Navigation Links
Abiraterone: Indication of considerable added benefit in certain patients
Date:1/6/2012

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
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(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. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
Breaking Medicine Technology: