3 The technologies
3.1 Pharmalgen bee venom extract (ALK-Abelló) has a marketing authorisation for the treatment of IgE-mediated allergy to bee venom. Pharmalgen wasp venom extract (ALK-Abelló) has a marketing authorisation for the treatment of IgE-mediated allergy to wasp venom. Pharmalgen bee venom extract and Pharmalgen wasp venom extract (from now on referred to as Pharmalgen) also have marketing authorisations for the diagnosis of IgE-mediated allergy to bee or wasp venom, but this indication is outside the scope of this appraisal.
3.2 Treatment with Pharmalgen is in two phases: an initial phase and a maintenance phase. Before people receive Pharmalgen treatment, IgE-mediated allergy to bee or wasp venom must be confirmed by case history and by in vivo and/or in vitro diagnosis. Pharmalgen is given by subcutaneous injection.
3.3 During the initial phase, an increasing dose of Pharmalgen is given until the maximum tolerated dose is reached. The following types of dosing schedules can be used during the initial phase: conventional (one injection every 3–7 days), modified rush (clustered; two to four injections weekly given at intervals of 30 minutes) or rush (injections at 2-hour intervals with a maximum of four injections per day). During the maintenance phase, Pharmalgen is administered at a dose of 100 micrograms every 4–6 weeks for at least 3 years. The dosage may be adjusted depending on the person's history of allergic reactions and sensitivity to the specific allergen used.
3.4 The summary of product characteristics (SPC) as provided by the manufacturer states that Pharmalgen is contraindicated in people with malignancies, severe chronic or seasonal asthma, and immunological conditions. It is also contraindicated in people with diseases or conditions that prevent the treatment of possible anaphylactic reactions, such as chronic heart and lung disease, severe arterial hypertension and treatment with beta-blockers. Pharmalgen is also contraindicated in people taking tricyclic antidepressants, monoamine oxidase inhibitors, and angiotensin-converting enzyme inhibitors, and should not be initiated during pregnancy. Pharmalgen treatment may be associated with local or systemic immunological reactions, which can include anaphylaxis. The SPC recommends that people be observed for at least 60 minutes after an injection of Pharmalgen. For full details of adverse effects and contraindications see the SPC.
3.5 Pharmalgen bee venom costs £54.81 for an initial treatment set and £63.76 for a maintenance treatment set (excluding VAT; 'British national formulary' [BNF] edition 61).The maintenance treatment set includes four vials; therefore, the cost per injection in the maintenance phase is £15.94. Pharmalgen wasp venom costs £67.20 for an initial treatment set and £82.03 for a maintenance treatment set (excluding VAT; BNF edition 61). The maintenance treatment set also includes four vials; therefore, the cost per injection in the maintenance phase is £20.51. Costs may vary in different settings because of negotiated procurement discounts.