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1.
JAMA Netw Open ; 4(5): e218816, 2021 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-33944925

RESUMO

Importance: List prices set by manufacturers for brand-name prescription drugs in the US have been increasing faster than inflation, although confidential manufacturer rebates offset some of these increases. Most commercially insured patients pay at least some out-of-pocket costs for prescription drugs, and higher patient spending is associated with lower adherence and worse health outcomes. Objective: To examine whether price changes for brand-name drugs are correlated with changes in patient out-of-pocket spending and whether this association varies by insurance benefit design. Design, Setting, and Participants: A cohort study of 79 brand-name drugs with available pricing data from January 2015 to December 2017 was conducted, with data obtained from a national commercial insurance claims database. Exposures: Change in the list prices set by manufacturers and estimated net prices after rebates among non-Medicaid payers. Main Outcomes and Measures: Change in median out-of-pocket spending among all patients and stratified by insurance pharmacy benefit design, including high-deductible insurance plans and plans with any amount of deductibles or coinsurance. Results: Among 79 drugs, median increases were 16.7% (interquartile range [IQR], 13.6%-21.1%) for list prices, 5.4% (IQR, -3.9% to 11.7%) for net prices, and 3.5% (IQR, 1.4%-9.1%) for out-of-pocket spending from 2015 to 2017. Changes in list prices were correlated with changes in net prices (r = 0.34; P = .002). Overall, changes in out-of-pocket spending were not correlated with changes in list prices (r = 0.14; P = .22) or net prices (r = 0.04; P = .71). Among 53.7% of patients who paid any drug deductible or coinsurance, median out-of-pocket spending increased by 15.0%, and changes were moderately correlated with changes in list prices (r = 0.38; P = .001) but not net prices (r = 0.06; P = .62). Conclusions and Relevance: Some commercially insured patients who pay only prescription drug copayments appear to be insulated from increases in drug prices. However, more than half of patients pay deductibles or coinsurance and may experience substantial increases in out-of-pocket spending when drug prices increase. Among these patients, there was no evidence that manufacturer rebates to insurers are associated with patients' out-of-pocket spending. Policies to rein in unregulated annual increases in list prices for brand-name drugs may have important consequences for patient out-of-pocket spending.

2.
Health Aff (Millwood) ; 40(5): 772-778, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33939506

RESUMO

List prices for brand-name drugs have risen steeply, often despite the introduction of competition from other brand-name drugs in the same therapeutic class. List prices, however, do not reflect any rebates that manufacturers provide payers. To understand how net prices (after rebates and other discounts) respond to competition, we compared changes in inflation-adjusted, revenue-weighted mean list and net prices of a one-month supply of three classes of diabetes drugs: glucagon-like peptide 1 (GLP1) agonists, dipeptidyl peptidase 4 (DPP4) inhibitors, and sodium glucose cotransporter 2 (SGLT2) inhibitors. These drug classes each had several brand-name products enter the market between 2005 and 2017. The annualized change in list price over this period was $75 (15 percent) for GLP1 agonists, $22 (8 percent) for DPP4 inhibitors, and $41 (11 percent) for SGLT2 inhibitors. In contrast, the annualized change in net price was $38 (10 percent) for GLP1 agonists, -$3 (-2 percent) for DPP4 inhibitors, and -$17 (-9 percent) for SGLT2 inhibitors, suggesting a variable impact of brand-name competition on net prices.

3.
Health Aff (Millwood) ; 40(5): 779-785, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33939520

RESUMO

Although generic drugs are typically inexpensive, rising prices among some generic drugs in recent years have raised concern. Using Medicaid data, we found that one in five generic drugs sold in the US experienced a price spike (defined as a doubling in price over the course of one year) initiated by at least one manufacturer during the period 2014-17. There was a trend toward fewer price spikes each year, from 7.8 percent of drugs in 2014 to 5.8 percent in 2017. Among drugs experiencing price spikes, 51 percent were injected products, 64 percent had three or fewer manufacturers, and 18 percent were in shortage at the time of the spike. Generic drug price spikes cost Medicaid $1.5 billion during 2014-16, representing 4.2 percent of all Medicaid generic drug spending in that period. The trend toward fewer price spikes over time may be due to increased public scrutiny and regulatory actions. However, price spikes can be very costly, and additional policies are needed to both ensure adequate competition and control prices among generic drugs.

