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PURPOSE: Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. METHODS: We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. RESULTS: Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids ( P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered ( P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% ( P < .001). For the same four opioids, median OOP costs doubled to quadrupled ( P < .001). CONCLUSION: Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain.

Context There are concerns that policies aimed to prevent opioid misuse may unintentionally reduce access to opioids for patients at end-of-life. Objective We assessed trends in opioid prescribing among patients on discharge from the hospital to hospice care. Methods This was a retrospective cohort study among adult (age ≥18 years) patients discharged from a 544-576 bed, academic medical center to hospice care between January 1, 2010 to December 31, 2018. Study data were collected from a repository of patients’ electronic health record data. Our primary outcome was the frequency of opioid prescribing on discharge to hospice care. Our primary exposure was the calendar year of discharge. We also investigated non-opioid analgesic prescribing and stratified opioid prescribing trends by patient characteristics (e.g., demographics, cancer diagnosis, and location of hospice care). Results Among 2,648 discharges to hospice care, mean (standard deviation) age was 65.8 (16.0) years, 46.3% were female, and 58.7% had a cancer diagnosis. Opioid prescribing on discharge to hospice care decreased significantly from 91.2% (95% confidence interval (CI) = 87.1%–94.1%) in 2010 to 79.3% (95% CI = 74.3%–83.5%) in 2018 adjusting for age, sex, cancer diagnosis, and location of hospice care. Prescribing of non-opioid analgesic medications increased over the same time period. Conclusions We observed a statistically significant decreasing trend in opioid prescribing on discharge to hospice care. Further research should aim to confirm these findings and to identify opportunities to ensure optimal pain management among patients transitioning to hospice care.

Background The role pharmacies play in addressing the opioid crisis and drug-related risks such as injection drug use is evolving. Estimating the prevalence of injection drug use at the community level is challenging because of the stigma of drug use. Many community pharmacies sell nonprescription sterile syringes; thus, pharmacy-level sales of injection equipment may be an indicator of drug-related harms and unmet needs of high-risk populations. Objectives To describe, compare, and assess the convergent validity of staff-reported nonprescription syringe (NPS) sales volume and NPS administrative sales data from community pharmacies in Massachusetts (MA) and Rhode Island (RI). Methods This study employed both prospective cross-sectional survey data collection and utilization of administrative pharmacy sales data. Between November 2017 and January 2018, we administered a telephone-based survey to estimate average weekly NPS type and volume for 191 chain pharmacies (CVS Health) located in communities experiencing fatal opioid overdoses above the state’s 2015 annual median rate. For the same time period, we obtained NPS sales data from surveyed pharmacies and all CVS Health pharmacies in the 2 states. We calculated Spearman correlations to assess convergence of average weekly volume between pharmacy staff reports and sales data. Results All pharmacies responded to the survey. Most (98.4%) pharmacies surveyed sold NPS, but 42.0% reported running out of stock monthly or more frequently. Pharmacy staff tended to under-report syringe sales. Staff-reported weekly NPS sales volume was 67,922 versus 70,962 syringes from administrative pharmacy sales data. Spearman correlation between reported and actual NPS sales was 0.40 (95% CI 0.27–0.51). Conclusion The counts of administrative pharmacy syringe sales data in MA and RI indicate high need, substantial volume, and notable access at community pharmacies. Future research should use NPS sales data rather than self-report data to track emerging trends and tailor local responses.

Objective Describe patient attitudes toward opioid treatment agreements (OTAs) and characterize perceptions of their impact on patient care, behavior, communication with prescribers, and engagement with the health care system. Design Qualitative descriptive study. Setting Federally qualified health center with six clinic locations serving a rural population. Subjects Patients were prescribed long-term opioid therapy and were required to sign an OTA through an in-person office visit with a clinical pharmacist. Methods Patients who signed an OTA were recruited to participate in semistructured, in-person, one-on-one interviews. Data were analyzed using immersion-crystallization methods. Results Among the 20 patients recruited, 50% were men; 70% were insured by the state’s Medicaid program; and 85% were using opioids for hip, back, and/or neck pain. Four major themes arose from the interviews. First, individuals who use long-term opioids experience a wide variety of opioid-related fears and stigmas. Second, individuals articulated real or potential benefits from implementing OTAs. Third, opinions differed on whether OTAs affected behavior and reduced opioid misuse and diversion. Finally, individuals provided feedback on the health care system’s OTA implementation process. Conclusions Patients experienced a wide variety of opioid-related fears and stigmas, including how OTA requirements can perpetuate these issues. Despite these feelings, participants articulated real or potential positive outcomes from the use of OTAs, although they were mixed on whether these agreements translated to any behavior changes. If OTAs are to become standard practice, future research is needed to describe the diversity of patient perspectives and experiences with OTAs and to evaluate their effect on patient outcomes.

Pharmacists' role in addressing the opioid crisis continues to expand, but lack of training specifically related to standardized prescription drug monitoring program (PDMP) use and communication strategies for provider and patient interactions remains a significant issue. We developed the Resources Encouraging Safe Prescription Opioid and Naloxone Dispensing (RESPOND) Toolkit to enhance community pharmacists' understanding of their role in addressing opioid safety; improve integration of PDMP into daily workflow; and enhance communication between pharmacists, prescribers, and patients.To describe the development of RESPOND Toolkit and summarize findings from initial pilot testing.RESPOND development was informed by focus groups with patients, prescribers, and pharmacists and an external advisory committee. Materials developed include a patient screeningcommunication algorithm, a provider communication checklist and an online continuing education course with three distinct modules. The RESPOND Toolkit was pilot tested in six community pharmacies in Oregon across two 6-month intervention phases. Pilot data collection included a pre-post intervention survey, pre-post knowledge assessment quizzes within the online course, and post-intervention semi-structured interviews. Interview feedback informed revisions after each phase to shape the final content, flow, and delivery of RESPOND.Sixteen of 21 pharmacists completed the online training, revealing a large, significant effect on knowledge gain across the three training modules (pre-score 57, post-score 84; p 0.001; Cohen's d = 1.85). Of these participants, 10 also completed the baseline and post intervention survey and showed non-significant moderate improvements in knowledge, perceived behavioral control, and self-efficacy to address opioid safety issues.The RESPOND Toolkit has promise as an effective and scalable approach to providing community pharmacist-tailored training, especially in the areas of effective communication and workflow integration, to promote behavioral shifts supporting opioid safety for patients. Further development and testing in a larger sample is warranted.

