Association Between Pharmacy Benefit Restrictions and Disease-Modifying Therapy Use in the Medicare Part D Program.

Background and Objectives: 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 (Parts A, B, and D), an MS diagnosis, and 1 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 ≥80%, MS-related emergency department 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 vs 58 years; p < 0.001), more likely to live in the south (38% vs 23%; p < 0.001), eligible through disability (67% vs 60%; p < 0.001), and more likely to have several chronic comorbid conditions. Patients enrolled in restrictive plans were less likely to be adherent to their DMT (54% vs 57%; p < 0.001; adjusted odds ratio [aOR] 0.92, 95% confidence interval [CI] 0.88-0.98) and had a higher rate of MS-related outpatient visits (1.7 vs 1.4 per year; p < 0.001; aRR 1.27, 95% CI 1.23-1.31). Discussion: 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.

Characteristics of Prescription Drug Use Among Individuals With Multiple Sclerosis in the US Medicare Population.

Background: Few studies have characterized the full spectrum of prescription drug use for individuals with multiple sclerosis (MS). The objective of this study was to describe patterns and expenditures for disease-modifying therapies (DMTs) and other prescription drugs among Medicare beneficiaries with MS. Methods: Using Medicare claims data in 2014, we identified a cohort of Medicare beneficiaries with 12 months of continuous eligibility and 3 or more MS-related inpatient, outpatient, or prescription claims. We quantified the number, type, and costs of prescribed DMTs and other medications for MS-related symptoms. Medication costs were calculated according to whether beneficiaries received additional subsidies, which eliminate most out-of-pocket costs. Results: Of 43,283 Medicare beneficiaries identified with MS, 70% were DMT users. Most used self-administered DMTs (67%), and 3% used natalizumab; 93% received a supportive care medication. Among the 82% of individuals without subsidies, the annual median total and out-of-pocket DMT costs were $56,794 (interquartile range [IQR], $44,837-$62,038) and $4566 (IQR, $849-$5270), respectively. The most commonly used supportive care drugs were antidepressants (62%), opioid analgesics (50%), antispasticity drugs (47%), and anticonvulsants (46%). Annual median total and out-of-pocket costs for these drugs were $15,134 (IQR, $6571-$19,620) and $255 (IQR, $56-$877), respectively. Conclusions: Most Medicare beneficiaries with MS using DMTs face considerable out-of-pocket costs. Beneficiaries also used a significant number of medications potentially used for MS-related symptoms, although total and out-of-pocket costs were modest.

Closing the Part D Coverage Gap and Out-of-Pocket Costs for Multiple Sclerosis Drugs.

OBJECTIVE: To determine whether closing the Part D coverage gap (donut hole) between 2010 and 2019 lowered patients' out-of-pocket costs for disease-modifying therapies (DMTs) for multiple sclerosis (MS). METHODS: Using nationwide Medicare Formulary and Drug Pricing Files, we analyzed Part D drug benefit design and DMT prices in 2010, 2016, and 2019. We calculated average monthly list prices for DMTs available in each year (4 DMTs in 2010, 11 DMTs in 2016, and 14 DMTs in 2019). We projected patients' annual out-of-pocket cost for each DMT alone under a standard Part D plan in that year. We estimated potential savings attributable to closing the coverage gap between 2010 and 2019 (beneficiaries' cost sharing dropped from 100% to 25%) under 3 scenarios: no increase in price, an inflation-indexed price increase (3% annually), and the observed price increase. RESULTS: Median monthly DMT prices rose from $2,804 to $5,987 to $7,009 over the years 2010, 2016, and 2019, respectively. Median projected annual out-of-pocket costs rose from $5,916 to $6,229 to $6,618. With unchanged or inflation-indexed DMT price changes, closing the coverage gap would have reduced annual out-of-pocket costs by $2,260 (38% reduction) and $1,744 (29% reduction), respectively. Despite having the lowest monthly price, generic glatiramer acetate had among the highest out-of-pocket costs ($6,731 to $6,939 a year) in 2019. CONCLUSIONS: Medicare Part D beneficiaries can pay thousands of dollars yearly out of pocket for DMTs. Closing the Part D coverage gap did not reduce out-of-pocket costs for patients because of simultaneous increases in DMT prices.

Patterns of Prescription Opioid Use Prior to Self-reported Heroin Initiation.

OBJECTIVES: To determine the association between self-reported heroin initiation and patterns of prescription opioid use. METHODS: Using linked Oregon Medicaid, prescription drug monitoring program, and Treatment Episodes Data Set data, we conducted a case-control study of individuals reporting heroin initiation between 2015 and 2017 during treatment intake. Prescription drug monitoring program data provided prescription opioid use patterns, including long-term prescription opioid therapy, in the year before self-reported heroin initiation. Four controls were matched to each case on aggregate prescription opioid use and demographics. RESULTS: About half (49%) of individuals who reported heroin initiation filled an opioid in the year before initiation. Individuals who initiated heroin (n = 306) were more likely to receive prescriptions from multiple prescribers (24% vs 18%, P = 0.007) and pharmacies (12% vs 5%, P < 0.001) compared with matched controls (n = 1224). Long-term opioid therapy (13% vs 14%, P = 0.74) was uncommon and did not differ between groups. CONCLUSIONS: Although prescription opioid use commonly preceded self-reported heroin initiation, long-term opioid therapy was not common. Although this study did not find an association between opioid discontinuation and heroin initiation, sample size and follow-up limitations preclude definitive conclusions. Efforts to limit prescription opioids should continue to evaluate for unintended harms.

