Much of the fine print of the sweeping Inflation Reduction Act, signed into law by President Biden last August and in effect since March, is still to be written – though going by the recent final guidance, the broad strokes of the law will not budge. The biopharma industry is sweating the long-term implications and warning that it could mean less lifesaving drugs make it to patients going forward.

The law was top-of-mind at this summer’s ASCO and BIO meetings, tentpole events in the biopharma conference calendar. In one panel discussion at the BIO event, Biogen Head of Corporate Development Adam Keeney said, “I don’t think we should debate a cap on out-of-pocket spending, or that insulin should be appropriately priced for the elderly population that needs it, but it does fundamentally change the way we are approaching investment internally versus externally. We are being forced to think about small molecule versus large molecule and how to get the biggest impact earliest.”

Among the possible knock-on effects:

• Patients will benefit in the near term but could lose out on new drugs in the long term. The law establishes a cap on out-of-pocket drug costs for Medicare patients through the Medicare Part D prescription drug benefit and limits the monthly cost of insulin to $35 for people on the program. Furthermore, it disincentivizes sharp price increases by requiring manufacturers to rebate Medicare when prices rise faster than inflation. It also authorizes the Centers for Medicare and Medicaid Services to negotiate prices for a select list of the drugs most costly to the Medicare Part D prescription drug benefit, the first ten of which are to be announced in September. However, it is likely that new drugs will be priced higher initially because of the law’s inflation rebate mechanism, with developers disincentivized from taking 5-10% annual price increases that many innovative therapeutics have commanded in the past.

• The small molecule pipeline could shrink because the legislation, as currently written, authorizes price negotiations for small molecule drugs within Medicare nine years after initial approval, while biologics get 13 years price control free, post-approval. As biopharmas shift gears towards more large molecule R&D in response (e.g., Pfizer’s $43 billion acquisition of Seagen), a number of therapy areas could be impacted, most notably neurology and cardiology, where small-molecule therapeutics dominate the pharmacopeia. Drug makers could shift their portfolios away from categories and indications with a long ramp-up time to profitability, such as cardiovascular conditions, or those disproportionately impacting elderly Medicare recipients. This shift could prove expensive to health systems, as generally self-administered small molecule drugs give way to more biologics, which often require injections or infusions in a clinical setting, adding costs and raising the risk of nonadherence.

• Market entry strategies will shift. Narrow windows for negotiation-free exclusivity could disincentivize drug development across therapeutic areas, but treatments for oncology and orphan conditions could be particularly hard hit. In addition, companies in these categories have traditionally pursued a “land and expand” strategy of commercialization by first gaining approval for an orphan indication in the U.S., then seeking to broaden the label. The IRA makes this tactic less attractive by shielding orphan indications, but not potential follow-on indications, from price negotiations and starting the clock at that initial approval, potentially forcing developers to reprioritize.

“You want that initial approval to be the most lucrative possible indication, because the clock is ticking,” said Mickey Popli, Director of Consulting Services at Clarivate. “That puts patients with rare diseases at a disadvantage, because manufacturers may delay or abort launches for those indications.”

Furthermore, oncology drugs typically win initial approvals for late-line treatment and gradually expand into more lucrative (and often more effective) use to treat earlier-stage patients, dealing developers a double hit.

• R&D efficiency is more critical than ever. With profitability constrained, pharmas will seek to make up lost ground by getting leaner and meaner and making better go-no-go decisions early in the R&D process.

“I think we’ll see a lot more companies cutting bait when it comes to clinical trials,” said Bill Melville, Lead Healthcare Research and Data Analyst at Clarivate. “Failing fast and not plowing resources into later-stage development is going to be the goal.”

The vise on revenues also makes differentiation essential.

“The companies that are developing me-too products will not benefit,” said Mike Ward, Global Head of Thought Leadership at Clarivate. “The future equivalent of the 7^th triptan or the 8^th PD-1 will not command high prices. Therefore, you need to understand what’s going to be hot and, should you take a candidate into clinical trials, how to make them more effective.”

In the long run, pharmas and biotechs will have to sit down with governments and make the case for paying for innovation. In the meantime, pharmas will need to make tough decisions while nurturing the pipelines of tomorrow.

“You may see a promising product in Phase 1, Phase 2, but if the opportunity is not there and you don’t spend that money, the product will die,” said TD Cowen Senior Biotechnology Analyst Ritu Baral at the BIO panel.

“Pharma has to play a role in maintaining a healthy ecosystem,” agreed Biogen’s Keeney. “The challenge with the IRA is that we as an industry have lost the argument around value. We have to change that dynamic to protect the contribution we provide to society.”

To learn more about how Clarivate helps biopharma companies optimize their commercial launch strategies, please visit us here. You can find information on Clarivate market access intelligence offerings here.

The post Four key points on the Inflation Reduction Act appeared first on Clarivate.

