Auditing the prescription drug consumer price index in a changing marketplace.

Changes in the dynamics of prescription drug markets have raised issues regarding whether the United States Bureau of Labor Statistics' (BLS') Prescription Drug Consumer Price Index (CPI-Rx) has adequately kept up with the evolving marketplace. The CPI-Rx limits its sampling frame to retail outpatient outlets and excludes prescription pharmaceuticals dispensed in non-retail settings such as hospitals, physician/clinic outpatient facilities, and nursing homes. Thus, the CPI-Rx overlooks the increasingly important specialty pharmaceuticals dispensed in non-retail settings, whose transactions are instead captured in the overall hospital and professional services component of the medical care CPI. Specialty drugs now account for about 55% of all U.S. drug spending, double the share of a decade earlier. To the extent specialty drug price growth differs from that of traditional pharmaceuticals, the CPI-Rx could provide an inaccurate measure of overall drug price inflation. We calculate a chained Laspeyres CPI using data from the Merative™ MarketScan® Databases for the years 2010-2019 and IQVIA-designated specialty drugs and offer evidence showing that by not sampling specialty drugs in non-retail settings, the CPI-Rx has understated overall U.S. prescription drug inflation by just under 75 basis points annually. We discuss implications for health care policy and suggest the BLS examine the feasibility of publishing an overall pharmaceutical price index incorporating both traditional and specialty pharmaceuticals dispensed in retail and non-retail settings.

Investing in Certified Community Behavioral Health Centers to Fulfill Their Promise.

Certified community behavioral health centers (CCBHCs) were established under section 223 of the Protecting Access to Medicare Act of 2014. CCBHCs had the goal of expanding access to care for people with behavioral health needs "regardless of ability to pay and place of residence." The authors used descriptive tables and a heat map to compare the geographic distribution of CCBHCs with county-level rates of mental illness, poverty, and population density. Regression models were employed to determine which county-level characteristics are most strongly associated with the establishment of a CCBHC. The authors found that population density is a stronger predictor of CCBHC presence than are rates of poverty or serious mental illness. Holding all other local characteristics constant, the authors observed that going from the population density typical of the most rural counties to that of the most urban counties was associated with an approximately 28-percentage-point increase (from 7% to 35%) in the likelihood of being served by a CCBHC. Expanding CCBHC services to areas with lower population densities likely requires an approach that is different from the current method of allocation of grant funds by the Substance Abuse and Mental Health Services Administration (SAMHSA). Two features of the program might be modified. The first would build on flexibilities incorporated into the most recent round of SAMHSA grantmaking, which explicitly aim to build infrastructure and capacity to develop a CCBHC. A second modification might seek to identify which certification requirements are essential to supporting CCBHC quality and access and eliminate nonessential requirements.

Improving Labor Outcomes among People with Mild or Moderate Mental Illness through Law and Policy Reform.

Mild and moderate mental illnesses can hinder labor force participation, lead to work interruptions, and hamper earning potential. Targeted interventions have proven effective at addressing these problems. But their potential depends on labor protections that enable people to take advantage of these interventions while keeping jobs and income.

Gone Too Soon: priorities for action to prevent premature mortality associated with mental illness and mental distress.

Globally, too many people die prematurely from suicide and the physical comorbidities associated with mental illness and mental distress. The purpose of this Review is to mobilise the translation of evidence into prioritised actions that reduce this inequity. The mental health research charity, MQ Mental Health Research, convened an international panel that used roadmapping methods and review evidence to identify key factors, mechanisms, and solutions for premature mortality across the social-ecological system. We identified 12 key overarching risk factors and mechanisms, with more commonalities than differences across the suicide and physical comorbidities domains. We also identified 18 actionable solutions across three organising principles: the integration of mental and physical health care; the prioritisation of prevention while strengthening treatment; and the optimisation of intervention synergies across social-ecological levels and the intervention cycle. These solutions included accessible, integrated high-quality primary care; early life, workplace, and community-based interventions co-designed by the people they should serve; decriminalisation of suicide and restriction of access to lethal means; stigma reduction; reduction of income, gender, and racial inequality; and increased investment. The time to act is now, to rebuild health-care systems, leverage changes in funding landscapes, and address the effects of stigma, discrimination, marginalisation, gender violence, and victimisation.

Toward Greater Accountability in Mental Health Care.

Lack of accountability contributes to the gap between best practices and potential outcomes. Few mental health providers routinely practice evidence-based care. In fact, within the mental health field, there is significant controversy over the use of evidence-based practices. Lack of accountability affects individuals receiving care at the patient level, provider level, and systems level. The authors identify several impediments to accountability in behavioral health care. These include failure to develop a diverse, well-trained workforce; challenges in measurement; misalignment of payment incentives; and misguided regulations. Accountability arrangements typically consist of several elements: a clear articulation of goals, objectives, or standards; metrics so that progress toward achieving goals can be tracked; and consequences for insurers, providers, and professionals for achieving or failing to achieve objectives. To advance system goals, the full complement of accountability tools should be consistently applied to all sources of behavioral health care and supports. The authors focus on three sets of accountability tools-performance metrics, payment incentives, and regulatory standards-that when implemented thoughtfully can help move the field toward more positive outcomes in behavioral health.

Accelerated Approval Of Cancer Drugs: No Economic Reward For Drug Makers That Conduct Confirmatory Trials.

