Spotlight on the EMD Serono Specialty Digest, 6th Edition

The biopharma company EMD Serono chooses the annual meeting of the Assn. of Managed Care Pharmacy (AMCP) each year to unveil its publication, “EMD Serono Specialty Digest,” now in its sixth year (and available at no cost at specialtydigest.emdserono.com). That makes sense as it works with managed care plans to develop the data that are published in this insightful report. The Specialty Digest is worth calling out because it focuses on one of the more dynamic, yet complex, parts of the overall pharma market: specialty pharmaceuticals, and the not-quite-corresponding patient-centered activity of specialty pharmacies.

Evidence of changing dynamics can be seen simply in the title of the report, which used to be “EMD Specialty Injectables Digest.” The simple fact of the matter is that not all specialty pharmaceuticals are injectables anymore, especially with some of the latest oncology products. Specialty pharmaceuticals, as defined by the URAC organization (urac.org) are those that have:

• special handling and administration
• unique inventory management
• a high level of patient monitoring
• more intense support than conventional therapies.

Other analyses include high cost and chronic conditions as qualifiers. It so happens that these definitions qualify two of the more energetic parts of drug development these days: oncology products (of which there are hundreds in trials) and biotech products. Not all specialty pharmaceuticals are available only through specialty pharmacies, and specialty pharmacies deal in many products (including generics) that might not be considered specialty pharmaceuticals.

The URAC definitions focus on several themes that are near and dear to us at Pharmaceutical Commerce: challenging inventory and handling processes; direct interaction between the pharma industry and patients; and patient support through activities like medication adherence programs.

Then there’s the money: because of the high costs generally associated with specialty pharmaceuticals, the healthcare delivery system is scrambling both to maximize drug availability, while containing costs. The Specialty Digest notes several trends on this point:

• a trend toward covering self-administered agents (SAAs) under the pharmacy benefit of health plans, while office-administered agents (OAAs) are covered under medical benefit. To the patient, this difference might be opaque, but it has consequences for payers who allocate their insurance coverage in variable ways;
• exclusive use of a specialty pharmacy, which might have varying relationships with manufacturers (and manufacturers, in turn, can choose to limit distribution to one or a few agents);
• more rigorous review of utilization of oncology products, an area where medical practices vary widely.

Both of these factors represent a tension among manufacturers, providers and payers. A manufacturer could, for example, strive to develop an SAA where an OAA (which can cost more to administer) has existed. That might be extremely valuable to a payer striving to control medical benefit costs, but the pressure to control pharmacy benefit costs could upset the applecart.

We applaud EMD Serono’s research and analysis in this area, which lends some clarity to the overall field.