CURRENTLY, SPECIALTY PHARMACY IS THE FASTEST-GROWING SECTOR WITHIN THE US DRUG MARKET.1 Since the mid-2000s, the specialty drug trend has surpassed both the overall and traditional drug trend.2

According to a report released in 2015, the specialty drug trend in 2014 was 30.9%, which was significantly higher than that of the traditional drug trend at 6.4%.2 Representing about 1% of all US prescriptions, specialty medications are estimated to contribute up to 44% of the overall drug spend within the next 3 years.2

These substantial changes within the specialty pharmacy market have influenced the increased number and types of specialty pharmacies managing these products (Figure 1). With a variety in the types of pharmacies dispensing specialty products, it can sometimes be difficult to identify key differentiators and specialty capabilities. Independent specialty pharmacies differ in their business model when compared with other pharmacy types.



The term “independence” may be defined as having no payer, pharmacy benefit manager, or other extra-organizational ownership. Having this business model as a key differentiator drives the independent specialty pharmacy to service patients and prescribers for recurring business, considering that no external entities are routing business to the independent pharmacy.

Measurement of success can also act as a key differentiator, as independent specialty pharmacies often reference data from patient and prescriber satisfaction surveys for performance indicators. An evaluation of pharmacy types dispensing specialty products can be challenging, as currently a standard definition of “specialty pharmacy” does not exist; however, many health care organizations have provided insight to defining this term.

The National Association of Specialty Pharmacy, Academy of Managed Care Pharmacy, and the Specialty Pharmacy Association of America have published specialty pharmacy definitions with similarities regarding how specialty pharmaceuticals are distributed and their patient-centric models of care.3

Another term that does not hold a standard definition is “specialty drug” or “specialty medication,” however, just as with the term, “specialty pharmacy,” organizations have tried to define it. Characteristics listed within various definitions may include baseline and continuous monitoring, high cost, restricted distribution models, specialized storage and handling, and the treatment of complex and chronic disease states.3

Without access to universally accepted definitions or practice standards, there are only a few other elements that may be used to further differentiate amongst the various pharmacy types dispensing specialty pharmaceuticals. These include:



Many specialty pharmacies look to various accrediting organizations to provide an external seal of approval on their clinical management programs.

Currently, the most widely accepted accreditation within the specialty pharmacy space is URAC, which provides standards for the pharmacy, customer service, drug/patient management, operations, and outcomes reporting.4

In addition to meeting the aforementioned standards, a pharmacy pursuing accreditation must also meet other characteristics outlined by URAC (eg, 24-hour customer service access).4 Based on 2015 data, at least 140 pharmacies have obtained URAC Specialty accreditation.5

Other nationally accepted accrediting organizations for specialty pharmacies include both the Center for Pharmacy Practice Accreditation and Accreditation Commission for Health Care. A newer approach for pharmacies to differentiate themselves within the specialty pharmacy space is to demonstrate their clinical expertise by having their clinicians become certified.

Within specialty pharmacy, there are 2 methods by which a clinician can demonstrate clinical excellence:
  1. Obtain board certification by the Board of Pharmacy Specialties in a specialty pharmacy-related disease state (eg, oncology)
  2. Obtain certification as a specialty pharmacist by the Specialty Pharmacy Certification Board 
The last 2 key differentiators for specialty pharmacies involve innovative service initiatives and partnership resources, which are best demonstrated by independent specialty pharmacies. This pharmacy type allows for a singular focus on specialty pharmacy management by providing patient-centric, high-touch care models individualized to the patient.

Independent specialty pharmacies also foster industry collaborations and the development of innovative services and programs that demonstrate both a patient-caring and entrepreneurial business philosophy. A simplified workflow of this patient-centric model is demonstrated in Figure 2.



Innovative Service Initiatives
Patient-Centric Delivery of Care
Care provided by independent specialty pharmacies is primarily focused on the individual patient, unlike other models that are grounded solely on population-based strategies and initiatives. A more thoughtful approach to patient care is demonstrated by independent specialty pharmacies that individualize specialty management and collaborate with key stakeholders (eg, patient, prescriber) in gaining access to specialty products.

One advantage independent specialty pharmacies possess is that they do not have a formulary to which they must adhere, but instead, follow the prescriber’s recommendation which allows patient care to be individualized. Independent specialty pharmacies also help both the patient and physician with medication-access needs by assisting with prior authorizations, appeals, and securing financial support.

Additional patient-centric services provided by independent specialty pharmacies that support a patient’s success on their health care journey include:
  • 24/7 availability of clinical support personnel
  • Click-to-chat technology, allowing for an online patient experience
  • Customized medication compliance packaging for complex therapies
  • Individualized care plans centered around patient assessment, education, training, and ongoing management
  • Phone applications
  • Prophylactic starter kits for mitigating adverse events, dose adjustments, and discontinuations 
Patient Advocacy
Independent specialty pharmacies have been known to have dedicated employees for patient advocacy. Patient advocacy focuses on three pillars:
  1. Advocating on a patient’s behalf to ensure maximum utilization of benefits and access to patient assistance programs to reduce out-of-pocket costs
  2. Educating non-profit patient advocacy groups on specialty pharmacy support for patients
  3. Creating opportunities for employees to better connect with patients through patient-led, educational programs. 
Patient advocacy efforts aim to increase patient access to non-profit advocacy groups and create a heightened level of employee empathy towards the patient’s perspective. Advocates networking and connecting with patients, caregivers, and meeting/conference attendees provide additional first-hand knowledge and appreciation of the patient’s health care journey.

