The Global Healthy Living Foundation (GHLF) today called conclusions from the Institute for Clinical and Economic Review’s forthcoming draft on osteoporosis treatments anti-patient and methodologically flawed.
“The study, which could be released as early as Friday, attempts to assess the value of different treatments by comparing an older generic drug to newer agents which have a different clinical objective,” said Louis Tharp, Executive Director and Co-Founder of GHLF.
The newer drugs, currently under FDA review, work differently and are designed to be taken for about a year by patients with a high fracture risk in order to quickly rebuild bone. Once bone is rebuilt, high-risk fracture is diminished and patients are treated with a cheaper generic drug which can also rebuild bone, but much more slowly and in a different way.(1)
“This is not an either-or choice,” said Tharp. “If you suffer a fracture while you are on the older, slower-acting medication when the newer medication could have prevented it, the cost to you, your family, society and your insurance company is much higher than if you had just taken the newer drug.(2,3,4) In addition, studies show that patients on the older drugs are often non-compliant with their dosing and do not continue to take it for the several years necessary to achieve an acceptable fracture-prevention level,(5)” he added.
“But if you don’t include the larger costs to society and productivity, and you bet on not having a fracture, the older, slower drug appears cheaper, and this is the calculation ICER and its insurance company clients prefer,” Tharp said.
According to drafts reviewed by GHLF, no osteoporosis patients or bone experts were on the voting committee that approved the draft.
(1) Amgen. (2016). Amgen And UCB announce positive top-line results from the phase 3 study of romosozumab in postmenopausal women with osteoporosis [Press Release]. Retrieved from http://www.amgen.com/media/news-releases/2016/02/amgen-and-ucb-announce-positive-top-line-results-from-the-phase-3-study-of-romosozumab-in-postmenopausal-women-with-osteoporosis/
(2) International Osteoporosis Foundation (2015). Treating osteoporosis. Retrieved from https://www.iofbonehealth.org/treating-osteoporosis
(3) International Osteoporosis Foundation (2015). What you need to know about osteoporosis. Retrieved from https://www.iofbonehealth.org/data-publications/fact-sheets/what-you-need-know-about-osteoporosis
(4) Bone Health and Osteoporosis: A Report of the Surgeon General. Office of the Surgeon General (US). Rockville (MD): Office of the Surgeon General (US); 2004. https://www.ncbi.nlm.nih.gov/books/NBK45502/
(5) Amy H. Warriner, MD and Jeffrey R. Curtis, MD, MPH, “Adherence to Osteoporosis Treatments: Room for Improvement” Curr Opin Rheumatol. 2009 Jul; 21(4): 356–362. doi: 10.1097/BOR.0b013e32832c6aa4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2913429/