Payers Focus More on a Biosimilar’s Price Than on Clinical Data: A Retrospective

It can be fun to go back in time! That’s the case with an old column I wrote for the Center for Biosimilars, just after Zarxio was approved. Here, I reprint a portion of the column, with some additional commentary.

A RAND study from 2014 boldly predicted $44.2 billion in savings from biologic drugs over the 10-year period ending in 2024. The study’s authors believed that upwards of 20% of the savings would come from the anti-TNF inhibitors alone.

These savings would salve the wounds of payers and purchasers suffering annual double-digit increases in specialty pharmaceutical costs. It has kept them up at night. Worries about the affordability of medicines have kept patients and their families on edge. All of this light focused through the magnifying glass, refracting to a point, has heated up attention on the first biosimilars in the 351(k) approval process. US health plans, pharmacy benefit managers, and insurer executives have been anticipating the push to biosimilars and their possible savings since the implementation of the Biologic Price Competition and Innovation Act in May 2010.

Expectations have pent up that biosimilars will begin to relieve the pressure building from the annual double-digit specialty drug trend. If payers are given 20% and 25% lower net prices, they will likely jump at the opportunity to save millions of dollars, if they can. That means putting net pricing ahead of clinical data when making coverage decisions (assuming no significant immunogenicity differences, as payers and providers would consider this a powerful disincentive).

Payers may presuppose that the Food and Drug Administration (FDA) will do its utmost to evaluate the equivalence in outcomes and pharmacokinetic/ pharmacodynamic characteristics of the agent. The real question is whether payers care enough about the clinical data to make extrapolation a potential issue if the FDA does not. They may well leave that decision to the prescribers, taking a more laisse faire approach, as they did in the very early days of generic drug introductions (before the days of automatic generic substitution).

Today’s Commentary:

Well, the verdict seems to be in, both from payers’ and providers’ perspectives. Payers are leaving it up to the FDA, and in some cases, without any clinical data in patients (just phase 1 trials in healthy volunteers), to determine the appropriateness of biosimilars in several disease states.

Proprietary market research, as well as individual conversations with payers, support that they have crossed a critical point of confidence—the safety and effectiveness of using a biosimilar instead of a reference product is no longer much of an issue. Any question about extrapolation, similarly, is no longer deemed clinically relevant in approved biosimilars. This may not be the case with a future product. We must also await experience involving FDA approvals of products with “skinny labels” or limited indications. In these cases, we don’t know yet whether plans and insurers will discourage use of a biosimilar for the reference product’s full slate of applications (privately, they have told me they wouldn’t discourage this use, assuming similar dosage forms).

However, payers hunger for biosimilar choices. Not necessarily to add to their formularies, but to force originator manufacturers to halt further price increases. They want the opportunity to worry less about one biologic agent for which next year’s expenditures will jump—and by how much exactly? The few biosimilars approved in the US have forced WAC pricing (and ASP pricing) down. We are expecting the same for the latest market entrants, like pegfilgrastim.

As for RAND’s predictions? Not enough has happened from 2014 until now to make one think that cumulative savings of $44 billion is realistic. It is possible, however, if one considers the near-term launches of trastuzumab and bevacizumab biosimilars. The one-year savings from adalimumab biosimilars may top $8 billion by itself (out of total revenues exceeding $20 billion prior to the introduction of these biosimilars).

It should not have even been this close.

Infliximab Biosimilars Savings Could Exceed $400 Million Dollars Annually

Everyone with an opinion believes that biosimilar drug use will save the health system considerable money. Calculations for biosimilar savings have been hampered by several factors. For example, previous high estimates have not been based on real-life scenarios. Only 3 biosimilars have been launched and utilized in the US; so little experience has been gained on which to base calculations.

Yet, isolating the savings associated with a single approved biosimilar does put their potential into perspective. It also demonstrates the promise of cumulative biosimilar savings with their launch and uptake. Based on current infliximab average sales prices (ASPs), wBiosimilar Savingshich considers discounts and rebates, one organization believes that a 50% marketshare for biosimilar infliximab could result in well over $400 million in annual savings system wide.

