Sign Of Substantial Added Benefit From Abiraterone In some Cancer of prostate Patients

February 15th, 2012 |

Reasons why you are men with metastatic hormone-refractory cancer of prostate who are don’t entitled to docetaxel therapy

Abiraterone (trade name: Zytiga®) has been approved since September 2011 males with metastatic cancer of prostate that is certainly don’t alert to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel. In the early benefit assessment pursuant to your “Act for the Reform from the Industry for Medicinal Products” (AMNOG), the German Institute for Quality and Efficiency in Medical care (IQWiG) examined whether abiraterone offers an additional advantage compared to the present standard therapy.

IQWiG finds indication of the considerable additional advantage of abiraterone in patients who aren’t entitled to prostate health. On the other hand, an additional benefit is just not proven in patients who can still be addressed with docetaxel, because the dossier submitted because of the drug manufacturer provides inadequate information just for this number of patients.

Separate assessment for a few groups of patients

In accordance with the specifications from the Federal Joint Committee (G-BA), IQWiG separately assessed abiraterone into two groups of patients. The G-BA has specified different appropriate comparator therapies for your two groups.

The “best supportive care population” contains patients who aren’t entitled to further treatment with docetaxel. The proper comparator therapy just for this group is palliative treatment with dexamethasone, prednisone, prednisolone or methylprednisolone, along with “best supportive care”.

“Best supportive care” means process that can offer the sufferer with the very best individually optimized supportive treatment to cure symptoms (e.g. adequate pain therapy) and improve total well being.

The “docetaxel-retherapy population” comprises patients who are still entitled to further treatment with docetaxel. The proper comparator therapy just for this patient population is docetaxel in combination with prednisone or prednisolone.

Indication of improvement in survival and delay in consequences of disease

One study (COU-AA-301), which considers patient-relevant outcomes and supplies relevant data, was contained in the assessment of additional advantage within the “best supportive care population”. These studies compared treatment with abiraterone versus placebo, every time along with prednisone and “best supportive care”.

IQWiG finds indication of your additional advantage in patients addressed with abiraterone: the above study provides indications that abiraterone can prolong survival and delay consequences of cancer of prostate, such as fractures or operations caused by bone metastases. Additionally, the “time to pain progression” was prolonged in study participants receiving abiraterone.

IQWiG classifies the extent on this additional advantage as “considerable”. The corresponding legal ordinance has specified three grades to determine the extent of additional advantage: “minor”, “considerable” and “major”.

The investigation data presented on health-related total well being assessments cannot be used as a result of prostate pain; an additional advantage of abiraterone is therefore not proven just for this outcome.

The indications of advantages for abiraterone are not together with proof of greater harm.

Additional advantage within the docetaxel-retherapy population not proven

The company presented inadequate data for your “docetaxel-retherapy population”. The necessary search in trial registries was missing within the dossier. Moreover, studies presented because of the manufacturer, such as indirect comparisons and one-arm studies, cannot be used caused by deficits in methods and content. An extra benefit with this patient group is therefore not proven.

G-BA decides on the extent of additional advantage

The process for inferring the conclusion for the extent of additional advantage is a proposal from IQWiG. The G-BA, that has opened a proper commenting procedure, decides on the extent of additional advantage.