Pursuing Value-Based Prices for Drugs: A Comprehensive Comparison of State Prescription Drug-Pricing Boards.

Policy Points In the absence of federal action on rising prescription drug costs, we reviewed the details of five states that have enacted prescription drug-pricing boards seeking to lower drug prices based on products' value. Within these states, six such boards are currently authorized; they have similarities but vary in terms of structure, authority, scope, and leverage. As of June 2021, only one of the boards in our sample has conducted pricing reviews; legislators in other states can learn from the successes and challenges of existing boards. Prescription drug-pricing boards represent a novel and promising way to curb state spending and pay for value in prescription drugs but face legal and political barriers in implementation. CONTEXT: Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with a variety of policies to contain spending and achieve value in prescription drugs. As part of this series of reforms, some state legislatures have recently authorized prescription drug-pricing boards to address the high prices of brand-name prescription drugs and assess the value of those drugs. METHODS: We identified state prescription drug-pricing boards in the United States, defined as any agency authorized by a state legislature to review specific drugs and pursue value-based drug prices. To describe the characteristics of the boards, we obtained public records of authorizing legislation, guidance documents, and board meeting minutes. We compared the boards' powers and responsibilities and analyzed completed pricing reviews. FINDINGS: Six state drug-pricing boards in five states met our definition; their design varied substantially. Two of the boards (New York Medicaid and Massachusetts) have authority over drug rebates paid by state Medicaid programs, one (New York Drug Accountability Board) has jurisdiction over state-regulated commercial insurance, and another three (Maine, Maryland, and New Hampshire) oversee non-Medicaid, state-funded insurance. Three boards are authorized to require manufacturers to confidentially submit information related to the pricing and clinical effectiveness of reviewed drugs to inform value determinations. Only one board (New York Medicaid) had completed pricing reviews as of June 3, 2021. CONCLUSIONS: Boards' structure, scope, and statutory leverages to compel manufacturers to negotiate lower net costs are key factors that influence whether and to what extent boards can achieve cost savings for states. Though legal constraints may limit the effective reach of prescription drug-pricing boards, these agencies can enable states to address rising prescription drug costs, in part by virtue of their very existence. To overcome practical limitations, states seeking to implement similar policies can build on the experiences and designs of current boards.

Medicare Advantage for Most.

Policy Points Fixing the ACA requires real cost containment in addition to better subsidies. Private Medicare (Medicare Advantage) plans are uniquely empowered to control costs and deliver good care. Medicare Advantage plans should serve as the public option on the ACA Marketplace. Medicare Advantage plans can also be deployed to voluntarily raise minimum employer-sponsored benefits and contain their costs.

Safe Step Act: does it undermine step therapy?

Drug expenditure in the United States has continued to increase unsustainably; the specialty of dermatology has been particularly affected. Resources are limited - someone has to make decisions about what treatments will be covered and how they will be reimbursed. Step therapy is a cost-control method used by insurers to encourage the use of the most cost-effective treatments before more expensive options are attempted. However, a rigid step therapy policy can be problematic when protocols are out of date, or delay necessary treatment leading to unnecessary suffering, increased morbidity, and overall cost. To address some of these concerns, the proposed Safe Step Act (S. 2546 and H.R. 2279) attempts to create a requirement that insurers provide a transparent, expeditious exceptions process for step therapy protocols. Increased flexibility in this process will allow for the unique circumstances of individual patients and improve access to expensive drugs for special cases. However, this bill may be exploited, further weakening insurers' ability to negotiate on cost. We should be cautious about measures that reduce the effectiveness of this tool, particularly if we, as a society, aim to expand access to basic care to all Americans.

International Experience in Therapeutic Value and Value-Based Pricing: A Rapid Review of the Literature.

OBJECTIVES: To characterize at a global level the concept of therapeutic value (TV) and describe the experience of value-based pricing (VBP) policies in 6 reference countries. METHODS: We conducted a rapid review of the literature that addressed 2 exploratory research questions. A systematic and exhaustive search was carried out up to July 2018 in MEDLINE (Ovid), Embase, Scopus, and Web of Science. RESULTS: The concepts of TV and VBP are related; value frameworks for medicines should include social preferences, comparative effectiveness, safety, adoption viability, social impact, high quality of evidence, severity of illness, and innovation. The added therapeutic value (ATV) is the manner of measuring the therapeutic advantages of new medicines compared with existing ones in terms of comparative effectiveness and safety. There are variations in the mechanisms of reimbursement and drug pricing regulation between the countries of study. CONCLUSION: In a VBP system it is essential to establish the TV and ATV of a new medicine. Although there are no methodological guidelines for the implementation of VBP policies, the process implies from the beginning the definition of TV categories that will be included in the drug pricing and reimbursement systems. Agreements between the pharmaceutical industry and governments have become a useful tool as a negotiating mechanism in most countries.

