http://medicalxpress.com/ en-us Medical Xpress provides the latest news from Institute for Quality and Efficiency in Health Care The fixed combination of the drugs saxagliptin and metformin (Komboglyze) has been approved in Germany since November 2011 for the treatment of type 2 diabetes mellitus. 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 this fixed combination product offers an added benefit versus the current standard treatment. Such an added benefit cannot be derived from the dossier, however, as the manufacturer did not submit any relevant data. http://medicalxpress.com/news/2013-04-added-benefit-saxagliptinmetformin-combination-proven.html Medications Mon, 29 Apr 2013 12:53:38 EST news286458812 For patients with bone and soft tissue tumours, the study data currently available allow no robust conclusions as to the advantages and disadvantages of using positron emission tomography (PET), alone or in combination with computed tomography (CT). This is because no studies have directly compared the benefit of these imaging techniques with conventional diagnostics. And the few available studies on diagnostic accuracy do not show any relevant differences. This is the conclusion of the final report of the German Institute for Quality and Efficiency in Health Care (IQWiG) published on 15th February 2013. http://medicalxpress.com/news/2013-03-benefit-pet-petct-bone-soft.html Cancer Thu, 07 Mar 2013 11:45:21 EST news281879108 Linagliptin (trade name Trajenta) has been approved since August 2011 to improve blood glucose control in adults with type 2 diabetes. The assessment of the new dossier according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) again showed that no added benefit of the drug over the appropriate comparator therapy (ACT) can be determined, because the pharmaceutical company has not submitted any relevant studies. This is the conclusion of the report by the German Institute for Quality and Efficiency in Health Care (IQWiG) published on 3rd December 2012. http://medicalxpress.com/news/2013-01-linagliptin-proof-added-benefit.html Medications Wed, 30 Jan 2013 09:38:58 EST news278761132 The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In an early benefit assessment according to the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether perampanel offers an added benefit over the previous standard therapy. However, no such added benefit can be derived from the dossier, because the manufacturer failed to present any relevant data in it for the comparison with the drugs lamotrigine or topiramate. http://medicalxpress.com/news/2013-01-perampanel-epilepsy-proof-added-benefit.html Medications Wed, 30 Jan 2013 09:38:36 EST news278761110 The drug aclidinium bromide (trade names Eklira, Bretaris) has been approved since October 2012 for widening the narrowed airways of adults with chronic-obstructive pulmonary disease (COPD). The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of the drug pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG). No proof of an added benefit of aclidinium bromide compared with the appropriate comparator therapy (ACT) can be inferred from the data in the drug manufacturer's dossier. http://medicalxpress.com/news/2013-01-added-benefit-aclidinium-bromide-proven.html Medications Wed, 30 Jan 2013 09:38:03 EST news278760982 Vemurafenib has been approved since February 2012 for the treatment of certain groups of adults with advanced melanoma. The drug offers major advantages in terms of survival, but also causes major side effects. Overall, there is an indication of a considerable added benefit. This is the conclusion of a dossier assessment by the IQWiG, Cologne, which was published in June 2012 and for which an English-language extract is now available. http://medicalxpress.com/news/2013-01-indication-considerable-added-benefit-vemurafenib.html Cancer Tue, 08 Jan 2013 10:38:49 EST news276863922 In order to widen the narrowed airways in patients with chronic obstructive pulmonary disease (COPD), tiotropium bromide (tiotropium in brief) is one of the drugs available that can be prescribed for inhalation. The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether tiotropium offers a perceptible advantage to patients compared to a dummy medication (placebo) and to other COPD drugs. In addition, the two currently marketed types of inhaler (HandiHaler and Respimat) for tiotropium (trade name: Spiriva) were compared. http://medicalxpress.com/news/2012-12-tiotropium-advantages-patients-copd.html Diseases, Conditions, Syndromes Tue, 11 Dec 2012 11:04:41 EST news274446271 For patients in whom a recurrence of bowel cancer is suspected, the study data currently available allow no robust conclusions as to the advantages and