Even in Europe, Biosimilar Uptake Depends on MD Comfort Levels

Sometime ago, the European Crohn’s and Colitis Organization (ECCO) found that sequential surveys had demonstrated improving physician comfort with prescribing biosimilar infliximab. This resulted in ECCO’s change in its position on switching infliximab. As one can imagine, this occurs only with experience, and often that experience is gained first by using the drugs in new patients only.

According to Ha Kung Wong, Partner, Venable LLP, physician comfort and education is still the primary determinant of biosimilar uptake, even in Europe. In his remarks at the recent ACI Biosimilar Summit in New York City, Mr. Wong emphasized that although price will enable a biosimilar to gain a foothold, it is not the only or most important factor. This is somewhat surprising; the competitive tendering system in many countries have resulted in significant price variation, including steep discounts in some locations.

Ha Kung Wong
Ha Kung Wong

Mr. Wong explained that in Norway and Denmark, Remsima uptake has risen through deep discounts, though in other countries, discounts were far less extreme. On the other hand, less variation has been seen with trastuzumab pricing. Mr. Wong said, “Regardless, the uptake of biosimilars has been quite high across the EU. For example, Samsung’s Imraldi reached 60% uptake in Germany after only a very short time.”

He pointed out that “price does increase marketshare. But growth in uptake is still driven by biosimilar use in new patients.” Ha Kung Wong said that even in the EU, resistance to switching patients from a reference product to a biosimilar continues.

“The number 1 factor is MD resistance to switching,” he stated, although patient resistance is also apparent. Considering the heavy involvement of EU countries in educating doctors and patients with regard to biosimilars, more needs to be done if systematic switching of patients to biosimilars will contribute more fully to the industry’s success.

This experience in Europe is extremely pertinent to the situation in the US. Physicians are beset by costly administrative efforts to meet payers’ prior authorization and step edit requirements, and they may be also less experienced in the prescribing of biosimilars than their European colleagues. If the relative value of the biosimilar is not substantial enough, expect that prescriber uptake will grow only slowly. Consider not necessarily the case of infliximab, but the newest categories to likely hit the market—the biosimilars for the treatment of cancer (e.g., trastuzumab and bevacizumab). These prescribers will need some time to become comfortable with treating their vulnerable patients with biosimilars, and the requirement for use in “new” patients may not apply. It would be feasible to switch cancer treatment after completion of any cycle, as well as for recurrent tumors.

In Moving Patients to Biosimilars, Transferring Patient Services Is Key

John Q. Smith, a patient of Dr. Kelly’s has been receiving his biologic therapy for rheumatoid arthritis for more than a decade. He has been in contact with the reference manufacturer’s patient services hub for several years, and utilizes it both for payment assistance and for nurse support. He appreciates the co-pay coupon, which can save him hundreds of dollars, especially since his health plan has a high deductible.

The following year, his employer has changed its sponsored plan, and Mr. Smith finds himself in a situation where originator biologic is no longer preferred (or even excluded). Barring a successful medical exception appeal, he will have to start biosimilar therapy. He worries not only about whether the biosimilar will be as effective and safe, but also whether he will have to bear more of the cost of treatment. I might argue that the biosimilar drug maker’s hub services are extremely important to gaining uptake for patients and even some providers.

From a 30,000-foot view, this may not be as widely considered as contracting with payers and health systems. Early on, I assumed that all manufacturers’ patient/provider hub services were as similar as the biosimilarity of the drugs. However, it is one of the ground-level details that optimizes (or undercuts) an opportunity for gaining biosimilar uptake.

Consider if a biosimilar maker’s services program exposed its patient population to significantly greater cost sharing. The collective howl would certainly be heard by their doctors (and probably their plan or insurer). If the physicians’ offices received worse coordination services or administrative assistance from the new hub provider, the push back would be considerable as well.

The bar for patient and provider hub services is pretty high, but it is consistent. For example, Janssen’s CarePath covers the bases for Remicade®. Merck’s Renflexis® Access Program focuses on copay and ongoing financial assistance for patients and on coverage/reimbursement/prior authorization support and answering coding questions for doctors’ offices. Pfizer’s enCompass offers similar support functions.

When biosimilar manufacturers do receive the opportunity for plan coverage, they must ensure a transition of services that feels seamless to the patient and provider. Otherwise, John Q. Smith and his brethren will make their dissatisfaction (and challenges) known to anyone who will listen. Without a smooth transition, biosimilar makers risk not only drug coverage, but their reputation as well.

Is Physician Resistance to Biosimilars Dissipating?

We tend to think of challenges to uptake of approved and marketed biosimilars coming from three areas: (1) the reference product manufacturers, (2) the physicians, and (3) the patients. The patent mazes and rebating strategies characterize the first, and patient advocates’ questions about nonmedical switching describe the last. Physician resistance, however, seems to be on the wane.

I was pleasantly surprised by conversations with health system chief medical officers and medical group administrators speaking about biosimilar implementation and adoption at the annual meeting of the American Medical Group Association last week in Phoenix. If this is any indication, the iPhysician resistance to biosimilars decreasingnitial trepidation of US physicians in using biosimilars in treatment-naïve patients is melting away. Medical society endorsement of the effectiveness of biosimilars and promises of significant cost savings seem to be convincing arguments on physician side. Of course, switching of a reference medication for a biosimilar in a patient established on treatment with the reference product remains another story.

Some of the physicians came to learn about biosimilars rather than share their experiences. They may or may not have been aware of the extensive European experience with specific biosimilar agents and drug classes, but they were willing to accept that (1) if the Food and Drug Administration (FDA) had approved the biosimilar, they expect it to be safe and effective and (2) that extrapolation would not be an issue if FDA approved the label. The use of biosimilars for nonapproved indications would be left up to individual physicians (and payers’ prior authorization systems).

It was clear that the potential of biosimilars to save their patients money was of paramount importance. This may signal a changing view that issues regarding safety and efficacy of approved biosimilars will be preempted by the need to address economic needs in initial prescribing for new patients.

There is also an indication that large medical groups and some health systems are willing to leave the decision making to the Pharmacy and Therapeutics Committee. If the P&T Committee places the biosimilar on the formulary, and it is a savings for their new patients, the biosimilar will be used. That also means that biosimilar adoption at this level will be seriously aided by the use of lower cost-sharing tiers for biosimilars. In other words, a separate biosimilar tier that requires less copayment or coinsurance than the reference product could be a real boost to patient use.

In other biosimilar news…Michigan’s governor has signed legislation making it the 37th state to expand its pharmacy laws to allow interchangeable biosimilar substitution. Now if there were only an interchangeable biosimilar to substitute!

Coherus Biosciences announced that it believes that it will obtain FDA approval and commercial launch for its delayed pegfilgrastim biosimilar in the second half of 2018, along with European approval during the same timeframe.

Pfenex disclosed that it is seeking partners for its own pegfilgrastim biosimilar, in addition to its biosimilar candidate to Lucentis®. Its stock price has taken a steep jump in recent weeks, rising to over $6 a share (from $4) since the beginning of March.