Expensive Drugs Research Articles

Improving Patient Access Scheme in Malaysia: lessons from Italy

PurposeMedicine prices are increasing globally, including in Malaysia where previous studies show prices higher than international averages. Patient Access Scheme (PAS) is a mechanism adopted by Malaysia in 2018 to facilitate access to expensive medicines, similarly used by Italy since 2005. This study aims to compare the implementation of PAS in Malaysia and Italy.Design/methodology/approachThis review systematically searched for peer-reviewed articles in PubMed, Scopus and ScienceDirect on how Italy implemented PAS system from 2012 to 2022 using the related keywords. The systematic review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.FindingsThe search identified 363 articles. A total of eight studies were included. Most of the studies found that PAS is able to control the expenditure on expensive drugs. PAS has also had several challenges, such as high administrative burden, high upfront cost and the need for good data infrastructure.Originality/valueThis study’s unique focus on Italy’s adoption of managed entry agreements (MEA) can provide valuable insights for Malaysia’s pricing mechanisms and access to expensive drugs. Notably, this research addresses a gap in the literature regarding the practical implications of MEA implementation in developing countries. The findings have the potential to improve access to essential medicines for Malaysian citizens while offering a fresh perspective on MEA utilization in emerging markets.

Telemedical follow-up in patients with inflammatory bowel diseases

Inflammatory bowel diseases (IBDs) represent a group of nosologies including Crohns disease and ulcerative colitis. These diseases lead both to the deterioration of the patients physical condition and to a pronounced decrease in the quality of life. Currently, healthcare costs of managing patients with IBDs are steadily increasing and are commonly associated with the need for examinations and therapy with expensive drugs and unplanned expenses of healthcare resources for unscheduled consultations, emergency hospitalizations, and surgical interventions. Deterioration of patients condition may be associated with self-cancellation of therapy after normalization of the state of health. The use of telemedical technologies (TMTs) is promising for maintaining remission of IBDs, improving adherence to therapy, and reducing the frequency of unscheduled visits to the clinic and the cost of treating IBD complications (including surgery). The efficiency and benefits of TMTs in patients with IBDs were assessed in comparison with standard face-to-face follow-up. A literature search relevant to the review was conducted in the PubMed database. Papers were selected that assessed the efficiency of telemedical interventions among patients with IBDs as compared to the standard face-to-face follow-up group. The evaluation criteria included the degree of the disease activity, risks of IBD recurrence, quality of life of patients, adherence to therapy, healthcare costs, and frequency of visits to healthcare facilities. Telemedical interventions were conducted using the Internet, mobile applications, various telemedical platforms, SMS messages, and phone calls. The telemedical follow-up groups received access to educational materials and online consultations with a specialist upon request and completed questionnaires to assess disease activity, adherence to therapy, and quality of life. The degree of IBD activity and risk of recurrence and the level of adherence to therapy did not differ significantly between the telemedical intervention and standard face-to-face follow-up groups. The study by L. Pang et al. showed that the patients quality of life in the group of telemedical intervention was significantly higher (p=0.03) [8]. Another advantage of using TMTs is the provision of access to educational materials about IBDs and the possibility of remote contact with the treating physician. The patients ability to obtain necessary information reduces the need for unplanned visits to medical facilities and the cost of organizing medical care for patients with IBDs. The use of TMTs allows to monitor IBD activity as effectively as face-to-face follow-up, improve the patients quality of life with IBDs, and reduce costs for organizing care for patients with these diseases by decreasing the frequency of unscheduled visits to the doctor and conducting unnecessary additional examinations.

P-504 Pregnancy outcome of intravenous immunoglobulin in women with recurrent pregnancy loss

Abstract Study question Does intravenous immunoglobulin(IVIG) increase live births in recurrent miscarriage(RM) women with cellular immune abnormality such as high NK cell level and cytotoxicity and TNF-α/IL-10 ratio? Summary answer IVIG treatment increased the live birth rate of RM women with abnormal cellular immunity. What is known already Various causes of RM have been identified but even with a detailed evaluation, almost half of the cases have unidentified etiologies. Immune imbalance is one of the proposed potential etiologies of these idiopathic RM. To regulate abnormal cellular immunity, treatment such as IVIG is proposed to improve pregnancy outcomes. However, the use of IVIG in RM is still controversial. In addition, one of the widely used indicators of immune imbalance in pregnancy is the NK cell level, but there is a disagreement in setting the cut-off value. The percentage varies from 12 to 18%. Study design, size, duration RM was defined as women with two or more spontaneous abortions and in total, 987 RM women visited Department of Obstetrics and Gynaecology, Konyang University Hospital(KYUH) from January 2007 to December 2020. Only those with a full evaluation and known treatment outcome were included. A total 204 idiopathic RM and 209 RM women with known aetiology were enrolled. Participants/materials, setting, methods We investigated the pregnancy outcome by sorting the patients into seven subgroups depending on abnormal cellular immunity including NK cell level, NK cell cytotoxicity and TNF-α/IL-10 ratio. Then, to verify the cut-off value(16.1%) of NK cell level which we set in our previous study, patients were classified into three groups according to their NK cell level: 1) <12%(low), 2) 12-16%(moderate), 3) >16%(high). Main results and the role of chance Among all RM women with at least one abnormal cellular immunity were treated with IVIG and the overall live birth rate (LBR) was 80.2%. The group which did not have IVIG treatment showed an overall LBR of 78.0%. Within the 7 groups with abnormal cellular immunity, the group with both high NK cell toxicity and TNF-α/IL-10 ratio showed the highest LBR, 100% of LBR and the group with both high NK cell level and TNF-α/IL-10 ratio showed the lowest treatment outcome, 71.4%. To verify the adequacy of our cut-off value, after excluding those with high NK cell cytotoxicity and TNF-α/IL-10 ratio, 152 patients were classified into low, moderate, and high level of NK cells. LBR were 81.0%, 72.5%, and 76.9%. Limitations, reasons for caution The study was designed retrospectively, resulting in numerous follow-up losses. It is a single-centered study that may not be enough to generalize the diagnosis method and treatments from these findings. Moreover, IVIG is an expensive drug that may lead to certain patient preferences. Wider implications of the findings The study may provide evidence in selecting RM patients with immune abnormalities to be treated with IVIG and raise their pregnancy outcomes. We can also apply these results to the reproductive failure group. A detailed evaluation and an evidence-based treatment are important. Trial registration number not applicable

In Silico and In Vitro Identification of P-Glycoprotein Inhibitors from a Library of 375 Phytochemicals.

Cancer therapy with clinically established anticancer drugs is frequently hampered by the development of drug resistance of tumors and severe side effects in normal organs and tissues. The demand for powerful, but less toxic, drugs is high. Phytochemicals represent an important reservoir for drug development and frequently exert less toxicity than synthetic drugs. Bioinformatics can accelerate and simplify the highly complex, time-consuming, and expensive drug development process. Here, we analyzed 375 phytochemicals using virtual screenings, molecular docking, and in silico toxicity predictions. Based on these in silico studies, six candidate compounds were further investigated in vitro. Resazurin assays were performed to determine the growth-inhibitory effects towards wild-type CCRF-CEM leukemia cells and their multidrug-resistant, P-glycoprotein (P-gp)-overexpressing subline, CEM/ADR5000. Flow cytometry was used to measure the potential to measure P-gp-mediated doxorubicin transport. Bidwillon A, neobavaisoflavone, coptisine, and z-guggulsterone all showed growth-inhibitory effects and moderate P-gp inhibition, whereas miltirone and chamazulene strongly inhibited tumor cell growth and strongly increased intracellular doxorubicin uptake. Bidwillon A and miltirone were selected for molecular docking to wildtype and mutated P-gp forms in closed and open conformations. The P-gp homology models harbored clinically relevant mutations, i.e., six single missense mutations (F336Y, A718C, Q725A, F728A, M949C, Y953C), three double mutations (Y310A-F728A; F343C-V982C; Y953A-F978A), or one quadruple mutation (Y307C-F728A-Y953A-F978A). The mutants did not show major differences in binding energies compared to wildtypes. Closed P-gp forms generally showed higher binding affinities than open ones. Closed conformations might stabilize the binding, thereby leading to higher binding affinities, while open conformations may favor the release of compounds into the extracellular space. In conclusion, this study described the capability of selected phytochemicals to overcome multidrug resistance.

Leveraging Cell Painting Images to Expand the Applicability Domain and Actively Improve Deep Learning Quantitative Structure-Activity Relationship Models.

The search for chemical hit material is a lengthy and increasingly expensive drug discovery process. To improve it, ligand-based quantitative structure-activity relationship models have been broadly applied to optimize primary and secondary compound properties. Although these models can be deployed as early as the stage of molecule design, they have a limited applicability domain─if the structures of interest differ substantially from the chemical space on which the model was trained, a reliable prediction will not be possible. Image-informed ligand-based models partly solve this shortcoming by focusing on the phenotype of a cell caused by small molecules, rather than on their structure. While this enables chemical diversity expansion, it limits the application to compounds physically available and imaged. Here, we employ an active learning approach to capitalize on both of these methods' strengths and boost the model performance of a mitochondrial toxicity assay (Glu/Gal). Specifically, we used a phenotypic Cell Painting screen to build a chemistry-independent model and adopted the results as the main factor in selecting compounds for experimental testing. With the additional Glu/Gal annotation for selected compounds we were able to dramatically improve the chemistry-informed ligand-based model with respect to the increased recognition of compounds from a 10% broader chemical space.

Pharmacoeconomic analysis of antiretroviral therapy regimes in the Syrian Arab Republic

Background. Due to the significant prevalence of human immunodeficiency virus (HIV) and limited funding in the Syrian Arab Republic (SAR), pharmacoeconomic study of antiretroviral therapy (ART) regimens is relevant, as it allows to choose a rational, pharmacoeconomically reasonable therapy for HIV-infected patients.Objective: to perform pharmacoeconomic analysis of ART regimens HIV-infected in patients in SAR.Material and methods. The following algorithm of actions was used: assessment of the cost of prescribed antiretroviral drugs; cost analysis of applied ART regimens. From the auction documentation, information was taken on the total number of purchased drugs and their cost at the end of the auction. To calculate prices in rubles, currency conversion was carried out as of January 1, 2021. To calculate the cost of an assigned regimen, the summation of the costs of its components was carried out. Based on the obtained data, the average cost of combinations of certain antiretroviral drugs classes was calculated. To predict the results of using various ART regimens for 5 years, discounting was used for each year of the time horizon, except for the first year.Results. It was revealed that the most expensive drugs are the reserve series: Fuzeon® (enfuvirtide; F. Hoffmann-La Roche Ltd., Switzerland) – 66,492.1 rubles and Isentress® (raltegravir; Merck Sharp & Dohme, Netherlands) – 31,634.6 rubles, and the lowest price per package was noted for Russian drugs Timazid® (zidovudine) – 471.0 rubles and Nikavir® (phosphazide) – 743.8 rubles (both – AZT Pharma K.B. LLC, Russia). The average cost of the first prescribed regimen was 8,970.0 rubles/month, while the most expensive first-line regimens included a protease inhibitors class drug as the third component. As a result of the analysis of the cost of second-line and third-line regimens, it was revealed that the average cost of second-line therapy per month exceeded the average cost of first-line therapy by 4 times (40,154.2 rubles/month). The initial “azidothymidine, zidovudine / lamivudine + efavirenz” group had fewer hospitalizations, lower mortality, and fewer years of life expectancy lost than on “azidothymidine, zidovudine / lamivudine + atazanavir, ritonavir” and “phosphazide + didanosine + efavirenz” regimens.Conclusion. A pharmacoepidemiological study showed that the cost of second-line therapy per month was 40,154.2 rubles, which exceeded the average cost of first-line therapy by 4 times (9,266.1 rubles). It was revealed that the average cost of the first prescribed ART regimen based on two nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitor was 2 times higher than the average cost of regimens based on two NRTIs + non-nucleoside reverse transcriptase inhibitors, which, along with clinical aspects, raised the question of the expediency of their appointment as first-line regimens.

One-year consumption pattern of intravenous immunoglobulin at a teaching hospital in Sari

