The regulatory pathway to approve ‘biosimilar’ competitors was signed into U.S. law in 2010, but savings have been slow to materialize until recently.
Early biosimilars have been few in number and generated limited savings compared to expectations. Slower uptake and muted savings raise fundamental questions around defining the success of biosimilars for all stakeholders, and particularly patients.
Yet by contrast, recent events suggest an inflection has occurred – events expected in the next few years potentially offer to bring further significant shifts. Savings enabled by the presence of biosimilars are modeled to exceed $100 billion in aggregate over the next five years, though volume and price dynamics remain volatile and significant uncertainty remains.
This webinar follows the early October release of a report on biosimilars, produced independently by the IQVIA Institute for Human Data Science as a public service, without industry or government funding, which takes a close look at the current state of the biologics market in the United States.
In addition to IQVIA Institute leadership, a panel of experts from healthcare and the nonprofit sector will discuss ongoing issues around biosimilars, including:
In late 2020, the IQVIA Institute convened a webinar to discuss the question, are we seeing a biosimilars turnaround? The multi-stakeholder panel answered many questions during the live session and followed up post-event to address additional ones.
Sameer Awsare, Associate Executive Director for The Permanente Medical Group
Juliette Cubanski, Deputy Director, Program on Medicare Policy at Kaiser Family Foundation
Pam Traxel, Vice President for Alliance Development and Philanthropy, American Cancer Society Cancer Action Network
Traxel: There are many barriers to patient adherence, and we should pay attention to each of these factors – logistics in filling a prescription, procrastination, concern about side effects, among many others that need to be addressed. There are many programs that are being used to communicate with patients to understand these barriers and try to resolve them.
Muñoz: Yes, and this stems from the idea that without interchangeability, biosimilars will mainly attract new patients, with few patients switching from an originator product that is working to a biosimilar product. In oncology, nearly every patient is a new patient due to the acute and episodic nature of the disease.
Traxel: Yes, I believe that the oncology patient experience is very different than other patient experiences. Oncology patients face less therapeutic choices and are less likely to be familiar with the specifics of their infused therapies. These patients have many other concerns in their cancer battle and the choice of medication is generally not one that is top of mind.
Cubanski: From a practical standpoint, the Most Favored Nation model that was initiated by the Trump Administration is not likely to have any impact in the near term, since a district court issued a preliminary injunction temporarily blocking HHS from implementing the model, and the CMS Innovation Center has stated that it will not move forward with the model without further rulemaking. But as for the bigger picture, if one of the motivating factors behind biosimilar development is bringing lower-cost versions of high-priced biologics to market, steps taken to lower prices of the originator biologics could dampen enthusiasm for biosimilar entry. On the other hand, policy actions taken to lower prices of biologics would generate savings for payers and patients, just as would bringing biosimilars to market.
Muñoz: One of the most significant issues to consider is that the financial incentives for biosimilar stakeholders are reduced if the spread between originator and biosimilar prices is narrower. In analyzing the current biosimilar pipeline, there appears to be a financial threshold, such that originator products with lower sales are not attracting biosimilar developers. Increasing this pricing pressure may reduce the number of products with a feasible market, potentially diminishing biosimilar development. The biosimilars available are for patients who are not necessarily financially motivated – they are often hitting out-of-pocket maximums. Payer motivation is based on a better negotiation amount, and the pressure from MFN or a policy like it could effectively limit the biosimilar market.
Traxel: I do not believe that this Executive Order will go into effect but if it did, I think it could potentially deter manufacturers from developing biosimilars. Under this proposal, biosimilars would be subjected to international reference pricing and it could narrow the differential in prices between originators and biosimilars.
Cubanski: To the extent accumulator programs increase the financial burden of high-cost drugs on patients, they are likely to affect perceptions of affordability. But beyond just the perception of affordability, the fact that many patients need to turn to manufacturer co-pay support programs for assistance indicates a fundamental concern with high-priced drugs, which is that patients wouldn’t be able to afford them if they had to pay the full price out of pocket. This is true for many originator biologics as well as the biosimilar equivalents as well. So it’s not just perceptions of affordability (or lack thereof) that are important, but lack of affordability as a real barrier to access.
Traxel: Co-pay accumulator programs expose patients to more cost to afford their therapies. These programs could result in patients choosing to be non-adherent and have worse health outcomes and create a financial barrier to patients affording care. These programs can put disease modifying and life-saving therapies out of financial reach for many patients.
Awsare: Although we have not measured hidden costs rigorously, we are able to obtain substantial savings when we move market share to a biosimilar. We feel that these savings outweigh the time spent on patient education. At Northern California Kaiser Permanente, we have clinical pharmacists available to support our patients and physicians when a biosimilar is used.
Traxel: Patient and providers are often required to change medications due to changes in formularies. Generally, these changes are required because they save the insurer and, in some cases the patient, money. When discussing the cost-effectiveness of biosimilars, it is important to define who is receiving the savings – the patient, the provider or the insurer. It is also crucial to remember that this practice exists beyond the issue of biosimilar prescribing and is common across many therapies.
Awsare: We need to continue to educate physicians and other healthcare providers on the efficacy and safety of biosimilars. There are numerous studies from across the world that indicate biosimilars are safe and have the same clinical effect as the originator biologic product. The FDA also published information for patients and physicians regarding this:
https://www.fda.gov/drugs/biosimilars/patient-materials
https://www.fda.gov/drugs/biosimilars/health-care-provider-materials
Research data on patient outcomes when switched to biosimilars, along with endorsements of biosimilars from physicians and other healthcare professional organizations will also make hesitant physicians and providers more comfortable switching a patient from an originator product to a biosimilar. Correcting misinformation on biosimilars and removing the interchangeability requirements (like the rest of the world) will increase biosimilar acceptance.
Traxel: The best solution is to point providers to published switching studies, which show the safety and efficacy of moving patients from an originator product to a biosimilar. Most providers want the ability to evaluate peer reviewed studies for themselves.
Awsare: As of today there is no biosimilar in the US that is interchangeable and the process of developing one is onerous. Since biosimilars have no clinical difference in efficacy from the originator product, the interchangeability designation is unnecessary, and the US is the only country in the world that has this requirement. It’s important to remember biologics are made from cell lines and that they are not the are not identical from one batch to the next (even for the originator product).
Traxel: Most physicians have little familiarity with the concept of interchangeability, since now this is a regulatory concept and not something they experience in their day to day work.
Cubanski: To the extent that high-cost drugs have sizeable rebates, passing on these rebates at the point of sale would help to lower patient out-of-pocket costs. There is a tradeoff with this idea, however, in that currently pharmacy benefit managers and plan sponsors use rebates to lower plan costs, which enables them to lower plan premiums for all enrollees. Point-of-sale rebates would lower costs for some patients while raising premium costs for enrollees overall.
Muñoz: Given the current election results, this particular policy is less likely to be enacted. Of the current biosimilar approvals, this would only affect insulins, where many patients already have low costs. For specialty pharmacy products, like the coming Humira biosimilars, many patients will likely continue to reach the maximum spend on their plans, and thus their annual cost exposure remains the same.
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