Tolvaptan (Jinarc ®) for the treatment of chronic kidney disease - alteration of the specific conditions

Zorginstituut Nederland carried out an assessment whether the specific conditions for tolvaptan (Jinarc ®) can be altered. Tolvaptan (Jinarc ®) is indicated for autosomal dominant polycystic kidney disease (ADPKD).

Current situation

Based on an earlier assessment by Zorginstituut Nederland, tolvaptan (Jinarc®) was placed on List 1B of the Medicine Reimbursement System (GVS).  We concluded that tolvaptan has a therapeutic added value compared to best supportive care for ADPKD patients with chronic kidney disease (CKD) stages 1 to 3. For the effectiveness of tolvaptan in patients with CKD stage 3b, the evidence was scant. As a result, reimbursement is currently possible based on the following condition:

Only for an insured person aged 18 years and older with autosomal dominant polycystic kidney disease (ADPKD) with chronic kidney disease (CKD) in stages 1 to 3a at the start of the treatment, with evidence of rapidly progressing disease, and in line with the guidelines as approved by the relevant professional groups in the Netherlands.

Conclusion regarding therapeutic value

Based on the data of the REPRISE study, we conclude that, in line with our previous assessment of patients with CKD stages 1 to 3, in comparison with best supportive care, tolvaptan has a therapeutic added value in patients with CKD stage 3b with evidence of rapidly progressing disease.

Zorginstituut's advice

Tolvaptan (Jinarc®) has already been included on List 1B with specific conditions for ADPKD. Based on the above considerations, we advise the Minister to alter the List 2 conditions for tolvaptan by including patients with CKD stage 3b. Altering this specific condition will be accompanied by additional costs.

Proposed conditions for tolvaptan

Only for an insured person aged 18 years and older with autosomal dominant polycystic kidney disease (ADPKD) with chronic kidney disease (CKD) in stages 1 to 3 when initiating treatment, with evidence of rapidly progressing disease, and in line with the guidelines as approved by the relevant professional groups in the Netherlands.

This report is a summary of recommendations by Zorginstituut Nederland. The original text of this excerpt is in Dutch.