Skylar Jeremias

Based on the success of a biosimilar switching program, Nedzad Pojskic, PhD, MSc, vice president of Pharmacy Benefits Management for Green Shield Canada, detailed why payers should become bigger advocates for biosimilar uptake, at the Festival of Biologics USA meeting.

Canada ranks third in the world in per capita spending on drugs ($1012 vs $1324 in Switzerland and $1457 in the United States), he said, explaining the need for biosimilar savings.

“I think it's really important to recognize that as payers in this country, we have to be explicit around being leaders in educating various stakeholders, whether they be physicians, other sorts of players in the system, patients, or those in leadership roles, to support a viable biosimilar market and to move forward,” said Pojskic.

 have begun executing biosimilars switching initiatives, Pojskic noted that Green Shield Canada was the first payer to have a policy that preferred biosimilars to originators.

Under the program, patients with a number of rheumatic conditions are either started on or switched to biosimilar versions of infliximab, etanercept, and rituximab, whose respective originator brands are Remicade, Enbrel, and Rituxan. Other biosimilar switches are expected with future program expansions.

Pojskic said that, for him, one of the most important lessons to come out of implementing a biosimilar transition program such as this was that payers are the real “gatekeepers” to biosimilar uptake.

“Evidence has shown us time and again that when payers allow open access to an originator and a biosimilar with no preferential policies for biosimilars, the uptake naturally flows to the originators….However, with more aggressive policies that target a sustainable biosimilar market and the uptake of biosimilars in preferential fashion, we start to see payers being a really important part of this equation,” he said.

When biosimilars and originators are treated equally on the formulary, patients and providers flock to originator products because they have historical comfort with using the dominant brands. As a result, biosimilar uptake occurs very slowly, Pojskic said.

So far, Green Shield Canada’s program is a success, generating an average of $8500 in savings per member annually.

Of the patients involved in the program, 55% transitioned to a biosimilar and 14% stayed on the originator but were billed for the price of the biosimilar, which resulted in reduced costs, Pojskic noted.

Pojskic also said that Green Shield Canada made it a priority to work with patients to ensure comfort with biosimilar switching, and this was successful. He reported that patients understood and were receptive to the change, had talked with their physicians about transitioning, and appreciated the support and aid given by nurses.

The Canadian health care system primarily functions as a Medicare-like structure that covers most aspects of hospital and physician care. However, pharmaceuticals are different in that they are funded both privately and publicly. Canada spent $39.8 billion on drugs in 2018, and of that, $12.30 billion and $14.33 billion was privately and publicly funded, respectively, and out-of-pocket costs for pharmaceuticals were $13.10 billion, Pojskic said.

The share of total pharmaceutical costs generated by biologics spending 

 year-over-year, from 20% in 2015 to 24.7% in 2019. Pojskic said that

number to grow as more biologics enter the market.

As biosimilars have entered the market, discounts from originator costs have ranged from 17% for filgrastim biosimilars to 50% for some infliximab biosimilars, he said 

Canada is one of the largest purchasers of originator infliximab, but at the end of 2018, uptake of infliximab biosimilars was only at 8% of total use, slightly above the United States (7%) but significantly trailing Norway (98%), Poland (96%), the United Kingdom (92%), Austria (89%), and Italy (79%), according to Pojskic’s presentation.

everal factors pose barriers to biosimilar uptake in Canada:

There are no interchangeability policies (pharmacists cannot simply substitute biosimilars without physician approval)

Payer policies offer reimbursement for biosimilars without making them preferred products

Switching to biosimilars was not encouraged until recently

Originator manufacturers interfere with biosimilar uptake

Pojskic said a major hurdle that had to be overcome when implementing the biosimilar transition program was addressing the common concern that there is not enough evidence to support the safety of biosimilar switching.

To combat this, Green Shield Canada produced a systematic review of studies showing that switching between originators and biosimilars was safe and effective. The review encompassed 178 studies, of which 140 were based on real world evidence, and included data on 21,000 patients and 10 biologic agents.

“There's plenty of evidence to support biosimilar transitioning and it all points in exactly the same direction. We knew that this evidence was more than enough to safely engage in biosimilar transitioning and to create a program,” said Pojskic.

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To overcome provider and patient preferences for brand originators, there has to be more of an incentive to use biosimilars, explains Nedzad Pojskic, PhD, MSc, Green Shield Canada.

Green Shield Canada: Preferential Status Is Vital to Biosimilar Uptake

During March, both state and federal legislators moved forward with bills to increase access to biosimilars, biosimilar advocacy organizations made changes to their guidelines, and experts criticized current and proposed policies that they said would not improve biosimilar uptake.

 a bill requiring the FDA to provide the public with educational information that is supportive of biosimilar adoption. The Advancing Education on Biosimilars Act was introduced in 2019 and was initially voted on in December 2020 but required a fresh vote for 2021.

Under the bill, the FDA would develop a biosimilars education website that would include information on key statutory and regulatory terms used in reference to biosimilars, including 

. The website also would be tailored to the needs of health care providers and would make comparative data for originators and biosimilars available.

