New Product Evaluation Summary - Leeds Formulary

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New Product Evaluation Summary Oralvac Compact® Oromucosal Solution 08/01/2014 Decision Summary Date of DTG 24/01/2014 DTG Decision Oct 2014
New Product Evaluation Summary Oralvac Compact® Oromucosal Solution Decision Summary Date of DTG Date of LAPC Date of funding Commissioning



DTG Decision Traffic Light List Funding decision Other considerations


Oct 2014 RED

Application summary  Oralvac Compact® is an oromucosal solution for the sublingual hyposensitisation treatment of allergic diseases such as rhinitis, conjunctivitis and bronchial asthma, which are caused by an IgE-mediated allergy.  Oralvac Compact® should be prescribed following diagnosis with a positive skin prick test and/or IgE test, with careful consideration to the patient’s history.  It is a tariff but unlicensed medicine (named patient basis) indicated for adults and children from 2 years of age.  Planned duration of therapy at LTHT would be 3 years (this is current practice for subcutaneous immunotherapy within LTHT)  There is evidence from meta-analysis and randomised controlled trials that sublingual immunotherapy results in a significant reduction in symptoms and medication requirements compared to placebo. However, this evidence is mainly from alternative sublingual therapy agents. The evidence for efficacy of Oralvac Compact is limited to patient reported data and post marketing surveillance studies.  Oralvac Compact® is currently being used at a number of other centres including Newcastle Upon Tyne NHS Trust which is our networked hospital for the Northern Immunology and Allergy Network.  Sublingual immunotherapy has been shown to be generally well tolerated and safe

Place in therapy / pathway It is proposed that patients will be offered a choice of sublingual or subcutaneous immunotherapy (currently the only option for adults is subcutaneous treatment with either Pollinex Quattro or Alutard SQ; Paediatrics currently have no immunotherapy on formulary). Patients who are currently receiving SCIT will continue to do so. This will only be offered to new patients. It will be used for 3 years, which is the same as we currently offer for Pollinex Quattro and Alutard SQ. The number of visits still needs to be determined

Points for consideration  Although the evidence for sublingual immunotherapy compared to placebo is good, the evidence specifically for Oralvac is limited. Despite this, other leading specialist centres are currently using this medication.  Provides an alternative oral route option to the only currently available subcutaneous injection route of therapy. Therefore useful for patients with needle phobias and children.

Claire Sanderson Specialist Pharmacist Medicines Information 08/01/2014