Using Real-Wold Data to Tackle Migraine Care Gaps
Although migraines affect 12% of people in Europe, millions suffer with poor migraine management. Eli Lilly’s OVERCOME (EU) study used real-world data (RWD) from over 20,000 people in Germany and Spain who live with migraine. Just over 40% had not received a formal diagnosis, and most patients who would be eligible for treatment had not used any. As a result, Lilly points out in a recent sponsored article that a European Migrain Action Plan could help address this care gap.
R-S-S Course: Economic Evalulation of Cancer Drugs – October 3rd
Regulatory Scientific and Health Solutions (R-S-S) is hosting a course entitled, “Economic Evaluation of Cancer Drugs.” The course is aimed towards professionals in health economics and outcomes research (HEOR), market access, and clinical oncology. Attendees will learn about the development, application, and interpretation of economic models for cancer drugs. The course takes place at the Hilton London Watford, Watford, UK on Monday 3rd October 2022. Register by 1st August 2022 for an early bird discount.
Biogen Settles MS Kickback Suit for $900M
Biogen has settled a whistleblower suit regarding kickbacks for its line of multiple sclerosis (MS) drugs. The company was sued for allegedly paying clinicians kickbacks when they prescribed its drugs Tecfidera, Tysabri, and Avonex. The settlement comes as competition from Novartis and Ocrevus closes in on Biogen’s MS drugs
Webinar: How Baylor Scott & White Health Successfully Integrated Medical Devices Systemwide – July 25th
Data standardization is across medical device types and manufactures is exceedingly uncommon and acts as a barrier to capturing and integrating data to improve quality of care. Baylor, Scott, and White Health tackled this problem by bringing together an interdisciplinary group of staff and implementing a scalable system enterprise-wide. Join Lisa Kilgore and Nathan Winn from Baylor and Scott in a webinar this Monday, July 25th, to learn more.
Webinar: AI and Machine Learning Technologies: The New Normal of the Pharmaceutical Industry – July 27th
Fierce Pharma and Orbita are hosting a webinar next Wednesday, July 27th, that will teach learners how conversational AI can help automate workflow, decrease costs, and improve efficiency. Panelists come from pharma leaders and will share their insights as well as real-life examples of clinicians implementing new AI-based solutions.
Syndicated Report: Real World Data Market
The newly released Real World Data Market report from Worldwide Market Reports provides a detailed analysis of real-world data (RWD) market and the potential impact of different market scenarios. Specifically, the report details how the RWD market was affected by the COVID-19 pandemic.
Developing a National Publicly Reported Health Outcomes Platform in the US to Improve Outcomes
The US lags behind other nations with similar economic development in key health outcomes like life expectancy and maternal mortality. [...]
J&J Tamps Down M&A Ambitions
Johnson & Johnson’s new CEO Joaquin Duato has repeatedly told analysts and investors that the company was going to pursue an aggressive M&A campaign. In a call earlier today, July 19th, Duato signalled a shift and toned down those ambitions as the company’s expected 2022 sales growth dropped from 4-5% to 3%. However, this does not mean that J&J has completely written off any acquisitions.
ICER Report At a Glance: Beti-Cel for Beta Thalassemia
Beta Thalassemia is a blood disorder that results in dangerously low levels of functional hemoglobin and requires expensive lifelong medical care, including regular blood transfusions. Beti-cel is a gene therapy by Bluebird Bio that can potentially cure the disorder by genetically modifying a patient's own hematopoietic stem cells (HSCs). The Institute for Clinical and Economic Review (ICER) has just released its assessment of Beti-cel, finding that it is effective and could save money on treatment, but more comprehensive long-term data would be necessary to determine the degree of the net health benefit over the current standard of care.
Abbvie Applies for EMA Marketing Authorization for Migraine Drug Atogepant
The drugmaker Abbvie has applied to the European Medicines Agency (EMA) for marketing authorization for Atogepant, its prophylactic migrain treatment. Data supporting the application comes from two phase three studies, which showed the drug was well tolerated and was effective at reducing the occurrence of migraines.
Joe Manchin Puts Democrats in a Corner with Drug Pricing Reform
Joe Manchin (W.V. - Dem) has rejected Democrat’s plans to pass climate and tax reform by July or August, saying that they must take a deal on healthcare and drug prices or wait until September. Other Democrats are livid, but may be forced to play ball with an upcoming midterm that is overshadowed by President Joe Biden’s historically low approval ratings.
Bavarian Nordic Makes Deal to Provide 1.5M Monkeypox Vaccine Doses to Unnamed European Country
The Danish drugmaker Bavarian Nordic has signed a deal with another unnamed European nation, this time promising 1.5 million doses of its monkeypox vaccine. This is the second deal with undisclosed European countries and comes hot off the heels of a deal with the US govt for 2.5 million.
Polpharma Files for EU Approval of Tysabri Biosimilar
Polpharma Biologics has filed for approval in the EU for its biosimilar of Tysabri, Biogen’s multiple sclerosis (MS) therapy. The application is the first of its kind in the EU, and covers the intravenous version of the drug. Biogen originally had 5 more years of exclusivity, but a key patent for the drug was revoked in a European court last year.