Also, Minnesota state legislators introduced a bill aimed at 

 to biosimilars by requiring health plans and pharmacy benefit managers to cover all versions of a biologic equally—biosimilars and originator products. The bill would create more opportunity for biosimilars to compete alongsideoriginators by denying payers the ability to make formulary decisions in favor of more costly biologics.

In an interview with The Center for Biosimilars®, Maria Manley, LLM, a life sciences expert, discussed the hoops pharmaceutical companies 

 to ensure that their products could still be marketed in the United Kingdom after the country’s official departure from the European Union, which was dubbed Brexit.

In light of Brexit, many companies had to transfer product marketing authorizations from UK entites into EU entities to ensure that their products were properly domiciled. Brexit also led to the establishment of a free trade agreement without tariffs or quotas between the United Kingdom and European Union.

In a March webinar sponsored by the Biologics Prescribers Collaborative, a 

 discussed former president Trump’s proposed Most Favored Nations policy, which was intended to change the reimbursement structure of Medicare Part B drugs to lower drug costs. This was frowned on by the panel because it would prevent an estimated 9% of Part B patients from having access to their medications.

The methodology behind the Institute for Clinical and Economic Review’s value assessments for drugs was also criticized by the panel. They argued that the assessments are based solely on clinical trial data and are conducted prior to drugs receiving FDA approval, making the assessments less representative of how drugs would perform in real-world settings.

Additionally, a white paper noted some reasons that biosimilars are currently 

 for the health care system. The authors pointed to CMS’ policy of allowing originators and biosimilars to have separate reimbursement codes and prices under Medicare Part B. The authors argued that the policy conflicts with the agency’s goal of fostering a competitive market for biologics.

Place generic drugs in Medicare Part D on generic formulary tiers with lower cost-sharing than brand name drugs

Ensure Medicare beneficiaries have access to new generics

Update Medicare Part D to include a dedicated specialty tier for generics and biosimilars

Reward Medicare health plans for encouraging use of lower-cost generics or biosimilars and eliminating barriers to access

End brand “rebate traps” that prevent use of generics and biosimilars

Increase the Medicare Part B add-on payment to providers who use biosimilars

Encourage adoption of biosimilars with a shared savings program

Repeal or amend the Medicaid drug price inflation penalty for generics

In other news, the Association for Accessible Medicines published a position paper that detailed a 

 for CMS to change some of its policies. Some of the policy changes suggested were rewarding Medicare plans that encourage use of generics and biosimilars, ending “rebate traps” that prevent access to generics and biosimilars, and increasing add-on payments for physicians who prescribe biosimilars.

The National Comprehensive Cancer Network released a 

 advising health care providers to lobby for policies that avoid payer formulary preferences and create more access to biosimilars. The guidelines also addressed issues regarding biosimilar procurement and the need to stock multiple biosimilars of the same drug, which is costly and leads to errors.

 Michel Robidoux, the president and general manager of Sandoz Canada, as chair of the trade association’s board. In a statement, Robidoux praised the successes of British Columbia and Alberta’s biosimilars initiatives that require patients with chronic conditions to be switched to certain biosimilars as a mode of creating savings on biologic spending.

The month of March brought intense debate and legislative action over biosimilar policies. 

Biosimilar Policy Roundup: March 2021

Phase 3 clinical trial results confirmed that a trastuzumab biosimilar candidate (EG12014) developed by EirGenix is biosimilar to the reference product (Herceptin), the company said in a 

EirGenix, based in Taipei, Taiwan, said it will move forward with plans to submit marketing approval applications to the FDA, the European Medicines Agency, and the Taiwan FDA.

If EG12014 is approved, Sandoz will be in charge of global marketing in the United States and European Union, but not in Taiwan and Mainland China, according to a licensing agreement between Sandoz and EirGenix signed in April 2019.

In 2020, global sales for Herceptin, facing heavy biosimilar competition in Europe, the United States, and elsewhere, dropped 34% from 2019, according to Roche’s 

. Overall, biosimilar competition eroded 

 of the company’s international revenues for 2020 and Roche anticipates losing another $5.1 billion to biosimilars in 2021.

The trastuzumab biosimilar candidate, if it is priced below reference, may be well received in Taiwan given that Taiwan’s National Health Insurance paid $57.9 million for Herceptin therapy in 2019.

The phase 3 trial was a multinational, multicenter, randomized, double-blinded study that enrolled 807 women with human epidermal growth factor receptor 2 (HER2)–positive breast cancer. Patients were randomly assigned 1:1 to two treatment groups and were administered anthracycline-based chemotherapy every 3 weeks for 12 weeks.

After receiving chemotherapy, patients were given either EG12014 or the reference drug in combination with paclitaxel once every 3 weeks for 12 weeks. All patients had tumor removal surgery scheduled to take place 3 to 6 weeks after completing neoadjuvant therapy.

During the surgery, investigators collected samples to assess the pathologic complete response (pCR), which was conducted by an independent central laboratory. The study’s primary endpoint of pCR was defined as no invasive cancer in the breast and axillary nodes.

