Précis
An infusion and specialty clinical pharmacist is a valuable integrated member of the health care team as demonstrated by cost avoidance and high satisfaction reported by both veterans and specialty providers.
Purpose
Demonstrate the impact of an infusion and specialty clinical pharmacist (ISCP) utilizing cost avoidance and satisfaction of services.
Methods
Cost avoidance was measured by totaling local and national conversion initiatives as well as intravenous immunoglobulin (IVIG) and tafamidis (Vyndamax; Pfizer) dose optimizations for fiscal year (FY) 2023 (October 2022-September 2023) and the first half of FY 2024 (October 2023-March 2024). Satisfaction with the ISCP services was assessed via veteran and specialty provider questionnaires, which consisted of Likert scale items, yes/no responses, and open-response questions. Veterans and providers were invited to participate in the questionnaire via email, SMS text messaging, or phone.
Results
Cost avoidance was calculated from 10 conversion initiatives and 2 medication dose optimizations. A total of 148 conversions were completed in addition to 5 IVIG and 2 tafamidis dose optimizations. The total annual projected cost avoidance was over $1.3 million. Veteran response rate to the questionnaire was 58.5% (79/135); 89% of those who responded were satisfied with the clinical attributes of the ISCP. Provider response rate was 89.5% (17/19); 88% of those who responded reported being “very satisfied” with clinical attributes of the ISCP. Regarding clinical experience, 94% of providers reported being “very satisfied” or “somewhat satisfied” with the ISCP’s clinical experience.
Conclusion
The ISCP is a key member of the specialty team, a determination based on projected cost avoidance and high satisfaction expressed by both veterans and specialty providers. The results support the value of ISCP positions in VA and private sector specialty clinics.
Introduction
Specialty medications, which are high-cost pharmaceuticals used to treat chronic medical conditions, require continuous monitoring and clinical oversight. They typically involve injectable or intravenous administration and may have complex storage requirements. In 2020, specialty medication expenditure in the United States was $265.3 billion, which accounted for almost 50% of total pharmaceutical expenditure for that year.1 Specialty pharmacist interventions have therefore become instrumental in medication optimization and cost avoidance.
Results of a study that evaluated pharmacist impact on the cost of specialty medications showed that 34% of pharmacist interventions could be directly associated with over $1.5 million in cost savings over 5 months.2 For example, intravenous immunoglobulin (IVIG), with a low volume of distribution, can be dosed utilizing ideal body weight (IBW) rather than actual body weight (ABW), and a 5-year retrospective analysis of 2564 patients receiving IVIG demonstrated $3.9 million in annual medication cost avoidance.3
Implementation of infusion specialty clinics can improve patient outcomes and facilitate interdisciplinary collaboration, study results have shown.1 In a 2022 American Society of Health-System Pharmacists (ASHP) survey, specialty providers reported that infusion and specialty clinical pharmacists (ISCPs) played an integral role in initial therapy selection, changes in therapy, and development of treatment algorithms.4,5 Veteran satisfaction with specialty medication services has not been noted in the literature; however, results of an ASHP provider survey showed that 43% of providers frequently or always collaborated with an ISCP to discuss treatment selection.5
Methods
The ISCP position at Veterans Affairs Maine Healthcare System (VAMHCS) was established in April 2022 to provide specialty medication management and recommendations in specialties such as rheumatology, dermatology, gastroenterology, pulmonology, neurology, and otolaryngology. The ISCP, with a scope of practice, reviews all specialty medication nonformulary requests and provides initial education and follow-up visits at 1-, 3-, and 6-month intervals after therapy initiation. In addition, the ISCP tracks high-cost medication use and prescribing practices to make recommendations based on current clinical literature for conversion initiatives and dose optimizations. The ISCP also implemented process improvements utilizing Lean Six Sigma tools, which have helped prevent medication order entry and dispensing errors.
