Aligning Cancer Therapeutic Evidence Between EMA and EU HTAs
Many of the health technology assessment agencies (HTAs) of EU member nations have evidence requirements for cancer drugs that are different than those of the European Medicines Agency (EMA). This disparity often delays patient access. In a new article in Value in Health, authors break down these different requirements to highlight the need for alignment between EMA and EU HTA requirements.
Aetion Announces Launch of RWE Oncology Initiative
Aetion has announced a new initiative to help companies across the oncology-related industries better understand the use of real-world evidence (RWE) in regulatory decision-making and clinical trials. The team-up, dubbed the Coalition for the Advancement of RWE through Randomized Controlled Trial Emulation (CARE) Initiative. Partners include industry giants, advocacy organizations, universities, and more.
UroGen Releases Real-World Data Showing Safety of JELMYTO in Upper Tract Urothelial Carcinoma Patients
UroGen has announced the release of new real-world data (RWD) supporting the safety of JELMYTO administration via percutaneous nephrostomy tube for patients with upper tract urothelial carcinoma (UTUC). The multi-center study was based on retrospective data from 32 patients and was recently published in The British Journal of Urology International.
PCOC 2022: AJMC Talks with Dr. Kashyap Patel About Value-Based Care
This year’s Patient-Centered Oncology Care 2022 saw several talks about defining value in oncology care, according to Dr. Kashyap Patel of Community Oncology Alliance and Carolina Blood and Cancer Care Associates. Patel spoke about this and other topics covered at the conference with the AJMC staff in a video interview.
Improving Cancer Outcomes with Value-Based Care and Reimbursement
At last month’s Community Oncology Alliance Payer Exchange Summit, a panel of speakers discussed how improving cancer outcomes and spending through value-based care and reimbursement requires a plethora of different strategies. The panel, entitled “New Strategies for Insurance Benefit Designs: From the Simple to the Complex,” noted that a one-size-fits-all approach can leave smaller practices behind.
UICC and WHO to Negotiate Prices for Cancer Generics and Biosimilars
Cancer drug price negotiations with the World Health Organization (WHO) and the Union for International Cancer Control (UICC) will center around biosimilars and generics. The goal is to increase access to life-saving medications for people living in low and low-middle income countries (LMICs). Negotiations will begin with drugs on the WHO’s Essential Medicines List.
Efficacy of Combination Therapy for Metastatic Breast Cancer Confirmed in Real-World Data Study
A new real-world data (RWD) study published in NPJ Breast Cancer has found that a combination therapy for a form of metastatic breast cancer (MBC) is more effective than monotherapy. The study investigated the use of palbociclib and an aromatase inhibitor (AI), comparing it to AI monotherapy. Data came from 2,888 patients in the Flatiron Health Analytic Database.
Using Real-World Data to Implement External Comparator Arm Studies
Single-arm trials (SATs) have entered the clinical trial space thanks to the growing abundance of real-world data (RWD) from sources like electronic health records (HER) that allows for the use of external comparator arms (ECAs). These trial formats help accelerate and enable research, especially when randomized controlled trials are infeasible. In a new article on PharmaPhorum, Dr. Gerd Rippin of IQVIA discusses the use of RWD in SATs.
Study Emulates Oncology Drug RCT Via Electronic Health Records
In a newly published study in Clinical Epidemiology, researchers were able to mirror the results of a randomized clinical trial (RCT) for a cancer drug using real-world evidence (RWE) gleaned from electronic health records (EHR). The researchers used an oncology dataset to emulate the PARSIFAL trial, which compared two drugs as adjuncts in breast cancer.
The Disconnect Between Clinical Trial and Real-World Populations Holds Back Oncology Care
Randomized controlled trials (RCTs) are the gold standard for regulatory approval. However, cancer trial participants are often not representative of real-world patient populations. As a result, patient outcomes may not mirror those found in trials. In a new article published on OncLive, Maurie Markman, MD, discusses the shortcomings of traditional RCTs and how unrepresentative patient populations hold back therapeutic development.
Improving Access to Cancer Therapeutics Through Value-based Care
Qatar provides free cancer care, greatly improving health outcomes at a substantial cost. A newly published pre-print paper in BMC Health Sciences Research examines and puts forward value-based care strategies for cancer care and value-assessment models to help reduce the financial burden of oncology care without sacrificing patient access to life-saving drugs.
Pfizer is a Fan of FDA’s Real-Time Oncology Application Review Process
Pfizer has expressed positivity towards the US Food and Drug Administration’s (FDA’s) Real-Time Oncology Review (RTOR) program. The RTOR will allow data submissions earlier in the review process in order to accelerate future decision-making and market access. Although the Alliance for Regenerative medicine has expressed concerns about the program, Pfizer is in support.
