Last week the wsj editorial page artfully described how comparative effectiveness research is being used to justify government deciding what medical technologies will be developed and what treatments we will receive:
What the editorial implied but not discuss is that CER methodology is used to 1) establish that a drug will work but that 2) the cost of the treatment is "not good value for money". Which means 'society', meaning government-paid CER munckins say it's not worth paying for the treatment. In 1994 NICE decided that the cost of Cerezyme, the first treatment for Gaucher's for the ‘average’ Gaucher’s disease patient exceeds the normal upper threshold for cost-effectiveness seen in NHS policy decisions by over ten-fold."
In a similar vein, Alan Garber suggests that individual response to new treatments should not be considered in determing what benefits health plans should cover under Obamacare because if we add every new techology that "is proven effective" would result in a "costly bundle of services." Cue the CER experts to decide what services and treatments are valuable and which are not, even if they help people live longer healthier lives. Garber also urges the US to adopt the CER tools used around the world.
WIth that in mind, here's how NICE, the Nirvana of the CER crowd handles Benlysta, the first new drug in 50 years to treat lupus:
"Lupus drug Benlysta from GlaxoSmithKline PLC (GSK, GSK.LN) and U.S.-based partner Human Genome Sciences Inc. (HGSI) doesn't represent value for money and should therefore not be made available on the publicly-funded National Health Service, Britain's healthcare watchdog NICE said on Friday.
Benlysta, or belimumab, is the first new lupus treatment in 50 years. It won U.S. marketing approval in March and European approval in July. Lupus is a chronic autoimmune disorder, with symptoms ranging widely in type and severity. An estimated five million people worldwide have the disease.
In draft guidance, the U.K.'s National Institute for Health and Clinical Excellence said, "NICE's independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE [Systemic lupus erythematosus], including the views of people with the condition, those who represent them, and clinical specialists.
"The evidence considered did not persuade the committee that belimumab was good value for money compared to standard care, as the cost per year of improved health is very high."
NICE also said Benlysta should be compared with rituximab, sold by Roche Holding AG (ROG.VX), because some people with severe lupus currently receive rituximab, although it isn't licensed for this use. However, NICE noted there were no reliable data to show the relative efficacy of the two drugs.
"Whilst recognizing the severity of the disease, the committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation," the agency said. The draft guidance is now open for consultation before further decisions on the medicine are made.
Glaxo said it was disappointed by the agency's stance.
"This initial decision is very disappointing for patients living with lupus who currently have very limited treatment options and we will do everything we can to change NICE's mind in an effort to ensure they get access to Benlysta on the NHS," said Simon Jose, General Manager, GlaxoSmithKline UK.
"NICE's current methodology means that it is difficult to meet their cost-effectiveness threshold given the nature of the disease and the comparison with unlicensed or cheap generic medicines. We had hoped that our offer of a patient access scheme would help overcome these challenges," Jose added.
Navid Malik, an analyst with Merchant Securities, echoed that surprise, saying, "It seems incredulous for NICE to say that just because patients are on Rituxan for Lupus, they should not be reimbursed and given Benlysta, (as) Rituxan doesn't work in Lupus and yet Benlysta has been shown in two phase III trials to work."