Impacto de la Ley de Dependencia sobre el gasto autonómico en servicios sociales / Impact of the Dependency Act on regional spending on social services

OBJETIVO: En este trabajo se cuestiona si el desarrollo del Sistema de Autonomía y Atención a la Dependencia (SAAD) contribuyó a incrementar el volumen de recursos del sistema público de servicios sociales (efecto desplazamiento) o, por el contrario, si dicho desarrollo se produjo a costa del resto de prestaciones de servicios sociales (efecto sustitución). MÉTODO: Se realiza una aproximación de datos de panel, orientada a explicar el comportamiento del gasto per cápita en servicios sociales para las comunidades autónomas españolas de régimen común en el periodo 2002-2016. RESULTADOS: La introducción del SAAD se asocia con un incremento del 14% en el gasto por habitante en servicios sociales. Este efecto se acerca al 25% cuando la variable explicada es el gasto en transferencias corrientes de carácter social. También se constata que los cambios legislativos introducidos en 2012 y 2013 se asociaron a una reducción del gasto per cápita en transferencias corrientes del 10%. CONCLUSIONES: Esta evidencia refutaría la hipótesis de que el SAAD ha originado meramente un efecto de «sustitución» en el gasto autonómico en servicios sociales

OBJECTIVE: In this paper we address whether the System for Personal Autonomy and Care of Dependent Persons contributes to increasing the volume of resources of the public social services system (displacement effect) or, on the contrary, whether this development has taken place at the expense of other social services (substitution effect). METHOD: Panel data analysis is used to explain how per capita expenditure on social services evolves in the Spanish Regions under the common regime in the period 2002-2016. RESULTS: The implementation of the Dependency Act is associated with a 14% increase in the level of per capita expenditure on social services. This effect raises 25% when the variable explained is expenditure on current transfers of a social nature. On the other hand, law changes introduced in 2012 and 2013 were associated with a reduction in per capita expenditure on current transfers of around 10%. CONCLUSIONS: This evidence would refute the hypothesis that the System for Personal Autonomy and Care of Dependent Persons had merely a "substitution" effect on autonomous spending on social services

Talkin' About a Resolution: Issues in the Push for Greater Transparency of Medicine Prices.

At the 2019 World Health Assembly, a significant new resolution was agreed by most countries to start publicly sharing information on the real net prices they pay for medicines in their health systems. The resolution also includes provisions for countries to support other transparency activities. However, an additional proposal to require pharmaceutical companies to submit information on their internal sales figures, internal research and development costs, clinical trial costs and marketing costs for each individual medicine as a condition of registration, and for governments to publish this, was not agreed. Pressure for coordinated international action to increase the transparency of medicine prices and costs has been building for some time, as confidential discounts and rebates on prices of medicines are common. We argue that while it is possible that stakeholders may benefit to some extent from greater transparency on prices, several important policy and economic issues need to be carefully considered. Such transparency, combined with widespread use of international reference pricing, might undermine companies' differential pricing strategies, which are important in fostering wider access to medicines in low- and middle-income countries in particular, noting that access to medicines issues can occur in high-income countries as well. Moreover, there is a further risk that these types of proposals will lead to price fixing, less competition and higher prices than might otherwise be the case. The lack of any commitments in the resolution to greater transparency in payer decision-making processes also risks undermining the credibility of the resolution. The resolution and further transparency measures could have the potential to undermine patient access to medicines in the developing world, lead to higher prices in some markets and compromise long-term development of new medicines for future generations.

Origins of the Crisis in Insulin Affordability and Practical Advice for Clinicians on Using Human Insulin.

PURPOSE OF REVIEW: High insulin prices and cost-related insulin underuse are increasingly common and vexing problems for healthcare providers. This review highlights several factors that contribute to high prices and limited generic competition in the US insulin market. RECENT FINDINGS: An opaque and complex pricing and reimbursement system for insulin, allegations of collusive practices by insulin manufacturers, and a lack of generic competition drive and sustain high insulin prices. When combined with increasing insurance deductibles and cost sharing, these factors contribute to cost-related insulin underuse and are associated with adverse clinical outcomes. Healthcare providers facing patients with type 2 diabetes who struggle to afford insulin should consider initiating or switching from analogue to human insulin as one way to help address the challenges of access and affordability. However, it is also important to support initiatives to advocate for affordable pricing for insulin for patients who can benefit from the flexibility offered by many of the newer insulin preparations.

O futuro do SUS: impactos das reformas neoliberais na saúde pública - austeridade versus universalidade / The future of the SUS: impacts of neoliberal reforms on public health - austerity versus universality

RESUMO O ensaio analisa os efeitos da política de austeridade sobre o Sistema Único de Saúde (SUS). Dados orçamentários e fiscais indicam que o Novo Regime Fiscal (NRF), criado pela Emenda Constitucional nº 95/2016 (EC 95), transformou o subfinanciamento crônico da saúde em desfinanciamento do SUS. Ademais, o NRF altera as relações entre as dimensões fiscal e social, uma vez que a despesa passa a ser avaliada a partir da pressão que exerce sobre o teto. Particularmente, o sistema de saúde universal se torna um excesso em relação ao limite estabelecido pela EC 95, pois os direitos sociais passam a aparecer como objeto de ajuste à fronteira fiscal, a partir da qual o gasto é tomado como irregular. Será mostrado que tais mudanças já implicam redução do orçamento disponível de saúde.