At VAMHCS, the ISCP closely collaborates with specialty providers, veterans, and the outpatient and inpatient pharmacy departments. Specialty medication education is essential because patients often have multiple associated comorbidities such as pain, disability, and fatigue.6 Medication education is affiliated with increased adherence and improved treatment outcomes, which can prevent disease progression and the need for more costly alternatives.5 The primary objective of this quality improvement (QI) project was to assess the impact of the ISCP at VAMHCS through analysis of cost avoidance and satisfaction of services. This QI project was approved by the VA’s Office of Research and Development and monitored by the VAMHCS Privacy Office.
Cost Avoidance: Conversions
The ISCP’s impact on cost avoidance was evaluated by retroactively compiling completed local and national conversion initiatives and IVIG and tafamidis dose optimizations. To complete these conversions, the ISCP utilized the US Department of Veteran Affairs pharmacoeconomic dashboards, prescription dispensing reports, and pharmacy- and therapeutics committee–approved medication use evaluations to identify eligible veterans. Each veteran’s electronic medical record (EMR) was reviewed to determine whether it was appropriate to convert to the preferred medication with a similar mechanism of action and safety profile (Table 1). They were excluded if found to have a contraindication to or prior trial of the preferred medication. Buy-in from both the providers and veterans was obtained, and veterans were educated on the change in medication by the ISCP and called for follow-up at 1- and 3-month intervals.
Specialty providers continued to monitor the veterans’ disease state in addition to the ISCP’s medication management. After successful conversion, the projected annual cost avoidance was retrospectively obtained using descriptive statistics by calculating the acquisition cost difference of the 2 specialty medications. The total number of conversions and associated cost avoidance were tracked for fiscal year (FY) 2023 (October 2022-September 2023) through the first half of FY 2024 (October 2023-March 2024) (Table 2).
Cost Avoidance: Dose Optimizations
IVIG is used to treat a number of conditions including immune deficiency, chronic inflammatory demyelinating polyneuropathy, and myasthenia gravis and was identified as a potential medication for dose optimization due to its low volume of distribution and ability to be dosed based on IBW vs ABW.3 ASHP conducted a retrospective study on the correlation of IVIG dose and serum immunoglobulin G (IgG) levels with 3 weight-based dosing methods, and the results determined that the dose of IVIG and the change in IgG levels correlated the strongest with IBW.7
Using ABW in patients with obesity or overweight can significantly increase the IVIG dose. In 2015, there was another retrospective study that determined patients with obesity (body mass index > 30) receiving IVIG could be dosed relative to their lean body equivalent without affecting outcomes.7,8 These cost avoidance opportunities were again identified through prescription dispensing reports as well as review of the veteran’s EMR (Table 2). For example, a veteran with an ABW of 70 kg and an IBW of 50 kg correlated to a 20-g dose difference and a $1160 difference in cost per dose.
Tafamidis (Vyndamax; Pfizer) is a specialty oral medication approved to reduce cardiovascular mortality and related hospitalization in those with transthyretin-related familial amyloid cardiomyopathy. The phase 3 ATTR-ACT trial (NCT01994889) was a 30-month randomized control trial that compared the safety and efficacy of both tafamidis 20 mg/day and tafamidis 80 mg/day vs placebo. Both treatment groups had significantly greater transthyretin stabilization compared with placebo. The 80-mg/day dose was associated with a higher mean transthyretin concentration than the 20-mg/day dose; however, the clinical significance of this is unknown. When compared with placebo, both treatment groups were found to significantly reduce all-cause mortality and cardiovascular-related hospitalizations.9
At VAMHCS, the ISCP informed eligible veterans of the dose decrease from tafamidis 61 mg or 80 mg daily to 20 mg daily; the veterans continued to be monitored by cardiology. The acquisition cost of the 20-mg capsule was approximately $10,500 less per patient per 30-day supply than the 61-mg or 80-mg daily dose, and this was added to the direct cost avoidance associated with dose optimizations.