The Food and Drug Administration uses expedited approval of drugs to speed the development and assessment of drugs that address unmet needs related to serious or life-threatening conditions. Drugs approved via this route rely on surrogate endpoints or other clinical indicators that are not direct measures of benefits to patients, such as survival or quality of life. Companies are required to conduct a clinical trial confirming that a drug provides long-term benefits that are clinically meaningful, but prompt completion of these trials frequently does not occur. Theory suggests that because confirmatory trials reduce uncertainty, they should provide an economic reward in the form of higher prices for a positive finding. We used a sample of physician-administered cancer drugs and data on average sales price to test this hypothesis. We found no significant relationship between confirmatory trial completion with a positive outcome and elevated prices. This represents a failure of the market to reward reduced uncertainty about a cancer drug's true benefits. This inefficiency would be mitigated if major payers such as Medicare built price schedules that directly rewarded completion of confirmatory trials. More completed trials would ensure that patients are receiving truly effective chemotherapies and not suffering the adverse effects of drugs that are ultimately not effective.

Biosimilar competition: Early learning.

Biologics accounted for roughly $145 billion in spending in 2018. They are also the fastest growing segment of the pharmaceutical industry. The Biological Price Competition and Innovation Act (BPCIA) of 2010 created an abbreviated pathway for biosimilar products to promote price competition in the market for biological drugs. There was great anticipation that the BPCIA would lead to a moderation in drug prices driven by market competition. The observed levels of competition and the accompanying savings have not reached those expected levels. We investigate the early impacts of biosimilar competition on the use and pricing of biological products. We focus especially on the ways in which altered market structures stemming from the implementation of the BPCIA have affected the prices for biological products subject to biosimilar competition. We do so by studying seven products that have recently faced biosimilar competition. We estimate fixed effects and Instrumental Variables models to estimate the impact of market competition on prices. Our results indicate that in the range of one to three entrants each additional marketed product results in a reduction in weighted average market prices of between 5.4% and 7% points. These are the result of a combination of reductions in originator prices and shifting in demand to biosimilar products.

COMMENTARY: Medicaid Expansion and Mental Health Care and Coverage.

No abstract available.

The Evolution of Supply and Demand in Markets for Generic Drugs.

Policy Points Much concern about generic drug markets has emerged in recent policy debates. Important changes in regulations, the structure of purchasing, and the length of the drug supply chain have affected generic drug markets. Effective price competition remains the rule in generic markets for large-selling drugs. Smaller markets and those for injectable products often have less price competition and are more susceptible to supply disruptions. CONTEXT: The image of generic drugs as a commodity sold in competitive markets is an oversimplification, as evidenced by increasing accounts of price spikes, sustained high price-cost margins, and market disruptions. The mismatch between the canonical economic model of generic drug markets and reality motivated our empirical project. METHODS: To explore recent changes in those factors impacting the supply and demand for generic drugs, we studied, from a variety of sources, the data on price, competition, supply disruptions and recalls, changes to the supply chain, and buy-side concentration. We examined quarterly data through 2018 for a cohort of 77 molecules that lost patent protection during the so-called patent cliff between 2010 and 2013. FINDINGS: On the supply side, we found that for large-market oral solids, generic entry and price declines were consistent with past studies showing a significant number of market entrants and substantial reductions in the average price of a molecule. In smaller markets for oral solids and injectable products, we observed fewer entrants, higher rates of exit, smaller price reductions, and, in some cases, considerable price instability. The number of reported shortages increased across all generic market types over time, with the rate of shortage increases especially pronounced in markets for injectable products. The number of product recalls also rose over our study period. Although we did not estimate causal effects, we did find several changes in the market environment for generic drugs that may contribute to these phenomena. The demand side for generics has become more concentrated. Supply chains rely more on producers outside the United States (particularly from China and India). Contracting practices have undergone changes that may inhibit competition in product supply. FDA regulatory scruitiny has increased. CONCLUSIONS: Competition in generic drug markets varies widely by market size and product form. Recent changes in demand-side market structure imply more downward pressure on prices stemming from buy-side concentration. The FDA's greater regulatory oversight puts upward pressure on costs, and the lengthening of the supply chain increases production uncertainty for producers. Demand and supply-side changes point to further market instabilities across all generic markets due to producers' changing economic position.

Decline In New Starts Of Psychotropic Medications During The COVID-19 Pandemic.

COVID-19 interrupted delivery of mental health care in the US. During the initial course of the COVID-19 pandemic new starts of antidepressants declined by 7.5 percent, anxiolytics by 5.6 percent, and antipsychotics by 2.6 percent compared with expected levels. Our findings suggest that there is large unmet need for mental health treatment in the US due to COVID-19.

Admission Practices And Cost Of Care For Opioid Use Disorder At Residential Addiction Treatment Programs In The US.

The use of acute, short-term residential care for opioid use disorder has grown rapidly, with policy makers advocating to increase the availability of "treatment beds." However, there are concerns about high costs and misleading recruitment practices. We conducted an audit survey of 613 residential programs nationally, posing as uninsured cash-paying individuals using heroin and seeking addiction treatment. One-third of callers were offered admission before clinical evaluation, usually within one day. Most programs required up-front payments, with for-profit programs charging more than twice as much ($17,434) as nonprofits ($5,712). Recruitment techniques (for example, offering paid transportation) were used frequently by for-profit, but not nonprofit, programs. Practices including admission offers during the call, high up-front payments, and recruitment techniques were common even among programs with third-party accreditation and state licenses. These findings raise concerns that residential programs, including accredited and licensed ones, may be admitting a clinically and financially vulnerable population for costly treatment without assessing appropriateness for other care settings.