A Conversation With Doug Long, IQVIA

Doug Long, Vice President of Industry Relations at IQVIA (formerly QuintilesIMS), spoke with us about some of the intracacies of the filgrastim and pegfilgrastim marketplace, and regarding improving access to biosimilars in general. 

Doug Long
Doug Long, IQVIA

BR&R: Do you think interest by manufacturers in biosimilars is gaining or waning at this time?

Doug Long: It’s somewhere in between those two. A lot of people are staying in the game to see how it plays out. Maybe discouraged most accurately describes their feelings at this time. They are discouraged, because there are 17 approved products but only 5 are available. And the uptake of those on the market is not that great, particularly compared with the uptake in Europe.

BR&R: I can see how manufacturers and payers would be discouraged right now. You’re right, in the European market, we’ve seen a great deal of uptake and significant discounting as well. So many factors affect biosimilar coverage and uptake. It may also relate to the individual biosimilar’s disparate marketplace situations.

DISTINCT MARKETS FOR BIOSIMILAR DRUGS

In the US, based on the utilization numbers seen today, do you believe the infliximab, filgrastim, or pegfilgrastim markets will best characterize how other biosimilars (e.g., Avastin® or Herceptin) will perform when available?

Long: Well, with the filgrastim molecule, you need to look at both filgrastim and pegfilgrastim, and their routes of administration (prefilled syringes and on-body injectors). Granix® and Zarxio® have the majority of the dollar share on the filgrastim side. It’s too early to tell on the pegfilgrastim side, though Amgen has a 61% share of that Neulasta® molecule with its Onpro® formulation. The addressable market for the molecule is really only the remaining 39%.

You also have to make a distinction between how much of the market is controlled by the pharmacy benefit managers compared with the hospital group purchasing organizations (GPOs) or buying groups. Most of the filgrastim and pegfilgrastim is controlled by the hospital buying groups, and that’s also going to be the case for the cancer-treating biosimilars. There’s no doubt in my mind that when Humira® or Enbrel® are available, the PBMs will embrace the biosimilars. There are just so more complexities on the hospital side of the market that it makes it more difficult for them to move towards the biosimilars.

DEEPER INTO THE FILGRASTIM/PEGFILGRASTIM SCENARIOS

BR&R: There’s an interesting situation brewing in the filgrastim market. The success of Granix and really Sandoz’s Zarxio penetrating the market has contributed significantly to the drop in total sales revenues for filgrastim sales combined. However, how much of this decrease is attributable to migration to pegfilgrastim, and Neulasta Onpro in particular?

Long: Sure, look at their revenues today. Filgrastim is at $611 million in annual sales and pegfilgrastim is at $4.3 billion. Of that $4.3 billion, Onpro accounts for 61%.

BR&R: At Coherus’ fourth-quarter earnings conference call, their CEO indicated that he thought the Onpro marketshare might be vulnerable to the pegfilgrastim biosimilar, which is available today in prefilled syringes. Obviously, that would mean selling Undenyca® at a more enticing price, below the 33% discount currently offered. Do you think that Onpro sales erosion is likely or does the formulation offer real value?

Long: That could work, but the thing about Onpro is that when you finish your chemotherapy for the week, they put the injector on you and you don’t have to go back to the doctor’s office for a pegfilgrastim injection the next day. That’s one of the reasons it is as popular as it is—it reduces hospital and doctor expenses at the end of the day, and is more convenient for the patient.

BR&R: Biosimilar manufacturers like Coherus have expressed interest in developing its own on-body injector for its biosimilar. It seems to present distinct advantages. Does that mean that the biosimilars will be relegated to fighting only for that prefilled syringe market, the remaining 39% of utilization?

Long: It’s probably too early to say. Fulphilia® has only been marketed since July, and the other one [Udenyca] was launched only recently. We’ll have to see what kind of uptake it gets. Also, we’ll have to see what happens when other players come to the market. The more drugs you have available, the more share erosion from the originator you’ll likely see. Yet that did not happen with Remicade…

BR&R: That may be more of a special situation, considering the actions taken by Janssen Biotech to prevent coverage of both Pfizer and Merck’s products.

The filgrastim/pegfilgrastim markets are also different for that reason: Amgen did not aggressively defend their market share on the prefilled syringe originator products (i.e., Neupogen® and Neulasta). Rather, they focused on getting conversions to Onpro. So the biosimilar manufacturers were not facing aggressive defensive tactics, like those employed by Janssen. 

Long: Yes, but they will defend Onpro as much as they can.

BR&R: And Amgen established Neulasta and the Onpro formulation at the same price point.

Long: It made sense. It was a good defense mechanism.

BR&R: It does force the biosimilar manufacturers to work harder to gain business.

