Progress of the conditional inclusion process for rhPTH 1-84 (Natpar®)
The National Health Care Institute advises the Director of Pharmaceuticals and Medical Technology at the Ministry of Health, Welfare and Sport to continue the conditional inclusion process of recombinant human parathyroid hormone 1-84 (rhPTH 1-84) (Natpar®). Since the start of the conditional inclusion process, 20 Dutch patients have been treated with rhPTH 1-84. On 4 October 2022, Takeda announced that the production issues cannot be solved and that production will therefore be discontinued worldwide at the end of 2024. The National Health Care Institute recommends that the conditional inclusion process for rhPTH 1-84 be continued until all Dutch patients who are currently being treated with rhPTH 1-84 have responsibly switched to an alternative. No new patients should be treated with rhPTH 1-84.
Registered indication
RrhPTH 1-84 (Natpar®) can be used for the treatment of adult patients with chronic hypoparathyroidism whose condition cannot be adequately controlled with standard therapy alone.
Course of the procedure
Since the start of the conditional inclusion process, 20 Dutch patients have been treated with rhPTH 1-84. At the start of the process, a total of 100 Dutch patients were expected to be eligible for treatment with rhPTH 1-84. During the sounding board group meeting, the professional group indicated that it will endeavour next year to switch all patients who are currently taking rhPTH 1-84 to an alternative product. Since rhPTH 1-84 fulfilled an unmet medical need, there are currently no adequate alternatives available (yet). Therefore, patients will most likely experience symptoms due to dysregulation. For this reason, the practitioners and the patients may want to determine together the best time for the switch to an alternative. The National Health Care Institute therefore advocates offering practitioners and patients sufficient room to switch to an alternative.
The National Health Care Institute's advice
The National Health Care Institute recommends that the conditional inclusion process for rhPTH 1-84 be continued until all Dutch patients who are currently being treated with rhPTH 1-84 have responsibly switched to an alternative. No new patients should be treated with rhPTH 1-84.