While much of the current headlines related to biosimilars are focused on the approval path in the U.S., we must begin to focus on the patient access implications of biosimilars. Clearly the issues are interconnected. The clinical profile, including interchangeability, will impact payers and prescribers and thus ultimately impact patient access to biosimilars.

There are five key interconnected factors that will impact patient access issues for biosimilars. There may be other issues that will impact the use and adoption but these key areas touch core issues from a patient access and reimbursement perspective.

The five key factors impacting patient access include:

Interchangeability
We know that interchangeability with the originator will be a key factor in determining the adoption and use of biosimilars. The ease of the biosimilar to be dispensed automatically without prior approval by the prescribing doctor could significantly impact a payer’s coverage restrictions. In recent guidance published by the FDA, it is proposed that manufacturers will be asked to prove biosimilarity and then provide additional clinical studies to get a determination on interchangeability. Getting the right approval pathway will be critical to the success of the biosimilar. Thought leaders in manufacturing are indicating that it may take years to determine the “full promise of biosimilars.”

When the FDA allows products to be labeled as interchangeable, payers will need to consider restrictions that require patients to switch treatment and will likely impact the degree to which coverage is restricted to the biosimilar product over the branded biologic.

Prescriber Confidence
Physician groups have publicly commented that interchangeability will be important to ensure uptake and utilization of biosimilars. There are particular concerns related to prescriber confidence with the first few biosimilars to market, specifically related to patient safety and a comparability of the efficacy. However, as the FDA requirements are expanded, this will increase the risk and development costs to manufacturers and thus will reduce the scale of potential cost savings that biosimilars may offer.

Manufacturers will also impact prescriber confidence with their marketing and clinical support for biosimilars. We expect that biosimilars will need marketing and support services very consistent with the branded product and such services will directly impact prescriber confidence. One concern being discussed in the marketplace is that manufacturers of biosimilars may not be factoring in the commercialization support that biosimilars will require to support their widespread use. From a prescriber confidence perspective, biosimilars will be similar to brands (rather than generics) and require clinical marketing strategies and tactics which will also impact the costs of commercializing biosimilars to be more consistent with brand products than generics.

Price Differentiation & Payer Requirements
Based on a recent survey of medical and pharmacy directors conducted by Xcenda, a full-service consultancy and managed markets agency, leading healthcare experts are now predicting that a biosimilar will cost 10% to 20% less than the branded biologic. The extent of the discount for biosimilars will depend on market competition. We know that in Europe biosimilars have often been just a 10% cost savings from the brand.

• Price differentiation will have a direct impact on the type of payer requirements biosimilars will face or benefit from.
• Based on price projections of savings of 10% to 20%, we would not expect payers to be likely to mandate a switch to a biosimilar.
• If the price differentiation is 40% or more, then patient switch requirements become more likely and this can vary by disease state and molecule.
• However, even for a more modest cost savings of 10% or 20%, we may see coverage restrictions that require new patients to utilize or try a biosimilar or otherwise document why they need the branded biologic.

These types of coverage restrictions are frustrating and costly for physician offices and we are seeing increased use of these types of restrictions in related areas, such as high-cost specialty oral products that compete with infused and injected biologics. The oral products may be a proxy for biosimilars in that we expect biosimilars to be like multi-source brand products and that coverage restrictions are not aggressively implemented by payers. Instead, biosimilars are likely to face the exact same tiers and restrictions as the branded biologic. This is similar to what we have seen in recent years with high-cost oral oncology products.

Price differentiation will definitely impact payer restrictions. We believe payers will implement coverage restrictions or step edits only as clinical confidence grows and market competition creates a greater price differentiation from the originator or other biosimilars. Modest price savings may not create significant new payer preferences to mandate use or switching of biosimilars initially.

One payer trend that will impact biosimilars is the growing number of payers that are asking PBMs to manage the specialty medical benefit in addition to the specialty pharmacy benefit. This trend will make it easier to manage payer benefits for biosimilars, which may include both medical benefit physician-administered products and self-administered injectables.

Manufacturer Support Services
At the center of any product is the patient experience. Patients and providers will be directly impacted by the manufacturer approach to marketing services, including patient support services. Such services can vary to include a wide range of commercialization support services but for biosimilars we believe prescribers and patients will especially need help with navigating coverage issues and restrictions. In fact, we believe that biosimilars will need such support services that are comparable with the branded products from both a prescriber and patient perspective.

This is very different from the experience of oral solid generics, where even basic patient support services are rare. However across biotech products in the U.S., Canada and even in Europe, there is a growing expectation that manufacturers will address the unique cost issues associated with specific products and that includes navigating healthcare coverage, restrictions to access, patient assistance and in many cases, also supporting appropriate use of the product with patient-focused support and adherence service.

Patient assistance for uninsured patients is likely to be a fundamental requirement as the anticipated discounts for biosimilars will not necessarily be significant. Biosimilars manufacturers will have to consider potential copayment assistance resources and programs for financially needy patients, as we expect copayment requirements will be similar to the branded biotech product. One of the most significant frustrations prescribers have with generic injectables today — beyond the current shortage and supply issues — is the lack of financial support especially for uninsured patients. Therefore, we expect this will be a key issue for biosimilars.

The recently released FDA guidance did not indicate whether manufacturers will have other post-approval requirements that impact marketing and support services, such as naming, labeling/tracking, and post-marketing monitoring requirements for a biosimilar. Given these unknowns, manufacturers must assume that they will need to address all of the same issues as their branded competitors.

We also know that in the current economic environment, healthcare providers expect and often demand to have this core type of support for all products. Product information, support for clinical questions from both patients and providers and reimbursement support will be critical for early adopter prescribers.

Additionally, biosimilars will need a comprehensive managed markets strategy in order to maximize their positioning with payers. Payer and provider support resources are critical to the product uptake and payer coverage of biologics and therefore essential to biosimilars.

There is great excitement and anticipation of the value biosimilars will provide to support patient access to potential life-saving treatments; however we must recognize that the products are still biotech products and therefore the savings opportunity may be more modest than initial projections and will clearly take longer to fully develop. Without dramatic price differentiation, biosimilars will face many of the same patient access issues as other biologics, but in an environment with increased competition, which should ultimately result in better support services for patients. Over time market competition will support cost savings but initially the focus needs to be on comprehensive support for biosimilar products to focus first on supporting patient access. Often these biologics compete primarily on strategies and services that support patient access issues.

From a patient access perspective, biosimilars will resemble brands rather than generics and therefore will require comprehensive commercialization strategy and tactics, including prescriber education, payer managed markets strategy and patient support services. Over time, biosimilars will create new market competition and opportunities for new strategies and services to support product access and growth.

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Peyton R. Howell, MHA, is president of AmerisourceBergen Consulting Services, a global organization dedicated to best-in-class manufacturer services, including patient and provider support, strategic consulting, and contract and clinical packaging. She can be reached at phowell@amerisourcebergen.com.