GlaxoSmithKline (GSK) has had its lupus treatment Benlysta (belimumab) turned down for use within the national healthcare system in Germany by the Institute for Quality and Efficiency in Health Care (IQWiG).
In a draft assessment the Institute said it was unable to determine if the drug offered additional benefits over current standard therapy, such as steroids and immunosuppressants, for systemic lupus erythematosus (SLE) as GSK had not provided comparison data.
In a statement, GSK said: "This is completely inexplicable from a medical point of view and disregards genuine progress in therapy.
"This may have dire consequences with respect to the often postulated ground-breaking innovations as it is the case for SLE to which no specific pathogenesis-interfering therapy or any licensed therapy has been found yet, even though the need for medical treatment is urgently required."
The UK-based pharma company's comments follow recent criticisms of the German drug approval system by Boehringer Ingelheim's chairman Andreas Barner, who said changes were needed after Boehringer failed to agree a price for its diabetes drug Trajenta (linagliptin), which it has yet to launch in the country.
It is the second major blow for GSK's Benlysta in recent weeks after the UK's National Institute for Health and Clinical Excellence (NICE) said the drug should not be available for routine NHS use in England as there was not enough evidence to indicate it was a cost-effective use of resources.
Benlysta was discovered by Human Genome Sciences, with GSK partnering with the US company to develop and market the drug. It has since been at the heart of ongoing talks between the two companies regarding a possible takeover by GSK.
Further no from IGWiG for Biogen Idec's Fampyra
In addition to its Benlysta guidance, IQWiG also released a draft assessment giving a negative appraisal of Biogen Idec's multiple sclerosis drug Fampyra (prolonged-release fampridine).
The body said the drug provided no additional benefit over physiotherapy in MS patients with walking disability, and that Biogen submitted data that only indirectly compared the two treatments.
Both GSK and Biogen have until May 23 to respond to the assessments, before the German Federal Joint Committee (G-BA) reviews IQWiG's recommendations and issues final guidance.
GSK said it will "analyse the Federal Joint Committee's argumentation thoroughly and will take appropriate action in the ongoing value assessment".