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Management Consulting, Healthcare Consulting, Brand Consulting, and Pricing Strategy
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Publications
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Denials, Delays and Deep Discounts: Poor Insurance Coverage for Pharmaceuticals at Launch
Informa PharmaIntelligence
For brand teams, launch year has become a nightmare of denials, delays and deep discounts.
For the one in 10 drugs tested in clinical trials that wins FDA approval, payer coverage is becoming an exception to the rule. Therapeutic drug purchases in the US are mediated largely by large national insurance companies that purchase drugs on behalf of patients and negotiate net price with drug makers as well as rationalize care. The co-mingled roles of large insurance companies in negotiating…For brand teams, launch year has become a nightmare of denials, delays and deep discounts.
For the one in 10 drugs tested in clinical trials that wins FDA approval, payer coverage is becoming an exception to the rule. Therapeutic drug purchases in the US are mediated largely by large national insurance companies that purchase drugs on behalf of patients and negotiate net price with drug makers as well as rationalize care. The co-mingled roles of large insurance companies in negotiating price on one hand and choosing which agents rationally patients should be allowed to use on the other hand set up an unfortunate scenario at launch. Uncover the strategies and trends:
*The new therapeutics from 2018 compared with most current approved drug lists of large national payers
*The types of new products making it to the published formularies
*Access scenarios for commercial versus MedicareOther authorsSee publication
Honors & Awards
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Tepper Recent Masters Alumni Award
Tepper School of Business
The Recent Alumni Award is intended to recognize either outstanding professional accomplishment and/or service to the Tepper School community by those who have graduated within the last 10 years.
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40 LGBTQ Leaders Under 40 Class of 2020
Business Equality (BEQ) Magazine
https://businessequalitymagazine.com/40-leaders-under-40-class-of-2020/
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Norris Turner, PharmD, PhD
I am excited to be partnered with the ADVI Health team! Together, I feel we are exceptionally positioned to enhance biopharma industry strategies, responding effectively to the rapidly evolving market dynamics of value-based care and healthcare quality. #biopharma #pharmaceuticalindustry #marketaccess #commercialstrategy #launchexcellence #healthequity #evidencegeneration #healthpolicy #valuebasedcare #qualitymeasurement #healthcarequality
9024 Comments -
Silas Martin
A recent article published in Health Affairs highlights the complications associated with using prior federal financial support as a tool in reducing drug prices and the negative impacts this will have on the overall R&D ecosystem. Federal funding can have both direct and indirect effects that are difficult to measure and associate with the research and development of a single novel therapy. Determining the value of a therapy should focus on the benefit the therapy brings to patients and society. See article here: https://lnkd.in/dr2nCqeB #Value #Innovation
421 Comment -
Mark Birse
❔ How do we position regional and community sites for success and mitigate risks for sponsors? ❔ In our new Oncology report, Parexel’s Karen McIntyre and Angela Hirst weigh in on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. 🚧 That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/etEhmCKC #ResearchSites #Oncology #NovelInsights
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Phil Garner
Kimberly Westrich (Chief Strategy Officer, National Pharmaceutical Council) shares her highlights in US healthcare value and access from March and April 2024. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #hta #healthtechnologyassessment #healthdata #ISPORAnnual
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Arnaud Lavenue
