Table 2.

Guidance on the economic evaluation of biosimilars in a selection of European countries, derived from guidelines of Health Technology Assessment (HTA) bodies or relevant literature

Country	Guidance on economic evaluation for biosimilars
England/UK[3]	Biosimilars might be included in a NICE Multiple Technology Appraisal.
Scotland[4]	Since May 2015, SMC does not require a full submission for a biosimilar for indications of the reference product that have been accepted for reimbursement. A full submission is required for indications/populations for which the reference product is not recommended by SMC.
Wales[5]	The advice of AWMSG for the reference product will automatically apply for the biosimilar (same indications/populations). When the reference product is not reimbursed, it is advised to engage with AWMSG.
Sweden	A health economic evaluation is not required for a biosimilar. Reference is made to the data provided for the originator product. The price of the biosimilar cannot exceed the price of the originator product. (Personal communication with TLV)
France[6,7]	Biosimilars are included in ASMR class V: no added therapeutic value. A health economic assessment is not conducted for products in this class.
Belgium[8,9]	Class 2 reimbursement is applied for biosimilars, where no added value is claimed. Applications for reimbursement in class 2 are not required to include an economic evaluation of the medicine.
Germany	Biosimilars are not included in HTA assessment. (Personal communication with IQWiG)
Netherlands[10]	ZIN does not have specific guidelines for biosimilars. An economic evaluation is not required when no added therapeutic value is claimed (List 1A).
Poland[11]	Biosimilars are not included in an HTA assessment, except when the reference product is not reimbursed.
Hungary[12]	Biosimilars can be reimbursed through a simplified procedure when the reference product is already reimbursed. This simplified procedure does not require an economic evaluation, only a comparison of price.

SMC, Scottish Medicines Consortium; NICE, National Institute for Health and Care Excellence; AWMSG, All Wales Medicines Strategy Group; TLV, Tandvårds- och läkemedelsförmånsverket (Dental and Pharmaceutical Benefits Agency); ASMR, Amélioration du Service Médical Rendu (Improvement in Actual Benefit); IQWiG, Institut für Qualität und Wirtschaftlichkeit im Gesundsheitswesen (Institute for Quality and Efficiency in Health Care); ZIN, Zorginstituut Nederland (National Health Care Institute).