With the implementation of the FDA's abbreviated biosimilar approval pathway, biosimilars have become one of the fastest-growing categories in the biopharmaceutical sector. While these lower-priced alternatives will offer value in terms of cost savings, many stakeholders have voiced concerns over switching to biosimilar products.
Three main stakeholders of market access will determine the commercial success of biosimilars: payors, providers, and patients.
Despite potential cost savings, many payors may be reluctant to aggressively steer utilization toward these agents until they have compelling data to demonstrate safety and efficacy profiles comparable to those of innovator products.
Similarly, prescribers and patients may prefer proven treatments for cancer, anemia, and other serious illnesses rather than taking a chance on a less-expensive product with no track record.
Given these concerns, nearly all biosimilars will face skepticism from payors, providers, and patients in the initial post-launch period. In addition, the issue of "interchangeability" is expected to play a crucial role in determining market access.
Manufacturers of biosimilars may have a difficult time countering this skepticism, and likely will need credible data from post-marketing studies to demonstrate longer-term safety and efficacy, as well as interchangeability.
US health insurers will be key to the successful uptake of biosimilars. How will insurers manage these products? Will payors steer beneficiaries toward these lower-cost alternatives, as they do with generic drugs, or will they be hesitant to drive utilization toward a new, unproven category?
To better understand payors' views on biosimilars, we recently surveyed Covance's panel of commercial payer decision makers, with survey respondents representing over 100 million covered lives. The survey explored several factors that may influence how payors manage biosimilars, including therapeutic area, type of FDA approval (that is, an abbreviated biosimilar pathway versus a full Biologic License Application [BLA]), interchangeability, and pricing.
This is what we discovered from our panel of commercial payors:
Some of the survey findings were particularly eye-opening. Payors were surprisingly broad in their interpretation of what makes a biosimilar interchangeable with a branded product. The majority of payors surveyed would be willing to make this determination based on factors other than a formal FDA designation of interchangeability. They expect to rely on compendia listings, clinical evidence demonstrating efficacy and safety, clinical guidelines, CMS coverage decisions, and key opinion leader input when making these determinations.
Payors were also very frank about the extent to which their views on biosimilars would be influenced by the provider and patient communities-the levels of support or opposition within these groups were ranked as two of the least important factors in payors' coverage decision making for biosimilars.
Whether or how quickly a biosimilar will be adopted may also differ by therapeutic area. For example, payors in the US historically have been fairly "hands off" in their management of oncology, but it isn't clear whether this approach will persist once biosimilars are available.
We compared our payors' views on biosimilars in oncology versus rheumatoid arthritis (RA). We found that payors are less likely to steer utilization toward biosimilars in oncology than in RA, but the difference is less pronounced than you might expect. Overall, payors are willing to create favorable policies for biosimilars if there is a potential for significant cost savings-even in oncology.
Of course, payors are just one of the stakeholders who will determine market uptake for biosimilars. Although payors can remove barriers to access for biosimilars and create incentives to encourage their use, ultimately the commercial success of biosimilars will depend on physicians' willingness to prescribe these products over the branded alternatives.
Physician attitudes toward biosimilars will probably also vary by disease state. For example, oncologists tend to be less cost-sensitive when making treatment decisions, and they are more likely to regard therapies as unique. Both factors could cause oncologists to resist biosimilar adoption. They may be skeptical about claims of interchangeability, even if the FDA grants a formal designation. In contrast, rheumatologists may be much more receptive to biosimilars, because RA has long been a field characterized by competition among multiple alternative therapies that-to at least some extent-may be viewed as substitutable.
One similarity between oncologists and rheumatologists is that both specialties rely heavily on "buying and billing." Providers' views on biosimilars may be very different in other therapeutic areas with different economic models. In dialysis, for example, bundled payment systems have created an urgent need for cost savings among providers, which may signal a willingness to use biosimilars. However, safety concerns over the 2013 recall of Omontys (a highly anticipated erythropoiesis-stimulating agent) may give pause to providers when they are faced with the prospect of switching to a new biosimilar version of an established product.
The seemingly conflicting economics of dialysis providers (i.e., economics vs safety) speak to the complexity of the dynamics surrounding biosimilar uptake in different markets. Therefore, when assessing the market potential for biosimilars, it is important to look at each therapeutic area individually.
Market Planning and Support
If you want to facilitate market access for your biosimilar product in this challenging environment, you will need to engage in the full spectrum of market access and health economic planning activities, such as:
You must begin these activities early in clinical development. Market access planning is an iterative, multi-year process that requires the involvement of nearly all major divisions within an organization.
You will also have to offer customer support resources that are at least on par with those being offered by companies with market-leading innovator products. These support resources-which include full-service reimbursement hotlines, patient support programs, and provider educational programs-will be especially important in specialty disease areas where providers have very high expectations regarding customer support.
The market access landscape is likely to become even more competitive when biosimilars enter the market, as companies with innovator drugs will ramp up their own customer support resources to further solidify brand loyalty and reduce the attractiveness of the new lower-priced alternatives.
The commercial path for biosimilars in many ways will be as challenging as that for a unique innovator biologic. For more than two decades, Covance has specialized in supporting the successful commercialization of biopharmaceuticals facing market challenges like these.