5.
Value Health ; 24(4): 473-476, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33840424

RESUMO

OBJECTIVES: Many countries use international (or external) reference pricing-benchmarking prices against those in other countries-to manage spending on prescription drugs. By contrast, the United States (US) allows manufacturers to set drug prices freely. In December 2019, a major bill passed the House of Representatives that would introduce international reference pricing to reduce US drug spending. In September 2020, President Trump issued an executive order to apply international reference pricing for drugs purchased under Medicare. As US policymakers consider adopting reference pricing, it is important to recognize four key administrative issues that have complicated other countries' experiences. METHODS: We analyzed the US policy proposals and literature on international experience with international reference pricing to identify implementation challenges and potential effects of US adoption of international reference pricing. RESULTS: Four key administrative issues were identified: lack of price transparency, delays in market approvals, the frequency of price revisions, and the prevalence of cross-referencing. CONCLUSIONS: Failure to account for the key issues in the emerging US approach will lead to overspending from overestimation of prices. Policymakers also need to recognize the collateral effects that the US adoption of international reference pricing may have on other countries' prices. Given the size of the pharmaceutical market in the US and other market issues, US reference pricing will likely increase drug list and net prices in other countries. Because of limitations in implementation and collateral effects, US policymakers should consider international reference pricing as a supportive tool alongside other cost containment policies, such as value-based pricing or volume agreements. International reference pricing could limit drug spending in the US but faces implementation challenges and will negatively affect other countries.

7.
Drug Saf ; 2021 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-33904111

RESUMO

INTRODUCTION: Since 2007, the US Food and Drug Administration has had the authority to require risk evaluation and mitigation strategy (REMS) programs for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Such programs can include requirements for patient monitoring, restrictions on dispensing or administration, and physician and pharmacy training and certification. However, there has been only scattered evidence on the impact of REMS programs on informed decision making, medication access, or patient outcomes. OBJECTIVE: The objective of this article was to describe a study that researchers at Brigham and Women's Hospital and Harvard Medical School will conduct in partnership with the Food and Drug Administration's Office of Surveillance and Epidemiology to investigate systematically how REMS programs have operated in practice. METHODS: Investigations include health insurance claims-based analyses to understand patterns of drug use, adherence to safety requirements, and patient outcomes under REMS programs; surveys and interviews to understand physician and patient experiences with REMS; and REMS program material-based and interview-based analyses to understand the effectiveness of risk communication in REMS programs. CONCLUSIONS: These research activities will evaluate the performance of REMS programs, provide information on the benefits and burdens to patients and healthcare providers, and generate recommendations for actionable steps to improve REMS programs overall.

8.
Clin Infect Dis ; 2021 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-33914860

RESUMO

One reason expressed in surveys of people reporting COVID-19 vaccine hesitancy is how rapidly these vaccines have reached the market. To estimate the length of time the COVID-19 vaccine spent in research and development as compared to other novel vaccines, we apply previously-established methods for estimating medical product development times, using the earliest associated patent filings cited by the manufacturer as the marker of when commercial development activity began. Applying these methods to a cohort of recently approved innovative vaccines and comparing them to the development time of the first-approved COVID-19 vaccine (BioNTech/Pfizer), we found patent filings for the technology in this COVID-19 vaccine occurred 10.0 years prior to regulatory authorization. Furthermore, the development timelines for innovative vaccines have been shortening since the 1980s and the COVID-19 vaccine comfortably fits within this pattern. Vaccine development timelines have now even drawn to parity with many of the most commonly-used drugs.

13.
Artigo em Inglês | MEDLINE | ID: mdl-33647951

RESUMO

CONTEXT: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled in United States v. Caronia that truthful off-label promotion was protected under the First Amendment, threatening government enforcement in this area. METHODS: The authors extracted cases from the WestLawNext database that mentioned Caronia from 2012 to 2019. They collected information about plaintiff, procedural history, product and manufacturer involved, and case outcome. Cases were categorized as either "follows," "does not follow," or "distinguishes" from Caronia. The authors qualitatively reviewed the full text of each case to verify whether Caronia was given substantive discussion for perceptions of off-label promotion, application of commercial speech rights, and how courts interpreted Caronia. FINDINGS: Among 42 cases in the study cohort, 22 (52%) followed Caronia's core holding that truthful, non-misleading off-label promotion was not actionable under FDA rules. By contrast, 20 cases (48%) treated Caronia negatively, either declining to follow (9 cases) or distinguishing it (11 cases). CONCLUSIONS: Enforcement on off-label marketing became more challenging after Caronia. This gives manufacturers greater flexibility to promote drugs for unapproved uses despite the substantial public health risks.