The  findings put the life science industries on favorable terms with consumer-facing giants like Apple (which counted five brands among the top 100), Huawei (5) and Hugo Boss (4) – all the more remarkable as pharma and medtech brands are generally not sold direct-to-consumer.

Source: Clarivate Trademark Strength Index and CompuMark data covering 145 million individual trademark records

Notable of this year’s list:

• BioNTech appears twice, first for the German biotech’s corporate brand, which achieved global household name status as a result of its revolutionary mRNA COVID-19 vaccine, and again for its BioNTainer mRNA production platform. BioNTainer features modular production units, GMP-compliant setup and personnel training, with each unit designed to function as a regional node in a global manufacturing network for rapid response to infectious disease outbreaks.
• Incyte also notches two mentions, first for the U.S.-based company’s topical JAK inhibitor for nonsegmental vitiligo and atopic dermatitis in patients ages 12 and up, OPZELURA, and again for QPARIK®, a registration covering prospective treatments for oncological, autoimmune, hematological and treatment graft versus host disorders.
• Medtech is holding its own here, with multiple trademarks including Zimmer Biomet’s dental and spine business spinoff ZimVie and bioMerieux’s stackable benchtop automated immunoassay solution VIDAS® KUBE.
• Across all sectors, the advent of AI was one of this year’s notable trends, and the inclusion of Bayer’s Cal.AI (Calantic) radiology solutions suite reflects this.
• In geographic terms, this year’s life science brands leaned toward Europe, with Germany and Switzerland accounting for six, and France and the U.K. one apiece. U.S.-based companies accounted for three brands and South Korea one. Beyond the life sciences, this year’s report featured a very strong showing from companies based in Mainland China, accounting for 27 brands.

To identify the Top 100 New Brands for 2023, analysts used Clarivate global trademark data covering 145 million individual trademark records to analyze applications filed worldwide between 2021 and 2022 with a verbal element. Brands were scored based on market footprint and geographic/economic coverage for each.

Read the full report here, and to learn more about Clarivate brand IP intelligence and trademark analytics solutions, please contact us here. Learn more about the broader Clarivate connected data and solutions offerings for the life sciences here.

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A U.S. Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers. The vote shows a regulatory agency grappling with the question of how to evaluate truly novel therapeutics for rare diseases where longitudinal data are not available.

“In recent years, FDA has increasingly shown an openness to surrogate endpoints as the basis for approval of a therapy,” said Bethany Kiernan, Director of Healthcare Research Analytics for Infectious, Niche and Rare Diseases at Clarivate. “The fact that the committee said, albeit not overwhelmingly, that efficacy data from Sarepta’s surrogate endpoint was good enough to support accelerated approval is interesting and very positive, especially for a disease like muscular dystrophy where there remains such high unmet need.”

For payers, however, the vote in favor of Sarepta Therapeutics’ SRP-9001 added urgency to the task of shoring up value assessment and utilization management practices. Payers in the United States are increasingly incorporating health economics outcomes research into their decision-making, inking outcomes-based contracts with manufacturers and, for DMD therapeutics, weighing the value of single versus chronic treatment for the disease, as the recent Clarivate report Five key trends in gene therapy approvals and access found.

An earlier Sarepta DMD drug, the antisense oligonucleotide (ASO) treatment EXONDYS 51, was priced at $300,000 a year for the average patient when it won FDA approval in 2016. The rare and inexorably fatal muscle wasting disease affects approximately one in every 3,500-5,000 newborn males worldwide, with symptoms typically first appearing in infants and toddlers. Most patients must use a wheelchair by the time they are in their teens.

Weighing unmet need against cost

Sarepta’s modest pricing of EXONDYS 51 surprised Wall Street – analysts had anticipated a higher sticker price for the injectable. With 11 gene therapies already approved payers are bracing for impact as Cortellis Competitive Intelligence data identifies another 30 in late-stage pipelines.

Unlike EXONDYS 51 and Sarepta’s two other ASOs, which target specific mutations on the dystrophin gene and require repeated treatments, SRP-9001 can be administered to patients with a broader range of mutations and is delivered in a single dose. It is also currently being tested for ambulatory patients, typically pre-teens who have not yet lost a lot of muscle function. A March 2022 Access & Reimbursement study by Clarivate found that many Managed Care Organization executives remain uncertain about covering these emerging DMD treatments, making collection of real world evidence a critical factor in securing access for patients. Payers are also eyeing a variety of stringent utilization management measures to prevent unnecessary care and rein in costs.

“With gene therapies, like any specialized treatment, payers are going to be very stringent in making sure patients meet the criteria for treatment, given the cost they’re carrying,” said Kiernan. “However, because this is a genetic condition and there’s a definitive diagnosis, hopefully that means the process will be relatively straightforward for patients and physicians.”

Prior authorizations are a top concern for neurologists when it comes to prescribing these next generation DMD gene treatments, as highlighted in the Access & Reimbursement survey, followed by excessive out-of-pocket costs, restrictions to the most severe cases and reauthorization roadblocks. Given the progressive nature of the disease, time-to-treatment will be of the essence for this wave of DMD therapeutics, should they win marketing approval. (Pfizer and Solid Biosciences have candidates in late-stage development too).

“With muscular dystrophy, genetic testing and other established diagnostic tests means that kids are often identified early on,” said Kiernan. “The Muscular Dystrophy Association and parents are very vocal and from the access side, there will be a push to accelerate that process as much as possible.”

To learn more about the challenges faced by payers, regulators and biopharmas working to bring safe and effective gene therapeutics to patients, please read the Clarivate report, Five key trends in gene therapy approval and access.

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Having done the seemingly impossible and crashed out mRNA COVID-19 vaccines in under a year’s time, Pfizer/BioNTech and Moderna are now chasing a new disease target: cancer.  

BioNTech founders, Ozlem Tureci and Ugur Sahin, made headlines last month when they told the BBC that an mRNA cancer vaccine could hit the market before the decade is out.  

“We feel that a cure for cancer or to changing cancer patients’ lives is in our grasp,” Tureci said in the BBC interview.  

Meanwhile, Merck has extended a partnership with Pfizer/BioNTech rival Moderna, aimed at co-developing and commercializing an mRNA vaccine/Keytruda® combination for the treatment of aggressive melanoma. Moderna recently initiated a patent lawsuit against Pfizer and BioNTech, claiming the companies stole components of their mRNA technology (an allegation Pfizer and BioNTech forcefully deny).  

Beyond these household names there is an entire world of innovator companies – plucky startups and well-resourced large pharmas alike – looking to leverage this emerging technology to treat and even cure a wide variety of diseases.  

RNA therapeutics actually burst onto the scene prior to the COVID-19 pandemic, with the FDA approval of Ionis/Biogen’s SPINRAZA®, for the treatment of spinal muscular atrophy, in 2016. In addition to that drug, Alnylam® Pharmaceuticals has had four FDA approvals of RNA therapies for rare diseases. The success of these treatments against previously  ’undruggable’  disease targets has given hope to patients and clinicians – and generated intense interest among potential investors and pharmas seeking points of entry into the space through acquisitions and partnerships (in fact, the total value of deals involving these companies was just shy of $18 billion last year, per BioWorld data).    

With any emerging therapeutic platform or modality, it can be hard to see the forest for the trees, the many bootstrapping biotechs working on different approaches and applications, often at very early stages, as well as the larger ecosystem of investors, partners and research centers supporting their work. To better understand the field and identify some promising innovators, Clarivate analysts pored over data on clinical trials and market approvals, deal valuations, patent filings and scientific publications in the space to identify seven RNA Technology Companies to Watch, including:  

• Aro Biotherapeutics, a Philadelphia, U.S. firm developing a small interfering RNA (siRNA) platform for oncology and rare disease therapeutics, 

• Cargene Biopharma Inc., a company based in Singapore working on an siRNA-based platform and treatments for a range of diseases, starting with ophthalmic conditions and liver diseases like nonalcoholic steatohepatitis (NASH), 
• DTx Pharma Inc., a San Diego (U.S.)-based company whose platform has the potential to address multiple therapeutic areas including central nervous system, cardiovascular, immunology and oncology, 
• Haya Therapeutics SA, a Lausanne, Switzerland-based biotech whose drug discovery engine drives a pipeline of lead, long non-coding RNA-targeting (lncRNA) anti-fibrotic candidates for tissues including lung, kidney, liver and solid tumor microenvironments, 
• Laronde, a Cambridge, Massachusetts, U.S. company whose platform of closed-loop, programmable RNA constructs aims to produce stable, enduring and tunable protein expression of diverse therapeutic proteins for a range of diseases, 
• Replicate Bioscience, another San Diego-based firm developing self-replicating (srRNA) immunotherapies with a focus on drug resistance in oncology as well as treatments for autoimmune and inflammatory disorders, 

• and Strand Therapeutics, based in Cambridge, Massachusetts and working on single-dose mRNA therapeutics for cancer immunotherapy, among other applications.  

In addition, we learned some interesting things about the RNA therapeutics marketplace, including:  

• This field is expanding rapidly, with the number of RNA patent filings and research publications increasing sharply over the past decade. Global patent filings for RNA therapeutics rose by 52% from 2010 to 2020, according to Derwent patents data, while Web of Science data show RNA-related research publications rising 160% between 2012 and 2021. 
• RNA technology activity is concentrated in the United States and Mainland China, with Mainland China-based companies having surpassed their U.S. counterparts in number of RNA patents filed in 2020 and in research publication in 2021. 
• Pharmas are scrambling to partner with or acquire RNA technology companies, with the volume and value of deals having soared since 2019, per BioWorld data.  

For more insights into this exciting field of therapeutics and a deeper look at each of the seven companies we’re keeping an eye on, please download the report, RNA Technology Companies to Watch.   

