Prescribing information

 

Xolair (omalizumab) is indicated as add-on therapy for the treatment of CSU in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment.1

What is the You First for Xolair CSU programme?

The You First for Xolair® (omalizumab) CSU Patient Support Programme Package Deal (‘You First for Xolair CSU programme’) is for NHS patients who are receiving Xolair as an add-on therapy for chronic spontaneous urticaria (CSU) or for whom the prescribing decision has been made. It successfully launched in 2021 to a first wave of UK hospitals and is now being widely expanded over 2022.

 

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There is also a separate You First for Cosentyx® (secukinumab) Patient Support Programme Package Deal for Cosentyx patients in dermatology that has different components. Click here for more information.

 

 

Through the You First for Xolair CSU programme, a dedicated nurse team from Bionical Solutions Limited, an independent service provider selected by Novartis UK, will assist in the support and management of eligible patients (see What’s included in the programme for more information).

The You First for Xolair CSU programme is offered to eligible patients who have been prescribed Xolair for CSU as per the Summary of Product Characteristics (SmPC). A patient may only be referred to the programme once the decision to prescribe Xolair in CSU has already been made by their prescribing clinician.

A service level agreement is required for each NHS organisation participating.

The You First for Xolair CSU programme has been developed and funded by Novartis Pharmaceuticals UK Limited and is run in conjunction with the hospital’s clinical team. It will be delivered with relevant COVID-19 protective measures in place (e.g. personal protective equipment worn during face-to-face visits).

Use the links below to find out more about the You First programme:

> What’s included in the programme?

> You First for Xolair CSU programme FAQs

> Example patient touchpoint and activity timeline

> How to get set up with You First

> Find your You First for Xolair CSU programme nurse by territory

 

Want to know more?

We would be delighted to take you through the programme, the sign up process, and answer any questions. Please get in touch by clicking here.

Submit your Expression of Interest now

Please use our online form to submit a formalised Expression of Interest in the You First programme.

 

The You First for Xolair CSU programme offers a dedicated nurse to support patients who are candidates for self-administration and who would like to be trained on how to self-administer Xolair, for the first 3 doses, as stated in the below sections of the SmPC:*1

Section 4.1:

  • “Patients with no known history of anaphylaxis may self-inject Xolair or be injected by a caregiver from the 4th dose onwards if a physician determines that this is appropriate (see section 4.4). The patient or the caregiver must have been trained in the correct injection technique and the recognition of the early signs and symptoms of serious allergic reactions.”

Section 4.4:

  • “[The] first 3 doses must be administered either by or under the supervision of a healthcare professional.”

Patients with a known history of anaphylaxis or who are unwilling to self-administer (e.g. needle-phobic) are not able to receive the self-administration training, and are not therefore not eligible for the You First for Xolair CSU programme.

The nurse visits are intended to take place at the patient's home to support hospital capacity.

Self-administration training includes:

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Discussing practicalities of taking Xolair such as dose and administration, drug interactions and storage

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Supporting early identification of any potential Xolair side effects

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Providing Xolair CSU specific patient information materials

 

You First is designed for you to decide what is right for you and your Xolair CSU patients and can include any one or more of the following services:

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Psychological support via motivational interviewing and mentoring

 

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Patient Reported Outcome (PROs) measures assessments including Dermatology Life Quality Index (DLQI), Urticaria Activity Score (UAS7), Urticaria Control Test (UCT)

 

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Clinical assessment data and PROs reported back to the NHS via a secure NHS email.

 
Icon with syringe Can the first doses of Xolair be provided at home? Yes for patients who are enrolled on the You First for Xolair CSU programme. The Xolair SmPC1 states that “the first 3 doses must be administered either by or under the supervision of a healthcare professional”, which allows for home administration under nurse supervision as the programme has been designed.

Initial March 2020 BAD COVID-19 guidelines supported hospital administration for initial doses balancing the risk of monitoring anaphylaxis with the need to keep people away from hospital as far as we are able to reduce coronavirus transmission.2 However, the You First for Xolair CSU programme was introduced in 2021, enabling full home administration from the first dose and fully virtual management of many CSU patients.

The You First for Xolair CSU programme nurses are all NMC registered nurses who specialise in Xolair. They receive a yearly update on anaphylaxis/basic life support and carry adrenaline, the first line treatment for anaphylaxis. The risk of anaphylactic events is very low – the Xolair SmPC states approximately 2 in 1000 (0.2%) based on both real-world and trial data1 – but nurses will monitor all patients for early signs of anaphylaxis during their injection visits.
Icon with rosette Can You First for Xolair CSU nurses provide the same high quality of service that we expect from our NHS nurses? You First for Xolair CSU nurses are experienced, NMC registered nurses. Each nurse receives specific training, competency assessment and validation. The You First for Xolair CSU programme adheres to all regulatory clinical standards. By building a relationship with the You First for Xolair CSU nurse, you will be able to make your own assessment of their skillset and decide the best way to work together.

