Matthew Deans

Specialty infusion pharmacy should be thought of in terms of superlatives, such as most complex and highest cost. From its origins as the first specialized practice of pharmacy, specialty infusion pharmacy has evolved to serve a distinct patient profile within the overarching umbrella that is specialty pharmacy.

Patients who receive care either through specialty pharmacy or specialty infusion pharmacy share a number of characteristics, such as having complex conditions treated with high-cost and complicated medications that require close clinical monitoring. However, it is specialty infusion patients who tend to have conditions that require multidisciplinary health care services.

Infused or injected medications are among the most complicated and often have the most specific management requirements, which include not just product distribution but management of the therapy administration as well. Specialty infusion drugs are distinct because they often require health care professional administration by clinicians with disease and product expertise. Infused therapies are among the costliest medications in the specialty drug category, which comprised 33% of overall drug costs in 2015.

And the differences go further. Specialty infusion pharmacy is distinct because many new specialty medications are biologics, meaning they are large-molecule medications that require injection or infusion. Additionally, many of these medications require protocols and expertise in the management of hypersensitivity or anaphylactic reactions.

Due to their extreme complexity and cost, specialty infusion drugs require highly specialized services and management for patients to achieve their therapy goals. Delivering these services safely and effec- tively requires seamless, personalized clinical care provided by multidisciplinary teams. The ability to provide expert-led, individualized treatment plans in the home and at alternate treatment sites is what makes it possible for patients, payers, manufacturers, and health care systems to use specialty infusion therapy to achieve optimal outcomes while controlling costs.

Due to the need for expanded health care services beyond medication dispensing, specialty infusion pharmacy is more likely to be covered by private payers under the medical benefit rather than the pharmacy benefit, which is another important distinction from noninfusion specialty pharmacy therapy.

In many cases, when patients are discharged from the hospital, they are responsible for independently following any discharge orders they receive, refilling prescriptions and scheduling follow-up appointments with their physicians. Often, they receive little to no proactive care, save perhaps a follow-up call from the hospital to ask whether they have any questions or concerns.

Alternatively, specialty infusion patients who transition from the hospital or other outpatient site of care to home infusion are admitted on service by a specialty infusion provider who oversees their care. Operating similarly to a hospital without walls, a high-quality specialty infusion provider ensures that patients receive seamless continuity of care in the comfort of their home or an alternate infusion site.

To ensure comprehensive and highly customized clinical management, the patient’s home infusion care team—including a care transition nurse, pharmacist, infusion nurse, and, for patients receiving clinical nutrition, dietitian&mdash;meets to review the medication profile, treatment plans, medication-specific protocols, patient comorbidities, and therapy goals. They collaborate with the patient and their caregivers to create an individualized care plan, beginning with education and training to fully explain the process while determining the level of assistance required.

Therapy management includes on-demand and/or dose-administration training visits, as well as collection and review of patient treatment outcomes data. High-quality home infusion providers offer 24/7 access to care, with the ability to speak with a pharmacist or nurse as needed, even at 3 am when the intravenous pump starts beeping or the patient feels ill.

Effective transitions and maintenance of specialized care reduce hospital readmissions, which is of ongoing importance to hospitals, payers, and patients, in terms of quality care and costs.

 Health care systems are increasingly recognizing the value of transitioning patients from the hospital to quality home infusion care, which maintains their reach and level of engagement within the community.

While many specialty pharmacy companies contract with nursing agencies to provide care in the home when needed, most specialty infusion providers retain their own multidisciplinary teams of clinicians, including pharmacists, nurses, and dietitians trained in infusion therapy management who follow best practices with consistent processes. These clinicians work closely with the patient’s doctor and other providers to communicate information regarding the patient’s health status and to coordinate changes in medication dose and other care as needed.

For example, Option Care’s specialized hereditary angioedema (HAE) therapy program helps patients with the condition avoid traveling to the emergency department (ED) to treat attacks of severe swelling. When patients call Option Care during an attack, a specially trained nurse travels to the home to provide therapy. The nurse tracks the patient’s response to therapy, determining how long an attack takes to subside, and closely watches for any sign of an anaphylactic reaction. Option Care’s registered nurses are highly trained in HAE to distinguish between an allergic reaction to a medication and a worsening HAE attack that requires treatment with a second dose. All information is reported to the physician, who adjusts the subsequent doses as neces- sary and directs the nurse to administer a second dose if needed.

A study of 158 HAE patients who had 1177 home nursing visits to treat attacks determined that the average response time from the patient’s call to the nurse arriving at the house was 64 minutes, and 76.4% of patients only needed 1 dose of a subcutaneous injection of ecallantide.4 In addition to the quality-of-life benefits, the cost savings of home injection of ecallantide are significant compared with the alternative of receiving care in an ED. Researchers calculated the cost savings of 258 home nurse visits to treat an attack and preventing ED visits as a savings of $632,874 to payers.

Nurses drive the quality of care in providing complex therapies and engagement with patients facing conditions that are treated with specialty infusion therapies. Even in the case of patient-administered injectable or infused medications, a high level of support is required to ensure that patients are following directions, are compliant with the ordered therapy, titrate doses if necessary, and manage other issues. For example, patients with amyotrophic lateral sclerosis can self-infuse edaravone after being appropriately trained by an infusion nurse; however, because medication is provided cyclically over 10 to 14 days, followed by a 14- to 18-day rest period each 28-day period, patients have intravenous access needs that require personalized clinical home care.