BACKGROUND: A large proportion of individuals who use heroin report initiating opioid use with prescription opioids. However, patterns of prescription opioid use preceding heroin-related overdose have not been described. OBJECTIVE: To describe prescription opioid use in the year preceding heroin overdose. DESIGN: Case-control study comparing prescription opioid use with a heroin-involved overdose, non-heroin-involved opioid overdose, and non-overdose controls from 2015 to 2017. PARTICIPANTS: Oregon Medicaid beneficiaries with linked administrative claims, vital statistics, and prescription drug monitoring program data. MAIN MEASURES: Opioid, benzodiazepine, and other central nervous system depressant prescriptions preceding overdose; among individuals with one or more opioid prescription, we assessed morphine milligram equivalents per day, overlapping prescriptions, prescriptions from multiple prescribers, long-term use, and discontinuation of long-term use. KEY RESULTS: We identified 1458 heroin-involved overdoses (191 fatal) and 2050 non-heroin-involved opioid overdoses (266 fatal). In the 365 days prior to their overdose, 45% of individuals with a heroin-involved overdose received at least one prescribed opioid compared with 78% of individuals who experienced a non-heroin-involved opioid overdose (p

PURPOSE Skilled nursing facility (SNF) residents are at increased risk for opioid-related harms. We quantified the frequency of opioid prescribing among patients discharged from an acute care hospital to SNFs. METHODS This was a retrospective cohort study among adult (≥18 years) inpatients discharged from a quaternary-care academic referral hospital in Portland, OR to a SNF between January 1, 2017 and December 31, 2018. Our primary outcome was receipt of an opioid prescription on discharge to a SNF. Our exposures included patient demographics (eg, age, sex), comorbid illnesses, surgical diagnosis related group (DRG), receiving opioids on the first day of the index hospital admission, and inpatient hospital length of stay. RESULTS Among 4374 patients discharged to a SNF, 3053 patients (70%) were prescribed an opioid on discharge. Among patients prescribed an opioid, 61% were over the age of 65 years, 50% were male, and 58% had a surgical Medicare severity diagnosis related group (MS-DRG). Approximately 70% of patients discharged to a SNF were prescribed an opioid on discharge, of which 68% were for oxycodone, and 52% were for ≥90 morphine milligram equivalents per day. Surgical DRG, diagnoses of cancer or chronic pain, last pain score, and receipt of an opioid on first day of the index hospital admission were independently associated with being prescribed an opioid on discharge to a SNF. CONCLUSION Opioids were frequently prescribed at high doses to patients discharged to a SNF. Efforts to improve opioid prescribing safety during this transition may be warranted.

CE Information Activity Available Online: To access the article and evaluation online, go to https://www.highmarksce.com/mscare. Target Audience: The target audience for this activity is physicians, advanced practice clinicians, nursing professionals, pharmacists, and other health care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Recognize the frequency of utilization of non-DMT medications by MS patients and integrate questions about their use into patient history. Characterize and be mindful of the out-of-pocket cost burden of DMT and non-DMT medication use in patients with MS. Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by The Consortium of Multiple Sclerosis Centers (CMSC) and Intellisphere, LLC. CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the health care team. This activity was planned by and for the health care team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit for learning and change. For Physicians: The Consortium of Multiple Sclerosis Centers designates this journal-based activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. For Nurses: This activity is awarded 0.5 contact hours of nursing continuing professional development (NCPD) (0.5 of these credits are in the area of pharmacology). For Pharmacists: This knowledge-based activity (UAN JA4008165-9999-22-020-H01-P) qualifies for 0.5 contact hours (0.05 CEUs) of continuing pharmacy education credit. For Physician Assistants: The Consortium of Multiple Sclerosis Centers has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.5 AAPA Category 1 CME credits. Approval is valid until April 1, 2023. PAs should only claim credit commensurate with the extent of their participation. It is the policy of the Consortium of Multiple Sclerosis Centers to mitigate all relevant financial disclosures from planners, faculty, and other persons that can affect the content of this CE activity. For this activity, all relevant disclosures have been mitigated. Disclosures: Francois Bethoux, MD, editor in chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has disclosed no relevant financial relationships. Alissa Mary Willis, MD, Associate Editor of IJMSC, has disclosed no relevant financial relationships. Daniel Hartung, PharmD, MPH, consults for the National Multiple Sclerosis Society and Sandoz Pharmaceuticals. Leorah Freeman, MD, PhD, has served as a consultant for Genentech, Celgene/Bristol Myers Squibb, EMD Serono, TG Therapeutics, and Novartis; and has received grant/program support from EMD Serono and Genentech. The staff at IJMSC, CMSC, and Intellisphere, LLC who are in a position to influence content have disclosed no relevant financial relationships. Laurie Scudder, DNP, NP, Continuing Education Director CMSC, has served as a planner and reviewer for this activity. She has disclosed no relevant financial relationships. Method of Participation: Release Date: April 1, 2022; Valid for Credit through: April 1, 2023 In order to receive CE credit, participants must: (1) Review the continuing education information, including learning objectives and author disclosures.(2) Study the educational content.(3) Complete the evaluation, which is available at https://www.highmarksce.com/mscare. Statements of Credit are awarded upon successful completion of the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. The CMSC and Intellisphere, LLC do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the CMSC or Intellisphere, LLC. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health care professionals without first evaluating their patients’ conditions, considering possible contraindications or risks, reviewing any applicable manufacturer’s product information, and comparing any therapeutic approach with the recommendations of other authorities.

Respond to Prevent (R2P) is a randomized clinical trial which sought to accelerate distribution of naloxone and other harm reduction materials from community pharmacies. R2P combined an online continuing education course with in-store materials, specifically designed for use in community pharmacies, and then supported implementation through the one-on-one educational technique of academic detailing.The objective of this paper is to describe and synthesize our experiences providing academic detailing as part of the R2P randomized trial.Closed-ended items from standardized post detailing questionnaires were analyzed with descriptive statistics. Open-ended items were content analyzed for key themes using immersion-crystallization qualitative methods.A total of 176 pharmacies participated in R2P with 175 receiving their initial academic detailing visit between August 2019 and May 2021. Initial visits were in-person and lasted a median of 35 minutes (interquartile range, 20-45 minutes). The R2P naloxone guide was the most common topic covered (n = 162, 92.6%). Following a fidelity check to assess adequacy of the R2P program implementation, 80 pharmacies (45.7%) required secondary academic detailing. Secondary detailing was more targeted and most frequently focused on the sale of nonprescription syringes (n = 28; 35.2%) or disposal container distribution (n = 30; 37.5%). Analysis of the open-ended items identified factors that the detailers perceived to affect the quality of academic detailing sessions, including the pharmacy environment, participant knowledge of and attitudes toward the subject matter, and ability of the detailer to remain flexible yet consistent.R2P provided a standardized process to foster naloxone distribution and engagement in harm reduction with demonstrated implementation in 175 community pharmacies across 4 states. Academic detailing was perceived to be well-received and effective at providing education and promoting distribution of naloxone and nonprescription syringes in community pharmacies. Additional research is needed to confirm these perceptions through evaluation post-intervention behavioral and attitude changes.

We report on efforts to measure readiness to adopt opioid safety initiatives in community pharmacies within 2 large chains. Previous studies identified lack of knowledge, confidence, or enthusiasm in addressing harm reduction efforts. We implemented an intervention that provided training to improve opioid safety. The goal was to increase naloxone prescribing and nonprescription syringe sales, reduce stigma, and decrease opioid overdoses among patients and customers.To assess pharmacy readiness for intervention delivery, by characterizing pharmacy culture around opioid safety; describing current practices and challenges interacting with patients and customers on naloxone, nonprescription syringe sales, and buprenorphine; and determining pharmacy defined goals for implementing the intervention.The sample included pharmacy managers and staff pharmacists from 2 large chains who completed a brief phone interview. Interviews consisted of Likert-scale and open-ended, theoretically driven questions. Questions focused on workplace culture, patient engagement, naloxone and buprenorphine prescribing, nonprescription syringe sales, and intervention goals. Coding categories for the open-ended questions were derived using a thematic review of responses.A total of 163 respondents described both workplace culture and how they encourage patient opioid safety as including public health awareness, patient engagement, and naloxone prescribing. Sale of nonprescription syringes exhibited high variability: no sales barriers (53.9%), sales with barriers (21.5%), and no sales (20.9%). Half of pharmacists (50.3%) interacted with buprenorphine prescribers outside of medication fills. Most respondents (68.7%) endorsed being ready to promote the intervention. Pharmacists named goals in adopting the intervention of wanting more knowledge and educational materials, talking points with patients, and best practices for offering naloxone.Community pharmacists, before implementation, described awareness of and receptiveness to opioid safety initiatives, with substantial barriers around nonprescription syringe sales. Assessed knowledge level, culture, and identified barriers that emerged in the readiness assessments can be used to tailor future pharmacy-specific programming.

