International supply side policies for biosimilars

INICIO/Informes | Posted 30/11/2018 post-comment0 Post your comment

A report published by the Canadian Agency for Drugs and Technologies in Health (CADTH) investigated how international supply side policies influenced the use of biosimilars [1].

Clinician indications V17A13

CADTH defines supply side policies as policies implemented by payers, and policies related to pricing and procurement.

The report investigated post-marketing supply side policies established in the US, Australia, New Zealand, Finland, France, Germany, The Netherlands, Norway, and the UK to encourage the use of biosimilars.

The report found that manufacturers are free to set the price in the US, Germany, and the UK. Although in the UK biosimilars are subjected to the Pharmaceutical Price Regulation Scheme rule, which sets price ceilings on the basis of negotiations and manufacturer profit levels. The UK system also uses tendering procedures at both the hospital and outpatient level.

In Norway, a free pricing policy without exceeding the price of the reference biological exists and mandatory discounts increase with time and the number of market entrants. While in Germany and The Netherlands, reference internal or fixed reference pricing is used.

Tendering at the national, regional or hospital level is used to further drive down the cost of the biosimilars in Germany, the UK, France, Norway, and The Netherlands. Finland and France have a mandatory price reduction for biosimilars.

In Germany, patients also have to pay the difference between the retail price and the reference reimbursement price incentivizing patients to choose the cheaper drug.

Finland insists that the price of the first reimbursable biosimilar is at least 30% lower than the reference biological [2]. The country also re-examines the prices of the reference biologicals once a biosimilar is launched in the market.

Beginning in October 2018, Australia put in place a mandatory discount of 25% on the price of the brand-name biological when its first biosimilar is listed. Pharmacists in the country are currently allowed to keep the difference when dispensing medicines cheaper than the government’s reimbursement price as an indirect incentive to dispense the cheaper biosimilars.

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1. CADTH Environmental Scan. International policies on the appropriate use of biosimilar drugs. October 2018 [homepage on the Internet]. [cited 2018 Nov 30]. Available from:
2. Kurki P. EU Member States have tools to reduce costs of bestseller biologicals but can they use them? Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):5-7. doi:10.5639/gabij.2018.0701.002

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Source: CADTH

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