September 2017 Edition Vol.11, Issue 9

Biosimilars Poised to Save Billions in Cancer Treatment

by Megan Garlapow, PhD

Estimates predict biosimilars could save the U.S. healthcare system anywhere between $44.2 and $250 billion between 2014 and 2024.1, 2 To date, only two biosimilars are on the U.S. market (for filgrastim and infliximab), with three more FDA-approved but not yet on the market (etanercept, adalimumab, and another infliximab biosimilar).

On September 14, 2017, the FDA approved Mvasi (ABP 215), a biosimilar candidate manufactured by Amgen and Allergan for bevacizumab [Avastin; Genentech/Roche] to treat a range of solid tumors.3

In a study of 642 patients, ABP 215 performed almost identically to bevacizumab when administered simultaneously with carboplatin and paclitaxel to patients with advanced non-small cell lung cancer.4

Another biosimilar candidate, MYL-1401O [Mylan and Biocon] is expected to have a December 3 FDA approval. MYL-1401O is a biosimilar to the US-licensed Herceptin [trastuzumab; Genentech].

Trastuzumab is a monoclonal antibody indicated for the treatment of HER2-positive metastatic breast cancer as well as adjuvant treatment of HER2 overexpressing breast cancer and metastatic gastric cancer. It is a targeted therapy that inhibits the proliferation of human tumor cells that overexpress HER2. Approximately 20% to 30% of primary invasive breast cancers overexpress the HER2 receptor.

 

About Biosimilars

A biosimilar product is a biologic medicine developed to be “similar to” an existing FDA approved biologic and has demonstrated no clinically meaningful differences in safety, purity, and potency compared with the reference biologic. A biosimilar is expected to have the same safety and efficacy profile as its reference biologic to treat the same condition(s).

Extensive pharmacokinetic, pharmacodynamic, and biological tests of the reference product and the biosimilar must demonstrate extensive similarity beyond some minor differences in clinically inactive components. Biosimilars are expected to offer a less-costly alternative to existing biologic products that have lost their exclusivity rights.

 

Financial Needs and Potential Savings

Though generics and biosimilars are different in how much they can save the healthcare system, “the potential for savings [with biosimilars] is extraordinary,” said Stephen Miller, MD, Senior Vice President and Chief Medical Officer of Express Scripts, in a webinar hosted by ZS Associates, a consulting firm, and OBR.7

Miller said the predicted $250 billion savings with biosimilars assumes only new patients who start receiving the biosimilar (ie, no substituting the reference product in established patients) and assumes the biosimilars are priced at a 30% discount from the reference product regardless of how many biosimilars come to market for the same product.1, 7 He emphasized that savings are only likely to begin in 2019 rather than 2017, as previously thought.

These estimates perhaps provide an outlook of optimism to address the rapidly expanding proportion of drug spends that are on specialty medications. As Miller explained, the vast majority of specialty medications are biologics. In 2016, the United States spent about $350 billion total on pharmaceutical products.

“About 2% of patients take a specialty medication, and they are responsible for about 37% of drug spend today,” he said. Fast-forwarding to 2019, the 2% of patients stays the same, but now because of new specialty products being introduced into the marketplace, “that pie has grown to $500 billion. And that 2% of patients is consuming about half of total drug spend.”

Previously, generics controlled the growth of drug spend, enabling financial headroom for paying for newer, expensive drugs arriving on the market. The optimism that Miller has stems in part from the number of companies that have registered biosimilar programs with the FDA.

“We have ten potential Humiras to come to market, seven potential Enbrels, six Herceptins, five Avastins, so the marketplace could become very exciting over the next several years,” noted Miller.

For plan sponsors, Express Scripts is already starting to incorporate into their thinking that multiples of these products could reach the marketplace over the next several years. “Hopefully this can provide us with the same headroom that generics did in the last decade,” he said. “To be very frank, it’s all financial. That is, these are equivalent products at a much lower cost, and we have got to do everything we can to drive out the waste in healthcare so that we can afford the new great [therapies].”