About the author

Matthew Arnold serves as a research analyst and content strategist. He joined Clarivate after covering the life science industries as a journalist for more than a decade. He has followed the evolution of pharma multichannel engagement from the dawn of DTC advertising to the advent of remote care and digital medicine.

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One of the key conundrums that the COVID-19 pandemic raised for drug and device companies was that of how to educate physicians about their products in a time of social distancing, lockdowns and limitations on in-person engagement. The prevailing model of face-to-face rep-physician meetings had been coming under strain for years as physicians and other healthcare professionals faced a time crunch and increasing employer limitations on rep engagement designed to constrain prescribing.

Digital technologies offered a potential means of reaching pressed-for-time physicians, through remote formats such as live video meetings as well as “self-detailing” programs and emails from reps. However, these formats hadn’t yet shown much traction, which discouraged many pharmas from investing in them. Would the urgent need for healthcare professionals to stay up to date on emerging treatments while keeping themselves and their patients safe change that calculus?

In January, Pfizer answered that question in the affirmative, reportedly planning to eliminate several hundred U.S. sales positions on the expectation that healthcare professionals would want around half their interactions with pharmas to be remote in the future. “We are evolving into a more focused and innovative biopharma company and evolving the way we engage with healthcare professionals in an increasingly digital world,” the company told Reuters in a statement.

It remains uncertain where the balance of remote versus in-person rep engagement is likely to land as the COVID-19 pandemic progresses to an endemic phase, but Clarivate physician survey data from 2021 and 2022 indicate that remote engagement is in demand, under certain circumstances, and will remain part of the multichannel mix for sales forces going forward.

Rep engagement for product education remains robust

In Clarivate’s surveys of U.S. physician multichannel behavior last year, we saw in-person rep visits making a tentative comeback, with 47% of all physicians having interacted with reps in the flesh over the previous three months as of July, 2021 – still far below the 63% of U.S. physicians reporting in-person details in March of 2020. Relatedly, use of non-personal avenues of rep engagement had declined from early-pandemic heights, but remained far more robust than they were pre-pandemic.

While in-person visits remained the most impactful form of physician engagement overall, with 66% of U.S. physicians saying they’d influenced their clinical decision-making, live remote engagements weren’t far behind, with 53% rating live webcasts with reps influential and 50% saying the same of live video meetings. In fact, 43% agreed that “face-to-face interaction with pharma sales reps through video calls is more engaging than any other form of remote interactions.” Other forms of remote engagement were deemed less influential, but can comprise important tools in a multichannel approach — 34% of physicians agreed that they appreciated it when reps checked in periodically over email.

Sixty percent of U.S. physicians expected to continue with remote rep meetings in the next 12 months, indicating that even as in-person visits pick up, remote formats are becoming routine.

Within this evolving multichannel mix, physicians are accessing different information sources to answer specific needs. They continue to rely on sales reps to provide info on products and services – in our 2022 study, 73% of dermatologists reported accessing information on specific products through reps, as did 61% of gastroenterologists. While the information needs of physicians can vary widely by specialty, this preference for accessing product information through reps remains a common theme.

Physician content needs and preferred channels are situational

Our 2022 study data shows that U.S. physicians across specialties are accessing information immediately before, during and after patient consultations. Sales reps make an impact in varying stages across specialties.

For example, 49% of medical oncologists access product information after patient consultations, but 59% say they are more likely to review clinical trial information after first accessing quality product information, while 18% will go directly to a product sales rep. However, while 14% of medical oncologists also access product services (e.g., patient education and assistance programs), 34% rely on product sales reps to access these services. By contrast, 80% of hematology non-oncologists prefer to research information and services on third party websites when accessing product services.

Opportunity for reps to address condition- and specialty-specific content needs

“We continue to observe circumstance-driven behaviors by physicians across specialties,” said Clarivate Analyst Archana Pandya. “More importantly, physicians make targeted decisions around disease specific patient care interactions. In this year’s study, we’re finding that U.S physicians are running into challenges around the diagnosis and treatment phase of specific diseases, and so express a need for information that will help them in each phase of the disease progression.”

In fact, 44% of cardiologists cited discerning symptoms upon presentation as a major challenge in the diagnosis phase. Among endocrinologists, 46% flagged a lack of details around patient history as a pain point. More than half of cardiologists (52%) and endocrinologists (58%) agree that medical information would be helpful to address those unmet needs in the diagnostic phase. During the treatment phase, 41% of cardiologists say medical information is helpful, while 55% of endocrinologists prefer patient services information.

“Altogether, there are different unmet needs across specialties that can be addressed with specific information sources allowing sales reps to provide the necessary information,” said Archana.

Clarivate will be publishing an updated suite of patient and physician studies over the second half of the year, with much more granular data on information-seeking behaviors around content needs by physician specialty and disease/condition-specific patient care interactions.

To learn more about Clarivate physician studies, please email us here.

