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The Secret’s Out: The Impact of Net Price Transparency
Pricing system pressures are increasing for the top four markets in Europe. Price transparency, changes to public health plans and curative therapies are set to disrupt traditional drug pricing. To navigate this ever-shifting landscape, companies must carefully consider product adoption and launch sequencing, and understand the potential impact that net price transparency might have. In […]
A New Pharmaceutical Strategy for Europe
In late November, the European Commission announced the adoption of a new healthcare plan – the Pharmaceutical Strategy for Europe. This plan aims to strengthen the European Health Union while ensuring affordable patient access across the entire European Union and supporting sustainable innovation for pharmaceutical industries. What’s Changing, and Why? Until now, patient access and […]
Do Germany’s New Hemophilia Regulations Have Wider-Reaching Implications?
In July 2019, the Drug Safety and Supply Law (GSAV) was passed by Germany’s Higher Chamber of Parliament, bringing about substantial changes to Germany’s health policy. Besides introducing new strategies for biosimilar uptake and cell and gene therapy monitoring, GSAV provides for more stringent control of the distribution of hemophilia products. Download the FULL Pricentric […]
Unlock Europe To Create Value
The European Union (EU) is the second largest pharma market in the world and represents a major opportunity for U.S. biotechnology companies. Due to the perceived complexity of launching in Europe, many biotech companies licence their products to partner companies. Often as a result, the full value of the product is not realised by the […]
Italy Tackles HTA, Pricing and Reimbursement Reforms
In July, new legislation set to overhaul the way pharmaceuticals are priced in Italy was finally implemented, following an announcement that dates all the way back to August 2019. The provision, which was signed by then Ministers Giulia Grillo (Health) and Giovanni Tria (Economy), has rolled out new criteria and methods by which the Italian […]
eBook – 2020 Stories That Shaped Commercialization
While many industries hit the pause button on their operations this year, the pharmaceutical industry never stopped, propelling new innovations to better serve patients, providers and stakeholders. At EVERSANA, we worked closely with manufacturers to tackle uncertain, complex market dynamics and solve pricing, access, reimbursement, adherence, and distribution challenges, and more. As we look forward […]
Compliance – The Competitive Differentiator to Commercialization: An Integrated Model Setting the New Global Standard
Posted by Vikram Anand, Nina Patel Lahanis, Larry Davis, PharmD, Carolyn Quon, PharmD, Lisa Rinker, Thomas Barton on October 1, 202010/1/20
The Compliance experts at EVERSANA prove how integrated life science compliance has earned its seat at the table by demonstrating the value of increasing data-driven and technology-infused competitiveness in the successful commercialization of a new-age biopharma product.
NEXT GENERATION COMMERCIALIZATION: A CONVERSATION WITH THE INNOVATORS
Sell, out-license or launch internally: these are the three traditional options to commercialize a pharmaceutical product. Selling and out-licensing are common but cause innovators to lose ownership in an investment that takes years to develop. Launching internally requires an average investment of $125MM+ before the product even hits the shelves. Until now, there was no […]
How to Get Your Digital Therapeutic Approved & Reimbursed in Europe and the U.S.
Patients, providers, and payers expect healthcare to be more accessible, intuitive, and adaptable to their needs. Barriers that have held back innovation in Digital Medicine and Telemedicine have been blasted apart with the recent relaxing of CMS and HHS requirements, continuing advances within the FDA’s Digital Health program, and additional reimbursement opportunities emerging globally. Get […]
Looking To Launch Or Commercialise In The US?
Launching a product is a serious undertaking, requiring a seamless approach to building a commercialisation strategy that includes all the variables needed to maximise the investment across the product’s lifecycle. Nowhere is this more true than the world’s largest market, the United States (US). We know that a successful product launch is critical to maximising […]
The Chronic Microcap Trap: How Launch Is The Escape for True Growth
Pre-commercial pharma companies face a common choice: commercialize products independently or collaborate with another pharmaceutical company as a commercialization partner. As the C-suite leaders in these organizations wrestle with the pros and cons of this choice, one factor they must consider is the impact their decision will have on their current and future market valuation. […]
The Importance of Digital Strategy in Pharma in the APAC Region
The Asia Pacific region continues to show great progress in digital health as pharmaceutical companies look at digital technologies as a tool to drive access and to start developing their digital strategies. To understand the strides and recent evolution of digital in pharma, our APAC team conducted a survey with top pharmaceutical companies in the […]
Improving Patient Outcomes Through Digital Health
Digital applications can work cohesively with therapeutics in the treatment of a broad range of diseases, from behavioral health to chronic conditions. In an interview with Debraj Dasgupta, Head of Strategy & Go-to-Market Planning at Nippon Boehringer Ingelheim Co., Ltd., Ed Cox, Executive Vice President, Strategic Alliances & Global Head of Digital Medicine at EVERSANA, […]
The Digitalization of Healthcare in Asia Pacific
The digitalization of healthcare in Asia Pacific is being utilized to enhance the patient-centered approach and expanding access to health. In a candid conversation with Abhishek Shah, CEO at Wellthy Therapeutics, Ed Cox, Executive Vice President, Strategic Alliances & Global Head of Digital Medicine at EVERSANA, uncovered the current healthcare landscape and how digital strategy […]
The Regulatory Landscape in Digital Health
Despite the advances in digital health and digital therapeutics in recent years, there remains an ambiguity in the digital space and uncertainty surrounding regulation and reimbursement of digital technologies applied to pharma, biopharma and medical device companies. In an insightful conversation that was part of EVERSANA’s Digital Symposium, Ed Cox, Executive Vice President, Strategic Alliances […]