Repository corticotropin injection is an expensive medication that was approved in 1952 for the treatment of many inflammatory conditions. The clinical evidence supporting the use of repository corticotropin (hereinafter referred to as corticotropin) has been weak, perhaps because its approval predated the modern review standards of the US Food and Drug Administration (FDA).To characterize the clinical evidence supporting the use of corticotropin for its FDA-approved indications.Studies were identified via electronic searches of Ovid MEDLINE, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), and the Cochrane Central Register of Controlled Trials (CENTRAL) from database inception to May 12, 2021 (the MEDLINE search was updated on June 8, 2021). Bibliographies of retrieved articles were also reviewed through ClinicalTrials.gov, FDA documents, and the manufacturer's website. Search terms included HP Acthar, ACTH gel, repository corticotropin, and terms for specific diseases, such as multiple sclerosis, nephrotic syndrome, rheumatoid arthritis, and West syndrome (or spasms, infantile). The review included randomized clinical trials (RCTs), nonrandomized and single-arm clinical trials, and prospective cohort studies that compared corticotropin with an active comparator, placebo, or no treatment. Data were extracted by 1 reviewer and verified by a second. Disagreements were resolved through discussion. Studies were qualitatively synthesized by indication to summarize important design features and results.Of 1059 records screened, 203 full-text articles were assessed for eligibility. A total of 41 studies involving 2235 participants met inclusion criteria; of those, 11 involved infantile spasms, 10 involved multiple sclerosis (MS), 11 involved rheumatological conditions, 7 involved nephrotic syndrome, 1 involved ocular conditions, and 1 involved sarcoidosis. Overall, 19 studies either included a single arm or exclusively compared different corticotropin dosing strategies. The evidence was most robust for the treatment of infantile spasms and MS. The largest number of studies comparing corticotropin with an active agent (n = 4) or placebo (n = 5) pertained to MS, with almost all studies finding that corticotropin performed better than placebo but no different than corticosteroids. For the treatment of infantile spasms, 8 controlled studies were identified (6 were randomized); of those, only 1 small RCT found corticotropin to be significantly superior to corticosteroids. Studies of patients with other conditions (n = 20) frequently lacked a control group (n = 12), were placebo-controlled (n = 5), or exclusively examined different corticotropin dosing strategies (n = 2). Placebo-controlled RCTs of rheumatoid arthritis, ankylosing spondylitis, optic neuritis, systemic lupus erythematosus, and nephrotic syndrome were generally small and did not consistently demonstrate that corticotropin was superior to placebo. Blinded RCTs showed a similar or greater number of adverse effects with corticotropin relative to corticosteroids.In this scoping review, few RCTs supported the clinical benefit of corticotropin for most FDA-approved indications. Most RCTs found that corticotropin was not superior to corticosteroids for treating relapses of MS or infantile spasms.

Background: In 2017, the United States Comprehensive Addiction and Recovery Act (CARA) expanded authorization to prescribe buprenorphine for opioid use disorder to nurse practitioners (NPs). In contrast to physicians, NPs were required to complete 16 additional hours of training on controlled substance prescribing before a buprenorphine waiver application. As this differential additional education mandate was seen as a potential barrier, we sought to evaluate the impact of this requirement on both waiver acquisition and prescribing of controlled substances, comparing NPs who obtained waivers to those who had not.Methods: Through 2016-2018 Oregon Prescription Drug Monitoring Program and linked NP licensure data, we identify factors associated with waiver acquisition at baseline (2016), and evaluated changes in controlled substance prescribing before (2016) and after waiver acquisition (2018). Using chi-square and Mann-Whitny U testing, we calculated and described controlled substance prescribing types, rates, and patient level quantities including co-prescribing of benzodiazepines and opioids by NPs. Multivariable linear regression compared prescribing by waivered and non-waivered NPs for significant changes in non-buprenorphine controlled substance prescribing.Results: Waivered NPs were more likely to have a psychiatric certification, have prior disciplinary action, and have generally higher levels of non-buprenorphine controlled substance prescribing than their non-waivered counterparts.. While there was a significant increase in opioid prescriptions per patient among waivered NPs, following CARA implementation, co-prescribing of benzodiazepines and opioids significantly declined among waivered NPs relative to non-waivered NPsConclusions: Although educational requirements were rescinded in 2021 for most applicants, enhanced opioid prescribing training should be incorporated into professional educational offerings regardless of regulatory mandate. We recommended continued focus on education regarding avoidance of high risk prescribing such as co-prescribing of opioids and benzodiazepines. NPs who acquire waivers may take on higher risk patients who are already using opioids and these findings may represent transitions in practice and patient setting.

Background Residential treatment is a common approach for treating opioid use disorder (OUD), however, few studies have directly compared it to outpatient treatment. The objective of this study was to compare OUD outcomes among individuals receiving residential and outpatient treatment. Methods A retrospective cohort study used linked data from a state Medicaid program, vital statistics, and the Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Episodes Dataset (TEDS) to compare OUD-related health outcomes among individuals treated in a residential or outpatient setting between 2014 and 2017. Multivariable Cox proportional hazards and logistic regression models examined the association between treatment setting and outcomes (i.e., opioid overdose, non-overdose opioid-related and all-cause emergency department (ED) visits, hospital admissions, and treatment retention) controlling for patient characteristics, co-morbidities, and use of medications for opioid use disorders (MOUD). Interaction models evaluated how MOUD use modified associations between treatment setting and outcomes. Results Of 3293 individuals treated for OUD, 957 (29%) received treatment in a residential facility. MOUD use was higher among those treated as an outpatient (43%) compared to residential (19%). The risk of opioid overdose (aHR 1.39; 95% CI 0.73–2.64) or an opioid-related emergency department encounter or admission (aHR 1.02; 95% CI 0.80–1.29) did not differ between treatment settings. Independent of setting, MOUD use was associated with a significant reduction in overdose risk (aHR 0.45; 95% CI 0.23–0.89). Residential care was associated with greater odds of retention at 6-months (aOR 1.71; 95% CI 1.32–2.21) but not 1-year. Residential treatment was only associated with improved retention for individuals not receiving MOUD (6-month aOR 2.05; 95% CI 1.56–2.71) with no benefit observed in those who received MOUD (aOR 0.75; 95% CI 0.46–1.29; interaction p = 0.001). Conclusions Relative to outpatient treatment, residential treatment was not associated with reductions in opioid overdose or opioid-related ED encounters/hospitalizations. Regardless of setting, MOUD use was associated with a significant reduction in opioid overdose risk.

ObjectiveTo describe pricing decisions, justifications, and attitudes among current and former biotech industry executives for companies that manufacture multiple sclerosis disease-modifying therapies.MethodsFour leaders in biotech who have been directly involved in multiple sclerosis disease-modifying therapy pricing or marketing volunteered to participate in 30-minute semistructured interviews conducted via telephone. An expert in qualitative methods moderated and analyzed the interviews alongside the principal investigator. Brief, preinterview online surveys were also administered to provide additional context and insight for discussion. Interviews were audio-recorded and professionally transcribed.ResultsParticipants consistently stated that initial price decisions were dictated by the price of existing competitors in the market. Revenue maximization and corporate growth were drivers of price escalations in the absence of continued market penetration. Lower revenue predictions outside the United States also informed pricing strategies. The growing complexity and clout of drug distribution and supply channels were also cited as contributing factors. Although decisions to raise prices were motivated by the need to attract investment for future innovation, recouping drug-specific research and development costs as a justification was not strongly endorsed as having a significant influence on pricing decisions.ConclusionsContrary to prevailing narratives that underscore drug development costs, findings from our interviews suggest that the existing price ecosystem, overall corporate growth, international pricing disparities, and supply chain–related distortions may play a more central role in drug pricing decision.

