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ORALAIR

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Opinions on drugs - Posted on May 21 2013

Reason for request

Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use.

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Clinical Benefit

Low

The actual benefit of the proprietary medicinal product ORALAIR is low.


Clinical Added Value

minor

The Transparency Committee took account of the small quantitative effect which ORALAIR has been shown to have on the treatment of rhinitis and conjunctivitis triggered by grass pollens. The APSIs (allergens prepared for a single individual), used in these same indications, because they are not proprietary medicinal products, have not undergone clinical assessment, nor do they have marketing authorisation.

Consequently, the Committee is of the opinion that ORALAIR, like GRAZAX, offers a minor improvement in actual benefit (IAB IV) in the management of allergic rhinitis and conjunctivitis triggered by grass pollens in patients who do not respond adequately to treatments that address the symptoms, i.e. antihistamines and/or corticosteroids administered by any route.


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