Healthcare Professionals (HCPs) involved in the care of patients on EAMS will be instructed to report all adverse events (AE), and special situations (SS) whether or not there is an associated AE within one business day of awareness on the provided electronic report form.

An AE is defined as any untoward medical occurrence or worsening of a pre-existing medical condition in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

The SS may include the following:

• use of a medicinal product during pregnancy and breastfeeding
• overdose
• misuse
• abuse
• off-label use
• medication error
• occupational exposure
• lack of therapeutic efficacy
• disease progression
• suspected Transmission of Infectious Agent (STIAMP)
• drug Interactions
• class action lawsuits
• death cases
• product Complaints with associated AEs/SSs
• product Complaints without associated AEs/SSs

The AE reporting form is available electronically to physicians taking part in this EAMS. Any issues accessing the AE reporting form should be addressed by sending an email to EAMS@incyte.com. Additional follow-up may be requested on all reports received to obtain further information.

All AEs and SSs reported will be entered into the Incyte safety database and will be linked to the patient by the specific EAMS protocol number and unique patient number. The patient’s identity will remain anonymous.

Training for Healthcare Professionals (HCPs)

In addition to the Physician Pack, comprehensive AE and SS training will be provided to all relevant HCPs prior to commencement of patient treatment, focusing on recognising, managing and reporting AEs and SSs during the scheme. Equally, the HCP’s obligation to keep their patients fully informed on their treatment will be emphasised. Pertinent patient related supporting documents such as the Patient Alert Card will be provided to facilitate this activity.

Additional information:

Incyte will request the baseline demographics data at the time of initial application and additional information at the time of re-supply request. This information will be recorded in a secure, password protected database. The purpose of this data collection (registry) is to ensure the safe and effective use of the product in line with the EAMS Treatment protocols

At the time of initial application for each patient, the following information will be requested from the HCPs:

• patient Age;
• patient Gender;
• date of Diagnosis
• prior Treatment History
• availability of biopsy materials
• underlying co-morbidities, including baseline data on history of diseases that may be relevant to know, for example cardiac disease and liver disease.
• concomitant medications;

If a patient is considered eligible and meets the EAMS criteria, a unique patient number will be assigned to this patient and communicated to the physician. This unique patient number will be required in all future communications and correspondence regarding this patient including re-supply request and reporting any adverse events to the applicant and MHRA.

At the time of re-supply, following information will also be requested from the HCP’s:

• new concomitant medications
• response assessment

All adverse event data including adverse drug reactions (serious and non-serious) reported will be entered into the Incyte safety database as per company procedures and will be linked to the patient by the assigned EAMS Protocol Number and unique EAMS Patient number

All reports of adverse events will be assessed to determine whether they are possibly related to pemigatinib. The registry data will categorise events by seriousness (serious or non-serious) and the reporter and the Scientific Opinion Holder should include an assessment of causality and relatedness where possible. An adverse event will be classified as an adverse drug reaction (ADR) by the reporter and by the Applicant, if there is a reasonable possibility of a causal relationship with the product

Patient Alert Card – This will be given to all patients before they start treatment. It is a wallet-sized card to be carried at all times to show at all medical visits to HCPs other than the prescribers (e.g. emergency HCPs). It has contact details of the treating physician and it alerts other HCPs that the patient is receiving Pemigatinib. It also contains information on the main symptoms of the adverse reactions and highlights the importance of notifying the treating physician immediately if symptoms occur, persist or worsen and also the importance of not attempting to self-treat any symptoms without consulting with an HCP first.

For patients approved under this scheme and requiring ongoing drug supply, the HCPs will be required to complete the Re-supply Form provided in the physician pack to request further cycles of treatment. The HCPs will also be asked for confirmation that they understand and agree to comply with their obligations to report all AEs and SSs to Incyte and that they are complying with this requirement. They will be also asked to confirm that all AEs and SSs experienced since the last re-supply request have been reported or there are no new AEs to report.

HCPs should report all known and suspected adverse drug reactions (ADRs) to the MHRA via the Yellow Card scheme. HCPs are requested to report all adverse events (serious and non-serious) to Incyte. While reporting these AE and ADRs, reporters are requested to state the manufacturer and that the product is unlicensed on the AE report. In addition to this, the EAMS patient ID number should be provided in the report narrative to help the MHRA identify that the AE is related to EAMS product and to help Incyte link the AE report to the correct EAMS patient.

A 3-monthly periodic safety report will be submitted to the MHRA to summarise data on safety and usage of Pemigatinib under the scheme.

Contact details for AE reporting: eumedinfo@INCYTE.com

Contact details

Michael Thompson
Incyte Biosciences UK Ltd
First Floor – Q1 The Square
Randalls Way
Leatherhead KT22 7TW

Telephone: +44 800 783 3711