US Drug Pricing Reform May Help Medicare Part D Beneficiaries with High Cancer Costs
Many US cancer patients enrolled in Medicare Part D programs forgo life-saving cancer care due to exorbitant treatment costs, which average out to $3,000 out-of-pocket for the first month’s prescription. According to a White House blog posted last Friday, April 23rd, new provisions in the Inflation Reduction Act’s drug pricing reform would help reduce costs for Part D patients and the healthcare system at large.
Cancer Treatments in Limbo Due to Abortion Bans
The cancer care for many US patients is in peril due to the legal consequences of the wave of abortion bans following the repeal of Roe v. Wade. States like Georgia have adopted laws that have legal ambiguity in definitions of medically-necessary abortion. As a result some patients will likely be denied care or have it delayed due to fears of legal repercussions.
BioGene Scores NICE Approval for Rare Lymphoma Drug Brukinsa
The UK’s National Institute for Health and Care Excellence (NICE) has approved BioGene’s drug Brukinsa for patients with Waldenstrom macroglobulinemia (WM), a rare form of B-cell lymphoma. The drug, approved for the same purpose last year in the US, will meet a previously unmet need due to issues with the current standard of care.
Webinar – A Journey without a Map: Building an Oncology Powerhouse Where Innovation Thrives – Sept. 21
The landscape of next-generation cancer treatment development is rapidly changing. Achieving success in advanced requires careful consideration of the shifting tides of the industry and quick adoption of new concepts and technologies. In an upcoming Endpoints webinar on September 21st, leaders from Astellas discuss how they built an oncology powerhouse.
Pfizer’s Oncology Chief Schmeltz Moves to Rare Disease Role
Pfizer is having another executive shakeup. Andy Schmeltz will leave his role as global president of oncology at Pfizer to take on a new role of managing the pharma juggernaut’s investment strategies. Suneet Varma will leave his position as the head of Pfizer’s rare disease division to fill in Schmeltz’s former role.
Whitepaper: Making APAC the Oncology Clinical Trial Destination
A new whitepaper from Premier Research makes the case that the Asia-Pacific (APAC) Region is the hot spot for oncology clinical trials. Currently, APAC stands as the region with the most ongoing oncology trials worldwide, with the number of active trials growing 138% over the last 10 years. In the whitepaper, the authors break down what factors are driving this growth and why clinical research organizations (CROs) should consider hosting their trials in the region. Chief among these reasons is the massive potential patient pool.
Value in Health: Defining a Core Data Set for the Economic Evaluation of Precision Oncology
Despite the growing abundance of multiomic data in precision oncology, the lack of standardization and interoperability impedes economic evaluation. In the latest issue of Value in Health, Samantha Pollard, PhD et al. found significant variability in published data resources. Through their work, they identified a core set of 68 data elements that they believe would support accurate and efficient economic evaluations.
Whitepaper – Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelinesv
Despite a growing understanding of cancer biology, only 10% of cancer treatments approved by the FDA have an overall survival benefit for patients. A newly available white paper lays out the current precision medicine landscape and how the shift towards adaptive trial designs could accelerate market access and improve patient outcomes
US FDA Gives Quick Approval for First Low-HER2 Breast Cancer Drug
The US Food and Drug Administration (FDA) has approved Enhurtu, the first drug to treat metastatic or unresectable low-HER2 breast cancer, a recently defined category of the disease. The drug, developed by AstraZeneca and Daiichi Sankyo, received expedited approval from the agency, in part because of the potential for the breast cancer category, which covers over half of cases previously defined as HER2-negative.
Free Ebook: Real-World Evidence in Oncology
Health economics and outcomes research (HEOR) and real-world evidence (RWE) are changing the clinical trial landscape in oncology. Oncology Central has released a free eBook about HEOR and RWE in oncology that includes peer-reviewed research articles and reviews, as well as access to a panel discussion.
US Court Rejects Novartis’s Appeal in Whistleblower Case
New Jersey’s Superior Court, Appellate Division, has rejected Novartis’s appeal of a 2019 verdict in a case against a former executive turned whistleblower. Min Amy Guo, then executive director of the company’s health economics and outcomes research team, was fired in 2013 after expressing concerns that a cancer drug study would violate laws preventing kickbacks. She filed suit the following year and five years later a New Jersey court ruled Novartis was guilty of retaliation and must pay Guo $1.8 million in damages.
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.
Syndicated Report: Global Gene Therapy Market Projections 2022-2031
Despite the global pandemic, cancer was still the leading cause of death in 2020. This pressing therapeutic need underlies the growth projected by Kenneth Research in their new report entitled, “Global Gene Therapy Market.” The report predicts that the gene therapy market will earn around $6 billion USD from 2022-2031 with a CAGR of ~34%.
