Pharmaceutical Costs Research Articles

Patent term extension and test data protection obligations: identifying the gap in policy, research, and practice of implementing free trade agreements.

Much of the academic literature criticizes the inclusion of patent term extensions (PTE) and test data protection into the pharmaceutical provisions and/or intellectual property (IP) chapters of free trade agreements (FTAs), with many arguing that such provisions will increase the cost of pharmaceuticals for the implementing government. Such arguments are often backed by studies conducted prior to the conclusion of the relevant FTA. This is problematic for several reasons, most notably that the studies make assumptions that subsequently turn out not to be false and that the claims are not revisited and supported with empirical data following implementation. This article reviews the experience of two jurisdictions - Canada and Australia - in order to provide an analysis of legislative and judicial practices with a focus on implications and the cost of FTAs. The article examines how Canada and Australia have implemented their FTA obligations domestically and on the hereto ignored but important role of courts. One key finding is how courts in both countries are vigilant in narrowing the scope of obligations under FTAs to accommodate the need of the domestic market. The article ultimately concludes by calling on governments to conduct a detailed analysis of PTE and test data protection so as to better inform and prepare policymakers and, ultimately, improved FTA provisions and health outcomes.

Development and Validation of txSim: A Model of Advanced Lung Cancer Treatment in Australia.

Since 2016, new therapies have transformed the standard of care for lung cancer, creating a need for up-to-date evidence for health economic modelling. We developed a discrete event simulation of advanced lung cancer treatment to provide estimates of survival outcomes and healthcare costs in the Australian setting that can be updated as new therapies are introduced. Treatment for advanced lung cancer was modelled under a clinician-specified treatment algorithm for Australia in 2022. Prevalence of lung cancer subpopulations was extracted from cBioPortal and the Sax Institute's 45 and Up Study, a large prospective cohort linked to cancer registrations. All costs were from the health system perspective for the year 2020. Pharmaceutical and molecular diagnostic costs were obtained from public reimbursement fees, while other healthcare costs were obtained from health system costs in the 45 and Up Study. Treatment efficacy was obtained from clinical trials and observational study data. Costs and survival were modelled over a 10-year horizon. Uncertainty intervals were generated with probabilistic sensitivity analyses. Overall survival predictions were validated against real-world studies. Under the 2022 treatment algorithm, estimated mean survival and costs for advanced lung cancer 10years post-diagnosis were 16.4months (95% uncertainty interval [UI]: 14.7-18.1) and AU$116,069 (95% UI: $107,378-$124,933). Survival and costs were higher assuming optimal treatment utilisation rates (20.5 months, 95% UI: 19.1-22.5; $154,299, 95% UI: $146,499-$161,591). The model performed well in validation, with good agreement between predicted and observed survival in real-world studies. Survival improvements for advanced lung cancer have been accompanied by growing treatment costs. The estimates reported here can be used for budget planning and economic evaluations of interventions across the spectrum of cancer control.

Antimicrobial Resistance: A Misuse or Overuse of Antibiotics?

The effectiveness of antibiotics in treating infections in patients is declining as antibiotic-resistant bacteria become alarmingly powerful. We might be failing to understand the cliche that the emergence of antibiotic-resistant bacteria is caused by the overuse and abuse of antibiotics. The high cost of pharmaceuticals serves as an example of the failure of the current system. One medicine costs over $5 billion and takes 15 years to create. There is minimal input into the open-loop system that produces new medications. Because pharmaceuticals are not tailored, this ineffective method produces drugs that are dangerous to the majority of the target population and only work for a small portion of that population. This issue can only be resolved by a complete return to nature rather than by just increasing R&D spending.

HPR129 Is Cost-Effectiveness Analysis a Tool to Exercise Value-Based Pricing or Monopsony Power? Evidence from Canada and Other Countries

Many countries are now considering value-based pricing (VBP) to curb the rising cost of pharmaceuticals and health care spending, while maximizing the value of the drug to the population. One of the most well-used tools to implement VBP in healthcare is using cost-effectiveness analysis (CEA) directly to drive the pricing strategy that sets the right incentives for healthcare systems, or indirectly as part of their multi-criteria decision analysis.

