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

Related medicine news :

1. Nurse Alert Provides Added Level of Senior Alert Care With New Nurse Triage Feature
2. Tafamidis: Approval denotes proven added benefit
3. No Added Cancer Risk From Hip Replacement Materials: Study
4. Platelet drug shows clinical benefits for severe, unresponsive aplastic anemia
5. Green Tea Weight Loss Results and Health Benefits Revealed
6. Early Surgery May Benefit Some With Heart Infection
7. How much would our health benefit from leaving the car at home?
8. MTSS-mba Membership Benefits Administration Software for Private and Taft-Hartley Employee Benefit Funds Releases New Pension Modules
9. Some Diabetics May Not Benefit From Daily Aspirin
10. Tai Chi increases brain size, benefits cognition in randomized controlled trial of Chinese elderly
11. Zane Benefits Announces Wellness HRAs: A New Way to Reward Healthy Employees
Post Your Comments:
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
(Date:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... 24, 2016 , ... The Haute Beauty Network, affiliated with ... as a prominent plastic surgeon and the network’s newest partner. , Dr. ... handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands by ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
(Date:6/23/2016)... RIDGE, Ill. and INDIANAPOLIS ... of students receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship ... The 2016 scholarship winners, announced today online at ... to let type 1 diabetes stand in the way ... Diabetes has supported the Foundation,s scholarship program since 2012, ...
Breaking Medicine Technology: