Drug Product Cost Research Articles

EXAMINING MICRO-ENVIRONMENTAL FACTORS OF PHARMACEUTICAL INDUSTRY

The pharmaceutical sector is expected to change as a result of a number of factors, including technological advancements, new laws, rising drug production costs, and new consumer demands. The organisation that establishes the comprehensive framework on the performance of the pharmaceutical industries, dictating all aspects of the behaviour of the market actors, is indirectly influenced by macro-environmental elements such as Political, Economic, Social, Technological, Legal, and Environmental factors. In order to have a competitive advantage over other market participants, the purpose of this research is to comprehend the macroeconomic reasons responsible for the business model revolution. To provide a comprehensive picture of the current market environment internationally and in the context of India, the studys existing literature on macroeconomic factors influencing the pharmaceutical landscape has been studied. KEYWORDS: Pharmaceutical Industry, Macro-Environment Element, Competitive Advantage

TNF-α: The shape of small molecules to come?

In 2020, the anti-tumor necrosis factor (TNF) monoclonal antibody Humira® generated US$165.8 billion in cumulative sales and snatched the crown for the industry’s most successful drug from Lipitor (atorvastatin). TNF-α is a major component in beneficial and disease-related inflammation and TNF-α-inhibitor biologics have gained widespread use in autoimmune diseases, such as rheumatoid arthritis (RA). Many more diseases could benefit from TNF-α inhibitors, such as Alzheimer’s disease (AD) or major depression. However, the nature of TNF-α-inhibitor biologics prohibits central nervous system (CNS) applications. Moreover, high drug production costs and pricing, together with antidrug immune reactions and insufficient patient coverage, argue for the development of small-molecule drugs. Recently, drug-like orally available small molecules were described with high activity in animal disease models with activities comparable to those of antibodies.

Application of physiologically based pharmacokinetic models to promote the development of veterinary drugs with high efficacy and safety.

Physiologically based pharmacokinetic (PBPK) models have become important tools for the development of novel human drugs. Food-producing animals and pets comprise an important part of human life, and the development of veterinary drugs (VDs) has greatly impacted human health. Owing to increased affordability of and demand for drug development, VD manufacturing companies should have more PBPK models required to reduce drug production costs. So far, little attention has been paid on applying PBPK models for the development of VDs. This review begins with the development processes of VDs; then summarizes case studies of PBPK models in human or VD development; and analyzes the application, potential, and advantages of PBPK in VD development, including candidate screening, formulation optimization, food effects, target-species safety, and dosing optimization. Then, the challenges of applying the PBPK model to VD development are discussed. Finally, future opportunities of PBPK models in designing dosing regimens for intracellular pathogenic infections and for efficient oral absorption of VDs are further forecasted. This review will be relevant to readers who are interested in using a PBPK model to develop new VDs.

Baricitinib: therapeutic potential for moderate to severe atopic dermatitis

ABSTRACT Introduction Atopic dermatitis (AD) is a chronic inflammatory skin disease mediated by multiple signals including janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway. Current therapeutic armamentarium consists of a limited number of drugs which may result in the insufficient management of AD. Preclinical evidence regarding inhibition of JAK/STAT led to the development of a promising class of therapeutics, namely, JAK inhibitors. Baricitinib, a novel JAK1/JAK2 inhibitor is currently under investigation in AD clinical trials. Areas covered This review offers an overview of Baricitinib and examines clinical efficacy and safety data in patients with moderate-to-severe AD. Expert opinion Baricitinib showed promising preliminary data in terms of efficacy in phase II and III trials, with a very rapid onset of response and great improvements of itch and sleep disturbances. These aforementioned aspects combined with the advantage of an oral formulation have reduced drug production costs compared to biologic agents and could lead to consideration of baricitinib as a first line systemic treatment. Also, in some countries, it could be a therapeutic option in the case of contraindication or failure of conventional systemic drugs prior to biologic therapies. Data related to long-term safety and efficacy will be important to refine the place-in-therapy of this drug.

Rapid development and deployment of high-volume vaccines for pandemic response.

Overcoming pandemics, such as the current Covid‐19 outbreak, requires the manufacture of several billion doses of vaccines within months. This is an extremely challenging task given the constraints in small‐scale manufacturing for clinical trials, clinical testing timelines involving multiple phases and large‐scale drug substance and drug product manufacturing. To tackle these challenges, regulatory processes are fast‐tracked, and rapid‐response manufacturing platform technologies are used. Here, we evaluate the current progress, challenges ahead and potential solutions for providing vaccines for pandemic response at an unprecedented scale and rate. Emerging rapid‐response vaccine platform technologies, especially RNA platforms, offer a high productivity estimated at over 1 billion doses per year with a small manufacturing footprint and low capital cost facilities. The self‐amplifying RNA (saRNA) drug product cost is estimated at below 1 USD/dose. These manufacturing processes and facilities can be decentralized to facilitate production, distribution, but also raw material supply. The RNA platform technology can be complemented by an a priori Quality by Design analysis aided by computational modeling in order to assure product quality and further speed up the regulatory approval processes when these platforms are used for epidemic or pandemic response in the future.