Pharmaceutical Purchasing: a Review of the Landscape and Implications for Antidotal Therapies.

The management of the poisoned patient often requires the utilization of uncommonly used pharmaceutical interventions. These interventions can be associated with significant costs to both the patient and treating institution. Pharmaceutical supply shortages and issues with accessibility of antidotal therapies complicate the management of many toxic exposures. These challenges are an inherent property of the pharmaceutical purchasing infrastructure in the United States, which is a complicated network of public and private intra-institutional agreements. The cost and availability of any given therapy is dependent on the individual contracting agreements between the treating institution, payer, pharmacy benefit manager, manufacturer or wholesaler, and in some cases a specialty pharmacy. Small or remote hospitals may experience greater challenges related to insufficient patient volume to achieve predicable prescribing patterns of rare and expensive medications, necessitating consignment purchasing arrangements. Although pharmaceutical costs are the focus of recent legislative attention, these reforms are not expected to significantly alter the cost or availability of antidotal therapies.

Healthcare cost and survival in patients with non-functioning pituitary adenoma.

Pituitary adenomas and their consequences impact mortality and morbidity. We studied the healthcare costs, survival, and cost-effectiveness of growth hormone (GH) vs no GH replacement in patients with non-functioning pituitary adenoma (NFPA). A cohort study including all NFPA patients followed from 1987 or the date of diagnosis until the time of death or December 31, 2019, in the Västra Götaland region, Sweden. Data to assess resource use, costs, survival, and cost-effectiveness were collected from patient records and regional/national healthcare registries. A total of 426 patients with NFPA (274 men) with a follow-up of 13.6 ± 6.8 years (mean ± SD) were included. The total annual healthcare cost was higher in patients receiving GH (€9287) than those without GH (€6770), mainly driven by a higher pharmaceutical cost. Glucocorticoid replacement therapy (P = .02), diabetes insipidus (P = .04), body mass index (BMI) (P < .01), and hypertension (P < .01) were all individually associated with a higher total annual cost. The survival rate was higher in the GH group (HR [hazard ratio] 0.60; P = .01) and reduced in patients with glucocorticoid replacement (HR 2.02; P < .01) or diabetes insipidus (HR 1.67; P = .04). The cost per gained life-year for GH vs no GH replacement was about €37 000. This healthcare utilization study identified several factors driving the cost of care in NFPA patients, such as GH replacement, adrenal insufficiency, and diabetes insipidus. Life expectancy was increased in those with GH replacement and reduced in patients with adrenal insufficiency and diabetes insipidus.

Medical Costs of Chronic Kidney Disease and Type 2 Diabetes Among Newly Diagnosed Heart Failure Patients With Reduced, Mildly Reduced, and Preserved Ejection Fraction

The economic burden of heart failure (HF) is enormous, but studies of HF costs typically consider the disease to be a single entity. We sought to distinguish the medical costs for patients with HF with reduced ejection fraction (HFrEF), mildly reduced ejection fraction (HFmrEF), and HF with preserved ejection fraction (HFpEF). We identified 16,516 adult patients with an incident HF diagnosis and an echocardiogram from 2005 to 2017 in the electronic medical record of Kaiser Permanente Northwest. Using the echocardiogram nearest to the first diagnosis date, we classified patients with HFrEF (ejection fraction [EF] ≤40%), HFmrEF (EF 41% to 49%), or HFpEF (EF ≥50%). We calculated annualized inpatient, outpatient, emergency, pharmaceutical medical utilization and costs and total costs in $2,020, adjusted for age and gender using generalized linear models, with further analysis of the effects of co-morbid chronic kidney disease (CKD) and type 2 diabetes (T2D). For all HF types, 1 in 5 patients were affected by both CKD and T2D, and costs were significantly higher when both co-morbidities were present. Total per-person costs were significantly higher for HFpEF ($33,740, 95% confidence interval $32,944 to $34,536) than HFrEF ($27,669, $25,649 to $29,689) or HFmrEF ($29,484, $27,166 to $31,800), driven by in- and outpatient visits. Across HF types, visits approximately doubled with the presence of both co-morbidities. Due to greater prevalence, HFpEF accounted for the majority of total and resource-specific treatment costs of HF, regardless of the presence of CKD and/or T2D. In summary, the economic burden was greater per HFpEF patient and was further amplified by co-morbid CKD and T2D. HFpEF accounted for the large majority of total HF costs, underscoring the need to implement effective treatments.