AN UNCLEAR FUTURE

BR&R: The Administration has several initiatives that may directly or tangentially affect the biosimilar market. These include the Medicare International Pricing Index, the move to place Part B drugs into Part D (and allow step therapy and other UM tools), the reevaluation of drug rebate safe harbors, and of course, the individual components of the Biosimilar Action Plan. Do you think this will ultimately result in artificial price deflation? Would that be helpful or harmful to biosimilar makers?

Long: That’s a question that I really don’t have an answer for. Who knows what’s going to happen? People have started to make moves to reduce WAC prices, like Amgen on their PCSK9 inhibitor and Gilead on their hepatitis C treatment. Gilead created an “authorized generic” to reduce its price dramatically.

People are starting to play around with it. Maybe to get adopted, a biosimilar maker may actually have to raise their drug’s WAC price higher than the originator, and then give a larger rebate.

More Details on Coherus Bioscience’s Udenyca Launch

Go big or go home, seems to be the message of Coherus’ President Dennis Lanfear. At the JP Morgan Investor Conference yesterday in San Francisco, he outlined what he considers a “full-on branded launch” for the biosimilar maker’s key product. Udenyca was officially launched on January 3.

In preparation for the launch of Udenyca, Coherus Bioscience secured $75 million in financing to shore up its cash position and to support its marketing effort.

Udenyca launch

The First Payer Deal for Udenyca

More than half of the current pegfilgrastim claims are reimbursed by commercial payers, with Medicare accounting for an additional one-third. Mr. Lanfear announced a couple of important payer developments that should benefit sales immediately. He said that Coherus “inked a deal with Anthem Blue Cross Blue Shield last week,” but did not elaborate on the terms. Although he alluded to a press release on Coherus’ website, none had been posted at the time of this writing. He also mentioned that Aetna and Blue Cross Blue Shield of South Carolina had independently begun “requesting Neulasta users to step through Fulphila or Udenyca before filling those claims.”

The group purchasing organization (GPO) market “is highly focused,” said Mr. Lanfear. “About a dozen players account for 95% of the market. 340B hospitals represents around $963 billion in annual revenue. Vizient accounted for $824 million in Neulasta sales last year (about 35% of the non-340B market), and welcomed us to the market.”

Targeting the Greatest Pegfilgrastim Market Opportunities

He believes, “Biosimilars with pass-through status can provide significant value in non-340B settings. They may be the lowest price side of the market, but most motivated.” According to Mr. Lanfear, these facilities’ efforts at cost recovery is expected to drive the market.

Udenyca and Fulphila are priced identically at $4,175 or at a 33% discount to Neulasta Udenyca’s 33% WAC discount per syringe to avoid payer disincentives. Specifically, after discounting and rebates, Amgen’s ASP for Neulasta was $4,422, which gives the payer an immediate ASP discount. In previous biosimilar launches, their manufacturers’ smaller discounts had actually resulted in higher ASP costs than the reference product. In those cases, payers were reluctant to encourage biosimilar use, at least until the biosimilar had sufficient time in the marketplace where its own ASP could be calculated. “Having our unique HCPCS code results in an ability to control our own ASP,” said Mr. Lanfear. This is the direct result of the current administration’s efforts to fix the original J-code rule.

Further, he believes that Coherus can take advantage of Udenyca’s reimbursement opportunity in the buy-and-bill sector. At present, Neulasta is reimbursed at ASP – 22.5%. [Non-340b] pass-through status will be designated in April 1, 2019, and Udenyca will be reimbursed at ASP + 6% for at least 2 years from that date. (Fulphila currently has pass-through status). This prevents biosimilars from being disadvantaged from the provider perspective.

A National and Regional Sales Structure

To support the new launch, Coherus has created a formidable sales force and structure, including:

  • 67 Oncology account managers
  • 7 Regional sales directors
  • 7 Key account directors
  • 7 Field reimbursement specialists
  • 7 Medical science liaisons
  • 3 Group purchasing directors
  • 4 Payer directors

Mr. Lanfear believes that creation of this extensive sales organization has not been done before with a biosimilar. And he emphasized that they expect to leverage this salesforce infrastructure for its pipeline products, including biosimilar adalimumab, biosimilar ranibizumab, biosimilar aflibercept, and a small-molecule treatment for nonalcoholic steatohepatitis (NASH).

Coherus has ramped up its production, to be able to handle demand from all its customers, and it has used the LASH Group to develop the Coherus COMPLETE support site for patients and providers.

Coherus’ plan for a “branded-type” launch for its biosimilar pegfilgrastim seems to afford benefits in pricing, sales, supply, and services. We await news of their progress.

Udenyca to Launch January 3, Same WAC as Mylan’s Fulphila

Coherus Biosciences surprised many on its third-quarter earnings call late yesterday. It will rely not on a lower price than its biosimilar competitor to gain marketshare after Coherus’ Udenyca launch, but on its ability to pull through on its patient and provider services and supply chain to gain significant marketshare for its biosimilar version of Neulasta®.

