The provision of home, self-administered omalizumab for chronic spontaneous urticaria via a pharmacist-led clinic and outsourced pharmacy

Sarah Denman is the Advanced Clinical Pharmacist for Clinical Immunology and Allergy at the Leeds Teaching Hospitals NHS Trust (LTHT). She is an independent prescriber and runs two pharmacist-led allergy clinics per week, with a particular interest in chronic spontaneous urticaria. She manages the LTHT Immunoglobulin Demand Management Panel and is the pharmacy representative on the NHS England Immunology and Allergy Clinical Reference Group (CRG).​

The Summary of Product Characteristics for omalizumab states that it should be administered by a healthcare professional.

This is due to the risk of anaphylaxis (incidence 0.1–0.2%). However, these reports of anaphylaxis are in asthma patients. None of the pivotal Phase III trials of omalizumab in chronic spontaneous urticaria (CSU) had any cases of omalizumab-induced anaphylaxis. There have been very few case reports of anaphylaxis in CSU specific patients and in those that are reported it is difficult to assess if it is true anaphylaxis or a flare of their CSU.

This low incidence of anaphylaxis, our own experience of lack of adverse reactions, good adherence to treatment and increasing patient numbers led us to develop a home omalizumab treatment pathway.

To provide a more cost-effective pathway that improves patient satisfaction/quality of life and increases nursing clinic capacity.

Training for self/carer administration is done by our clinical nurse specialists. Once the patient has completed the competency training and transferred to home treatment they are followed up in the pharmacist-led, consultant supported clinic. If patients are continuing on treatment then the independent prescribing pharmacist writes an outpatient prescription, which the patient takes to the outsourced pharmacy.

Since 2010, we have treated 123 patients with omalizumab for CSU (current cohort = 97). We have 68 (70%) patients on home treatment. In June 2016, the duration of home treatment ranged from 1 to 19 months (average 7, median 7). No patient has transferred back to hospital treatment. There have been no reported cases of anaphylaxis or other serious adverse effects.

Patients report a preference to home treatment as it reduces the time burden of receiving treatment and it can be fitted around work/life commitments, thus improving quality of life.

Many patients require repeated courses of omalizumab for CSU. This results in significant nursing clinic capacity issues. Each nurse administration appointment is approximately 15 minutes, with 68 patients on home treatment this equates to a saving of 17 hours of nurse time per month.

The home omalizumab pathway is also more cost effective. This is due to the reduced nursing clinic attendance and the use of an outsourced pharmacy.

In summary, home omalizumab treatment for CSU is safe, results in improved patient satisfaction, improved clinic capacity and is more cost effective than hospital administration. We believe this model is transferable in part, or wholly, to other centres that offer omalizumab for CSU.