Benepali (Enbrel Biosimilar) Approved by Sweden HTA with 10% Discount: NOVEL Health Strategies Insights

 

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The pricing strategy for Biosimilars is still evolving. Few years ago it was assumed that Biosimilars would command low discount compared to small molecule generics. However, recent events illustrate two ends of the pricing spectrum for Biosimilars. Here we briefly discuss the two examples:

Sweden Approval of Benepali

Benepali is the biosimilar version of Amgen and Pfizer’s mega blockbuster drug Enbrel. Amgen markets Enbrel in the United States and Pfizer markets it outside the US and Canada. In 2015, Enbrel’s sales in the US and Canada were $5.4 Billion.

Today Sweden’s HTA agency approved Benepali for reimbursement at only 10% discount compared to Enbrel. This price discount is relatively low compared to typical price discounts for biosimilar ESAs and GM-CSFs.

The HTA agency’s comments for the Benepali were:

 

HTA believes that Benepali has the same efficacy and safety of Enbrel

Extensive analysis of Benepalis immunogenicity showed that the immune response to etanercept and its influence on the efficacy and safety comparable between Benepali and Enbrel

Norway’s Aggressive Price Negotiation for Biosimilar Remicade

 

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Remicade is an Anti-CD 20 mAb marketed by Janssen. In 2015, Remicade’s sales were $6.6B. The biosimilar version of Remicade, called Remsima was approved in Norway after negotiating ~70% discount.

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Hepatitis C Drugs Rake in $21 Billion in Global Sales in 2015: NOVEL Health Strategies HCV Update

Official numbers are out. In 2015, the global sales of three Hep C blockbusters (Harvoni, Sovaldi and Viekira pak) reached almost $21 Billion.  While this is a record, the peak sales are estimated to be more than $34 Billion.

While payers have acknowledged that these drugs are cost effective (even UK’s NICE has said Sovaldi is cost effective), the challenge is near term budget impact.  These drugs have sparked policy discussions and questions, including a recent article on access to HCV drugs for US Veterans.

2016 will be an interesting year as another bunch of new HCV drugs will be reaching the market (with similar efficacy and safety). We already saw the news that Merck has priced its new HCV drug at 30% discount compared to Gilead (Good news for payers and patients!). Hopefully these drugs with high cure rates will be accessible to all 170 million people worldwide who are infected with different genotypes of this virus.

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Global HCV Sales for 2015 (Source: Gilead, Abbvie and NOVEL Health Strategies Analysis)