Access to Technology and the Rise of Digital Health in Asia Pacific
The access to technology, development of telehealth and evolution of digital therapeutics are thriving in Asia Pacific; and pharmaceutical companies are levering the momentum to reach to a broader segment of the patient population. Ed Cox, Executive Vice President, Strategic Alliances & Global Head of Digital Medicine at EVERSANA, interviewed Anish Shindore, Head of Digital […]
Digital Innovation in Asia Pacific
Digital medicine and digital therapeutics are transforming the healthcare industry by changing the care delivery format, and they have the potential to improve patient adherence and outcomes. In our recent Digital Symposium, Ed Cox, Executive Vice President, Strategic Alliances & Global Head of Digital Medicine at EVERSANA, interviewed David Keene, CEO at IntroSpect Digital Therapeutics […]
Outlook: Digital & Pharma in Asia Pacific
Asia Pacific is one of the fastest-growing regions for digital innovation in the pharmaceutical and biotechnology industries. Its promising outlook is mainly driven by necessity, commercial flexibility and a broad talent pool. In a candid conversation broadcasted during the EVERSANA’s Digital Symposium, Ed Cox, Executive Vice President, Strategic Alliances & Global Head of Digital Medicine, […]
Leading and Decision-Making in Uncertain Times
By definition, leaders must have followers, who are defined as people who must be shown the way. While this is within most leaders’ grasps when the road ahead is straight and wide and the destination is visible, more is demanded of them when the road splits, narrows and dusk falls. The current crisis presents special […]
What is Your Data Integration and Analytics Platform Strategy?
If I Could Only Ask Two Questions, the First One Would Be: What is Your Data Integration and Analytics Platform Strategy? It’s really simple, data analytics drives decisions. In the healthcare industry, we use data to better understand the complexity of disease, improve forecasting and communications with patients, design more effective clinical trials, predict trends, […]
What kind of clinical data is required for FDA clearance of a Digital Medicine?
What kind of clinical data is required for FDA clearance of a Digital Medicine? It depends. Digital therapeutics and digital medicines that are subject to FDA regulation are considered medical devices. The amount of clinical data required by FDA generally depends on risk. Many moderate risk (class II) medical devices seeking 510(k) clearance are required […]
What specifically triggers FDA regulation of a digital medicine?
I often meet with Digital Health or Pharmaceutical clients to discuss their commercialization journey, and they ask me the same question. What specifically triggers FDA regulation of a digital medicine? Some of these products require FDA clearance and some do not. Regulatory oversight of digital medicines depends primarily on intended use, which is generally captured […]
Validate and Inform your Account Access Strategies and Tactics
With $250 million in product revenue, our client is the U.S. subsidiary of a European niche biopharmaceutical company looking to build its presence in the U.S. marketplace in anticipation of future product launches. See how the Health Strategies Insights by EVERSANA Team helped the client put an account strategy in place for each key payer […]
Oncology Treatment Access in 2020 and Beyond
2020 promises to be eye-opening as the coming election will surely provide clarity to the path that we will be taking for oncology treatment access. From international reference pricing, acceleration of biosimilars and generics, and allowance of reimportation – pressure continues to mount to reduce pharmaceutical prices, especially those used to treat cancer. Much of […]
Patient Recruitment & Retention: A Perspective From “The Other Side” [Webinar]
[Webinar: 23 Minutes] With over 20 years experience on the clinical research arena, Mike Ryan shares the importance of patient engagement from the clinical trial all the way across the drug development continuum. He highlights that although some patients might not qualify for the clinical trial, they should continue to be relevant as future clients/patients […]
Realizing Value from Digital in the Healthcare Environment [Webinar]
[WEBINAR – 20 MINUTES] The advancements of Digital Therapies are promising but commercial success is not always guaranteed. This presentation explores the pitfalls and challenges of selling products into the uniquely complicated and regulated healthcare market. It will lay the groundwork for digital companies to have successful commercial strategies and be able to: Answer questions […]
The New Roaring 20s: How Outsourced Commercialization is the Revolution We Need
The “Great Gatsby Era” was an exciting time of new prosperity, infinite creativity and dramatic social change. Long-standing social norms and traditions gave way to the “mass culture” and consumerism that modernized American society. “What will they think of next?” was a popular expression that defined the era. On the 100-year anniversary of this revolutionary […]
Increase Your Speed to Market
Commercial Strategies for a Successful Product Launch. With the launch of new blockbuster drugs becoming less frequent, there is increased scrutiny on the importance and success of clinical trials, mandatory to determining the safety and efficacy of a developing product. The road to commercialization is daunting – the process of bringing a product to market […]
Improving the Impact of an Oncology Patient Access Program
Our client, a specialty pharmaceutical company focused on the research and development of new therapies in two high-cost complex drug categories, sought to benchmark its patient assistance program against those of its competitors in order to improve relationships within target oncologists’ offices. The Challenge The client needed to assess the image of its patient assistance […]
Strategies to Ensure Market Success of a Rare Disease Product Launch
Small patient populations, complex administration, high costs of therapies, and government policy interventions are just a few obstacles in rare disease. EVERSANA’s Managing Director, Bill O’Bryon, and Senior Director, Diann Johnson, outline key insights to consider in your launch strategy: Market dynamics impacting rare disease therapies The entire rare community: patients, caregivers, providers & advocates […]
After FDA Approval, Can Gene Therapies Achieve Marketing Success?
