Developing Prioritization Criteria to Identify Target Drugs for CalRx,the California Generic Drugs Initiative

ObjectivesThis study aimed to establish criteria to identify priority drugs for CalRx, a California-sponsored initiative to support the manufacture and distribution of affordable generic drugs.MethodsA web-based ranking exercise was implemented with key stakeholders in August 2020, using pricing, spending, and public health criteria identified through a review of academic literature and public health agency reports. A total of 39 of 40 invited stakeholders in 4 different categories—patient advocates, healthcare providers, health insurers, and health policy and economic experts—participated in this study (98% response rate).ResultsDrugs that treat large populations, drugs that represent high cost to payors, and drugs that represent high cost to consumers were ranked a priority, receiving > 10% of ranking weights. Drugs that treat conditions with high morbidity or mortality, drugs without therapeutic alternatives, and drugs treating vulnerable populations represented criteria of further interest (9%-10% of weights). Shortage risk and curative effect (8%-9% of the weights), high price increases, communicable disease treatments, and high unit prices (< 8% of the weights) represented the bottom of the priority distribution.ConclusionsThis study suggests that drugs that treat large populations, drugs that represent large costs to payors, and drugs that represent large costs to consumers should be the priority for California’s CalRx generic drug initiative. A prioritizing algorithm will assist California in determining top drugs to target from a public health and spending perspective as it plans the rollout of the CalRx initiative and negotiates with drug manufacturers.     

Paying for Cures: Perspectives on Solutions to the “Affordability Issue”

Curative therapies and other medicines considered “game-changing” in terms of health gain can be accompanied by high demand and high list prices that pose budget challenges to public and private payers and health systems—the so-called affordability issue. These challenges are exacerbated when longer term effectiveness, and thus value for money, is uncertain, but they can arise even when treatments are proven to be highly cost-effective at the time of launch. This commentary reviews innovative payment solutions proposed in the literature to address the affordability issue, including the use of credit markets and of staged payments linked to patient outcomes, and draws on discussions with payers in the United States and Europe on the feasibility or desirability of operationalizing any of the alternative financing and payment strategies that appear in the literature. This included a small number of semistructured interviews. We conclude that there is a mismatch between the enthusiasm in the academic literature for developing new approaches and the scepticism of payers that they can work or are necessary. For the foreseeable future, affordability pressures will continue to be handled by aggressive price bargaining, high co-pays (in systems in which this is possible), and restricting access to subgroups of patients. Of the mechanisms we explored, outcomes-based payments were of most interest to payers, but the costs associated with operating such schemes, together with implementation challenges, did not make them an attractive option for managing affordability.     

The ICER Value Framework: Integrating Cost Effectiveness and Affordability in the Assessment of Health Care Value

What should be the relationship between the concepts of cost effectiveness and affordability in value assessments for health care interventions? This question has received greater attention in recent years given increasing financial pressures on health systems, leading to different views on how assessment reports and decision-making processes can provide the best structure for considering both elements. In the United States, the advent of explicit value frameworks to guide drug assessments has also focused attention on this issue, driven in part by the prominent inclusion of affordability within the value framework used to guide reports from the Institute for Clinical and Economic Review. After providing a formal definition of affordability for health care systems, this article argues that, even after using empirical estimates of true health system opportunity cost, cost-effectiveness thresholds cannot by themselves be set in a way that subsumes questions about short-term affordability. The article then presents an analysis of different approaches to integrating cost effectiveness and budget impact assessments within information to guide decision making. The evolution and experience with the Institute for Clinical and Economic Review value framework are highlighted, providing lessons learned and guiding principles for future efforts to bring measures of affordability within the scope of value assessment.     

Affordability Challenges to Value-Based Pricing: Mass Diseases,Orphan Diseases,and Cures

Objectives

To analyze how value-based pricing (VBP), which grounds the price paid for pharmaceuticals in their value, can manage “affordability” challenges, defined as drugs that meet cost-effectiveness thresholds but are “unaffordable” within the short-run budget.

上海市社区口服降糖药的可负担性评价

目的：评价上海市社区口服降糖药的可负担性。方法：采用世界卫生组织/国际健康行动组织（WHO/HAI）的标准化调查方法进行价格调查,采用WHO/HAI标准化可负担性评价方法、贫化法和灾化法3种方法对口服降糖药物的可负担性进行评价。结果：在社区医疗机构,大部分口服降糖药的可负担性较差,仿制药的负担性均优于原研药;城镇居民与农村居民相比负担较重,不同种类的口服降糖药在上海市居民中致贫作用差异较大,约20倍;5种口服降糖药会导致上海市10多万居民陷入灾难性支出。医保政策可以大幅降低口服降糖药带来的负担,缩小高价药品与低价药品之间的致贫差距。结论：上海市口服降糖药的可负担性较差,建议相关部门做好原研药品价格调整与监管,鼓励和引导仿制药品的研发,推进异地医保对接,以提高糖尿病患者的可负担性。     

Affordability of Different Isocaloric Healthy Diets in Germany—An Assessment of Food Prices for Seven Distinct Food Patterns

