biosimilars pricing strategy

If the price is jacked up 9% per year, that would be an increase of 53.9%, to $58,482. Please email us at: McKinseys new weekly newsletter, featuring must-read content on a range of topics, every Friday. The global biosimilars market is expected to grow from $15.67 billion in 2021 to $19.10 billion in 2022 at a compound annual growth rate (CAGR) of 21.8%. A scoping review of the literature to identify all known ties between the medical product industry and the parties and activities in the healthcare ecosystem. There is also an unresolved debate over whether comparative originators for trials need to be US-sourced, as is the case under current guidance.14 14.Generics and Biosimilars Initiative, Pharma associations issue position paper on biosimilar switching.15 15.Center for Biosimilars, Paper Argues That Bridging Studies Are Redundant, Unnecessary.16 16.Food and Drug Administration, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.. 6 As time goes on, competition can lead to declining prices for both reference products and biosimilars, and we can expect to see increased savings for the healthcare system. Still, four biosimilar manufacturers have received Complete Response Letters for distinct products in the past two months alone, potentially suggesting the FDAs expectation for clinical evidence may not be fully aligned with manufacturers.13 13.Center for Biosimilars, FDA Rejects Mylan and Biocons Follow-On Insulin Glargine. Gaining further clarity on approval thresholds will serve to increase success rates and, ultimately, approvals. By doing so, they can potentially reallocate the savings generated by biosimilars to other areas of care and provide more cost effective alternatives to patients who may not have been able to afford them before. This could . There is generally weaker demand for retail products and self-injectable biologics, likely reflecting lower levels of awareness and pressure that can be applied in those segments (beyond tenders) compared with hospital-administered products (Exhibit 1).6 6.Academy of Managed Care Pharmacy Guide to Pharmaceutical Payment Methods, 2018. Evernorth is uniquely positioned to help with this. Lastly, patient assistance programs and indigent patient programs would need to be at par with reference products. 15:29 Audio Listen to this article Economics of biosimilar pricing. In Europe, pricing of biosimilars already has begun to affect the market for biologics. As part of fulfilling these additional . Operational considerations from 4 critical elements may be included in the implementation strategy. Keep up with the latest news, insights, and offerings from Evernorth. Its Humira biosimilar, Amjevita, is scheduled to hit the market in January 2023, giving it a six-month head start on the others. The authors suggest, at minimum, voluntary implementation of these policies where it is not feasible to make them mandatory. IQVIA AG, Analytic Link 2018. AbbVie will begin granting country-by-country licenses to both companies in Europe, with an expected US license delayed until mid-2023.8 8.AbbVie Announces Global Resolution of HUMIRA (adalimumab) Patent Disputes with Samsung Bioepis, April 2018. Lowering development costs via innovation is an essential discussion to accelerate to ensure a sustainable future. Our client's biosimilar business strategy needed to consider a 5-year perspective on a new and emerging biosimilar environment. The industry, meanwhile, could increase investment in bioanalytical methods, optimize design and recruitment for biosimilar clinical studies, and explore options to recruit patients in markets with limited access to biologic therapies. Amid rising competition, there is little sign that pervasive discounting will abate anytime soon. Also, new entrants are competing aggressively to capture share, with makers of Flixabi, for example, challenging the early leads of Inflectra and Remsima. View the job description, responsibilities and qualifications for this position. Buske C, Ogura M, Kwon HC, Yoon SW. An introduction to biosimilar cancer therapeutics: definitions, rationale for development and regulatory requirements. By using this site (i.e., by clicking on the site), you consent to our use of cookies and similar technologies, as described in our Cookies and Similar Technologies Policy In the publication, the authors point out that achieving universal health coverage requires universal access to safe, effective, quality-assured, and affordable drugs and vaccines, and they highlight the role of generics and biosimilars. Value-Based Management of Specialty Drugs: Practical Considerations and Implications for. It could also ease pressure on a limited pool of patients and investigators. In the US, there are several regulatory efforts in progress that relate to biosimilars. Optimize plan design and formulary management In contrast to accelerating European growth, the US market remains fairly flat. Never