GVS assessment of Brimonidine Stulln 2mg/ml eye drop solution for decrease of increased intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
The National Health Care Institute has completed its assessment whether Brimonidine Stulln 2mg/ml eye drop solution, single-use packaging (further described as 'Brimonidine Stulln') is interchangeable with a product that has been included in the Medication Reimbursement System (GVS). The National Health Care Institute's advice is to include Brimonidine Stulln 2mg/ml eye drops on List 1B of the Medicine Reimbursement System (GVS).
Registered indication
Brimonidine Stulln is indicated for decrease of increased intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension:
- as monotherapy for patients for whom treatment with topical beta-blockers is contraindicated;
- as additional treatment with other eye pressure-reducing medication, when the desired IOP is not achieved with monotherapy.
The recommended dosage is one drop of Brimonidine Stulln in the affected eye(s), twice a day, with an interval of approximately 12 hours. No dose adjustment is required for elderly people. Brimonidine Stulln is not recommended for use in children younger than 12 years and is contraindicated for newborns and young children (younger than 2 years).
Assessment
Brimonidine Stulln is the first preservative-free variant of the brimonidine eye drops containing a conservative (Alpagan® and various generics) that are already listed on List 1A in cluster 0S01EADG.
In principle, the policy is to cluster the products by substance name, unless there is an exception. Since 2002, eye drops containing preservatives and preservatives-free eye drops have not been grouped into one cluster, as the preservative-free eye drops have a demonstrable therapeutic added value in the following subpopulations of patients:
- those with a proven allergy to the preservative in question;
- those for whom preservatives are contraindicated, such as in case of damage to the corneal epithelium or perforated corneal transplants;
- those who are chronic frequent users of eye drops, particularly in case of dry eye syndrome and glaucoma;
- patients in which the preservative gives rise to side-effects.
It is therefore not recommended to cluster Brimonidine Stulln with the brimonidine eye drops containing preservatives. Therefore, Brimonidine Stulln is not interchangeable with another medicine that is included in the GVS and cannot be placed on List 1A. It has been reviewed whether Brimonidine Stulln is eligible for inclusion on List 1B.
The National Health Care Institute concludes that the efficacy of Brimonidine Stulln and Alpagan® (and its generics) is at least equivalent, and that there are previously mentioned advantages of preservative-free eye drops for specific subpopulations of patients. Brimonidine Stulln therefore has added value compared to brimonidine eye drops containing a preservative in these specific subpopulations of patients and can be placed on List 1B.
The National Health Care Institute's advice
Based on the considerations mentioned in the report, the National Health Care Institute advises the Minister for Medical Care to include Brimonidine Stulln 2mg/ml eye drops, single-use solution on List 1B of the Medicine Reimbursement System (GVS).