As I prepare to join you all tomorrow at the National Pharmaceutical Congress Institute webinar on Pharmacare featuring experts Mihai (Mike) Csaki, Zal Press, Pamela Fralick, and Eileen McMahon, I wanted to share my thoughts. I picked up 3 key pieces of information to put context, perspectives and opinions on this highly-debated reform. 1. Making contraception and diabetes medications free for Canadians The office of Prime Minister issued a communiqué on May 24. Extracts: · The medications many Canadians need are often too expensive, leading to fewer visits to pharmacies, less treatment, and more frequent health scares. · The cost of contraceptives, and medications for those who are diabetic, is one of the largest barriers to access. · We're making sure Canadians get the medication that they need, when they need it. Source: https://rb.gy/q9hdml 2. Improving Coverage and Access to Innovative Medicines for Canadians: Standing Committee of Health study of Bill C-64 On May 22, Innovative Medicines Canada - Médicaments novateurs Canada issued a position statement including context, four recommendations and proposed next steps for a collaborative approach. Extracts: Reco #1: The Government of Canada should build on Canada’s extensive existing coverage rather than replacing it with limited public formularies. The limited available funding should be used to address the unique gaps or limitations in coverage in consultation with each jurisdiction. Reco #2: The Government of Canada should leverage existing efforts to reduce costs currently being undertaken by the pan-Canadian Pharmaceutical Alliance (pCPA) through joint pricing negotiations. Standalone federal initiatives would have limited additional benefit. Source: https://rb.gy/ihldbw 3. Addressing the impact of Bill-64: Healthcare experts weigh in on the pros and cons of the new legislation This week, the National Pharmaceutical Congress Institute issued a white paper including survey results and opinions from industry experts. Extracts: · “With the advent of AI and technology, we are living in dynamic times when it comes to healthcare...We have to be supportive of any initiative that wants our best interests, even if it’s not perfect and we struggle to please everybody. There’s no perfect system for everyone. The goal is to aim for the best and try to improve”. · The majority (over 50%) of surveyed participants also believed the greatest challenge in implementing Bill C-64 could be the lack of provincial cooperation. Source: https://lnkd.in/gVdiyGUS I look forward to participating in the event and hearing from the panel as we continue to see the shaping of Canadian healthcare changes. My name is Arnaud Lavenue and I'm a senior partner at Toc Toc Communications. I'm passionate about bringing pharmaceutical brands to life to their full potential so that they can help the patients who need them most. Thank you for liking, commenting, or following.
624 Comments -
Tina W.
⤴ A manufacturing and production scale-up #strategy is taking shape at Eli Lilly and Company to keep up with global demand for anti-obesity medications, the expected increase in managed care coverage, more indications coming online, and even a new device securing EU clearance for diabetes patients: 💉 "Also helping is European regulatory approval of a multidose injection device called Kwikpen that will allow more people with diabetes or obesity to access the drugs" 🏭 "The company has seven manufacturing sites either ramping up or under construction" #ProductionCapacity #PharmaManufacturing #SupplyChain #EliLilly #Mounjaro #Zepbound #Phama #Healthcare
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Harshal Kubavat, PhD
Sunshine, Strategy and (competitive) Solutions! Heading down to South San Francisco and the Bay Area soon! While virtual meetings are great <cough> Teams, Zoom, and Meets </cough>, INOVIS is all about real-life connections too. DM or email me if you're ready to connect...for coffee (or mimosas, no judgment) and chat about all things competitive intelligence (CI) - or anything else on your mind! #competitiveintelligence #strategicplanning #BayAreaConnect PS. Our capabilities and solutions have been growing from strength to strength! Let's chat about how INOVIS can help you stay ahead of the curve. PPS. Seen my latest book on CI? Its got all you need to know to level up in the competitive insights world!
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Sean McCooe
New Report Solidifies Greater Philadelphia Region as Global CGT Leader Leading the Way: Cell and Gene Therapy in Greater Philadelphia,” a sector snapshot commissioned by the Chamber of Commerce for Greater Philadelphia and conducted by Ninigret Partners LLC. The report is stacked with impressive stats about cell and gene therapy progress in the Greater Philadelphia Region, focusing specifically on developments over the last five-plus years. Among other industry-leading stats, the report shares the Greater Philadelphia Region is the (national/international) leader in translational science, and a Top 5 location for Phase I and II trials in both novel cell and gene therapies and is now home to 60 of the estimated 500 CGT companies worldwide (more than 10%), including five of the Top 100 “Companies to Watch.” https://lnkd.in/eZQXKap8 #upenn This report is stacked with impressive stats about cell and gene therapy progress in the Greater Philadelphia Region, focusing specifically on developments over the last five-plus
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Tina W.