Veteran Satisfaction
Veterans who had face-to-face, phone, or video appointments with the ISCP from April 2022 through February 2024 also received the satisfaction questionnaire. Veterans must have been prescribed a specialty medication through at least 1 of the following specialties: dermatology, gastroenterology, neurology, pulmonology, rheumatology, or otolaryngology. Veterans were sent the questionnaire retrospectively, and the time between the initial appointment with the ISCP and when they received the questionnaire could have been as long as 22 months. In total, 135 veterans were included to receive the satisfaction questionnaire; the Qualtrics platform was utilized for questionnaire distribution. Qualtrics is a customer experience management platform that focuses on collecting, organizing, and understanding important data relative to customers and employees. VA has a Qualtrics account that is validated by the VA’s privacy office and information technology support.
A 12-item questionnaire was developed to assess overall veteran satisfaction with their experience with the ISCP at VAMHCS. The questionnaire was carefully worded to avoid feedback on processes and policies, which was not the intent of the evaluation. At the beginning of the questionnaire, there was a disclaimer expressing that participation would not affect future care in any way. There were 7 Likert scale items, 2 yes/no responses, and 3 open-response questions. The 7 Likert scale items were ranked from very dissatisfied to very satisfied. Yes/no responses included: “If a problem were to arise, I would feel comfortable contacting the infusion and specialty clinical pharmacist,” and “I use my medication(s) more appropriately after speaking with the infusion and specialty clinical pharmacist.” Open-ended questions included: “What did the infusion and specialty clinical pharmacist do well?” “What can the infusion and specialty clinical pharmacist do to improve?” and “Please share any additional information about your experience.”
Eighty-four of the veterans received the questionnaire via email and the remaining veterans, who did not have an email address readily available, were contacted via phone. Veterans’ cell phone numbers and emails were extracted via chart review and tracked in a Microsoft Excel spreadsheet, which was imported into Qualtrics. Veterans received an initial email and cell phone text (if provided in the chart) from the Qualtrics platform inviting them to complete the online questionnaire. Reminder emails and texts were sent weekly for 3 weeks. Those who did not have an email or cell phone listed in their chart were contacted on their home phone. The questionnaire items were read verbatim and tracked via Microsoft Forms. There was 1 health care team member (not an ISCP) who collected verbal responses from veterans via phone. Personal calls were made to veterans who had initially received the Qualtrics email and/or text message but had not responded. The questionnaire was open for response collection from veterans from November 30, 2023, to March 14, 2024.
Provider Satisfaction
The ISCP works closely with providers from multiple specialties at VAMHCS. To obtain provider feedback, an electronic questionnaire was developed using Microsoft Forms. The questionnaire consisted of 9 Likert scale items and 4 open-response questions. The wording was carefully selected to avoid feedback on processes and policies, which was not the intent of the evaluation. At the beginning of the questionnaire there was a disclaimer expressing that participation would not affect the professional relationship with the ISCP. Nineteen specialty providers were sent the questionnaire link via VA Microsoft email. The questionnaire was open for response collection from providers from November 30, 2023, to December 1, 2023.
Results
Cost Avoidance
The ISCP’s impact on direct cost avoidance was totaled from the cost conversion initiatives as well as IVIG and tafamidis dose optimizations. Four conversion groups had 1 preferred and 1 nonpreferred medication (asthma, parathyroid in women, migraines [Botox or tablets]). Two groups had a preferred, secondary preferred, and tertiary preferred option (chronic idiopathic constipation and migraine injectables). Lastly, the psoriasis conversion had 4 therapeutic options (preferred, secondary preferred, tertiary preferred, and nonpreferred) (Table 1). A total of 148 conversions were completed from FY 2023 through the first half of FY 2024, resulting in $946,903 projected annual cost avoidance. Dose optimizations were completed for 5 IVIG and 2 tafamidis patients, adding $380,325 to the projected annual cost avoidance. The total annual projected cost avoidance from conversion initiatives and dose optimizations was $1,327,228.
