scholarly journals Assessing the Accuracy of Sales Forecasts Submitted by Pharmaceutical Companies Applying for Reimbursement in Austria

2021 ◽  
Vol 12 ◽  
Author(s):  
Michael Kossmeier ◽  
Madeleine Themanns ◽  
Lena Hatapoglu ◽  
Bernhard Kogler ◽  
Simon Keuerleber ◽  
...  

Objectives: Reimbursement decisions on new medicines require an assessment of their value. In Austria, when applying for reimbursement of new medicines, pharmaceutical companies are also obliged to submit forecasts of future sales. We systematically examined the accuracy of these pharmaceutical sales forecasts and hence the usefulness of these forecasts for reimbursement evaluations. Methods: We retrospectively analyzed reimbursement applications of 102 new drugs submitted between 2005 and 2014, which were accepted for reimbursement outside of hospitals, and for which actual reimbursed sales were available for at least 3 years. The main outcome variable was the accuracy ratio, defined as the ratio of forecasted sales submitted by pharmaceutical companies when applying for reimbursement to actual sales from reimbursement data. Results: The median accuracy ratio [95% confidence interval] was 1.33 [1.03; 1.74, range 0.15–37.5], corresponding to a median overestimation of actual sales by 33%. Forecasts of actual sales for 55.9% of all examined products either overestimated actual sales by more than 100% or underestimated them by more than 50%. The accuracy of sales forecasts did not show systematic change over the analyzed decade nor was it discernibly influenced by reimbursement status (restricted or unrestricted), the degree of therapeutic benefit, or the therapeutic area of the pharmaceutical product. Sales forecasts of drugs with a higher degree of innovation and those within a dynamic market tended to be slightly more accurate. Conclusions: The majority of sales forecasts provided by applicants for reimbursement evaluations in Austria were highly inaccurate and were on average too optimistic. This is in line with published results for other jurisdictions and highlights the need for caution when using such forecasts for reimbursement procedures.

2003 ◽  
Vol 29 (4) ◽  
pp. 525-542
Author(s):  
Merri C. Moken

The use of pharmaceutical products in the United States has increased more than the use of any other health resource from 1960 to 1990. In excess of 9,600 drugs were on the market in 1984, and the Food and Drug Administration (“FDA”) approves approximately 30 new drugs and countless new applications for alterations of already existing drugs each year. In 2001, the $300 billion pharmaceutical industry sold $154 billion worth of prescription drugs in the United States alone, nearly doubling its $78.9 billion in sales in 1997. With such a rapid increase in market domination and expenditures, the U.S. government and many hospitals have focused their attention on the sales and pricing practices of pharmaceutical companies, as well as other potential factors contributing to these escalating prices. One such cause of the steadily increasing prices of brand name pharmaceuticals is the sale of fake or counterfeit pharmaceuticals (also called “look-alike” drugs).


2021 ◽  
Vol 13 (7) ◽  
pp. 3599
Author(s):  
Yoshimi Harada ◽  
Huayi Wang ◽  
Kota Kodama ◽  
Shintaro Sengoku

Biotech startup firms developing pharmaceutical seeds from scientific and technological innovation are burdened by significant Research & Development (R&D) expenses, long-term R&D operations, and low probability of R&D success. To address these challenges while sustainably creating innovations and new drugs, business alliances with existing pharmaceutical companies are one of the most important issues on the management agenda. The present study explores the necessity and significance of business alliances with pharmaceutical companies for the development of drug-discovery by Japanese biotech startup firms under high uncertainty. This study investigates the types of alliances to understand the origins of sustainability of these creative activities. First, we investigate and analyze the details of the partnership and its impact on the products under development based on the publicly available information of 16 drug discovery biotech startup firms in Japan that had become public since 2010. As a result, all firms continued their operations with the funds obtained from the business alliances with pharmaceutical firms at the time of their initial public offering (IPO). In addition, 56% of these firms’ alliance projects (n = 73) were seeded-out, and 32% seeded-in, indicating that they had adopted flexible alliance strategies not limited to seed-out ones. For sustainable going concern of the biotech startup business, it is valuable to consider multiple strategic options: “in-licensing and value up”, “best-in-class”, “platform leadership” and “first-in-class” depending on the characteristics of seeds and environmental restrictions.


2020 ◽  
Vol 36 (1) ◽  
Author(s):  
Chise Tateno ◽  
Yuha Kojima

AbstractWe have succeeded in stable mass production of chimeric PXB-mice, whose liver is repopulated by human hepatocytes at a ratio of more than 70%, and we are providing these mice to academia and pharmaceutical companies to support the development of new drugs or studies of liver function. Furthermore, we isolated human hepatocytes, called PXB-cells, from the chimeric mice, and provide them for clients weekly for in vitro studies. In this review, we summarize the existing characterizations of PXB-mice and PXB-cells and their present and future applications.


2021 ◽  
Vol 3 (2) ◽  
pp. 37-52
Author(s):  
Antonio Pesqueira

Using Big Data in the pharmaceutical industry is a relatively new technology, and the benefits and applications are yet to be understood. There are some cases currently being piloted, but others have already been adopted by some pharmaceutical organizations, proving the unmet need in a field that is still in its infancy. This paper aims to understand how and if Big Data can contribute to commercial innovation, as well as future trends, investment opportunities. Participants from 26 pharmaceutical companies participated in different focus groups where topics were grouped by individuals and evaluation areas were discussed to discover any potential connections between Big Data and Innovation in commercial pharmaceutical environments. This study used the collected data to analyze and draw conclusions about how many life sciences leaders and professionals already know about Big Data and are identifying examples and processes where Big data is supporting and generating innovation. In addition, we were able to understand that the industry is already comfortable with Big Data, and there were some very accurate research results regarding the most pertinent application fields and key considerations moving forward. Using the network analysis findings and the relationships and connections explained by respondents, we can reveal how Big Data and innovation are interconnected.


2021 ◽  
Vol 14 (1) ◽  
pp. 13-21
Author(s):  
Gamil Q. Othman ◽  
Abdulsalam M. Halboup ◽  
Mohammed M. Battah

Objectives: To evaluate the ethics of pharmaceutical marketing practices in Sana’a city, Yemen. Methods: A cross-sectional study was conducted among 400 physicians and 50 pharmaceutical companies in the period from March to August 2018. Data about pharmaceutical marketing ethics were collected from physicians and pharmaceutical companies using two types of self-administrated, structured questionnaires. Data were analyzed with appropriate statistical tests using IBM SPSS Statistics, version 21.0. Results: The majority of physicians (60.0%) agreed that medical samples had been used most frequently as a promotional tool for pharmaceutical marketing, followed by gifts (14.0%). More than half of physicians were satisfied with the way of pharmaceutical marketing in Yemen. Personal relationships and medical samples and gifts were the factors affecting their prescriptions, being reported by about a third of physicians each. Meanwhile, most physicians (44.0%) preferred medical conferences and exhibitions as a promotional benefit to be gotten for prescribing the company’s products. The majority of physicians (62.0%) agreed that the availability of medical samples affect their prescriptions, and about 28.2% of physicians reported that all medical samples are used by their patients. Most physicians (37.0%) perceived that only 50% of medical representatives respond well to their queries related to marketed drugs, and 41.5% of physicians agreed that global companies are more compliant with ethical marketing. About 60% of the physicians reported not facing unethical promotions, and the majority (54.0%) agreed that unethical pharmaceutical marketing is the responsibility of companies, physicians, and representatives. There was a statistically significant difference in the proportion of drug prescriptions affected by medical representative visits and availability of medical samples on prescription in relation to the work experience of physicians. On the other hand, there was a statistically significant difference in facing an unethical promotion offered by companies for prescribing their products and the attribution of unethical pharmaceutical marketing in relation to the type of medical profession of physicians. Conclusions: Pharmaceutical marketing in Yemen still depends on traditional tools, with the lack of ethical guidelines or codes for pharmaceutical marketing in the country. Work experience and medical profession of physicians can significantly affect pharmaceutical marketing. The spread of unethical marketing is the responsibility of pharmaceutical companies, physicians and medical representatives. Therefore, it is recommended to develop well-defined and updated ethical standards and national guidelines for pharmaceutical marketing by the Ministry of Public Health and Population. Furthermore, official campaigns should be regularly carried out to control and restrict unethical promotion. Further studies on the ethics of pharmaceutical marketing are also recommended. Pharmaceutical companies should continuously train their medical representatives and provide physicians with the latest medical knowledge about new drugs. Keywords: Pharmaceutical marketing, Ethics, IFPMA guidelines, Sana’a


Parasitology ◽  
1997 ◽  
Vol 114 (7) ◽  
pp. 137-144 ◽  
Author(s):  
M. H. ROOS

Parasitic helminths (worms) cause serious infectious diseases in humans and domestic animals. Control of these infections relies mostly on chemotherapeutics (the anthelmintics), but resistance has developed against most of these broad-spectrum drugs in many parasite species. These resistant parasites are being used to elucidate the molecular mechanisms of drug resistance and drug action. This has led to the development of sensitive assays to detect resistant parasites, but this has not delayed the emergence of additional drug resistant parasite populations. Therefore, as development of new drugs by pharmaceutical companies is slow, we may have to be prepared for a time when broad-spectrum drugs are no longer effective, especially against worms of sheep.


2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Nagasundaram Nagarajan ◽  
Edward K. Y. Yapp ◽  
Nguyen Quoc Khanh Le ◽  
Balu Kamaraj ◽  
Abeer Mohammed Al-Subaie ◽  
...  

Artificial intelligence (AI) proves to have enormous potential in many areas of healthcare including research and chemical discoveries. Using large amounts of aggregated data, the AI can discover and learn further transforming these data into “usable” knowledge. Being well aware of this, the world’s leading pharmaceutical companies have already begun to use artificial intelligence to improve their research regarding new drugs. The goal is to exploit modern computational biology and machine learning systems to predict the molecular behaviour and the likelihood of getting a useful drug, thus saving time and money on unnecessary tests. Clinical studies, electronic medical records, high-resolution medical images, and genomic profiles can be used as resources to aid drug development. Pharmaceutical and medical researchers have extensive data sets that can be analyzed by strong AI systems. This review focused on how computational biology and artificial intelligence technologies can be implemented by integrating the knowledge of cancer drugs, drug resistance, next-generation sequencing, genetic variants, and structural biology in the cancer precision drug discovery.


2008 ◽  
Vol 24 (02) ◽  
pp. 140-145 ◽  
Author(s):  
Christopher McCabe ◽  
Karl Claxton ◽  
Anthony O'Hagan

Pharmaceutical regulators and healthcare reimbursement authorities operate in different intellectual paradigms and adopt very different decision rules. As a result, drugs that have been licensed are often not available to all patients who could benefit because reimbursement authorities judge that the cost of therapies is greater than the health produced. This finding creates uncertainty for pharmaceutical companies planning their research and development investment, as licensing is no longer a guarantee of market access. In this study, we propose that it would be consistent with the objectives of pharmaceutical regulators to use the Net Benefit Framework of reimbursement authorities to identify those therapies that should be subject to priority review, that it is feasible to do so and that this would have several positive effects for patients, industry, and healthcare systems.


10.5912/jcb29 ◽  
1969 ◽  
Vol 9 (3) ◽  
Author(s):  
Daniel G Brown

The Drug Price Competition and Patent Term Restoration Act (Publ. No. 98-417, 98 Stat. 1585 (1984)), commonly known as the Hatch–Waxman Act (the Act) provides the statutory framework by which most generic drugs are approved for marketing in the USA. Most provisions in the Act concern the standards and procedures the US Food and Drug Administration (FDA) must follow to approve generic drugs. A relatively small number of the provisions, however, create a framework for resolving patent disputes between the brand and generic pharmaceutical companies. These provisions have been the subject of much recent activity, in the US Courts, in Congress, in the FDA itself and in the White House. Much of the activity revolves around a publication by FDA entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known colloquially as the Orange Book.Under present FDA practice, the mere listing of a patent in the Orange Book corresponding to a brand pharmaceutical product invokes a number of statutory provisions that confer valuable exclusivity rights on the brand company, and also possibly on one or more generic companies. This situation creates a strong incentive for patentees and brand pharmaceutical companies to list patents in the Orange Book. A number of recent court cases have addressed the remedies and damages available when the listing is found to be improper. Thus far, the most successful means to challenge or prevent improper listings has been through private and governmental enforcement of the antitrust laws.


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