miss an insight. Subscribed to {PRACTICE_NAME} email alerts. Companies need to adopt agile go-to-market strategies to compete locally. Where biosimilars are marketed in the US, uptake remains low. Sales & Earnings Biosimilars Strategy Pfizer Delivers On Biosimilars Strategy Reports Biosimilars Sales Up By 19% To $911m In 2019 31 Jan 2020 News Jessica Merrill @Jessicaemerrill jessica.merrill@informa.com David Wallace @Genericbulletin david.wallace@informa.com Executive Summary Additionally, payers would need to consider tiering biosimilars as well as managing out-of-pocket costs in a way that would ensure that biosimilar adoption remains an attractive proposition. All rights reserved. Watch the video above to learn more about our history of leadership creating a pathway for biosimilars and driving to the lowest net cost therapy. We use cookies and similar technologies to understand how you use our site and to create more valuable experiences for you. For pharmacy products, average invoice prices are often closest to the price patients pay during their deductible, notwithstanding pharmacy mark-ups. Rapidly trading-off resources based on dynamic market conditions. Companies should also consider diversifying organizational structures, including finding local partners, employing contracted field forces, or sharing resources. Amgen is: By the Numbers: 11 medicines in our portfolio in inflammation and cancer Invested more than $2 billion across the development of biosimilar medicines One area deserving of attention is the requirement for therapeutic equivalence trials, which account for at least 75 percent of development costs. Tendering, in which suppliers must compete for contracts, has also been widely and successfully used to reduce prices; however, this can also drive small suppliers from the market, leading to decreased competition. Research, Market conditions, consumers' willingness to pay, competition, trade margins, expenditures incurred, etc., are all considered while developing a pricing strategy. 6 Moreover, the complexity of monoclonal antibodies makes their development and manufacturing costs much higher than for the biosimilars that are currently on the market in the EU. It can enable quick decisions and can help manufacturers calibrate risk/reward ratios, ultimately helping them free up space in their P&Ls to build an agile go-to-market approach (see Section 4). Calvo: Pricing of biosimilars will inevitably be closely tied to the originator compound. Throughout this report, the term "follow-on biologic" is . AbbVie Announces Global Resolution of HUMIRA (adalimumab) Patent Disputes with Samsung Bioepis, April 2018. One key variable in driving uptake of biosimilars will be the new reimbursement rules set forth by The Centers for Medicare & Medicaid Services (CMS). The KOL also talks about newer therapies that might overthrow current market leaders, and the future of newer biologics in the market. Partnering to capture opportunities in the periphery. While adoption has been slow in the US, reasonably competitive pricing and wider availability of biosimilars is finally leading to growth and additional . 1. All rights reserved. Availability of programs and services may vary by location and is subject to change. How can the US healthcare system learn from the European Union on market penetration for biosimilar products? Markets Covered: 1) By Product: Adalimumab Biosimilars; Infliximab Biosimilars; Cipleumab 2) By Application: Crohn's Disease; Psoriatic Arthritis; Rheumatoid Arthritis; Ulcerative Colitis;. However, there may be an opportunity to further streamline the regulatory process and accelerate path to market. The Manager, Biosimilar Strategic Pricing, Contracting & Reimbursement Analytics, is principally responsible for being a strategic and trusted advisor across the Marketing, Sales/Account . Pricing strategy and value management are an increasingly important requirement. Basing generic/biosimilar price on a percentage of the originator price: Similar to internal reference pricing, a fixed discount could discourage price competition. The Business Research Company's Biosimilars Market 2022 - Opportunities And Strategies - Global Forecast To 2031 Avail a limited period discount of 33% on our uniquely designed Opportunities . Researchers conducted a qualitative study with Blue Cross Blue Shield plans interested in implementing value-based specialty pharmacy management to observe the plans objectives, strategies, and factors influencing their ability to execute on these strategies. FDA will also continue to educate clinicians, patients, and payors about biosimilar and interchangeable products as we seek to increase awareness about these important new treatments.18 18.HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, US Department of Health and Human Services, May 2018. The dynamics of the US market are changing as the regulatory environment evolves. Payers price & market access policies supporting a sustainable biosimilar medicines market, Simon Kucher & Partners, September 2016. We need to tear down the rebate wall and create better contracting models that help patients access cost-saving biosimilar treatments.10 10.Novartis CEO: How To Create Cheaper Alternatives To The Most Expensive Drugs, Forbes, April 2018. In the managed care pharmacist and provider surveys, educational programs were rated as strategies with the highest likelihood of success. CG-CSF and G-CSF Biosimilars Production Capacity, Revenue, Price and Gross Margin (2015-2022) 7.1.4 Company's Main Business and Markets Served 7.1.5 Company's Recent Developments/Updates 8 G . Before the IRA passed, CMS paid biosimilars a rate of the biosimilar's ASP plus an add-on of 6% of the reference biological product's ASP. Our recommended response is to get ahead of the game, by identifying partners across the spectrum to pilot distribution, delivering provision in higher-impact segments and channels. 2020;368:l5444. Ying Chen is a specialist in McKinseys Brussels office, Jennifer Dikan is a consultant in the Philadelphia office, Jennifer Heller is an associate partner in the Chicago office, and Jorge Santos da Silva is a partner in the Zurich office. The infrastructure bill includes a drug waste provision from the Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act, which requires manufacturers to rebate the amount wasted back to CMS. Further, they note that efforts from all stakeholders are necessary ,as no single policy will achieve this goal. Over the last 30 years, the biologics class of drugs (monoclonal antibodies, cellular growth factors, erythropoiesis stimulating factors, and granulocyte colony stimulating factors) represents one of the fastest growing sectors of the drug industry world-wide.2 These drugs have applications both in supportive care as well as therapies for chronic autoimmune disorders and cancer care. The biosimilar market is already under pressure from the dual and related impacts of price discounting and competition, particularly in Europe. A strong data and analytics platform can also drive sales force productivity and inform financial management, forecasting, and drive critical internal discussions. Changes in percentage spend across bevacizumab products, 2018-2020 3 The emergence of biosimilars will provide additional opportunities for savings, but careful planning is required to capture them. Biosimilarsthe second wave, QuintilesIMS, presentation, 2017. We estimate sales will potentially triple in size to $15 billion by 2020, or closely thereafter. The 3 biosimilars for oncology biologics launched in 2019 achieved significant uptake within their first year . Why Congress should not follow the National Academy of Science, Engineering, and Medicines recommendation to remove the JW modifier. Switching to a lower-cost biosimilar seems to be the dominant choice from a health economics perspective. Abuses of Government Programs and Regulations, Supply Chain Economics Favor Higher Cost Drugs, Profitability over Public Health and Innovation, Senate Moves Forward with $1.2 trillion Infrastructure Bill, Includes Funding Offset from Bachs Drug Vial Waste Research. These models all can apply but should be regarded as menu options that can be flexibly applied to local conditions. Espaol [PDF]| [PDF] |Ting Vit [PDF] | [PDF] |Tagalog [PDF] | [PDF] | [PDF] |Kreyl [PDF], Franais [PDF] |Portugus [PDF] |Polski [PDF] | [PDF] |Italiano [PDF] |Deutsch [PDF] | [PDF] |More [PDF]. The next wave of oncology drugs promises similar dynamics, with a high number of experienced players expected to compete for market share. It could make sense for large pharmaceutical companies focused on specialty care to move away from traditional unit-price maximization. NCD would be followed by implementation by all regional Medicare contractors to prepare their own local coverage determination. Strategies to achieve fairer prices for generic and biosimilar medicines. Biosimilarsthe second wave, QuintilesIMS, presentation, 2017. The FDA also discussed refreshed guidance on communication of pharmaco-economic data between biosimilar manufacturers and intermediaries including PBMs, hospital-based pharmacies, and therapeutics committees: I think were going to go beyond where we did in the original guidance and create a more robust framework for those conversations to happen in an unimpeded way.12 12.FDA Writing Laxer Biosimilar Interchangeability, Communication Rules, FDA Week, April 28, 2018. FDA website, Biosimilars Product Information, June 2018. Vas Narasimhan, CEO of Novartis, has been outspoken on the topic of rebates, recently saying, The rebate wall stifles competition by blocking biosimilar access and uptake. Terms of UsePrivacy Policy Notice of Privacy Practices, Accessibility Health Care Fraud Nondiscrimination Notice CCPA Notice. Were always looking upward. Counter-biosimilar messaging aims to delay the inevitable