Navigation Links
Added benefit of Cannabis sativa for spasticity due to multiple sclerosis is not proven
Date:9/17/2012

An extract from the plant Cannabis sativa (trade name Sativex) was approved in May 2011 for patients suffering from moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis (MS). 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 the new drug, which is used as a mouth spray, offers an added benefit over the optimized standard therapy. However, no such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the specifications of the Federal Joint Committee (G-BA) and chose a different comparator therapy.

Comparison of different possibilities for optimizing treatment

The extract from Cannabis sativa, which contains the active ingredient combination of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), is approved as add-on therapy to the already used antispastic drugs. Usually, drugs such as baclofen or tizanidine are given to treat muscle spasms. The cannabis extract can be considered when, despite an individual, patient-tailored use of these drugs, the symptoms caused by spasticity cannot be adequately relieved.

The G-BA specified an optimized standard therapy containing baclofen, tizanidine or drugs that are approved for the treatment of spasticity in underlying neurological diseases as the appropriate comparator therapy. At least two previous attempts at treatment were to have been made, in each of which different oral antispastic (spasmolytic) drugs had been used in an optimum way. Again, at least one product was to have contained the active ingredients baclofen or tizanidine. The aim of the assessment by IQWiG was to compare the additional administration of the Cannabis sativa extract with other available possibilities for optimizing treatment and to assess the added benefit.

Optimization of premedication was not planned in any of the studies

However the manufacturer deviated from this specification of the G-BA, without providing adequate justification for doing so. In its dossier, the manufacturer drew no conclusions about the extent and probability of the added benefit compared to the appropriate comparator therapy specified by the G-BA. The studies submitted by the manufacturer were not suitable for reaching conclusions on added benefit in comparison with an optimized standard therapy. This was because in none of these studies was it planned to optimize the antispastic premedication. Instead, this treatment was to be continued unchanged. Therefore there is no proof from the manufacturer's dossier of an added benefit of Cannabis sativa extract compared to the appropriate comparator therapy of the G-BA.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which provides further information and can result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.

An overview of the results of the benefit assessment by IQWiG is given by an English-language extract. You can also find easily understandable and brief German-language information on the website gesundheitsinformation.de, published by IQWiG.

The G-BA website contains general English-language information about the procedure of benefit assessments pursuant to 35a Social Code Book (SGB) V and specific German-language information on the assessment of Cannabis sativa.


'/>"/>

Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. Tafamidis: Approval denotes proven added benefit
2. Telaprevir: Added benefit in certain patients with hepatitis C
3. Keeping Up a Healthy Lifestyle Pays Off in Added Years: Study
4. Belimumab for lupus erythematosus: Added benefit not proven
5. Added benefit of fampridine is not proven
6. Added benefit of eribulin in breast cancer is not proven
7. Added benefit of linagliptin is not proven
8. Collagenase for Dupuytrens contracture: Added benefit not proven
9. Abiraterone: Indication of considerable added benefit in certain patients
10. Nurse Alert Provides Added Level of Senior Alert Care With New Nurse Triage Feature
11. Tafamidis: Approval denotes proven added benefit
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... ... June 23, 2017 , ... The Aesthetic Channel has recently highlighted ... has come up with a proprietary technique that he calls the AuraLyft ... dropped. For all ages, patients can expect to look refreshed, rejuvenated, and revitalized. ...
(Date:6/23/2017)... ... June 23, 2017 , ... PureLife Dental is pleased to announce that California ... members. As part of the amalgam separator endorsement, all CDA members may purchase an ... off the retail value. This partnership between PureLife and CDA is especially timely as ...
(Date:6/23/2017)... ... June 23, 2017 , ... Jusino Insurance ... to communities in the greater Chicago metropolitan area, is embarking on a charity ... youth in Chicago. , Founded in 1897, Hephzibah Children’s Association is one of ...
(Date:6/22/2017)... Rosa, CA (PRWEB) , ... June 22, 2017 , ... ... been named as a Top Doctor for 2017. Each year, research and information firm, ... country. First winning the title in 2015, this marks the 3rd time that ...
(Date:6/22/2017)... ... 2017 , ... The VA Maryland Health Care System has ... the Baltimore VA Medical Center, a division of the VA Maryland Health Care ... promote waste reduction and promote recycling. Also, Practice Greenhealth has recognized the ...
Breaking Medicine News(10 mins):
(Date:6/14/2017)... HAMPTON, Va. , June 14, 2017  ivWatch ... safety and effectiveness of intravenous (IV) therapy, is pleased ... in the category of Nonsurgical Hospital Supplies and Equipment ... premier awards program for the medtech industry. The award ... at the Jacob K. Javits Center in ...
(Date:6/11/2017)... , June 10, 2017  Eli Lilly and Company ... from three Phase 3 studies of galcanezumab, an investigational ... including late-breaking data on several key secondary endpoints for ... results from these studies (EVOLVE-1, EVOLVE-2 and REGAIN) will ... annual scientific meeting in Boston . ...
(Date:6/8/2017)... 2017   Responding to Heath Ledger,s father,s ... of singer Chris Cornell in May, the mental ... a free online psychiatric drug side effects ... about psychotropic drug risks. The father of ... an accidental overdose, has called for tighter rules on prescription ...
Breaking Medicine Technology: