The German Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that abiraterone can be of considerable added benefit to patients who are not eligible for further treatment with docetaxel.
In contrast, an added benefit is not proven in patients who can still be treated with docetaxel, as the dossier submitted by the drug manufacturer provides inadequate information for this group of patients.
Abiraterone has been approved since September 2011 for men with metastatic prostate cancer that is no longer responsive to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel.
In an early benefit assessment pursuant to the “Act on the Reform of the Market for Medicinal Products” (AMNOG), IQWiG examined whether abiraterone offers an added benefit compared with the present standard therapy.
In accordance with the specifications of the Federal Joint Committee (G-BA), IQWiG separately assessed abiraterone in two groups of patients. The G-BA has specified different appropriate comparator therapies for the two groups.
The “best supportive care population” contains patients who are not eligible for further treatment with docetaxel.
The appropriate comparator therapy for this group is palliative treatment with dexamethasone, prednisone, prednisolone or methylprednisolone, as well as “best supportive care”.
The “docetaxel-retherapy population” comprises patients who are still eligible for further treatment with docetaxel. The appropriate comparator therapy for this patient population is docetaxel in combination with prednisone or prednisolone.
One study (COU-AA-301), which considers patient-relevant outcomes and provides relevant data, was included in the assessment of added benefit in the “best supportive care population”. This study compared treatment with abiraterone versus placebo, in each case combined with prednisone and “best supportive care”.
The above study provides indications that abiraterone can prolong survival and delay consequences of prostate cancer, such as fracutres or operations due to bone metastases.
In addition, the “time to pain progression” was prolonged in study participants receiving abiraterone.
IQWiG classifies the extent of this added benefit as “considerable”. The corresponding legal ordinance has specified three grades to determine the extent of added benefit: “minor”, “considerable” and “major”.