adoption of biosimilars as opposed to maintaining market share for biologics. There is a dominant choice. The current generation of biosimilars is far more complex than earlier generations and must be tested and launched into much more restrictive analytical and clinical environments than just a few years ago. Biosimilar products need to be priced at a level where providers would be encouraged to consider incorporating biosimilars in their offerings. The discussion on whether comparative originators for the trials need to be sourced from the US (current guidance) or globally is still open. Browse our featured research or explore our work by article type. McKinsey_Website_Accessibility@mckinsey.com. To summarize, several challenges could prevent biosimilar entry into an already tightly-held market, prompting strategic thinking, careful planning, and clear implementation policies. This trend seems to be continuing, and in Q2 2022 alone, savings in drug spend are estimated to be $3.2 billion. BMJ. pricing is a key issue for expensive-to-develop biosimilars entering an increasingly crowded autoimmune disease market.biosimilars are intended to relieve healthcare-associated cost burden; however, the economic effects of incorporating them into clinical practice are unclear, due to increased time and staff costs required for switching patients For biosimilars, the situation is more complex since they are, by definition, highly similar as opposed to identical. Despite the promises that this class of drugs presents, both from a cost perspective as well as access, their market penetration does not seem to be likely very soon. Pricing strategy involves changing and adjusting the price of goods and services in response to market factors. Approval of the first biosimilar bevacizumab, a monoclonal antibody, in the true cancer therapeutic class is expected later this week. Companies must balance commercial and developmental tactics within a biosimilar's overarching commercial strategy. The global pegfilgrastim biosimilars market is expected to grow from $0.8 billion in 2020 to $0.88 billion in 2021 at a compound annual growth rate (CAGR) of 10%. Authorized biologics are nonbranded copies of the originators; therefore, they are . The discount rates applicable to the biosimilar and its originator According to Article 25, the discount rates are defined as follows: for the general pharmacies market: 40% for the biosimilars. The published literature on biosimilars is also mounting. The Policy describes how you can control the use of cookies at any time. 2022 MJH Life Sciences and Center for Biosimilars. The FDA has issued interchangeability guidance, but uncertainty remains at all levels of the systemincluding state pharmacy laws and local prescribers. Unlike the European Union, the US biosimilar market is influenced by regulatory agencies such as the FDA, payers (CMS, HHS-state Medicaid and managed care organizations, Medicare advantage plans, and commercial plans), wholesalers and group purchase organizations, and consumer advocacy groups amongst many other factors. Taught By. Guideline on Similar Biological Medicinal Products, CHMP/437/04, 2005. ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf. Originally published Meanwhile, pharmaceutical companies would stand to make a lot more money. BioRationality: A Dr Sarfaraz Niazi ColumnFDA Launches Biosimilar Regulatory Science Program, Biosimilars Policy Roundup for October 2022Podcast Edition, WHEN CHOICE ARRIVES: Competition & Consequences. Here are three ways plan sponsors can promote and manage the appropriate use of biosimilars to improve drug affordability and access for members. Estimates on cost savings for biosimilar products as compared to originator products are believed to be about 25 percent initially. Promotional material, and the sales force will be trained so that when the product is approved they can promote the drug to physician, pharmacist and nurses. While biosimilar approval and adoption have been slow, theyre gaining momentum. In fact, the NPV achieved with a high class share similar to that of biosimilar filgrastim ($203 million) would not be significantly different from that achieved with a lower class share in the price-parity scenario ($191 . Instead of debating 'first-shot' vs 'set-aside' vaccine approaches, hospitals' study. WHEN CHOICE ARRIVES: Competition & Consequences. According to multiple reports, including a 2013 Institute of Medicine report, the US healthcare system ranks at the bottom of most developed economies while simultaneously being the most expensive.1 The primary reason for this discord in efficiency is a lack of competition in the healthcare markets coupled with a lack of agility. Academy of Managed Care Pharmacy Guide to Pharmaceutical Payment Methods, 2018. Biosimilars provide an opportunity for hospitals and health systems to lower their costs of providing care without lowering their quality of care. Improving