Decision

Abrocitinib: Treatment protocol: Information on the Pharmacovigilance System

Published 2 February 2021

This decision was withdrawn on 5 May 2022

Granting of 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

Abrocitinib for the treatment of adult and adolescent patients with severe atopic dermatitis requiring treatment with systemic therapy and have had inadequate response or have lost response to approved systemic therapies, or those who are ineligible or intolerant of approved systemic therapies.

Information on the Pharmacovigilance system

Provision of abrocitinib through EAMS is designed to provide early access to this medicine (prior to licensing the product in the UK). The prescribing physician is reminded to adhere to the EAMS Treatment protocol – Information for Healthcare Professionals.

Prior to EAMS enrolment, a written contract will be executed between Pfizer and the participating institutions. Enrolment of a patient in to the EAMS will be initiated through a dedicated Pfizer EAMS project. The treating physician or designee will be required to enter limited anonymised patient information and to complete the inclusion /exclusion criteria in order for Pfizer to check patient eligibility against the criteria of the EAMS. It will be necessary for all healthcare professionals (HCPs) involved in the EAMS to register for training purposes.

Upon successful registration on the EAMS, each prescribing dermatologist will be provided with an electronic version of the physician’s pack containing the following documents:

• Patient Access Form to make first drug order and subsequent re-supply requests
• EAMS Treatment Protocol – Information on the pharmacovigilance system and requirements for reporting safety data (this document)
• EAMS adverse event reporting form
• EAMS Treatment Protocol – Information for Healthcare Professionals
• EAMS Treatment Protocol – Information for Patients
• Patient Informed Consent form
• Patient Card
• Guide for Healthcare Professionals
• EAMS Protocol number

The Pfizer medical affairs team will either visit the Trust or carry out a virtual training for relevant Trust staff who will be supporting the EAMS.

Adverse event/Adverse drug reaction reporting

HCPs involved in the EAMS will be instructed to report to the company all serious and non-serious adverse events (AEs) within 24 hours of the HCP’s knowledge of the event using the adverse event reporting form.

An adverse event (AE) is any untoward medical event occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Although not always adverse events by regulatory definition, reports of lack of efficacy and at risk scenarios* whether or not there is an associated AE, must be reported.

*At risk scenarios include:

• Exposure during pregnancy (maternal and paternal)
• Exposure during breast-feeding
• Medication errors
• Overdose, Misuse and Extravasation
• Occupational exposure

If only limited information is available initially, further follow-up will be requested by the company and all events will be followed to resolution or stabilisation.

All adverse event data will be entered into the Pfizer safety database in accordance with Pfizer procedures and will be linked to the patient by the unique patient number and EAMS protocol number. NHS England though the online Blueteq system will allocate each patient a unique identifier upon enrolment into the EAMS program for abrocitinib. This will allow tracking of patients from baseline and throughout the treatment period. Pfizer shall allocate a number for patients enrolled from devolved nations. This will also be used for monitoring safety information as necessary.

All serious suspected adverse drug reactions (ADRs) will be reported to MHRA within 15 calendar days of receipt. All suspected ADRs with a fatal outcome will be reported to the MHRA within 7 calendar days of receipt, further information will be provided within 8 days. All non-serious suspected ADRs will be reported to MHRA within 90 calendar days of receipt.

If appropriate, all reports will be followed-up as necessary to obtain supplementary detailed information significant for the scientific evaluation of the cases. The data management of all AE/safety information will be in accordance with Pfizer’s procedures. In addition, data on the safety and the usage of the product under the scheme will be discussed in 3 monthly periodic reports prepared by Pfizer. These reports will be provided to the MHRA every 3 months for the first year after positive scientific opinion. A final periodic report will be provided following scientific opinion expiry and will be submitted within 1 month after EAMS expiry.

More detailed information on how and what to report will be included with the programme materials available for download from the dedicated Pfizer EAMS Drug Registry.

Training for healthcare professionals

All HCPs involved with the management of the EAMS will receive training from Pfizer in addition to the information they receive in the physician’s pack upon set up. The Pfizer UK medical team will provide training upon receipt of positive scientific opinion from the MHRA. Before requesting to register the patients into EAMS, each participating physician will be trained by the Pfizer medical team. This will include a non-promotional presentation of key clinical data, focusing on ensuring safe use of the product, product information, and the logistics of the EAMS.

The Training will pay particular attention to ensuring that the physician can recognise, manage and appropriately report adverse events using the EAMS specific AE reporting form. The training at each site will be documented and participation sheets(s) kept on record by Pfizer.