Education & Training
In 2014, one independent specialty pharmacy was awarded an innovation award by Specialty Pharmacy Times for launching their large-scale education and quality department. Over the years, this department has evolved from performing only internal employee orientation and training to acting as an industry educational and consultative forefront for external partners (eg, pharmaceutical companies, retail pharmacies, managed care clients).

From a quality perspective, this department is responsible for continuous quality improvement, with an emphasis on patient safety and optimizing the patient’s therapy experience.

Expansion of Private-Label Specialty Pharmacy Services into Retail, Grocery, and Hospital Markets
Independent specialty pharmacies have created service offerings into new markets by providing private-label, customizable sets of specialty services from which retail, grocery, hospital markets, and prescribers can select based on identified needs.

These programs allow for quick market entry and speed-to-market partnerships that aim to get clients operating as a specialty pharmacy and/or supporting specialty pharmaceutical needs without having to invest the dollars and/or personnel to build from the ground up.

Access Services (Hub)
Independent specialty pharmacies can serve as a one-stop shop for pharmaceutical manufacturers with an exclusive service and distribution offering. The independent specialty pharmacy is the sole source for customized patient journey programs, prescriber reimbursement, distribution solutions, and commercial/noncommercial specialty product distribution.

The value of an exclusive hub solution is evident in the longitudinal data that allows for timely actions to support the real-world experience trends of specialty agents. Some independent specialty pharmacies have created a separate, firewalled patient and prescriber hub solution to support manufacturer needs.

These offerings are likely to be more of an à la carte service, where the manufacturer selects the best service to fit the stakeholder’s needs. Additional hub services can include unique specialty distribution solutions targeted to a specific product, allowing for maximum patient access and prescriber use.

Commercialization of Products
Independent specialty pharmacies can be very helpful to the brand teams of pharmaceutical manufacturers faced with commercialization decisions of a specialty product. Often, the rich experience of a specialty pharmacy team can be leveraged when anticipating launch challenges and opportunities. Independent specialty pharmacies with a history of manufacturer partnerships and positive launch experiences can offer a consultative approach to best practices for success.

When considering that 1 of the key differentiators of an independent specialty pharmacy is its business model, the launch success of a brand team is also a success for the pharmacy. It is within these partnerships and collaborations that independent specialty pharmacies soar, providing patients with a well-designed journey that allows for proper data collection, assessment, and clinical intervention.

Commercialization considerations do not end with the launch of a product, however. For independent specialty pharmacies, an ongoing dialogue with the manufacturer around post approval, real-world experiences is vital to a nimble relationship that is flexible enough to address the needs for change based on reported trends.

A specialty pharmacy’s ability to deliver timely, accurate, and complete data should be a key consideration in a commercialization plan. With the increasing need to describe the patient experience, independent specialty pharmacies are uniquely situated to report on important factors, such as adverse events, patient-reported outcomes, compliance measures, and patient durability.

Many limited distribution drug (LDD) pharmacy panels include a mix of different specialty pharmacy types. A relatively recent trend emerging among manufacturer commercialization strategies includes selecting an LDD specialty pharmacy panel exclusively comprised of independent specialty pharmacies. Examples of products following this trend are Imbruvica (Pharmacyclics/Janssen) and Zydelig (Gilead).

By selecting a patient-centric, high-touch panel of independent specialty pharmacies for product management and distribution, manufacturers can leverage the innovative service initiatives of these pharmacies to maximize their drug product launch. For some specialty products, a manufacturer may select an exclusive specialty pharmacy to service the needs of patients and prescribers.

In many instances, manufacturers have selected an independent specialty pharmacy as the exclusive distributor due to the need for a high-touch program that supports stakeholder needs. Two examples of this approach were seen in the distribution of Cometriq (Exelixis) and Keveyis (Taro).

Summary
In summary, independent specialty pharmacies offer services and programs designed to maximize the patient’s medication journey in an individualized and caring way. It is this business model that provides an individualized, patient-centric focus of care. When specialty pharmaceutical manufacturers partner with independent specialty pharmacies to provide a customized patient-centric solution for their product, it is the patient who benefits with a healthier, happier life.

Furthermore, the independent specialty pharmacy’s entrepreneurial business philosophy provides opportunities to design innovative customized programs benefiting patients, physicians, manufacturers, and other health care segments. SPT

References
  1. American Journal of Managed Care. The growing cost of specialty pharmacy – is it sustainable http://www.ajmc.com/payer-perspectives/0213/the-growing-cost-of-specialty-pharmacyis-it-sustainable. Published February 2013. Accessed January 2016.
  2. Express Scripts. The Express Scripts drug trend report. http://lab.express-scripts.com/drug-trend-report/#sthash.BS9yhkty.dpuf. Published March 2015. Accessed January 2016.
  3. Hagerman J, Freed S, Rice G. Specialty pharmacy: a unique and growing industry. American Pharmacists Association; Pharmacy Today; Published July 2013.  Accessed January 2016 http://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry
  4. URAC. Specialty Pharmacy. https://www.urac.org/accreditation-and-measurement/accreditation-programs/all-programs/specialty-pharmacy. Accessed January 2016.
  5. URAC. URAC directory of accredited companies. https://www.urac.org/directory/DirectorySearch.aspx. Accessed January 2016.