access to fairly priced, quality-assured generics and biosimilars is essential to realizing the potential public health and cost-saving benefits of these drugs, according to an editorial published in The BMJ, which also lays out strategies to achieve this goal. Modification of those requirements could change the landscape, especially as more players enter the market. The JV developed a Humira biosimilarImraldithat is set to launch in Europe in October.22 22.Reuters, AbbVie, Samsung Bioepis in deal; Humira biosimilar US release in 2023. Biogens biosimilar division is on track to make $500 million in sales this year, and the company said in April 2018 it plans to raise its stake in the JV to 49.9 percent.23 23.FiercePharma, Biogen to boost stake in biosims joint venture as competition to its MS meds mounts.. Two factors are at play: First, buyers are becoming increasingly sophisticated, often coordinating tenders to boost competition between suppliers and facilitating switching via robust education initiatives or trials and experience in market. However, they also acknowledge biosimilars have not realized the cost advantages currently associated with generics, at least in part due to the complex production processes and more extensive regulatory requirements biosimilars need for approval compared with generics. As companies plot a way forward, there is work to be done in defining specific product strategies that prioritize revenue sources, identify specific markets and indications, and make/buy decisions to take. Because biologics and biosimilars treat rare conditions and are sourced from more complex living molecules than normal drugs, pharmaceutical manufacturers can impose high prices. The European market is expected to continue to mature and the US offers opportunities, despite many practical challenges. Hospitals could start studies of their own employees to answer important questions, including whether the first-shot approach has downsides when compared to the set-aside strategy. While 11 biosimilars have Food and Drug Administration (FDA) approval as of June 2018, only three are actively marketed, while the others are either tied up in patent disputes (for example, Amjevita [adalimumab]) or are awaiting patent expiry (for example, Erelzi [etanercept])7 7.FDA website, Biosimilars Product Information, June 2018. Some of these controls may include: Some providers and patients are still new to biosimilars, while others might be misinformed about their safety, efficacy and possible financial benefit. Avastin, as a reference drug for bevacizumab, has two biosimilars: Mvasi, launched in 2019, and Zirabev, launched in 2020. There may be several Covid-19 vaccines by winter, but there will also need to be a study comparing the viruses to one another as part of rolling out widespread vaccination. Since the FDA's approval of the first biosimilar Zarxio (filgrastim-sndz) from Sandoz, a division of Novartis Pharmaceuticals Corp. on March 6, 2015, the agency has approved almost 40 more agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). The market was worth around $2.5 billion in 2017, comprising 36 approved biosimilars by May 2018, and we expect it to grow closer to $4 billion by the end of 2018, bolstered by biosimilars of at least five new reference biologics, including high-value molecules such as adalimumab and trastuzumab.2 2.IQVIA Analytics Link database. In April 2018 CMS released its final rule on biosimilars for the Medicare program, announcing it would lower the maximum co-payment amount for low-income subsidy (LIS) beneficiaries for biosimilars and interchangeable biosimilars to match the lower co-pay amount required for generic and preferred multiple-source drugs. Estimates suggest that global sales topped $15 billion in 2020, representing a compound annual growth rate of 56 percent since 2015 (Exhibit 1). Biosimilars Action Plan (BAP) Educational Materials for Patients Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure. For the three biologic molecules of etanercept, infliximab and insulin glargine . With some of the worlds best-known biologics continuing to face patent expiration in the coming years, the biosimilars market is set for continued growth. For. Manufacturers will continue to increase focus in fast-growing Europe, while the US keeps progressing slower with the promise of enormous potential. doi: 10.1136/bmj.l5444. Medicare cannot indiscriminately cover the cost of Aduhelm for the treatment of Alzheimer's disease without first evaluating whether it truly works. All rights reserved. September 29, 2022 $599.00. It takes 7 to 8 years to develop a biosimilar, at a cost of between $100 million and $250 million. Zelenetz AD, Ahmed I, Braud EL, et al. We'll email you when new articles are published on this topic. BRIC-MS policymakers are keen to encourage the development of local manufacturing capabilities in the biologics sector, however, and foreign companies attempting