Tag: Novartis

Food for Thought: IQWiG Updates Report on Alzheimer Drugs

Galantamine and transdermal rivastigmine plaster can delay loss of cognitive function in Alzheimer’s disease (AD) patients, Germany’s Institute for Quality and Efficacy in Health Care (IQWiG) said in a preliminary report published on its website. In 2007, IQWiG had issued a negative report on the benefit of donezepil, galantamine and rivastigmine, however in 2009 the institute initiated an update, adding additional published and unpublished studies for the appraisal of galantamine and including the rivastigmine plaster which entered the German market in 2007.

IQWiG now states that galantamine at higher doses has a positive effect on cogitation and retentiveness of female patients with mild and moderate AD. However, it added that there was no evidence of improvement of daily routine abilities or psychopathological symptoms such as unrest and depression in both male and female patients. In addition, IQWiG notes that patients often dropped out of the study because of side effects such as nausea, vomitus or diarrhea. It also states that it did not find evidence supporting a galantamine treatment for more than 12 months.

For the rivastigmine plaster, IQWiG said it found hints that the 10 square centimeter plaster improves cognition of patients under 75 years of age; however it states that the data were not resilient enough to support an assessment as “proof of efficacy.”

IQWiG said that both manufacturers, the pharma companies Janssen-Cilag and Novartis, provided all study data requested by IQWiG, including unpublished data comprising 48% of study patients. Juergen Windeler, head of IQWiG said in a statement that this was further underlining the necessity to introduce mandatory publication of clinical study data.


Food for Thought: Simply Obscene

In a recent article (“Simply Obscene”) the influential German news magazine “Der Spiegel” (20/2010, May 17, 2010) stated the pharma industry was using “with the unscrupulousness of a stock jobber” a loophole in Germany’s highly regulated health care system to charge extremely high prices for basically useless cancer medications. In particular, the article featured Yondelis by Pharma Mar, Nexavar by Bayer, Hycamtin and Tyverb by GlaxoSmithKline, Erbitux by Merck KGaA, Sutent by Pfizer, Iressa by AstraZeneca, Avastin, Xeloda, Mab-Thera and Herceptin by Roche and Alimta by Lilly as examples for cancer drugs providing only marginal survival benefits at enormous costs and stated this was “lawful looting of the health care system”.  The only exception according to the authors of the article was Novartis’ Gleevec.

This week, the Competence Network Malignant Lymphomas published an open “letter to the editor”  (only available in German) stating that in the case of lymphoma therapy the authors of the article had done “obviously sloppy work”: “Therapy costs of lymphocyte-specific antibody Rituximab [MabThera] amount to €24,000, not €134,000 per year. Several independent studies have demonstrated that overall survival in both follicular and diffuse large B cell lymphoma is prolonged on average by several years (!), in fact without substantial side effects.” Der Spiegel had stated extension of survival in these two indications was “not proven”.

The letter also said that administrative costs for studies to optimize therapies had increased by a a factor of 10 in the last couple of years due to legal requirements.

The article of Spiegel magazine is available online in German, however without the tables featuring treatment costs and extension of survival for the drugs mentioned.

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