As the fastest growing segment of pharmacy, specialty drugs now account for nearly 40 percent of drug spending.¹ The number of specialty pharmaceuticals among the top-selling drugs was 6 out of 10 in 2013 and is projected to be 9 out of 10 in 2020.² Many of these are breakthrough therapies for cancer, hepatitis C, HIV, autoimmune disorders and multiple sclerosis. And with nearly 700 specialty drugs under development,³ specialty pharmacies are a vital partner to manufacturers in commercializing their products.

A rapidly changing specialty drug market

The specialty market is constantly evolving: while many specialty pharmacies are consolidating, many more are emerging. The acquisition of specialty pharmacies by managed care organizations and pharmacy benefit managers is a driving force as well.

Also of significance is the rise in specialty dispensing by health systems and community practices: in 2016, 47.1 percent of hospitals with more than 600 beds operated a specialty pharmacy, and the number of oncology practices dispensing medication more than doubled from 2013 to 2016.⁴

In today’s specialty market, manufacturers have many options about how and where to make their drugs available. When considering network design, a specialty pharmacy can be an important partner that helps ensure a consistent patient experience, appropriate medication use and continuity of care. Below are some key areas of consideration for manufacturers when evaluating a specialty pharmacy partner.

1. Patient support

A successful specialty pharmacy partnership begins with a mutual focus on the patient. Seek a partner that provides clinical support, patient education about the therapy and disease state, as well as program-specific clinical assessments and adherence programs. Additionally, consider if the pharmacy has the flexibility and ability to integrate non-nursing clinical support into the program, if needed. For certain products, dietitians, mental health professionals, occupational therapists or other specialists, in addition to specialty pharmacy clinicians, may be needed to achieve the level of patient support that leads to improved outcomes.  

Clinical services are essential, but also consider other areas of pharmacy specialization needed to offer patients comprehensive support. For example, specialty pharmacies can differ in the level of assistance that they provide to help patients find the lowest out-of-pocket option for therapy. To help patients overcome financial barriers to access, choose a partner with benefit experts who understand regional and governmental payer requirements and assist with prior authorizations, appeals and letters of agreement, when allowed by the payer. Partners that facilitate the application and enrollment process for funding from manufacturer co-pay assistance and foundation assistance programs help patients who might struggle to navigate these processes on their own.

Finally, consider the pharmacy’s culture. Is it patient focused? Clinical and regulatory associate training is crucial, but specialty pharmacies dedicated to high-touch patient support also emphasize customer service and compassionate care as part of their training curriculum. Patient-centric specialty pharmacies frequently assess patient satisfaction to ensure that the highest levels of support are consistently delivered.

2. Clinical expertise

Just as medical doctors and treatments have become more specialized, so have pharmacies. It’s important to assess the clinical capabilities of the specialty pharmacy when choosing a partner. Offering 24/7 clinical support, specialty pharmacies provide a range of services and resources for patients who may be taking medications with complex dosing, administration and side effects. 

Excellent care that promotes patient safety involves advocating for patients across multiple care providers, educating patients and caregivers, coordinating labs, providing reminders for doctors’ visits, performing clinical assessments and more. To deliver this kind of care, specialty pharmacies must have clinical expertise about the disease state, patient population and associated therapies. Expertise about the payer requirements and clinical documentation needed to support the prior authorization process is also critical. Clinical training and specialty pharmacist certifications can also help ensure that pharmacy teams have the most up-to-date information when providing care. 

Pharmacists are specialized clinical experts who play a central role counseling patients; however, registered nurses can also provide telephonic or in-person clinical education for patients and their caregivers. By working with an in-home nurse for products that can eventually be self-administered, patients and caregivers have the flexibility to determine when they are ready to administer independently. For products that always require nursing support for administration, specialty pharmacies can offer home or infusion suite site of care options.