Background: There is an increasing trend to use intravenous immunoglobulin (IVIG) for new indications, mainly off-labeled conditions for numerous diseases. IVIG is an expensive drug and is occasionally not available, so it is recommended that medical centers evaluate how to use it permanently. This study aimed to assess the pattern of IVIG use in an educational hospital.
 Methods: All patients who received IVIG for any condition for a year were enrolled in this cross-sectional observational study. A predesigned checklist form was used to gather demographic, clinical, and biochemical data. The collected data were compared to the FDA recommendations for IVIG use.
 Results: Overall, in 62.8% of the patients, IVIG was administrated for FDAapproved indications, 21.2% for off-label uses, and the remaining 16% for investigational conditions. The most common cause of IVIG use was for primary immunodeficiency disease (PID) in 22 patients (19.5%). The highest prevalence of primary diagnoses in patients receiving IVIG was immune thrombocytopenic purpura (ITP). In addition, Chronic inflammatory demyelinating polyneuropathy (CIDP) (28.4%) and final diagnoses were ITP and Guillain-Barré syndrome (GBS) in 30% of patients. 26.5% of patients experienced side effects, and headache, fever and chills, and inflammation of the injection site were the most common adverse drug reactions.
 Conclusion: National or local drug protocols are needed to prescribe more rational IVIG utilization and assist physicians in using IVIG for approved or high evidence-based indications.

Comparison of Price Index Methods and Drug Price Inflation Estimates for Hepatitis C Virus Medications

Measuring drug price inflation is challenging because new drugs continually enter the market, some drugs transition from branded to generic, and current inflation indexes do not account for these market basket changes. Instead, they measure the price increases after new drugs have been launched. Therefore, the public pays the higher costs of newer and usually more expensive drugs, but the inflation indexes do not reflect the increases over existing drugs previously used to treat the same conditions. To assess how price index methods can affect estimates of drug price inflation using a case study of hepatitis C virus (HCV) medication and to explore other approaches for constructing a price index. This cross-sectional study used data from outpatient pharmacies to compile a list of all HCV medications that were ever on the market (brand and generic) from 2013 to 2020. Using National Drug Codes of HCV drugs, a 20% nationally representative sample of Medicare Part D claims from 2013 to 2020 was queried. Alternative drug price indexes, including product-level vs class-level product and quantity definitions were developed in which gross vs net price definitions were used and an adjustment was created and applied to capture treatment duration because newer drugs often required a shorter duration. Price index value and rate of inflation from 2013 to 2020 for each methodologic approach to constructing a drug pricing index. In all, 27 different HCV drug regimens were identified in Medicare Part D claims in 2013 to 2020. A product-level approach for measuring inflation estimated a 10% gross drug price increase from 2013 to 2020 for HCV drugs, whereas a class-level approach including the higher prices of the new drugs showed a 31% gross price increase. After adjusting for manufacturer rebates to estimate net prices, the findings showed that HCV drug prices fell by 31% from 2013 to 2020. The findings of this cross-sectional study indicate that the current product-level methods to estimate drug price inflation underestimated price increases for HCV drugs by failing to include the high launch prices of new market entrants. Using a class-level approach, the index captured higher spending on new products at launch. Prescription-level analyses, which did not consider shorter durations of treatment, overestimated price increases.

Incorporating Added Therapeutic Benefit and Domestic Reference Pricing Into Medicare Payment for Expensive Part B Drugs

ObjectivesIdentify expensive Part B drugs and evidence for each drug’s added benefit and model a reimbursement policy for Medicare that integrates added benefit assessment and domestic reference pricing. MethodsA retrospective analysis using a 20% nationally representative sample of 2015 to 2019 traditional Medicare Part B claims. Expensive drugs were defined as having average annual spending per beneficiary exceeding the average annual social security benefit ($17 532 in 2019). For expensive drugs identified in 2019, added benefit assessments conducted by the French Haute Autorité de Santé were collected. For expensive drugs with a low added benefit rating, comparator drugs were identified in French Haute Autorité de Santé reports. For each comparator, average annual spending per beneficiary in Part B was computed. Potential savings from 2 reference pricing scenarios were calculated: reimbursing expensive Part B drugs with low added benefit at the level of each drug's (1) lowest cost comparator and (2) beneficiary-weighted-average cost of all comparators. ResultsThe number of expensive Part B drugs grew from 56 in 2015 to 92 in 2019. Of the 92 expensive drugs in 2019, 34 offer low added benefit. Implementing reference pricing for these expensive drugs with low added benefit could have saved an estimated $2.1 billion if prices were set based on spending for their lowest cost comparator, or $1 billion if prices were set based on the weighted average of spending for comparators. ConclusionReference pricing based on added benefit assessment could be used to address the launch prices for expensive Part B drugs with low added benefit.

