The Specialty Drug Opportunity


What community pharmacies need to know.

October 28, 2015

With spending on specialty medications now accounting for one-third of total prescription drug spending,1 and projected spending estimated to top $400 billion by 2020,2 it's no wonder that specialty Product Access Sidebardrugs are top of mind for every healthcare stakeholder. As more and more highly targeted and high value medications are introduced into the marketplace (the development of which has been driven by federal actions such as the Precision Medicine Initiative3), the pharmaceutical world is seeing two things: a continued shift to a narrower, more personalized approach to treating specific patient populations with rare conditions, and treatment of more common chronic conditions with new groundbreaking drugs. For example, according to U.S. News and World Report, more than 15 million people with a history of heart disease could qualify for treatment with one of two new injectable cholesterol drugs that are currently in the pipeline.4

What does this mean for community pharmacy? Specialty drugs are forging an evolution in the way we look at prescription drugs - and the way we look at the pharmacist's role in dispensing these drugs and caring for the patients who take them. Pharmacists, with deep roots in their community, have the potential to offer unmatched continuity of care for patients being treated with specialty therapies.

While specialty pharmaceuticals create a new opportunities for community pharmacies who may want to expand their therapeutic reach in caring for patients with chronic diseases, it also requires a deliberate approach that balances the needs of the pharmacy's patient population with the therapies the pharmacy is equipped to manage. Insight into this opportunity begins with a better understanding of what constitutes a specialty drug, the complex conditions they are used to treat and important considerations for when and how specialty drug dispensing can be incorporated into a community pharmacy setting.

What is a specialty drug and what does the future look like for the conditions they treat?
While there is no universal definition for a specialty drug, IMS Health defines specialty pharmaceutical products as having at least five of the following eight attributes: Biotech product; Injectable formulation; REMS program; Treats a chronic condition; Specialist-initiated; Requires special handling (cold-chain); Costs in excess of $6,000 per year; Limited distribution.5 Each of these attributes lends their own unique consideration for the community pharmacy.

According to IMS, the drug research and development pipeline has shifted to specialty medicines over the past decade, with 42 percent of the late stage pipeline now specialty.6 In 2014, the FDA approved 27 specialty drugs, an increase from 2013 and 2012 when there were 19 and 22, respectively. The current drug pipeline, encompassing both traditional and specialty medicines, indicates that cancer and diabetes will remain top targets for innovation in drug development.7

Specialty drug dispensing in the community pharmacy setting.
For retail pharmacies, specialty drugs can create opportunities for the continuity of care for existing patients, but there are multiple considerations that must come into play before determining how specialty fits into an existing business. Realizing the inherent growth opportunities in the specialty market also means understanding and preparing for the unique requirements of specialty therapies. Considerations for pharmacies looking to expand further into specialty include:

  • Identifying where the pharmacy can make the most impact. Pharmacists should take a look at the unique health needs of the communities they serve and find areas where they can provide needed support to either existing patients or potential patients, or where they can leverage relationships with providers. Then focus efforts on these key therapeutic areas and build a clinical value proposition for the pharmacy's specialty offering, establishing the pharmacy as a destination of support for patients within a specific disease state. A key to success in specialty dispensing includes developing an access strategy to match both business model and therapeutic focus, which may include access to payer contracts. Where limited distribution products are prescribed , partnering with an existing specialty pharmacy might be necessary to ensure timely access to therapy.
  • Planning for high-touch patient services. Pharmacies should consider the potentially intensive patient supervision and counseling required to ensure patient safety, medication adherence and quality outcomes for patients on specialty therapies. Before beginning therapy, patients must be educated on self-administration, proper storage and the importance of adhering to complex regimens. Throughout the course of treatment, pharmacies should plan for efficient, proactive, on-going communication with patients to ensure safety and to immediately address any concerns. Providing clinical access to pharmacists and care coordinators and planning for phone based counseling all needs to be balanced.
  • Heightening expertise. Being a reliable expert for patients with specific disease states builds on the trust community pharmacists are known for. Leveraging and maintaining knowledge and training on conditions of focus is essential, as is including all appropriate staff in that effort. Additional nursing staff may be required for proactive patient education, adherence and side effect management along with counseling when patient care challenges arise.
  • Coordinating insurance benefits. Workflows need to be in place for insurance benefit verification and reporting requirements for specialty therapies. This includes reviewing a patient's insurance to ensure coverage of a prescribed specialty drug and coordinating with both the prescriber and plan to approve prior authorization requirements. Standards also need to be in place to address the potential reporting requirements from the manufacturer and the payer.
  • Developing an adherence program. Every patient, every medication and every treatment regimen is different. Contributing to therapeutic success demands developing, implementing and managing adherence programs that can keep patients on their care path for the extent of their journey. Part of getting a patient on therapy and keeping them on therapy is ensuring the patient can afford their medication. This is particularly critical, as a high-cost drug can sometimes force a patient to choose between their mortgage and their medication. As a result, patients may require assistance in securing reimbursement. It is critical that pharmacies have knowledge of financial assistance programs, including available manufacturer sponsored co-pay programs and foundation-based patient assistance programs that can make all the difference in a patient's ability to stay on therapy. Third party services are available to pharmacies seeking additional support in preventing script abandonment.
  • Making infrastructure investments. The pharmacy should prepare for potential operational investments, such as equipment or temperature-controlled storage space to support the unique requirements of certain specialty drugs. This also includes planning for new systems or system enhancements that help ensure prior authorizations are in place and meet and deliver on all data requirements.

Specialty drugs - the future of pharmacy?
Community pharmacies are uniquely positioned to provide greater access to vital medications for patients in their communities. Perhaps more than any other healthcare provider, pharmacists have long been at the forefront of managing a patient's medication and therapeutic experience. Inherent drug education and payer interaction, coupled with unequivocal access, positions community pharmacies as a foremost care provider in the delivery of specialty therapies. If specialty drugs are the future of pharmacy, pharmacies can become an integral part of the delivery of specialized care in every community.

1 Johnson, S. R. (2015, April 14). Specialty drugs, Medicaid expansion drive jump in prescription spending. Modern Healthcare. Retrieved August 10, 2015.
2 Barrett, P., & Langreth, R. (2015, June 3). Pharma Execs Don't Know Why Anyone Is Upset by a $94,500 Miracle Cure. Retrieved August 10, 2015.
4 Sternberg, S. (2015, July 6). Groundbreaking specialty drugs come with high costs. Retrieved August 10, 2015, from
5 Succeeding In The Rapidly Changing U.S. Specialty Market. (2014). Retrieved August 17, 2015.
6 Keshavan, M. (2015, April 14). Specialty Drugs Driving up the U.S. Medication Spend. Retrieved August 17, 2015 from
7 Buffery, D., Specialty Drugs Top the Trends in the 2014 Pipeline, American Health & Drug Benefits, (March 2014) Retrieved August 17, 2015

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