This is not to imply that Coherus will not offer contracts to group purchasing organizations (GPOs), hospitals, and payers.  The company intends to do so. However, the wholesale acquisition cost (WAC) for Udenyca® will match that of Mylan’s Fulphila®—$4,175 per vial, or a 33% discount from Amgen’s reference product. Denny Lanfear, CEO of Coherus added that the company’s contracting plans “will deliver additional value to payers.”

Jim Hassard, Coherus

AWAITING HCPCS CODING

Unlike other biosimilar manufacturers, this is their first product to reach the market. Not only was manufacturing and production a priority, but company infrastructure had to be ready for launch. Although Coherus pointed out that the sales force for Coherus is fully in place, they are holding back the Udenyca launch until the Center for Medicare and Medicaid Services (CMS) designates a Q code for claims and billing purposes. Therefore, the goal is a Udenyca launch date of January 3, 2019.

Jim Hassard, Vice President for Marketing and Market Access, emphasized that “Our overall launch strategy goes beyond pricing, to reliable supply and services. We’re committed to world-class execution and salesforce effectiveness.” The company’s Coherus Complete, patient and provider service site, is operational, and this will include copay support for eligible patients. Mr. Hassard stated, “This price is attractive to payers without diminishing our value proposition. We can deliver significant savings to the health system versus Neulasta.”Coherus Biosciences

CAN UDENYCA GRAB SOME ONPRO MARKETSHARE?

One interesting statement made during the call was the expectation that Coherus will go after some of Neulasta Onpro’s share of the market. Amgen’s on-body injector accounts for about 60% of all Neulasta utilization today, “but this growth has flattened out,” Chris Thompson, Vice President of Sales, emphasized. “We’re looking at the whole market, not just prefilled syringe market,” he said. “We think we’ll be able to sell through the Onpro market,” meaning that their pricing and services will attract some of this marketshare. In fact, Coherus executives believe that biosimilars may eventually garner nearly 70% of the pegfilgrastim market.

Coherus believes that there is pent-up demand for the biosimilar in the hospital segment today, which is why GPOs may represent promising contracting opportunities. They are seeking parity positioning at the payer and pharmacy benefit manager level.

This sounds fairly reasonable. Yet the vast majority of biosimilar consultants and payers with whom I had communicated had anticipated that Coherus would launch with at least a modest WAC discount relative to Mylan’s Fulphila. On the conference call, the investment banking participants wanting information on the Udenyca launch seemed caught off guard as well.

UDENYCA REVENUE TO SUPPORT COHERUS FOR NOW

Perhaps this strategy gives Coherus ample room for contracting while retaining a respectable net cost. Mr. Thompson said, “We’ll roll out a comprehensive contracting strategy for GPOs in the next week or two. It will be competitive and designed to win.”

It may need to be. Relying on better services and perhaps even a better supply chain (albeit one that is brand new) may not be sufficiently persuasive to hospital and payer P&T Committees. And Coherus needs to generate revenue from its sole product to feed its new sales team, new product development, and hungry investors.

Coherus Gets FDA Approval for Its Pegfilgrastim Biosimilar

With the Food and Drug Administration (FDA) approval today of Coherus Bioscience’s Udenyca™ (pegfilgrastim-cbqv), the second pegfilgrastim to compete with Amgen’s Neulasta®, much attention will be now focused on the company’s November 8 earning call.

The FDA approved Udenyca on the basis of a supportive analytical similarity package, but with phase 1 data only. Over 600 healthy subjects were given the agent to test its pharmacokinetic, pharmacodynamic, and immunogenicity safety.

We should learn a great deal by the end of the week about the nature of the competition for the injectable pegfilgrastim marketplace into 2019. In the press release announcing the approval, the company said it will reveal its launch plans, including pricing, during its week’s call. On Monday, November 5, we should hear the first information about whether Mylan’s first-to-market entry, Fulphila®, has gained some traction against the injectable form of Neulasta. Mylan launched Fulphila at the end of July.

In a previous post, we discussed how Amgen’s Neulasta Onpro® patch has already captured upwards of 80% of the pegfilgrastim business. Because of the convenience of the patch formulation, it would be surprising if Onpro’s share of market eroded significantly. However, Amgen must ensure that the net cost difference between the biosimilars and Neulasta Onpro is not noteworthy. Otherwise, payers’ can be expected to try to disadvantage Onpro through step edits or greater patient cost sharing. That would take a sizable bite out of Amgen’s large slice of the $4 billion pegfilgrastim pie.

The FDA approved Udenyca for the following indication: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It was not approved for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. This indication language does not differ from that for Fulphila. Neulasta has the additional indication of increasing survival in patients acutely exposed to myelosuppressive doses of radiation.

Undenyca was also approved for sale in the EU, although Coherus has not launched there, awaiting a marketing partner.