Hoping to become a top-five player in the world’s largest pharmaceutical market, Novartis recently donned a “U.S- first” mindset. But its journey to reach the goal will require a wide-ranging strategy as it seeks to execute in a challenging and competitive market.
Novartis is taking a comprehensive approach to executing the “U.S.-first” strategy, U.S. innovative medicines president Victor Bulto said in an interview last week. Its areas of focus include early research, drug profile selection, dealmaking, clinical development, plus commercialization and patient services, he said.
To Bulto, putting an emphasis on the U.S. market is an obvious pathway; it's the largest pharma market in the world and it's growing fast. Having spent 18 years at Novartis across both Europe and the U.S., Bulto understands that the two markets are very different.
In Europe, governments use national medical schemes to provide patient access at the lowest possible costs. In those countries, a drugmaker's commercial efforts are front-loaded as they work to negotiate pricing and reimbursement, Bulto said.
By comparison, “in the U.S., when you launch a product, that’s when the challenge really begins,” Bulto said during an interview on the sidelines of the J.P. Morgan Healthcare Conference in San Francisco.
Lowering patient 'friction' with unified functions
The unique challenge in the U.S., as Bulto sees it, is getting patients to start and remain on their therapies. For every 100 specialty scripts written in the U.S., only 30 patients remain on that given medication three months later, Bulto said. At Novartis, the company wants to reduce patient “friction” as much as possible, he added.
Under a massive reorganization, Novartis has combined its oncology and non-oncology franchises into a global innovative medicines business. It also divided the company by its U.S. and international market businesses. Bulto was elevated to Novartis’ executive committee as part of the overhaul. For his part, Bulto is busy reshuffling the U.S. structure as well.
What Vas has done is, he’s made it very clear to every function in the organization, when there’s a tradeoff, it’s the U.S. first.
Previously, Novartis’ commercial team was divided into seven franchises based around different therapeutic areas, each with their own support functions. Now, instead of building organizations around products, Bulto is combining them around functions such as market access, patient services, marketing and customer engagement.
This is all geared at tackling that “friction” in the U.S. market.
“It was true five to 10 years ago that the emphasis needed to be on therapeutic area knowledge,” Bulto said. “That’s not true anymore.”
Today, about 80% of the problems causing the “frictions” are shared across therapeutic areas, including daunting prior authorization requirements and copay burdens on patients, Bulto said.
PCSK9 and upcoming PD-1 tests
Right now, Bulto’s strategy to tackle patient friction is being put to test with the launch of cholesterol drug Leqvio, an siRNA tareting PCSK9 production. Novartis has projected a slow sales ramp because the drug is administered by healthcare professionals and therefore requires a buy-and-bill reimbursement model, which is foreign to cardiologists.
Educating cardiologists about the buy-and-bill model has been difficult, Bulto said, drawing a comparison to how anti-VEGF injections were first introduced to ophthalmologists.
To help doctors who don't want to adopt the buy-and-bill model, Novartis established a network of injection centers—at nearly 1,000 strong—to administer Leqvio. Currently, half of Leqvio injections are given that way, Bulto said. The drug has reimbursement policies covering 76% of commercial patients, which Bulto said is already better than the two self-administered PCSK9 inhibitors. And two-thirds of patients have $0 copays to get the med.
Despite this progress, Bulto maintains that it will take time for Leqvio to gain wide traction as “that’s the curve of any cardiovascular launch.”
Meanwhile, another test could be right around the corner. Novartis and partner BeiGene are awaiting a delayed FDA decision on PD-1 inhibitor tislelizumab. With multiple PD-1/L1 inhibitors already on the market, launching yet another option would be no cakewalk.
For now, Novartis remains mum about its commercial plan around tislelizumab. Bulto said the company is still working on its strategy and that “it’s too early for us to share.”
“The idea is not to compete frontally against these well-established players, but rather be smart about the combination strategy and how we go about it,” Bulto said.
'U.S.-first' from the beginning
Novartis’ U.S.-first mentality also affects its global research functions. For the company, the work starts with early research investment to focus on areas with high unmet need and growth potential in the U.S., Bulto said. That’s why the Swiss drugmaker recently outlined five core therapeutic areas of focus—cardiovascular, immunology, neuroscience, solid tumors and hematology.
Bulto also advises his R&D colleagues about what he called “target product profiles,” or developing drugs with characteristics that would be a fit for the U.S. market. On that front, Bulto said the newly passed Inflation Reduction Act is already affecting Novartis’ R&D decision-making because the company's projections around net value for drug candidates is changing.
Having the right product profile also means designing clinical trials with comparator arms that mirror the U.S. treatment standards versus the EU’s, plus recruiting more U.S. patients. Sometimes, sacrifices have to be made, the exec says.
“What [CEO] Vas [Narasimhan] has done is, he’s made it very clear to every function in the organization, when there’s a tradeoff, it’s the U.S. first,” Bulto said.
Novartis is also shifting the company’s organization more to the U.S. on the human capital front. The company used to rely on importing talent from Europe and other parts of the world to the U.S.—as is Bulto’s case. But the company has recently started deliberately hiring people with deep expertise in the U.S., Bulto said. For example, Novartis in late 2021 brought on food company Kellogg’s Gail Horwood as its chief marketing and customer experience officer.
Right now, the No. 1 priority for Bulto, he said, is to get the new machinery and organizational models to work, all under the new “U.S.-first” flag.