Results of the study demonstrated that EG12014 was bioequivalent to the reference product in terms of clinical response, and the safety profiles between the two were comparable in the preoperative treatment setting.

The trial results come after results from a different study, presented at the National Comprehensive Cancer Network (NCCN) Virtual Annual Conference 2021, showed 

 rates for Amgen’s trastuzumab biosimilar, which launched on the US market in July 2019.

Positive phase III clinical results for EirGenix's proposed trastuzumab biosimilar. News release. EirGenix. March 24, 2021. Accessed March 25, 2021. 

http://www.eirgenix.com/en/news/show.aspx?num=168

EirGenix, in partnership with Sandoz, announced positive safety and efficacy results for its trastuzumab biosimilar in patients with breast cancer.

Phase 3 Trial Demonstrates Bioequivalence for EirGenix’s Trastuzumab Biosimilar Candidate 

To be effective in improving physician and patient confidence in biosimilars, educational material needs to be readily available, accessible for all types of learners, and distributed regularly, a panel of physicians argued in a recent webinar.

The webinar was presented by the Biologics Prescribers Collaborative and featured 3 physicians who discussed some major hindrances to biosimilar uptake and access and whether currently proposed solutions would succeed.

All the panelists pointed to education as a main way to build physician and patient confidence in biosimilars.

Angus Worthing, MD, a rheumatologist at Arthritis and Rheumatism Associates in Wheaton, Maryland, said that the FDA’s efforts to promote patient-friendly information and the existence of the Purple Book, a public list of existing biologics in the United States, are helpful but not enough. He also stated that the Advancing Education on Biosimilars Act of 2020, which 

 in the Senate in December 2020, is a great step forward.

In regard to issuing a positive message on biosimilars, David Charles, MD, chairman of the Alliance for Patient Access and a practicing neurologist at Vanderbilt University in Nashville, Tennessee, said that, “patients and clinicians need to hear it over and over and over from multiple sources. So, the idea of having 1 clearinghouse for education is great, but you also want educational materials available in other locations and in different media.”

Charles described how educational material should be provided in different media, including written, video, and auditory formats, to cater to the different ways that people learn.

Dennis Cryer, MD, chief medical officer at CryerHealth and a member of the Global Liver Institute’s board of directors in Washington, DC, argued that educational material should be easy to find and promoted through organizational newsletters and distributed to patients in easy-to-understand written or electronic formats.

“Make sure patients can get them and that they don’t have to go look for them or go to the FDA website and try to navigate that to find what they’re looking for, because that could be a significant barrier,” said Cryer.

, a controversial proposal put forth by the Trump administration in its final days that addressed international reference pricing. The policy, blocked in January by a federal judge, was intended to change the way Medicare Part B drugs are reimbursed so that payment is based on the lowest adjusted international sales price instead of a drug’s average sales price.

Although the policy was intended to lower prescription drug prices, Worthing argued that an estimated 9% of Medicare Part B patients would have lost access to coverage for their medications because physicians wouldn’t be able to afford to provide the drugs under the lower reimbursement system.

Additionally, the policy would’ve gone into effect during the COVID-19 pandemic and expired after 7 years, potentially preventing many elderly patients with chronic conditions from having access to disease managing medications. “This is just the worst time to be doing anything like that,” said Worthing.

Worthing also said that he was surprised that the proposal was introduced with so little preliminary discussion. There was no time for a proper preview or for health care systems to comment. The lack of a comment period, he argued, was problematic because that left it up to the courts to stop the program from being implemented and provide a review phase.

Another topic of controversy among panelists was the Institute for Clinical and Economic Review

, which are reports aimed at assessing the savings value of drugs based on clinical trial data. The data focusses on quality-adjusted life years gained by a patient while taking a drug. However, the appropriateness of this assessment is debatable.

Charles argued that despite ICER’s good intentions to address rising health care costs, some physicians have concerns about the organization’s methodology. Clinical trial data are typically intentionally narrow and include small patient populations, making them less representative of a drug’s value in a real-world setting.

Additionally, Charles states that “it really makes no sense” for ICER to issue a value to a drug before receiving FDA approval because no physicians have had an opportunity to prescribe them yet.

“If, as some assert, the methods that ICER is employing have flaws and those results are then used by payers to restrict patient access to new and innovative therapies, that’s where I as a clinician really have a problem with that. I want, and my patients want, access to more therapies—not restrictions placed by insurance companies or other [entities].”

Cryer elaborated, saying that the perspective of patients, in addition to physicians’, should be taken into consideration when assessing a drug’s value because they are the people who are going to be most affected.

He added that assessing drug value before the FDA has approved any indications is flawed because, at that time, no one knows how a drug will be used and what kind of patients will use it.

A panel of physicians gave advice on how biosimilar educational materials should instill confidence in these medications and which policies may be more harmful than beneficial.

Skylar Jeremias

Green Shield Canada: Preferential Status Is Vital to Biosimilar Uptake

Biosimilar Policy Roundup: March 2021

Phase 3 Trial Demonstrates Bioequivalence for EirGenix’s Trastuzumab Biosimilar Candidate

What Should Educational Materials Include to Instill Confidence in Biosimilars?