Memorandum

Fiasp now available in the UK, Germany at no extra cost to NovoRapid – April 16, 2017

Novo Nordisk’s next-generation prandial insulin Fiasp (faster-acting insulin aspart) launched in the UK on Monday April 10, right on time with the company’s official UK launch date. The product also launched in Germany on April 1. The company announced the EMA-approval of Fiasp on January 10and the new insulin also just became available in Canada, its first market globally. We’re extremely excited that the new product – which has shown faster onset/offset vs. NovoRapid (insulin aspart) in clinical studies – is priced on par with its predecessor in the UK and will be reimbursed by NHS. We’re hopeful that on-par pricing would allow continued access to this next-generation product in Germany as well – Novo Nordisk has faced an unfortunate string of “no additional benefit” IQWiG rulings for Tresiba (insulin degludec) and Xultophy (insulin degludec/liraglutide), leading the company to withdraw these products from the German market rather than accept generic-level reimbursement. That all said, it’s also possible that Fiasp, as a modified formulation of insulin aspart, may not need to undergo an IQWiG ruling as Sanofi’s Toujeo (U300 insulin glargine) did not. While it’s true that phase 3 studies of Fiasp showed marginal rather than disruptive A1c improvements vs. NovoRapid, the PK/PD profile of faster-acting insulin aspart seems decisively better (onset of exposure 11.8 minutes faster, maximum concentration 25.7 minutes faster, and offset 35.4 minutes faster vs. NovoRapid) – for patients, this could mean lower hypoglycemia risk and less fear of hypoglycemia, tighter postprandial control, and improved quality of life, all of which we view as essential outcomes beyond A1c. We also see great potential for Fiasp for use in insulin pumps and closed loop systems. With a price equal to that of NovoRapid and with all these important benefits, we think it should be a no brainer for payers to reimburse Fiasp, and we applaud Novo Nordisk for this pricing strategy which will maximize patient access.

In late March, the company resubmitted Fiasp to the FDA following an initial Complete Response Letter (CRL) in October. As we await this regulatory decision, we’re also thinking ahead to pricing in the US – where controversy over cost of insulin has reached a boiling point – and we very much hope that Fiasp will also be priced on par with NovoLog on this side of the Atlantic.

-- by Payal Marathe, Helen Gao, and Kelly Close