Methodology: All data cited are from Clarivate physician studies, including Taking the Pulse U.S. 2021 (March-May 2021) and Re-Taking the Pulse: COVID Toolkit U.S. 2021 (July-August 2021), along with the recently published specialty-specific data from Clarivate’s Physician Multichannel Study, Phase I, Taking the Pulse U.S. 2022 (April-June 22). For more information on sales rep dynamics, stay tuned for insights from Phase II of our 2022 HCP Study, Re-Taking the Pulse, which will be published in November 2022.

About the author
Matthew Arnold serves as a research analyst and content strategist. He joined Clarivate after covering the life science industries as a journalist for more than a decade. He has followed the evolution of pharma multichannel engagement from the dawn of DTC advertising to the advent of remote care and digital medicine.

The post Remote and in-person, sales reps continue to inform patient care, but physician needs vary appeared first on Clarivate.

A new report from Clarivate offers some steps life science companies can take to de-risk their clinical trials and improve their odds of market approval.

Among these are:

• Understanding the nuances of target markets
• Engaging regulators early and often
• Strategically selecting participants and making trials patient-centric
• Understanding diseases and treatments from a patient POV
• Building resiliency into clinical trial protocols
• Utilizing a variety of data sources to mine insights

Understanding the nuances of target markets

Choosing which markets to enter when and in what order requires understanding more than just local regulatory and reimbursement processes. It also requires thinking about how the product stands to benefit the local population, what sites and investigators are available to conduct trials, and what the path to approval looked like for in-market competitor products.

In one recent study^[2], nearly half of recent market launches observed missed their first-year forecasts due to market issues such as HEOR data that was too weak to substantiate pricing or higher than expected discounts and rebates. A solid understanding of local market practices, regulator and payer concerns can help companies build needed evidence generation into trials.

Engaging regulators early and often

The work of building a robust regulatory strategy is best begun as soon as candidates are identified. Companies can help to expedite the process by initiating discussions with agencies in target markets as early as possible in order to understand pathways to expedited approval, local agency collaboration with regulatory authorities in other markets, feasibility of real world evidence to support analysis and expectations around study populations.

Increasingly, regulators are insisting that products be studied in local patient populations before they will consider them for approval. One recent example of this is the FDA’s rejection of an Innovant/Eli Lilly and Company oncology candidate based on clinical trials conducted solely in Mainland China.

Strategically selecting participants and making trials patient-centric

Effective recruitment and retention of patients requires an understanding of which patients are most likely to benefit from an investigational product, where the pain points for participation are and how to reduce the burden on patients, and which sites and investigators are best suited to the trial. Choosing the right participant segments can realize greater efficiency and better study outcomes, while a more frictionless patient experience can boost retention rates.

“Choosing the right participant segments can realize greater efficiency and better study outcomes, while a more frictionless patient experience can boost retention rates.”

Johnson & Johnson has patients in 32 countries vet its clinical trial protocols to make it easier for patients to participate. A pioneer of patient-centered clinical trial design, the company was pushing into at-home direct-to-patient clinical trials even before the pandemic, and has invested in diversifying its pool of trial participants and making pediatric clinical trials easier for patients and caregivers.

Understanding diseases and treatments from a patient POV

Gathering deep patient insights at the outset of the development phase can help companies avoid pitfalls down the road. Knowing, for example, the burden of diagnostics and tests on patients, patient preferences on mode and frequency of administration, and perceptions of risk/benefit tradeoffs can inform product and protocol design, and ultimately even market access conversations.

“Gathering deep patient insights at the outset of the development phase can help companies avoid pitfalls down the road”

Most importantly, these insights can help ensure a product that meets patient needs, ultimately improving uptake, outcomes and quality of life while bolstering a company’s argument for access and reimbursement.

Building resiliency into clinical trial protocols

Protocol amendments can add greatly to the time and cost of a clinical trial. To avoid them, companies can work to anticipate possible impediments such as trial disruptions or changing regulatory demands and build in compensation measures, such as master protocols, less stringent inclusion criteria and adaptability of visit types and site responses.

The COVID-19 pandemic has put the need for flexibility into stark relief. Clarivate data show that since March, 2020, more than 1,450 trials have reported a delay due to COVID, with the biggest impacts felt in trials concerning treatments for rare and neurological diseases.

Utilizing a variety of data sources to mine insights

Triangulating traditional and emerging data sources, including real world data, social data and digital health intelligence as well as site and investigator benchmarking and epidemiological data, can help companies spot potential roadblocks and design flaws as well as opportunities.

Having the right people asking the right questions and equipped with the right tools early in the process of trial design can help to set companies up for success.

For more detailed insights into this topic, read the full report here.

References

^[1] Project ALPHA, 2022. Estimates of Clinical Trial Probabilities of Success. [Online]

Available at: https://projectalpha.mit.edu/pos/

[Accessed 20 5 2022]

^[2] Ford J, Fezza T, Elsner N, et al. Key factors to improve drug launches (March 20, 2020). Deloitte Insights. [online]

Available at: https://www2.deloitte.com/us/en/insights/industry/life-sciences/successful-drug-launch-strategy.html

[Accessed 20 5 2022]

The post How a “fail fast” approach can set clinical trials up for success appeared first on Clarivate.

• Much of care delivery has gone virtual. Three in five physicians in the United States (60%) report having conducted virtual consultations, as do 35% of patients. Physicians indicate that nearly 1 in 4 patient consults (23%) are now performed virtually.

• Patients and physicians alike are seeking more info online. Physicians are relying more on online medical journals, conferences, CME and interactions with peers to inform their practice. The share using physician-only social networks on a monthly basis has increased to 82%, from 58% in 2019, and 37% read pharma email newsletters weekly, versus 30% pre-pandemic (some specialists are more digitally-mature than others – particularly hematology-oncologists, endocrinologists and gastroenterologists).Meanwhile, 37% of patients say they spend a lot more time researching health information because of the pandemic. Patients are most active searching for online health information when preparing for a doctor visit, when 19% do so; after a doctor’s appointment (20%); and after receiving a prescription but before getting it filled (19%).More patients are using both pharma and third-party online info sources. For example, 26% of patients reported visiting pharma condition sites monthly in 2021 – up from 19% a year previous, at the outset of the pandemic. Thirty-nine percent of patients reported visiting general health websites such as WebMD on a monthly basis in 2021 – up from 32% a year before.
  Implications for pharma:
  The shift toward online information-seeking underscores the importance of investing in sponsored content on trusted third-party websites for both patients and healthcare professionals (HCPs), as well as replenishing owned digital assets with highly-relevant and up-to-date content, whether patient- or HCP-facing. Fully 56% of patients surveyed for the Cybercitizen Health® U.S. 2021 study had researched prescription drug topics online in the past year

• Physician working hours are just getting back to normal after a big spike, likely driven in part by time spent seeing patients remotely. On average, physicians surveyed in the summer of 2021 reported a 13-hour workday, down from an average 16-hour workday in spring, when they were spending 7.9 hours seeing patients. Where telehealth users were spending more time seeing patients in the spring, by summer average time seeing patients was down to 6.7 hours overall, with telehealth users spending slightly less time on patient visits than non-users.
  Implications for pharma:
  This may indicate that healthcare professionals and practices have summited a telehealth adoption learning curve, and the easing of the time crunch could impact rep access.

• Patients aren’t always getting the support they need – while 56% of patients have received patient support resources from their doctor, some highly valued resources see only modest utilization, including referrals to credible online health resources, patient support programs, condition management tools and health insurance assistance. Thirty-six percent of physicians say they struggle to provide their patients adequate education and support resources when conducting virtual patient consultations.Patients are also struggling with medication adherence – 20% had not filled a prescription in the past 12 months (up from 16% in 2020), and 31% reported being non-compliant with their treatment after getting a prescription filled, up from 26% in 2020.
  Implications for pharma:
  Pharmas can help to make this transition easier for both patients and physicians by providing patient education and support resources (including adherence tools) in digital formats easily-sharable during or following virtual consults.Companies can utilize the sales channel to disseminate these resources — nearly half of physicians say they prefer to receive patient support (48%) and financial resources (47%) through reps rather than doing their own research.

• The shift to remote consults, conferences and meetings will likely be an enduring one, though it may soften somewhat as COVID-19 rates come under control. While 53% of patients expect to make more in-person doctor visits as the COVID-19 crisis abates, 40% say they plan to use virtual consults for most follow-ups. Physicians expect to attend slightly more conferences virtually than in-person post-pandemic, and anticipate seeing reps virtually much more frequently than they did pre-COVID-19.
  Among U.S. physicians; Source: Clarivate, Cybercitizen Health(R) U.S. 2021

   

  Implications for pharma:
  While in-person rep interactions are now coming back, it’s not at the expense of remote rep touchpoints, for which monthly reach has doubled in the past year. Pharmas can utilize live video calls and webcasts to render a personalized and impactful interaction.
  Virtual conferences are an important source of clinical information in this emerging hybrid online-offline world. Companies can enhance the virtual conference experience with in-demand features like resource centers, access to experts, and KOL sessions.

Methodology: All data cited are from Clarivate patient and physician studies, including Cybercitizen Health U.S. 2021, fielded in April and May, 2021, Taking the Pulse U.S. 2021 (March-May 2021), and Re-Taking the Pulse: COVID Toolkit U.S. 2021 (July-August 2021).  

To learn more about Clarivate studies of patient, physician and payer multichannel behavior, or to talk to a multichannel expert, visit our Multichannel Insights page: https://clarivate.com/products/biopharma/customer-engagement/multichannel-insights/

The post Five ways COVID-19 has changed healthcare provision and what it means for pharmas appeared first on Clarivate.

