From The Editor | September 20, 2017

What These Two Mottos Must Mean For The Biosimilar Industry

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By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

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Last week, I attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference. It never fails that, after a good conference, I return to the office with the daunting task of writing an article about my key takeaways. Though I come from a writing background, it’s always a struggle to see “the forest through the trees,” if you will. And this conference was chock-full of good takeaways (trees) — many of which I plan to explore more fully in articles about the individual panels.

In the span of two days, those in attendance garnered insights into a number of aspects of biosimilar development, including interchangeability and forthcoming development challenges posed by the FDA’s guidance; regulatory best practices when working with the FDA; and the extent at which biosimilars have expanded access to biologics in Europe, especially in poorer nations. On top of the more scientific, best-practice-type of information, we received several “teaser” insights into a forthcoming RAND Corporation report that aims to update its widely cited 2015 biosimilar predictions. The AAM also announced the release of its own new report, which revealed biosimilars are expected to increase patient access to the top seven biologics by 2025. While estimates show 2.7 million patients will be taking either the brand or biosimilar version of the top seven biologic drugs by 2025, we could also see an additional 1.2 million patients begin biologic treatments (reaching 4.9 million in 2025), thanks to biosimilars.

But in addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply. In the past, I’ve often highlighted a few different mottos in the biosimilar space. These have included “education, education, education,” and “data, data, data.” These mottos remain just as important today — in fact, they surfaced a number of times throughout this conference. But I’d argue two others have earned motto status, including “collaboration” (x3) and “accessibility” (x3).

Collaboration Must Extend Beyond Companies, Trade Organizations

Collaboration is certainly not a new concept for pharma companies. Last year, this event emphasized the importance of biosimilar companies collaborating with other biosimilar companies in trade organizations, such as the Biosimilars Council, to ensure their perspectives were heard in the development of regulations and standards for the biosimilar industry. Now, that’s not to say there isn’t still a great need for company-to-company collaboration in certain areas. The Centers for Medicare and Medicaid Services’ (CMS’) unpopular policies for biosimilar coding have come up for debate again, and members of the Biosimilars Council continue to draw attention to the ongoing Risk Evaluation and Mitigation Strategy (REMS) abuses and the importance of the proposed CREATES Act.

But this year, I think it’s a testament to how far the U.S. industry has come in the past year or so that the need for collaboration has extended well beyond company-to-company partnerships and trade organization membership. We’re now seeing increasing calls for companies to work more intensely with payers and patient organizations. While we may have been anticipating more exciting leaps from payers this year after CVS and UnitedHealth jumped on board so quickly with Zarxio last year, we’re also seeing payers’ reticence to embrace Inflectra. Many are chalking this up to the existing (and frustratingly opaque) payer-contracting structures in place for J&J’s Remicade — and Pfizer has already announced it will be taking J&J to court over this very matter. (This will likely not be exclusive to J&J’s contracts.)

In fact, during the final session of the conference, a panel of industry leaders from Mylan, Pfenex, Apobiologix, and Sandoz argued the industry needs to turn its eyes to what “cannot be seen on the surface” when it comes to innovators’ existing relationships with payers, physicians, and patients. For instance, we can easily see the extent innovators go to in marketing their products through direct-to-consumer advertising. However, we aren’t seeing what really keeps these brand products on the market, and that’s their contracting system with payers. Just as one expert argued the importance of working together as the Biosimilars Council to help promote what biosimilars are bringing to the table, they also emphasized the importance of working one-on-one with payers.

In past articles, I’ve explored the conflicted attitude toward biosimilars from two very different types of payers — integrated delivery networks (IDNs) and regional insurers. The phrase “watching and waiting” is prominent in each (regardless of the strides we’ve seen with IDN Kaiser Permanente). But there’s been an equal amount of watching and waiting occurring in payer organizations and biosimilar companies. After all, there’s been great anticipation that payers will be the ones to champion the growth of biosimilars. But that hasn’t happened, which, I’d argue, suggests the need for stronger relationships with biosimilar companies. Edric Engert, managing director of Abraxeolus Consulting, posed the important question, “What can be done to get the ball rolling so payers aren’t just sitting and waiting, and we on the company side are not watching and waiting for them to do something, too?”  

One potential way to “get the ball rolling” was highlighted by Pfenex’s chief business officer, Patrick Lucy, who emphasized the importance of payers establishing a biosimilar tier for members, rather than employing methods to make patients switch treatments or forcing biosimilars to fit into specialty or generics tiers.

“There are ways to get members to consider biosimilars as an option without knocking treatments off of formularies or eliminating treatment selections,” he explained. “Rather, a biosimilar tier could be used to help educate and incentivize members to consider switching to a biosimilar.”

Though we saw some early movement with a biosimilar tier in one organization —the Ohio Public Employees Retirement System (OPERS) — there is still plenty of room to grow, and manufacturers can and should communicate these ideas to educate payers and help them move forward with biosimilars.  

Accessibility Means More Than Just Access To Biosimilars

If we approach this term on the surface level, it means just what it sounds like: greater access to biologics and biosimilars. But I’d argue accessibility extends far beyond opening doors for more patients to get access to biologics. It also has to do with making the quite complicated concepts surrounding this particular industry more accessible. 

A phrase repeated many times throughout this conference was “in the weeds.” And in this industry, there are a number of places we find ourselves easily “in the weeds.” If it’s not the science behind biologics, biosimilars, and immunogenicity, it’s medical/pharmacy benefits, labeling, coding, and billing. As Rachel Sher, deputy general counsel for the AAM, described, these issues get complex quite quickly, and even those working on the Hill can’t grasp the complexity. The same goes for patients and even physicians.

We’ve seen the notable Biosimilars Forum study highlighting physician knowledge gaps about biologics and biosimilars. And it’s likely not a coincidence that anti-biosimilar campaigns have latched onto the less-understood topics in the biosimilar space, like switching, interchangeability, and immunogenicity, in order to sow doubt.

A panel discussion of four representatives from patient-advocacy groups emphasized the importance of exposing patients to what biosimilars are and how they work in a number of trusted, diverse materials — on paper and the Web. But the area the industry really needs to emphasize above all the other “weeds” is safety and efficacy. As Michele McCourt, senior director of the co-payment assistance foundation for CancerCare, discussed, safety and efficacy play the most integral role in medication decisions, as opposed to brand loyalty.

The four representatives were also emphatic about the need for industry partners, not only to promote education on biosimilars and to learn more about important industry-wide challenges and developments, but to help open the door to payers and pharmacy benefit managers (PBMs). As one expert argued, it would be immensely helpful for patient advocates to be at the table during negotiations with PBMs and insurers.

Transparency in these relationships is another facet of making these products more accessible to other stakeholders. Carlos Sattler, Sandoz’s VP and head of clinical development and medical affairs, said it best when he pointed out that the biosimilar industry is still a “fragile” space. “A lot of moving parts have to come together in order for this to become a sustainable industry overall,” Sattler concluded. And the key to managing these moving parts is going to be bringing all stakeholders together to demonstrate how biosimilars are part of the solution to high drug costs, not part of the problem.