How Did Kaiser Permanente Reach 95%+ Utilization of Biosimilar Herceptin and Avastin so Quickly?

The secret is in the sauce that makes Kaiser Permanente a truly integrated payer, and in its devout avoidance of the Achilles heel of other payers.

At this week’s GRx+Biosims meeting, two sessions with KP’s executives made it startling clear—if you don’t accept rebates, the decision to move to biosimilars is simple.

Amy Gutierrez, PharmD

Amy Gutierrez, PharmD, Senior Vice President and Chief Pharmacy Officer, Kaiser Permanente National Pharmacy Programs and Services, emphasized the organization, especially its California regions (which account for 80% of its membership), is highly integrated. The medical groups and Kaiser pharmacies “strongly collaborate,” coming up with evidence-based reviews of formulary drugs.

At a separate session, Sameer Awsare, MD, Associate Executive Director, The Permanente Medical Group, elaborated, “Our drug information services are critical in doing the evidence-based review.” When an oncology clinician is part of the review, he said, “it’s hard for other oncologists to go against these recommendations. This results in widespread buy-in to the formulary decisions.”

Formulary adherence is about 95%, according to Dr. Gutierrez, and in California, “the plan does not require prior authorizations.”

The Looming Patent Cliff

“Biosimilars are safe, and they have been shown to be as effective as innovator products,” asserted Dr. Awsare. He listed the many reasons why uptake has been slow—pay-for-delay, misinformation, patent litigation, and perverse incentives among the top factors. “Biosimilars have reduced costs because of increasing competition.”

Dr. Gutierrez stated that newer therapies can cost from $500,000 to $2 million. “How can we afford these newer treatments? The abandonment rate for medications that cost patients $250 or more is 69%, and 52% when the out-of-pocket costs are between $125 and $250.” This has significant implications for Kaiser and its 12.3 million members.

With 71 drug patents set to expire through 2023, representing $55 billion in costs, “We hope to take advantage of this with biosimilars,” she said.

Kaiser Permanente’s Biosimilar Journey

The health plan was an early adopter of Zarxio® (filgrastim-sndz). “We learned the ropes with that one,” said Dr. Gutierrez.

Dr. Awsare explained that when Zarxio first came out, the providers questioned the results of the European studies. Kaiser performed a study with its own patients (the first 700 patients to receive the product). “It turned out we saw even less neutropenia than with Neupogen—maybe it’s even a ‘biobetter’,” he stated. The result is that Kaiser Permanente now has 98% uptake on Zarxio, according to Dr. Awsare.

Kaiser decided in 2017 to cover Inflectra (infliximab-dyyb). “At that time, the professional [gastroenterological] societies were inferring this was not the best course of treatment,” said Dr. Gutierrez, and Kaiser Permanente delayed using the biosimilar for the inflammatory bowel disease indications. Kaiser started a registry to ensure that no safety signals were seen after the switch.

When Fulphila (pegfilgrastrim-jmdb) was approved, Kaiser soon decided to cover it in preference to the reference product. And when Amgen launched its biosimilar bevacizumab (Mvasi®) and trastuzumab (Kanjinti®), Kaiser Permanente jumped in with both feet. “The oncology doctors were ready to move to biosimilar trastuzumab and bevacizumab when they were launched,” said Dr. Awsare. “We went to 97% uptake on the Avastin biosimilar in only a month.”

Finally, Ruxience was also rapidly added to the formulary. Kaiser does focus on covering only one biosimilar in a class, to maximize its leverage.

Dr. Gutierrez emphasized that the plan has the ability to get “immediate P&T decisions and put coverage in place rapidly.” This has resulted in biosimilar uptake of 80% to 95%, depending on the product. She explained, we’ve seen greater (and faster) adoption rates with supportive care medications versus direct treatment.”  Overall, the plan has saved about $200 million since we began covering our first biosimilar.”

In cases where a product has a “skinny label,” Kaiser is open to approving off-label indications, if the evidence supports it. “We’re working with our physician groups to gain that evidence,” she said.

Dr. Gutierrez advised that supply and stocking is important. “We might be ready to start using the biosimilar immediately,” she said, “but the manufacturer may not be ready to meet our supply needs. We’re getting better at that.”

“We work to minimize use of evergreening products whenever possible to maximimize the impact of the future biosimilars market,” added Dr. Gutierrez. “We are a leader in US biosimilar use. Manufacturers know that Kaiser Permanente can switch medication coverage fast, and this gives us significant leverage.”

