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New drugs:T-score for transparency

Aust Prescr 2011;34:26-7

Access to information about drugs is essential for the quality use of medicines. Pharmaceutical companies and regulatory agencies, such as the Therapeutic Goods Administration (TGA), hold large quantities of information about individual drugs, but do not always share this information. To encourage transparency, Australian Prescriber rates companies' willingness to provide clinical information about new drugs. Table 1 shows how the companies have performed between January 2009 and December 2010.

The TGA is now publishing Australian Public Assessment Reports (AusPARs) for prescription medicines. While the Editorial Executive Committee welcomes this move to greater transparency, it will still ask companies to provide the clinical evaluations for their new products. While there are similarities, the AusPAR may not include all the details found in the regulator's clinical evaluation.

For 2011, the T-score has been revised to include the AusPAR.

The revised T-scores will be as follows: manufacturer provided complete clinical evaluation manufacturer provided additional useful information manufacturer provided the AusPAR and/or the product information manufacturer declined to supply data manufacturer did not respond to request for data

Table 1 Pharmaceutical company responses to requests for clinical evaluation data for drugs marketed Jan 2009 – Dec 2010 Company Drug manufacturer provided clinical evaluation Amgen denosumab Ferring degarelix Pfizer anidulafungin eletriptan PharmaLink cilostazol Phebra caffeine citrate Roche methoxy polyethylene glycol-epoetin beta tocilizumab Sanofi Pasteur H5N1 influenza vaccine Shire icatibant Wyeth methylnaltrexone manufacturer provided additional useful information Abbott omega-3-acid ethyl esters Celgene azacitidine Commercial Eyes melatonin CSL H1N1 influenza vaccine Japanese encephalitis vaccine Eli Lilly prasugrel Company Drug Genzyme plerixafor GlaxoSmithKline pneumococcal polysaccharide conjugate vaccine Merck Sharp & Dohme rizatriptan Orphan nitisinone Sanofi-Aventis alfuzosin Servier agomelatine UCB Pharma certolizumab pegol Wyeth desvenlafaxine succinate manufacturer provided only the product information Actelion miglustat Baxter Healthcare vaccinia smallpox vaccine Bayer Schering rivaroxaban CSL nebivolol GlaxoSmithKline dutasteride pazopanib Hospira clofarabine Janssen-Cilag doripenem Merck Sharp & Dohme etoricoxib sugammadex Novartis valsartan, amlodipine/valsartan, valsartan/hydrochlorothiazide daptomycin Phebra arsenic trioxide Sanofi Pasteur influenza seasonal vaccine UCB Pharma lacosamide manufacturer declined to supply data Boehringer Ingelheim dabigatran etexilate CSL H5N1 influenza vaccine CSL Bioplasma human C1 esterase inhibitor Ipsen triptorelin embonate Janssen-Cilag etravirine ustekinumab Merck Sharp & Dohme golimumab Novartis indacaterol vildagliptin manufacturer did not respond to request for data Alexion Pharmaceuticals eculizumab GlaxoSmithKline ambrisentan H5N1 influenza vaccine

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