Additionally, the HCP will be trained on further additional risk minimisation measures. To reaffirm the importance of reporting obligations, a reminder shall also be provided and inserted accordingly at the point of product ordering. As part of this training, the HCP receives the Guide for Healthcare Professionals and the Patient Card. The HCP will be asked to provide the Patient Card to each patient at initiation of their treatment (see below).

HCPs will also be advised to train patients/caregivers to manage and report adverse events.

Additional risk minimisation materials

Patient card

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

The Patient Card shall contain the following key messages:

• Contact details of the abrocitinib prescriber.
• Language that the patient card should be carried by the patient at any time and to share it with HCPs involved in their care (i.e., non- abrocitinib prescribers, emergency room HCPs, etc.)
• Information regarding laboratory tests that the prescriber may obtain before starting and while taking abrocitinib.

• Description of signs/symptoms of infections the patient needs to be aware of, so that they can seek attention from their HCP:

• Language to advise patients and their HCPs about the risk of live vaccinations when given during abrocitinib therapy.

• Description of signs/symptoms of deep venous thrombosis or pulmonary embolism which the patient needs to be aware of, so that they can seek immediate attention from an HCP.

• Description of targeted risks for awareness by the patient and for HCPs involved in their care including:
  • The need for laboratory monitoring.
  • A reminder for women to use contraception, to inform that abrocitinib should not be used during pregnancy, and to notify their HCPs if they become pregnant while taking abrocitinib.

Guide for Healthcare Professionals

This will be provided to all prescribing clinicians following registration onto the EAMS. The objective of the Guide for Healthcare Professionals is to provide an appropriate tool designed to enhance the awareness and knowledge of prescribers about the following safety concerns and to ensure the optimal use of Abrocitinib.

The Guide for Healthcare Professionals was developed to inform prescribers about the risks and provide recommendations on how to mitigate the risk through appropriate monitoring and management:

• Venous thromboembolism
• Infections (including serious and opportunistic infections, herpes zoster and eczema herpeticum)
• Malignancy
• Embryofetal toxicity following exposure in utero and effects on female fertility
• Use in breast-feeding

Additional information

Drug registry

The purpose of this data collection (EAMS Drug Registry) is to ensure the safe and effective use of the product in line with the EAMS Treatment Protocol. Following the HCP’s registration, HCPs will be requested to confirm that the patient has signed an informed consent form and provide the following baseline characteristics:

• Demography (date of birth, age and gender)
• Results of diagnostic investigations including but not limited to EASI, IGA and/or PP-NRS4 scores
• Medical history including documented recent history of inadequate response to or loss in response to treatment with approved systemic therapies or those who are ineligible or intolerant of approved systemic therapies for control of their disease.
• Immunisation as per UK guidelines
• Screening for Hepatitis B and C
• Screening for Tuberculosis
• Hb, neutrophil count, platelet count, ALC and lipid parameters
• Documentation of concomitant medications
• Contraception check
• Urine pregnancy test – for women of childbearing potential

Medication will not be supplied until it is confirmed that the patient has signed the informed consent and that all HCPs involved in the programme have read the EAMS materials supplied in the Physician’s pack on registration onto the EAMS Drug Registry and will comply with the adverse event reporting requirements during the program. During the EAMS, every effort should be made to ensure that all required tests and procedures are completed as described in the programme materials. All adverse events will be reported to Pfizer in line with the requirements for adverse event reporting.

Once treatment commences, the treating physicians will receive an alert via the EAMS Drug Registry every month as a reminder to report any adverse events. To enable further supply of the EAMS drugs, HCPs will need to confirm that patients are still suitable for treatment and that all AEs have been reported. Upon successful registration and first request of EAMS drug supply, 3 months of abrocitinib will be supplied. A request for re-supply for an additional 3 months would need to be made for every subsequent re-order. If treatment has been discontinued or the dose has been reduced due to an adverse event, the HCP will be prompted to complete an adverse event form or confirm that the adverse event has already been reported to Pfizer.

Contact details

Contact details for reporting AEs:

Email Transmission: GBR.AEReporting@pfizer.com

Facsimile Transmission: 0800 015 6401 (toll free) 0845 300 8032 (toll) (alternatively + 1 973 660 8929)

Contact details for the EAMS programme (excluding AE reporting)

Contact Details for Medical Information

Pfizer Limited Medical Information, Tel +44 (0) 1304 616161