Specialty infusion also requires expertise in sterile compounding and in the storage and handling of a variety of complex infused and injectable medications. From patients to payers, stakeholders should ensure that their specialty infusion pharmacy providers have the highest level of independent accreditation, such as URAC specialty pharmacy accreditation. This certification ensures safe, high-quality care, and processes that lead to better patient out- comes. Compounding pharmacies should be independently accredited—for example, by the Pharmacy Compounding Accreditation Board, a service of the Accreditation Commission for Health Care&mdash;ensuring that they meet and keep pace with the most rigorous stan- dards as determined by the US Pharmacopeial Convention guidelines.

An example of a medication that requires high-level clinical management and support is Blincyto (blinatumomab), an infused immunotherapy for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia. It requires both precise compounding in a sterile clean room and careful support during treatment. Infusion is started in the hospital for the first 9 days of the first cycle and the first 2 days of the second cycle. For the next 19 days of the first cycle and 26 days of the second cycle, the medication may be infused in the patient’s home. During treatment, the infusion is continuous and, if it is stopped for more than 4 hours at any point, the patient is at risk for hospital readmission. Understandably, many physicians prefer to work with any of the manufactur- er’s limited distribution home infusion providers to ensure high quality of care.

As a limited distribution provider of Blincyto, Option Care creates customized care plans that include working closely with the referring provider to determine the specific set of services each patient requires, clearly establishing responsibilities of various team members (from specialty infusion to cancer specialists) and providing the patient with education and support before they leave the hospital. Option Care staff receive specialized training on managing patients who receive Blincyto, and they take regular refresher courses to keep current with the latest product-specific information. In addition, Option Care reports all adverse events (AEs) to the drug manufacturer, and both teams meet routinely to analyze and discuss any emerging trends. The benefits of this principled partnership are clear, with the ability to collect data at the point of care—such as the percentage of patients completing their ordered Blinctyo treatment cycles&mdash;contributing to both clinical and quality management.

The ability to mitigate and manage costs through various means in the extremely expensive world of specialty infusion pharmacy is essential. Customized and comprehensive clinical care leads to good outcomes, which translates into cost savings in a number of ways, including prevention of AEs and readmission to the hospital.

The level of care provided via specialty therapy programs ensure good outcomes, which lower costs. For example, Option Care's nutrition therapy program includes the administration of Gattex (teduglutide) for select patients with short bowel syndrome (SBS) to increase gastrointestinal absorption of nutrients. Close clinical management confirms that the therapy is as effective as possible, helping patients reduce their dependence on parenteral support.

The results of a study presented at the American College of Gastroenterology’s annual scientific meeting in 2015

 regarding patients with SBS demonstrated that those who were administered home-infusion services with parenteral support and Gattex in a closely monitored home-care setting tended to have reductions in the number of days per week that infusions were required; some patients had complete independence.

Findings such as these help manufacturers validate successful outcomes and demonstrate the value of these costly therapies in the real world, when the therapies are supported by high-quality clinical care. The care provided by the specialty infusion provider features regular patient assessment, education, and follow-up, which includes routine visits by skilled nurses, patient monitoring by a nutrition team, and patient oral intake guidance offered by dietitians. Also of note are the cost savings due to reduction in need for parenteral nutrition support, an extremely expensive therapy.

Clearly recognizing its value, payers seek to drive patients requiring specialty infusion to low-cost home care rather than hospitals, the setting of highest cost.

 The qualifier here is “high-quality home care,” as demonstrated through accreditation and outcomes. Although payers understand the cost benefits, the savings are for naught if home infusion is not managed by a high-quality provider and leads to a costly infusion-related AE.

The benefits of home infusion of specialty medications are many. Patients prefer receiving care in the comfort of their home. Health systems and health care providers are grateful for the assurance that discharged patients continue to receive comprehensive care that helps increase compliance and prevent hospital readmission. Manufacturers appreciate that costly, complex specialty medications are administered and managed by highly skilled clinicians. Payers know their patients are getting excellent care at the lowest cost.

Specialty infusion pharmacy services are an important component of specialty pharmacy. Whether you are a professional representing a payer, health system, or drug manufacturer, specialty infusion pharmacy services can deliver meaningful value to you and your patients, optimizing access, improving outcomes, and reducing costs. 

Express Scripts Lab. Express Scripts 2015 

https://lab.express-scripts.com/lab/drug-trend-report

Min S-J. The care transitions intervention: results of a randomized controlled trial.

Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial.

Assessment of home infusion program for treating nonlaryngeal hereditary angioedema attacks. 

Kennedy S, Curry K and Ford D. Implementation and assessment of a hereditary angioedema home infusion program. Poster presented at the National Home Infusion Association Annual Conference and Exposition; 2012 April 23-25; Phoenix, Arizona.

Petruccelli K, Youssef N., LI B, Curry K. Teduglutide treatment in adult patients with short bowel syndrome (SBS): initial clinical experience of management through a specialized infusion pharmacy (SIP) service. Poster session presented at: the American College of Gastrenterology’s (ACG) 80

Annual Scientific Meeting; 2015 oct. 16-21; Honolulu, HI.

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Specialty infusion pharmacy should be thought of in terms of superlatives, such as most complex and highest cost.