Iraqi regulatory authority current system and experience with biosimilars.

Biological medicines have significantly altered treatment for many patients with chronic diseases such as cancers, autoimmune diseases, and diabetes. However, the high cost of biological medicines has limited patients' access to them. Iraq is one of the countries that have decided to increase access to these medicines through biosimilars, which are copies of originator biological medicines. Prior to 2019, the Iraqi National Regulatory Authority (NRA) had no clear guidelines in place for biosimilars uptake. Therefore, approvals of many biosimilars were delayed. As a response to that, a new pivotal committee was found within this authority, and the first version of Iraqi basis and guidelines for the approval of biosimilars was enacted. With the implementation of the Iraqi biosimilars guidelines and escalating the cooperation within the Iraqi NRA, many benefits have been attained in a short time including the approval of many essential biosimilar products which has resulted in a total cost savings estimated to exceed 50 million USD in just the year 2020. However, there are still some barriers towards making the utmost benefit from biosimilars in Iraq, such as lack of familiarity of these products among the Iraqi health care providers which requires appropriate biosimilars-awareness enhancement strategies.

The Economic Burden of Out-of-Pocket Expenses for Plastic Surgery Procedures.

BACKGROUND: Health insurance reimbursement structure has evolved, with patients becoming increasingly responsible for their health care costs through rising out-of-pocket expenses. High levels of cost sharing can lead to delays in access to care, influence treatment decisions, and cause financial distress for patients. METHODS: Patients undergoing the most common outpatient reconstructive plastic surgery operations were identified using Truven MarketScan databases from 2009 to 2017. Total cost of the surgery paid to the insurer and out-of-pocket expenses, including deductible, copayment, and coinsurance, were calculated. Multivariable generalized linear modeling with log link and gamma distribution was used to predict adjusted total and out-of-pocket expenses. All costs were inflation-adjusted to 2017 dollars. RESULTS: The authors evaluated 3,165,913 outpatient plastic and reconstructive surgical procedures between 2009 and 2017. From 2009 to 2017, total costs had a significant increase of 25 percent, and out-of-pocket expenses had a significant increase of 54 percent. Using generalized linear modeling, procedures performed in outpatient hospitals conferred an additional $1999 in total costs (95 percent CI, $1978 to $2020) and $259 in out-of-pocket expenses (95 percent CI, $254 to $264) compared with office procedures. Ambulatory surgical center procedures conferred an additional $1698 in total costs (95 percent CI, $1677 to $1718) and $279 in out-of-pocket expenses (95 percent CI, $273 to $285) compared with office procedures. CONCLUSIONS: For outpatient plastic surgery procedures, out-of-pocket expenses are increasing at a faster rate than total costs, which may have implications for access to care and timing of surgery. Providers should realize the increasing burden of out-of-pocket expenses and the effect of surgical location on patients' costs when possible.

Medicaid expansion in opt-out states would produce consumer savings and less financial burden than exchange coverage.

In the twenty-three states that have decided against expanding Medicaid under the Affordable Care Act, uninsured adults who would have been eligible for Medicaid and have incomes at or above the federal poverty guidelines are generally eligible for Marketplace (insurance exchange) premium tax credits and plans with generous benefits. This study compared estimated out-of-pocket spending for care and premiums, as well as the financial burdens they impose, for the families of these adults under two simulation scenarios: obtaining coverage through a silver plan with subsidized cost sharing and enrolling in expanded Medicaid. Compared with Marketplace coverage, Medicaid would more than halve average annual out-of-pocket spending ($938 versus $1,948), while dramatically reducing the percentage of adults in families with out-of-pocket expenses exceeding 10 percent or 20 percent of income (6.0 percent versus 17.1 percent and 0.9 percent versus 3.7 percent, respectively). Larger reductions would be seen for families with smokers, who under Medicaid would no longer be subject to Marketplace tobacco user surcharges. Medicaid expansion may offer a greater opportunity than access to Marketplace insurance to promote the financial well-being of previously uninsured low-income adults.

Legal, ethical, and economic implications of breaking down once-daily fixed-dose antiretroviral combinations into their single components for cost reduction.

The availability of generic lamivudine in the context of the current economic crisis has raised a new issue in some European countries: breaking up the once-daily fixed-dose antiretroviral combinations (FDAC) of efavirenz/tenofovir/emtricitabine, tenofovir/emtricitabine, or abacavir/lamivudine, in order to administer their components separately, thereby allowing the use of generic lamivudine instead of branded emtricitabine or lamivudine. The legal, ethical, and economic implications of this potential strategy are reviewed, particularly in those patients receiving a once-daily single-tablet regimen. An unfamiliar change in antiretroviral treatment from a successful patient-friendly FDAC into a more complex regimen including separately the components to allow the substitution of one (or some) of them for generic surrogates (in the absence of a generic bioequivalent FDAC) could be discriminatory because it does not guarantee access to equal excellence in healthcare to all citizens. Furthermore, it could violate the principle of non-maleficence by potentially causing harm both at the individual level (hindering adherence and favouring treatment failure and resistance), and at the community level (hampering control of disease transmission and transmission of HIV-1 resistance). Replacing a FDAC with the individual components of that combination should only be permitted when the substituting medication has the same qualitative and quantitative composition of active ingredients, pharmaceutical form, method of administration, dosage and presentation as the medication being replaced, and a randomized study has demonstrated its non-inferiority. Finally, a strict pharma-economic study supporting this change, comparing the effectiveness and the cost of a specific intervention with the best available alternative, should be undertaken before its potential implementation.

