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Table 1 Orphan drugs reimbursed in Latvia

From: Impact of orphan drugs on Latvian budget

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Drugs withdrawn from the European Community register of designated orphan medicinal products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)
  1. *Drugs withdrawn from the European Community register of designated orphan medicinal products