The COVID-19 pandemic has strained healthcare systems across the globe and affected every patient on Earth – some, of course, more than others.

For some patients, pandemic-related disruptions have perhaps meant an elective surgery deferred or a follow-up doctor visit done through an app rather than in person. For those in historically excluded communities whose access to healthcare was already constrained, the pandemic and its cascade of healthcare disruptions, delays and barriers has been far more severe.

In the United States, the pandemic has disproportionately impacted the health of minority communities, including Black, Indigenous, Latinx and Pacific Islander Americans. According to data from the Centers for Disease Control and Prevention¹, non-Hispanic Black Americans are as likely as non-Hispanic white Americans to be diagnosed with COVID-19, but are 2.6 times more likely to be hospitalized as a result and nearly 2 times more likely to die from it.

The reasons for this disparity are many and complex. Black Americans are more likely to face barriers to care, including poor transportation options, a lack of local specialist physicians and inflexible work situations that make taking time off to seek care prohibitively difficult. They are also much less likely than white Americans to have access to private health insurance (in 2019, 43.5% of non-Hispanic Black Americans were privately insured, compared to 74.7% of non-Hispanic white Americans²).

Tentative steps forward for telehealth in the U.S.

Telehealth technologies, including virtual visits and remote monitoring, offer a potential (if partial) means of addressing these disparities by reducing barriers to care. Telehealth use has increased exponentially in the U.S. since the beginning of the pandemic, fueled by policy moves lifting regulatory barriers and incenting utilization. A Clarivate survey of physicians found that at the pandemic’s outset, in the spring of 2020, 21% of U.S. physicians reported having used virtual consults to treat patients in the previous three months – up from single digits in 2019³. By summer 2020, after the initial wave of infections, that figure had climbed to 80%, softening only slightly to 65% by spring 2021.

This trend has broadened receptivity to telehealth among physicians and patients alike, and shifted expectations around the healthcare experience. In a recent Clarivate survey, U.S. patients were asked how they saw their use of virtual doctor visits changing once pandemic mitigation measures have lifted.  Respondents anticipated more in person visits, but saw virtual visits making up more than a quarter of consultations with doctors (26%, down from 35% in the spring of 2021) post-pandemic⁴.

However, many of the government, insurer and employer policies driving telehealth adoption are temporary measures that could sunset with the end of the federal Public Health Emergency, or earlier. Moreover, many patients face barriers to accessing telehealth services – for example, more than a third of Black households (36.4%) lack a computer or broadband access⁵. Pandemic disruptions may be making these problems worse – in a recent survey of hospital and healthcare industry leaders by Healthcare Business Insights, 92% agreed that COVID-19 had exacerbated digital inequalities for patients⁶.

The transportation challenge of our time

“The pandemic really highlighted the inequities that we have, both in the broader society and in healthcare delivery,” said Dr. Denise White Perkins of Detroit’s Henry Ford Health System. “When we converted the majority of our visits to virtual care at the start of the pandemic, it became immediately obvious that there were certain segments of the population we were serving that did not have equal access, whether that was knowing how to use the technology or the more upstream issues of having broadband access in their neighborhoods.”

Forty years ago, said Dr. Perkins, hospitals in Detroit gave patients cab vouchers and bus passes to ensure they could make appointments.

“Telehealth has become the new transportation challenge,” she said. “If we’re going to be delivering care across this platform, then we need to be thinking about what systems and resources and processes we need to put in place to get patients to that visit, and we need to have a diverse group of stakeholders at the table helping us to figure that out.”

Those stakeholders include healthcare payers, providers, drug and device companies, academic medical centers and governments, as well as patient advocates, community organizations and institutions. All have a vital role to play in realizing the promise of these technologies to address deeply-engrained racial and other inequities in our healthcare systems.

We have just completed a report on this topic, drawing on Clarivate and other data as well as interviews with experts from payers, providers and advocacy organizations addressing healthcare inequities facing Black Americans. You can download it here. To learn more about these issues and how companies can help make a difference, visit CEO Action for Racial Equity.

The post Realizing telehealth’s promise for addressing disparities in healthcare appeared first on Clarivate.

Every vaccine and drug goes to market under a distinct brand name, and the COVID-19 vaccines and treatments are no different.

“The pharmaceutical naming process is extremely complex,” says Danielle Waterman, noting that a pharma company may consider a dozen or more names in search of one that’s distinctive as well as compelling. It can be a tricky business, and an important one not just for commercial reasons, but also for patient safety.

Danielle’s group helps to vet potential names for clients across a range of industries, but pharmaceuticals require some special considerations. Ultimately, their goal is to make sure they are uncovering any similar names that might lead to prescription errors, because otherwise, somebody could get the wrong medicine.

“It is getting a little better as you have fewer handwritten prescriptions, but in our searches we have to consider how it’s going to look if you write them out by hand – for example, an ‘L’ and a ‘T’ can look an awful lot alike, as can a ‘B’ and a ‘D.’ Most analysts I work with have been doing it for 20 years, so they really know what to look for.”

