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The American Journal of Managed Care Special Issue: Pharmacy Benefits
A Gray Area for Reimbursement: Medical Foods for Non–Inborn Errors of Metabolism
Leslie Wilson, PhD; Tracy Kuo Lin, MSc, PhD; Anna Oh, RN, MPH; and Vicky Cao, PharmD
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5-ASA to Sulfasalazine Drug Switch Program in Patients With Ulcerative Colitis
Jason R. Goldsmith, MD, PhD; Akbar K. Waljee, MD; Tom George, PharmD; Alexandra Brown, BS; Hae Mi Choe, PharmD; Mohamed Noureldin, MBBS; Steven J. Bernstein, MD, MPH; and Peter D.R. Higgins, MD, PhD
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Bradley S. Stolshek, PharmD; Sally Wade, MPH; Alex Mutebi, PhD, MSc; Ajita P. De, MA, MPhil, MS; Rolin L. Wade, MS; and Jason Yeaw, MPH
Cost of Biologic Treatment Persistence or Switching in Rheumatoid Arthritis
Tao Gu, PhD; Alex Mutebi, PhD; Bradley S. Stolshek, PharmD; and Hiangkiat Tan, MS, BSPharm
Impact of Medical and/or Pharmacy Reimbursement on Adult Vaccination Rates
Gaurav Deshpande, PhD, MS; Jay Visaria, PhD, MPH; Joseph Singer, MD; and Kelly D. Johnson, PhD, MPH
Treatment Patterns Among Adults With ADHD Receiving Long-Acting Therapy
Zhou Zhou, MS; Zheng-Yi Zhou, PhD; Sneha S. Kellar, MPH; Vanja Sikirica, PharmD, MPH; Jipan Xie, MD, PhD; and Regina Grebla, PhD
Modeling the Impacts of Restrictive Formularies on Patients With HIV
James Baumgardner, PhD; Caroline Huber, MPH; Mina Kabiri, PhD; Lara Yoon, MPH; Jacki Chou, MPP, MPL; and John Romley, PhD

5-ASA to Sulfasalazine Drug Switch Program in Patients With Ulcerative Colitis

Jason R. Goldsmith, MD, PhD; Akbar K. Waljee, MD; Tom George, PharmD; Alexandra Brown, BS; Hae Mi Choe, PharmD; Mohamed Noureldin, MBBS; Steven J. Bernstein, MD, MPH; and Peter D.R. Higgins, MD, PhD
A 5-aminosalicylic acid (5-ASA) drug switch program switching from 5-ASA to sulfasalazine was instituted for insured patients with ulcerative colitis. Unanticipated barriers limited the number of patients who switched, but significant cost savings were still obtained.
ABSTRACT

Objectives: To switch patients with ulcerative colitis (UC) from costlier 5-aminosalicylic acid compounds to sulfasalazine and assess (1) the cost savings, (2) the barriers to switching, and (3) adverse events (AEs) and adherence at 3 months after the drug switch.

Study Design: An open-label, pharmacist-administered drug switch program coordinated at an academic inflammatory bowel disease center.

Methods: A clinical pharmacist contacted patients with UC who were prescreened by physicians and covered by specific insurers to enroll them in the drug switch program. Enrolled patients were followed for 3 months to assess AEs and medication adherence. Reasons for declining to participate were recorded.

Results: A total of 205 eligible patients were identified; only 14 enrolled, and 10 remained on sulfasalazine for the entire 3-month follow-up period. The enrollment rate was only 4.9%, yet a net cost savings of $22,828/3-month to the insurer was achieved (including program administration costs but excluding AE costs), with co-pays reduced by approximately $25 per month per patient. The rate of AEs on sulfasalazine (28.6%) was similar to that found in previous reports. Significant unanticipated barriers to switching were encountered, namely patient desire to not alter an existing effective drug regimen.

Conclusions: A pharmacist-administered drug switch program in patients with UC was significantly more difficult than anticipated, with questionable achievement of cost savings. This experience suggests that future drug switches and studies should focus on patient preferences for drug switching, as this may have implications for switching from brand name to biosimilar drugs.

Am J Manag Care. 2018;24(Spec Issue No. 8):SP303-SP308
Takeaway Points

A 5-aminosalicylic acid to sulfasalazine drug switch program was instituted for patients with ulcerative colitis. Major unanticipated barriers limited the number of patients who switched, but significant savings were still achieved.
  • Although only 4.9% of eligible patients successfully switched (n = 10), the annualized net cost savings was $91,313.
  • The greatest barrier to switching was a desire among patients to “not rock the boat,” which appears to be unique to drug switch programs involving active chronic disease.
  • This barrier could impede switching of patients from brand name biologics to new, cheaper biosimilars. Patient financial incentives were minimal in our program and could be amplified for biosimilars.
Approximately 800,000 patients in the United States live with ulcerative colitis (UC),1 an inflammatory condition of the large intestine. Patients with UC experience extensive morbidity, including abdominal pain, diarrhea, weight loss, and fever. Chronic inflammation can lead to colon cancer, whereas other complications often necessitate bowel resection; additionally, severe extraintestinal manifestations exist.2,3 Sulfasalazine and 5-aminosalicylic acid (5-ASA) agents are effective medications for the induction of remission and maintenance in mild to moderate UC.4 These oral medications are cost-effective therapy for UC, and regular use of these agents can greatly reduce the costs of UC to patients, payers, and society.5 Additionally, the current literature suggests a chemoprotective effect of 5-ASAs, helping to tamp down the increased risk of colorectal cancer seen in patients with UC,6-8 providing further long-term positive outcomes and cost benefits.8 Sulfasalazine is a very effective, low-cost therapy for UC, with a 72% success rate for induction and maintenance of remission in patients with UC.9,10 Unfortunately, sulfasalazine has lost popularity in the gastrointestinal community because up to 30% of patients experience an adverse event (AE).11 Nausea, headaches, and fever are the most common reactions; thus, newer 5-ASA products that lack the sulfa moiety unique to sulfasalazine, and with fewer AEs, have been developed, but these have substantially greater costs. Sulfasalazine has the longest track record, has similar or better efficacy than its derivative 5-ASAs,4,12,13 and is the cheapest of all available formulations. Furthermore, some of the AEs associated with it may be avoided through slow upward titration to a limiting dose, but this requires active management by clinical staff and so is often not attempted before switching to a 5-ASA.

