Abstract
Introduction: Sickle cell disease (SCD) is the most common inherited blood disorder in the United States (US). Affected individuals suffer from multiple complications due to deoxygenation-induced polymerization of hemoglobin S in red blood cells. Injury from SCD starts at birth and accumulates over time causing significant end-organ damage and ischemic tissue injury, leading to fatigue, pain (vaso-occlusive crisis [VOC]), and other clinical complications. For many patients, SCD related pain exists at a nearly constant baseline of low-to-moderate intensity while exacerbations to severe intensity occur unpredictably. Per clinical guidelines, opioids are recommended for treatment of acute pain episodes (i.e. VOC) as well chronic pain that cannot be otherwise managed, and many SCD patients require long-term opioid therapy to achieve adequate pain relief. Given limited real world data on current opioid treatment patterns among SCD patients, this study was undertaken to describe opioid utilization patterns in a large cohort of SCD patients in the US.
Methods: The Truven MarketScan® Commercial and Medicaid administrative claims databases were used to identify patients with SCD (1 inpatient or 2 outpatient claims with ICD-9 282.6x, 282.41, and/or 282.42) recorded in each calendar year from 2009 to 2014; 1 cohort was constructed for each year, and patients may have been diagnosed previously. Patients aged ≥9 months at the first indication of SCD were included. In each cohort, patients were required to be enrolled in medical and pharmacy benefits for the calendar year in which they were identified. The final cohorts were restricted to patients with 12 months continuous medical and pharmacy benefits coverage prior to their first SCD indication in the cohort year.
Prior year utilization of opioids and morphine equivalent daily dose (MEDD) was measured for each cohort using outpatient pharmacy claims. MEDD was defined as the daily dose multiplied by a drug-specific morphine conversion factor, and was calculated among the subset of opiates with a known conversion factor, and reported as the mean of a patient's average MEDD over the year prior to their first indication of SCD in the cohort year. VOCs were identified by ICD-9 codes 282.42, 282.62, 282.64, and 282.69 in the year prior to the cohort year.
Results are reported as ranges across the annual cohorts and stratified by payer (Commercial or Medicaid) and age group (<6, 6-11, 12-17, 18-30, 31-44, 45+).
Results: There were 2,619-3,285 Commercial and 4,807-7,007 Medicaid SCD patients identified in each of the annual cohorts. The mean age was 27 in Commercial cohorts and >50% were female. The mean age was 18 in the Medicaid cohorts and about 50% were female.
The proportion of SCD patients prescribed opioids remained stable each year across the study period, with consistently more Medicaid patients using an opioid (65%-70%) compared to Commercial patients (54%-57%) [Table]. Medicaid patients had more opioid days supplied and opioid claims per patient across all age groups. Among both payers, opioid claims and days supplied were consistent over time (Table). SCD patients had markedly higher use of opioids in the prior year compared to the 30 day prior use in the general US population, but all remained steady over time (Figure).
The proportions of patients with a VOC and patients using opioids increased markedly between age 12-17 and 18-30 in Medicaid and Commercial patients. MEDD and average days supplied per patient also increased substantially between age 12-17 to age 18-30 in both payers (Table), which coincided with the transition from pediatric to adult care.
Medicaid patients reached a utilization level of ≥4 months supply of opioids earlier (age 18-30) than Commercial patients (age 31-44) and had double the average days supplied in each adult (age ≥18 years old) age group.
Conclusions: While concerns rise about epidemic opioid use in the US general population, opioid use in the SCD population has remained steady. Nevertheless, opioid use in this population is significant and increases dramatically when patients with SCD are transitioned to adult care. This pattern may reflect the chronic or accumulated damage from SCD. Better treatments/strategies to decrease opioid use by decreasing acute and chronic pain and SCD complications may be warranted, especially for adult patients.
Ballas: Novartis: Honoraria, Speakers Bureau. Kanter: GBT: Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Bluebird Bio: Membership on an entity's Board of Directors or advisory committees, Research Funding; NHLBI (sickle cell disease research advisory committee): Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Apopharma: Research Funding; Pfizer: Research Funding; MUSC: Other: The site PI for sponsored research conducted at MUSC who receives funds from: Novartis, bluebird bio, GBT, Sancillo, Apopharma, Pfizer; American Society of Hematology (Sickle Cell Disease Guideline Panel): Membership on an entity's Board of Directors or advisory committees; Sancillo: Research Funding. Agodoa: Global Blood Therapeutics, Inc.: Employment, Equity Ownership. Howard: Global Blood Therapeutics: Employment, Equity Ownership. Wade: Truven Health Analytics, an IBM company which received project funding from Global Blood Therapeutics: Consultancy. Noxon: Truven Health Analytics, an IBM company which received project funding from Global Blood Therapeutics: Employment. Dampier: Pfizer, Lilly, Novartis, Sancilio: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.
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