COST VARIATION ANALYSIS OF ANTIMALARIAL DRUGS : A REVIEW

Background: Malaria has been a major issue in India for ages. There are numerous antimalarial brands available on the market. Costly medications can place an economic burden on patients, resulting in lower compliance or even noncompliance. Noncompliance leads to insufficient therapy, which increases morbidity. Increases in patient pharmaceutical costs were found to be related to worse adherence to prescribed medicine. As a result, this study was conducted to analyze the cost variation of malaria drug-therapy. Methods: Price in Indian rupees (₹) of antimalarial drugs manufactured by different pharmaceutical companies in India, in the same strength and in same dosage form were obtained from Current index of medical specialties (CIMS) January-April 2023. Cost ratio and cost variation percentage were calculated and data was analysed. Results: The highest cost ratio and percentage cost variation were observed for Quinine injection 300mg/ml, with a cost ratio of 7 &amp; a percentage cost variation of 599.65%.The lowest cost ratio was found for Mefloquine tablet 250mg injection, with a cost ratio of 1.01 and a percentage cost variation of 1.35%. Overall, the injectable antimalarial medications showed a considerable cost ratio and cost variation Conclusions: Ceiling cost of drugs are fixed by national pharmaceutical pricing authority (NPPA) government of India in accordance with DPCO 2023.Despite this there exists a wide variation of drug costs within one drug with the availability of various brands

Advanced oxidation-based combined conditioning technologies to improve sludge dewaterability: A mini review

With the acceleration of urbanization, sludge production is increasing significantly. The high moisture content of sludge brings great challenges to subsequent incineration or landfill disposal. The advanced oxidation process (AOP) destroys extracellular polymeric substances (EPS) by generating oxidative hydroxyl radicals or sulfate radicals, thereby improving the sludge dewaterability. Due to the promising treatment efficiency of this process, it has become the research focus of chemical conditioning. However, the relatively high cost of pharmaceuticals and subsequent environmental risks limit the widespread application of advanced oxidation methods. Moreover, in order to compensate for the limitations of single sludge conditioning technology, the sludge conditioning technology is currently being developed in the direction of a combined process. Based on AOP, this paper reviews the improvement of sludge dewaterability by other sludge conditioning methods and their combinations in recent years, analyzes the shortcomings of the current technology, and looks into the future development of this technology.

Supervised Learning by Evolutionary Computation Tuning: An Application to Blockchain-Based Pharmaceutical Supply Chain Cost Model

A pharmaceutical supply chain (PSC) is a system of processes, operations, and organisations for drug delivery. This paper provides a new PSC mathematical cost model, which includes Blockchain technology (BT), that can improve the safety, performance, and transparency of medical information sharing in a healthcare system. We aim to estimate the costs of the BT-based PSC model, select algorithms with minimum prediction errors, and determine the cost components of the model. After the data generation, we applied four Supervised Learning algorithms (k-nearest neighbour, decision tree, support vector machine, and naive Bayes) combined with two Evolutionary Computation algorithms (ant colony optimization and the firefly algorithm). We also used the Feature Weighting approach to assign appropriate weights to all cost model components, revealing their importance. Four performance metrics were used to evaluate the cost model, and the total ranking score (TRS) was used to determine the most reliable predictive algorithms. Our findings show that the ACO-NB and FA-NB algorithms perform better than the other six algorithms in estimating the costs of the model with lower errors, whereas ACO-DT and FA-DT show the worst performance. The findings also indicate that the shortage cost, holding cost, and expired medication cost more strongly influence the cost model than other cost components.

Sugammadex Vial Wastage: Implications for the Cost of Anesthesia Care in Children: Research Letter.

Sugammadex Vial Wastage: Implications for the Cost of Anesthesia Care in Children: Research Letter.

