CER Daily Newsfeed

RWE Is Ready — Decision Making For Pharmaceuticals Isn't

(4/1, Dan Schell, Clinical Leader) comments “...If there is one misconception about RWE, it is that the industry simply needs more data. In reality, the challenge is not volume but usability. ‘The challenge is fragmentation,’ [Merck, KGaA’s Gorana Capkun] explained. ‘Data exists, but it’s not necessarily collected with the question you have in mind.’ That creates limitations around depth, completeness, and connectivity. Key endpoints may be missing, datasets may not link together, and in markets like the U.S., patients moving between health plans can disrupt longitudinal tracking.” Full

Congress, End the ‘Prior Authorization’ Health Care Scam

(3/31, Anath Hartmann, The Washington Times) comments “...In a New York State physicians survey, more than 40% of doctors said delays related to prior authorization had ‘led to serious adverse outcomes’ for a patient, and almost 50% said such delays had resulted in a patient simply abandoning treatment. The Doctor Knows Best Act would help stop this by ‘prohibit[ing] health insurance plans (including federal health care programs) from imposing a prior authorization requirement, utilization management technique (e.g., step therapy or fail-first protocol), or medical necessity review for any item or service for which benefits are available under the plan.’” Subscription Required

Novo’s Wegovy Cleared by UK Drug Price Watchdog for Heart Disease, Expanding Access by 1.2 Million People

(3/31, Elsa Ohlen, CNBC) reports “...The new recommendation the National Institute for Health and Care Excellence (NICE), England’s drug price regulator, will significantly expand access to Wegovy on the country’s National Health Service (NHS). Around 1.2 million people could use the medicine to help protect them against having further heart attacks or strokes, as it is made available for this condition, NICE said in a statement on Wednesday.” Full

MFN: England’s HTA Appraisals ‘Hold Steady’ For Now

(4/1, Francesca Bruce, Pink Sheet) reports “...NICE, the health technology appraisal institute for England and Wales, acknowledges the challenges that companies are facing in relation to US most favored nations pricing polices, said the organization’s director of medicines evaluations, Helen Knight.” Subscription Required

EMA Publishes Final Real World Data Chapter of EU Data Quality Framework

(4/1, Joanne Walker, The Evidence Base) reports “...EMA positions the RW-DQF as a companion to the EMRN framework and a practical reference for regulatory use. In the document, the Agency notes that ‘the application of the RW-DQF is strongly encouraged as a best practice framework for guiding the assessment of RWD quality in regulatory contexts.’ Rather than introducing prescriptive requirements, the framework supports structured evaluation without defining fixed thresholds or prioritizing specific metrics. Instead, it enables assessors to determine whether a dataset is appropriate based on its intended use and regulatory context, allowing for flexibility across different data sources.” Full