- A key barrier separating Roche's Hemlibra from patients in England has been removed, as the country's National Health Services announced Wednesday that it will cover the hemophilia drug.
- Specifically, the agency agreed to fund Hemlibra for the estimated 2,000 English patients living with severe hemophilia A. The European Medicines Agency first cleared Hemlibra in early 2018 to treat a subset of that population, but has since broadened the approval to include any patient with severe hemophilia A.
- The decision should further boost the drug's sales, which hit 535 million Swiss francs during the first six months of the year. Investment bank Jefferies has forecasted $5 billion in peak annual sales of Hemlibra.
Solid efficacy and more convenient dosing is allowing Hemlibra (emicizumab) to take market share away from older hemophilia treatments.
The drug doesn't come cheap, however. As of the end of 2018, Roche had set Hemlibra's annual list price at approximately $492,000 for an average weight person with hemophilia A — and that was for each year after the first year's loading dose, which was about $38,000 more expensive.
Roche is likely providing Hemlibra to NHS England at a discount, though both parties declined to comment about their pricing agreement, citing confidentiality reasons. NHS has successfully nudged companies to offer up therapies at lower costs in the past, like when Novartis agreed to a U.K. price for its CAR-T therapy Kymriah (tisagenlecleucel) that was nearly a quarter cheaper than the $475,000 it charges in the U.S.
For Roche, a discount may be well worth it. The agreement with NHS England opens the door to 2,000 more patients and faster growth in Europe, particularly among certain patients.
European regulators first approved Hemlibra in 2018 as a preventive treatment for patients who had severe hemophilia A and tested positive for inhibitors, a type of antibody that attacks infused clotting factor and makes it ineffective. The regulators later granted it approval for patients without inhibitors — a population which, while much larger, has had less time to come onto Hemlibra therapy.
"We're very early on the non-inhibitor reimbursement discussions because, well, the wheels of reimbursement are growing slowly in most of the European countries," Bill Anderson, CEO of Roche Pharmaceuticals, said during the company's second quarter earnings call.
Anderson said that, outside the U.S., most of the Hemlibra business is rooted in inhibitor patients. That should change moving forward, though, as the company expects growth to come from patients with non-inhibitors.
Roche estimates Hemlibra has 14% share of the U.S. hemophilia A drug market, with three percentage points coming from patients with inhibitors and 11 from patients without them. In the inhibitor market, which represents about 5% of the overall population, Hemlibra holds 60% share by Roche's accounts.