A specialty pharmacy is a very specific way to provide specialty drugs to a patient population who requires complicated services and extensive care. It is a patient-focused model that may include more services than a retail pharmacy, such as:
 
  • clinical interventions
  • patient advocate support
  • patient monitoring for safety and efficacy
  • payer and/or manufacturer reporting
  • adherence management
  • communication and follow-up with the physician
  • shipping coordination
  • enrollment in patient assistance programs
  • financial assistance
  • prior authorization assistance
  • psychosocial, emotional assessment

Specialty pharmacies are seen as a reliable distribution channel for high cost medications, offering convenience to the patient and lower costs while maximizing insurance reimbursements from those companies that cover the drug. They incorporate disease state management programs and the pharmacy staff is highly trained in the treatment of many chronic diseases.

Some examples of the diseases are various types of cancer, HIV, hepatitis C, hemophilia, Crohn disease, multiple sclerosis, and rheumatoid arthritis.

Immediately upon receiving a prescription for a specialty medication, the specialty pharmacy’s health care professionals schedule a consultation with the patient to discuss their treatment plan to ensure they are comfortable with all aspects of their care. This is the first of many opportunities for patients to ask questions, learn more about their therapies, and build a rapport with the specialty personnel.

Specialty pharmacy professionals stay in contact with patients throughout their treatment, offering patient-specific care and making sure they get their medications and/or medical supplies quickly and accurately.

Specialty pharmacy has grown from a small niche market to a growing industry. Collaborating with a retail pharmacy, hospital, or drug manufacturer is becoming more popular. As a result, patient adherence and patient care is improving.

Pharmacy benefit managers (PBMs) often provide and recommend use of specialty pharmacies in their network. They can negotiate better prices and frequently offer related chronic disease services to health plans and employers.

What is a specialty medication?
Because most specialty medications are very high priced, you might think it is as simple as that; however, there is much more to it than cost. The development and use of specialty pharmaceuticals have significantly affected global health care practices and costs. Although the development of, and health care spending on, specialty drugs has increased over the past decade, there is no universally accepted definition of a specialty medication. A specialty pharmaceutical differs from other medications for many reasons.

Biologics
First, specialty medications are typically biologics—large molecular chemicals derived from living organisms or containing components of living organisms. Biologic medications include blood components, cells, allergens, genes, tissues, and recombinant proteins.

Administration
A specialty medication can be self-administered at home or may administered by a health care professional in a physician’s office, clinic, infusion center, or an outpatient hospital. They are often injectable or infused, but can also be oral or inhaled. There is no limit to the type of dosage form offered by a specialty medication.

Special Handling Requirements
Due to the molecular complexity of a specialty medication, they sometimes require special handling. When technicians or pharmacists are preparing these medications for administration, they are often required to wear protective gear such as nitrile gloves or safety goggles. The medications may also be temperature sensitive and require special handling through the shipping process such as refrigeration or freeze protection.

Limited Distribution Network
In a limited distribution network, a manufacturer contracts with one or a few specialty pharmacies to dispense medications that treat very rare diseases and require close patient supervision. The specialty pharmacies are selected based on their expertise and ability to offer optimal patient outcomes. Manufacturers want to ensure that patients receiving their medications are receiving the best possible care the pharmacy can provide.

Centers for Medicare and Medicaid Services (CMS)
For lack of a better definition, CMS Part D drug benefit defines a specialty medication as a drug with a minimum monthly cost of $670 and requires a higher cost share for the patient.

Specialty Pharmacy: A Growing Industry
The rate of increase in spending on specialty medications is outpacing by far the rate of increase in spending for other drugs. It is the fastest growing segment of drug spend under the pharmacy benefit. In the next 5 years, specialty medications are predicted to account for 50% of overall drug spending, approximately $250 billion.  

As research into rare and complex diseases continues, more specialty medications are reaching the market. In the mid-1990’s, fewer than 30 specialty medications existed, whereas there are currently more than 300 specialty drugs on the market. Currently, most drugs in the pipeline are specialty pharmaceuticals, particularly oncology agents.
The federal government has prioritized research to help patients suffering from complex and rare diseases by approving incentives, such as fast tracking and priority review, to accelerate approvals of new medications.

Conclusion
Specialty pharmacies provide a specific patient population through clinical support and medication therapy management for rare, complex diseases or illnesses. They offer many benefits for their patients such as: delivery coordination for medications which often require special handling; insurance support and verification; patient advocate programs; clinical interventions; integrated nursing staff; specialized pharmacists and other health care providers. Specialty pharmacy continues to evolve to help patients navigate the challenges of affordability and accessibility regarding their specialty medications.  

About the Author
Nicole Kruczek, RPh, MPBA
, earned her B.S. Pharmacy from Temple University, School of Pharmacy and her Masters in Pharmacy Business (MPBA) degree at the University of Pittsburgh, Joseph M. Katz Graduate School of Business, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicine. She has spent the last 10 years as a Manager, Pharmacy Operations leading a high performing team of pharmacists and technicians.