Despite little evidence supporting its superiority to glucocorticoid therapy, use and expenditures for repository corticotropin (rACTH) injection (H.P. Acthar Gel; Mallinckrodt) have increased dramatically in the last 5 years, particularly among a small number of nephrologists, rheumatologists, and neurologists. Recently, the manufacturer justified the extremely high and rapidly increasing cost of rACTH by citing the ongoing need to generate clinical data to support its use. We test this assertion by investigating the quality and provenance of the evidence likely to emerge in the foreseeable future. We identified all completed, in-progress, and proposed studies of rACTH registered at ClinicalTrials.gov. 75 studies representing 2,953 participants met inclusion criteria. Studies addressed primarily nephrologic (n = 23), rheumatologic (n = 28), and neurologic (n =22) indications. Of the 23 studies proposed for renal indications (enrollment, 33 ± 49 [mean ± SD]), 11 were not randomized, 8 compared only different rACTH treatment regimens, and 4 compared rACTH to placebo. No studies of rACTH proposed for renal indications included an rACTH-free arm receiving active treatment (ie, another form of immunosuppression). We conclude that evidence emerging in the foreseeable future is unlikely to broadly support rACTH use over lower-cost glucocorticoid-based alternatives for renal indications.

Objective To estimate unintended pregnancies averted and the cost effectiveness of pharmacist prescription of hormonal contraception. Methods A decision-analytic model was developed to determine the cost effectiveness of expanding the scope of pharmacists to prescribe hormonal contraception compared with the standard of care and contraceptive access in clinics. Our perspective was that of the payor, Oregon Medicaid. Our primary outcome was unintended pregnancies averted. Secondary outcomes included: costs and quality-adjusted life years (QALYs). Model inputs were obtained from an analysis of Medicaid claims for the first 24 months after policy implementation in Oregon, and the literature. Univariate and bivariate sensitivity analyses, as well as a Monte Carlo simulation, were performed. Results Among Oregon's Medicaid population at risk for unintended pregnancy, the policy expanding the scope of pharmacists to prescribe hormonal contraception averted an estimated 51 unintended pregnancies and saved $1.6 million dollars. Quality of life was also improved, with 158 QALYs gained per 198,000 women. Sensitivity analysis demonstrated that the model was most sensitive to the effect on contraceptive continuation rates. If contraceptive continuation rates among women receiving care from a pharmacist are 10% less than among clinicians, than pharmacist prescription of hormonal contraception will not avert unintended pregnancies. Conclusion Pharmacist prescription of hormonal contraception averts unintended pregnancies and is cost effective. Full implementation of the policy is needed for maximum benefits. Prospective data on the effect of the policy on contraceptive continuation rates are needed.

To describe early utilization of pharmacist prescription of contraception in Oregon's Medicaid program.Using Oregon Medicaid claims data, we conducted a retrospective analysis and quantified overall and monthly trends in pharmacist-prescribed contraceptives from January 1, 2016, to December 31, 2017. Our population was restricted to patients obtaining a new prescription for oral and transdermal methods and who had continuous Medicaid coverage during the study period. We summarized demographic and utilization characteristics, including whether patients were continuing or switching methods or initiating contraception. New prescriptions were those written to patients who did not have one for hormonal contraception in the prior 30 days. To assess program safety, we examined rates of prescriptions to patients with medical contraindications to contraceptive use.Among the 3,614 patients receiving a new prescription for oral or transdermal contraceptives in the Oregon Medicaid program from all health care providers, 367 (10%) received their prescription from a pharmacist. Five months after implementation, pharmacists filled an average of 61 prescriptions per month as the prescriber. Most claims originated from retail chain pharmacies (94%) in urban locations (71%). The majority of patients who were prescribed contraception by pharmacists (73.8%) had no history of contraceptive prescriptions in the preceding 30 days (n=252). Ages ranged from 13 to 49 years, fewer patients lived in a rural location (35.7%), most received a combined hormonal pill (90.5%), and the average day's supply dispensed was 65 (range of 21-364 days). Fewer than 5% (12) of patients had a diagnostic code indicating a possible contraindicating comorbidity.Among Medicaid enrollees, we found that 10% of all new oral and transdermal contraceptive prescriptions were written by pharmacists.

The high cost of multiple sclerosis (MS) disease-modifying therapies can negatively affect access for patients through increased payer restrictions and higher out-of-pocket spending. Our objective was to describe changes in pharmacy benefit coverage and cost-sharing amounts for MS disease-modifying therapies in the Medicare Part D program, using enrollment-weighted Prescription Drug Plan Formulary files for the period 2007-16. Among therapies available throughout the study period, the rate of prior authorization use increased from 61-66 percent of plans to 84-90 percent. The share of plans with at least one therapy available without limitations declined from 39 percent to 17 percent. The projected cumulative out-of-pocket spending for 2019 was $6,894. The therapy with the highest out-of-pocket spending was generic glatiramer acetate. Policy makers need to consider both access restrictions and a growing cost-sharing burden as potential consequences of high and rising drug prices for people with MS.

BACKGROUND: Although direct-acting antivirals (DAA) have revolutionized the treatment of chronic hepatitis C virus (HCV), many state Medicaid programs have limited coverage because of their expense. In 2015, the Centers for Medicare & Medicaid Services (CMS) notified states about the legality of Medicaid coverage limitations, particularly within managed care programs. OBJECTIVES: To (1) examine how relaxation and alignment of hepatitis C policies within the Oregon Medicaid program affected DAA utilization and (2) describe changes in DAA coverage policies and patient characteristics of treated individuals over time. METHODS: We manually collected DAA Medicaid drug policies in the state of Oregon before and after the CMS notification was released. After categorizing DAA policies into 2 groups based on baseline prior authorization criteria (restrictive and permissive), we evaluated how changes in these DAA policies affected utilization over 3 time periods (pre-CMS period, post-CMS period, and fibrosis policy alignment). Immediate and gradual changes in trend were assessed using an interrupted time series regression model. Finally, we examined patient characteristics and liver disease complications over time as policy restrictions were removed and aligned with one another. RESULTS: From 2014 to 2018, Oregon's coordinated care organizations and fee-for-service drug policies relaxed liver fibrosis and substance abstinence coverage criteria leading to immediate increases in DAA use in 2016 (0.62 prescriptions per 10,000 enrollees per month; 95% CI = 0.17 to 1.08) and 2018 (1.07 prescriptions per 10,000 enrollees per month; 95% CI = 0.63 to 1.51) among more restrictive coordinated care organizations at baseline. This was followed by a decrease in trend after the 2016 and 2018 impact (-0.05; 95% CI = -0.11 to -0.001 and -0.07; 95% CI = -0.13 to -0.02, respectively). Over the 3 periods, there was a decrease in treated individuals with liver-related complications (P < 0.0001) and an increase in those with a substance use diagnosis (P = 0.0013). CONCLUSIONS: Reducing coverage limitations resulted in treatment of patients with fewer liver-related complications and more substance use disorders. Expanding access to treatment did not result in sustained increases in utilization, and additional interventions may be necessary to meet HCV elimination goals. DISCLOSURES: This study was funded in part by AbbVie Pharmaceuticals, which did not have any role in the study design, collection, analysis and interpretation of data, writing the report, or the decision to submit the report for publication. Hartung received support for his work on this study via a grant from AbbVie Pharmaceuticals. The other authors did not receive any financial support for their contributions to this study. The authors have no other financial disclosures to report. This study was presented at the Academy Health Annual Research Meeting in Washington, DC, on June 3, 2019.