Affordability of different isocaloric healthy diets in Germany—an assessment of food prices for seven distinct food patterns Background: For decades, low-fat diets were recommended as the ideal food pattern to prevent obesity, type 2 diabetes and their long-term complications. Nowadays, several alternatives considering sources and quantity of protein, fat and carbohydrates have arisen and clinical evidence supports all of them for at least some metabolic outcomes. Given this variety in diets and the lack of a single ideal diet, one must evaluate if patients at risk, many of which having a lower income, can actually afford these diets. Aim: We modelled four-week food plans for a typical family of two adults and two school children based on seven different dietary patterns: highly processed standard omnivore diet (HPSD), freshly cooked standard omnivore diet (FCSD), both with German average dietary composition, low-protein vegan diet (VeganD), low-fat vegetarian diet (VegetD), low-fat omnivore diet (LFD), Mediterranean diet (MedD) and high-fat moderate-carb diet (MCD). The isocaloric diets were designed with typical menu variation for all meal times. We then assessed the lowest possible prices for all necessary grocery items in 12 different supermarket chains, avoiding organic foods, special offers, advertised exotic super foods and luxury articles. Prices for dietary patterns were compared in total, stratified by meal time and by food groups. Results: Among all seven dietary patterns, price dispersion by supermarket chains was 12–16%. Lowest average costs were calculated for the VegetD and the FCSD, followed by HPSD, LFD, VeganD, MedD and—on top—MCD. VeganD, MedD and MCD were about 16%, 23% and 67% more expensive compared to the FCSD. Major food groups determining prices for all diets are vegetables, salads and animal-derived products. Calculations for social welfare severely underestimate expenses for any kind of diet. Conclusions: Food prices are a relevant factor for healthy food choices. Food purchasing is financially challenging for persons with very low income in Germany. Fresh-cooked plant-based diets are less pricy than the unhealthy HPSD. Diets with reduced carbohydrate content are considerably more expensive, limiting their use for people with low income. Minimum wage and financial support for long-term unemployed people in Germany are insufficient to assure a healthy lifestyle.     

Trends in Health Care Financial Burdens, 2001 to 2009

Context: Over the past decade, health care spending increased faster than GDP and income, and decreasing affordability is cited as contributing to personal bankruptcies and as a reason that some of the nonelderly population is uninsured. We examined the trends in health care affordability over the past decade, measuring the financial burdens associated with health insurance premiums and out-of-pocket costs and highlighting implications of the Affordable Care Act for the future financial burdens of particular populations.Methods: We used cross sections of the Medical Expenditure Panel Survey Household Component (MEPS-HC) from 2001 to 2009. We defined financial burden at the health insurance unit (HIU) level and calculated it as the ratio of expenditures on health care—employer-sponsored insurance coverage (ESI) and private nongroup premiums and out-of-pocket payments—to modified adjusted gross income.Findings: The median health care financial burden grew on average by 2.7% annually and by 21.9% over the period. Using a range of definitions, the fraction of households facing high financial burdens increased significantly. For example, the share of HIUs with health care expenses exceeding 10% of income increased from 35.9% to 44.8%, a 24.8% relative increase. The share of the population in HIUs with health care financial burdens between 2% and 10% fell, and the share with burdens between 10% and 44% rose.Conclusions: We found a clear trend over the past decade toward an increasing share of household income devoted to health care. The ACA will affect health care spending for subgroups of the population differently. Several groups’ burdens will likely decrease, including those becoming eligible for Medicaid or subsidized private insurance and those with expensive medical conditions. Those newly obtaining coverage might increase their health spending relative to income, but they will gain access to care and the ability to spread their expenditures over time, both of which have demonstrable economic value.     

少数民族居民对疟防费用和集资意愿调查

目的　探讨爱尼人和基诺族对疟疾防治费用的支付能力和意愿及其研究方法。方法　对户主进行问卷调查 ,对资料进行统计学处理。结果　向东村爱尼人的人均年收入和现金收入较石嘴村基若族的高 ,但年人均医药费支出更低 ,支付能力更强 ;向东和石嘴愿意集资开展疟疾防治的家庭比例分别是 96 4 % (95 %CI:87 5 %～ 99 6 % )和84 1% (95 %CI :6 9 9%～ 93 4 % ) ,人均年愿意集资额分别为 (13 2 8± 2 2 1)元和 (4 35± 1 71)元 ;高、中、低收入家庭的人均年愿意集资额无显著性差异 (P >0 0 5 )。结论　人们的集资意愿除受支付能力外 ,尚受其它因素的影响。     

Analysis of the injection force of solostar® compared with other disposable insulin pen devices at constant volume flow rates

Insulin pen devices have greatly enhanced the portability and accessibility to insulin therapy for millions of people with diabetes. Comparison research data should be reviewed thoroughly.In this issue of Journal of Diabetes Science and Technology, the study presented by Thomas van der Burg is balanced in number of samples tested, same tensile meter, and identical units per second delivery rate into an open beaker. Mean plateau force of SoloSTAR^® and KwikPen™ were significantly lower. KwikPen and SoloSTAR utilized 5-mm length 31-gauge (G) needles vs 6-mm 31G needles for FlexPen^® and Next Generation FlexPen^®, perhaps skewing results in favor of shorter needles instead of device design.Individual understanding of correct insulin use, appropriate self-monitoring of blood glucose, vision and dexterity capability, and affordability of therapy must be considered first. SoloSTAR holds one unique market advantage, delivery of up to 80 units of insulin per injection.