HPR18 International Generic Availability Improvements between 2010 and 2021

Although expensive new medicines occupy much policy attention, older and less expensive generic drugs make up the majority of drugs used internationally and are vital to population health. This research aims to rank a group of countries with similar pharmaceutical environments on their generic drug market’s vitality.

HPR16 Incorporating Added Therapeutic Benefit and Domestic Reference Pricing into Medicare Payment for Expensive Part B Drugs

This study identifies expensive drugs reimbursed by Medicare Part B and evidence for each drug’s added therapeutic benefit. A reimbursement policy for Medicare Part B that integrates added benefit assessment and domestic reference pricing is then modeled.

Clinical and statistical analysis of factors affecting compliance in schizophrenia patients

Patients with schizophrenia have an increased risk of non-compliance with medical therapy, which, as a rule, leads to exacerbation or relapse of the disease, repeated hospitalization, and impaired social adaptation. The aim of the study was to analyze clinical and organizational factors that affect the compliance of schizophrenia patients. We examined 157 patients with a diagnosis of schizophrenia aged 23 to 52 (38.5±8.1) years. The study was carried out a week before discharge from the hospital. Clinical-psychopathological, clinical-dynamic, psychometric, and statistical research methods were used. It was found that only 11.4% of males and 20.7% of females were fully compliant. Taking medications under the relatives’ control was observed in a third of men and half of women. The probability (chance) of compliance overestimation by the attending physician using the clinical method is 1.8 times higher than when using the corresponding questionnaires. The higher the criticism of the disease was, the higher was patients’ compliance after discharge. The following risk factors for non-compliance in patients with schizophrenia have been identified: male gender; history of alcohol abuse; early discharge of patients from the hospital with clinically expressed anxiety, depression, and a sense of hopelessness; complete absence or insufficient explanation to the patient of the principle and procedure for taking supporting therapy; prescribing many oral or expensive drugs. Thus, compliance in schizophrenia patients is a dynamic formation, which is formed under the influence of a whole complex of individual, personal, social, environmental, and clinical factors, which should be taken into account when forming therapeutic tactics.

Emergency use of nebulized milrinone, a phosphodiesterase 3 inhibitor, in status asthmaticus: a case report in Suriname

Data indicate the benefits of phosphodiesterase inhibitors as an add-on treatment in severe asthma, but mainly because of the limited tolerability, no compound reaches the market. Low- and middle-income countries (LMIC) face the challenge of successfully treating status asthmaticus, due to little or no access to expensive drug regimens. We describe a case of a 25-year-old man admitted to the ICU with status asthmaticus where nebulized milrinone was used as a last resort as there was no improvement with optimal standard management. After initiation of nebulized milrinone the patient could be smoothly weaned from ventilation and discharged.

Canadians Need Improved Access to Drugs for Rare Diseases, Not More Denial.

Sirrs et al. (2023a) discuss what they consider "explosive growth" (p. 11) in the research and development (R&D) and commercialization of expensive drugs for rare diseases (DRDs). They contend that the "status quo is no longer an option" (Sirrs et al. 2023b: 75), so it is critical to drastically reduce the prices of DRDs and/or ration access.

A Systematic Evaluation of Cost-Saving Dosing Regimens for Therapeutic Antibodies and Antibody-Drug Conjugates for the Treatment of Lung Cancer

Expensive novel anticancer drugs put a serious strain on healthcare budgets, and the associated drug expenses limit access to life-saving treatments worldwide. We aimed to develop alternative dosing regimens to reduce drug expenses. We developed alternative dosing regimens for the following monoclonal antibodies used for the treatment of lung cancer: amivantamab, atezolizumab, bevacizumab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and ramucirumab; and for the antibody-drug conjugate trastuzumab deruxtecan. The alternative dosing regimens were developed by means of modeling and simulation based on the population pharmacokinetic models developed by the license holders. They were based on weight bands and the administration of complete vials to limit drug wastage. The resulting dosing regimens were developed to comply with criteria used by regulatory authorities for in silico dose development. We found that alternative dosing regimens could result in cost savings that range from 11 to 28%, and lead to equivalent pharmacokinetic exposure with no relevant increases in variability in exposure. Dosing regimens based on weight bands and the use of complete vials to reduce drug wastage result in less expenses while maintaining equivalent exposure. The level of evidence of our proposal is the same as accepted by regulatory authorities for the approval of alternative dosing regimens of other monoclonal antibodies in oncology. The proposed alternative dosing regimens can, therefore, be directly implemented in clinical practice.