The effect of out-of-pocket costs on initiation of disease-modifying therapies among medicare beneficiaries with multiple sclerosis.

BACKGROUND: Medicare beneficiaries with multiple sclerosis (MS) often face high out-of-pocket (OOP) costs for disease-modifying therapies (DMTs). It is unclear how cost-sharing affects therapy initiation. OBJECTIVES: To estimate the effects of patient cost-sharing on initiation of a DMT among Medicare beneficiaries with a new diagnosis code for MS. METHODS: Using Medicare claims data from 2010 to 2014, we identified a cohort of individuals with at least one inpatient or two outpatient diagnostic claims for MS. We restricted this group to beneficiaries with continuous Part A, B, and D coverage in the year before and after their initial diagnosis. To estimate the effect of cost-sharing on time to self-administered DMT initiation, we compared beneficiaries with a Low-Income Subsidy (LIS), who are shielded from cost-sharing, to those without LIS using multivariate Cox Proportional Hazards models adjusting for potential demographic and health-related confounders. RESULTS: There were 39,661 Medicare beneficiaries who met inclusion criteria; 3827 had full LIS benefits throughout the study period. Beneficiaries were predominately White (36,447, 91.9%) and female (29,406, 74.1%). LIS recipients were generally younger (55 vs 67 years, p<0.001) and more likely to be enrolled through disability eligibility (79% vs 36%, p<0.001). In the year after their index diagnosis, 434 LIS recipients initiated DMT versus 1682 non-LIS (11% vs 5%; p<0.001). Among those who started a DMT, the average time to initiation was 115 days in those with LIS and 137 days for non-LIS (p<0.001). After adjustment for covariates, individuals with LIS benefits were significantly more likely to initiate a DMT in the year following their diagnosis (adjusted hazard ratio 1.4, 95% CI 1.25 to 1.57). The effect of OOP costs on initiation did not differ by demographic subgroups. CONCLUSIONS: Medicare beneficiaries with MS who are shielded from traditional cost-sharing are more likely to initiate a DMT in the year following receipt of their first diagnosis code. Future work should examine the effect of cost-related treatment delays on relapse rates and disability progression.

Prescription Opioid Dispensing Patterns Prior to Heroin Overdose in a State Medicaid Program: a Case-Control Study.

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 < 0.001). For both heroin- and non-heroin-involved overdose cases, the likelihood of receiving an opioid increased with age. Among heroin overdose cases with an opioid dispensed, the rate of multiple pharmacy use was the only high-risk opioid pattern that was greater than non-overdose controls (adjusted odds ratio 3.2; 95% confidence interval 1.48 to 6.95). Discontinuation of long-term opioid use was not common prior to heroin overdose and not higher than discontinuation rates among non-overdose controls. CONCLUSIONS: Although individuals with a heroin-involved overdose were less likely to receive prescribed opioids in the year preceding their overdose relative to non-heroin opioid overdose cases, prescription opioid use was relatively common and increased with age. Discontinuation of long-term prescription opioid use was not associated with heroin-involved overdose.

Effect of generic glatiramer acetate on spending and use of drugs for multiple sclerosis.

OBJECTIVE: To estimate changes in costs and utilization trends for disease-modifying therapies (DMTs) from 2011 to 2017 in the US Medicaid program. METHODS: Using quarterly Medicaid State Drug Utilization Data from 2011 to 2017, we summarize trends in spending, utilization, and costs per prescription for 15 multiple sclerosis (MS) DMTs including brand and generic versions of glatiramer acetate. We use interrupted time series regression to estimate the effect of market entry of generic glatiramer acetate on cost per prescription of other self-administered DMTs. RESULTS: Gross annual expenditures on MS DMTs increased from $453 million to $1.32 billion between 2011 and 2017 within the Medicaid program. Increased spending was primarily driven by increases in per prescription costs, which doubled during the study period. Although total utilization was stable, product specific utilization shifted from injectable to oral DMTs. However, throughout the study, the plurality of utilization was glatiramer acetate. The introduction of generic glatiramer acetate in Q2 of 2015 was associated with an immediate increase of $441 (95% confidence interval [CI] $184-$697; p < 0.001) in the cost per prescription of branded glatiramer acetate followed by a gradual $52 per prescription reduction (95% CI -$86 to -$18) over time. There were minimal changes in the costs for the other DMTs. CONCLUSIONS: Spending on MS DMTs in the Medicaid program have more than doubled over the last 7 years primarily as a function of higher costs per prescription. Introduction of a generic glatiramer acetate product in 2015 had nominal effects on overall price trajectories and utilization within the class.

Qualitative study on the price of drugs for multiple sclerosis: Gaming the system.

OBJECTIVE: To describe pricing decisions, justifications, and attitudes among current and former biotech industry executives for companies that manufacture multiple sclerosis disease-modifying therapies. METHODS: Four 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. RESULTS: Participants 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. CONCLUSIONS: Contrary 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.

Trends In Coverage For Disease-Modifying Therapies For Multiple Sclerosis In Medicare Part D.

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.