Formerly an obscure subsection of the pharmacy sector, specialty pharmacy is now an area that most health care professionals recognize. Specialty products now dominate the drug pipeline, having gained more approvals than traditional medications since 2010. Specialty medications are the major reason for increased drug spending, which is anticipated to hit $400 billion by 2020.
The National Association of Specialty Pharmacy (NASP) was founded in 2012 to support the rapidly growing specialty pharmacy industry. Without an intimate knowledge of the industry, some may ask, “What makes these specialty drugs so special?” Drugs are classified as specialty products most often due to the cost and complexity of the therapy.
NASP defines specialty pharmacy as “a state-licensed pharmacy that solely or largely provides only medications for people with serious health conditions requiring complex therapies. These include conditions such as cancer, hepatitis C, rheumatoid arthritis, HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, human growth hormone deficiencies, hemophilia, and other bleeding disorders. In addition to being state-licensed and regulated, specialty pharmacies should be accredited by independent third parties, such as URAC, the Accreditation Commission for Health Care, the Center for Pharmacy Practice Accreditation, or the Joint Commission, in order to ensure consistent quality of care.”
Specialty pharmacies connect patients who are severely ill with the medications that are prescribed for their conditions, provide the patient care services that are required for these medications, and support patients who are facing reimbursement challenges for these highly needed but also frequently costly medications.
Specialty medications have a complex profile that require intensive patient management and, in some cases, special handling. Although some are taken orally, many of these medications need to be injected or infused, at times in a physician’s office or hospital.
Specialty pharmacies provide services that include training in how to use these medications, comprehensive treatment assessment, patient monitoring, and frequent communication with caregivers and the patient’s physician or other health care providers.
The expert services that specialty pharmacies provide drive adherence and persistency, proper management of medication dosing and adverse effects, and ensure appropriate medication use. The specialty pharmacy patient-centric model is designed to provide a comprehensive and coordinated model of care for patients with chronic illnesses and complex medical conditions, achieve superior clinical and economic outcomes, and expedite patient access to care.”
The American Pharmacists Association describes specialty medications as having some or all of the following key characteristics:
Treatment of complex, chronic, and/or rare conditions.
High cost, often exceeding $10,000, with some costing more than $100,000 annually.
Availability through exclusive, restricted, or limited distribution.
Special storage, handling, and/or administration requirements.
Ongoing monitoring for safety and/or efficacy.
Risk evaluation mitigation strategy.
Although the origins of specialty pharmacy began with oral transplant and HIV therapies, most people associate medications falling into this category as injectable or infusion products. Most recently, oral oncolytics have dominated the industry with respect to new drug launches.
Specialty pharmacies are designed to manage patients with these disease states. Along with a disease state knowledge-base, these pharmacies have tools to complete the required handling, storage, and distribution of complex medications that require high-touch patient management.
The American Pharmacists Association lists some of the services offered by specialty pharmacies that go beyond the typical retail level:
24-hour access to pharmacists
communication and follow-up with the physician
dispensing of specialty pharmaceuticals and shipping coordination
enrollment in patient assistance programs
patient education and medication adverse effect counseling
patient monitoring for safety and efficacy
payer and/or manufacturer reporting
proactive patient outreach for prescription refill and renewal
prior authorization assistance
Several specialty medications belong to an exclusive or limited distribution network. This model restricts the distribution channel for a pharmaceutical product to one (exclusive) or a few (limited distribution) network of pharmacies. There are several reasons why a pharmaceutical manufacturer may choose this type of distribution model.
First, it can ensure safe distribution of high-risk medications to small patient populations. Second, it allows the manufacturer to have added control over the patient’s experience with their product.
Pharmacies who agree to the limited distribution network make promises to follow specific procedures outlined by the manufacturer to aid in patient safety, adherence, and outcomes. Examples of this may include how often outreach is made for counseling and/or order scheduling, patient education provided by the pharmacy, the type of information collected from the patient and/or prescriber, or financial assistance programs offered.
This information may be useful for manufacturers to evaluate the collected data for trends, which is made possible by working with a smaller number of pharmacies. Although specialty pharmacy medications are the minority of available drug products, they are the most costly and complex.
Specialty pharmacies have the required infrastructure to manage patients and their medications needed to treat these complex disease states.
Dimensions: Specialty Management Solutions. http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=21176. Published May 16, 2016. Accessed August 2, 2018.
Emerging Trends in the Specialty Drug Industry. Drug Topics. https://www.elsevier.com/__data/assets/pdf_file/0020/317432/Emerging-Trends-in-the-Specialty-Drug-Industry_eBook.pdf. Accessed August 2, 2018.
NASP Definitions of Specialty Pharmacy and Specialty Medications. http://naspnet.org/wp-content/uploads/2017/02/NASP-Definitions-final-2.16. Published February 24, 2016. Accessed August 2, 2018.
Specialty pharmacy: A unique and growing industry. Home. https://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry. Accessed August 2, 2018.
About the Author
Michelle Byrne earned her Doctor of Pharmacy degree from Duquesne University and is currently enrolled in the Master of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Michelle has worked in the specialty pharmacy industry for the past 9 years, starting as a clinical pharmacist and working in leadership roles within her organization. Michelle’s current role is Pharmacy Manager, Quality & Regulatory and Pharmacist-in-Charge for her site within the Specialty Operations division of her organization.