Veteran Satisfaction
The overall questionnaire response rate for veterans was 58.5% (79/135). Thirty-six responses were obtained via phone and 43 responses via Qualtrics (Table 3). Of the respondents, 89% reported that they were satisfied with the clinical attributes listed on the questionnaire (overall experience, accessibility, responsiveness to questions, professional demeanor, communication, and effectiveness of follow-up calls). There may have been a confounder as 1 veteran selected “very dissatisfied” for each clinical attribute. However, in the open-response section, the veteran noted that “she did great, much appreciated service, felt like she respected me!!”
Veterans (100%) reported they would feel comfortable contacting the ISCP if a problem were to arise. Nearly all (99%) reported using their specialty medications more appropriately after speaking with the ISCP. In the open-response section, veterans commented on respectful and professional communication with the ISCP and the effectiveness of medication education (Table 4).
Provider Satisfaction
The overall response rate for specialty providers was 89.5% (17/19) (Table 5). Eighty-eight percent of providers reported being “very satisfied” with the clinical experience of the ISCP, and 94% of providers reported being “very satisfied” or “somewhat satisfied” with the clinical experience. The majority of providers (94%) reported being “very satisfied” with the ISCP’s coordination of patient care, communication, professionalism, responsiveness to inquiries, accessibility, and overall experience. Providers reported being able to dedicate more time to veterans’ appointments and needs as a result of time saved from the ISCP services. Many providers commented on the importance of having an ISCP in the specialty clinic as part of the health care team (Table 6).
Discussion
There is an emerging role for pharmacists in specialty care to assist with medication management, given the complexity and cost of specialty medications. The ISCP at VAMHCS has had a significant impact on VA medication expenditure through cost avoidance and dose optimization initiatives, which have been associated with more than $1.3 million in projected annual cost avoidance. In addition, there were opportunities for indirect cost avoidance identified over the course of this QI project, which were not able to be measured. These include process improvements such as creating medication order sets and calling veterans prior to shipment of costly refrigerated medications to avoid replacements. Order sets were created by the ISCP to streamline the medication ordering process for specialty providers to prevent potential dispensing errors.
An additional potential indirect cost avoidance was identified with the reduction in infusion time associated with IVIG dose optimizations. A retrospective analysis of 2564 patients receiving IVIG over 5 years estimated an annual infusion time savings of 1366 hours by dosing IVIG utilizing IBW.3 Dosing IVIG by IBW decreases the amount of product in individuals with overweight or obesity, and it also decreases infusion time, therefore decreasing nurse labor and veterans’ time at appointments.
Of the specialty providers who completed the questionnaire, 94% reported being “very satisfied” with the ISCP’s coordination of patient care, communication, professionalism, responsiveness to inquiries, and accessibility. Many specialty medications have varying loading and maintenance dosing dependent on the indication, which can lead to order entry errors. The majority (88%) of providers self-reported that with the assistance of the ISCP they were somewhat or very likely to have made fewer order entry errors, which can be costly and impact patient safety and treatment outcomes. In addition, 99% of veterans self-reported that it was very likely that they used the specialty medication more appropriately after initial education with the ISCP. Questionnaire results highlighted the ISCP’s positive impact on patient care, including improved medication safety, communication, and understanding of specialty medication therapy.
Cost avoidance results and positive feedback from both specialty providers and veterans support the value of ISCP positions at other VA health care systems as well as within private sector specialty clinics. Non-VA clinics could additionally benefit from collaboration with a specialty clinical pharmacist to assist with formulary management, prior authorizations, and pharmacogenomic interventions. Highlighting the impacts of the specialty clinical pharmacist will play a key role in future negotiations for reimbursement of pharmacist services and role classifications.
Limitations
About the Authors
Miranda Beaudoin Rampone, PharmD, MSCS, CSP, is an infusion and specialty clinical pharmacy practitioner at US Department of Veterans Affairs in Augusta, Maine.
