GVS advice testosterone undecanoate (Nebido®)
The National Health Care Institute has completed its reassessment of the medicinal product testosterone undecanoate (Nebido®) in the context of interchangeability within the current cluster. This product is indicated for the treatment of hypogonadism (testosterone deficiency). The National Health Care Institute concludes that testosterone undecanoate (Nebido®) is no longer interchangeable with Sustanon® and advises the Minister to place Nebido® on List 1B of the Medicine Reimbursement System (GVS).
Indication for which reimbursement is requested
Since 2012, the testosterone preparation Nebido® for intramuscular injection has been included in the Medicine Reimbursement System (GVS) on List 1A of the Healthcare Insurance Regulation. It is part of the same cluster as Sustanon® ‘250’ for intramuscular injection. Nebido® consists of testosterone undecanoate 1000 mg/4 ml. Sustanon® ‘250’ 1 ml ampoule consists of testosterone propionate (30 mg), testosterone phenylpropionate (60 mg), testosterone isocaproate (60 mg) and testosterone decanoate (100 mg).
Both medicinal products are registered as supplement therapy for hypogonadism in men, when testosterone deficiency has been confirmed based on clinical characteristics and biochemical tests.
National Health Care Institute's advice
The National Health Care Institute concludes that testosterone undecanoate (Nebido®) is no longer interchangeable with Sustanon® and advises the Minister to place Nebido® on List 1B.