According to Brian Bourbeau, the Director of Practice Operations at Oncology Hematology Care at the US Oncology Network, regarding biosimilar savings, “We were more optimistic two years ago when we were expecting about 30% savings, initially, as filgrastim had a biosimilar come to market. Now, two years later, it’s getting to where we expect a 28% savings.”

He also pointed out that notably, the savings with biosimilar products are not as deep as generics “where you can regularly see decreases of 80%-90% from the reference product,” he said.

Bourbeau said the two biosimilars currently on market in the United States have or are expected to decrease in cost over time. With infliximab, however, US Oncology hasn’t seen that; “the reference product has ramped up about 6% per year over the last two years,” said Bourbeau. He noted that it’s still too early to tell how the actual sales price will decrease and how increased competition will affect prices.

 

Obstacles to Uptake and Concerns about Reimbursement

Though biosimilars must meet a high standard of interchangeability, experts expect the use of the reference product—long-term maintenance vs. short-term use—to affect uptake. The interchangeability of a biosimilar with an FDA-approved reference product means the biosimilar meets strict standards of safety and efficacy that match those of the reference product. This allows a pharmacist to substitute a biosimilar for the reference product without the intervention of the prescribing healthcare provider.

As Bourbeau explained, “What we’ve seen so far is that physicians are receptive to the idea of new patients moving to the biosimilar, but they’re resistant to changing patients who are on one biologic to another, even if the biologic is a biosimilar. It can be unknown if there might be any different reactions upon switching, especially biologics that may be known for reactions in the reference product.”

Bourbeau said that doctors learn in the first dose how a patient is going to react to a biologic, such that changing treatment may introduce an unknown risk. “Biologics that have relatively shorter duration of treatment will experience a quicker adoption and market-share shift. Anything that is used for maintenance will take longer to see a switch,” he said.

Christina Corridon, MBA, MPH, Associate Principal at ZS Associates, corroborated this opinion when presenting results from a survey conducted by ZS.7 Switching patients currently on therapy is “a very critical and uncertain topic in the biosimilar landscape.”

Results from the survey, which included 200 oncologists, 25 payers, and 27 pharmacy directors, also noted an obvious lack of education and limited understanding of biosimilars across all stakeholder groups. Oncologists in the survey indicated cost, ease of reimbursement, availability of guidelines, and brand of manufacturer as the primary drivers of adoption.

Around half of oncologists in the survey indicated they would begin using biosimilars upon approval, though Corridon cautioned, “in market research, people often over-state results, though this does indicate that there is a willingness to use [biosimilars].”

 

 

Barriers to Reimbursement

US Oncology sees current billing and reimbursement policies for biosimilars as a barrier to adoption. Biosimilars receive their own billing code, and for practices this adds an element of financial risk. “Biosimilars are not billed with the same code as their reference products and receive their own billing code. For practices, Bourbeau says this adds an element of financial risk, especially to physicians who are administering and billing their own IV medications.

“When you introduce a new code, or are given instructions by the government to bill unspecified or otherwise not classified codes, there’s a lot of financial risk,” said Bourbeau.

He also said that this can also affect Medicaid reimbursement as these patients are frequently in a difficult reimbursement environment, thereby limiting access to new therapies such as biosimilars. This, of course, also impacts adoption of biosimilars.

Miller agreed with Bourbeau, citing a dynamic policy environment, and described the cases in which FDA-approved biosimilars haven’t yet reached the market because they are tied up in litigation.

Jonas M. Congelli, RPh, Director of Pharmacy Services at Hematology Oncology Associates of CNY further explained some of the obstacles with reimbursement and J-coding. “I think the biggest is the confusion that exists in that these are not just ‘generics,’ yet everyone would like them to be used as such. Clinically, I don’t feel that this would be a problem, but for billing and reimbursement, it’s another story,” he said.