Bryce A. Edwards, PharmD, RPh, is an inpatient pharmacist at US Department of Veterans Affairs in Augusta, Maine.
Allison Spaulding, PharmD, is a pharmacist at VA Maine Healthcare System in Augusta, Maine.
Leslie Ochs, PharmD, PhD, BCPS, is an associate professor of social and administrative pharmacy at the University of New England School of Pharmacy and a pharmacist at CVS Health in Portland, Maine.
There were several limitations to this QI project, including the inability to quantify indirect cost avoidance due to lack of specific time-saving and error-avoiding metrics. In addition, the direct cost avoidance was expressed as projected annual cost avoidance. Actual cost avoidance would be dependent on veteran medication adherence in addition to veteran tolerability and clinical response to the converted medication.
Several factors may have contributed to the veteran questionnaire response rate of 58.5%, including extended length of time since the appointment with the ISCP (up to 22 months), potential phone call variance, and incomplete responses. Several veterans explained that they did not remember their experience with the ISCP and therefore did not complete the questionnaire. When veterans were contacted via telephone, some asked follow-up or clarifying questions, and others provided feedback based on their overall experience with the pharmacy, specialty clinic, or their personal success with the medication, all of which were not the intent of the questionnaire. Lastly, questions were asked on a Likert scale with only 5 options as well as yes/no responses, which both limited potential responses.
Conclusion
This QI project illustrates that an ISCP can be a valued health care team member integrated into the specialty medication care provided to patients. This clinical pharmacist can assist in reducing overall health care burden by being a key collaborator in specialty treatment selection, education, and monitoring of specialty medications. The ISCP can also have a substantial impact on specialty medication expenditure by retroactively completing medication conversions and dose optimizations based on current clinical data and patient-specific appropriateness.
REFERENCES
1. Stubbings J, Pedersen CA, Low K, Chen D. ASHP National Survey of Health-System Specialty Pharmacy Practice-2020. Am J Health Syst Pharm. 2021;78(19):1765-1791. doi:10.1093/ajhp/zxab277
2. Lankford C, Dura J, Tran A, et al. Effect of clinical pharmacist interventions on cost in an integrated health system specialty pharmacy. J Manag Care Spec Pharm. 2021;27(3):379-384. doi:10.18553/jmcp.2021.27.3.379
3. Figgins BS, Aitken SL, Whited LK. Optimization of intravenous immune globulin use at a comprehensive cancer center. Am J Health Syst Pharm. 2019;76(suppl 4):S102-S106. doi:10.1093/ajhp/zxz233
4. Lee J, Tong K, Stroedecke N, et al. Implementation of an integrated ambulatory care pharmacist collaborative care workflow model in specialty clinics in a large academic health system. Am J Health Syst Pharm. 2023;80(13):842-851. doi:10.1093/ajhp/zxad091
5. Zuckerman AD, Mourani J, Smith A, et al. 2022 ASHP Survey of Health-System Specialty Pharmacy Practice: Clinical Services. Am J Health Syst Pharm. 2023;80(13):827-841. doi:10.1093/ajhp/zxad064
6. Kibbons AM, Peter M, DeClercq J, et al. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs Real World Outcomes. 2020;7(4):295-305. doi:10.1007/s40801-020-00213-8
7. Anderson CR, Olson JA. Correlation of weight-based i.v. immune globulin doses with changes in serum immunoglobulin G levels. Am J Health Syst Pharm. 2015;72(4):285-289. doi:10.2146/ajhp140171
8. Hodkinson JP, Lucas M, Lee M, Harrison M, Lunn MP, Chapel H. Therapeutic immunoglobulin should be dosed by clinical outcome rather than by body weight in obese patients. Clin Exp Immunol. 2015;181(1):179-187. doi:10.1111/cei.12616
9. Damy T, Garcia-Pavia P, Hanna M, et al. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart Fail. 2021;23(2):277-285. doi:10.1002/ejhf.2027
The authors have no potential conflicts of interest to disclose.