Magnetic Control of Protein Expression via Magneto-mechanical Actuation of ND-PEGylated Iron Oxide Nanocubes for Cell Therapy.

Engineered cells used as smart vehicles for delivery of secreted therapeutic proteins enable effective treatment of cancer and certain degenerative, autoimmune, and genetic disorders. However, current cell-based therapies use mostly invasive tools for tracking proteins and do not allow for controlled secretion of therapeutic proteins, which could result in unconstrained killing of surrounding healthy tissues or ineffective killing of host cancer cells. Regulating the expression of therapeutic proteins after success of therapy remains elusive. In this study, a noninvasive therapeutic approach mediated by magneto-mechanical actuation (MMA) was developed to remotely regulate the expression of the tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) protein, which is secreted by transduced cells. Stem cells, macrophages, and breast cancer cells were transduced with a lentiviral vector encoding the SGpL2TR protein. SGpL2TR comprises TRAIL and GpLuc domains optimized for cell-based applications. Our approach relies on the remote actuation of cubic-shape highly magnetic field responsive superparamagnetic iron oxide nanoparticles (SPIONs) coated with nitrodopamine PEG (ND-PEG), which are internalized within the cells. Cubic ND-PEG-SPIONs actuated by superlow frequency alternating current magnetic fields can translate magnetic forces into mechanical motion and in turn spur mechanosensitive cellular responses. Cubic ND-PEG-SPIONs were artificially designed to effectively operate at low magnetic field strengths (<100 mT) retaining approximately 60% of their saturation magnetization. Compared to other cells, stems cells were more sensitive to the interaction with actuated cubic ND-PEG-SPIONs, which clustered near the endoplasmic reticulum (ER). Luciferase, ELISA, and RT-qPCR analyses revealed a marked TRAIL downregulation (secretion levels were depleted down to 30%) when intracellular particles at 0.100 mg/mL Fe were actuated by magnetic fields (65 mT and 50 Hz for 30 min). Western blot studies indicated actuated, intracellular cubic ND-PEG-SPIONs can cause mild ER stress at short periods (up to 3 h) of postmagnetic field treatment thus leading to the unfolded protein response. We observed that the interaction of TRAIL polypeptides with ND-PEG can also contribute to this response. To prove the applicability of our approach, we used glioblastoma cells, which were exposed to TRAIL secreted from stem cells. We demonstrated that in the absence of MMA treatment, TRAIL essentially killed glioblastoma cells indiscriminately, but when treated with MMA, we were able to control the cell killing rate by adjusting the magnetic doses. This approach can expand the capabilities of stem cells to serve as smart vehicles for delivery of therapeutic proteins in a controlled manner without using interfering and expensive drugs, while retaining their potential to regenerate damaged tissue after treatment. This approach brings forth new alternatives to regulate protein expression noninvasively for cell therapy and other cancer therapies.

Pharmacoeconomic Appraisal of Treating Head and Neck Cancer with Various Chemotherapy and Chemoirradiation Regimens Using Branded and Jan-aushadhi Drugs in India.

According to recent studies, head and neck cancers (HNC) make up a substantial proportion of all cancers in India and are proportionately high in the lower socioeconomic people practising tobacco and alcohol. Chemotherapy is a crucial component of treating HNC, and this study was carried out to determine the Cost Minimization Analysis (CMA) by comparing the price of the high and least expensive branded drugs marketed in India. This study was performed to understand the cost difference (CD), Cost ratio (CR) and percentage of cost variation (PCV) of both individual drugs and the standard anticancer regimens. The Current Index of Medical Stores was used to determine the costs of the most and least expensive branded medications and analysed. The results indicated that Paclitaxel-Cisplatin-5 Fluoruracil chemotherapy regimen exhibited the greatest variance in cost, with the Jan Aushadhi brand of medicine costing 8.1 times and 4.3 times less than the most expensive and cheapest branded drugs, respectively. The cost of the concurrent cisplatin regimen with Jan Aushadi Medicine was Rs 1764, Rs 3489.64 with the lowest branded drug, and Rs 8477 with the most expensive branded drug. Also when compared to Jan Aushadhi medication, the cost of Ciplatin was 4.8 times higher with the most expensive branded drug and 2 times higher with the least expensive branded drug. As far as the authors are aware of this is the first study that addresses the pharmacoeconomic appraisal of treating HNC with various chemotherapy and chemoirradiation regimens. This study will help oncologists, pharmacists, and healthcare workers comprehend the financial advantages of treating breast cancer with less expensive chemotherapeutic agents instead of brand-name medications.

