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28 May 2008

Proposal to amend the listings of venom allergy kits

Following feedback from clinicians, PHARMAC is proposing to change the listing description of bee and wasp venom allergy kits in the Pharmaceutical Schedule. Please note that this proposal would not affect the access to these medications. Proposal Summary To prevent the potential for wasp venom kit prescribing and/or dispensing errors we propose to amend the Bee and wasp venom allergy kits Special Authority so that each venom allergy treatment has its own Special Authority. This would mean that the currently listed wasp venom kit products are not interchangeable. Background Bee and wasp venom allergy kits are listed in Section B of the Pharmaceutical Schedule under the Respiratory System and Allergies therapeutic group as follows:

Antiallergy Preparations BEE VENOM ALLERGY TREATMENT Maintenance kit - 6 vials 120 μg freeze dried venom, 6 diluent 1.8 ml Treatment kit – 1 vial 500 μg freeze dried venom, 1 diluent 9 ml, 3 diluent 1.8 ml WASP VENOM ALLERGY TREATMENT Treatment kit (Paper wasp venom) - 1 vial 500 μg freeze dried polister venom, 1 diluent 9 ml, 1 diluent 1.8 ml Treatment kit (Yellow jacket venom) - 1 vial 500 μg freeze dried vespula venom, 1 diluent 9 ml, 1 diluent 1.8 ml

Currently the products have a common Special Authority form (SA0053), wherein prescribers must indicate which product is to be used. Special Authority approvals for bee and wasp venom allergy treatments are not interchangeable, but approvals for the two listed wasp venom allergy treatments (paper wasp (polister) and yellow jacket (vespula)) are interchangeable. Because of this, there is scope for error in the prescribing and/or dispensing of allergy treatments. Proposal PHARMAC proposes to change the structure of this section of the Pharmaceutical Schedule, from 1 August 2008, so that: · paper wasp (polister) and yellow jacket wasp (vespula) would be listed as distinct items from each other; and · the three products would have individual Special Authority forms.

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In addition, PHARMAC proposes slight modifications to the Special Authority applicant criteria as follows:

Special Authority for Subsidy Initial application only from a relevant specialist any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria: Both: 1 RAST or skin test positive; and 2 Patient has severe generalised reaction to the sensitising agent; and 3 Applicant has the expertise and facilities to perform resuscitation in the event of anaphylaxis Renewal only from a relevant specialist any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria: Both: 1 The treatment remains appropriate and the patient is benefiting from treatment; and 2 Applicant has the expertise and facilities to perform resuscitation in the event of anaphylaxis

If the proposal is accepted by the PHARMAC Board or Chief Executive (under delegated authority) the listing of Bee and Wasp Venom in the Pharmaceutical Schedule would be as follows:

Antiallergy Preparations BEE VENOM ALLERGY TREATMENT Maintenance kit - 6 vials 120 μg freeze dried venom, 6 diluent 1.8 ml Treatment kit – 1 vial 500 μg freeze dried venom, 1 diluent 9 ml, 3 diluent 1.8 ml PAPER WASP VENOM ALLERGY TREATMENT Treatment kit - 1 vial 500 μg freeze dried polister venom, 1 diluent 9 ml, 1 diluent 1.8 ml YELLOW JACKET WASP VENOM ALLERGY TREATMENT Treatment kit - 1 vial 500 μg freeze dried vespula venom, 1 diluent 9 ml, 1 diluent 1.8 ml

Existing Special Authority approval numbers for wasp venom allergy treatments would be transferred to both paper wasp (polister) and yellow jacket wasp (vespula). Feedback sought

We welcome your feedback on this proposal; to provide feedback please submit it in writing by 5 pm, 12 June 2008 to: Sean Dougherty Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington 6143 Email: sean.dougherty@pharmac.govt.nz Fax: (04) 460 4995

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