Fixing the Price of the Orphan Drug Siklos®: The Council of State Takes over the Decision

in European Journal of Health Law
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Fixing the Price of the Orphan Drug Siklos®: The Council of State Takes over the Decision

in European Journal of Health Law




Haute Autorité de Santé 2005Recommandations pour la pratique clinique: Prise en charge de la drépanocytose chez l’enfant et l’adolescent. Retrieved 21 December 2013


On 9 July 2003the European Commission granted an orphan designation (EU/3/03/154) to Addmedica for hydroxycarbamid for the treatment of sickle cell syndrome within the eu: European Medicines Agency 2008 Committee for orphan medicinal products Pre-authorisation Evaluation of Medicines for Human Use public summary of positive opinion for orphan designation of hydroxyurea for the treatment of sickle cell syndrome. Retrieved 21 December 2013


European Medicines Agency 2007European public assessment report (epar) for Siklos EMA/825511/2010. Retrieved 21 December 2013


Haute Autorité de Santé 2007Avis de la Commission de Transparence Siklos. Retrieved 24 December 2013


On 26 September 2012the manufacturer called for the second time the Council of State to suspend the unilateral decision of the ceps to fix the price of the pharmaceutical drug. The Council of State rejected the stay the judge deciding that the application was moot because the price decision was already executed (already published in the official journal). ce 26 September 2012 n°361787. Available at:


S. Murteira A. Millier and M. Toumi“Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: market access implications”Journal of Market Access & Health Policy 2 (2014) 22814.


NICE 2013Technology appraisal guidance 294 — Aflibercept solution for injection for treating wet age-related macular degeneration. Retrieved 10 January 2014


NICE 2013Technology appraisal guidance 283 — Ranibizumab for treating visual impairment caused by macular oedema secondary to retinal vein occlusion. Retrieved 10 January 2014


Ministère de la Santé 2012«Point sur l’utilisation de la spécialité Avastin® par voie intra oculaire [Press release]» 30-7-2012. Available at:


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    Timeline of the legal proceedings between the company Addmedica and French hta authorities regarding the reimbursement and pricing of the pharmaceutical drug Siklos®

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