Critical analysis of the prescription and evaluation of protein kinase inhibitors for oncology in Germany

The prices of oncology drugs have been rising progressively in recent years. Despite accounting for only a small share of prescriptions, oncology drugs are the most expensive drugs on the market. However, the association between drug price and clinical benefit often remains questionable. Therefore, we set out to analyze the development of prescription and benefit assessment of protein kinase inhibitors. We identified 20 protein kinase inhibitors with oncological indications that were newly approved by the European Medicines Agency (EMA) between 2015 and 2019, based on the Arzneiverordnungsreport (AVR, Drug Prescription Report). For these 20 drugs, the number of prescriptions, sales, defined daily dose (DDD), and DDD costs were identified for the year of approval and for 2020, respectively, based on data from the Wissenschaftliches Institut der Ortskrankenkassen (WIdO, Scientific Institute of the General Local Health Insurance Fund, AOK). Moreover, the additional benefit assessments by the Gemeinsamer Bundesausschuss (GBA, Federal Joint Committee) were considered for each drug. It is shown that the share of a drug in prescriptions, sales, and DDD does not correlate with the clinical benefit of the drug as measured by the additional benefit assessment by the GBA. Lastly, the advertisement pattern of protein kinase inhibitors in a representative oncology journal does not correlate with drug benefit. In conclusion, the immense costs of oncology drugs are therefore largely caused by drugs for which no additional benefit has been proven by the GBA. In order to ensure the long-term stability of health care systems, price-regulation measures are urgently needed, especially for drugs whose additional benefit has not been proven.

A Study of Regulations Combating Counterfeit Medicines Across India, USA, and Europe

Counterfeiting is the deliberate and fraudulent production of products including mislabeling in attempts to deliberately morph its identity and source for making its appearance as genuine and as it is concerning the original product. Counterfeit medicines are pharmaceutical medicinal products without anyActive pharmaceutical ingredient (API), substandard quality API, or a fraction of the original amount of API stated as a different API, cross-contaminated API, and expiry products that are repacked including formulations done incorrectly and produced in substandard conditions. Expensive drug's extensive demand like steroids, antibiotics, cancer-treating drugs, vaccines, antivirals, and antihistamines are targets for counterfeiting. Patients deceived into buying counterfeit drugs are people seeking to buy discounted medications and involved in inappropriate usage. With identical labels as well as nearly resemblance to originals, these counterfeits are cheaper to make. Counterfeit medicines kill and threaten the lives of abused patients, fooled by false appearances. Medicines and health-care items are different from other commodities, and their fakes are different from other fakes. They are deceived by misleading characteristics and harm and risk the lives of several mistreated victims daily. This variety of terms and definitions, which might differ from one nation to the next, leads to a lack of awareness of the issue on a worldwide scale. The European Union's mainly prefers the term “counterfeiting,” lately the phrase “falsification” even if the US uses the phrase “false” or “fake” more. We must comprehend the phrase “medicine” and its meanings to define the many terminologies used to describe counterfeiting.

The White Coat Cape: An Ethical Analysis of Emerging Therapies to Treat Spinal Muscular Atrophy

The recent emergence of promising therapies to treat neuromuscular diseases such as spinal muscular atrophy raises important questions regarding the ethical permissibility of allowing a parent to refuse these Food and Drug Administration-approved drugs. The 3 most recent drugs targeting spinal muscular atrophy have all been approved since 2019, lack long-term data regarding potential side-effects and long-term benefits, and are costly. Indeed, onasemnogene abeparvovec-xioi (Zolgensma) has been called the most expensive drug in the world. Contemporary analyses of innovative therapies, compassionate use medications, off-label usage, and emerging therapies tend to focus on the importance of informed consent in framing the ethical dimensions of these medications. This manuscript utilizes a narrative framework of "rescue" to explore the competing perspectives of optimistic physicians and parents, who may decline the therapies finding the benefit-burden profile does not weigh in favor of their use. Ultimately, this paper concludes that such refusal should be considered ethically permissible until such time as more long-term data are available for these medications and their cost has decreased substantially.