Not So Different: A Podcast From The Center For Biosimilars

As fee-for-service models give way to value-based healthcare delivery models, US providers and patients alike can hopefully forward to lower healthcare costs, increased quality of care, and improved outcomes. But what role will biosimilars have to play in value-based care?  This week on the podcast, we're speaking with Jeffrey Scott MD, chief medical officer of Integra Connect, a company that uses cloud-based technologies and services that help specialty care providers optimize their performance in the ongoing shift to value-based models. Scott spoke with us about value-based contracting in the biosimilars context. 

In October of this year, the nonprofit organization HealthyWomen, a group that seeks to educate women to make informed choices about their health, hosted its first Biosimilars and Women’s Health Science and Policy Forum. This week on the podcast, we’re speaking with one of the presenters from that meeting, Lisa Kennedy Sheldon, PhD, APRN, AOCNP, FAAN.  

Back in September, AARP, issued its latest Rx Price Watch report, which highlighted the problem of skyrocketing drug costs; it found the retail prices for widely used drugs increased well above the rate of inflation, and that’s a troubling trend for Medicare beneficiaries. This week on the podcast, we’re speaking with one of the authors of that report, Leigh Purvis, MPA, who says that the problem of high costs will eventually impact all Americans. 

With new research being presented, and with new biosimilars in the pipeline that target inflammatory bowel disease, October was a notable month for biosimilars in the gastroenterology space. This week on the podcast, we’re rounding up the top developments in gastroenterology for the month of October 2019. 

In August of this year, the US District Court for the District of New Jersey ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi. As a result of that decision, biosimilar etanercept appears to be on a lengthy hold in the US market, and that has a number of biosimilar stakeholders concerned.  This week on the podcast, we’re speaking with Rick Lozano, vice president of Biosimilars and Integrated Business Development for AmerisourceBergen. We discuss the ruling in the case, its potential impacts on the healthcare system, and what drug makers can do now to help educate other stakeholders about biosimilars and improve uptake. 

It’s widely expected that the United States will see launches of one or both of the FDA-approved biosimilars, Ruxience and Truxima, in the coming months, but just how ready is the United States to bring these products to the clinic, especially given the fact that subcutaneously administered reference rituximab has taken on such a key place in clinical practice, and given the fact that both biosimilars have so-called “skinny labels” because of issues related to intellectual property and exclusivities? Over the past year, we’ve had the opportunity to explore these questions and more with a variety of experts in the oncology field. This time on the podcast, we’re rounding up some of the key insights they’ve shared. 

Among the biggest biosimilars news of this year was the launch of the first 2 anticancer biosimilars; stakeholders have been eager to see whether these products can jumpstart what has been described by some as a sluggish US market for biosimilar products. This week on the podcast, we're speaking with an expert who's sharing her insight into these developments in the oncology space. Christina Corridon, MPH, MBA, is a principal at the professional services firm ZS Associates, where she is a leader in ZS' oncology practice and leads their biosimilars vertical. Christina joined us to talk about the state of play in the US biosimilars market, what we can learn from ongoing experience, and how sustainable the US market for biosimilars may be today. 

The question of whether anticancer biosimilars will achieve strong uptake in the United States, and whether they will produce much-needed cost savings, is one that has pervaded the conversation about US biosimilars for some time. Shortly after Amgen launched the first 2 such agents, biosimilar trastuzumab and bevacizumab, OneOncology, a group that comprises 4 large community oncology practices and 100 sites of care, announced that it had made those 2 biosimilars preferred agents.   This week on the podcast, we’re speaking with Jeffrey Patton, MD, chief executive officer of Tennessee Oncology, a partner practice of OneOncology, and the President of Physician Services for OneOncology. Patton shares with us the rationale for the adoption of biosimilars, how patients are responding, and lessons learned. 

In its semiannual drug pricing forecast, healthcare performance company Vizient said that biosimilars will be a key part of combatting rising spending on drugs. This week on the podcast, we're speaking with Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient, on how oncology biosimilars are poised to make an impact.