Continuous Drying of Pharmaceutical Powders Using a Twin-Screw Extruder

Continuous manufacturing of pharmaceuticals offers such benefits as production flexibility, reduced drug product costs, and improved product quality. Moving toward continuous manufacturing requires suitable small-scale equipment, either by development of new equipment or optimization of existing equipment. In primary manufacturing, particle properties are often altered during crystallization and have to be restored during subsequent processing. Drying a crystallized product is one of the most challenging steps, especially since attrition and agglomeration can occur. To that end, we investigated the drying behavior of a crystalline model compound with moisture levels of up to 10 wt % in a corotating twin-screw extruder. The feed mass flows on a piece of small-scale equipment used for pharmaceutical production varied between 0.5 and 2.0 kg/h. Experiments were conducted to evaluate the drying performance in various process settings. Because of a very narrow and consistent residence time distribution, extrusi...

US-Based Drug Cost Parameter Estimation for Economic Evaluations.

In the United States, more than 10% of national health expenditures are for prescription drugs. Assessing drug costs in US economic evaluation studies is not consistent, as the true acquisition cost of a drug is not known by decision modelers. Current US practice focuses on identifying one reasonable drug cost and imposing some distributional assumption to assess uncertainty. We propose a set of Rules based on current pharmacy practice that account for the heterogeneity of drug product costs. The set of products derived from our Rules, and their associated costs, form an empirical distribution that can be used for more realistic sensitivity analyses and create transparency in drug cost parameter computation. The Rules specify an algorithmic process to select clinically equivalent drug products that reduce pill burden, use an appropriate package size, and assume uniform weighting of substitutable products. Three diverse examples show derived empirical distributions and are compared with previously reported cost estimates. The shapes of the empirical distributions among the 3 drugs differ dramatically, including multiple modes and different variation. Previously published estimates differed from the means of the empirical distributions. Published ranges for sensitivity analyses did not cover the ranges of the empirical distributions. In one example using lisinopril, the empirical mean cost of substitutable products was $444 (range = $23-$953) as compared with a published estimate of $305 (range = $51-$523). Our Rules create a simple and transparent approach to creating cost estimates of drug products and assessing their variability. The approach is easily modified to include a subset of, or different weighting for, substitutable products. The derived empirical distribution is easily incorporated into 1-way or probabilistic sensitivity analyses.

Essential drugs production in Brazil, Russia, India, China and South Africa (BRICS): opportunities and challenges.

The objective of this work is to elucidate various essential drugs in the Brazil, Russia, India, China and South Africa (BRICS) countries. It discusses the opportunities and challenges of the existing biotech infrastructure and the production of drugs and vaccines in member states of the BRICS. This research is based on a systematic literature review between the years 2000 and 2014 of documents retrieved from the databases Embase, PubMed/Medline, Global Health, and Google Scholar, and the websites of relevant international organizations, research institutions and philanthropic organizations. Findings vary from one member state to another. These include useful comparison between the BRICS countries in terms of pharmaceuticals expenditure versus total health expenditure, local manufacturing of drugs/vaccines using technology and know-how transferred from developed countries, and biotech entrepreneurial collaborations under the umbrella of the BRICS region. This study concludes by providing recommendations to support more of inter collaborations among the BRICS countries as well as between BRICS and many developing countries to shrink drug production costs. In addition, this collaboration would also culminate in reaching out to poor countries that are not able to provide their communities and patients with cost-effective essential medicines.

Drug utilization and cost in a Medicaid population: A simulation study of community vs. mail order pharmacy

BackgroundOutpatient drugs are dispensed through both community and mail order pharmacies. There is no empirical evidence that substitution of community pharmacy with mail order reduces overall drug expenditures. The need for evaluating the potential effects on utilization and costs of the possible extension of mail order services in Medicaid provides the rationale for conducting this study. This study compares drug utilization and drug product cost in community vs. mail order pharmacy dispensing services in a Medicaid population.MethodsThis study is a retrospective cohort study comparing utilization and cost patterns in community vs. mail order pharmacy. A simulation model was employed to assess drug utilization and cost in mail order pharmacy using community pharmacy claim data. The model assumed that courses of drug therapy (CDT) in mail order pharmacy would have utilization patterns similar to those found in community pharmacy. A 95% confidence interval surrounding changes in average utilization and average cost were estimated using bootstrap analysis. A sensitivity analysis was performed by varying drug selection criteria and supply, fill point, and medication possession ratio (MPR). Sub-analyses were performed to address differences between mail order and community pharmacy related to therapeutic class and dual-eligible patients.Data for the study derived from pharmacy claims database of Ohio Medicaid State program for the period January 2000-September 2004. Drug claims were aggregated to obtain a set of CDTs representing unique patient IDs and unique drug products. Drug product cost estimates excluded dispensing fees and were used to estimate the cost reduction required in mail order to become cost neutral in comparison with community pharmacy.ResultsThe baseline model revealed that the use of mail order vs. community pharmacy would result in a 5.5% increase in drug utilization and a 5.4% cost reduction required in mail order to become cost neutral. Results from Ohio Medicaid drugs for chronic use revealed a 5.1% increase in utilization and a 4.9% cost reduction required to become cost neutral in comparison with community pharmacy.ConclusionThe results of the simulation model indicate that mail order pharmacy increases drug utilization and can also increase drug product cost if the cost per unit is not reduced accordingly. Prior consideration should be given to the patient population, day-supply, disease, therapy, and insurance characteristics to ensure the appropriate use of mail order pharmacy services.

