	To get the right drug in the right amount at the right time to the patient in the most cost-effective manner, the following strategies must be used:

		 Establish reasonable member cost sharing.

	This multifaceted approach to drug benefit management works for all US Food and Drug Administration-approved drug therapies, including the expensive biologics, injectables, and infusibles we collectively refer to as specialty pharmacy.

	Cost and utilization management strategies focus on the use of benefit design to optimize prescribing patterns, ensure affordability and use of the most appropriate drug, and prevent waste. Payers should require prescribers to follow evidence-based clinical guidelines to ensure appropriate use of specialty drugs and minimize the risk to patient safety. Specialty pharmacy providers and pharmacy benefit managers provide technology-driven tools to help optimize the amount and type of medications prescribed for patients.

	Tools that are highly effective for controlling the cost and use of specialty drugs adjudicated under the pharmacy benefit include prior authorization, quantity limits, and in some cases, step edits. Most are administered through the online, real-time drug claim adjudication systems. Prior authorization helps ensure that physicians follow evidence-based guidelines and minimizes off-label prescribing. Quantity limits help to ensure proper dosing and prevent waste. Step therapy drives utilization to nonspecialty first-line therapies before moving to preferred specialty products.

	Member cost sharing for specialty drugs should reflect the increased cost of these therapies, without creating a barrier to access and adherence. Some payers have expanded their benefit designs to include a specialty tier (usually a fourth tier) with fixed copayments or coinsurance coupled with minimum and maximum dollar amount per script. With coinsurance, out-of-pocket maximums are especially important to ensure that specialty therapies remain affordable for patients. Affordability affects whether patients refill their prescriptions and persist with therapy.

	A detailed review of cost-sharing data supplied by employers in the Pharmacy Benefit Management Institute's Prescription Drug Benefit Cost and Plan Design Report indicates that specialty cost-sharing amounts still typically fall under the preferred or nonpreferred brand amounts in a 3-tier plan design.

 Each year, more employers add a cost-sharing tier dedicated to specialty pharmacy. 

 show average co-payments and coinsurance for specialty drugs in 4- and 5-tier plan designs. These data are directional in nature because of the small number of employers using 4- and 5-tier approaches to cost sharing.

	Specialty therapies also require high-touch patient services, such as nurse case management. Adherence to prescribed medication regimens is critical, often with significant challenges. The side effects of specialty drugs can be severe and difficult to manage, often discouraging adherence and persistence.

	Specialty pharmacy providers offer varied services to help patients manage these issues and remain compliant. Some use outbound telephone calling, passing patients to a pharmacist if they are having problems with medications. Others provide more comprehensive medication therapy management programs that involve collaboration of pharmacist, patient, and physician. Specialty pharmacy providers that offer a high level of care management may use case managers. Patient education is a critical component of overall case management.

	It is time for our industry to set aside the shock-and- awe discussions about the billions of dollars yet to be spent on specialty pharmacy companies. Pharmacy benefit managers, managed care organizations, and disease management companies need to educate payers about how to manage specialty pharmacy therapies with patient-focused methodologies. Stakeholders in the drug benefit industry already have the requisite tools and clinical strategies to effectively manage both the cost and utilization of sophisticated biotechnology and specialty drugs.

MedImpact HealthCare Systems, Inc, San Diego, CA.

Dana H. Felthouse, MBA, Vice President, Marketing Communications, MedImpact HealthCare Systems, Inc, 10680 Treena Street, San Diego, CA 92131. E-mail: dana.felthouse@medimpact.com.

Pharmacy Benefit Management Institute. Prescription Drug Benefit Cost and Plan Design Report. 2009-10 ed. Scottsdale, AZ: Pharmacy Benefit Management Institute, LP; 2009:14.

	Dana H. Felthouse, MBA is the Vice President of Marketing Communications for MedImpact HealthCare Systems, Inc.

Published in Oncology & Biotech News. February 2011.

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To get the right drug in the right amount at the right time to the patient in the most cost-effective manner

Dana H. Felthouse, MBA

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