disadvantages of using positron emission tomography (PET), alone or in combination with computed tomography (CT). This is because no studies have directly compared the benefits of these imaging techniques in recurrent colorectal carcinoma (bowel cancer) with conventional diagnostic techniques. Although PET or PET/CT show a higher diagnostic accuracy, i.e. in certain cases recurrences can be detected more reliably, it is still unclear how this actually affects patient-relevant outcomes such as quality of life. This is the conclusion of the final report of the German Institute for Quality and Efficiency in Health Care (IQWiG) published on 24th October 2012. http://medicalxpress.com/news/2012-12-benefit-pet-petct-recurrent-bowel.html Cancer Mon, 10 Dec 2012 11:49:28 EST news274362561 If narrowed or blocked coronary vessels have to be widened or opened, a vascular support (stent) is usually inserted. Drug-coated stents are preferred for patients at high risk of renewed narrowing of vessels (restenosis). However, the use of antibody-coated stents has been increasing in recent years. Current studies provide indications that these new antibody-coated stents more frequently lead to myocardial infarction and make re-operation necessary. This is the conclusion reached in the rapid report of the German Institute for Quality and Efficiency in Health Care (IQWiG), as published on 12 October 2012. http://medicalxpress.com/news/2012-11-myocardial-infarction-re-operation-greater-drug-coated.html Cardiology Wed, 14 Nov 2012 10:21:07 EST news272110857 Vandetanib (trade name Caprelsa) has been approved in Germany since February 2012 for adult patients suffering from a particular form of aggressive thyroid cancer. The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, there is no proof of added benefit, because no data on patient-relevant outcomes for those patients for whom the drug is approved were presented by the drug manufacturer in its dossier. In view of these deficiencies, IQWiG considered itself compelled to declare the contents of the dossier as "incomplete". http://medicalxpress.com/news/2012-11-vandetanib-thyroid-cancer-proof-added.html Cancer Fri, 09 Nov 2012 13:18:41 EST news271689514 Belatacept (trade name Nulojix) has been approved since June 2011 to prevent a rejection reaction of the body to the donor organ (transplant) in adults who have received a kidney transplant. The Institute for Quality and Efficiency in Health Care (IQWiG) has examined the added benefit of the drug pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG). http://medicalxpress.com/news/2012-11-belatacept-kidney-transplant-minor-added.html Medications Fri, 09 Nov 2012 13:17:20 EST news271689428 The humanized antibody ipilimumab (trade name Yervoy) has been approved since August 2011 for the treatment of adult patients with advanced melanoma (black skin cancer) who have already been treated. The term "advanced" means that the melanoma can no longer be removed by an operation or that metastases have formed. The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, the drug offers major advantages with respect to overall survival, but is accompanied by major potential harm in the form of side effects. The overall conclusion is that ipilimumab offers considerable added benefit. http://medicalxpress.com/news/2012-11-considerable-added-benefit-ipilimumab-advanced.html Cancer Fri, 09 Nov 2012 13:11:23 EST news271689070 The clot-inhibiting drug apixaban (trade name: Eliquis) was approved in May 2011 for the prevention of thrombosis (blood clots) after operations to replace a hip or knee joint. 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 the added benefit of apixaban. http://medicalxpress.com/news/2012-09-proof-added-benefit-apixaban-hip.html Medications Mon, 17 Sep 2012 10:53:40 EST news267098004 Tafamidis meglumine (trade name: Vyndaqel) was approved in November 2011 for the treatment of transthyretin amyloidosis in adults. This rare disorder ("orphan disease") is caused by a defective gene and is associated with progressive nerve damage (neurological degeneration) that tafamidis is supposed to delay. According to § 35a SGB (Social Code Book) V, an added benefit is regarded as proven if a drug for a rare disease - known as an orphan drug - has been approved. The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed tafamidis at the request of the Federal Joint Committee (G-BA). http://medicalxpress.com/news/2012-09-tafamidis-denotes-proven-added-benefit.html Medications Mon, 17 Sep 2012 10:34:43 EST news267096867 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. http://medicalxpress.com/news/2012-09-added-benefit-cannabis-sativa-spasticity.html Medications Mon, 17 Sep 2012 10:31:52 EST news267096705