Drug Expenses Research Articles

Generic antibiotics in Japan

Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk particle and amount of solubilizer. The Japanese government hopes to increase the diffusion rate of generic drugs (in terms of quantity) from 20.2 % in 2010 to 30 % or more in 2012, and therefore it will be necessary to clarify the advantages of generic antibiotics in terms of expenditure and equivalency with the branded drugs.

Diagnostic value of mini-laparoscopy in patients with abdominal neoplasm

Blood biochemistry, ascites tests, and imaging examinations have low sensitivities in abdominal neoplasm diagnoses. In addition, exploratory laparotomy is not suitable for final stage patients. Mini-laparoscopy has recently emerged as a new diagnostic technology for abdominal disease. The aim of this research was to evaluate the value of mini-laparoscopy in diagnosing abdominal neoplasms. Clinical and operational data were retrospectively analyzed in 20 cases with pathologically confirmed abdominal malignancies. Of these, 10 cases were each diagnosed by mini-laparoscopy and exploratory laparotomy. The surgical and anesthesia expenses, perioperative nursing, monitoring and treating charges, postoperative hospital stay and complications were compared between groups. The surgical and anesthesia costs were statistically lower in patients who received a mini-laparoscopy (P<0.01). Perioperative drug expenses and nursing and monitoring charges were also significantly decreased (P<0.05 and P<0.01, respectively). Further, the gastrointestinal function recovery time and postoperative hospital stay were significantly reduced in the mini-laparoscopy group. There was no significant difference between the two groups regarding the preoperative hospital stay and postoperative complications. Mini-laparoscopy effectively reduces surgical injury and treatment costs, and is capable of safely diagnosing abdominal tumors. Moreover, the procedure is also easy to perform.

Treatment of Depression in Patients with Epilepsy

In this article, we review the current best evidence for the treatment of depression in patients with epilepsy. Depression is a common epilepsy comorbidity, but it is often unrecognized. The most important step in appropriately managing mood disorders in this population is making the diagnosis. Clinical vigilance and routine use of a validated screening tool can improve detection and quality of care. As is increasingly the case for the general population, persons with epilepsy are often interested in exploring alternative therapies for chronic conditions, including depression. Unfortunately, the benefit of complementary and alternative therapies for depression currently is largely unproven for persons with a seizure history, although an early study of exercise for mild depression has shown some benefit. Concerns about drug interactions, side effects, and expense may be barriers to the prescription of antidepressant medications for people requiring chronic antiepileptic drug (AED) therapy. For this reason, use of an AED with mood-stabilizing properties has appeal and may be appropriate for selected individuals with mild depressive symptoms. Undue fear of lowering seizure threshold should not preclude the prescription of an antidepressant medication, as the perceived risks are often overestimated and rarely outweigh the risk of leaving depression untreated. At present, the best evidence for efficacy and safety support the use of citalopram, sertraline, or mirtazapine as initial pharmacotherapy, whereas bupropion should be avoided. Start low, go slow, and use the lowest effective dose. Cognitive behavioral therapy is a valuable adjunct to antidepressant therapy in this population. For people with refractory partial epilepsy and refractory depression, vagus nerve stimulation has some appeal, in that it may be beneficial for both conditions, but the efficacy of vagus nerve stimulation in improving mood in patients with epilepsy remains unclear.

The Benefit and Efficiency of the Disease Management Program for Type 2 Diabetes

Euro 1.1 billion were spent in 2009 for disease management programs (DMPs) in Germany, among them the DMP for type 2 diabetes mellitus (T2DM). Earlier studies of DMPs failed to take sufficient account of patient- and physician-related selection effects. We used innovative methods to study the medical benefit of the DMP for T2DM among insurees of the Techniker Krankenkasse, a German health insurance provider. For this study, we analyzed claims data of the Techniker Krankenkasse from 2006 to 2008. We developed and implemented a sophisticated control group design based on propensity score interval matching. We considered a large number of variables in the baseline assessment, including socio-economic parameters, comorbidities, levels of nursing care, drug expenses, and hospital expenses. The DMP participants did not differ from the control group with respect to the incidence of relevant comorbidities. They underwent emergency hospitalization somewhat less frequently than the control group and also generated lower costs for inpatient treatment. In every three-month period studied, the DMP participants received more prescriptions, had more contacts with physicians in private practice, and submitted higher claims for health insurance benefits than the control group. The current DMP for T2DM in Germany is not adequately effective. This study does not reveal any clear medical benefit from DMP participation. Selection effects were largely eliminated by means of a sophisticated control group design. Analyses of other DMPs with this method are currently being planned.

Hope for better environments in overcoming and curing blood cancer

It was 17 years ago when my life was shattered by disease acute myeloid leukemia. I had to undergo extremely painful treatment procedures to fight-off disease. The first chemotherapy session was a failure, and so I had to go through 7 more chemotherapy sessions and even a lung surgery for treatment of complications of anticancer treatments. After enduring 4 years of aggressive treatment to cure AML, I decided to form an organization to support and care for patients suffering from this awful disease. Thus, having survived long fight against AML, I became a co-founder of Korea Blood Cancer Association (KBA). The KBA is a unique organization that provides support to adult blood cancer patients. It was first established as Saebitnuri Association in December, 1995, by patient volunteers who overcame their diseases, with view to help, support, and share pains of other blood cancer patients and their families. The Saebitnuri association was reborn as KBA in February, 2003, and was officially authorized as an incorporated body under Department of Cancer Policy, Ministry of Health and Welfare. The motto of KBA is and information, and association has been active in various programs directed at helping patients. The ultimate mission of KBA is to help patients overcome their diseases in better environments and provide support so that they recover completely. Because I, myself, have suffered from blood cancer and 80% of full-time staff at KBA has first-hand experience of struggle against blood cancer, we do not regard our work as just a job; in fact, we provide best support for blood cancer patients by embracing them on their stance. On basis of their own experience of receiving medical treatment, our employees alleviate anxiety of patients undergoing treatment; in addition, they also provide them with practical help by educating them regarding various issues such as treatment, lifestyle, and nutrition. Since we have blood disease experts in Board of Directors, we can chart out several programs that enable patients to interact with medical team, which in turn, helps improve quality of medical consultation and related services. The patient-oriented services provided by KBA can be classified into following 6 categories: medical treatment support (medical and drug expenses and blood donation card), consultation (information center HOPE, Q&A forum at our website, and counseling by phone or visit), education (medical seminar on blood diseases), self-support (mountain climbing, picnic, etc), publication (monthly newsletter HOPE and disease guidebook distributed for free), and collaborations with other organizations (local and overseas exchange program). The KBA is primarily involved in sharing patients' difficulties by providing them financial support for treatment and blood donation cards. A major percentage of support is sourced by many commercial organizations, including Hyundai Home Shopping, Korea Agro-Fisheries Trade Corp., and Money Today; other organized ventures; and individuals. With view to providing patients with practical guidelines, information center, HOPE, facilitates personal interaction between patients and the survivors (KBA staff) and has launched a Q&A forum at our website. Education programs, such as seminars on blood diseases, are open to any individual seeking support and accurate medical information during his/her fight against cancer. To improve patients' understanding about their disease and treatment, we publish guidelines for overcoming blood diseases and monthly newsletter HOPE, which contains survivor's essays and information regarding medicine, social welfare system, and nutrition. More than 7,000 copies of HOPE are distributed every month for free. The KBA also organizes cultural events that help patients interact closely and provide physical and mental support. The association is also involved in on-going overseas' exchange programs under collaboration with organizations in USA and Japan. Korean Society of Hematology (KSH) will continue to develop advanced treatment modalities. And we hope that KSH will try on improving reimbursement system of health insurance to help patients suffering from physical as well as mental pain due to financial burden. Lastly, we hope see day when KBA and KSH will work together to provide patients with better environments for overcoming blood cancer and achieving complete cure.

The necessity for training specialized human resources in pharmacoeconomy

The necessity for training specialized human resources in pharmacoeconomy

Descriptive Analysis and Review of Utilization of Rituximab In the Maintenance Treatment of Non-Hodgkin's Lymphoma In Five University Teaching Hospitals In Quebec, Canada.

