Please note that an Expression of Interest here does not equate to a legally binding service-level contract to commence the You First for Xolair CSU programme.
It includes a short overview of the programme and confirmation of your details so that we can arrange an initial meeting.
Please find the submission fields at the bottom.
Novartis Pharmaceuticals UK Limited (“Novartis”) has established the You First for Xolair® (omalizumab) CSU Patient Support Programme Package Deal (the “Programme”), defined under the supplementary information to Clause 19.1 of the ABPI Code of Practice 2021 (as amended from time to time) (the “Code”). The Programme aims to enhance the care of patients receiving Xolair for the management of Chronic Spontaneous Urticaria (“CSU”), it is also a patient support programme.
The Programme is being provided on behalf of Novartis by Bionical Solutions Limited (part of the Bionical Group) (“Bionical”) of The Piazza, Mercia Marina, Findern Lane, Willington, Derbyshire, DE65 6DW | email: [email protected] | Tel: 01283 753220.
What does the Programme offer?
Nurse support and self-administration training to patients, this includes:
- discussing practicalities of taking Xolair such as dose and administration, drug interactions and storage;
- supporting early identification of any potential Xolair side effects; and
- providing Xolair CSU specific patient information materials.
In addition, the Programme can also include any of the following services:
- baseline NICE recommended clinical assessments;
- psychological support via motivational interviewing and mentoring techniques to support patients to achieve their health and lifestyle goal. Motivational interviewing techniques provide an organised and systematic way of helping people to recognise their problems and to address them appropriately; and
- clinical assessment data and patient reported outcomes (PROs) reported back to the NHS via a secure NHS email. The PROs include:
- Dermatology Life Quality Index (DLQI)
- Urticaria Activity Score (UAS7)
- Urticaria Control Test (UCT).
More details of what is included in the Programme may be found via the Novartis healthcare professional webpage for the Programme or can also be discussed with a Novartis representative.
If you are interested in signing up to this Programme, please sign this Expression of Interest Form and submit to Novartis. If approved, the Form will be forwarded to Bionical who will contact you. Further details are set out in the Service Level Agreement, a separate agreement that you will be expected to enter into with Bionical.
Adverse Events, Special Reporting Situations or Product Quality Complaints
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (UK). Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com. If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected].
You acknowledge and agree that Novartis personnel may report any Adverse Events, Special Reporting Situations or Product Quality Complaints relating to any Novartis product of which they become aware.
Disclosure and Transfer of Value
In accordance with clause 28 of the Code, you and Novartis will together comply with any applicable disclosure requirements in relation to this Programme, including your professional relationships with decision-making authorities regarding Novartis products (either marketed or under investigation).
Novartis is required by the Code to document and publicly disclose certain transfers of value made to healthcare professionals and healthcare organisations, and these include information about the payments or other transfers of value provided. Such disclosure may be made using any media, including printed reports, electronic communication, the website of Novartis or its affiliates or other platforms. Novartis may disclose such information to the ABPI, its contractors and sub-contractors as may be required in furtherance of the objectives of the Code.
You will clearly declare payments or other transfers of value provided and this declaration will comply with the requirements of the Code.
EXPRESSION OF INTEREST FORM FOR THE YOU FIRST FOR XOLAIR® (OMALIZUMAB) CSU PATIENT SUPPORT PROGRAMME PACKAGE DEAL
The Programme is subject to the following:
- The decision to prescribe Xolair has been made solely on clinical grounds and in accordance with the indication and the marketing authorisation as specified in the Summary of Product Characteristics.1 The site shall confirm in writing to Novartis that the prescribing decision to initiate each of the patients on to Xolair has been made independently from the availability of the Programme.
- The site acknowledges:
- Novartis is not requesting that the site’s participation in the Programme with any intention to induce, influence or reward the past, present or future administration, consumption, prescribing, purchase, recommendation, sale, supply or use of Xolair; and
- It will not nor does it endorse advertising its prescription only medicines to the general public, raising unfounded hopes of successful treatment, providing misleading information relating to safety of a product, or encouraging members of the general public to ask healthcare professionals to prescribe a specific prescription only medicine;
- There is no requirement for the site to purchase any specific minimum or otherwise specified volume of Xolair.
- The Programme is implemented and carried out on Novartis’ behalf by Bionical.
- The site may cancel its participation in the Programme upon provision of one (1) month’s notice via email to, or a conversation with, a Novartis Representative; alternatively, by liaising directly with the service provider, Bionical. Novartis may modify these services at any time with immediate effect upon provision of written notice to the site. In the case of cancellation of the Programme by Novartis, such cancellation shall only be effective upon the provision of six (6) months’ written notice to the site.
I confirm (i) my interest in receiving the Programme, funded by Novartis and implemented by Bionical, (ii) my acceptance of the terms outlined in this form, and (iii) that I would like to be contacted by Bionical to arrange an initial meeting to provide more information on the Programme.
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