All the buzz today is specialty. Everything seems to be special. There are conferences and organizations dedicated to the specialty space. There are a growing number of specialty pharmacies. It is an industry unto itself. And as more and more manufacturers focus on the development of drugs to treat rare diseases, the specialty market is likely to grow even more. Specialty products are becoming budget busters for payers. And management of specialty drugs continues to dominate within payer organizations. What does that mean for your market access team?
Years and years ago, specialty products were defined based on limited characteristics like cost and/or administration. These products treated conditions with few (if any) options. Manufacturers had little concern about coverage and market access teams had little involvement with payers for these products.
However, as the specialty drug market has expanded over the years, so too has its definition.
The Pharmaceutical Care Management Association (PCMA) acknowledges that specialty drugs should be defined by a full range of attributes (PCMA), including:
- Prescribed for a person with a complex or chronic medical condition, defined as a physical, behavioral, or developmental condition that may have no known cure, is progressive, and/or is debilitating or fatal if left untreated or under-treated;
- Treats rare or orphan disease indications;
- Requires additional patient education, adherence, and support beyond traditional dispensing activities;
- Is an oral, injectable, inhalable, or infusible drug product;
- Has a high monthly cost;
- Has unique storage or shipment requirements, such as refrigeration; and
- Is not stocked at a majority of retail pharmacies.
This expansion in what is considered specialty, the number of products now available, and the traditionally high cost of these products has also expanded the importance of the market access team.
Market Access Teams
Specialty products can pose challenges for market access teams used to negotiating with payers primarily around rebate levels or discounted pricing. While price and net cost are always considerations, discussions with payers about coverage and reimbursement for specialty products can be more complex. Payers look at the clinical trial patient characteristics, the inclusion and exclusion criteria, and the outcome metrics quite closely in their reviews of these products. That’s not to say these aren’t part of the review for all new products, but the scrutiny for specialty products is clear.
Market access teams need to be armed with clear clinical value messages for payers. A solid patient profile and rationale for the benefit of the product for those patients must be available and easily communicated by the market access team. A new approach that focuses less on how much of a discount you’re willing to give and more on where the product fits in the treatment paradigm is needed.
In today’s managed markets environment nearly every category is under scrutiny as payers look for ways to reduce cost. Specialty is no exception. One size fits all messaging won’t work. Negotiations strictly based on cost and rebate or discount offers won’t work. A knowledgeable team, experienced in working with payers, who can communicate the value of your specialty product and negotiate favorable coverage – not only in terms of dollars but also clinical criteria – is vital.
Is your market access team ready?
Viking Healthcare Solutions has established itself as the premier provider of corporate account services and strategic planning support for the pharmaceutical and biotech industries. VHS Insights, our research division, specializing in payer profiling, market research and analytics, can help you find answers to inform your payer strategy. We support traditional and rare/specialty organizations to create, maintain, defend, and protect access to your product throughout its lifecycle. Bank on our experience to help you achieve successful product commercialization. Contact us at http://www.vikinghcs.com/connect.