Similar-sounding brand names, too, can lead to confusion – the antidepressant Brintellix and the clotting medication Brilinta, for example, or the anticoagulant Heparin and the plasma expander Hespan. Although used for very different indications, their similar names can lead to human error, resulting in potentially dangerous prescribing or dispensing mistakes.

Coming together for a shared cause

When COVID-19 began to break out in early 2020, Waterman’s team saw a big shift in the kinds of asks coming their way, as focus shifted to cleaning and antibacterial products, charitable fundraising efforts and remote technologies.

“It seemed like every industry and every client was coming together and saying, ‘Okay, what can we do to address COVID?’”

Waterman and her colleagues were already working remotely, and as a New Englander accustomed to long winters, she felt well-acclimatized for the lockdowns, but saw the toll it took on her coworkers with kids, particularly little ones. Her own son graduated high school in their back yard, donning cap and gown and setting up folding chairs for a virtual ceremony conducted over Zoom.

It was a hopeful indication when, in the summer of 2020, still just months into the pandemic, her team started getting searches for possible COVID-19 vaccines and treatments.

“We started to get the names in and that was really exciting – like, oh, they’re really making progress,” said Waterman. Given that her team typically fields search requests for prescription drugs and vaccines a year-and-a-half to two years before they reach patients, the speed with which these medicines moved through the Emergency Use Authorization process was surprising.

The team of experienced trademark analysts quickly jumped in to support, helping customers to bring distinctive brands to market.

“I’ve been in trademarks for 27 years, and I’ve never seen things come to market so quickly,” said Waterman. “It’s really a medical miracle.”

United by a common cause, a global team of Clarivate experts partnered with pharmaceutical companies to fight COVID-19. The reward for their ingenuity: Life-saving vaccines brought to market in record time. Get the full story.

Interested in working at Clarivate? Visit: careers.clarivate.com.

Learn about #LifeatClarivate with diverse voices from colleagues around the world.

The post What’s in a name? Trademarking COVID-19 solutions appeared first on Clarivate.

Xavi Moreno took a roundabout path to working on products designed to address the COVID-19 pandemic. Throughout childhood, the Barcelonian software engineer had wanted to be an eye doctor, so that he might one day treat people like his uncle, who had lost his vision. In high school, although he did well in biology, he came to realize that his true passion was in mathematics.

Around this time, he was taking the train home from school one day when he noticed a young man typing unintelligible gobbledygook into his laptop.

“It was this gibberish language,” said Moreno, “and I thought, that’s not an article or anything.”

Although usually something of an introvert, his curiosity was piqued. Moreno sidled up to him and asked what he was doing. “He was super kind,” said Moreno. “He was at university doing aeronautics, and he explained to me that he was programming in Visual Basic. He gave me some tips, showed me a video render. And so that night I got home and opened up my computer and started fiddling with it, typing some code, creating some dummy games, and I realized that I wanted to do software engineering.”

Fast forward to the early summer of 2020, when he joined the Clarivate consulting services team as a Python developer just as a second wave of COVID-19 cases was hitting in much of Europe and the United States. Although based in Barcelona, his start date meant that his time at Clarivate has been spent primarily as a remote colleague. “I’ve actually been to the Barcelona office, but just once,” he laughs.

Technology solutions to help customers grow and scale their work to develop the COVID-19 vaccine

Moreno’s fluency with Python was put straight to work finetuning a backend tool that a client was using to power automated testing across an array of portfolios, including products being tested against COVID-19.

Working in scrum methodology-style agile sprints, Moreno and his colleagues, most of whom were based in the United States, spent six months divided into two-week programming marathons, each punctuated by iterative sprint ceremonies where they reported their progress and received client feedback. It dawned on him gradually that the urgency of the work the team was doing was tied to the pandemic response.

As part of the Clarivate consulting services team, Xavi was able to work on client projects directly related to COVID-19 treatments. His work helped clients automate processes and accelerate the pace of drug development.

“And then one day, I woke up and read on Twitter that the company was releasing this [COVID-19] solution, and I realized that I’d had a hand in that. That was [a good feeling].”

“It’s the type of job that’s always different,” said Moreno. “In software engineering or data science, the tools might be the same, but the domain is always changing. Right now, I’m learning a lot about drug discoveries and clinical trials.”

With his knowledge and an expert technology skillset, Xavi and the Clarivate consulting services team were able to help accelerate drug development as life science companies raced against the clock to bring vaccines and treatments to the global population.

United by a common cause, a global team of Clarivate experts partnered with pharmaceutical companies to fight COVID-19. The reward for their ingenuity: Life-saving vaccines brought to market in record time. Get the full story.

Interested in working at Clarivate? Visit: careers.clarivate.com.

Learn about #LifeatClarivate with diverse voices from colleagues around the world.

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