🔥 Coming out of one of the Fireside Chat sessions at the 2024 ASGCT Annual Meeting is more on the need for guidelines, a framework of 'global regulatory convergence' in Cell and Gene Therapy, particularly in the development, manufacturing, and access. Leading the discussion is US #FDA's Marks, CBER Director. 🌎 Marks explained to the audience that varied countries' criteria for CGTs, from preclinical testing to manufacturing, make it difficult for patients in certain parts of the world to obtain treatments, particularly those in the rare disease space. Forward-looking: "Five to 10 years from now, Marks’ vision is that there will be enough global regulatory convergence “such that we can get to where we are currently with vaccines” internationally. “It would reduce regulatory burden.”" #ASGCT #CellAndGeneTherapy #CellTherapy #GeneTherapy #RegulatoryAffairs #Oversight #Innovation #Biotech #Healthcare
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Seema Shah Ahuja
"IQVIA estimates that the dearth of a Humira (adalimumab) biosimilars last year cost patients and employers cumulatively $6 billion." #Biosimilars #Adalimumab like #Hulio from #BioconBiologics can provide #affordable #access to #patients and save billions for the Government. #Biosimilars are the way forward for affordable biologics therapy. Read the article: US Specific "The biosimilar Hulio was offered last year at a WAC of $498 for a month's supply, versus $3,461 for Humira, according to a Samsung Bioepis biosimilar report. Still, the vast majority of prescriptions filled in 2023 were for the Humira originator product, prompting market research group IQVIA to conclude that “maintaining patients on Humira comes at a cost of up to about $6 billion per year for patients and employers, compared to a full transition to adalimumab biosimilars.” Biocon Biologics Matt Erick Joshua Salsi https://lnkd.in/gN74FShF
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Tina W.
👑Royalty Pharma's expanding portfolio...buys in, to the tune of $525M, to the biotech ImmuNext for a cut of Sanofi's acquired MS Drug, frexalimab. 💰 This will yield the right to earn royalties and milestone payments from the autoimmune disease drug, on global sales up to $2B, on a 'tiered royalty structure' Frexalimab’s Potential and Sanofi’s #Strategy 📒 Mid-stage P3 results on this were published in NEJM "Sanofi plans to seek approval for the medicine in 2027, anticipating annual sales of over 5 billion euros (approximately $5.4 billion) and royalties through 2041" 📈 This investment highlights the potential benefits of frexalimab in the treatment of multiple sclerosis (MS) and Royalty Pharma's strategic approach to portfolio diversification. #RMS #MultipleSclerosis #Biotech #Innovation #Sanofi #RoyaltyPharma #Pharma #Healthcare
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Tyson Kuehl
The long awaited IQVIA Institute report on The Use of Medicines in the U.S. 2024: Usage and Spending Trends and Outlook to 2028 is here! Please share! Key findings: 1) Overall spending growth in the U.S. market for medicines slowed to 2.5% in 2023, reaching $435Bn at net price level, reflecting a sharp decline in COVID-19 vaccines and therapeutics. 2) Spending growth accelerated to 9.9%, when COVID-19 vaccines and therapeutics are excluded, driven by innovation in areas such as oncology, immunology, diabetes, and obesity. 3) Health services utilization including visits, diagnostics, elective procedures and drugs declined 3% from 2022, reflecting a 4-6% reduction across all indicators except for new prescriptions, which rose 3%. 4) The average out-of-pocket cost per retail prescription increased in 2023, driven primarily by higher brand costs for GLP-1 agonists in diabetes and obesity; however, patient out-of-pocket costs remained less than $20 for 90% of prescriptions. As always, thank you for you and your team's research Murray Aitken! #PharmaSpending #DataScience #USMedicines #HealthcareData #transformhealthcare #savelives What are your thoughts? Eliza Silvester Nitin Patel Matthew Smith Matt Doyle Valerie Eng Gopa Radhakrishnan, MPH Gary Minarich Avinob Roy Carmen Sivakumaren, PhD Abir Yamak, Ph.D. Eric E. Bayir, MSc, MBA Patrick Gorman, PhD Indraneel Mukherjee John DeMarrais Kurt Conger Ben Taylor Alexander Colgan Greg Plante Charles Vizzini Eric Louie, MD Edward Winslow, MD MBA
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Aaron Jason Martin
