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NICE guidance says yes to Pharmalgen for bee and wasp allergy

NICE, the healthcare guidance body, has, publishedguidance today (Wednesday 22 February), recommending Pharmalgen (made by ALK-Abelló) 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. It is estimated that of all deaths from anaphylaxis between 1992 and 2001 in the UK, approximately 62%, were a result of reactions to wasp venom and approximately 9% were caused by reactions to bee venom. Less common allergic reactions are conjunctivitis, rhinitis and gastrointestinal reactions.

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.

Professor Carole Longson, Director, Centre for Health Technology Evaluation at NICE said: "Reactions from bee and wasp stings can be very frightening and in some cases, life-threatening. Therefore, NICE is pleased to be able to recommend Pharmalgen as a clinically and cost effective preventative treatment for bee and wasp allergy in final guidance issued today. I am sure this decision will be welcomed by all those affected by this often distressing allergy."

The final guidance is available at the NICE website at: http://www.nice.org.uk/guidance/TA246

NICE has now issued final guidance to the NHS. Once NICE issues its guidance on a technology it replaces any guidance by individual NHS trusts across England and Wales.

Ends

Notes to Editors

About the guidance

1. The final guidance is available from Wednesday 22 February at the NICE website at: http://www.nice.org.uk/guidance/TA246

2. For further details on developing technology appraisals, see the NICE website.

3. Pharmalgen (ALK-Abelló) Bee Venom Extract has a UK marketing authorisation for the diagnosis and treatment of IgE-mediated allergy to bee venom. Pharmalgen Wasp Venom Extract has a UK marketing authorisation for the diagnosis and treatment of IgE-mediated allergy to wasp venom.

4. NICE will not be looking at the use of Pharmalgen in the diagnosis of allergy to bee and wasp venom.

5. 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.

6. During the initial phase, patients receive an increasing dose of Pharmalgen until the maximum tolerated dose is reached. During this 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 of Pharmalgen 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.

7. Pharmalgen Bee Venom Extract 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 Extract 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.

8. 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.

9. This is the first NICE technology appraisal for this particular condition.

10. NICE has not considered Pharmalgen for any other condition.

11. The Scottish Medicines Consortium has not produced guidance on Pharmalgen.

References

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.

About NICE

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.

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.

4. NICE provides advice and support on putting NICE guidance and standards into practice throughits implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 21 February 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.