The impact of external reference pricing on pharmaceutical costs and market dynamics

Growth in the cost of prescription drugs in the US has generated significant interest in the use of external reference pricing (ERP) to tie prices paid for drugs to those in other countries. We used data from the Pricentric ONE™ database, an international drug pricing database, to examine product launch timing, launch price, and price changes from January 2010 – October 2021 in both ERP and non-ERP settings, with a focus on 100 high-priced drugs of interest to Medicare and Medicaid. We found that ERP policies were associated with a 73% reduction in the likelihood of drug launch within 9 months of regulatory approval relative to non-ERP settings. In addition, while ERP was associated with statistically significant reductions in annual drug price changes, such policies did not impact launch price. In addition, no single ERP feature (e.g., number of countries referenced, ERP calculation) was materially associated with the outcomes of interest. We conclude that ERP policies do not appear to impact drug launch price and may delay access to new therapies, raising questions about the utility of such policies in the US and potential consequences abroad.

Cost-Minimization Analysis of Medications Used in the Management of End-stage Renal Disease

Abstract: Aim/Background: Several branded pharmaceuticals and generic medicines are available in the market for the management of End-Stage Renal Disease (ESRD) as a supportive care, and clinicians are unaware of the cost minimization and cost consequences aspects of these medications. Thus, this study aimed to compare the prices of branded versus generic medicines for ESRD treatment and to present the cost savings with a generic alternative. Materials and Methods: A prospective observational study was conducted among ESRD patients from three different tertiary care teaching hospitals in South India. The cost of branded pharmaceuticals were determined using the most recent current index of medical specialties, while the prices of generic medicines were accessed using the Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana scheme, 2022. Results: The data were collected from 385 patients with ESRD. All Jan Aushadhi generic medicines were less expensive when compared to the branded medicines. The cost of ESRD medicines accessible in India varies greatly. The greatest difference in percentage cost savings were noted with amlodipine 5 mg tab (93.03%), voglibose 0.2mg/tab (88.10%), calcium carbonate + Vitamin D3 supplements 500 mg tab (80.27%), torsemide 10 mg tab (78.01%), and hematopoietic agent, erythropoietin 2000 U/inj (75.38%). Conclusion: The haematopoietic medicines and antidiabetic insulin injections were the most expensive medicines among the study population. Our research indicates that replacing the generic medicines with the branded medicines could help in reducing the cost burden. Healthcare professionals may consider prescribing generic medicines for cost-savings. Keywords: Pharmacoeconomics, Cost minimization, End stage renal disease, Antibiotics, Insulin, Jan Aushadhi.

Quantitative cost‑effectiveness index of cancer treatments.

In spite of advancements being made in technology and treatment strategies, which have markedly improved the survival rate of patients, the cost of cancer care worldwide has increased over the past decades. The presence of several cost-effectiveness ratios has provided significant indexes to assess the balance between cost and effectiveness. However, the currently available indexes still fail to provide a comprehensive and objective evaluation of cancer treatment. Therefore, the present study developed a novel approach, namely a quantitative cost-effectiveness index of cancer treatment, based on the calculation of the hospitalization expense index and efficacy evaluation index. The present study used the data of 16 patients with childhood acute myeloid leukemia who received the high-dose chemotherapy as an example, and the quantitative cost-effectiveness index was used to evaluate the value of this approach. As the increasing prevalence of cancer and the rising cost of pharmaceuticals have contributed to the expenditure, the development of this index may help to solve the current dilemma of cancer treatment and may prove to be essential for the development of an effective approach which may be accessible to and affordable by common persons; thus would then lead to a higher cure rate.