Multiple sclerosis (MS) is a prevalent and debilitating neuroinflammatory disease associated with a significant economic burden. Direct healthcare costs, which can average $70,000 a year, have risen rapidly over the last decade and are driven by the escalating cost of disease-modifying therapies (DMTs). Despite a growing number of DMTs, annual increases in price for most DMTs have commonly exceeded 10% over the last 15 years. The high cost of MS DMTs has created economic hardships for patients in terms of high out-of-pocket costs and insurance company-induced barriers. Although generic versions of glatiramer acetate and dimethyl fumarate have provided some lower cost options, the median annual price for branded products currently exceeds $90,000. The goal of this paper is to examine the economic landscape of MS DMTs in the USA. Recent economic analyses have provided new insights into the relative value of DMTs. Robust economic modeling studies suggest that costs per quality-adjusted life-year for most DMTs exceed commonly endorsed thresholds for what is considered a reasonable value in the USA. Because of higher efficacy and lower net costs, ocrelizumab and alemtuzumab are considered the best value. It is likely that generic versions of dimethyl fumarate and glatiramer acetate are also economically attractive. DMTs provide clinical benefit for patients with MS; however, their high cost can be a financial burden and impede access. High DMT prices are the principal reason why cost-effectiveness studies have indicated the economic value of most DMTs is questionable.

Background Pharmacies sometimes restrict access to buprenorphine-naloxone (buprenorphine) for individuals with opioid use disorder. The objective of this study was to quantify the frequency of barriers encountered by patients seeking to fill buprenorphine prescriptions from pharmacies in United States (US) counties with high opioid-related mortality. Methods To characterize buprenorphine availability, we conducted a telephone audit ("secret shopper") study using a standardized script in two randomly selected pharmacies (one chain, one independent) in US counties reporting higher than average opioid overdose rates. Availability across pharmacy type (chain versus independent), county characteristics (rurality, region, overdose rate), and day of week were analyzed using univariate tests of categorical data. Independent predictors of buprenorphine availability were then identified using a multivariable binomial regression model. Results Among 921 pharmacies contacted (467 chain, 454 independent), 73 % were in urban counties and 42 % were in Southern states. Of these pharmacies, 675 (73 %) reported being able to dispense buprenorphine. There were 183 (20 %) pharmacies that indicated they would not dispense buprenorphine. Independent pharmacies (adjusted prevalence ratio [aPR], 1.59; 95 % CI 1.21–2.08) and pharmacies in Southern states (aPR 2.06; 95 % CI 1.43–2.97) were significantly more likely to restrict buprenorphine. Conclusions In US counties with high overdose mortality rates, one in five pharmacies indicated they would not dispense buprenorphine. Buprenorphine access limitations were more common among independent pharmacies and those in Southern states. Pharmacy-directed interventions may be necessary to ensure timely buprenorphine access for patients with opioid use disorder.

PURPOSE We examined the impact on geographic distribution of medications to treat opioid use disorder (MOUD) in Oregon after the Comprehensive Addiction and Recovery Act (CARA) was implemented in February 2017 to include nurse practitioner (NP) prescribers. METHODS We conducted interrupted time series analysis with linear regression on prescriptions dispensed for buprenorphine used for MOUD in the Oregon Prescription Drug Monitoring Database written by physician (MD/DO) and NP prescribers January 1, 2016, to December 31, 2018. We analyzed total prescriptions by prescriber type and pharmacy ZIP Code using STATA 16.1. FINDINGS From January 1, 2016, to December 31, 2018, 420,765 eligible prescriptions were written by waivered MD/DO and/or NP prescribers. Prior to CARA, buprenorphine use was increasing steadily at 140 prescriptions per month (95% CI: 78-201; P < .01). Following CARA, dispensing increased by 88 prescriptions per month (95% CI: 23-152; P = .01). The absolute number increased in rural areas immediately after CARA implementation (368 prescriptions; 95% CI: 124-613; P < .01). NP contribution to total buprenorphine prescribing increased significantly in both urban and rural areas (0.44% per month [95% CI: 0.30%-0.57%; P < .01] and 0.74% per month [95% CI: 0.62%-0.85%; P < .01]). The contribution of NPs had a particularly large impact for very rural (frontier) areas, where NPs provided 36% of all buprenorphine prescriptions by the end of 2018. CONCLUSION Changes in federal law regarding MOUD had a positive impact on both supply and geographic distribution in Oregon, particularly in frontier areas comprising 10 of 36 counties (27%).

Objective:To determine the association between Medicare Part D Plan disease-modifying therapy (DMT) restrictiveness and adherence and outcomes among people with multiple sclerosis (MS)Methods:We used Medicare claims data from 2010 to 2014 to identify individuals with a full year enrollment (Part A, B, D), an MS diagnosis, and one or more self-administered DMT prescription. Plans were considered restrictive if all available DMTs required a prior authorization or step therapy restriction; otherwise they were considered permissive. We compared DMT adherence, defined as a medication possession ratio (MPR) >=80%, MS-related emergency department (ED) or inpatient admissions, and outpatient visits by Part D plan restrictiveness. We used multivariate regression models to control for patient demographics and comorbidities.Results:There were 37,713 Medicare beneficiaries with MS who were enrolled in either restrictive (n=29,901) or permissive (n=7812) Part D plans during the study period. Patients enrolled in restrictive plans were older (60 versus 58 years; pConclusions:Medicare beneficiaries with MS enrolled in restrictive Part D plans were less adherent to their DMT and had higher rates of MS-related outpatient visits.

This cross-sectional study evaluates opioid prescribing patterns from 2009 to 2018 in a network of community health centers that frequently treat low-income patients in the US., Key Points Question Are there prescribing patterns for opioid medications in safety-net clinics? Findings In this cross-sectional study of 3 227 459 opioid prescriptions abstracted from electronic health records of patients treated at a network of community health centers between January 1, 2009, and December 31, 2018, the number of prescriptions per 100 primary care patients decreased 73.7% from 110.8 in 2009 to 29.1 in 2018. Other metrics of opioid use decreased to a similar degree. Meaning Opioid prescribing in a large network of community health centers decreased from January 1, 2009, to December 31, 2018, which likely reflects a mix of federal, state, and local policies and initiatives directed at reducing harms associated with increased opioid prescribing in the early 2000s., Importance Understanding opioid prescribing patterns in community health centers (CHCs) that disproportionately serve low-income patients may help to guide strategies to reduce opioid-related harms. Objective To assess opioid prescribing patterns between January 1, 2009, and December 31, 2018, in a network of safety-net clinics serving high-risk patients. Design, Setting, and Participants Cross-sectional study of 3 227 459 opioid prescriptions abstracted from the electronic health records of 2 129 097 unique primary care patients treated from 2009 through 2018 at a network of CHCs that included 449 clinic sites in 17 states. All age groups were included in the analysis. Main Outcomes and Measures The following measures were described at the population level for each study year: (1) percentage of patients with at least 1 prescription for an opioid by age and sex, (2) number of opioid prescriptions per 100 patients, (3) number of long-acting opioid prescriptions per 100 patients, (4) mean annual morphine milligram equivalents (MMEs) per patient, (5) mean MME per prescription, (6) number of chronic opioid users, and (7) mean of high-dose opioid users. Results The study population included 2 129 097 patients (1 158 413 women [54.4%]) with a mean (SD) age of 32.2 (21.1) years and a total of 3 227 459 opioid prescriptions. The percentage of patients receiving at least 1 opioid prescription in a calendar year declined 67.4% from 15.9% in 2009 to 5.2% in 2018. Over the 10-year study period, a greater percentage of women received a prescription (13.1%) compared with men (10.9%), and a greater percentage of non-Hispanic White patients (18.1%) received an opioid prescription compared with non-Hispanic Black patients (9.5%), non-Hispanic patients who self-identified as other races (8.0%), and Hispanic patients (6.9%). The number of opioid prescriptions for every 100 patients decreased 73.7% from 110.8 in 2009 to 29.1 in 2018. The number of long-acting opioids for every 100 patients decreased 85.5% during the same period, from 22.0 to 3.2. The MMEs per patient decreased from 1682.7 in 2009 to 243.1 in 2018, a decline of 85.6%. Conclusions and Relevance In this cross-sectional study, the opioid prescribing rate in 2009 in the CHC network was higher than national population estimates but began to decline earlier and more precipitously. This finding likely reflects harm mitigation policies and efforts at federal, state, and clinic levels and strong clinical quality improvement strategies within the CHCs.