AbstractAbstract 1511 Background:Rituximab, a monoclonal antibody targeting CD20 receptors widely used in the treatment of non-hodgkin lymphoma, is now being used in various indications, on and off-label. For five University Hospitals in Quebec, Canada, rituximab represents more than 10% of the total drug expenses. Pharmacy managers gave the Therapeutic Drug Management Program (TDMP – www.pgtm.qc.ca) the mandate to evaluate rituximab use in those centers. Objectives:The objectives of the study were to describe rituximab use for all indications in our hospitals and to review the utilization of rituximab in maintenance therapy for follicular lymphoma according to predefined criteria. Methods:A review of pharmacy databases was performed to identify patients who received rituximab between April 1st 2008 and March 31st 2009. Every patient file containing rituximab was reviewed. Patients' medical records were also reviewed for pathology and side effects. No sampling was performed. Results:At least one dose of rituximab was administered to 797 adult patients during the study period. Median age was 62. The most frequent indications were follicular lymphoma (36%) and diffuse large B-cell lymphoma (26%) followed by chronic lymphoid leukemia (CLL) (8%). Various off label indications, including idiopathic thrombocytopenic purpura, hemolytic anemia and Waldenstrom macroglobulinemia, represented 30% of our population. At the time of data analysis, 42% of patients were still treated with rituximab, 45% had finished their planned treatment and 6% had discontinued treatment because of adverse events or disease progression. Thirty-eight patients (4.8%) died during the study period. Rituximab was also used in 41 pediatric patients for various indications, mostly for nephrotic syndrome (27%). The evaluation of patients outcome for off-label indications could not be performed due to the complexity, variety and chronic courses of diseases treated. For the 232 patients receiving rituximab as maintenance therapy, only 76% of patients had follicular lymphoma. Of these, 53% received rituximab maintenance after first-line treatment with R-CVP and 19% after R-CHOP. Only one patient receiving maintenance treatment stopped therapy because of disease progression. No death was reported. Conformity to utilization criteria was excellent for dose and frequency (100% and 99%) but lower for duration and indication (87 % and 70%). Of note, 13% exceeded the planned two years treatment length and fourteen patients received maintenance therapy following induction chemotherapy for CLL. Conclusions:Rituximab was used in various on and off label indications and utilization criteria should be developed and followed in each centers. Pharmacy and therapeutics committees should also request an annual summary of efficacy and security for the off-label indications. Almost a third of patients treated with maintenance rituximab did not receive it for follicular lymphoma. A review of the literature should be performed and recommendations be made for other indications for maintenance treatment. Disclosures:Off Label Use: review of utilisation or rituximab: non hematologic indications.

Use of Systemic Antifungal Agents In Patients with Acute Leukemia: a Prospective Analysis Covering Clinical Parameters, Side Effects, Drug Interactions and Costs

