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

"Better than the Beatles?" 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) ▲ general trend of R & D efficiency (data source: reference [1], content team drawing of Wuxi apptec) eRoom's law is sometimes described as "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 ▲ some parts of the efficiency of the R & D process have improved significantly, while others have declined significantly (data source: reference [1], content team drawing of Wuxi apptec) Many countries and regulatory agencies are struggling with the standards that they hope to set "better than the Beatles", and the diversified needs caused by rapid aging and population 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 Drug bidding is a normal part of market access, but will it 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 Data source: reference [9], with the development of time, the price of related drugs will be paid more and more attention 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 behind the transformation of five relevant value evaluation frameworks in the United States (data source: reference [10], content team drawing of Wuxi apptec) is oncology, as well as a number of new frameworks created in 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 To convey your values 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 not new 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 How to deal with the value assessment in 2020 and actively respond to the work of the whole organization? Start from one place, determine in advance which places will be the focus of investment, accurately estimate the negotiation to be carried out, and how low the price will be; understand the key countries where value driven relationship can be established and maintain the partnership In terms of communication, especially in risk and reputation teams, it is necessary 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 Establish a new partnership 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 Appendix: relevant agencies, English abbreviation of the bill, English full name, Chinese Translation: data source: reference [9], [10], reference materials for drafting of content team of Wuxi apptec: [1] Scannell, J., blanckley, A., Boldon, H et al Diagnosing the decline in pharmaceutical R & D efficiency Nat Rev drug discov 11, 191 – 200 (2012) doi: 10.1038/nrd3681 [2] Susan E Bates PD-1 Pandemonium at the American Association for Cancer Research Annual Meeting The Oncologist May 2019, vol 24, no 5, 571-573 doi:10.1634/theoncologist.2019-0281 [3] Karen Honey AACR Annual Meeting 2019: PD-1 Pandemonium April 12, 2019 Retrieved Dec 12, 2019 from https://blog.aacr.org/pd1-pandemonium/ [4] Dana-Farber Cancer Institute What is PD-1 and Immunotherapy? May 22, 2019 Retrieved Dec 12, 2019 from https://blog.dana-farber.org/insight/2019/05/the-science-of-pd-1-and-immunotherapy/ [5] The CRI Anna-Maria Kellen Clinical Accelerator PD-1/PD-L1 Landscape Retrieved Dec 26, 2019 from https://www.cancerresearch.org/scientists/immuno-onco