An urgent call to raise the bar in oncology.

Important breakthroughs in medical treatments have improved outcomes for patients suffering from several types of cancer. However, many oncological treatments approved by regulatory agencies are of low value and do not contribute significantly to cancer mortality reduction, but lead to unrealistic patient expectations and push even affluent societies to unsustainable health care costs. Several factors that contribute to approvals of low-value oncology treatments are addressed, including issues with clinical trials, bias in reporting, regulatory agency shortcomings and drug pricing. With the COVID-19 pandemic enforcing the elimination of low-value interventions in all fields of medicine, efforts should urgently be made by all involved in cancer care to select only high-value and sustainable interventions. Transformation of medical education, improvement in clinical trial design, quality, conduct and reporting, strict adherence to scientific norms by regulatory agencies and use of value-based scales can all contribute to raising the bar for oncology drug approvals and influence drug pricing and availability.

Improving Quality as a Solution to the Health Care Cost Problem? Health Policy Experts and the Promotion of a Controversial Idea.

CONTEXT: In the late 2000s, the contention that quality improvements achieved by reforms in the delivery of care would slow the growth of costs throughout the US health care system became the predominant strategy for cost containment in the discourses and programs of all the 2008 presidential candidates. The question that this paper addresses is why, despite all of the critiques of this idea (especially those of the Congressional Budget Office), what the author terms the quality solution has remained credible enough to be a possible argument in policy makers' discourses and programs. To answer this question, the article explores the role of health policy experts-who are expected to provide credibility and legitimacy to proposals defended by policy makers-in supporting and diffusing this quality solution. METHODS: The empirical research combines written sources with evidence from 78 interviews. FINDINGS: This article highlights the political factors that explain the rise and growing prominence of the quality solution in the community of policy analysts: the political support for delivery reform-oriented research since the 1980s and also the importance of political calculations for prominent health policy experts. CONCLUSIONS: This policy history contributes to works that underscore the political dimension of policy analysis.

The ACA a Decade In: Resilience, Impact, and Vulnerabilities.

A decade after its enactment, the Affordable Care Act remains both politically viable and consequential, despite Republican efforts to end it. The law's impact on insurance coverage is substantial but remains distant from universal coverage, while its contributions to cost control are at best limited. National public opinion data collected by the author in 2018 reveal both strengths and vulnerabilities in the act.

Cost conscious care: preoperative evaluation by a cardiologist prior to low-risk procedures.

Background: Preoperative testing before low-risk procedures remains overutilised. Few studies have looked at factors leading to increased testing. We hypothesised that consultation to a cardiologist prior to a low-risk procedure leads to increased cardiac testing. Methods and results: 907 consecutive patients who underwent inpatient endoscopy/colonoscopy at a single academic centre were identified. Of those patients, 79 patients (8.7%) received preoperative consultation from a board certified cardiologist. 158 control patients who did not receive consultation from a cardiologist were matched by age and gender. Clinical and financial data were obtained from chart review and hospital billing. Logistic and linear regression models were constructed to compare the groups. Patients evaluated by a cardiologist were more likely to receive preoperative testing than patients who did not undergo evaluation with a cardiologist (OR 47.5, (95% CI 6.49 to 347.65). Specifically, patients seen by a cardiologist received more echocardiograms (60.8% vs 22.2%, p<0.0001) and 12-lead electrocardiograms (98.7% vs 54.4%, p<0.0001). There was a higher rate of ischaemic evaluations in the group evaluated by a cardiologist, but those differences did not achieve statistical significance. Testing led to longer length of stay (4.35 vs 3.46 days, p=0.0032) in the cohort evaluated by a cardiologist driven primarily by delay to procedure of 0.76 days (3.14 vs 2.38 days, p=0.001). Estimated costs resulting from the longer length of stay and increased testing was $10 624 per patient. There were zero major adverse cardiac events in either group. Conclusion: Preoperative consultation to a cardiologist before a low-risk procedure is associated with more preoperative testing. This preoperative testing increases length of stay and cost without affecting outcomes.

Selecting digital health technologies for validation and piloting by healthcare providers: a decision-making perspective from ontario.

Digital health technologies (DHTs) such as health apps are rapidly emerging as a major disruptor of health care. Yet there is no well-established process of decision making for selecting DHTs that are worthy of investing resources in their validation to determine whether they are ready (safe, effective, and not too costly) for health related use. We report here on an Ontario-based initiative to support such decision making. Specifically, we developed a decision-making algorithm that uses approved criteria including the strategic direction of the health research institute and the hospital, and availability of resources. The Council of Academic Hospitals of Ontario has adapted our approach for other hospitals. We hope that other healthcare organizations, in and beyond Ontario, will consider this and alternative approaches, and that research will be conducted to evaluate such approaches.