AbstractAbstract 2568 Introduction:Invasive mycoses show high morbidity and mortality rates among immunocompromised patients (pts), and have multiplied the use and costs of systemic antifungal drugs (SAD). Especially pts with induction chemotherapy for acute leukemia and pts after allogeneic stem cell transplantation are at a high risk. This challenges physicians, as various drug-related aspects have to be considered. As side by side comparisons in unselected high-risk pts with different SAD are lacking, we prospectively analysed the frequency, clinical relevance and severity of SAD-related problems in consecutive pre- and acute leukemic pts, a ‘typical’, rather than highly-selected study cohort, in order to improve the efficacy and safety of SAD treatment. Methods:SAD-analysis was performed by daily participation on ward rounds, consultation of ward physicians and review of pts' medication charts and laboratory values. Pt characteristics, side effects (SE), in particular development of renal and hepatic toxicity, potential drug interactions (DI), treatment outcome and costs were assessed. SAD were given according to EORTC-adapted guidelines. Results:Currently, data from 100 consecutive pts have been obtained (AML n=71, ALL n=20, MDS n=9), these showing a median age of 59 years (range 19–75). For SAD use and their respective indications, see Table 1. The frequency of 1, 2 or 3–5 SAD regimens/pt was 56, 28 and 16, respectively, with SAD combination therapy rarely being applied (3%). Pts with relapsed leukemia (n=28) vs. with initial leukemia diagnosis (n=72) received more than one subsequent SAD in 64% vs. 36%, respectively. The importance of detailed DI analyses was stressed with a substantial median number of 22 concomitantly administered medications (range 1–50). We identified 47 potentially interacting combinations of SAD and concomitant drugs (Table 1). In total, 88% of pts receiving SAD were affected by at least one DI.Table 1SAD indications, quantity and frequency of potential DILiposomal (lip.) Amphotericin BCaspofunginFluconazolePosaconazoleVoriconazole# pts3812523329Pts treated prophylactically8 (21%)052 (100%)29 (88%)1 (3%)Pts treated empirically15 (39%)2 (17%)07 (21%)5 (17%)Pts treated preemptively18 (47%)10 (83%)04 (12%)21 (72%)# potentially interacting drug combinations13314107# pts analyzed with regard to DI3811433329Pts exposed to ≥ 1 DI37 (97%)8 (73%)40 (93%)22 (67%)16 (55%)Pts exposed to ≥ 3 DI28 (74%)024 (56%)8 (24%)1 (3%)SE leading to a change of SAD occurred in 13%, 10% and 6% of pts receiving lip. amphotericin B, voriconazole and posaconazole, respectively. Fluconazole, which was applied prophylactically and was low dosed in all cases, and caspofungin, showed very favourable safety profiles, necessitating no therapy adaptations. Determining renal function (RF) deterioration by comparing median eGFR values at SAD-initiation vs. after SAD-medication-end revealed a considerable eGFR decrease of 17% for lip. amphotericin B, whereas caspofungin and azole SAD had no major effects on RF. Pts with liver predamage were preferably treated with caspofungin (median baseline bilirubin level of 0.9 mg/dl compared to ≤ 0.7 mg/dl for all other agents), showing excellent tolerability. In 2009, SAD accounted for 20% of our department's inpt drug expenses, including chemotherapeutics. Median SAD costs per analysed hospital stay in our pt cohort were 2813€, with 64% of pts inducing costs higher than 1000€. According to the increased SAD use in pts with relapsed leukemia, costs in this cohort exceeded those of pts with initial diagnosis by 109% (4794€ vs. 2290€). As posaconazole is increasingly used for prophylaxis and treatment of fungal infections, we are currently obtaining serum posaconazole levels using our previously published HPLC method for quantification [Neubauer W. J Chromatogr B 2009] to ensure sufficient protection in these high-risk pts. Data on obtained serum levels will be presented at the meeting. Conclusion:This ongoing real-life analysis highlights the high number of aspects related to SAD-treatment in a high-risk pt cohort and the need for close monitoring of pts to avoid negative effects of DI and to reduce the rate of SE. By detecting and analyzing frequent DI, SE as well as pharmacoeconomic aspects, it suggests to valuably contribute to a safe, efficient and economically appropriate use of SAD. Disclosure:Metzke:MSD Merck Sharp & Dohme GmbH: Research Funding. Engelhardt:MSD Merck Sharp & Dohme GmbH: Research Funding.

Potential Cost Savings for a Health System–Based Employee Outpatient Pharmacy

Abstract Hospitals everywhere are faced with the same dilemma as other companies, struggling to manage rising health care expenses while providing optimal care for their employees. One of the often overlooked drug expense is the drugs consumed by the facility's employees. Although the average pharmacy department manager has a considerable amount of experience and expertise in dealing with drug expense issues for inpatients or even classic outpatients, the path to optimizing the drug expense investment strategies for their fellow employees can be difficult and elusive to discern. This article should provide a pharmacy manager with a few examples of how to contain costs for employee outpatient pharmacies.

Year one evaluation of regional pay for quality (P4Q) oncology program.