It's no secret that biosimilars that treat inflammatory diseases have struggled to gain ground in the United States, but given the benefits that biosimilars can offer, some physicians are taking matters into their own hands with concerted efforts to bring biosimilars to the clinic. This week on the podcast, we're speaking with Colin C. Edgerton, MD. He's one of the founding members of Articularis Health Group, which has created a value-based rheumatoid arthritis treatment pathway that has boosted biosimilar use. 

In July, the Trump administration withdrew its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations. HHS previously said that the rule would counteract incentives behind higher list prices.  Withdrawal of the rule was a discouraging development for many physicians who hoped that the proposal could give relief to their patients at the pharmacy counter. This week on the podcast, we’re speaking to one such physician, Madelaine Feldman, MD. 

The Biosimilars Council, a part of the Association for Accessible Medicines, recently issued a white paper in which it condemns abuses of the patent system that delay biosimilar competition. The group estimates that the financial impact of these delays has cost the US healthcare system $7.5 billion in lost savings since 2015. This week on the podcast, we’re speaking with Christine Simmon, executive director of the Biosimilars Council, about the paper, about patent thickets, and about what policy issues the organization wants to see addressed to move the needle on biosimilars. 

At the beginning of this year, we spoke with Laura Joszt, associate editorial director and the host of The American Journal of Managed Care’s podcast, Managed Care Cast, about where biosimilars stood at the end of 2018. Now, halfway through the year, we’re continuing that conversation with a look at how biosimilars have fared so far in 2019.

Industry group the Biosimilars Forum recently put forth 3 policy proposals that it says could save the US healthcare system billions of dollars. This week on the podcast, we’ve invited the forum to tell us more about their proposals and other policy issues related to biosimilars. Joining us this week are Juliana Reed and Molly Burich. Reed is the vice president corporate affairs, global biosimilars lead at Pfizer, and is also president of the forum. Burich is director of public policy, biosimilars, and reimbursement at Boehringer Ingelheim, and an officer in the forum. 

While pay-for-delay issues have been big news on Capitol Hill recently, some experts have questions about whether these kinds of settlements are really at the heart of delayed biosimilar competition, and they offer alternative ways to think about—and to fix—the problem. This week on the podcast, we’re speaking with 2 such experts, Imron Aly, JD, and Joel Wallace, JD. Both are partners at Schiff Hardin LLP and have extensive experience with Hatch-Waxman and biosimilars intellectual property issues.  

Recently, the FDA released its long-anticipated final guidance on demonstrating interchangeability, and developers have been grappling with how the guidance will impact them. This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.

Amid growing concern about the skyrocketing cost of insulin in the United States, the FDA held a public hearing this month about biosimilar insulins. This week on the podcast, we caught up with one of the experts who testified at the hearing: Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient. He shared his thoughts with us on biosimilar insulins, interchangeability, biosimilar suffixes, and what milestones lie ahead as the United States approaches its 2020 transition of insulins to regulation as biologics. 

The cost of cancer care is on the rise worldwide, and biosimilars present one option for bringing down costs. However, those savings depend on adoption and use of biosimilars, and hesitancy to use these agents on the part of prescribers has been well documented. One newly published study reported on a survey conducted among European Society for Medical Oncology (ESMO) members and attendees of the 2017 ESMO Congress in Madrid, Spain, concerning biosimilars. This week, we’re speaking with the study’s lead author, Rosa Giuliani, MD. She’s a medical oncologist at The Christie Hospital, Manchester, United Kingdom, and Chair of the ESMO Global Policy Committee.

In a 2-part proposal published on the Health Affairs blog, a team of authors argued that efforts to induce lower prices through competition via biosimilars will inevitably fail. Instead, they write, prices for innovator biologics should be regulated by the US government after patent expiry.This week on the podcast, we’re talking with Mark Trusheim, MS, one of the authors of the proposal. 

Recent months have seen a variety of proposals to bring down the cost of prescription drugs, but will any of them have staying power? This week, senior editor Allison Inserro speaks with Robin Feldman, professor at the University of California, Hastings, College of the Law, and author of the new book Drugs, Money, and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices.