Valued Services from Specialty Pharmacy: A Manufacturers Perspective

Specialty product manufacturers collaborate with specialty pharmacies because of the services and support pharmacies provide in their shared mission to achieve optimal clinical outcomes.

Use of specialty medications to treat complex, chronic conditions such as rheumatoid arthritis, multiple sclerosis, and cancer is projected to reach $235 billion by 2018. The current trend is likely to continue, given the number of biologics in the pipeline to meet the medical needs of these most complex of disease states. There were 19 specialty products approved in 2013, with 150 additional specialty products currently in phase 3.

In 2013, specialty medications represented less than 1% of all US prescriptions and at the same time accounted for more than 25% of the country’s total pharmacy spend, according to Express Scripts’ Drug Trend Report.

Given that the specialty product growth trajectory is likely to continue, manufacturers of specialty products are focused on developing distribution strategies for their products that optimize the patient journey and medical community experience. Mitigating barriers to therapy and maximizing positive clinical outcomes are key drivers of manufacturer specialty pharmacy service model strategies.

An effective strategy to support complex disease states requires focused and targeted services for patients, prescribers, and payers. The growth of specialty product markets has been matched by the increased sophistication of the specialty pharmacy business model. Manufacturers of specialty products will continue to collaborate with specialty pharmacy providers (SPPs) to assist in the management of these complex products by providing customized care management services and innovative drug delivery systems. Many payers prefer the specialty pharmacy channel for their members to ensure appropriate utilization management and services for complex and high-cost therapies.

The manufacturers of these complex and costly products will continue to collaborate with their specialty pharmacy trading partners to take advantage of the myriad of services that the specialty pharmacies offer in support of the manufacturer and patients. The good news is that both manufacturers and SPPs have the same ultimate goal. The common focus is to deliver excellence in drug therapies that will optimize clinical outcomes and result in the best possible patient and provider experience.

As manufacturers develop their plans for SPP collaboration, there is a need to identify reliable barometers for identifying specialty pharmacies that distinguish themselves as leaders in a particular therapeutic category. While there are industry accreditations such as URAC that demonstrate an SPP’s commitment to the specialty pharmacy model, there does not exist a vehicle that targets expertise in a key disease state area. Therefore, manufacturers will conduct their own due diligence to validate that an SPP has the requisite disease state expertise.

The Optimal Service Model

Manufacturers must first define their organizational needs, determine the strategy to meet those needs, and execute on the tactics to meet business objectives.

The million-dollar question for a manufacturer is, “What SPP services would add the most value to deliver the best outcomes and facilitate a superior patient and prescriber experience?” Before a manufacturer can answer this question, there needs to be a careful consideration of several factors to determine the appropriate service model.

At the top of the list for this exercise is understanding the product profile, including:

• Product indication
• Disease state complexity
• Product mode of administration
• Product dosing
• Product tolerability/side effect profile
• Size of patient population
• Site of care for administration
• Need for diagnostic testing

The next step is to understand the needs and goals of internal and external stakeholders, including:

• Patients/caregivers
• Prescribers
• Payers
• Brand teams
• Sales
• Patient services teams
• Information management teams

Other considerations in the development of value-added services include:

• Payer coverage/barriers to access
• Cost of product versus competitor’s price
• Competitor service models for like products
• Value of speed to therapy
• Risk evaluation and mitigation strategy (REMS) requirements

Services

The first rule of understanding the specialty pharmacy model is to accept the reality that all specialty pharmacies are not created equal. There may be a significant variation in service-level models from SPP to SPP, given the variation in business models and SPP management interpretations. Some services are consistent across the channel, such as dispensing of prescriptions, patient counseling, and refill management. In other instances, a particular service at one pharmacy may be considered a core service while at another pharmacy the same service may be considered a customized service. When building a service model, manufacturers should clearly understand the distinction between core and customized specialty pharmacy service.

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Core services are those that are part and parcel to the pharmacy standard practice of care. For many SPPs, these could include such services as:

• Prescription receipt/processing
• Product dispensing
• Refill reminder programs
• Benefit investigation
• Financial assistance support
• Standard patient education/clinical counseling
• Call center services

Customized services are those that are offered in addition to the pharmacy’s standard of care model and therefore may require separate fair market value payment from the manufacturer.

These could potentially include such services as:

• Enhanced/customized data reporting
• Targeted patient outreach that is additive to the pharmacy’s standard compliance and persistency protocols
• In-home nursing services such as injection training
• Shipment of product starter/welcome kits directed by the manufacturer

The unavoidable variations across the specialty pharmacy market with respect to core versus customized services pose a challenge for manufacturers whose goal it is to provide a consistent patient and provider experience. Manufacturers strive to build a consistent service model for patients and the medical community and will work with their trading partners in an effort to minimize the variations across the specialty pharmacy channel.