6013 Background: Oncology clinical pathways are common in current practice. However, little information is available evaluating the cost savings of enacting pathways. This study evaluates the potential cost savings of a payer-based P4Q program employing clinical pathways. Methods: A P4Q program was enacted in five northeastern states, USA, beginning August 1, 2008, and consisted of physician generated treatment (i.e., breast, lung, and colon-rectal cancer) and supportive care pathways (i.e., colony-stimulating factors, erythropoietin stimulating agents, and antiemetics). Feedback was provided to participants regarding compliance, and increased fee schedules in year 1 were adjusted in year 2 contingent on compliance in year 1. Savings analysis used the difference in participating and nonparticipating practice growth rates from the year prior to the program (pre) to the first year of the program (Yr 1) to estimate yearly savings for the participating practices. Results: 57 participating practices (176 physicians, 10,432 patients) and 43 nonparticipating practices (194 physicians, 14,137 patients) contributed to the analysis. The pre to Yr 1 growth rate in cost was 7.7%, -3.0%, and 2.8% for antineoplastic drugs, supportive care drugs, and nondrug services respectively in the participating practices and 15.4%, 2.4%, and 19.0% in the nonparticipating practices. Estimated savings were calculated for antineoplastic drugs ($6,766,500), supportive care drugs ($1,427,108), nondrug services ($4,039,359), and total ($12,232,967). When the costs of the Yr 1 fee schedule increase for participating practices were factored out, the total savings were estimated at $8,585,148. Conclusions: This study suggests pathway programs may reduce the costs of cancer care by reducing the growth rate of both drug and nondrug expenses. Further evaluations should explore indications of how these costs were reduced (e.g., drug selection) and consider clinical outcomes and compliance in relation to costs savings. The primary limitations of the study derive from the nonexperimental research design which allows confounds to causal inference. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration P4 Healthcare P4 Healthcare

A New Measure of Medication Affordability

This study developed a new measure of medication affordability that examines out-of-pocket drug expenses relative to available household resources. The authors assessed the spending patterns of ~2.1 million poor households (≤100% federal poverty level) of adults aged 51 and older by Medicaid status. The data were drawn from the 2000–2001 Health and Retirement Study. Household spending was categorized into three broad types: basic living, health care, and discretionary. Older (aged 51 or older) poor households without Medicaid allocated about 72% of their total resources ($17,421, SE $783) to basic living needs. In comparison, those with Medicaid had scarcer total resources ($12,498, SE $423) and allocated 85% to basic living needs. Medication costs consumed the largest proportion of health care expenses for both types of poor households (Medicaid: $463, SE $67; non-Medicaid: $970, SE $102). After paying for basic living needs and health care costs, these families had, on average, only $16 left each week. Poor families have very few resources available for anything beyond basic living needs, even when they have Medicaid coverage. There is no great reservoir of discretionary funds to pay for increases in cost-sharing under Medicaid and Medicare Part D.

Hat sich die Arzneitherapiesicherheit in den letzten Jahren in Deutschland verbessert?

The goal of drug therapy to prolong life or to improve the quality of life can be accomplished by modern drug therapy to a respectable degree. However, the risks of drug therapy have increased through more specific drugs and lead to often surprisingly multi-faceted side effects as in the case of biologicals. We have performed a systematic review of meta analyses, clinical studies, and reviews of the last five years concerned with adverse drug reactions (ADR) and adverse drug events (ADE). From these data emerges a distinct lack of reliable studies for Germany on incidence, severity and preventability of ADR and ADE; however, there are indications of their increase as is also evident from other countries. There are indications also for a better incidence management culture and better documentation. The step to utilize computerized physician order entry and decision support systems is a proven method to reduce medication related problems, leading also to reduction of in-hospital time and reduced drug expenses. Taking this decisive step to improve drug safety requires an appreciation of the magnitude of the problem and the determination to change an established but inferior system of drug administration in a fundamental way.

Which Cost Are We Talking About?

