From The Editor | January 31, 2018

2018 CBI Biosimilars Summit Unveils New Industry Focus Areas

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

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Last week, I returned to Alexandria, VA for CBI’s 13th Annual Biosimilars Summit. This year was different from last year in a few delightful ways. For one, I did not find myself with no cell signal sloughing through a foot of snow down an unpaved logging road in the middle of the woods to get there. Second, I was given the honor of kicking off the conference with my partner-in-crime, Eric Sjogren, director of strategic business intelligence at Merck. (Stay tuned for a future article based on our discussion.)

However, perhaps the most notable difference from last year was how I felt leaving the conference. Last year, when writing a summary of the event, there was one question I couldn’t quite shake off: would 2017 be a standstill year for biosimilars? Sjogren and I touched on a number of ways this wasn’t actually the case in our presentation; however, this time, I didn’t leave facing the same question about the new year. For those of you who attended the event, you may think I’m somewhat crazy for saying so. After all, if there were several words to describe the general feelings/morale about biosimilars, they would be “grounded,” “uncertain,” and (politely) “frustrated.” In the words of Robert Frost, “There are miles to go before [we see optimal biosimilar uptake and acceptance].” As more real-world evidence demonstrating biosimilars’ efficacy and safety is released, I daresay I speak for many in the U.S. who are left asking, “What more do we need?” Well, this event turned me on to a few areas that could use some work and renewed attention.

Looking Beyond The Patient And Provider

One thing I particularly admired about this conference last year, which remained the same this year, was the diverse array of attendees and the informal, discussion-based atmosphere. The event covered a number of topics one has come to expect at a biosimilar conference: the patent dance, interchangeability, and biosimilar naming (and some novel aspects too, which I’ll hit on shortly). But though there are not many new developments in those areas, the discussion amongst the various stakeholders added much-needed depth and debate.

In fact, it was this environment which reinforced what I’d argue is an integral point for the industry moving forward. In an age where “collaboration” and “open innovation” are buzzwords for pharma, I find the biosimilar industry itself has a lot of room to grow. When we hear the words “education,” our first impulse is targeting patients and physicians (and many of the current educational efforts do so). These stakeholders should, of course, remain top priorities.

But education in this industry must also extend far beyond these two stakeholder groups. There are a number of other organizations I’ve run across in my time in this space, including America’s Health Insurance Plans (AHIP), the National Association of Specialty Pharmacy (NASP), the National Business Group on Health (NBGH), the Pharmaceutical Care Management Association (PCMA), the National Community of Pharmacists Association (NCPA), and the Healthcare Transformation Alliance (HTA). Though on the surface these groups represent different stakeholders and have different goals, the common denominator among them is they represent a number of the biggest stakeholders biosimilars need to win over beyond patients and physicians: pharmacy benefit managers (PBMs), insurers, specialty/community pharmacists, and employers.

Rather than asking whether 2018 will be a standstill year, the dialogue throughout this year’s CBI event hinted at the importance of the biosimilar industry expanding its outreach to some potentially overlooked stakeholders — one of which has rarely been discussed to date at industry conferences.  

The Importance Of The Employer

It’s no secret that one of the more discouraging events of 2017 was payers’ decisions to keep Inflectra and Renflexis either off of or situated less favorably than Remicade on their 2018 formularies. The industry has heralded payers as the key to greater uptake. As such, it was surprising to see less confidence in the infliximab biosimilars this year than there was Zarxio right out of the gate. (Of course, I do acknowledge the differences in their molecular complexities.) In the past few months, I’ve written about the importance of working more closely with payers and still feel this is important for companies and trade groups moving forward.

But at the CBI event, I was confronted with another important stakeholder that’s rarely mentioned today: the employer. During her presentation, Sheila Arquette, the executive director of NASP, pointed out that the complexities of payer contracting methods are a high hurdle for biosimilar companies to overcome in the currently uncertain market. As such, Arquette suggested focusing on employer groups, since many of them may be self-funded and/or more in control of their health coverage decisions. By talking to them about the opportunities offered by biosimilars, manufacturers could see employers lead the biosimilar “ground-swell” efforts. For instance, they may be in a better position to speak to employees and incentivize certain treatment options, like biosimilars.

The notion that larger self-funded employer groups are potentially more willing to take the risk and jump on board with biosimilars was seconded by Edric Engert, managing director of Abraxeolus Consulting. According to Engert, he’s observed that large, self-funded employers, as opposed to the national health plans, are more willing to experiment with new provider reimbursement methods beyond the tradition capitation rates and fee-for-service rates. Arquette took it a step farther by pointing out that smaller self-funded employer groups could also have an interest in new strategies. For instance, given their size and, often, younger population, small employers actively look for ways to continue to attract and retain talent — and healthcare coverage is a key factor. (Also included in the conference’s speaker lineup was the National Business Group on Health, which shared some great insights into what large employers look for and the role they could play in the growth of the biosimilar market. Stay tuned for a future article!) 

Uncertainty & Sharing Risk: Contractual Evolutions

Last year, each presentation and discussion, regardless of stakeholder, was tempered by uncertainty. This year was no different. In fact, one presenter asked for a show of hands of attendees who felt more certain in their roles about biosimilars. Not one hand was raised (and there were upwards of 70 people in the room). This is probably not surprising to a majority of you. What I found particularly helpful, however, was the discussion about that uncertainty and how it affects the varying stakeholders, especially within the supply chain. For instance, during the payer panel, the discussion turned to the need for greater risk-sharing among manufacturers, wholesalers, and payers.

It’s become particularly clear over the last year that a number of controversial payer contracting tactics are making waves in the biosimilar industry. Pfizer’s lawsuit against J&J was the biosimilar industry’s first attempt to call into question these practices that have, over time, become standard. An important — and difficult-to-answer — question asked during the conference was how these contracting practices could shift away from being as restrictive as they often are today.

Obviously, a big barrier to evolving the contracting system is patient and physician uncertainty, as this takes a toll on manufacturers’ abilities to share risk with suppliers to help balance uncertain supply/demand needs. For instance, as a recent HDA Research Foundation report highlighted, though any new product has supply/demand-related concerns, the lack of knowledge and trust of biosimilars poses even greater challenges in inventory target setting and demand forecasting for suppliers. As such, there are situations where there may be clinical confidence or certainty about a treatment, but the biosimilar company may not be able to share the risk of a contract.

Continuing to educate patients, providers, and payers (and hopefully, a wide array of the other key stakeholders) remains a top priority for the biosimilar industry in 2018. Over time, these efforts will alleviate some of the demand forecasting uncertainties. But it will also come down to greater communication between biosimilar companies and stakeholders within the supply chain about the best ways to overcome supply/demand-related concerns. Ultimately, building confidence in biosimilars will not just require clinical certainty of providers and patients; it will also require companies to share the risk of a contract, in turn bolstering overall confidence in biosimilars.