Patient monitoring through a clinical management program allows clinicians to track outcomes and provide outreach, support, and education at key intervals in a patient's therapy.
Patient monitoring through a clinical management program allows clinicians to track outcomes and provide outreach, support, and education at key intervals in a patient’s therapy.
The management of immune globulin (IG) therapy can be fraught with various complications—clinical product variations, administration considerations, patient monitoring, reimbursement challenges, and increasing data needs of all stakeholders, to name a few. Barnes Healthcare Services, with 11 locations in Georgia, Alabama, and Florida, utilizes Managed Health Care Associates’ (MHA’s) Clinical Therapy Management (CTM) program module focused on IG therapy as part of its strategy to optimize outcomes and provide outstanding service for those IG patients and prescribers.
Complexity of Immune Globulin Treatment
Intravenous IG (IVIG) is approved by the FDA for 7 indications and subcutaneous IG (SCIG) is currently approved for primary immunodeficiency. However, IVIG and SCIG are often used off-label for a variety of disorders that encompass diseases in neurology, hematology, immunology, nephrology, rheumatology, and dermatology. It is estimated that more than 150 off-label uses for IG have been reported in the literature.1 There are product factors to take into consideration when selecting IG therapy, such as volume load, sugar content, sodium content, pH, and osmolality.2 Patient factors must also be taken into account, with particular attention paid to those patients who have cardiac impairment, thromboembolic risk, renal dysfunction, anti-immunoglobulin A antibodies, or who fall into a pediatric or geriatric age range.
Adverse event management of IG therapy is essential to successful treatment, both in proactively educating patients about the potential for adverse events and in tracking and monitoring any adverse events that may occur. Tracking clinical outcomes is also an important component of an IG management program, and is a complicated endeavor, given the wide range of indications treated by IG products. Utilizing clinical software designed to address the complicated nature of IG products is a key element to a successful clinical program.
Barnes Healthcare Services
In 1909, Barnes Drug Store opened its doors in Valdosta, Georgia, with a retail pharmacy and soda shop. During the next 105 years, Barnes grew into Barnes Healthcare Services and has evolved into a complex care provider of specialty, retail, and infusion medication and ventilation services. Barnes Precision Specialty Pharmacy, an arm of Barnes Healthcare Services, aims to create better models of care for patients with chronic and complex conditions. Barnes Precision Specialty Pharmacy utilizes an integrated care team to deliver the highest quality patient care. The Barnes Healthcare focus is on optimizing patient outcomes in addition to maintaining the usual adherence-based focus prevalent in the pharmacy industry. That optimization strategy has led to Barnes growing into the second-largest primary immune deficiency IG provider in the southeastern United States. Taking care of a large census of IG patients is challenging, and therapy management software is central to providing the optimal outcomes that Barnes Healthcare Services patients require and deserve.
MHA’s Clinical Therapy Management for Immune Globulin
The IG module in MHA’s CTM program is one in a set of comprehensive modules designed by MHA Specialty Pharmacy Solutions to provide a clinical support pathway to help pharmacies enhance their specialty patient care and facilitate the collection of clinical and dispensing metrics for specialty reporting. The CTM for IG clinical pathway provides clinicians with the tools necessary to deliver consistent patient-centered care. Utilizing professionally peer-reviewed information, clinicians can use the program to conduct specific pharmacy outreaches to patients at key intervals during their IG therapy in order to provide timely education and treatment support.
The CTM program allows for individualized pharmacy patient counseling, including proactive education for patients on side effect mitigation strategies. In addition, the CTM for IG allows clinicians to track adverse events over time and record the side effect duration after each infusion to look for patterns or helpful administration tips that might lessen their frequency or intensity. Barnes Healthcare uses CTM to ensure consistent clinical care for patients. The scripted therapy-specific questions prompt clinicians to gather the right data on each patient in order to optimize the plan of care. Through integration with the pharmacy dispensing and billing system, Barnes Healthcare is able to have patient demographic information and dispensing history fed directly into the CTM for IG module, eliminating the need for duplicate entry. Once the patient follow-up is done in CTM, a simple progress note is entered in the dispensing system from a template, indicating that the patient’s clinical assessment was completed using CTM for IG.
Part of what makes a clinical management program for IG therapy so complicated is the wide range of indications that it is used to treat. MHA’s CTM for IG therapy provides comprehensive yet specific disease state pathways through assessments for immunodeficiency; neurological and muscular disorders; idiopathic thrombocytopenia; bone marrow transplant; solid organ transplant; autoimmune blistering; Graves ophthalmopathy; and neonatal alloimmune thrombocytopenia. In addition, for those indications not specifically accounted for by one of the specific disease state pathways in the IG module, there is the ability to complete a general IG assessment for the patient and to track and monitor outcomes for every indication. This allows specialty pharmacies to clinically manage and assess varied and complex indications commonly found in treatment with IVIG and SCIG therapy.