16.
Milbank Q ; 99(1): 240-272, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33751664

RESUMO

Policy Points  Spending on prescription drugs is much higher per capita in the United States than in most other industrialized nations, including France.  Lower prescription drug spending in France is due to different approaches to managing drug prices, volume of prescribing, and global health budgets.  Linking a drug's price to value both at the launch of the drug and over its lifetime is key to controlling spending. Regulations on prescription volume and global spending complement the interventions on prices.  If the United States adopted the French approach to regulating drug pricing, Medicare could potentially save billions of dollars annually on prescription drug spending. CONTEXT: Prescription drug spending per capita in the United States is higher than in most other industrialized countries. Policymakers seeking to lower drug spending often suggest benchmarking prices against other countries, including France, which spends half as much as the United States per capita on prescription drugs. Because differences in drug prices may result from how markets are organized in each nation, we sought to directly compare drug prices and pricing regulations between the United States and France. METHODS: For the six brand-name drugs with the highest gross expenditures in Medicare Part D in 2017, we compared the price dynamics in France and the United States between 2010 and 2018 and analyzed associations between price changes in each country and key regulatory events. We also comprehensively reviewed US and French laws and regulations related to drug pricing. FINDINGS: Prices for the six drugs studied were higher in the United States than in France. In 2018, if Medicare had paid French prices for the brand-name drugs in our cohort, the agency would have saved $5.1 billion. We identified 12 factors that explain why the United States spends more than France on drugs, including variations in unit prices and the volume of prescriptions, driven by use of health technology assessment and value-based pricing in France. CONCLUSIONS: Key drivers of lower drug spending in France compared to the United States are that the French government regulates drug prices when products are launched and prohibits substantial price increases after launch. The regulation of prescription drugs in France is governed by rules that can inform discussions of US prescription drug policy and potential Medicare price negotiations.


Assuntos
Redução de Custos , Regulamentação Governamental , Medicare Part D/economia , Medicamentos sob Prescrição/economia , Custos e Análise de Custo , Custos de Medicamentos/legislação & jurisprudência , França , Cobertura do Seguro , Legislação de Medicamentos , Estados Unidos
18.
Med Care ; 59(3): 266-272, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33560766

RESUMO

BACKGROUND: Opioid use disorder (OUD) affects millions of Americans, but only a fraction receive treatment. Many patients with OUD are enrolled in Medicaid, but elements of different state Medicaid programs' drug benefit designs may impact patients' access to life-saving care. OBJECTIVE: To describe medication for OUD (mOUD) use in Medicaid and examine the relationship between mOUD use and state drug benefit design plans. DESIGN/SUBJECTS: Cross-sectional study using Medicaid State Drug Utilization Data from 2018 to quantify office-based mOUD and the Medicaid Behavioral Health Services Database to extract copay amounts and coverage limits for mOUD. We excluded states with <5% coverage and assessed for associations between copays or coverage limits and mOUD dispensing using simple linear regression. MEASURES: Proportion of mOUD prescriptions relative to all prescriptions, opioid prescriptions, and the state-level prevalence of pain reliever use disorder and association between copays, coverage limits and these proportions. RESULTS: There was substantial variability in mOUD use. Although state Medicaid drug benefit designs also varied, we found no significant relationship between copay requirements (yes/no), coverage limits (yes/no), copay amount ($0-$0.99 vs. $1 or more), and mOUD utilization measures. CONCLUSIONS: Substantial state-level variation exists in mOUD use, but we did not find a significant association between copays or coverage limits and use in Medicaid. Further research is needed to assess other potential impacts of mOUD drug benefit design elements in Medicaid.