Novartis are committed to helping patients achieve their goals and, as such, will work with you and your team to ensure You First for Xolair CSU services are tailored to meet the needs of you and your patients. If you would like to, contact us to organise a competency assessment of your dedicated You First for Xolair CSU nurse.
Icon with nurse How do You First for Xolair CSU nurses differ from homecare nurses? Whilst homecare nurses provide a valuable service administering treatments to patients, the You First for Xolair CSU programme offers a dedicated nurse local to your service who has specialist training and experience on Xolair for Chronic Spontaneous Urticaria.
Icon with clipboard and plus sign How is patient information and data that are collected and/or shared for the purposes of the You First for Xolair CSU programme protected? All You First for Xolair CSU nurses are trained to conduct accurate, relevant patient assessments, which are stored and shared securely via NHS networks. Information sharing and storing, like many aspects of the programme, can be tailored to suit local needs and processes. You First for Xolair CSU adheres to all regulatory clinical standards enforced by the CQC, the Care Inspectorate in Scotland and the RQIA in Northern Ireland.
Icon showing two people talking How do You First for Xolair CSU nurses communicate with the NHS team? You First for Xolair CSU nurses will be working as part of the hospital team to enhance the patients’ experiences, being an extension of the service, not a separate one. Clinical assessments are shared with you and patient management issues are escalated in line with the centre’s protocols so you stay fully in control.
Icon of a shield What insurance or safeguards are in place should the programme be stopped? Novartis is committed to You First for Xolair CSU and offer 3 year agreements for the programme, providing long-term reassurance that the support You First for Xolair CSU offers patients will be maintained.
Icon of scales How is equity of care maintained when not all patients will be eligible for this service? You First for Xolair CSU can help improve the equity of care by allowing follow-up patients on Xolair to be managed at home without compromising appointments with more complex patients (e.g. with history of anaphylaxis, not willing to self-administer) that may be in your clinic. You First for Xolair CSU also supports the NHS’s comprehensive model for personalised care close to home objectives by offering additional support to Xolair patients who need it.

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Patient and nurse agree on how to handle the training and the administration of Xolair for CSU based on patient/carer competence and preference.

 
Timeline* Week 0 Week 4 Week 8  
Setting Home Home Home From the 4th dose, patients/carers who are competent are able to self-administer.
Dose 1st 2x 150 mg Xolair injections 2nd 2x 150 mg Xolair injections 3rd 2x 150 mg Xolair injections
Nurse Support Option 1
  • Nurse administers dose
  • Discussions on self-administration and training could start depending on patient/carer competence and preference
  • Nurse administers dose
  • Nurse delivers further training for patient/carer on self-administration
  • Self-administered dose by patient or carer if training completed on Week 4 and patient/carer considered competent
  • Nurse supervising
Nurse Support Option 2
  • Nurse administers dose
  • Discussions on self-administration and training could start depending on patient/carer competence and preference
  • Self-administered dose by patient or carer if training completed on week 0 and patient/carer considered competent
  • Nurse supervising
  • Self-administered dose by patient or carer if considered competent
  • Nurse supervising
Patient Reported Outcomes PROs to be provided to patient. Assessment of PROs from previous month. Assessment of PROs from previous month.

If after Week 8 or Week 12 the patient or carer is not comfortable in self-administering Xolair, You First nurse support can continue for up to 3 years if needed.

The first step of getting set up is to get in touch for an introductory meeting to discuss the programme and your initial queries.

Once you are ready to proceed with setting up You First, you need to complete a formalised Expression of Interest form here.

The You First for Xolair CSU programme team will then seek to arrange a service level agreement (SLA) with your NHS organisation before the services can begin. This will finalise what's included in the programme as part of your requirements.

Find your You First for Xolair CSU programme nurse by territory

Look up your local, dedicated You First nurse by clicking the regions on the map below. The map represents the You First for Xolair CSU programme nurse team as of April 2022 and may vary based on team changes. We would be pleased to provide more information on your local You First nurse at an initial meeting.

Want to know more?

We would be delighted to take you through the programme, the sign up process, and answer any questions. Please get in touch by clicking here.

Submit your Expression of Interest now

Please use our online form to submit a formalised Expression of Interest in the You First programme.

 

*Ongoing nurse administration of Xolair for up to 3 years (if required).

CSU, chronic spontaneous urticaria; CQC, Care Quality Commission; DLQI, Dermatology Life Quality Index; PRO, Patient Reported Outcome; RQIA, Regulation and Quality Improvement Authority; UAS7, Urticaria Activity Score; UCT, Urticaria Control Test.

Patients are able to withdraw from the programme completely at any time.

Ongoing quarterly reviews between the You First for Xolair CSU programme team and the Trust will be arranged from the point of initiation of the You First for Xolair CSU programme with such reviews covering HCPs satisfaction and feedback with the You First for Xolair CSU programme, and usage of the nurse and anticipated patient numbers.

If the You First for Xolair CSU programme nurse is used for any other activity outside of the You First for Xolair CSU programme, Novartis UK may terminate the You First for Xolair CSU programme by giving no less than 30 days’ written notice.

References

  1. Xolair® (omalizumab) 150 mg Summary of Product Characteristics.
  2. British Association of Dermatologists (BAD). COVID-19 Guidance for managing urticaria patients on omalizumab during the coronavirus pandemic. Published 26 March 2020.
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UK | April 2022 | 196843
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. 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]