[The costs of new drugs compared to current standard treatment]. / Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen.

BACKGROUND: Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. METHOD: We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. RESULTS: If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions.

Cigarette price minimization strategies in the United States: price reductions and responsiveness to excise taxes.

INTRODUCTION: Because cigarette price minimization strategies can provide substantial price reductions for individuals continuing their usual smoking behaviors following federal and state cigarette excise tax increases, we examined independent price reductions compensating for overlapping strategies. The possible availability of larger independent price reduction opportunities in states with higher cigarette excise taxes is explored. METHODS: Regression analysis used the 2006-2007 Tobacco Use Supplement of the Current Population Survey (N = 26,826) to explore national and state-level independent price reductions that smokers obtained from purchasing cigarettes (a) by the carton, (b) in a state with a lower average after-tax cigarette price than in the state of residence, and (c) in "some other way," including online or in another country. Price reductions from these strategies are estimated jointly to compensate for known overlapping strategies. RESULTS: Each strategy reduced the price of cigarettes by 64-94 cents per pack. These price reductions are 9%-22% lower than conventionally estimated results not compensating for overlapping strategies. Price reductions vary substantially by state. Following cigarette excise tax increases, the price reduction available from purchasing cigarettes by cartons increased. Additionally, the price reduction from purchasing cigarettes in a state with a lower average after-tax cigarette price is positively associated with state cigarette excise tax rates and border state cigarette excise tax rate differentials. CONCLUSIONS: Findings from this large, nationally representative study of cigarette smokers suggest that price reductions are larger in states with higher cigarette excise taxes, and increase as cigarette excise taxes rise.

[Briefing and accusation of medical malpractice--the second victim]. / Aufklärung und Behandlungsfehlervorwurf--Das zweite Opfer.

In June 2012, the German Medical Association (Bundesärztekammer) published the statistics of medical malpractice for 2011 [1]. Still ENT-specific accusations of medical malpractice are by far the fewest in the field of hospitals and actually even in the outpatient context. Clearly most of the unforeseen incidents still occur in the disciplines of trauma surgery and orthopedics. In total, however, an increasing number of errors in treatment can be noticed on the multidisciplinary level: in 25.5% of the registered cases, an error in treatment was found to be the origin of damage to health justifying a claim for compensation of the patient. In the year before, it was only 24.7%. The reasons may be manifold, but the medical system itself certainly plays a major role in this context: the recent developments related to health policy lead to a continuous economisation of medical care. Rationing and limited remuneration more and more result in the fact that therapeutic decisions are not exclusively made for the benefit of the patient but that they are oriented at economic or bureaucratic aspects. Thus, in the long term, practising medicine undergoes a change. According to the §§ 1, 3 of the professional code of conduct for doctors (Musterberufsordnung für Ärzte; MBO-Ä) medical practice as liberal profession is principally incompatible with the pursuit of profit, however, even doctors have to earn money which more and more makes him play the role of a businessman. Lack of personnel and staff savings lead to excessive workloads of physicians, caregivers, and nurses, which also favour errors. The quality and even the confidential relationship between doctor and patient, which is important for the treatment success, are necessarily affected by the cost pressure. The victims in this context are not only the patients but also the physicians find themselves in the continuous conflict between ethical requirements of their profession and the actual requirements of the realities in the healthcare field. But also the technical and scientific progress bear new risks beside the therapeutic successes, further especially bigger hospitals require high efforts regarding organisation favouring errors in cases of deficiencies. Even the increasing juridification of the medicine that is expected to achieve a provisional highlight with the planned law of patients' rights leads to an important focus on the quality of medical care [2]. The explicit legal regulation of patients' rights, which have never been out of question up to now, confirms the impression of patients who have to be protected from their doctors. This development favours a natural mistrust in the quality of the treatment and the desire of legal verification in cases of treatment failures. A totally perfect and error-free treatment, however, will never occur. Already this fact leads to the obligation to do everything possible to reduce the risk to an absolute minimum. The risks that might arise from a relation of treatment are manifold. Not only may the patient undergo risks that arise in particular from lacking or insufficient briefing, complications, or medical malpractice. Also the doctor has to fear legal consequences if he does not stick clearly to the increasing requirements that jurisdiction and legislation impose - not least by the planned law of patients' rights. In the following, the basic principles and particularities will be described that apply for the patients' briefing. Further the different types of medical malpractice will be explained in relation to the resulting procedural consequences. Finally some current problematic fields will be described with regard to other possible liabilities or responsibilities of physicians in hospitals or doctor's offices.

Wellness incentives in the workplace: cost savings through cost shifting to unhealthy workers.

The Affordable Care Act encourages workplace wellness programs, chiefly by promoting programs that reward employees for changing health-related behavior or improving measurable health outcomes. Recognizing the risk that unhealthy employees might be punished rather than helped by such programs, the act also forbids health-based discrimination. We reviewed results of randomized controlled trials and identified challenges for workplace wellness programs to function as the act intends. For example, research results raise doubts that employees with health risk factors, such as obesity and tobacco use, spend more on medical care than others. Such groups may not be especially promising targets for financial incentives meant to save costs through health improvement. Although there may be other valid reasons, beyond lowering costs, to institute workplace wellness programs, we found little evidence that such programs can easily save costs through health improvement without being discriminatory. Our evidence suggests that savings to employers may come from cost shifting, with the most vulnerable employees--those from lower socioeconomic strata with the most health risks--probably bearing greater costs that in effect subsidize their healthier colleagues.