NICE says yes to Pharmalgen for bee and wasp stings
In preliminary draft guidance issued today (Friday 30 September), the National Institute for Health and Care Excellence (NICE) has recommended Pharmalgen (made by ALK-Abello) as a treatment option for IgE-mediatedi bee and wasp venomii allergy in people who have had:
- a severe systemic reaction to bee or wasp venom, or
- a moderate systemic reaction to bee or wasp venom and who have one or more of the following: raised baseline serum tryptaseiii, a high risk of future stings, or are anxious about future stings.
Treatment with Pharmalgen should be initiated and monitored in a specialist centre experienced in venom immunotherapy.
Bee and wasp venom contains chemicals that produce an intense, burning pain followed by redness and swelling when a person is stung. This usually eases within a few hours, but less than 0.5% of the population who are stung by a bee or wasp experience a severe allergic reaction known as anaphylaxisiv. Less common allergic reactions are conjunctivitis, rhinitis and gastrointestinal reactions. Bee venom allergy occurs largely in those who are exposed to bees and are frequently stung, such as beekeepers, their relatives or neighbours. Wasp venom allergy is much more common in the UK, occurring as a result of random occasional stings. Every year in the UK there are 2-9 deaths from anaphylaxis as a result of bee or wasp stings. Wasp stings in the UK cause twice as many deaths due to anaphylaxis as bee stingsv.
Pharmalgen works as a preventative treatment in those people who experience allergic reactions to bee or wasp stings. The treatment works by administering gradually increasing doses of the allergen by injection, which over time desensitises a person with an allergy by altering their immune system. Treatment is carried out in two phases: the initial phase and the maintenance phase, which lasts three years.
This draft guidance has been issued for consultation; NICE has not yet issued final guidance to the NHS.
Professor Peter Littlejohns, Clinical and Public Health Director at NICE said: “The reactions that some people experience to stings from bees and wasps can be distressing, frightening and sometimes life-threatening. People who have had a serious reaction to a sting can often experience extreme anxiety about possible future stings, and this can affect their daily lives. So we are pleased to be able to recommend Pharmalgen as an effective, preventative treatment in preliminary recommendations issued today. The draft guidance has been issued for consultation, giving commentators, consultees, healthcare professionals and members of the public an opportunity to comment on the recommendations.”
The draft guidance is available for consultation on the NICE website from Friday 30 September until Friday 21 October at http://guidance.nice.org.uk/TA/Wave23/28
Comments received during this consultation will be reviewed by the independent Appraisal Committee at their next meeting on Thursday 1 November. NICE expects to issue final guidance to the NHS in February 2012. Until this time, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
Final guidance is expected to be published in February 2012.
Notes to Editors
About the guidance
1. The draft guidance is available from Friday 30 September on the NICE website at http://guidance.nice.org.uk/TA/Wave23/28
For advanced, embargoed copies, please contact the press office.
2. Pharmalgen (ALK-Abello) Bee Venom has a UK marketing authorisation for the diagnosis and treatment of IgE-mediated allergy to bee venom. Pharmalgen Wasp Venom has a UK marketing authorisation for the diagnosis and treatment of IgE-mediated allergy to wasp venom.
3. NICE will not be looking at the use of Pharmalgen in the diagnosis of allergy to bee and wasp venom.
4. Treatment with Pharmalgen is in two phases: an initial phase and a maintenance phase. Before people receive Pharmalgen, IgE-mediated allergy to bee or wasp venom must be confirmed by case history and by in vivo and/or in vitro diagnosis. Pharmalgen must be given by subcutaneous injection.
5. During the initial phase, patients receive an increasing dose of Pharmalgen until the maximum tolerated dose is reached. During the initial phase, patients may undergo a conventional dosing schedule (one injection every 3-7 days), a clustered dosing schedule (2-4 injections per week at intervals of 30 minutes) or a rush dosing schedule (one injection every 2 hours with a maximum of 4 injections per day). During the maintenance phase, a concentration of 100 micrograms/ml is administered every 4 -6 weeks for a period of at least 3 years. The dosage of Pharmalgen may be adjusted depending on the person's history of allergic reactions and sensitivity to the specific allergen used.
6. Pharmalgen bee wasp 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 4 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; ‘British national formulary' [BNF] edition 61). The maintenance treatment set also includes 4 vials; therefore, the cost per injection in the maintenance phase is £20.51. Costs may vary in different settings because of negotiated procurement discounts.
i. IgE (immunoglobulin)-mediated reactions are acute and frequently have a rapid onset.
ii. Venom is the poisonous secretion of an insect or animal usually transmitted by a bite or sting.
iii. Tryptase is an enzyme of human mast cells that has been implicated as a pathological mediator of various allergic and inflammatory conditions.
iv. Anaphylactic, generalised type I reactions (that is, immediate hypersensitivity reactions) involve immunoglobulin E (IgE)-mediated release of histamine. Anaphylaxis can be severe and potentially fatal. Anaphylactic reactions are of variable presentation and typically come on quickly (within 15 minutes from the sting), although they may occur up to one hour after the sting. Initial symptoms are usually cutaneous (in the skin) followed by hypotension (low blood pressure), with light-headedness, fainting or collapse. Some people develop respiratory symptoms due to either asthma or laryngeal oedema (allergic swelling of the throat). However, a few people have little or no warning before collapsing and losing consciousness.
v. Final scope for the appraisal of Pharmalgen for the treatment of allergy venom, found at http://guidance.nice.org.uk/TA/Wave23/28/Scope/pdf/English
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.
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This page was last updated: 29 September 2011