PFE withdraws BOSULIF from Germany and calls for ‘urgent review’ of the AMNOG procedure

To date, the conventional wisdom in Germany has been that scoring a ‘4 / non-quantifiable’ from the G-BA was enough to secure favourable pricing negotiation with the GKV. Today, Pfizer has announced that they are pulling BOSULIF from the German market due to an inability to agree with the GKV on the magnitude of BOSULIF’s 130b rebate, challenging this perception and calling for an “urgent system review”.

BOSULIF was assessed under the AMNOG procedure as an orphan therapy, which means that Pfizer was not initially required to submit data for BOSULIF vs. the G-BA’s choice of comparator, and that the lowest achievable benefit score for the product would be a ‘4 / non-quantifiable’. Due to the nature of the evidence submitted for the product – from a single-arm, Phase I / II trial –  this is exactly the score that was awarded by the G-BA. Other manufacturers presenting similar evidence packages for their products – and receiving similar scores – have sailed through the GKV negotiation stage (for example, ADCETRIS). Pfizer is the first company to withdraw a product that has received a positive benefit score from the market.

What was different in BOSULIF’s case? Although the exact nature of the GKV pricing negotiation levers are not public, it is known that the process relies to some extent on each of: the G-BA additional benefit score, the therapy’s projected budget impact, the unmet need in the indication, and international reference pricing. The GKV may have felt that BOSULIF, as the 5<sup>th</sup> licensed TKI in Germany, was not fulfilling a particularly high unmet need, and as a result they may have been unwilling to accept Pfizer’s desired price for BOSULIF.

It’s also worth noting that Pfizer has a history of taking a stand when it comes to market access and pricing issues in Germany – BOSULIF’s example calls to mind Pfizer’s response to the introduction of jumbo group reference pricing in the market in 2004. Rather than lower the price of SORTIS / atorvastatin, Pfizer elected to maintain its price and have patients pay the difference in cost (most other manufacturers opted to lower the price of their products after the legislation was introduced).