We thus attempted such an active management approach to achieve cost savings while maintaining clinical efficacy. In this study, we undertook a medication switch program for all patients cared for by the University of Michigan Health System (UMHS)’s Ulcerative Colitis Clinic who were on 5-ASA products for their UC and were enrolled in a health plan participating in this program, in order to help decrease the medication cost burden to both the patients and payers.

METHODS

Program Overview

This program was implemented at UMHS, a nonprofit teaching institution that provides more than 2.3 million outpatient visits annually at 3 hospitals and 30 health centers, including 120 primary care or specialty clinics. It serves a large multipayer population. The program was developed in a similar fashion to a previous switch program by UMHS that involved the use of generic simvastatin from branded atorvastatin (Lipitor).14

Patients received a letter informing them of a cost-saving opportunity by switching from a 5-ASA to sulfasalazine. Gastroenterologists received an introductory email about the switch program, reasons for the switch, and how it would be conducted. In addition, presentations about the program were given to the gastroenterologists at their divisional meetings and the inflammatory bowel disease work group meetings.

Patient Selection

Eligible patients were identified from electronic health records (EHRs). Patients were identified as eligible if, as of October 2014, they (1) had a diagnosis of UC, (2) were on a 5-ASA other than sulfasalazine at stable dosages, (3) were receiving care from a UMHS gastroenterologist, (4) were approved for the switch by their gastroenterologist, and (5) were insured by Blue Cross Blue Shield of Michigan or Blue Care Network. Patients who had a sulfa allergy or intolerance were excluded from the switch program. This trial was presented at the monthly UC clinic physician meeting, and preapproval for the drug switch by the patient’s gastroenterologist was obtained through secure email by the clinical research coordinator or clinical pharmacist before the patient was contacted by phone (contact via the aforementioned mailings occurred prior to physician approval). The presentation was generally well received. The objections to enrollment from the gastroenterologists were for patients who (1) recently had their disease become well controlled, (2) had a history of unstable disease, or (3) had an undocumented history of failed sulfasalazine therapy. The Figure outlines this process.

Program Design

The clinical research coordinator created an electronic database that included fields for (1) patient demographics (eg, name, age, sex, address, phone), select medication history, simple clinical colitis activity index (SCCAI) score,15 and most recent laboratory values (erythrocyte sedimentation rate, C-reactive protein, comprehensive metabolic panel, complete blood counts, and fecal calprotectin) from our health system’s electronic data warehouses; (2) responses from the introductory script and questionnaire (eAppendix A [eAppendices available at ajmc.com]); and (3) fields for the data to be collected throughout the study, as described below.

Using a standardized script approved by UMHS’ institutional review board (IRB) (eAppendix A), the clinical pharmacist informed patients about the program, explained that their physicians had approved the switch, and asked them whether they wanted to switch from their current 5-ASA to sulfasalazine. If a patient was not interested in switching, the pharmacist documented why they were uninterested in switching. If patients were not reached, a voicemail was left following an IRB-approved script (eAppendix B). A maximum of 6 attempts were made to contact each patient, including morning and afternoon phone calls. An information sheet was mailed to patients who could not be contacted. Patients who elected to switch received new prescriptions for sulfasalazine titration (500 mg once daily for 3 days; then 500 mg twice daily for 3 days; then 1000 mg in the morning and 500 mg in the evening for 3 days; then 1000 mg twice daily) and folic acid (1 mg once daily), which were sent to their preferred pharmacy within 24 hours. Each patient also received a letter confirming the medication change. Two weeks after the medication change, patients were contacted for follow-up SCCAI score, steroid prescription use, and hospital or provider visits for UC activity. If SCCAI score was less than 4, patients were continued on therapy and follow-up laboratory tests were electronically entered for draw 4 to 6 weeks later. These laboratory tests included a comprehensive metabolic test (serum levels of sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine, glucose, calcium, total protein, albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase), complete blood count, erythrocyte sedimentation rate, C-reactive protein, and fecal calprotectin. If SCCAI score was 4 or higher, the sulfasalazine dose was further escalated as follows: 1500 mg in the morning and 1000 mg in the evening for 3 days; 1500 mg twice daily for 3 days; 2000 mg in the morning and 1500 mg in the evening for 3 days; then 2000 mg twice daily for 3 days. Additional follow-up occurred 2 weeks afterwards, including a new SCCAI score and assessment of steroid prescription use and hospital or provider visits for UC activity. In the additional follow-up, if the SCCAI score was less than 4, patients were continued on therapy and follow-up laboratory tests were electronically entered for draw 4 to 6 weeks later. If SCCAI score was 4 or higher, patients were routed to a gastroenterologist for determination of further sulfasalazine dose escalation or switching to alternative therapy. The patients’ EHRs were updated to reflect the change in medication and a note was entered into the medical chart for each patient encounter.


 
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