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    Home > Medical News > Medical World News > How is the research and development of new drugs getting better and better?

    How is the research and development of new drugs getting better and better?

    • Last Update: 2020-01-06
    • Source: Internet
    • Author: User
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    The discussion about cost and value has become more complicated and even more commercial The eager expectation of innovation from all walks of life, the impact of centralized purchase pricing, payers, patient rights groups and regulatory agencies are all challenging the leaders of the pharmaceutical industry, requiring the pharmaceutical industry to prove the initial data related to the population, as well as protect the value, so as to make it last forever Talking about the value of drug R & D in 2020 can not be separated from the eRoom law about the input-output rate of drug R & D Compared with the existing therapeutic drugs, many new drugs have small incremental benefits As time goes on, drug development is becoming slower and more expensive The smaller the incremental revenue of new drugs, the larger the scale of clinical trials needed to prove the revenue of new drugs; at the same time, it is more difficult to maintain the commercial scale of the revenue of new drugs Such a paradigm would double the cost of developing new drugs every nine years (adjusted for inflation) ERoom's law, sometimes described as the need to "be better than the Beatles." As you can imagine, if new bands are required to be better than the Beatles, it will be more difficult to make new records As the categories of innovative drugs become more and more crowded and generic drugs become more and more common, the cost of incremental innovation also increases In 2019, cancer drugs were criticized for following the trend of detection of "me too" compounds Dr Richard pazdur, director of FDA's center of excellence in oncology, criticized the industry for repeatedly testing very similar therapeutic drugs, especially after witnessing many failures FDA has approved six checkpoint inhibitor immunotherapy drugs (targeting PD-1 / PD-L1 drugs) for 14 different types of cancer treatment But according to the Cancer Research Institute, there are more than 2250 clinical trials in progress, many of which are similar Many countries and regulators are grappling with the "better than the Beatles" standards they want to set, as well as the diverse demands of rapid aging and demographic change These countries will not accept a premium for me too drugs Therefore, the pharmaceutical industry must balance expectations with uncertainties in research, supply chain and cost Japanese regulators are planning around the reality of the world's fastest-growing aging population The aging of the population often means that more will be spent and patients' out of pocket expenses will increase In order to protect consumers and maintain the state's relevant resources at a normal level, we will not compromise on the tough stance of abolishing high pricing for drugs with insufficient innovative technology But on the other hand, the industry believes that Japan has a friendly environment for the latest compounds and needs to continue to maintain such a reputation Falling into this dynamic, pharmaceutical companies must improve the flexibility of commercialization according to relevant drug pricing schemes In 2020, if these companies are committed to improving their position in local prescription concentration, it is necessary to shift more and more investment from drug sales to solution sales Bidding is a normal part of market access, but will the bidding for drugs with haggard prices push the new competition to the bottom? Drug bidding is a process in which countries, local governments, medical systems, etc negotiate and sign purchase contracts for drugs The purchaser requires that pharmaceutical companies bid for specific batch commitments, and then make choices based on the lowest cost or the best cognitive value Compared with the recommended method, drug bidding has greater influence; in most regions, relevant agencies require drug procurement bidding For example, in Germany, pharmacists can only provide the preferred drug specified by the patient care plan In many of the world's growing healthcare systems, drug bidding is getting more and more attention and localization Such a trend is more likely to exclude innovative drugs Relevant plans are putting pressure on pharmaceutical companies If they want to compete, they need to cut prices substantially The third-party value framework is promoting value dialogue Examples of these third-party value frameworks include ICER (Institute for clinical and economic review) and ASCO (American Society of Clinical Oncology) and many other institutions (see the end of this paper for their English abbreviations, English full names and Chinese full names) Over the past two decades, these institutions have launched a variety of assessment tools to help assess the cost and impact of drugs in specific treatment categories With the passage of time, the price of related drugs will attract more and more attention from all walks of life One of the reasons is the adoption rate and accessibility ICER, by using new tools, is making data easier for pharmaceutical and insurance companies to access At the same time, some notable adoption cases, even though the argument about the quality adjusted life year (QALY) index is a bit dazzling, but the influence of these adoption cases is becoming a hot topic Sanofi and regeneron, in collaboration with ICER, decided to lower the net price of cholesterol drug praluent Both the Department of Veterans Affairs and CVs Caremark, a prescription drug benefits management subsidiary of CVs, use ICER indicators to assess coverage exclusions The second driving force for change is oncology and the new frameworks created over the past five years to assess the cost of these oncolytic drugs There are 850 new cancer drugs in the related pipeline Evaluation data show that the most recent median price was $160000, with some exceeding $500000 It is generally agreed that no framework is perfect, but these practices have been seen as a good start in the value dialogue Since these third-party frameworks are often used to assess value prior to release, companies also focus on communicating value earlier In this regard, Europe is the first country to start, and relevant countries have readjusted the communication process to support the ever-changing evaluation process of nice (the National Institute for health and care excellence) and other health technology evaluation committees Now, other regions are following suit It is expected that important communication strategies will be re formulated in the next 18 months New approaches, including these frameworks, may be adopted earlier and more transparent at the same time These initiatives will bring new pressure on early data and integrated clinical and commercial development In a world focused on creating value, the motivation for maintaining reputation comes from the company's emphasis on its own value We have seen that price commitments are fulfilled; value based contracts are signed Over the past five years, you've seen a major shift between the number of companies emphasizing price commitments and the number of new value-based linked insurance coverage In 2020 and beyond, these contracts will be more and more focused on outcomes, and will be close to vested interests, protecting the integrity of data between the partnership and patients, healthcare providers In such circumstances, pharmaceutical companies face two main challenges, including specific understanding of what needs to be measured and how to communicate Medical service providers are no strangers to the challenges of measurement Health service providers, the first "crab eaters" in health policy reviews, are hesitant to enter value-based care In order to improve the outcome contract, the payer clearly points out which patients are being treated, and negotiates some expensive drugs from the perspective of each of these patients They are working with research institutions to narrow down the most likely beneficiaries into key ways to manage the budget and achieve member results Communication is another key element of value The company should establish a value concept to make the cross functional system consistent with all price behaviors These value behaviors that ensure the value portfolio have the following characteristics: strategic, clear-cut goals; economic benefits; politically feasible; accessible, and can stand the test; integrated into the strategic plan of cross business departments and franchising The dialogue about prices and whether drugs can deliver value against prices is accelerating In the face of such a trend, the discourse mode of the pharmaceutical industry must be changed The work of the whole organization starts from one place, determines in advance which places will be the focus of investment, accurately estimates the negotiations to be carried out, and how low the price will be; understands the key countries in which value driven relationships can be established, and maintains partnerships In terms of communication, especially risk and reputation teams, they need to work with clinical and business leaders to re plan the way and time to start communication in price sensitive and value driven markets As the pricing dispute continues, a special communication channel will be established to discuss the price transparency in a resonant way and strive to improve the accessibility of drugs Work with insurance companies, policy makers, and Medicare and Medicaid Services (CMS) to engage in a dialogue on drug reimbursement and payment strategies that are appropriate to the new pace of innovation In addition, before drug pricing, we should give full consideration to the voice of patients, especially in the pay as you go market Considering the voice of patients will help to find out the price sensitive patient segments and determine the best pricing strategy Attachment: English abbreviation, English full name and Chinese translation of relevant agencies and bills: Disclaimer: This article is only for the purpose of information exchange The views in this article do not represent the position of Wuxi apptec, nor do they represent the support or opposition of Wuxi apptec Original title: Viewpoint "better than the Beatles"? New drugs, how to achieve "enduring innovation" A kind of
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