Medical Service Quality, Efficiency and Cost Control Effectiveness of Upgraded Case Payment in Rural China: A Retrospective Study.

Background: As the principal means of reimbursing medical institutions, the effects of case payment still need to be evaluated due to special environments and short exploration periods, especially in rural China. Methods: Xi County was chosen as the intervention group, with 36,104, 48,316, and 59,087 inpatients from the years 2011 to 2013, respectively. Huaibin County acted as the control group, with 33,073, 48,122, and 51,325 inpatients, respectively, from the same period. The inpatients' information was collected from local insurance agencies. After controlling for age, gender, institution level, season fixed effects, disease severity, and compensation type, the generalised additive models (GAMs) and difference-in-differences approach (DID) were used to measure the changing trends and policy net effects from two levels (the whole county level and each institution level) and three dimensions (cost, quality and efficiency). Results: At the whole-county level, the cost-related indicators of the intervention group showed downward trends compared to the control group. Total spending, reimbursement fee and out-of-pocket expense declined by ¥346.59 (p < 0.001), ¥105.39 (p < 0.001) and ¥241.2 (p < 0.001), respectively (the symbol ¥ represents Chinese yuan). Actual compensation ratio, length of stay, and readmission rates exhibited ascending trends, with increases of 7% (p < 0.001), 2.18 days (p < 0.001), and 1.5% (p < 0.001), respectively. The intervention group at county level hospital had greater length of stay reduction (¥792.97 p < 0.001) and readmission rate growth (3.3% p < 0.001) and lower reimbursement fee reduction (¥150.16 p < 0.001) and length of stay growth (1.24 days p < 0.001) than those at the township level. Conclusions: Upgraded case payment is more reasonable and suitable for rural areas than simple quota payment or cap payment. It has successfully curbed the growth of medical expenses, improved the efficiency of medical insurance fund utilisation, and alleviated patients' economic burden of disease. However, no positive effects on service quality and efficiency were observed. The increase in readmission rate and potential hidden dangers for primary health care institutions should be given attention.

Drug Policy in Romania.

OBJECTIVES: The objectives of this article were to describe the characteristics of the drug policy in Romania in the last 10 years and to present the consequences in terms of patient accessibility to drugs. METHODS: The Romanian health care system with pricing and reimbursement legislation was studied while considering the evolution of pricing and reimbursement processes, the key stakeholders, and the reasons behind changes. A critical appraisal was done covering published materials on the effects of pricing and reimbursement decisions. RESULTS: Romania uses an external reference pricing model considering the lowest price from 12 European Union countries. The result is the visible list price, which is used by the payer as the basis for the reimbursement prices. The reimbursed price depends on the type of drug and the therapeutic area. The claw-back taxation reduces the reimbursement prices by another 12% to 75%, depending on the type of reimbursement for each drug: unconditional (more than 4000 drugs) or conditional (19 drugs) reimbursement. As a consequence, the Romanian prices are one of the cheapest in the European Union, some drugs are leaving the country subject to intracommunity trade and more than 2000 drugs have disappeared from the market in the last 5 years. CONCLUSIONS: The drug policy in Romania is centered on price reduction using different techniques and no value-based criteria are used. The pricing is not included in the health technology assessment system, managed entry agreements are not used, and the main effect visible at the patient level is the lack of drugs for some therapeutic areas.

Drug Policy in Estonia.

The aim of this article was to present a general overview of the health care system as well as pricing and reimbursement environment in Estonia. In Estonia the main stakeholders in the pharmaceutical sector are the Ministry of Social Affairs, the State Agency of Medicine, and the Estonian Health Insurance Fund. The national health insurance scheme is public, and approximately 95% of the population is covered by it. It is a social insurance, and universal and equal access to health care based on national health insurance is granted. The Estonian Health Insurance Fund is financed from social taxes and state budget and is responsible for the reimbursement of pharmaceuticals in the hospital setting. It acts as an advisory body to the Ministry of Social Affairs on the process of reimbursement regarding cost effectiveness. Pharmaceutical products' reimbursement dossiers submission and decisions are dealt with on the state level. Health technology assessment analyses are required by the authorities and the Baltic Guidelines for Economic Evaluations of Pharmaceuticals have to be followed. The reimbursement lists are positive lists only, and the criteria upon which reimbursement decisions are based are officially defined. Revisions of reimbursement are performed depending on the need and they are based on the prices of reference countries.

[A pragmatic approach to managing expensive therapies]. / Une approche pragmatique pour gérer les traitements onéreux - Chroniques génomiques.

Inflated drug prices necessarily raise the issue of rational allocation of health care resources. The system operated by the NICE agency in the UK attempts to do this by calculating the cost per quality-adjusted life year gained (QALY) and recommending funding only for drugs whose cost per QALY falls under a certain threshold. The whole process is documented in detail and easily accessible, and often results in significant discounts on drug prices. Given that some kind of rationing of health care is inevitable, the rational and transparent process followed by NICE has a number of positive features.