It is difficult to discuss cost, because the meanings of the word are so varied. It can be used as a noun or a verb: The cost is reasonable. It cost him his life savings. It can be used to define an amount of money to be paid for a service: The average wholesale cost of one day's 400 mg. dose of imatinib therapy for chronic myelogenous leukemia is $130.1 It can denote something more important than money: In 2009, it is estimated that breast cancer will cost 40,170 women their lives.2 Its meaning changes as a consequence of vantage point: The cost of cancer care to society is unsustainable. No cost is too high for my daughter's treatment if there is any chance it will help her. At the end of medical school, student indebtedness averaged more than $100,000 in 2004.3 The cost to support one year's graduate medical education may be as high as $150,000.4 The accounting term “cost of goods sold” has a specific meaning that differs from the asking price, which is also different from the final sales price. The patient's bill for the drugs in one cycle of FOLFOX VI listed a cost of more than $8,000: the average sales price (ASP, the estimated acquisition price to a practice) is approximately $4,200. Therefore, the allowable 106% ASP Medicare cost is $4,452, though Medicare would pay only 80% of that amount or $3,561, leaving a cost of more than $890 for the patient and secondary insurance.5 (This is an approximation, ignoring drug waste, home infusion medications, and other factors.) I asked my peers what the cost of caring for patients with cancer meant to them. They recognized the costs for patients but also mentioned awareness of what it takes to provide services to others, including preparation for a career in oncology and the expense of college and medical school as well as the time, sacrifice, and tension of deferred gratification inherent to medical education. Many recognized the uncompensated time associated with running a small business, which involves borrowing money for drug purchases and medical supplies; leasing, buying, and maintaining office space; hiring, supervising, and paying staff while worrying about their job satisfaction; and interacting with lawyers, accountants, professional and business liability insurance agents, and health plan and hospital administrators—along with the frustration of understanding where exactly we were trained to do this. They mentioned the difficulty of hiring new physicians, whose high expectations are matched by knowledge of the high compensation medical oncologists have recently achieved4 and a realization of the gap between the supply and demand for oncologists.5,6 They acknowledged the emotional strain of dealing with patients who died more often than hoped for, and the unsettling necessity of going right from pronouncing a patient dead to seeing a different patient, with no opportunity to adjust, let alone grieve. With greater trepidation, I asked my patients what the phrase “cost of care for cancer” meant to them. Perhaps not surprisingly, the majority of responses were quite literal discussions of the expense of care. “Out of pocket” expenses were mentioned most frequently. Those with Medicare receiving expensive oral medication were frustrated by “the doughnut hole” and acutely aware of their responsibility to pay 100% of costs for drug expenses under $295, 25% of costs between $296 and $2,700, and 100% of costs from $2,701 to $6,154 annually, despite often having believed they had more complete coverage.7 Those with traditional insurance were amazed at the frequent requirement for visit copays and expressed disbelief at the cost associated with treatments, emergency room visits, radiologic tests, surgical procedures, and hospitalizations. One patient, a childhood cancer survivor with a secondary treatment-related malignancy, had reached the end of her lifetime insurance benefit and was simply distraught. They were mystified by bills and confused by provider multiplicity, varied billing formats, and lack of help in understanding when and to whom personal payments are due. They also mentioned cost of time, lost in both going for treatment and being unable to accomplish things because of a lack of energy from their disease. During our conversations on cost of care, patients expressed gratitude for my services and those of my staff. As difficult as these discussions are, their value to us and our patients is “priceless.” As always we welcome your feedback and suggestions. Please send comments to moc.liamg@ssuennm.

Generic versus Branded Pharmaceutical Strategic Considerations: An Irish Focus with Global Perspective

This article seeks to explore strategic considerations in the competition between generic and branded pharma drugs in Ireland. In a global environment, with trends in cost-saving substitution models and growing consumer awareness, Ireland has remained a high-price under-genericized market. Irish government initiatives toward control of drug expenses are influenced by factors such as quality, reliability of supply, and public perception and concerns. Other elements affecting market trends are changes in regulatory requirements, number of competitors, and health professionals’ preferences. These variables, among others, drive the necessity for strong strategy portfolios to be undertaken by the branded and generics industry alike. Indeed, such strategies may incorporate activities such as lobbying, negotiation, patent protection, brand defense, life cycle management, consolidation, and driving consumer awareness.