Cost-minimization analysis of darbepoetin alfa versus epoetin alfa in the hospital setting

The cost of darbepoetin alfa versus that of epoetin alfa in a hospital setting was studied. The study was an observational, retrospective review of the hospitalwide use of darbepoetin and epoetin during hospital admissions beginning in the period from January 2003 through April 2003. After the identification from daily charge reports of patients who used at least one of the study drugs during an admission, charts were requested for review. Drug product costs were determined from hospital purchasing information. Material and labor costs were combined to estimate drug administration costs. Total costs were calculated as the sum of drug product costs and administration costs. A total of 429 epoetin records and 80 darbepoetin records were included. The two cohorts were similar with respect to demographic characteristics. With respect to costs, the only significant difference between cohorts was in daily administration costs, which were lower for patients receiving darbepoetin. Sensitivity analysis found lower costs for darbepoetin only after the dose-conversion ratio (DCR) was increased to above 256.74 units:1 microg. The overall DCR based on the median daily dose of each drug was 244.90 units:1 microg. A cost-minimization study in a hospital showed no cost difference between treatment with epoetin and darbepoetin.

Beliefs of Community Pharmacists on Prevention and Correction of Potential Drug Therapy Problems

Objective: To describe likelihood and affective evaluation ratings for salient beliefs of community pharmacists about trying to prevent and correct potential drug therapy problems, and to describe normative belief and motivation to comply ratings about trying to prevent and correct potential drug therapy problems. Design: Descriptive statistics from a self-administered mail survey. Participants: A convenience sample identified salient beliefs about trying to prevent and correct potential drug therapy problems, and a random sample of Michigan community pharmacists (n = 555) completed a self-administered mail survey regarding these beliefs. Main Outcome Measures: Likelihood and affective evaluation ratings of 22 salient beliefs and normative belief and motivation to comply ratings of six salient others. Results: Pharmacists believed that trying to prevent and correct drug therapy problems could lead to valuable consequences, regardless of whether the efforts were a success or a failure. The pharmacists also believed they could have a positive impact on the quality of drug therapy; however, they seemed less convinced that failure would lead to health complications in patients or unnecessary health expenditures. Pharmacists were most motivated to comply with the expectations of patients. Conclusions: Assisting community pharmacists in adopting pharmaceutical care can be accomplished by (1) providing programs where the process of trying to prevent and correct drug therapy problems can be experienced, (2) promoting an understanding of the relationships between drug product costs and healthcare costs due to patient morbidity, (3) devising mechanisms to increase patient demand for pharmaceutical care and drug utilization review, and (4) assisting community pharmacists to obtain reimbursement for time spent trying to prevent and correct drug therapy problems.

Developing drug-use profiles from drug-charge records

The potential for developing a drug-use profile from drug-charge records was studied at an 830-bed community hospital. Patient drug charges were reviewed retrospectively for one year (1975) to identify: (1) which key drugs accounted for a high percentage of cost and usage; (2) where key drugs were used within the hospital; (3) how they were used; and (4) who were the chief prescribers. Of the drugs used, 8% accounted for 80% of total drug product costs. Seven drug groups (10% of the total drug groups) appeared in the top 10 of both drug cost and quantity categories. Six individual drugs also appeared in the top 10 of both categories. According to cost, cephalosporin antibiotics were ranked first among drug groups but were sixth according to quantity. Analgesics-antipyretics were ranked first among drug groups by quantity and second by cost. Cephalothin was ranked first among individual drugs by cost and was not in the top 10 in quantity. Diazepam was ranked first among individual drugs by quantity and third by cost. Patients' drug-charge records can be used effectively to generate drug-use profiles for ongoing drug use review, quality assurance and cost containment programs.

Inequivalency of Nitrofurantoin Products

To the Editor.— The equivalence of drug products containing the same active ingredient is being actively debated in connection with topics such as brand name vs generic products, repeal of antisubstitution laws, and national health insurance programs with maximum allowable drug product cost (MAC) provisions. The argument most often advanced to support the equivalence of the vast majority of the drug products available in the United States is that relatively few recent studies have actually demonstrated significant differences between competing products. Digoxin tablets are frequently cited as an example of a drug product that is prone to bioavailability problems. 1,2 We wish to call attention to our recently completed evaluation of 14 nitrofurantoin products. 3 These studies were conducted under the sponsorship of the Tennessee Department of Public Health as part of an ongoing effort to develop a drug formulary system that will provide an assurance of drug product quality