A key feature of the CTM for IG program is that it allows for standardization of the collection and reporting of clinical metrics. These metrics make it possible to easily track and monitor clinical parameters over time. Diagnosis information, treatment interval, adverse event monitoring, discontinuation information, missed work and functional assessments, and other disease-specific assessments can be collected in a standardized manner. For example, CTM provides Barnes Precision Specialty Pharmacy with the ability to track and monitor the number and type of infections a patient with immune deficiency reports, both at baseline and throughout their course of IG treatment. In addition, the number of courses of antibiotics and hospitalizations can be tracked in order to start to quantify clinical outcomes. Alternatively, a patient with a neurological or muscular condition can document changes in specific sensory and motor symptoms and determine the duration of symptom relief reported with each IG infusion.
Reporting for Immune Globulin Therapy
The ability to quickly and easily report outcomes and metrics is increasingly important for all stakeholders in specialty pharmacy. EMD Serono recently released the 10th edition of the EMD Serono Specialty Digest: Managed Care Strategies for Specialty Pharmacies. The report reviews market data on health plan management of specialty pharmaceuticals and identifies common trends across plans. The 10th edition of the EMD Serono Specialty Digest encompasses data from 91 health plans that covered over 124 million lives.3
Among the significant findings in the EMD Serono Specialty Digest, it was noted that less than 47% of plans are highly satisfied with their specialty pharmacy provider’s (SPP’s) reporting services. In addition, significant differences were found in the ratings of several metrics in how valuable the services were to the plan versus the satisfaction with the service they were receiving from their current SPP. For example, 80% of plans surveyed list measurement of adherence and persistency as a most valuable service, but only 46% were satisfied with the reporting services measuring adherence and persistency that they are receiving from their current SPP. 3
The CTM program has the potential to bridge gaps between payer expectations and satisfaction with specialty pharmacy services through its comprehensive reporting capabilities. To monitor and track adherence and persistency, CTM includes a medication possession ratio report that can be executed and sorted by payer, drug, patient, provider, or a combination of those elements. CTM also includes a proportion of days covered report for those therapies that include more than 1 drug in the treatment regimen. In addition, clinicians at the specialty pharmacy can run a missed dose report to combine patient-reported missed doses with the reason and timing of the missed doses for a multimodal approach to adherence tracking. The CTM for IG module also allows for tracking of persistency, including whether or not the patient is currently persistent and total days of persistency.
Additionally, the EMD Serono Specialty Digest indicated that 59% of plans surveyed listed the tracking of medication discontinuation as a most valuable service, while only 33% of plans were satisfied with the discontinuation reporting they receive from their current SPP.3 The CTM program includes a discontinuation report detailing first and last fill date, date of termination, reason for discontinuation, and any medication switching information. The report can also be run by provider, payer, drug, patient, or a combination of those parameters.
A further 52% of plans surveyed in the EMD Serono Specialty Digest listed the tracking of patient interventions as a most valuable service, with only 45% indicating satisfaction with the reporting of patient interventions that they receive from their current SPP.3 CTM’s reporting capabilities include an action items report that details all the interventions made for a specific patient over time. and can be run by action items that are due as well as action items that have been completed. This allows for quantification and monitoring of workload and number of interventions.
CTM for IG also offers manufacturer-specific reporting features, and Barnes Healthcare utilizes this functionality to comply with reporting agreements for IG manufacturers. All of the required data fields are populated and sent in the correct format with a click of a button, ensuring compliance with pharmaceutical reporting requirements. CTM for IG is just one strategy that Barnes Healthcare Services uses to manage a complex therapeutic category and work toward optimal patient outcomes and excellent customer service to all stakeholders. SPT
The above information is a selective summary of publicly available information and is accurate as of the date of writing. Please consult the sources for complete reference information. The views expressed in this article are those of the authors alone and not of Managed Health Care Associates, Inc, or Barnes Healthcare Service.
About the Authors
John Ford, RPh, BCNSP, joined Barnes Healthcare in 2006 as a pharmacist and has since held several positions including pharmacy manager, director of infusion services, director of pharmacy services, and his current position, vice president of clinical services. He has 24 years of experience in hospital, retail, home infusion, and outpatient oncology infusion settings, and is a member of the American Society for Parenteral and Enteral Nutrition, the National Home Infusion Association, and the National Association of Specialty Pharmacy, where he serves on the membership committee. As vice president of clinical services, John leads the clinical team at Barnes Healthcare, a regional complex care provider of specialty, infusion, and ventilation services in Florida, Georgia, and Alabama. In addition, John oversees the clinical initiatives of Barnes Precision Specialty Pharmacy.
Stacey Ness, PharmD, RPh, CSP, MSCS, AAHIVP, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence, and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, National Association of Specialty Pharmacy, Specialty Pharmacy Certification Board, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a certified multiple sclerosis specialist, a credentialed HIV pharmacist, a Certified Specialty Pharmacist, and currently serves as the director of specialty clinical services at Managed Health Care Associates, Inc, a health care services organization based in Florham Park, New Jersey.