As the targeted treatment space for ALK-positive non-small cell lung cancer becomes more crowded, Takeda is trying to get ahead of the competition with a drug pricing tool that’s rarely used among U.S. oncology players.
Takeda recently launched a value-based pricing program for its ALK lung cancer med Alunbrig in collaboration with Point32Health, a combination of Tufts Health Plan and Harvard Pilgrim Health Care covering 2 million people in the New England area.
Under the agreement, Takeda will offer a “significant” rebate to Point32Health if a patient doesn’t stay on Alunbrig past three months because of efficacy or tolerability reasons, Dion Warren, Takeda Oncology’s U.S. head, explained in an interview. The size of the refund would be tied to the number of members on the drug, a Point32Health spokesperson told Fierce Pharma. Patients would also get a refund from their plans for out-of-pocket costs, the spokesperson said.
Takeda’s move comes shortly after Pfizer launched a pilot program called Pfizer Pledge for its first-generation ALK med Xalkori, as Stat reported last month. The Pfizer program, based on warranties, promises to refund the entire cost of Xalkori if a patient stops treatment within the first three months. Xalkori currently bears a monthly wholesale acquisition cost of about $19,100, while Alunbrig’s list price is about $17,000 per month.
Xalkori is the old ALK med that every subsequent offering in the class has bested during clinical trials. For Takeda’s Alunbrig, the drug reduced the risk of disease progression or death by 51% over Xalkori in newly diagnosed patients with ALK-positive non-small cell lung cancer. The phase 3 Alta-1L data earned Alunbrig an FDA nod for first-line use last May.
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The new Point32Health deal was meant to “broaden access and stand behind the value of Alunbrig,” Warren said. The program is unique in that it doesn’t have any eligibility limitations, so it’s available for all potential patients, he said.
Takeda chose Alunbrig for its first value-based purchase deal because of the ALK drug’s clear efficacy and safety profile. Still, for any drug, some patients may discontinue treatment early because they don’t respond to or can’t tolerate it.
“What we’re trying to do is offer this risk-sharing agreement to take some of those initial concerns … off the table,” Warren said.
With Alunbrig being a single-agent therapy, it’s also straightforward for Takeda to track and understand the med's performance in the real world while executing the data-driven agreement, he added.
But the three-month refund window Takeda is offering is much shorter than the time many patients experienced without disease progression in the med’s late-stage clinical trial. To hear Warren tell it, the first three months of treatment often determine whether a treatment is right for a patient.
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Alunbrig is only one of several of Big Pharma’s ALK medicines that are fighting for share in a niche market. The current market leader is Roche’s Alecensa, which got its front-line label in 2017. With a monthly list price of about $16,078, Alecensa brought in third-quarter sales of 357 million Swiss francs ($390 million), up 18% year over year. By contrast, Alunbrig’s haul during the three months were 3.1 billion Japanese yen ($27.3 million).
“While we don’t currently have a rebate program for Alecensa, we’re conducting a number of pilots across our oncology portfolio, including ways to reimburse medicines based on different indications, outcomes, and regimens,” a spokesperson for Roche’s Genentech said in a statement to Fierce Pharma.
Zykadia maker Novartis also doesn’t have a dedicated outcome-based program for its ALK drug, a company spokesperson said. But the company offers patient assistance programs and a co-pay support project, where a patient can get a drug with no out-of-pocket costs or free of charge, the spokesperson added.
Meanwhile, Pfizer in March moved its third-generation tyrosine kinase inhibitor Lorbrena into front-line ALK-positive lung cancer on the back of phase 3 data showing it could improve upon Xalkori’s progression-free survival showing by 72%. And small biotech Xcovery has been looking for a marketing partner for its phase 3 candidate ensartinib, though it hasn’t had any luck.
Outcomes-based drug pricing is still fairly rare in the U.S., although players in the drug reimbursement system are increasingly looking to new strategies to pay for expensive drugs. Novartis, for example, offers a program for its spinal muscular atrophy gene therapy Zolgensma where payments can be made in installments over years only when the drug continues to work.
Takeda, while testing the water with Alunbrig’s Point32Health deal, plans to expand value-based pricing with other payers and into other cancer drugs. It’s a “key approach” that the Japanese pharma intends to use more broadly, Warren said.
“We need to learn through this experience and continue to broaden our approach to access so we can benefit as many patients as possible,” Warren said. “This is the first for us—it’s not going to be the last.”