ABSTRACT The essay analyzes the effects of the austerity policy on the Unified Health System (SUS). Budgetary and fiscal data indicate that the New Tax Regime (NTR), created by Constitutional Amendment nº 95/2016 (CA 95), has transformed chronic underfunding into reduction of the health budget. In addition, the NTR alters the relations between the fiscal and social dimensions, since the expense is now evaluated from the pressure exerted on the cap. Particularly, the universal health care system becomes an excess in relation to the limit established by CA 95, since social rights begin to appear as an object of adjustment to the fiscal frontier, from which the expense is taken as irregular. The article shows that such changes already imply reduction of the available health budget.

Challenges in the Regulation of High-Cost Treatments: An Overview From Brazil.

Regulation of drug prices that ensures adequate access to effective treatments and promotes innovation is a global challenge. In the United States, the government does not regulate drug prices when they come onto market. On the other hand, in countries such as France and Brazil, government agencies are responsible for setting up price limits by leveraging the interests of the companies and the countries' population. In Brazil, safety and efficacy of drugs are regulated by the Brazilian Health Regulatory Agency, and drug prices are regulated by the Pharmaceutical Market Regulation Chamber with a participation of Brazilian Health Regulatory Agency. Here, we introduce the current challenges faced by the Brazilian government in the drug price regulation and present proposed initiatives aiming to streamline access to innovative treatments for its citizens.

Perfil das ações judiciais em assistência à saúde com bloqueio de verbas públicas no Estado de Santa Catarina / Profile of lawsuits in health care with blockade of public funds in the state of Santa Catarina, Brazil / Perfil de los juicios en salud con bloqueo de fondos públicos en el estado de Santa Catarina, Brasil

Objetivo: analisar o perfil situacional dos bloqueios de valores decorrentes do descumprimento de decisões judiciais em assistência à saúde, no Estado de Santa Catarina. Métodos: foram considerados os processos com determinação de bloqueio nas contas do Estado de Santa Catarina, nos meses de dezembro de 2015 e dezembro de 2016, em que os autores requereram medicamentos, insumos e nutrição. Resultados: a maioria das ações são ajuizadas individualmente e por escritórios de advocacia particulares. Medicamentos configuraram como o objeto mais solicitado, prescritos em sua maioria pelo nome comercial e não padronizados em listas oficiais em mais de 70% dos casos. Em 2015, o gasto mensal foi de R$ 135.549,39, e, caso o Estado tivesse realizado a aquisição, o gasto mensal seria de R$ 82.016,29. Em dezembro de 2016, o gasto com bloqueio foi de R$ 833.634,88, enquanto por meio de compra administrativa seria de R$ 447.357,68. Observou-se um crescimento de 858,82% dos gastos com bloqueios, do ano de 2015 para 2016. Conclusões: os resultados obtidos podem contribuir para o melhor planejamento do cumprimento das decisões judiciais em saúde, evitando que não onerem ainda mais os cofres públicos e prejudiquem o orçamento da saúde pública.

Objective: to analyze the situational profile of value blocks resulting from non-compliance with health care court decisions in the State of Santa Catarina. Methods: re considered the processes with determination of blockage in the accounts of the State of Santa Catarina, in December 2015 and December 2016, in which the authors requested drugs, inputs and nutrition. Results: most actions are filed individually and by private law firms. Medicines were the most requested object, mostly prescribed by trade name and not standardized on official lists in more than 70% of cases. In 2015, the monthly expense was R$ 135,549.39, and if the State had made the acquisition, the monthly expense would be R$ 82,016.29. In December 2016, the cost of blocking was R $ 833,634.88, while through administrative purchase would be R $ 447,357.68. There was a growth of 858.82% in spending on blockages, from 2015 to 2016. Conclusions: the results obtained can contribute to better planning compliance with health court decisions, avoiding that they do not burden the public coffers even more and undermine the public health budget.

Objetivo: analizar el perfil situacional de los bloques de valor resultantes del incumplimiento de las decisiones de los tribunales de atención médica en el Estado de Santa Catarina. Métodos: Consideramos los procesos con determinación de bloqueo en las cuentas del Estado de Santa Catarina, en diciembre de 2015 y diciembre de 2016, en los que los autores solicitaron medicamentos, insumos y nutrición. Resultados: la mayoría de las demandas se presentan individualmente y por firmas de abogados privadas. Las drogas fueron el objeto más solicitado, en su mayoría recetados por nombre comercial y no estandarizados en las listas oficiales en más del 70% de los casos. En 2015, el gasto mensual fue de R $ 135.549,39, y si el Estado hubiera realizado la adquisición, el gasto mensual sería de R $ 82.016,29. En diciembre de 2016, el costo del bloqueo fue de R $ 833,634.88, mientras que a través de la compra administrativa sería de R $ 447,357.68. Hubo un crecimiento del 858.82% en el gasto en bloqueos, de 2015 a 2016. Conclusiones: los resultados obtenidos pueden contribuir a una mejor planificación del cumplimiento de las decisiones judiciales en salud, evitando que no carguen aún más las arcas públicas y socavaren el presupuesto de salud pública.