Drugs With ‘Unsupported Price Increases' Add $5bn To US Spending – ICER
(10/8, Cathy Kelly, Pink Sheet) reports “...The Pharmaceutical Research and Manufacturers of America sharply criticized the report in a statement. ‘This is a flawed report that cherry picks a few medicines in an effort to advance the false narrative that spending on medicines is increasing, which is not consistent with current data,’ PhRMA argued. ‘By focusing on a small set of medicines that do not yet have generic equivalents, the report ignores the fact that medicines are the only part of our health care system with built in cost containment due to future competition from generics and biosimilars.’” Paid Subscription Required
Humira, Cialis and Other Drug Prices Have Jumped. Are the Increases Justified?
(10/9, Aimee Picchi, CBS News) reports “...Pfizer, which makes nerve and muscle pain drug Lyrica, said the report ‘contains certain methodological limitations.’ ‘It does not consider external factors that naturally affect the price of drugs, does not assess the true value the medicine brings to patients over time and does not consider what the appropriate value-based price should be,’ the company said in a statement to CBS MoneyWatch. Pfizer added that pricing is also partially based on the need to fund new research to develop new medications, as well as to ‘reflect the benefit they bring to patients and society.’” Full
ICER's Concern for Patients: Where's the Beef?
(10/9, Patricia Goldsmith and Carole Florman, STAT News) comments “...If ICER really wanted to consider patient experiences, why did it put the burden of quickly developing and presenting patient experience data squarely on the shoulders of patient advocacy groups? It said that ensuring complete data wasn't its job. At the National Health Council's conference on value assessment, ICER's executive vice president and chief operating officer, Sarah Emond, said that patient groups can choose to provide input — on ICER's schedule — or not. If they don't, ICER will proceed with the information it has regardless of how complete it is.” Full
Speeding Innovation with Real-World Evidence
(10/9, Kimberly Blackwell, M.D., LillyPad) comments “...When developing new targeted therapies, RWE helps us match the genetic markers we find in some in tumors with the potential treatments most likely to make an impact. Working backwards, RWE can also help identify the patients who don't respond to standard treatment options, and more quickly focus our research on opportunities that may work better for them. Additionally, RWE can be used to help identify patterns of response earlier, which helps differentiate whether a potential therapy is truly effective at treating disease, or if the changes we observe during the study are the result of other causes, such as genetics, environment, lifestyle factors, etc.” Full
Introducing New Patient Engagement in Quality Measurement Rubric
(10/8, National Health Council Blog) comments “The National Health Council partnered with the Pharmacy Quality Alliance and the National Quality Forum to create the Patient Engagement in Quality Measurement Rubric. This guide was created to help include meaningful patient engagement to the quality measure lifecycle. ‘By ensuring the patient and caregiver communities are involved from the start of the quality-measurement process, we will develop measures that are meaningful to the patient and that measure what is most important to them,’ said Eleanor Perfetto, PhD, MS, Executive Vice President of Strategic Initiatives at the NHC.” Full
ICER to Assess Treatments for Non-Alcoholic Steatohepatitis
(10/8, ICER Press Release) “The Institute for Clinical and Economic Review announced today that it plans to assess the comparative clinical effectiveness and value of obeticholic acid (Intercept) for the treatment of non-alcoholic steatohepatitis (NASH). Obeticholic acid has received a breakthrough therapy designation from the FDA, with an anticipated decision expected in the first half of 2020.” Full
Novartis Real-World Evidence Confirms High Efficacy, Long-Term Response and Favorable Safety Profile of Cosentyx® in Clinical Practice
(10/9, Novartis Press Release) “...‘These extensive results confirm what has been previously observed in Phase 3 clinical trials, and support our continued use of Cosentyx in psoriatic disease, to offer patients improved symptom control and quality of life,’ said Prof. Matthias Augustin, Director of the Institute for Health Services Research in Dermatology and Nursing. ‘Real-world evidence and observational studies help to bridge the gap in knowledge that exists between clinical trials and clinical practice. They provide important insights about patient characteristics, disease severity and management. Moreover, they also support the evidence of the treatment effectiveness in the routine clinical practice.’” Full
Parexel and Datavant Enter Multi-Year Strategic Partnership to Enable the Connection of Real-World Data Across All Parexel Clinical Trials
(10/9, Parexel Press Release) “...‘Across the industry, real world evidence is becoming an essential component to evaluating the safety and effectiveness of drug therapies and ultimately to delivering therapeutic advances. However, one of the most significant barriers to generating real-world evidence is overcoming limitations of single data sources,’ said Parexel CEO Jamie Macdonald. ‘Partnering with Datavant has provided Parexel the ability to link disparate data sets to drive the complex analyses necessary for providing innovative scientific and clinical data strategies. We're delighted to expand and extend our strategic partnership by using Datavant's technology across our entire portfolio, making the ability to link data available to more customers on a broader scale.’” Full
Disappointment in the Value-Based Era: Time for a Fresh Approach?
Jose F. Figueroa, MD, MPH, et al.
October 9, 2019, JAMA
Landscape Analysis of Health Technology Assessment (HTA): Systems and Practices in Asia
Teerawattananon Y, et al.
October 9, 2019, International Journal of Technology Assessment in Health Care