The Evolving Specialty Marketplace
Trends that affect how pharmacies do business
by Joseph Morse, President and COO, Therigy
The world of specialty pharmacy is continually changing and growing. Accreditation has become a common occurrence, with payers requiring specialty pharmacies to be accredited by one of three key organizations — ACHC, The Joint Commission or URAC. In recent years, the trend has shifted from ACHC toward URAC accreditation since payers want providers aligned with their own accreditation.
The government’s programs are resulting in greater integration of services among health systems, physicians and specialty pharmacies. As of July 2012, 89 new accountable care organizations had entered into agreements with the Centers for Medicare & Medicaid Services. By doing so, these ACOs take responsibility for the quality of care they provide to Medicare patients in return for the opportunity to share in savings realized through high-quality, well-coordinated care. The number of ACOs is certain to grow in the future and result in greater integration of the specialty pharmacy services.
Medications, their means of administration and the complexities of treatment also continue to have an impact on specialty pharmacies. This year saw the introduction of some exciting, new drugs.
One example is Krystexxa for refractory chronic gout. “Since there’s a high degree of anaphylaxis with this intravenous drug, it requires a lot of support and must be administered in a health care setting where allergic reactions can be treated,” says Todd Weber, managing partner at Specialty RN Source. “The drug isn’t very well-known, but it’s pretty much the only therapy available for patients who have exhausted all other options and still have high uric acid levels.”
Benlysta, the first new treatment for patients with lupus in 50 years, also made its debut. Typical treatment for lupus has included the use of steroids, anti-inflammatories and anti-malarial drugs to target and control symptoms. Benlysta, a B-lymphocyte stimulator-specific inhibitor administered via IV infusion, affects the survival of B cells. “Since the potential for anaphylaxis exists with this drug, it is given in a physician’s office or other supervised setting,” explains Kathy McKay, RN, BSN, director of nursing with Specialty RN Source. “Once the patient is stabilized on therapy and tolerance is known, the physician may approve infusions at home.”
In May 2012, the FDA approved Elelyso for long-term enzyme replacement therapy for adult patients with Gaucher’s disease Type 1, a rare genetic condition. This medication is manufactured through recombinant DNA technology using a plant-cell-based process, specifically carrot plant root cells. Elelyso is administered via IV infusion over one to two hours every two weeks.
Within the next year or so, Biotest Pharmaceuticals hopes to introduce Bivigam, a polyspecific immunoglobulin for the treatment of antibody deficiencies. In August, the U.S. Food and Drug Administration raised no questions on the clinical efficacy and safety of the ready-for-use 10 percent solution, stabilized by glycin. Biotest is currently planning a new, additional validated test system for the detection of thrombogenic activity.
The impact of new drugs on specialty pharmacies
Biotech and specialty drugs such as these increasingly require infusion by a nurse clinician. In response, some specialty pharmacies have begun expanding their infusion capabilities and services by establishing or expanding their specialized infusion nursing capabilities.
This only makes sense because the marketplace has and will continue to reward those pharmacies that become best-in-class for a specific disease state. Manufacturers want the greatest competency to manage drugs in patients. Physicians need the knowledge and services pharmacies provide to help manage these patients. PBMs are also relying on specialized pharmacies, as evidenced by a recent RFP sent out by a national PBM for an oncology-specific network comprised of best-of-class pharmacies.
While opportunities for established specialty pharmacies continue to grow, so does the number of competitors. In some cases, health care companies with pharmacies and an infusion division are expanding the infusion division or spinning it off. Some entrepreneurs who sold pharmacies several years ago are re-entering the market now that their non-competes have expired, increasing the number of specialty pharmacies nationwide.
With so many choices, manufacturers are challenged to figure out how to differentiate pharmacies, tier them to qualify them and align their product needs with the capabilities of pharmacies. Accreditation is often a key criterion they use.
That takes accreditation from an option to a necessity. As a part of accreditation, pharmacies must have a systematic therapy management program to assess patients who self-administer meds. To meet patients’ holistic needs, specialty pharmacies must expand nursing in the home and better coordinate the continuity of care with prescribers. Technology will play a key role as specialty pharmacies advance the management of specialty therapies.
Mobile devices are now commonplace with all socioeconomic and age groups, enabling direct communication via texts and emails to promote drug education on side effects and compliance. Better customer support, as well as the timing and delivery of medications, will grow in the future with the advent of new ways of using these devices.
In addition, pharmacies will rely more on technology to reduce capital and operating expenses by leveraging cloud-hosted system application models such as therigySTM. Through these means, pharmacies will be able to provide more effective, higher-quality patient therapy without investing in expensive hardware.
The need for additional certifications
While accreditation is essential for specialty pharmacies, additional certifications for clinical staff members may also be required. The newly formed Immunoglobulin Nursing Society (IgNS) is on track to develop a certification program for immunoglobulin administration and the management of patients receiving therapy. This past August, IgNS held its inaugural meeting to advance the knowledge and skills of nurses and other health care professionals in the clinical practice of Ig therapy. Their goal is to develop the standards of care and best practice guidelines for a nationally recognized certification program.
As McKay states, “Immunoglobulins are used to treat a diverse group of patients and disorders, so nurses require a specialized and expanded knowledge base and skill set. A certification program ensures that a clinician has met core educational requirements and possesses the skill and practices according to the standards of care. As new and more specialty infusion therapies emerge, we may see additional certifications emerge as well.”
However, nurses may not be the only professionals who’ll need new certifications. In March of this year, the Board of Pharmacy Specialties announced it would be conducting delineation studies in cardiology and infectious diseases. If the studies provide information suggesting these two areas should be recognized as specialty practices in pharmacy, BPS will issue a call to the profession for a petition for new specialty recognition. The process leading to the administration of a certification exam will take approximately three years to complete.
In May, BPS completed a review of role delineation studies of critical care pharmacy and pediatric pharmacy and decided enough evidence exists to warrant petitions for BPS consideration of these two areas as possible pharmacy specialties. It plans to double the number of specialties for which pharmacists can become BPS board-certified by 2016.
In August, the Specialty Pharmacy Certification Board announced it had contracted with SeaCrest Company to launch a new professional certification program for specialty pharmacists. The Certified Specialty Pharmacist credential will validate pharmacists’ expertise in all specialty pharmacy practice settings. The group also plans to develop therapeutic category subspecialty “endorsements” that will require additional assessment testing once a pharmacist has been certified, as well as differentiated certifications for nurses and other health care professionals.
Specialty pharmacy is the fastest-growing segment of the industry, and with the aging of America and a plethora of drugs coming to market, the forecast is for continued, rapid growth. However, challenges do exist, from increased competition to the need for differentiation to finding new ways of doing business better and more economically. To prosper, specialty pharmacies need to move now to prepare for the days ahead