Congelli explained how the Centers for Medicare and Medicaid Services is trying to address the separate J-coding of a biosimilar and its reference product by putting all biosimilars for a reference product within the same J-code while the reference product continues with its own separate J-code. “Why would they only want the biosimilar products to be competing against themselves? It’s hard enough to manage ASP as a sole source product and next to impossible once another product gets added to the same J-code. Placing all the products into the same J-code is not the answer either, at least not yet,” he said.

Additionally, beyond FDA approval, each state’s boards of pharmacies need to have regulations allowing biosimilars to be dispensed. Miller said they’ve been working over the last three years with many of the leading pharmaceutical companies to pass legislation or regulations in states. “We already have [regulation] in 34 states and believe that within the next 18 months, we’ll be able to get all 50 states to be able to use biosimilars when they come to market,” explained Miller.

 

Future Directions to Ease the Adoption of Biosimilars

According to Bourbeau, removing barriers, both public and private, to adoption of biosimilars is needed so that billing and reimbursement is less cumbersome. Increasing value-based programs where use of lower-cost medications, such as biosimilars, is another solution. That would help biosimilars and other therapeutic interchange, where there is more than one product on the market with the same efficacy and safety, but one is lower in cost than another.

“Today, reimbursement does not encourage therapeutic interchange. Programs such as the Oncology Care Model encourage therapeutic interchange and will likely encourage adoption of biosimilars.” Bourbeau would like to see more of that as well as publishing of results from those programs to help value-based care move along.

Congelli resonated Bourbeau’s statement, explaining, “If the reimbursement and interchangeability concerns are addressed, then I see no issue in the rapid uptake of biosimilars.”

Miller encouraged the United States to recognize the success of biosimilars in the rest of the world and to bring biosimilars onto the market. “This is part of the conundrum we find ourselves in: We’re leading in biotech, yet we’re not taking advantage of biosimilars,” concluded Miller.

 

References

  1. The $250 billion potential of biosimilars. http://lab.express-scripts.com/lab/insights/industry-updates/the-$250-billion-potential-of-biosimilars
  2. Mulcahy AW, Predmore Z, Mattke S. The cost savings potential of biosimilar drugs in the United States. https://www.rand.org/pubs/perspectives/PE127.readonline.html
  3. FDA approves first biosimilar for the treatment of cancer. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm
  4. FDA Briefing Document. Oncologic Drugs Advisory Committee Meeting. BLA 761068: ABP215, a proposed biosimilar to Avastin (bevacizumab). July 13, 2017. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566365.pdf
  5. ODAC recommends first potential gene therapy and two biosimilars. July 2017. https://obroncology.com/article/odac-recommends-first-potential-gene-therapy-and-two-biosimilars/
  6. FDA Briefing Document. Oncologic Drugs Advisory Committee Meeting. BLA 761074: MYL-1401O, a proposed biosimilar to Herceptin (trastuzumab). July 13, 2017. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566369.pdf
  7. The advent of biosimilars in oncology: planning proactively for change. https://www.youtube.com/embed/jVq2IL-2Q50/?autoplay=1&mkt_tok=eyJpIjoiTnpGbE16azBPVGt6TkdaaCIsInQiOiJrbFcrWjg4UERndXduaXFyWXJ0SmV3eU94VHQrVllVenJqeCs5SnpWaWtNSTVHeFZpaExEdUw1NEYyN1hLemZkdVhRZE9yTVZqR1k5VFJoQUdZdThHRFhwNVgxRjN5R2NCSEdsMHZYSkNvZjNGaThoWjVPU0lJYXdiM04xMmFJbCJ9

Post a Comment

Your email is never shared. Required fields are marked *

OBR Archives

To view previous issues of OBR green contact you can visit our archives. The entire library of OBR green articles is searchable.