GVS advice dexamethasone/levofloxacin eye drops (Ducressa®) for use by adults after cataract surgery
The National Health Care Institute has assessed whether dexamethasone/levofloxacin (Ducressa®) can be included in the Medicine Reimbursement System (GVS). This medicinal product can be used after adult cataract surgery to prevent and treat inflammation and prevent infections. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) not to include dexamethasone/levofloxacin on List 1B of the GVS. The added value of the product after cataract surgery has not been demonstrated. It is also no longer mentioned in the treatment guideline. In addition, the National Health Care Institute recommends that from June 2023 an additional condition should be introduced to no longer compensate dexamethasone/tobramycin (Tobramycin®) for the prevention of infections after cataract surgery.
Condition for which the medicinal product can be applied
In cataracts, the lens is cloudy, causing blurred vision and faded colours. In cataract surgery, the cloudy lens is replaced by an artificial lens. After the operation, the eye may become inflamed, although this is rare.
Ducressa eye drops is a solution containing 1 mg dexamethasone and 5 mg levofloxacin per ml. The marketing authorisation holder has requested reimbursement for the prevention and treatment of inflammations, and the prevention of infections after cataract surgery in adults.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of VWS not to include dexamethasone/levofloxacin on List 1B of the GVS. The added value of the product after cataract surgery has not been demonstrated. It is also no longer mentioned in the treatment guideline.
In addition, the National Health Care Institute recommends that from June 2023 dexamethasone/tobramycin (Tobramycin®) should no longer be reimbursed for the prevention of infections after cataract surgery. The additional List 2 condition in the GVS for dexamethasone/tobramycin will become:
- Only for an insured person who is prescribed this medicinal product for a treatment other than after cataract surgery.
Medicine Reimbursement System (GVS)
Dexamethason/levofloxacine eye drops (Ducressa) is an extramural drug. Extramural drugs are medicinal products for use outside the hospital, available at the pharmacy on prescription from a physician. They will only be reimbursed from the basic health care package if they are listed in the GVS. The amount of the reimbursement depends on the list the product is on. Interchangeable medicinal products are clustered on List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed on List 1B. There is no reimbursement limit for these products. Additional conditions may apply for reimbursement. In that case, a medicinal product is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute on the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.