WTO TRIPS Agreement- Current state of Pharmaceutical Industry and Policy Options for Bangladesh

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires adoption of a minimum patent standard for all countries. It is often argued by developing countries that the introduction of a uniform (and minimum) patent standard for all countries irrespective of their level of development would prevent people from access to medicines. Moreover, in developing countries, the drug expenses are being paid out of pockets by the patients unlike developed countries where insurance companies bear the burden. In this regard an empirical study was conducted on pharmaceutical stakeholders consisting of leading pharmaceutical companies, drug administration of Bangladesh (the regulatory authority), leading experts on industrial pharmacy, academics and leaders of Bangladesh Association of Pharmaceutical Industries. The study finds that price of medicines will go up and access to health will be denied once Bangladesh enters the patent regime. The perceived impact on the industry however is mixed. The paper concludes with some policy considerations that the government and the industry should consider to ensuring that the patients have access to medicines at an affordable price.

Extension of market exclusivity and its impact on the accessibility to essential medicines, and drug expense in Thailand: Analysis of the effect of TRIPs-Plus proposal

In Thailand and the US negotiating FTA, the 'TRIPs-Plus' is one of the US proposal which would result in an extension of market exclusivity of innovative drugs. In addition, it would foreseeably lead to high and unaffordable medicine prices and inaccessibility to essential medicines. To quantify the impact on medicine expense and medicine accessibility. Based on 2000 to 2003 Thai Food and Drug Administration (FDA)'s and the Drug & Medical Supply Information Center (DMSIC), costs and accessibility were estimated upon the price and quantity costing between innovative drugs and their generics plus some parameters found from their competitive behaviour. Thereafter, we simulated the 10-year potential additional expense on the 2003 unit price of the patented and monopolized non-patented medicines. In 2003, the availability of generics helped to save 104.5% of actual expense and the accessibility would increase by 53.6%. By extension of market exclusivity, given that there were 60 new items approved annually, the cumulative potential expense was projected to be $US 6.2 million for the first year to $US 5215.8 million in tenth year. The TRIPs-Plus proposal would result in a significant increase in the medicine expense; and a delay in the increase in drug accessibility via generics. Several options as well as other related mechanisms to help reduce the negative impact are proposed.

Single Use of Rasburicase (rasb) Leads to Insufficient Tumor Lysis Syndrome (TLS) Control in Adults: Outcome and Resource Utilization in a One Year Real-Life Observational Study

TLS due to the rapid lysis of tumor cells following initiation of chemotherapy can lead to the release of intracellular components into the extracellular space. Among these hyperuricemia might exceed the excretory capacity of the kidneys and lead to renal failure. Rasb is a recombinant urate oxidase given during the first 3–5 days of chemotherapy to effectively lower uric acid serum levels. Limited data suggest that a single prechemotherapy dose of rasb might be sufficiently efficacious and this single dose regimen is widely used to reduce treatment costs.We analyzed the clinical and economical data of all adults who received rasb for prophylaxis or treatment of TLS at a university hospital during a one year period. The goal was to describe treatment patterns and outcome outside of clinical trials and to verify whether patients with TLS can be treated cost-effectively. 38 patients (pts) received rasb, however 1/3 of the pts were treated off-label for other reasons then TLS. 24 pts (median age 66 yrs, 21 male) received rasb for malignancy-associated hyperuricemia and were eligible for further clinical and economical evaluation. 2/3 of these pts were treated for hematological malignancies (acute leukemia 6pts, lymphoma 8 pts) and 8 pts for solid tumors. Apart from hydration (mean volume 2 l per day; all pts), furosemide (mean dose 80 mg/day; all pts) and urinary alkalinization with sodium bicarbonate (pH > 7; 7 pts), 20 patients received a single 7,5 mg dose of rasb and 4 pts received multi dose. In 14 pts a tumor lysis was observed. 6 pts died, three fatalities were directly associated with TLS. Mortality was higher among pts with single dose rasb vs. multi dose rasb (30% vs. 0 %) and higher among patients with urinary alkalinization (71% vs. 5%). No anaphylaxis, hemolysis or methemoglobinemia was observed in this cohort.The mean duration of hospitalisation was 23 days, the mean treatment costs were 16.200 €. The costs exceeded the revenues based on diagnosis related groups for Germany (G-DRG) in 18 pts and resulted in a 7% funding gap. 107.000 € were spent for drugs for these patients, 10% of these for rasb.We conclude from this observational study thatTLS is a menacing disease, resulted in a 12,5 % mortality and should therefore be cautiously monitored and treated,single dose rasb was associated with a higher mortality rate then multi dose,urinary alkalinization cannot be recommended when rasb is used,TLS leads to a 7 % underfunding in the respective G-DRGs,for TLS pts. the usage of rasb elevates the total drug expenses by 10%.

