1. Comparing HTA recommendations
HTA recommendation for 9 European jurisdictions classified according to 3 categories
Jurisdiction (Agency)
Reimbursed
Reimbursed with restrictions
Not reimbursed
Belgium (National Institute for Sickness and Invalidity Insurance (INAMI))
Insured (Class 1)
Orphan drugs
Not Reimbursed
Insured (Class 2)
England (National Institute for Health and Care Excellence (NICE))
Recommended
Optimised
Not recommended
France (French National Authority for Health (HAS))
Approved
Approved with restriction
Germany (Federal Joint Committee (G-BA))
Indication of a considerable additional benefit
N/A
Hint of considerable additional benefit
Proof of a significant additional benefit
Minor additional benefit
Additional benefit has not been proved
Italy (Italian Medicines Agency (AIFA))**
Reimbursed Class A
Reimbursed class H
Ireland (National Centre for Pharmacoeconomics (NCPE)
Reimbursement Recommended
Reimbursement not recommended
Reimbursement not recommended at submitted price
Netherlands (National Health Care Institute (ZIN))
Insured (Annex 1A)
Insured with restrictions
Insured (Annex 1B)
Expensive drugs policy
Sweden (Dental and Pharmaceutical Benefits Agency (TLV))
General
Limitations
Scotland (Scottish Medicines Consortium (SMC))
Accepted
Restricted
Not Recommended
One hundred and two NASs approved by the European Medicines Agency (EMA) from 1 January 2008 to 31 December 2012 were identified from the EMA online database.
HTA recommendations were collected for each NAS and approved indication(s) from the official national agency websites for the following agencies: The Belgium Health Insurance Agency (INAMI); National Centre for Health and Care Excellence (NICE) in England; French National Authority for Health (HAS); Federal Joint Committee (G-BA) in Germany; National Centre for Pharmacoeconomics (NCPE) in Ireland; Italian Medicines Agency (AIFA); Dutch National Health Care Institute (ZIN); Scottish Medicines Agency and The Dental and Pharmaceutical Benefits Agency (TLV) in Sweden.
The quantity of information available varied between jurisdictions as this research only collected data available in the public domain. Published reimbursement recommendations were recorded and classified into three categories: recommended, recommended with restrictions and not recommended.
Definitions NAS: This includes chemical, biological and radiopharmaceutical substances that have not been previously available for therapeutic use in humans to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in humans. This term also includes: An isomer, mixture of isomers, a complex or derivative or salt of a chemical substance previously available as a medicinal product but differing in properties with regard to safety and efficacy from that substance previously available; a biological substance previously available as a medicinal product, but differing in molecular structure, nature of source material or manufacturing process; a radiopharmaceutical substance that is a radionuclide or a ligand not previously available as a medicinal product. Alternatively, the coupling mechanism linking the molecule and the radionuclide has not been previously available.
Applications that are excluded from the study: vaccine; any active substance that has previously been approved either by the EMA or by a member state; any other application, where new clinical data were submitted; generic applications; those applications in which a completely new dossier was submitted from a new company for the same indications as already approved for another company; and applications for a new or additional name, or a change of name, for an existing compound (i.e. a ‘cloned’ application).
From Allen N, Walker S, Liberti L. Do HTA processes correlate with reimbursement recommendations following EMA approvals? Poster presented at ISPOR 6th Asia-Pacific Conference. Beijing, China. September 6-9, 2014