Navigation Links
Abiraterone: Indication of considerable added benefit in certain patients

Abiraterone (trade name: Zytiga) 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), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy.

IQWiG finds an indication of a considerable added benefit of abiraterone in 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.

Separate assessment for two groups of patients

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".

"Best supportive care" means the therapy that provides the patient with the best possible individually optimized supportive treatment to alleviate symptoms (e.g. adequate pain therapy) and improve quality of life.

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.

Indication of increase in survival and delay in consequences of disease

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".

IQWiG finds an indication of an added benefit in patients treated with abiraterone: the above study provides indications that abiraterone can prolong survival and delay consequences of prostate cancer, such as fractures 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".

The study data presented on health-related quality of life assessments cannot be used; an added benefit of abiraterone is therefore not proven for this outcome.

The indications of advantages for abiraterone are not accompanied by proof of greater harm.

Added benefit in the docetaxel-retherapy population not proven

The manufacturer presented inadequate data for the "docetaxel-retherapy population". The required search in trial registries was missing in the dossier. Moreover, studies presented by the manufacturer, such as indirect comparisons and one-arm studies, cannot be used due to deficits in methods and content. An added benefit in this patient group is therefore not proven.

G-BA decides on the extent of added benefit

The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.

Contact: Anna-Sabine Ernst
Institute for Quality and Efficiency in Health Care

Related medicine news :

1. Boceprevir: Indication of added benefit for specific patients
2. Prasugrel: Indications of an additional benefit for some patients, but also of greater harm
3. Sanofi Pasteur announces FDA approval of menactra meningococcal conjugate vaccine indication for infants
4. Indications of Alzheimers disease may be evident decades before first signs of cognitive impairment
5. Early indications of Parkinsons disease revealed in dream sleep
6. Ticagrelor: Considerable added benefit for specific patients
7. Considerable proportion of patients with advanced cancer continue to undergo common cancer screening
8. Pirfenidone: Extent of added benefit assessed
9. AML patients have high response rate with vorinostat added to treatment
10. Calorie count plus points based on added sugars, sodium, and saturated and trans fats recommended as new front-of-package nutrition labeling system
11. Hospitals encouraged to consider value-added service of hospital-based radiology groups
Post Your Comments:
(Date:12/1/2015)... ... 01, 2015 , ... Nurotron Biotechnology Co., Ltd., maker of cochlear implant systems, ... , The order will be from the China Disabled Persons’ Federation, a central government ... effective solution for children and adults suffering from severe and profound hearing loss ...
(Date:11/30/2015)... ... 2015 , ... Third Molar SEO , one of ... launched a sleek, mobile-ready and user-centric redesigned website. , Vivek Srivastava, founder and ... the benefits that its SEO services provide to dentists and why Third Molar ...
(Date:11/30/2015)... (PRWEB) , ... December 01, 2015 , ... ... Christina Colon as a 2015-2016 inductee into its VIP Woman of ... pharmacy. NAPW is the nation’s leading networking organization exclusively for professional women, boasting ...
(Date:11/30/2015)... ... 01, 2015 , ... Live Very Well is excited to ... on . The multi-carrier insurance exchange platform offers individual vision and ... to compare, quote and match plans to meet their needs. , Beginning ...
(Date:11/30/2015)... ... November 30, 2015 , ... Stress, anxiety, illness, infection or even ... about possible tumors? , Heather Spader, MD, a new pediatric neurosurgeon at Joe DiMaggio ... signs might point to tumors. , “Bad headaches that don’t go away, ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... , Nov. 30, 2015  QT Vascular Ltd., ... and together with its subsidiaries, TriReme Medical LLC and ... company engaged in the design, assembly and distribution of ... vascular disease, is pleased to announce that a three-judge ... Court of Appeals for the Federal Circuit ("Federal Circuit") ...
(Date:11/30/2015)... Nov. 30, 2015  DURECT Corporation (Nasdaq: ... Matt Hogan , Chief Financial Officer, will ... on Tuesday, December 8 at 2:45 pm ... at the Westin Grand Central Hotel in ... for one-on-one meetings at this conference; interested ...
(Date:11/30/2015)... DUBLIN , Nov. 30, 2015 ... addition of the "Orphan Drugs Market 2015-2019" ... ) has announced the addition of the ... their offering. --> Research and Markets ... the "Orphan Drugs Market 2015-2019" report ...
Breaking Medicine Technology: