A few days ago FiercePharma, which bills itself as the “pharma industry’s daily monitor,”
I found myself in London a few weeks ago, and stopped by the offices of NICE, Britain’s National Institute for Health and Care Excellence, to dig deeper into why Sovaldi costs more in the US and to learn what recommendations NICE was making for Sovaldi—information that might be useful for reporters stateside. NICE conducts cost effectiveness analyses of new drugs and makes recommendations to the National Health Service about which drugs offer enough therapeutic value to warrant coverage by the health service. Since 2000, NICE has appraised over 500 healthcare technologies and has approved almost 80 percent of them including those okayed for restricted use. The Institute’s technology appraisals are binding on NHS doctors, hospitals, and primary care facilities, since the drugs are paid for out of the public purse. NICE’s clinical guidelines, which offer guidance in a specific therapeutic area, are not binding but most doctors follow them. The public can always pay privately for a drug NICE doesn’t approve for public funding. The Institute is currently considering whether Sovaldi will be approved for public funding by the National Health Service. The decision process involves input from patient groups, academics, providers, and the drug makers, and the Institute is expected to issue a draft guidance this month. (Draft guidance typically contains provisional recommendations for whether or not a technology should be funded and under which clinical conditions.) A final decision is expected by October. In the meantime, the National Health Service in England has agreed to pay 19 million pounds ($32.3 million) to treat with Sovaldi some 500 patients who have acute liver failure and who are waiting for a liver transplant. In other words, the drug is being limited to the sickest patients in Britain. That’s essentially the same recommendation made this spring by the California Technology Assessment Forum, a group funded by insurers.