RESEARCH OBJECTIVE: The impact of prescribing initiatives that encourage dose reductions is still largely unknown. Our objective was to determine whether the degree of opioid dose reduction among patients with high‐dose chronic opioid treatment (COT) associates with suicide, opioid overdose, other opioid‐related adverse events, or buprenorphine fills. STUDY DESIGN: In this retrospective cohort study, we identified patients with COT in 2014 or 2015 with 12 months of follow‐up to determine opioid dose trajectory and an additional 12 months of follow‐up to identify outcomes. We characterized dose trajectories in 12 months after a period of COT as abrupt discontinuation, dose reduction with discontinuation, dose reduction without discontinuation, and no dose reduction or discontinuation. We also characterized the effect of patient demographics (age, race, gender, rural vs. urban), prescription profile during COT, and diagnoses of alcohol abuse, depression, or any drug abuse. Multivariate logistic regression was used to examine the effect of dose trajectories on suicide (fatal or non‐fatal), opioid overdose (fatal or non‐fatal), other adverse events, and buprenorphine fills in the following year. Other adverse events included a diagnosis of adverse effects, opioid abuse, opioid dependence, or unspecified opioid use diagnosed in outpatient, inpatient (hospital), or emergency department settings. POPULATION STUDIED: We studied 17,990 continuously enrolled Medicaid recipients in Oregon with high‐dose COT. All analyses used the Oregon Medicaid claims data linked with the Oregon Prescription Drug Monitoring Program (PDMP) and vital statistics data sets covering calendar years 2014 to 2017. PRINCIPAL FINDINGS: In the 12 months after the high‐dose COT period, there were 1,328 (7.38%) individuals with an abrupt discontinuation, 2,953 (16.41%) with a dose reduction with discontinuation, 4,282 (23.8%) with a dose reduction without discontinuation, and 9,427 (52.40%) with no dose reduction or discontinuation. Patients who abruptly discontinued had the highest odds of fatal or nonfatal suicide (adjusted odds ratio (aOR) 12.1, 95% confidence interval (CI) 3.5, 41.6), fatal or nonfatal overdose (aOR 2.6, 95% CI 1.4, 4.7), or other adverse events (aOR 2.0, 95% CI 1.4, 2.7). Among those who had an opioid overdose, patients who discontinued opioid use after COT were more likely to overdose on heroin than those who did not discontinue opioid use (P

Access to providers of treatment for opioid use disorder is a critical challenge to confronting the opioid epidemic. In 2017, the Comprehensive Addiction and Recovery Act (CARA) expanded buprenorphine prescribing privileges to nurse practitioners (NP). This research examined the effect of this regulatory change on buprenorphine prescribing in the state of Oregon. We performed an interrupted time‐series (ITS) analysis to examine the effect of CARA implementation (February 2017) on buprenorphine prescribing for medications to treat opioid disorders (MOUD) from January 1, 2016 to December 31, 2018. Specifically, we characterized changes in the trend and patterns of buprenorphine prescribing overall, by prescriber type (NPs vs MD/DO), and geographic designation. Our ITS regression models estimated prepolicy trends, immediate changes after CARA implementation, and changes in trend following implementation. We used Oregon Prescription Drug Monitoring Program data linked to a provider and dispensing characteristic files. Our study sample post‐CARA included 179 NPs with a total of 440 525 buprenorphine prescriptions statewide written by all prescribers. Prior to CARA implementation, the trend in total buprenorphine dispensing was increasing by 149 prescriptions per month (P

The net effects of prescribing initiatives that encourage dose reductions are uncertain. We examined whether rapid dose reduction after high dose chronic opioid treatment (COT) associates with suicide, overdose, or other opioid-related adverse events. This retrospective cohort study included Oregon Medicaid recipients with high-dose COT. Claims were linked with prescription data from the Prescription Drug Monitoring Program (PDMP) and death data from vital statistics, 2014 to 2017. Participants were placed into four mutually exclusive dose trajectory groups following the high-dose COT period, and Cox proportional hazard models were used to examine the effect of dose changes on patient outcomes in the following year. Of the 14,596 high-dose COT patients, 4,191 (28.7%) abruptly discontinued opioid prescriptions, 1,648 (11.3%) reduced opioid dose prior to discontinuing, 6,480 (44.4%) had a dose reduction but never discontinued, and 2,277 (15.6%) had a stable or increasing dose. Discontinuation, whether abrupt (adjusted hazard ratio (aHR) 3.63; 95% CI 1.42-9.25) or with dose reduction (aHR 4.47, 95% CI 1.68-11.88) significantly increased risk of suicide compared to those with stable or increasing dose. In contrast, discontinuation or dose reduction reduced the risk of overdose compared to those with a stable or increasing dose (aHR 0.36 - 0.62, 95% CI 0.20 - 0.94). Patients with an abrupt discontinuation were more likely to overdose on heroin (vs. prescription opioids) than patients in other groups (p

Objective\ud \ud To estimate differences in treatment costs and health outcomes between non-myeloablative hematopoietic stem cell transplantation (HSCT) and disease-modifying therapies (DMTs) for the treatment of relapsing-remitting multiple sclerosis (RRMS).\ud \ud \ud Methods\ud \ud We collected data on costs and reimbursements for patients who underwent HSCT for RRMS at Northwestern Memorial Hospital in Chicago (USA) between January 2017 and January 2019. The costs of HSCT were compared against those for DMTs in the United States, obtained from the literature. We also conducted a literature review to interpret the cost comparisons in terms of disease control and patients’ wellbeing defined as no evidence of disease activity (NEDA), neurologic disability by the Expanded Disability Status Scale (EDSS), and quality of life by the short form SF-36, respectively.\ud \ud \ud Results\ud \ud Outside of the data, herein, no other studies on cost of HSCT for RRMS were found in the literature. HSCT mean total costs, based on our own hospital, were $85,184 (range $70,635 to $120,260). Mean revenue collected was $95,268 (range $16,544 to $173,204). In comparison, according to the literature, 2019 DMT costs in the USA ranged from $80,000 to $100,000 per year per patient. Compared to DMTs, studies of HSCT reported greater improvement in no evidence of disease activity, disability, and quality of life.\ud \ud \ud Limitations\ud \ud Costs of HSCT would be expected to vary by conditioning regimen utilized, patient selection, center experience, and regional variation. No cost data on other HSCT regimens or on the three most recently licensed DMTs, alemtuzumab, ocrelizumab, and cladribine, are available. Randomized trials for cost comparisons are missing and variations in HSCT designs, populations, and methodology preclude more precise cost estimates.\ud \ud \ud Conclusion\ud \ud Costs of non-myeloablative HSCT after which DMTs are indefinitely discontinued, are approximately the same cost as those for one year of prescription DMTs. Since DMTs assessed in this analysis are given on an ongoing basis, whilst HSCT is not, HSCT is expected to produce long-term cost-savings. When considered alongside the available clinical evidence, which suggests that HSCT may generate more health gains than DMTs, HSCT is likely to represent a cost-effective use of resources. Model-based health economic analyses are required to substantiate this conclusion.

