Dive Brief:
- After months of pointed negotiations, Vertex and English health authorities have agreed on a reimbursement plan for the Boston biotech's cystic fibrosis drugs.
- England's National Health Services previously agreed to cover Vertex's earliest cystic fibrosis drug, Kalydeco, for certain patients. But when it came to two newer treatment options, called Orkambi and Symdeko, the two parties butted heads about whether the drugs were cost-effective. The list prices on Kalydeco, Orkambi and Symdeko are $311,000, $272,000 and $292,000, respectively.
- The parties didn't disclose how much NHS will now pay to access Vertex's portfolio. Still, the new deal removes the company's biggest commercial barrier and provides a clear path to the estimated 8,000 people in England living with cystic fibrosis. The deal allows doctors to prescribe Kalydeco to a wider pool of patients, and to prescribe Orkambi and Symdeko to patients who meet age and genetic criteria included in the drugs' labels.
Dive Insight:
Though financial details aren't public, there are some clues as to what NHS will pay for Vertex's medicines. During a June meeting of the U.K.'s House of Commons, Parliament Member Seema Kennedy noted how NHS "significantly" increased its offer after Vertex rejected a 2018 proposal.
That proposal would have provided 500 million pounds — worth roughly $660 million at the time — in exchange for five years of access to Kalydeco (ivacaftor) and Orkambi (lumacaftor/ivacaftor). NHS would also have access to two drugs that weren't yet approved: Symdeko (tezacaftor/ivacaftor) and a closely watched triplet that, just this week, received U.S. approval. Combined, Vertex's portfolio can treat an estimated 90% of the cystic fibrosis population.
The U.K. is second largest cystic fibrosis market in the world with 10,000 patients total and 8,000 in England alone. Depending on the number of patients who ultimately get a Vertex drug and the per-patient list price, analysts expect Vertex could earn somewhere between $420 million to $515 million each year from the U.K. market.
On the higher end, RBC Capital Markets models 5,700 patients soon getting access to Vertex's drugs at a hypothetical price of 70,000 pounds per year. Provided Vertex's triplet, branded as Trikafta in the U.S. gains European approval, RBC expects the number of eligible patients will grow to approximately 8,500.
"There is no cap on patient numbers, and each and every patient in England who might benefit can now get these treatments, free on the NHS. Clinicians will be able to begin prescribing these drugs within 30 days," the agency said in an Oct. 24 statement.
Vertex's cystic fibrosis products brought in $1.8 billion in net revenue over the first six months of this year. On the heels of Trikafta's U.S. approval, the company raised its 2019 net revenue guidance to a range of $3.7 billion to $3.75 billion, up from $3.6 billion to $3.7 billion.