Improve Access to Mental Healthcare by Paying Trainees
Access to mental healthcare in the US has been a growing issue for decades, only made worse by the COVID-19 pandemic. Unfortunately, the slow trickle of trainees is far from sufficient to bridge this gap. Instead, at the current rate, there will be 14,000 less psychiatrists practicing in 2030. In a new Health Affairs article, authors discuss how paying trainees for the care they deliver could support efforts to reverse this troubling trend.
Study Finds Healthcare IT Yields Incremental Improvements
Despite the widespread digitization of healthcare, a systematic review found improvements in healthcare productivity have been incremental rather than leaps and bounds. The study reviewed 975 research papers and was conducted as part of MIT’s Work of the Future project. IT applications have increased productivity, but only between 1-3%.
Biosimilar Boom May be on the Horizon, Potentially Saving Patients Billions
Biosimilars, biologic generics, hold substantial promise in expanding access to lifesaving biologics, but growth has taken a while to ramp up. With 100 biosimilars currently in the pipeline, the industry may be set up for rapid growth in the next two years. With the potential influx of new biosimilars that are significantly cheaper than their reference drugs, patients could collectively save $100 billion in the next 5 years.
How to Change Clinical Practice Using Health Economics and Outcomes Research
In 2005 and 2009, I published HEOR studies that led to an 80% drop in the number of US [...]
COVID-19 Pandemic Causes Largest Drop in Childhood Vaccinations in 30 Years
A report published by the World Health Organization (WHO) and UNICEF shows that 25 million children missed key childhood vaccines due to the COVID-19 pandemic. Coverage with the DTP3 vaccine, which protects against tetanus, pertussis and diphtheria, fell to 81% from 86% in 2019.
US Congress Makes Another Push for Drug Pricing Regulation
With tough odds in the upcoming midterm elections in mind, Democrats in the US Senate are making another push for drug pricing regulation. The latest attempt would limit the out-of-pocket drug costs to $2,000 and let Medicare negotiate drug prices. The proposal would also let the Department of Health and Human Services (HHS) select a small set of drugs for price negotiation, beginning with 10 in 2026 and steadily increasing as time passes.
STATUS List 2022 Spotlights: Admiral Rachel L. Levine and Dr. Kirsten Bibbins-Domingo Talk Health Equity
STAT upcoming STATUS LIST 2022 will feature two leaders in health equity in their own spotlight sessions. Assistant Secretary for Health for the U.S. Department of Health and Human Services (HHS) Admiral Rachel L Levine will speak about her work towards trans health equity and goals for the agency on July 26th. On September 20th, Kirsten Bibbins-Domingo, M.D., Ph.D., M.A.S., the new editor-in-chief of JAMA, will talk about her vision for the journal amidst the wake of the controversial statements about racial equity by the previous editor-in-chief.
CBO: Senate Drug Price Cuts Would Curb Development of 10 Drugs Over 30 Years
Despite fears that drug pricing regulations would dampen innovation, an analysis by the US Congressional Budget Office found that the drug pricing proposal put forward by Senate Democrats would stifle development of 10 drugs in the next 30 years. This amounts to just shy of 1% of the estimated 1,300 approvals in that time period. The projected losses are much less than previous bills.
World Orphan Drug Congress Europe 2022 – 14-17 November 2022
Taking place in Spain this year, the World Orphan Drug Congress, the leading conference for orphan drugs and rare diseases worldwide, takes place in Sitges, Spain, from 17-14 November. The conference will bring together professionals from healthcare, research, regulatory agencies, payer organizations, and other key decision-makers to one place to connect and share ideas.
Novavax COVID-19 Vaccine Gets Emergency Use Authorization from FDA
The US Department of Health and Human Services (HHS) has announced that 780,000 doses of Bavarian Nordic’s should be headed to the US by the end of the month. The vaccines, at Bavarian Nordic’s Denmark facilities, are currently undergoing an FDA inspection and authorization. The announcement comes as the disease pops up across the country.
780,000 Doses of Bavarian Nordic Monkeypox Vaccine to be Shipped to US by End of July
The US Department of Health and Human Services (HHS) has announced that 780,000 doses of Bavarian Nordic’s should be headed to the US by the end of the month. The vaccines, at Bavarian Nordic’s Denmark facilities, are currently undergoing an FDA inspection and authorization. The announcement comes as the disease pops up across the country.
Teva Asks US Supreme Court to Reverse Loss in “Skinny Label” Patent Suit, Says Decision is Competition-Killing for Generics
According to Teva Pharmaceuticals, the company’s legal battle with GSK over “skinny labels” portends a greater threat to the generic drug market. Skinny labeling is a practice where a manufacturer can get its generic approved by applying for some of the original drug’s indications, but not all. GSK and others argue that the practice is infringement because the generics are often prescribed off-label for the original drug’s indications. Teva has asked the US Supreme Court to reverse the decision, which ordered the company to pay GSK $235 million.