The impact of price policy on demand for alcohol in rural India.

Whether raising the price of addictive goods can reduce its burden is widely debated in many countries, largely due to lack of appropriate data and robust methods. Three key concerns frequently raised in the literature are: unobserved heterogeneity; omitted variables; identification problem. Addressing these concerns, using robust instrument and employing unique individual-level panel data from Indian Punjab, this paper investigates two related propositions (i) will increase in alcohol price reduce its burden (ii) since greater incomes raise the costs of inebriation, will higher incomes affect consumption of alcohol negatively. Distinct from previous studies, the key variable of interest is the budget share of alcohol that allows studying the burden of alcohol consumption on drinker's and also on other family members. Results presented show that an increase in alcohol price is likely to be regressive, especially on the bottom quartile, with a rise in the budget share of alcohol given budget constraint. This outcome is robust to different econometric specifications. Preliminary explorations suggest that higher per capita income increases the odds of quitting drinking. Results reported have wider implications for the effective design of addiction related health policies.

Health policy in times of austerity-A conceptual framework for evaluating effects of policy on efficiency and equity illustrated with examples from Europe since 2008.

The objective of this paper is to provide a framework for evaluation of changes in health policy against overarching health system goals. We propose a categorisation of policies into seven distinct health system domains. We then develop existing analytical concepts of insurance coverage and cost-effectiveness further to evaluate the effects of policies in each domain on equity and efficiency. The framework is illustrated with likely effects of policy changes implemented in a sample of European countries since 2008. Our illustrative analysis suggests that cost containment has been the main focus and that countries have implemented a mix of measures that are efficient or efficiency neutral. Similarly, policies are likely to have mixed effects on equity. Additional user charges were a common theme but these were frequently accompanied by additional exemptions, making their likely effects on equity difficult to evaluate. We provide a framework for future, and more detailed, evaluations of changes in health policy.

Cardiology Consultation in the Emergency Department Reduces Re-hospitalizations for Low-Socioeconomic Patients with Acute Decompensated Heart Failure.

BACKGROUND: Re-hospitalization after discharge for acute decompensated heart failure is a common problem. Low-socioeconomic urban patients suffer high rates of re-hospitalization and often over-utilize the emergency department (ED) for their care. We hypothesized that early consultation with a cardiologist in the ED can reduce re-hospitalization and health care costs for low-socioeconomic urban patients with acute decompensated heart failure. METHODS: There were 392 patients treated at our center for acute decompensated heart failure who received standardized education and follow-up. Patients who returned to the ED received early consultation with a cardiologist; 392 patients who received usual care served as controls. Thirty- and 90-day re-hospitalization, ED re-visits, heart failure symptoms, mortality, and health care costs were recorded. RESULTS: Despite guideline-based education and follow-up, the rate of ED re-visits was not different between the groups. However, the rate of re-hospitalization was significantly lower in patients receiving the intervention compared with controls (odds ratio 0.592), driven by a reduction in the risk of readmission from the ED (0.56 vs 0.79, respectively). Patients receiving the intervention accumulated 14% fewer re-hospitalized days than controls and 57% lower 30-day total health care cost. Despite the reduction in health care resource consumption, mortality was unchanged. After accounting for the total cost of intervention delivery, the health care cost savings was substantially greater than the cost of intervention delivery. CONCLUSION: Early consultation with a cardiologist in the ED as an adjunct to guideline-based follow-up is associated with reduced re-hospitalization and health care cost for low-socioeconomic urban patients with acute decompensated heart failure.

What do we mean when we talk about the Triple Aim? A systematic review of evolving definitions and adaptations of the framework at the health system level.

Notwithstanding important contributions of the Triple Aim, uncritical enthusiasm regarding the implications of the framework may be leading to inconsistent use, particularly when applied at the health system level, which goes beyond the original positioning of the framework as a strategic organizing principle to guide improvement initiatives at the organizational or local community level. We systematically identified uses of the Triple Aim that extended beyond its original intention to focus on uses at the whole health system level, to assess convergence and divergence with the original definition. We also attempted to identify consistencies in the way the Triple Aim was adapted for different contexts and settings. Data sources were indexed databases, web search engines, and international experts. Forty-seven articles were included in the analysis. We found that the definition of the Triple Aim has been subject to important modifications when the framework is used to define goals for whole health care systems or globally. Despite widespread recognition of the name, what constitutes the Triple Aim framework varies. We identified the need to consider the inclusion of at least two additional aims of health care systems - the provider experience of care, and the desire to achieve health equity for populations.

High-Value, Cost-Conscious Care: Iterative Systems-Based Interventions to Reduce Unnecessary Laboratory Testing.

