New research results quantify the extent to which centralized value assessments by the U.K.’s National Institute for Health and Care Excellence (NICE) lead to coverage denials and patient access restrictions to new drugs and biologics. The analysis, conducted by Context Matters, a healthcare information and data analytics technology platform company, and sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA), shows use of centralized cost-effectiveness standards by NICE and similar appraisals in other countries limit patients’ access to new cancer treatments, which evolve rapidly and are increasingly personalized. 

According to the Context Matters analysis of NICE decisions over the last seven years (2007 to 2013): 

• NICE rejected all six cancer medicines that it reviewed in 2013
• Cancer medicines were more than three times likely to be rejected than non-oncology medicines
• Nearly 60% of oncology medicines were rejected, compared to only 16% of non-oncology products
• Almost 80% of cancer medicines reviewed in the last seven years have been given some kind of access restriction.

“These findings underscore the challenges created by coverage and payment policies that rely on centralized, one-size-fits-all value assessments,” said John J. Castellani, president and CEO, PhRMA. “While it’s important to ensure health care decisions are grounded in the best available evidence, it also is essential to ensure it is not misapplied in ways that deny patients’ access to valuable treatment advances. We need approaches that put the patient at the center of health care decision making and support patients and physicians in choosing the treatment options that best meet the individual’s needs.”

Castellani noted the five-year relative survival rates for cervical, breast and colorectal cancer are higher in the U.S. (67%, 90% and 65% respectively) than they are in the U.K. (59%, 78% and 51%, respectively).

Dr. Yin Ho, founder and CEO of Context Matters, and study author, said the findings of this analysis “calls into question whether current HTA models are sufficiently flexible to account for variability in patient needs and preferences and recognize the way that understanding of a new treatment’s value emerges over time.”

Additional analysis released by Context Matters indicated global variability in the HTA decisions of several major countries’ organizations compared with the U.K.’s NICE. NICE agreed with other agencies 56% of the time over oncology reviews, and 81% for non-oncology reviews. 

“The degree of variability of these decisions, especially for cancer medicines, illustrates the complexity of the environment our innovator companies must navigate in order to deliver life-saving medicines to patients,” said Castellani. “The fact that the same body of high quality evidence can elicit such different decisions reveals the subjective nature of these assessments.”