Secure antiretroviral therapy delivery in a resource‐limited setting: streamlined to minimize drug resistance and expense

We report the design and analysis of a streamlined approach to the delivery of antiretroviral therapy (ART) that minimized risk for emergence of ART drug resistance (ART-DR) in a resource-limited setting. The algorithm of care for persons with HIV comprised generic, fixed-dose, twice-daily stavudine, lamivudine and nevirapine (GPO-VIR), scheduled and unannounced pill counts and measurement of viral load at months 6 and 18 after initiation of ART. We evaluated adherence as measured by pill counts, HIV suppression and programmatic costs. Over a 4-year period, 214 of 330 patients (64.8%) were enrolled; baseline median CD4 count was 84 cells/microL. At month 1, nine patients (4.2%) discontinued GPO-VIR because of skin rash. At month 6, 199 patients (93%) achieved viral load < or =400 HIV-1 RNA copies/mL, with current alcohol use the sole predictor of treatment failure [adjusted Relative Risk (aRR)=1.67; 95% confidence interval=1.05-2.48; P<0.001]. Most patients (97%) with HIV suppression at month 6 had viral loads < or =50 copies/mL at month 18; all had > or =75% visit compliance and 192 (98%) had > or =75% adherence measured by pill counts. The estimated annual costs were $111.92 per patient for the pill counts, home visits and viral load measurement. Secure ART delivery, while minimizing risk for non-adherence and ART-DR, is clinically and economically feasible in this resource-limited setting.

Factors Associated with Quality of Life in Chronic Hepatitis C Patients Who Received Interferon Plus Ribavirin Therapy

Antiviral treatment leading to impaired quality of life in chronic hepatitis C patients has been reported in the West. To promote high quality care, we explored the quality of life in Taiwanese chronic hepatitis C patients treated with antiviral therapy by means of comparing quality of life, social support and its factors. One hundred and fifteen patients with chronic hepatitis C, enrolled from hospitals in Central Taiwan, were treated with interferon plus ribavirin. A structured questionnaire was used for data collection, including the Hepatitis Quality of Life Questionnaire (HQLQ), Inventory of Socially Supportive Behaviors (ISSB) and clinical demographics. The data were analyzed by the methods of means, correlation and regression. The study patients included 60 men (52.2%) and 55 women (47.8%), with 98 (85.2%) older than 40 years. The drug expenses of 71 (61.7%) patients were paid for by the Bureau of National Health Insurance of Taiwan. The patients had a low mean HQLQ score of 58.13 +/- 17.21. Three scales which had HQLQ scores below 50 were general health perceptions (49.39), vitality (49.32) and role disability: physical (47.48). The mean ISSB score was 71.15 +/- 19.61. Only financial stress (p = 0.006) had significant difference in HQLQ. Treatment duration (r = -0.23) correlated negatively with the general health domain of HQLQ, and tangible support (r = -0.21) correlated negatively with HQLQ scales. Financial stress and tangible support were significant predicting variables for HQLQ. The study found that patients with chronic hepatitis C who received interferon plus ribavirin therapy had poor quality of life during the treatment period. There was significant difference among patients with different financial stress, and a negative relationship between tangible support and hepatitis quality of life. Financial stress and tangible support are predictors of quality of life for all subjects. The results of this study might assist healthcare personnel to comprehend the quality of life and its related factors in patients with chronic hepatitis C treated with antiviral therapy.

Medicare Part D

Medicare Part D