Without a doubt, gene therapy is transforming healthcare by revolutionizing patient care from conventional treatment models to curative therapy models. There are more than 7,000 distinct types of rare and genetic diseases and 400+ million individuals suffering from a rare disease. With a market that is fragmented, there is a need for an innovative, end-to-end […]
Global Biosimilar Competitor Assessment – Who Wins in Biosimilar Access and Why?
The introduction of biosimilar products has created interesting changes in payer behavior across the global markets. For both innovator and biosimilar companies, it has been an effort to understand the demands of payers and succeed in what looked like a ‘winner-takes-all’ opportunity. As the first round of biosimilar introductions has passed, there are some interesting […]
How do we pay for a cure?
Setting drug prices is a high-stakes endeavor, and that is especially true for the latest round of gene and curative products coming to market in Europe. Drugmakers need to consider several factors that can help them set their product prices appropriately, including the risk of recurrence/relapse, differences in efficacy among cures, and comparators, including full […]
Innovative Therapies Call for an Integrated Drug Safety and Compliance Model
In this article, Herbert Lee, PharmD, Senior Vice President, Medical Communications and Pharmacovigilance, makes the case for an integrated approach to ensuring the safe and effective use of medications by patients. From emerging therapies to innovative technologies, the healthcare industry is changing – demanding that we do business differently. Working in one of the most […]
Navigating Channel Distribution in a New (and more complex) Biopharma World
Every twist and turn in the bench-to-bedside commercialization journey introduces increasing regulatory complexity, product-specific special handling requirements, and evolving industry guidelines. With more than 300 client case studies to draw from, we’ve found three opportunities (or pitfalls) that manufacturers must address in their channel distribution strategy: How quickly can you get your product into your […]
Are We Transforming In The Right Way?
Why Product Launches Can’t Be Distracted By Empty Promises. We can all agree that innovations in therapeutic development have advanced beyond traditional product launch strategies and service models. In every step of the product lifecycle, we see pockets of transformation. The problem is exactly that – “pockets” of transformation. Your product launch strategy has to […]
The Impact of Technology on Advancing Diabetes Care
Statistics from the World Health Organization report that over the past 25+ years, the number of people around the world diagnosed with diabetes has almost quadrupled to 422 million. According to the Centers for Disease Control, diabetes is the seventh leading cause of death in the United States with an annual financial impact of $327 […]
Gene Therapy for Rare Disorders
With only three approved products in the marketplace, how do we build a regenerative medicine ecosystem that delivers more value to patient’s faster?
‘Tis the season for pharma in China, as the government expedites uptake of new urgently needed drugs
PRICENTRIC BRIEF: Universal health insurance coverage for 1.3 billion people means China must increase uptake of “clinically urgently needed new drugs” already approved in the US, EU, and Japan Mostly oncology products are being imported, along with HIV/AIDS medicines Pharma is agreeing to steep discounts to be reimbursed on China’s national drug lists THE DETAILS […]
“Who wants the biggest slice of the biosimilar pie?”: The Humira biosimilar wave in Europe
PRICENTRIC BRIEF: Biosimilar competition in Europe has brought about discounts to AbbVie’s blockbuster immunosuppressant drug Humira upwards of 80% during tendering Overall, biosimilar uptake has increased in Europe because biologic “copycats” are cheaper, but full faith in these products is still required from physicians and patients In the US, Coherus struck preemptively with a 33% […]
Biosimilar Pricing in Europe
This report titled Biosimilar Pricing in Europe is published by Pricentric, by EVERSANA. It examines the pricing and pricing trends of biosimilar drugs in the US and EU5. It particularly looks at the pricing of Infliximab and its effect in the markets.
The Brink of the Biosimilar Revolution
Although biosimilars have not had the immediate uptake in the United States that they have had in Europe, health plans expect these products will become a staple of therapy for some diseases by 2020—if the price is right. Since the first biosimilar was approved in the United States in 2015, brand marketers have been bracing […]