to service emerging markets via biosimilar imports will face challenging administrative, regulatory, and pricing barriers. Frank RG. All products and services are provided by or through operating subsidiaries or affiliates of Evernorth. Production Plus Profit Pricing (P-quad) FAQ, What A Waste! Now,. european sales of biosimilars are growing, amid increasing acceptance that they are equal to patented drugs in terms of safety, efficacy, and immunogenicity. Center for Biosimilars, FDA Rejects Mylan and Biocons Follow-On Insulin Glargine., Generics and Biosimilars Initiative, Pharma associations issue position paper on biosimilar switching., Center for Biosimilars, Paper Argues That Bridging Studies Are Redundant, Unnecessary., Food and Drug Administration, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.. Five things to know about biosimilars right now. Apply for the Job in Associate Director, Pricing and Contracting Strategy - Biosimilars at Weston, MA. Estimated Change in Total Drug Spend After Biosimilar Competition There is scope for them to deploy strategies that discourage entry or make it unprofitable. The emergence of biosimilars will provide additional opportunities for savings, but careful planning is required to capture them. 16. The second involves driving budget impact at payers and providers and working on producing savings through incentives. A popular misbelief prevails in the United States that our healthcare system is the best and most efficient in the world. The average price reduction of biologics due to introduction of biosimilars was 27% in the EU in general, and 50% in Romania, Bulgaria, and Czech Republic. The biosimilar industry has developed rapidly and regulation has advanced significantly since the early 2000s with approval processes now in place in many countries. For example, ASP per unit for Neulasta (pegfilgrastim) was nearly $4,500 in January 2019, when only one biosimilar was on the market. It is a much tougher uphill battle for the branded originators. Figure 3: Pricing of biosimilars across selected European countries. The key advantage of utilizing biosimilars is reduced costs to both the healthcare system and patients. . Plan sponsors leverage several tools to ensure members have access to safe and effective specialty medications, while simultaneously managing rising drug costs. We conduct non-partisan, independent research, and make our work accessible and informative to policymakers and the general audience alike. Please try again later. Novartis CEO: How To Create Cheaper Alternatives To The Most Expensive Drugs, Forbes, April 2018. In response, companies need to incorporate agile capabilities, comprising three key components: We see three commercial modelspush for land grab, value partner, and pull the end market. The first requires companies to focus on price cuts and volume gains, and in particular to boost tender and pricing capabilities. In January 2017, the FDA released its first draft guidance on demonstrating interchangeability of biosimilars. AbbVie, which makes Humira, has earned nearly $200 billion from the sale of this drug. Deployment of commercial and medical resources (for example, in the form of a field force and/or patient support programs) in the US is high risk: requiring meaningful investment in exchange for an uncertain return. Global price declines and rising competition are expected to continue creating challenges in producing sustainable returns. Some of these are likely on IP hold. Intellectual Property Strategy & BioSimilars II 11:00. While generic medications can be 80% to 85% cheaper than brand name counterparts, GoodRx research found that biosimilars are only 10% to 37% cheaper than biologics. However, the ever-escalating cost of care threatens access to life saving medications and posts a threat of financial toxicity for both individuals and the healthcare system.3. CMS-4182-F. HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, US Department of Health and Human Services, May 2018. The fact that adalimumab is a core business for many companies suggests there are challenging times ahead. That may, for example, mean adjusting investment models across regions as incentives change, requiring flexibility around budgeting, commercial deployment, and sales/key account effectiveness. Let us consider the challenges associated with a successful launch of biosimilars in the United States. 10 in this analysis, we review the effect of some of these policies and discuss factors that may The wave of Humira biosimilars in 2023 could lead to savings for patients and payers and the knock-on effect of improved access due to lower costs. Assuming AbbVie executives hold to their price increase pledge, raising their prices by only 6% per year, by 2023 when patent expirations will bring a rash of biosimilars to market, Humira's price after rebates would have risen 33.8%, to $50,844.

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