Real-World Evidence Should Be Part of Clinical Trials in Oncology
(3/28, Sarah Alwardt, PhD, OncLive) comments “...According to the National Cancer Institute, standard of care is defined as treatment that experts agree is appropriate, accepted, and widely used. If a study is comparing new treatment options with a standard treatment that has not changed for years, why not use historic RWE as the control? If multiple biopharma companies are developing new drugs for the treatment of renal cell carcinoma, and each is conducting trials with nearly identical control groups, the possibility exists for all to draw data from the same control group. This may present some risk to the biopharma companies but could be a major boost for patients in the form of faster access to promising new therapies.” Full
Clinical Pathways Lead to Reduction in Spending Within the Oncology Care Model
(3/28, Hannah Slater, Cancer Network) reports “In a study, published in the Journal of Clinical Oncology: Oncology Practice, researchers demonstrated that the reduction of drug spending by using value-based clinical pathways to optimize chemotherapy utilization is possible and can increase the chances of a practice's success within the Oncology Care Model. Researchers indicated that misguided perceptions that drug prices are outside the control of oncologists has led to many OCM participants focusing their efforts on other areas to reduce costs, such as reducing preventable emergency department visits and hospital admissions.” Full
How Economists Calculate The Costs And Benefits Of COVID-19 Lockdowns
(3/27, Chris Conover, Forbes.com) comments “...More concretely, a COVID-19 treatment that was found to save lives at a cost of $311,194/QALY would be quickly deemed ‘cost-ineffective’ by those in our health system in charge of allocating scarce resources...Yet if a hypothetical federal agency were to propose some public health regulation to ‘flatten the curve’ at a cost to the economy that was shown to be less than $311,000 per statistical life year for each of the unknown COVID-19 whose lives were estimated to be spared by such a rule, that would pass the [Value of a Statistical Life] sniff test.” Full
The Precision Medicine Revolution
(3/27, Joel Diamond, MD, Medical Economics) comments “...Precision medicine is rapidly becoming recognized as the new standard of care. The potential for improving quality and safety of care—as well as patient loyalty—is tremendous. And because it empowers providers with new information and robust clinical decision support, it promises to enhance satisfaction as well.” Full
UK: COVID-19: NICE Updates Guideline as Sanofi Announces Vaccine Development
(3/30, Anna Smith, PharmaTimes) reports “...As more pharmaceutical companies race to find a vaccine to the growing pandemic, Sanofi is the latest to offer its services in the form of a collaboration with Translate Bio to develop an mRNA vaccine. The French pharma giant announced that the partnership will use Translate Bio's mRNA platform to discover, design and manufacture a number of SARS-CoV-2 vaccine candidates, with Sanofi advancing them for further development.” Full
UK: Does NICE Hold the Cards to Drug Pricing and Reimbursement?
(3/30, Rebecca Lanning, Pharmafield) comments “...President Trump is said to be actively taking advice on how the NHS can pay more for US medicines and NICE's price cap – usually beyond the reach of political interference – has been identified as a key target for US negotiators. However, as long as negotiators focus on the inflexibility of NICE's cost-effectiveness threshold, the threat to the NHS budget in a future trade deal is minimised. As the eventual approval of Orkambi – or the accelerated appraisal of Trikafta – shows, the role of NICE is changing but it isn't due to Brexit or the demands of a foreign president.” Full
People or Profit: What Is the Best System to Regulate Drug Prices?
(3/30, Conor Kavanagh, Pharmafile) reports “...A key principle of the German drug pricing system that differentiates it from the US system is that there will be no increase in prices without incremental benefit. This is decided through the Gemeinsamer Bundesausschuss (G-BA) – a quasi-public entity governed by the national associations of physicians, dentists, hospitals, sickness funds, and patient advocates – carrying out assessments which are based on patient-relevant clinical endpoints such as overall survival, functional ability, and reduction in symptoms, rather than on intermediate endpoints such as reduced tumour size or a change in biomarker levels.” Full
NIH-Funded Studies Show Stents and Surgery No Better than Medication, Lifestyle Changes at Reducing Cardiac Events
(3/30, National Institutes of Health Press Release) “Invasive procedures such as bypass surgery and stenting—commonly used to treat blocked arteries—are no better at reducing the risk for heart attack and death in patients with stable ischemic heart disease than medication and lifestyle changes alone. However, such procedures offer better symptom relief and quality of life for some patients with chest pain, according to two new, milestone studies.” Full
Utilization of Clinical Pathways Can Reduce Drug Spend Within the Oncology Care Model
Hertler A, et al.
March 20, 2020, JCO Oncology Practice
The Implementation of Health Technology Assessment Principles in Public Decisions Concerning Orphan Drugs
Brenna E, et al.
March 26, 2020, European Journal of Clinical Pharmacology
Matching-Adjusted Indirect Treatment Comparison of Siponimod and Other Disease Modifying Treatments in Secondary Progressive Multiple Sclerosis
Imtiaz A. Samjoo, et al.
March 27, 2020, Current Medical Research and Opinion
Current Medical Research and Opinion
Extending an Open-Source Tool to Measure Data Quality: Case Report on Observational Health Data Science and Informatics (OHDSI)
Brian E Dixon, et al.
March 29, 2020, BMJ Health & Care Informatics
BMJ Health & Care Informatics
What "Evidence" in Evidence-Based Medicine?
March 29, 2020, Topoi
Real-World Direct Healthcare Costs of Treating Recurrent High-Grade Serous Ovarian Cancer with Cytotoxic Chemotherapy
Lucy Gilbert, et al.
March 30, 2020, Journal of Comparative Effectiveness Research
Journal of Comparative Effectiveness Research
Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease
John A. Spertus, M.D., M.P.H., et al.
March 30, 2020, The New England Journal of Medicine