Table 1 Orphan drugs reimbursed in Latvia
Reimbursement Lists | ||||
Trade Name | Active Substance | Orphan Indication | Inclusion Date | Reimbursement List |
Glivec* | Imatinib | Ph+ CML; Ph+ ALL; MDS/MPD; GIST; DFSP; HES and CEL | April 2013 | List A (previously List C) |
Nplate | Romiplostim | Idiopathic thrombocytopenic purpura (ITP) | March 2014 | List B |
Wilzin* | Zinc | Wilson’s disease | June 2014 | |
Sutent* | Sunitinib | GIST | December 2014 | |
Sprycel | Dasatinib | Ph+ CML; Ph+ ALL | October 2010 | List C |
Tasigna | Nilotinib | Ph+ CML | December 2010 | |
Mozobil | Plerixafor | HSCT in patients with lymphoma and multiple myeloma | January 2015 | |
CCUH Program | ||||
Trade Name | Active Substance | Orphan Indication | ||
Elaprase | Idursulfase | Hunter syndrome (Mucopolysaccharidosis II – MPS II) | ||
Myozyme | Alglucosidase alpha | Pompe disease | ||
Aldurazyme* | Laronidase | Mucopolysaccharidosis I (MPS I) | ||
Kuvan | Sapropterin | Hyperphenylalaninaemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency | ||
Cystadane | Betaine | Homocystinuria | ||
Increlex | Mecasermin | Primary insulin-like growth factor 1 deficiency (primary IGFD) | ||
Votubia | Everolimus | Renal angiomyolipoma and subependymal giant cell astrocytoma associated with tuberous sclerosis complex (TSC) | ||
Individual Reimbursement | ||||
Trade Name | Active Substance | Orphan Indication | ||
Revatio | Sildenafil | Pulmonary arterial hypertension (PAH) | ||
Volibris | Ambrisentan | PAH | ||
Tracleer* | Bosentan | PAH; systemic sclerosis | ||
Nexavar | Sorafenib | Hepatocellular carcinoma; renal cell carcinoma; differentiated (papillary/follicular) thyroid carcinoma | ||
Atriance | Nelarabine | T-ALL and T-LBL | ||
Sutent* | Sunitinib | GIST | ||
Glivec* | Imatinib | Ph+ CML; Ph+ ALL; MDS/MPD; GIST; DFSP; HES and CEL | ||
Sprycel | Dasatinib | Ph+ CML; Ph+ ALL | ||
Mozobil | Plerixafor | HSCT in patients with lymphoma and multiple myeloma | ||
Arzerra | Ofatumumab | Chronic lymphocytic leukaemia (CLL) | ||
Nplate | Romiplostim | ITP | ||
Revolade* | Eltrombopag | ITP | ||
Exjade | Deferasirox | Chronic iron overload due to blood transfusions in patients with beta thalassaemia major, other anaemias, and non-transfusion-dependent thalassaemia syndromes | ||
Wilzin* | Zinc | Wilson’s disease | ||
Cystadane | Betaine | Homocystinuria | ||
Diacomit | Stiripentol | Dravet’s syndrome (Severe myoclonic epilepsy in infancy – SMEI) | ||
Drugs withdrawn from the European Community register of designated orphan medicinal products | ||||
Trade Name | Active Substance | Withdrawal Date | Reason of Withdrawal | |
Aldurazyme | Laronidase | June 2013 | End of the period of market exclusivity | |
Wilzin | Zinc | October 2014 | ||
Revolade | Eltrombopag | January 2012 | Request of the sponsor | |
Sutent | Sunitinib | July 2008 | ||
Glivec | Imatinib | November 2011 | End of the period of market exclusivity (for Ph+ CML) | |
April 2012 | Request of the sponsor (for other indications) | |||
Tracleer | Bosentan | May 2012 | End of the period of market exclusivity (for PAH) | |
April 2014 | Request of the sponsor (for systemic sclerosis) | |||