Outlook for AP - ISPOR musings part 2 The impact of CMS's negotiations for the top 10 drugs by Medicare spend have already triggered some widespread discussion in the US on what this means for Pharma clinical development programs and launch considerations. Easily 40% of the conversations at ISPOR were centered around this issue. Essentially, with a compressed product life cycle for top selling drugs, the risk of even "blockbuster" product revenues not recouping total net investments adequately, are a real possibility. How shortened product lifecycles impact the investment appetite of institutional and private investors also remain to be seen, but a good guess would be that investors will be especially picky (more than before) about where to put their money. Industry strategies will certainly evolve in complexity. Go for orphan populations at a lower risk of being hauled up for CMS negotiations? Forgo blockbuster revenues in favour of moderate diverse portfolios? Prioritise speed of access (especially in Europe) over revenue maximisation in the US? There were certainly no easy answers and certainly not much discussion regarding the potential impact on Asia Pacific at ISPOR. Many markets in Asia as is, face significant lags or bypasses in drug launches (as a fraction of total launches in the US). Some may argue that we don't need all the launches, but that's besides the point. The point is that comparatively challenging P&R mechanisms, regulatory environments, infrastructural and health literacy gaps in parts of Asia already make it a relative afterthought in the launch strategies of many major innovative companies. Swathes of the AP region is at risk of falling behind in health outcomes in the medium to long term, should industry strategies evolve further on the back of domestic US and EU policies, unless the region steps up. How? I'm no expert but my thoughts nonetheless: 1. We need acceleration and maturation of our P&R mechanisms. Local affiliates of MNCs need to step up HTA and market access capabilities to adapt global, but also nimbly develop ground up localised, narratives, strategies and proposals. Agencies need to get creative with balancing evaluation rigour with pragmatic and speedy access solutions. 2. Health systems need to evolve to avoid the wrong pocket problem. Health economics helps you make short term buying decisions to manage healthcare costs but economic evaluations at a whole of government level helps you make long term value decisions that prevents those costs in the first place. There shouldn't be a blind rush to adopt HTA by institutions with a healthcare-only perspective (not with its current narrow perspective) or the wrong pocket problem we're seeing in many systems will persist. 3. Data integration. Data integration. Data integration. 4. Innovate locally/regionally and commercialize quickly within the region (I'd imagine with a huge dose of state intervention for it to make financial sense)
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Tina W.
📰 A potential new competitor in the #AtopicDermatitis space is on the developmental horizon, with this news from J&J regarding its new acquisition, gaining a key bispecific: Johnson & Johnson (J&J) enters a definitive agreement with Swiss biotech Numab Therapeutics AG to acquire global rights to NM26, a phase II-ready bispecific antibody for atopic dermatitis (AD). ✴ To facilitate the deal, Numab Therapeutics will spin off its wholly-owned subsidiary, Yellow Jersey Therapeutics, which holds NM26 rights, to its shareholders. ✴J&J will purchase Yellow Jersey Therapeutics from Numab’s shareholders for $1.25B. 🔬 NM26 targets two clinically proven disease-driving pathways in AD: IL-4R alpha subunit and IL-31. J&J believes NM26 has the potential to transform the standard of care for AD. ⚙ Additionally, J&J sees NM26 as a potential treatment for other inflammatory skin diseases involving Th2 inflammation and itch. The drug was discovered and engineered by Numab using its proprietary MATCH technology platform. The transaction is expected to close 2H24. https://lnkd.in/evV65_RZ #JnJ #bispecifics #AD #NumabTherapeutics #YellowJerseyTherapeutics #Pharma #Healthcare
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Maria Whitman
The 340B Drug Pricing Program has grown significantly in recent years. States have responded by passing additional legislation, creating a complex policy landscape that’s challenging for both manufacturers and providers. My colleagues explore pharma’s and states’ policy responses, analyze how successful these responses have been and offer recommendations for how pharma can adapt in a dynamic environment. #healthcare #pharma #340B #drugpricing #publicpolicy https://lnkd.in/eJwm-NrN
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