BACKGROUND: Inappropriate testing contributes to soaring healthcare costs within the United States, and teaching hospitals are vulnerable to providing care largely for academic development. Via its "Choosing Wisely" campaign, the American Board of Internal Medicine recommends avoiding repetitive testing for stable inpatients. We designed systems-based interventions to reduce laboratory orders for patients admitted to the wards at an academic facility. METHODS: We identified the computer-based order entry system as an appropriate target for sustainable intervention. The admission order set had allowed multiple routine tests to be ordered repetitively each day. Our iterative study included interventions on the automated order set and cost displays at order entry. The primary outcome was number of routine tests controlled for inpatient days compared with the preceding year. Secondary outcomes included cost savings, delays in care, and adverse events. RESULTS: Data were collected over a 2-month period following interventions in sequential years and compared with the year prior. The first intervention led to 0.97 fewer laboratory tests per inpatient day (19.4%). The second intervention led to sustained reduction, although by less of a margin than order set modifications alone (15.3%). When extrapolating the results utilizing fees from the Centers for Medicare and Medicaid Services, there was a cost savings of $290,000 over 2 years. Qualitative survey data did not suggest an increase in care delays or near-miss events. CONCLUSIONS: This series of interventions targeting unnecessary testing demonstrated a sustained reduction in the number of routine tests ordered, without adverse effects on clinical care.

A Troubled Asset Relief Program for the Patient-Centered Medical Home.

The patient-centered medical home (PCMH) costs a lot to build and maintain. Deficiencies have become apparent: it has provided few of its advertised benefits and is becoming a troubled asset. A troubled asset relief program for the PCHM is needed (PCMH-TARP). This report presents a PCMH-TARP that places patients' interests first. The PCMH-TARP addresses regulatory barriers and greatly simplifies the complexity of the PCMH blueprint. A disruptively renovated PCMH will stand on a foundation of measures that matter to patients.

The impact of formulary drug exclusion policies on patients and healthcare costs.

OBJECTIVES: In an attempt to increase the efficiency of their drug benefit policies, insurers are increasingly excluding drugs from their formularies that they deem to be of low value. Our objective was to identify and review empirical evaluations of drug exclusion policies and examine how they affected patients and healthcare costs. STUDY DESIGN: Literature review. METHODS: We performed a literature search to identify empirical studies that evaluated drug exclusion policies. We reviewed each study to determine how the policy impacted patients (ie, if disease control or frequency, or severity of symptoms, were affected) and if healthcare costs (eg, drug expenditures and costs associated with physician office visits, hospitalizations, laboratory tests) changed. RESULTS: We included 26 studies pertaining to 27 drug exclusion policies. Twenty studies reported the impact of 21 drug exclusion policies on patients: 6 (28.6%) policies were reported to have had a positive impact, 6 (28.6%) to have had a negative impact, and 9 (42.8%) to not have impacted patients. Eighteen studies reported the impact of 19 drug exclusion policies on overall healthcare costs: 14 (73.7%) policies were reported to have reduced costs, 1 (5.3%) to have had a neutral impact on costs, and 4 (21.1%) to have increased costs. CONCLUSIONS: Although there were important exceptions, most studies found that drug exclusion policies reduced costs and did not negatively impact patients.

Guideline Adherence Regarding the Use of Expensive Drugs in Daily Practice: The Examples of Trastuzumab in Breast Cancer and Bortezomib in Multiple Myeloma.

BACKGROUND: The present study was designed to obtain insights into guideline adherence regarding the use of expensive drugs in The Netherlands in daily practice and into the patients' perspective on the decision-making process. MATERIAL AND METHODS: A retrospective review of medical charts regarding the use of trastuzumab in early and metastatic breast cancer (EBC/MBC) and bortezomib in multiple myeloma (MM) was conducted. Prescription according to clinical practice guidelines was assessed. The review was supplemented with patient interviews. RESULTS: Of 702 adjuvant-treated EBC patients, 97% had a documented human epidermal growth factor receptor 2 (HER2) testing (23% HER2 positive). 92% (147/160) of the HER2-positive EBC patients were treated with trastuzumab. Of 594 MBC patients, 81% had a documented HER2 testing (19% HER2 positive). 82% (75/91) of the HER2-positive MBC patients were treated with trastuzumab. Of 68 MM patients, 50% were treated with bortezomib. Reasons not to treat were consistent with the guidelines. Patients were generally satisfied with the decision-making process; improvements in patient education were suggested (e.g., repeating the information given, adding information on side effects). CONCLUSIONS: Guidelines were generally well followed with respect to trastuzumab and bortezomib, indicating that funding did not influence the treatment decisions of physicians. In view of the growing numbers of both cancer patients and expensive new anticancer drugs, and increasing budget constraints, it is unclear whether the present-day policies will guarantee a similar level of guideline adherence. Patient involvement in decision-making could be increased by improving the patient education on treatment.