Identifying the Suite of Services

While the need for some services is consistent across the spectrum of products, each product that falls into the specialty pharmacy category demands its own set of unique services. A self-injectable agent that is mature may not require the intense level of services as an agent that must be infused or is associated with a comprehensive REMS program. An oral product may not require the same level of nursing support as a product that is administered intravenously or intramuscularly.

Nursing services span the range from telephonic to in-home injection training, depending on the product profile and specific patient needs.

A product that has a side effect profile with tolerability issues may require a more comprehensive compliance and persistency program than a product that is generally well tolerated. The design of the compliance and persistency program must consider the product characteristics, including tolerability, mode of administration, and dosing frequency. Specialty pharmacies hold a unique position as they are the final stop in the delivery of critical specialty products to patients who are dealing with complex conditions. The SPP clinicians have the advantage of a holistic view of the patient’s medical and therapy profile and therefore are best positioned to positively impact adherence goals.

Benefit investigation and prior approval facilitation efforts tend to be fairly standard across the channel. Specialty pharmacies typically provide financial assistance such as administration of manufacturers’ co-pay programs, referral to manufacturers’ patient-assistance programs, and working with foundations to identify funds to support patient therapies. There can, however, be wide variations in the pharmacy operational process to achieve the end result of mitigating administrative and financial barriers to specialty therapies. In some instances there are enhanced or additional services beyond the standard, such as facilitation of medical exception/appeals or co-pay support services that could move the service into the customized bucket.

The comprehensive data services that specialty pharmacies provide are the golden nugget for manufacturers. SPPs are able to provide robust transaction-level data and offer market intelligence that would not otherwise be available to manufacturers. When determining the level and frequency of the data that a manufacturer desires, there are a few key questions that will inform the final data strategy, including:

• What are the critical data elements needed to effectively manage the business?
• What is the frequency of the data reporting that supports actionable strategies/tactics?
• How will the data be interpreted to ensure that they are reflective of the actual market dynamics?
• Does my organization have the expertise and bandwidth to receive and process the data into meaningful data metrics?

Determining and implementing a data strategy that will ultimately deliver the desired business outcomes takes a village. The scope and effort for this task cannot be underestimated as both manufacturers and SPPs are faced with many moving parts that will influence the quality and completeness of the data.

The data effort is impacted by privacy regulations such as those established in the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act as well as some state regulations on the sharing of protected health information. Patient consent is a key driver of the level of information that manufacturers can expect to receive given the increasingly more onerous scrutiny of regulators. In today’s environment, a successful data strategy requires close collaboration with cross-functional stake holders.

Once the manufacturer has completed its due diligence regarding optimal support programs for its specific product, the next step is to determine the SPP services that will most closely align with brand objectives. It is crucial to implement programs that meet the needs of external stakeholders including patients/caregivers, prescribers, and payers. In addition, internal cross-functional teams have a vested interest in leveraging the SPP services that will deliver the most value that, absent the SPP services, would not be available.

Manufacturers seek to deliver a service model that will balance the needs of all stakeholders while delivering maximum value to their organization. With the scope of specialty products in the pipeline, specialty pharmacy will continue to play a key role in delivering superior disease management market services. Each product has its own unique challenges and therefore will require a customized service level approach to meet its potential.

The most important critical success factor when formulating a service model strategy is close collaboration between the manufacturer and its specialty pharmacy trading partners. Manufacturers must not create a service model in a vacuum, but rather should work in concert with the SPP providers to identify strategies that will deliver the desired outcomes and are executable as well as measurable.

A careful assessment of the specialty pharmacies that have demonstrated market leadership in a therapeutic category is the cornerstone in building an effective service model for specialty products. This may include larger national SPPs and/or smaller niche players. Innovative partnerships built on a solid foundation will ultimately deliver the common goal for both manufacturers and SPPs of a service model that delivers excellence in patient care. SPT

About the Author

Maryann Dowd, RPh, has over 30 years of experience in the health care sector spanning retail/specialty pharmacy, biotechnology, and management consulting. Maryann specializes in channel optimization, providing strategic and tactical insight into the specialty pharmacy service model. She has held various leadership roles at Biogen Idec, Pricewaterhouse Coopers, and EMD Serono. She has provided thought leadership in the management of multi-sponsored risk evaluation and mitigation strategies programs and led an innovative limited distribution track and trace program designed to mitigate diversion and counterfeiting of high-target biologics. Maryann practiced pharmacy at CVS Health in Massachusetts after graduating from Massachusetts College of Pharmacy. She is a member of the editorial board of Specialty Pharmacy Times.