Budget impact analysis of anakinra in the treatment of familial Mediterranean fever in Italy

ABSTRACT Introduction: Familial Mediterranean Fever (FMF) is a hereditary autoinflammatory disease that significantly reduces occupational productivity and quality-of-life in affected patients. Italy has an estimated FMF prevalence of 1 in 60,000 people. While colchicine is the primary treatment for FMF, biologics are administered to intolerant and non-responder patients. Anakinra and canakinumab are the only biologics approved and reimbursed for FMF in Italy. Both medicines have demonstrated efficacy in FMF patients yet differ in treatment costs. This study aimed to perform a budget impact analysis (BIA) following anakinra’s reimbursement for FMF treatment, considering pharmaceutical costs from the Italian National Healthcare Service (NHS) perspective. Methods: A ‘Reference scenario’ (all patients treated with canakinumab) was compared to an ‘Alternative scenario’, with increased anakinra market shares. The target population was estimated based on the Italian population, epidemiological and market research data. Drugs costs were estimated based on Summary of Product Characteristics and net ex-factory prices. Sensitivity analyses were implemented to test results’ robustness. Results:The base case analysis showed an overall cumulative expenditure of €30,586,628 for ‘Reference scenario’ and € 16,465,548 for ‘Alternative scenario’. A cumulative savings of €14,121,080 (46.2%) was calculated over 3 years as a result of the reimbursement and increasing uptake of anakinra. The sensitivity analyses, even considering a discount of 50% for canakinumab, confirmed the base case results. Conclusions: Anakinra’s introduction, in FMF treatment, provides a financially sustainable option for Italian patients, with savings increasing according to greater use of anakinra.

Economic Impact of European Liver and Intestine Transplantation Association (ELITA) Recommendations for Hepatitis B Prophylaxis After Liver Transplantation.

The European Liver and Intestine Transplant Association, ELITA, promoted a Consensus Conference involving 20 experts across the world which generated updated guidelines on HBV prophylaxis in liver transplant candidates and recipients. This study explores the economic impact associated with the implementation of the new ELITA guidelines. To this aim, a condition-specific cohort simulation model has been developed to compare new and historical prophylaxis, including only pharmaceutical cost and using the European perspective. The target population simulated in the model included both prevalent and incident cases, and consisted of 6,133 patients after the first year, that increased to 7,442 and 8,743 patents after 5 and 10years from its implementation. The ELITA protocols allowed a cost saving of around € 235.65 million after 5years and € 540.73 million after 10years; which was mainly due to early HIBG withdrawal either after the first 4weeks or after the first year post Liver Transplantation (LT) depending on the virological risk at transplantation. Results were confirmed by sensitivity analyses. The money saved by the implementation of the ELITA guidelines would allow healthcare decision makers and budget holders to understand where costs could be reduced and resources re-allocated to different needs.

Economics And Pricing of Certain Segments of The Pharmaceutical Market

Pharmaceutical innovations over the past half century have made it possible to effectively treat and prevent a wide range of diseases. These achievements were so important for modern healthcare that equal access to them is considered one of the basic human rights. This article examines the economics and pricing in certain segments of the pharmaceutical market. The authors analyze various aspects affecting drug prices and price formation mechanisms in various segments of the pharmaceutical industry. The article considers the role of pharmaceutical companies, government regulators and consumers in determining the prices of medicines. The authors investigate the influence of factors such as research and development costs, production costs, patent protection, supply and demand, as well as political and regulatory measures on the formation of prices for pharmaceuticals. It is noted that although the demand for medicines is one of the driving forces of pharmaceutical spending, price increase is the main problem for health system managers, as drug prices increasingly seem unfair. The paper also analyzes various pricing strategies used by pharmaceutical companies, including differentiated pricing, cost pricing and pricing based on the value for a patient. The authors explore the advantages and limitations of each strategy and offer recommendations on the optimal choice of pricing strategy in different segments of the pharmaceutical market. The article ends with the main conclusions and offers recommendations for pharmaceutical companies and government regulators regarding effective pricing in certain segments of the pharmaceutical market, taking into account economic, political and social factors. The study has an important meaning for understanding the complexities and challenges associated with pricing in the pharmaceutical industry and helps to determine optimal pricing strategies for various market segments.