ObjectiveTo describe recommendations made by an interdisciplinary controlled substance committee and acceptance by primary care providers.DesignRetrospective cohort study.SettingMultisite federally qualified health center using an interdisciplinary committee to provide patient-specific recommendations to prescribers with patients using prescription opioids and other controlled substances.SubjectsPatients prescribed long-term opioids.MethodsWe identified and characterized committee recommendations to prescribers between January 1, 2013, and December 31, 2016. We manually reviewed electronic medical records to determine if recommendations were accepted at eight months. The primary outcome was the overall acceptance rate of recommendations. Secondary outcomes were the acceptance of recommendations to reduce opioid doses and change in opioid dose from baseline.ResultsThe committee made 337 recommendations for 94 patients. Of those, 169 recommendations (50.1%) were accepted within eight months. The most common recommendation was to change opioid prescribing (N = 53, 56.4%), but recommendations varied. For patients with a recommendation to change opioid prescribing, this was accepted in 31 of 53 patients (58.5%). Overall, opioid doses decreased from 60 morphine equivalents per day (interquartile range [IQR] = 27.5–135, range = 5–1,260) at baseline to 40 morphine equivalents per day (IQR = 15–105, range = 0–1,260) at eight months (P ConclusionsAn interdisciplinary committee was well positioned to offer primary care providers with nonopioid options to manage chronic nonmalignant pain and provide support in reducing opioid doses. About half of recommendations were accepted by primary care providers. Future research should focus on strategies to improve the utility of this approach and its impact on clinical outcomes.

PURPOSE: Public and private payers have implemented benefit limitations to reduce high-risk opioid prescriptions. The effect of these policies on the increase of out-pocket payment is unclear. To understand this gap, we compared the discrepancies in trends between opioid prescription fills vs claims among Medicaid beneficiaries. METHODS: Data from the Oregon Prescription Drug Monitoring Program (PDMP) and Oregon Medicaid administrative claims were used to identify Medicaid beneficiaries 18 years and older enrolled at least one full month from 2015 to 2017. Generalized linear models assessed the trends in the monthly rates of opioid PDMP prescription fills and pharmacy claims per 1000 eligible members. Rates by morphine equivalent dose (MED) tier (120 MED) and co-prescribed opioid and benzodiazepine were also assessed. RESULTS: During the study period, an average of 495 355 Medicaid members had 2 797 054 opioid PDMP fills and 2 472 155 opioid Medicaid pharmacy claims. Study participants had 15.4 (95% confidence interval [CI] 13.6 to 17.0; P < .001) more prescriptions per 1000 member per month in the PDMP data (114.1 [SD 7.4]) compared with the Medicaid claims data (98.7 [SD 7.9]). Similarly, there were 1.9 more co-occurring opioid/benzodiazepine prescriptions per 1000 members per month observed in the PDMP data than the Medicaid claims data (95% CI 1.7 to 2.1; P < .001). At each MED tier, the PDMP fills were consistently higher than the claims (P < .001). CONCLUSIONS: Higher rate of fills in the PDMP compared to pharmacy claims suggests that there may be an increasing trend of out-of-pocket payment among Medicaid beneficiaries.

Co-occurring heroin and methamphetamine use is a growing public health problem. This study assessed the characteristics of Medicaid patients admitted to substance use disorder (SUD) treatment programs for heroin and methamphetamine use compared with patients admitted for heroin only.The study identified patients who entered treatment for heroin and methamphetamine and those admitted for heroin only between 2014 and 2017 from the Oregon Treatment Episode Data Set linked with Medicaid enrollment, and medical and pharmacy claims. We used a cross-sectional design to compare demographics, type of treatment, and substance use characteristics between the two groups. We used logistic regression models to assess differences in the odds of opioid-related and all-cause adverse events.Among the 3802 study sample, 2004 (53%) were admitted for both heroin and methamphetamine use. The heroin and methamphetamine group were more likely to be younger, female, White or American Indian/Alaska Native; and had more comorbidities than patients admitted for heroin only. Patients admitted for heroin and methamphetamine treatment were less likely to receive any medication for opioid use disorder (MOUD) (56% vs 75%, p 0.001) and received fewer days of MOUD treatment (mean 188 vs. 265 days, p 0.001) compared to the heroin only group. The heroin and methamphetamine group were more likely to receive buprenorphine (28.1% vs 24.2%) and less likely to receive methadone (39.9% vs 62.5%). The heroin and methamphetamine group began use at a younger age, used and injected more frequently than those admitted for heroin only. Patients treated for heroin and methamphetamine had 17% lower odds of OUD-related adverse events (aOR 0.83; 95% CI 0.70-0.99) and 52% higher odds of all-cause adverse events (aOR 1.52; 95% CI 1.14-2.03) relative to the heroin only group.Patients admitted for both heroin and methamphetamine reported greater addiction severity (more frequent use, earlier onset of use, and injection use), yet less commonly received MOUD compared to those who were admitted for heroin only. These findings indicate substantial missed opportunities for MOUD treatment even among people who successfully engage with the SUD treatment system.

Background Although prescription drug monitoring programs (PDMPs) have been widely implemented to potentially reduce abuse of prescription opioids, there is limited data on variations in PDMP use by prescriber specialty. Such knowledge may guide targeted interventions to improve PDMP use. Methods Using data from Washington state Medicaid program, we performed a retrospective cohort study of opioid prescribers and their PDMP queries between Nov 1, 2013 and Oct 31, 2014. PDMP registration was mandatory for emergency physicians, but not for other providers. The unit of analysis was the prescriber. The primary outcome was any prescriber queries of the PDMP. We used multivariate regression models to identify variations in PDMP queries by prescriber specialty, as well as to explore explanatory pathways for observed variations. Results We studied 17,390 providers who prescribed opioids, including 8718 (50%) who were not registered with PDMP, 4767 (27%) who were registered but had no recorded use of the PDMP, and 3905 (23%) PDMP users (queries/user: median 18, IQR 5–64). Compared to general medicine physicians, PDMP use was higher for emergency physicians (OR 1.4, 95%CI: 1.2–1.7), and lower for surgical specialists (OR 0.1, 95%CI: 0.08–0.1), obstetrician-gynecologists (OR 0.2, 95%CI: 0.1–0.2) and dentists (OR 0.4, 95%CI: 0.4–0.5). Higher use by emergency physicians appeared to be mediated by higher registration rates, rather than by provider level predilection to use the PDMP. Conclusions A minority of opioid prescribers to Medicaid beneficiaries used the PDMP. We identified variations in PDMP use by prescriber specialty. Interventions to increase PDMP queries should target both PDMP registration and PDMP use after registration, as well as specialties with current low use rates.