The analysis, conducted by Wayne H. Winegarden, PhD, Senior Fellow in Business and Economics, Pacific Research Institute, accrued the lion’s share of the annual savings to employer-sponsored health plans ($262 million to $315 million, compared with no sales of infliximab biosimilars). Medicare accounted for up to $150 million savings annually.

Dr. Winegarden tested several scenarios. The calculation considered the cost of the infliximab regimen based its various indications. He calculated biosimilar savings using different add-on percentages to ASP (including the current ASP + 4.3% payment and up to ASP + 20%), as well as different marketshares of the biosimilars (from 10% to 90%).

The current marketshare of the two available infliximab biosimilars—Inflectra® and Renflexis®is below 5%, based on data from the first quarter of this year. This is partly because of Janssen’s tactics in matching the net costs of biosimilars with additional rebates on Remicade. This raises two important points: Dr. Winegarden’s analysis reveals savings accruing to the health care system (not necessarily to the payer). Also, the very existence of infliximab biosimilars has resulted in significant net savings compared with the price increases seen prior to their introduction.

It is a bit more difficult to pinpoint the system savings resulting from the use of the first biosimilar approved in the US, filgrastim-sndz (Zarxio®). The other branded product, tbo-filgrastim (Granix®), was launched a couple of years earlier and gained its own marketshare from the reference brand Neupogen®. No doubt, Zarxio contributed to some level of cost savings. In other words, the infliximab example is an easier calculation with a cleaner result.

With eight biosimilars for six reference products awaiting their turn to hit the market, and drugs like adalimumab and etanercept among them, it is easy to see how biosimilars savings can easily exceed $10 billion. Just not yet.

Payers’ Expectations for Biosimilars Reflect a Conflicted Environment

Hopeful but not enthusiastic. Preparing but not anticipating. Those are the impression one gets when speaking to medical directors and pharmacy directors of health plans, insurers, and pharmacy benefit managers about biosimilars today. Although savings associated with biosimilar use have been limited so far, one recently released survey of these payers revealed expectations that seem to reflect today’s environment.

payer expectations of biosimilarsIn December 2017, executives from the TPG-National Payer Round Table (NPRT) obtained 77 responses to their Web-based survey (a 31% response). At that time, only eight biosimilars had been approved (Pfizer’s Ixifi™ [infliximab] was not yet approved by the Food and Drug Administration). Thirty-nine percent of the respondents were from national plans, 27% were from regional organizations, and the remainder were from local health plans.

Fifty-three percent of the respondents indicated a willingness to permit biosimilar use for all originator-approved indications, regardless of the FDA’s approved labeling. Twenty-five percent expected a biosimilar to be the only product covered on formulary. In order to enhance conversion and uptake, nearly half (48%) believe that the biosimilar will be associated with lower cost sharing than the originator. This could come in the form of a separate biosimilar tier, with a fixed copay or percent co-insurance that is significantly lower than that for the originator drug.

Uncertainty About When and How Much 

The study results were released as a poster at the 2018 annual meeting of the Academy of Managed Care Pharmacy last week. In an interview with Biosimilars Review & Report, Richard A. Brook, MS, MBA, Senior Vice President at TPG-NPRT, said, Health plans generally expect their costs to go down with the use of biosimilars. However, a lot of uncertainty remains as to the timing and magnitude of these savings.”

Indeed, some of the respondents were quite cynical about the savings seen in 2018. Forty-five percent believe there will be less than 10% savings from biosimilars overall this year. A further 16% do not anticipate any savings from biosimilars. The picture brightens significantly when the timeframe is moved two years out—by 2020, 29% believe savings will exceed 20%, and 47% think that savings will be 10% to 20%. Only 2% think no savings will be accrued. This is likely in line with expectations that etanercept, pegfilgrastim, and some oncology biosimilars will be available for use by 2020.