DIFFERENCES IN APPROACH TO BIOSIMILARS- NICE VS. SMC RECOMMENDATIONS

Author(s)

Izmirlieva M*, Ando G IHS, London, United Kingdom

OBJECTIVES: Several biosimilar products have been approved for marketing in the European Union, but their market penetration remains slow. Lack of clear reimbursement guidance could be one of the reasons for this slow penetration. This study examines how many, if any, biosimilar products have been assessed in the United Kingdom by NICE and by the SMC and to what extent recommendations by the two HTA organisations are consistent. METHODS: Secondary research was conducted, including a review of all NICE and SMC final guidance and of guidance in progress by NICE to compare the HTA process outcome and issues raised by the two HTA agencies. RESULTS: NICE has issued only one final guidance for a biosimilar product (Omnitrope) and has another guidance in progress (for epoetin including biosimilars). The SMC has issued guidance for 4 biosimilar versions of filgrastim (Ratiograstim, TevaGrastim, Zarzio and Nivestim), 2 biosimilar versions of epoetin (Binocrit and Retacrit) and 1 version of somatropin (Omnitrope). All SMC guidance for biosimilars issued to date has been positive. The NICE guidance for Omnitrope is positive despite some reservations about the economic model. CONCLUSIONS: Considering the limited overlap between NICE and SMC decisions (only one drug - Omnitrope - was considered by both agencies), it is difficult to assess consistency in the SMC approach compared to NICE’s approach at this stage. Based on the biosimilars HTA guidance by NICE and the SMC to date, a cost-minimisation analysis may be acceptable for biosimilars even if such an approach - in the absence of a full cost-effectiveness model - might be rejected for an originator product. Both HTA agencies recommend that prescribing for biosimilars should be by brand name to avoid automatic substitution in the pharmacy.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

BI3

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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