3. Quality

It goes without saying that a manufacturer should expect its specialty pharmacy partner to have high-quality operations. National accreditation by URAC, the Accreditation Commission for Health Care and other third-party organizations demonstrates a specialty pharmacy’s commitment to ensuring the highest levels of quality and patient safety. Accreditation has become nearly mandatory for specialty pharmacies to gain access to limited distribution products and payer contracts. A dedicated quality team within a specialty pharmacy’s organizational structure indicates a strong focus on continuous improvement.

4. Reach and Partnership

With many new specialty pharmacies entering the market, consider the pharmacy’s reach and ability to support not only patients, but also prescribers within community practices and health systems. Pharmacies that provide national dispensing and nursing support, field-based provider sales teams and managed care sales teams have a greater range of services that can help reduce administrative burdens and increase access and site of care options for the patient. Manufacturers’ network design considerations should include specialty pharmacies that have strategic alliances with prescribers, as well as a field sales team to support the needs of the referring practice.

Independent specialty pharmacies are able to play a unique role in product commercialization as in-office dispensing and health system specialty pharmacies become more prevalent. Even practices with mature specialty pharmacy capabilities need a pharmacy partner to help with access gaps due to network or payer exclusions, reimbursement issues and patient logistical challenges; and independent pharmacies have more flexibility to design partnerships that provide clinical coordination. Forward-thinking specialty pharmacies are offering partnership models that include analytics and consulting capabilities across satellite locations, ensuring that prescriptions stay with the health system or practice when they can dispense. Manufacturers desiring high-touch care should consider specialty pharmacies that have the freedom to design patient-focused programs and the reach and partnerships that keep the dispense closest to the provider.

5. Experience

Experience working with a variety of programs allows specialty pharmacies to have a deeper understanding of the patient journey, regulatory requirements and pharmacy processes that are necessary to ensure a supportive patient experience.  Experienced pharmacies can offer thought leadership as a program is being designed, implemented and optimized. 

Manufacturers benefit from specialty pharmacies with dedicated resources focused on implementation, program and account support. Implementation teams ensure that program tasks, including those involving other entities like hubs or data aggregators, are clearly defined and executed.  Account and program managers ensure strategic alignment and tactical execution of the program within the pharmacy.

6. Actionable analytics

Finally, a specialty pharmacy’s management system and reporting capabilities determine the analytics that can be delivered back to the manufacturer. For data to be actionable, it must be accurate, updated frequently and cover a range of reporting areas.  Reporting can include product and inventory analytics, call center activity, care coordination details and reimbursement outcomes. Clinical reporting, including patient-reported outcomes, may be included if clinical assessment data elements are captured in the pharmacy’s system. Experience working with data aggregators and hubs, availability of custom reporting options and report delivery options are other areas to consider when evaluating a pharmacy’s analytic capabilities.

Partnership that supports successful commercialization

Specialty drug growth shows no signs of slowing down. Manufacturers should evaluate potential specialty pharmacy partners through the lens of short- and long-term business goals and seek organizations with a track record of high-quality, patient-centric specialty pharmacy dispensing. Finding a partner who will collaborate to address the unique requirements of the patient population and the product will ensure the right fit and create a path to success.

<sup>1. IMS Health. Medicines Use and Spending in the U.S. – A Review of 2015 and Outlook to 2020. April 2016. Available online at http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2015-and-outlook-to-2020
2. 2014-2015 Economic Report on Retail, Mail and Specialty Pharmacies. Philadelphia, PA: Pembroke Consulting and Drug Channels Institute; January 2015.
3. IMS Health. Overview of the Specialty Pharmacy Drug Trend: Succeeding in the Rapidly Changing U.S. Specialty Pharmacy Market. (2014). Available online at http://docplayer.net/4230764-Overview-of-the-specialty pharmacyecialty-drug-trend.html
4. The 2018 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. Philadelphia, PA: Pembroke Consulting and Drug Channels Institute; February 2018.</sup>