19.
Value Health ; 24(2): 182-187, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33518024

RESUMO

OBJECTIVE: Buprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions. METHODS: We first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA. We then used National Drug Codes to identify each drug in the Medicaid State Drug Utilization Data and extracted annual utilization rates and spending between 2002 and 2018 by drug and according to whether a brand-name or generic version was dispensed. We compared these trends to market and regulatory factors that affected competition, which we identified through searching the Federal Register, Westlaw, PubMed, and Google News. RESULTS: Brand-name buprenorphine-naloxone sublingual tablet and film formulations (Suboxone) were dispensed 2.7 times more (n = 634 213 140) and reimbursed 4.4 times more (n = $4 440 556 473) than all other formulations combined (n = 237 769 689; $1 018 988 133). We identified numerous market and regulatory factors that contributed to an estimated 9-year delay in generic versions of the tablet formulation and 6-year delay for generic versions of the film formulation. CONCLUSIONS: Brand-name buprenorphine formulations have been widely used in Medicaid, leading to substantial costs, in part because generic versions were delayed by multiple years owing to market and regulatory factors. Timely availability of low-cost generics could have helped encourage OUD treatment with buprenorphine during the height of the opioid crisis.


Assuntos
Buprenorfina/economia , Buprenorfina/uso terapêutico , Medicaid/economia , Antagonistas de Entorpecentes/economia , Antagonistas de Entorpecentes/uso terapêutico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Buprenorfina/administração & dosagem , Combinação Buprenorfina e Naloxona/economia , Combinação Buprenorfina e Naloxona/uso terapêutico , Uso de Medicamentos , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Competição Econômica , Humanos , Antagonistas de Entorpecentes/administração & dosagem , Tratamento de Substituição de Opiáceos/economia , Tratamento de Substituição de Opiáceos/métodos , Patentes como Assunto , Estados Unidos
20.
JAMA Intern Med ; 181(4): 490-498, 2021 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-33616607

RESUMO

Importance: Numerous cancer drugs have received accelerated approval from the US Food and Drug Administration (FDA) based on clinical trial outcomes that are otherwise not acceptable for traditional FDA approval; the accelerated approval process allows outcomes based on surrogate measures that are only reasonably likely to estimate clinical benefits. In England, the National Institute for Health and Care Excellence (NICE) evaluates the clinical benefits and cost-effectiveness of drugs after they have received regulatory approval and issues recommendations regarding their coverage in the National Health Service (NHS). However, the level of concordance between European and FDA decision-making in the context of drugs qualifying for FDA accelerated approval is unknown. Objective: To compare FDA accelerated approval decisions for cancer drugs with NICE coverage decisions. Design, Setting, and Participants: This retrospective cohort study compared cancer drug indications that received FDA accelerated approval from December 11, 1992, to May 31, 2017, with the same set of drug indication pairs in England until August 31, 2019. Data from European Public Assessment Reports developed by the European Medicines Agency (EMA) and public appraisal documents from NICE were used to determine NHS coverage recommendations. National Institute for Health and Care Excellence (NICE) public appraisal documents were analyzed for drug indications, characteristics of clinical evidence, cost-effectiveness, and coverage decisions. Data were analyzed from September 1 to December 31, 2019. Main Outcomes and Measures: Cancer drug indication coverage decision by NICE. Results: From 1992 to 2017, 93 cancer drug indications received FDA accelerated approval, 6 of which were subsequently withdrawn, leaving 87 cancer drug indications on the market. As of August 2019, 5 of these indications had been withdrawn or denied market authorization for the European Union by the EMA. From the cohort of EMA-approved drugs, an additional 7 drug indications were not recommended by NICE and were not deemed to have sufficient clinical benefits or cost-effectiveness to warrant mandatory public coverage in England; 5 drugs were not recommended based on clinical benefit and cost-effectiveness criteria, and 2 drugs were not recommended based on cost-effectiveness criteria alone. In total, 12 drug indications were not recommended for public coverage in the NHS, and an additional 30 drug indications were not reviewed by either the EMA (14 drug indications) or NICE (16 drug indications) by the study end date. Most drug indications recommended by NICE were conditional on the negotiation of additional confidential discounts, the imposition of restricted indications that limited prescribing to specific patient subgroups, or the collection of additional data. Among the 9 drug indications with evidence of overall survival benefit at the time of NICE review, 2 were not recommended for public funding based on cost-effectiveness criteria. Conclusions and Relevance: In this cohort study, 30 cancer drug indications that were granted accelerated approval by the FDA were not subsequently reviewed by either European regulators or NICE, and 12 drugs were denied authorization or coverage owing to insufficient safety, clinical efficacy, or cost-effectiveness. National Health Service coverage of cancer drugs given FDA accelerated approval commonly required additional price concessions, restrictions to approved indications, or review of additional data.

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