Background Oregon's Medicaid program is delivered through 16 Coordinated Care Organizations (CCOs) participating in a statewide performance improvement program to reduce high-dose opioid prescribing. CCOs were allowed flexibility to develop their own dose targets and any policies, trainings, guidelines, and/or materials to meet these targets. In this study, we characterize CCO strategies to reduce high-dose opioid prescribing across the 16 CCOs. Methods We reviewed relevant CCO documents and conducted semi-structured interviews with CCO administrators to acquire opioid-related policies, practices, timelines and contextual factors. We applied a systematic coding procedure to develop a comprehensive description of each CCO's strategy. We used administrative data from the state to summarize contextual utilization data for each CCO. Results Most CCOs selected a target daily morphine milligram equivalent (MME) dose of 90 mg. Sixteen issued quantity limits related to dose, eight restricted specific drug formulations (short-acting or long-acting), and 11 allowed for time-limited taper plan periods for patients over threshold. Many CCOs also employed provider trainings, feedback reports, and/or onsite technical assistance. Other innovations included incentive measures, electronic health record alerts, and toolkits with materials on local alternative therapy resources and strategies for patient communication. CCOs leveraging collaborations with regional partners appeared to mount a greater intensity of interventions than independently operating CCOs. Conclusions CCOs developed a diversity of interventions to confront high-risk opioid prescribing within their organization. As healthcare systems mount interventions to reduce risky opioid prescribing, it is critical to carefully describe these activities and examine their impact on process and health outcomes.

Objective While literature on pharmacists' engagement with prescription drug monitoring programs (PDMPs) is growing, no formal synthesis of findings has been conducted to provide overarching recommendations for research or practice. The objective of this study was to identify and synthesize findings from current literature on community pharmacists' attitudes toward, knowledge of, and registration and utilization behaviors regarding PDMPs. Data sources Electronic databases (MEDLINE, PsychINFO, Cochrane Database of Systematic Reviews, Google Scholar, and the Brandeis University PDMP Center of Excellence) and reference lists from relevant manuscripts were searched for relevant English-language manuscripts. Key words used in searches included pharmacist, prescription drug monitoring program, opioid safety, attitudes, knowledge, and utilization. Study selection Papers were included from January 1, 2008 up to October 6, 2017. Three authors independently screened articles for full text review; 2 authors independently conducted full text review for final study selection. Discrepancies were resolved through consensus. Data extraction Data were extracted to an evidence table, coded by topic category, and checked for accuracy. Results Fifteen manuscripts met inclusion criteria. The studies varied greatly in methodological approach. In general, pharmacists' attitudes and knowledge of PDMPs positively influenced likelihood to register and use their state's program. Targeted training had a substantial impact on knowledge, registration, and utilization. Conclusion Pharmacist-targeted PDMPs and opioid safety training is highly recommended to increase knowledge of and insight into behavioral change.

Background and aims In response to the opioid overdose epidemic, US state Medicaid programs have adopted restrictive policies for opioid analgesics, yet effects on prescribing patterns and health outcomes are uncertain. This study aimed to examine effects of a prior authorization policy for extended-release/long-acting (ER/LA) opioids on opioid use in the Oklahoma, USA state Medicaid program. Design Retrospective difference-in-differences design study comparing changes in opioid use in Oklahoma Medicaid to control (Oregon Medicaid). Setting Oklahoma and Oregon, USA. Participants Medicaid beneficiaries in the Oklahoma and Oregon fee-for-service Medicaid programs between July 2007 and June 2009 (33 724 in Oklahoma and 13 520 in Oregon) MEASUREMENTS: The primary outcome was incident opioid-naive ER/LA opioid use. Secondary outcomes included other opioid and non-opioid pain medication use. We also examined indicators of high-risk prescribing (e.g. high-dosage opioid use) and opioid-related hospitalizations or emergency department (ED) visits. Findings The prior authorization policy was associated with a 0.7 percentage point reduction in the likelihood of incident opioid-naive ER/LA opioid use [95% confidence interval (CI) = -1.16 to -0.33 percentage points; 70% pre-policy mean reduction, a 1.4 percentage point decrease in likelihood of any new ER/LA opioid prescriptions (95% CI = -2.1 to -0.7 percentage points; 33% pre-policy mean reduction) and a decline of 0.16 in total ER/LA opioid prescriptions per enrollee (PPE) (95% CI = -0.29 to -0.04 PPE)]. There was a significant increase in the number of short-acting opioids filled after the policy (0.36; 95% CI = 0.22-0.50 PPE), increases in likelihood of having overlapping opioids and benzodiazepines, but significant reductions in likelihood of having overlapping opioids. No significant changes in opioid-related hospitalizations or ED visits were observed. Conclusions In Oklahoma, USA's July 2008 prior authorization policy for extended-release/long-acting opioids appears to have reduced the number of opioid-naive patients initiating extended-release/long-acting opioid use by more than half, but may also have increased short-acting opioid prescriptions by 7%.

Background High dosage opioid use is a risk factor for opioid-related overdose commonly cited in guidelines, recommendations, and policies. In 2012, the Oregon Medicaid program developed a prior authorization policy for opioid prescriptions above 120 mg per day morphine equivalent dose (MED). This study aimed to evaluate the effects of that policy on utilization, prescribing patterns, and health outcomes. Methods Using administrative claims data from Oregon and a control state (Colorado) between 2011 and 2013, we used difference-in-differences analyses to examine changes in utilization, measures of high risk opioid use, and overdose after introduction of the policy. We also evaluated opioid utilization in a cohort of individuals who were high dosage opioid users before the policy. Results Following implementation of Oregon's high dosage policy, the monthly probability of an opioid fill over 120 mg MED declined significantly by 1.7 percentage points (95% confidence interval [CI]; -2.0% to -1.4%), whereas it increased significantly by 1.0 percentage points (95% CI 0.4% to 1.7%) for opioid fills < 61 mg MED. Fills of medications used to treat neuropathic pain also increased by 1.2 percentage points (95% CI 0.7% to 1.8%). The monthly probability of multiple pharmacy use declined by 0.1 percentage points (-0.2% to -0.0) following the prior authorization, but there were no significant changes in ED encounters or hospitalizations for opioid overdose. Among individuals who were using a high dosage opioid before the policy, there was a 20.3 percentage point (95% CI -15.3% to -25.3%) decline in estimated probability of having a high dosage fill after the policy. Conclusions Oregon's prior authorization policy was effective at reducing high dosage opioid prescriptions. While multiple pharmacy use also declined, we found no impact on opioid overdose were observed.

Multiple sclerosis (MS) is a disabling, chronic disease that imposes a significant economic burden on patients and the US healthcare system. The largest cost component for individuals with MS are prescription drugs, specifically disease-modifying therapies (DMTs). Despite an increase in the number and diversity of DMTs over the past 10 years, acquisition costs for all DMTs have escalated dramatically at rates substantially higher than medical inflation. Currently, costs for most DMTs exceed $70,000 a year. Recent cost-effectiveness studies suggest the cost for nearly all DMTs exceeds generally accepted thresholds for what is considered a good value in the USA, even after factoring expected rebates. The high cost of DMTs is symptomatic of systemic dysfunction in the pharmaceutical market. Strategies aimed at reigning in high-cost medications include proposals ranging from increasing pricing transparency to allowing Medicare to negotiate directly with manufacturers. Because the economics of pharmaceuticals are inherently complex, a diversity of approaches will be required.