How large a charge is too large?
Yervoy, (the only melanoma treatment proven to extend life in melanoma patients) was rejected by the National Institute for Health and Clinical Excellence (NICE). Not nice for patients, and benefits were NOT in question--the British oversight group apparently had difficulty with the price.
The editor notes that beyond individual centers making economic decisions on some expensive medicines, this is the first time to his knowledge that a large regulatory agency has rejected a product based on price. What NICE found problematic was how benefits might be predicted and which patients might be predicted to benefit.
Further details will no doubt emerge, yet early information found NICE balancing the 30% of patients who will get some benefit and the 10% of patients getting long-term benefit against the $125,600 (80,000 pounds) of expense. The agency found it challenging that at present, there is no simple way to identify who will actually get the 30% or 10% benefits.
The economics of medicine may play an ever increasing role as more expensive biotech products become available. Pharmacoeconomics and the analysis of the expense of breakthrough medicines versus their prices is essential to making strong decisions. Where and how are lines in the sand drawn and who will decide?
It must also be remembered that development costs are born by the companies and many many products that carry significant expense never pass research stages and do not come to market. On the other hand, patient expense or insurer expense can become a significant burden for any health system. The human toll and risk sharing and pooling of resources for high cost medications is clearly part of the future.
Imagine being the patient who has the disease, yet can not get the treatment. The World Health Organization has done work with the use of essential drugs and clearly, much more research and work is needed. The drums of patient advocacy groups are already beating and this topic is one we will revisit often in the future.
Added information will be found in the UK press. Scientific comment is pending and clear pharmacoeconomic analysis, research and guidelines are needed.