Navigation Links
Abiraterone: Indication of considerable added benefit in certain patients
Date:7/10/2012

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: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-221-356-85153
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... Angeles, CA (PRWEB) , ... January 18, 2017 , ... ... hazards while driving during a rain storm by slowing down and increasing the space ... on Fox 40. Los Angeles based car accident attorney Raymond R. Hassanlou notes that, ...
(Date:1/19/2017)... CA (PRWEB) , ... January 19, 2017 , ... Bill ... 2017 collaboration with the American Heart Association; “Howe” Healthy is Your Heart Drawing ... stay healthy and active. Each year, Bill Howe Plumbing, Heating & Air receives over ...
(Date:1/19/2017)... ... ... Connecticut Dermatology Group (CDG) is proud and excited to welcome back to ... Kim brings an extensive background in cutting-edge dermatology care and research to Connecticut’s largest ... Dr. Kim to the CDG team” said President and Managing Partner Dr. Steven A. ...
(Date:1/19/2017)... ... , ... The 21st Century Cures Act’s Impact on Medical Devices:, What You ... 1:30 p.m. – 3:00 p.m. ET, http://www.fdanews.com/21stcenturycures          , What do ... this year? , The passage of the act means devicemakers will be scrambling to ...
(Date:1/19/2017)... ... ... Sales Focus Inc. (SFI), a Maryland-based sales outsourcing company, announced today that ... 20 years SFI has been recognized as the world’s leader in Intelligent Sales Outsourcing ... US market. The new clients include: Panacea Pro, Campseekers, Contentmart, Stress Pal, Ariello, ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... Marks E-QURE , s 3 ... agreements in Israel and Argentina ... billion global market ... devices for the treatment of advanced wound care, announced today it signed a ... Colombia for the Company,s patented Bio-electrical Signal Therapy device ("BST Device"), ...
(Date:1/19/2017)... 2017  ViewRay, Inc. (Nasdaq: VRAY ... clinical MRI-guided radiation therapy system, announced today that it ... million through a private placement of its common ... financing and was joined by certain of ViewRay,s ... Venture Partners, and an additional new institutional investor, ...
(Date:1/19/2017)... , Jan. 18, 2017 The Global Therapy ... and access to partnering deals and agreements entered into ... in partnering deals - Top deals by value - ... development, technology type The report provides understanding and ... by the world,s leading healthcare companies. The report ...
Breaking Medicine Technology: