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Access to Biosimilars

Patient access issues and opportunities

By Peyton R. Howell, AmerisourceBergen Consulting Services

Published May 4, 2012

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

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