A Blueprint for Successful Infliximab Biosimilar Switching

Payers have not been quick to add biosimilar infliximab to their drug coverage. Yet, biosimilar switching is the objective for most health plans and insurers who are thinking about long-term savings. Even if they do not exclude the reference product Remicade® from coverage, some health plans, like Kaiser, have been moving forward in this effort.

At the Academy of Managed Care Pharmacy’s Nexus 2018 meeting in Orlando this week, two clinical pharmacy specialists from Kaiser Foundation Health Plan of the Northwest described what may be a best practice in converting patients to biosimilar Inflectra®.

RELEVANCE OF BIOSIMILAR SWITCHING AT THE PLAN LEVEL

Kayla Hubrich, PharmD, emphasized the importance of patient education, and patients’ reliance on Google for research. She said, “When patients will turn to Google and type in ‘Should I switch to an infliximab biosimilar?’ the first search result they see is an ad for ‘Finely Tuned,’ a Janssen website.” This, of course, discourages the use of biosimilars.

At Kaiser Foundation Health Plans, coverage decisions are made at a national level for its 12.5 million members and implemented at the regional plan level, according to Lynsey Smith, PharmD. The health plan made Zarxio® its preferred filgrastim product in 2016, and registered 96% of all filgrastim dispensings in self-injected settings, and 100% of all clinical administrations for this biosimilar.

Biosimilar switching
Source: Kaiser Foundation Health Plan

Obtaining that level of use means that not only treatment-naive patients were using Inflectra, but also those using Remicade in the past. Dr. Smith outlined the key steps in this conversion, starting with the providers. “For new starts,” said Dr. Smith, “the tactic was just to have the doctor choose the biosimilar” using tools incorporated into the electronic health record that encouraged them to order the preferred product. Concerning those patients needing to be converted from the reference product, Kaiser asked the prescriber to sign a ‘Therapeutic Equivalency Protocol’ agreement, which authorized the plan to make the switch. The biosimilar switching agreement was voluntary, and virtually all the rheumatologists, dermatologists, and gastroenterologists signed. “One GI out of 20 declined to authorize the switch in patients already receiving Remicade,” she said.

Kaiser emphasized patient notification and education. A letter, signed in their doctor’s name, was sent to each patient at least 2 weeks before the conversion date, explained Dr. Smith. Clinical Pharmacy Services was enlisted to answer patients’ questions via phone and E-mail. Patients were also given informational handouts about the biosimilar switching program at their infusion center.

“During this process, the clinical pharmacists received 30 to 40 calls,” she said. “The patients’ main concerns were whether the product was going to work as well as their old drug and whether they would receive the same copay assistance as before.” Active patient outreach was not conducted after the switch was instituted. Any patients reporting issues or concerns were triaged through Clinical Pharmacy Services.

Dr. Hubrich added that infusion center pharmacists reviewed all patients scheduled for infusions one week ahead of their appointment. The infusion center confirmed that the provider signed a TEP document, that patients were sent the notification letter, and that the infliximab order changed to Inflectra. Kaiser also developed a nurses’ protocol for the biosimilar switch and worked to educate practice staff about the program.

 

INFLIXIMAB SWITCHING PROGRAM RESULTS

The conversation program began on May 1, 2017, with dermatologists and rheumatologists, focusing on patients who were getting their first infliximab treatment. Dr. Hubrich stated that notification letters were sent to 158 patients. Three weeks later, current patients began to be switched from Remicade to Inflectra. The GI conversion began on May 11, 2017 with treatment-naïve patients, and letters were sent to 188 adult patients (as Inflectra did not have the pediatric ulcerative colitis indication). Active therapeutic switching began in September. “The one GI who declined to sign the TEP agreement joined in 2018,” said Dr. Hubrich. This is likely because of the experience of this doctor’s peers.

A total of 22 patients (6.4%) across specialties reported adverse events, with nine being changed back to reference product (2.6%), five changed to a different medication class, four resulted in a dosage increase, one patient decided to discontinue therapy, and three continuing biosimilar infliximab treatment without any change. They did find that 12.8% of patients experienced some “nocebo” effects, despite the fact that “no statistically significant changes in effectiveness and safety were observed after a medican of four infusions in 9 months of study.”

Dr. Smith asserted that communication was critical to the success of the program, with patients and providers. The provider’s agreement to sign the TEP document was a necessary step, and was accepted by all Kaiser’s specialist providers.

It must be emphasized that Kaiser has a different magnitude of leverage over its physicians than a network plan like Aetna or CIGNA. Yet a biosimilar switching program like this could be a blueprint for other integrated health plans to move forward if they desire to move patients quickly and efficiently to biosimilar therapy.