Prescriptions Conformity with National Formulary: A Literature Review to Explore the Need for Pharmaceutical Cost Containment

The government has created the National Formulary (Fornas) as a tool for control of quality and cost control. Patients’ prescriptions should be based on the national Formulary during the era of national health coverage. If prescriptions complied with the national Formulary, the cost would reduce. This research aimed to determine the factor of non-conformity between prescriptions and the national Formulary measures it and explores the need for pharmaceutical cost containment. This study applied the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) method between 2014 and 2022. The search terms “Kesesuaian Fornas” were utilized on Google Scholar, Pubmed, ScienceDirect, and Scopus. The evaluation was organized by factor and subsequent action. Searches of the databases Google Scholar (2,246), Pubmed (0), ScienceDirect (1), and Scopus (0) yielded a total of 247 results. Following the selection procedure, 34 articles were included in the analysis. The average conformity of prescription with Fornas was 71.02%. Prescription adherence, drug availability, and formulary Conformity with Fornas were the primary factors in the conformity of prescriptions with the National Formulary. Conformity with the national Formulary for prescriptions can be enhanced through three primary actions: increasing prescription adherence, updating the Formulary, and procuring following the electronic catalog.

Self-Care and Compliance with Medication and Their Relationship to the Quality of Life of Patients with Heart Failure.

Heart failure is a major health problem, often accompanied by limited physical activity and severe effects in various areas of patient quality of life. Self-care, as well as compliance with medication, can further contribute to clinical stability and improved patient outcomes. The purpose of this chapter is to assess the effect of self-care and compliance with medication, on the quality of life of patients with heart failure. The research sample consisted of 67 patients diagnosed with heart failure who visited the cardiology outpatient clinic of a general hospital in the capital of Greece. The assessment of self-care behavior was performed by the scale EHFScBS and SCHFI v.6, the Morsiky Green Levine Adherence Scale (MAQ) was used for the evaluation of adherence to medical treatment, while for the evaluation of the quality of life the questionnaire MLWHFQ was used. The multifactorial linear regression analysis showed that age, compliance with medication and scoring in the dimension "Self-care confidence" relates independently to the overall quality-of-life scale rating. In particular, participants over 80 had a significantly higher score, that is, worse quality of life, compared to those under the age of 70 (p<0.001), while participants with low compliance with treatment had a significantly worse quality of life compared to participants with high compliance (p<0.001). It has been noticed that the better self-care they had and the higher compliance with their medication, their quality of life was better. Self-care behavior and adherence to medical treatment of patients with heart failure are related to their quality of life. Age, educational level, and "Self-care confidence" are factors that influence self-care behavior, compliance with medication, and quality of life. In-depth patient information on the need for adherence to therapeutic guidelines may help to reduce pharmaceutical costs and maximize the therapeutic effect. For this reason, health professionals treating these patients should take into account all the factors that negatively affect their quality of life and treat them with the appropriate interventions.

Prescription of Gastric Acid Secretion Inhibitors before and after the Withdrawal of Ranitidine

Background: In September 2019, ranitidine, the largest share in the gastric acid secretion inhibitor market, was identified as a carcinogen, and sales were banned. The purpose of this study was to investigate how the gastric acid secretion inhibitor market changed after ranitidine withdrawal.Methods: From January 2010 to December 2021, the prescription dose and cost of gastric acid secretion inhibitors were calculated monthly. To investigate the effect of ranitidine withdrawal on the gastric acid secretion inhibitor market, we developed a time-series autoregressive model using data from January 2010 to October 2019. In addition, the P-value was calculated by interrupted time series analysis using the data dating between 2010 and 2021 (interrupted time: October 2019).Results: Since 2010, proton pump inhibitors have increased their market share in terms of prescription volume and drug costs. This trend accelerated since ranitidine was withdrawn from the market in September 2019. In 2021, it was estimated that ranitidine prescriptions would be transferred as follows: famotidine's increased prescription volume was estimated at 323 million (pharmaceutical cost, 53.2 billion won), proton pump inhibitors (PPIs) at 223 million (89.9 billion won), and lafutidine at 137 million (20.5 billion won).Conclusions: The market share expansion of PPIs accelerated due to the withdrawal of ranitidine. The ranitidine prescription was partially transferred to the same H &lt;sub&gt;2&lt;/sub&gt; blockers, such as famotidine and lafutidine, and there was also a significant transfer to PPIs.