This does beg the question, lets assume a positive phase 3 trial from Normay published in 2018, could doctors prescribe Rituximab then ? If not what is the formal approval process, who makes an application and to what regulatory bodies and how long would it take? If this has already been discussed elsewhere aplogies, just let me know.
We have discussed it a bit but I am not sure anybody knows all the answers. Doctors can prescribe rituximab for ME in most countries if there is a source of funds and they are prepared to take on the responsibility of off label treatment. They are doing so in the USA and have done so in other countries.
Normally everyone thinks in terms of a licence for a drug for a disease. However, lupus has been treated for decades with all sorts of things and there are no licences for treating lupus (maybe one or two). If a drug company has a licence for a drug so that it can sell the drug to a pharmacy then the only real question is who approves the doctor taking it from the pharmacy and treating something else. In the UK in the NHS it is the body called NICE. Traditionally NICE works like the Medicines Control Agency that gives licences in that it asks the company to justify the treatment. However, this is completely illogical since what matters is not whether the company has a right to sell the medicine but whether patients are entitle to it as part of their public insurance system because it works.
I think that if the Norwegian phase 3 study comes out clearly positive there will be a sort of tsunami effect on decision making that will simply be unblockable. Government run health care systems may still drag their feet as much as possible but eventually they will be swept with the tide, as they have been in RA. If the pennypinching going on in the UK and elsewhere continues to tighten then there may come a time when this sort of thing just gets blocked - and that may be yet another reason to get private insurance as well for those not already daignosed! But as things are I think organisations like NICE will be put in a legal position they have never been in before. They will not be able to say - we will not fund yet because the company has not provided enough data, because the company has nothing to do with it.
Put another way, if the phase 3 study is clearly positive all the regulatory rules are irrelevant. We will be in a new ball park and PWME will be in a totally different position when it comes to pushing for treatment. I think a number of practitioners within government health care systems will make sure they find ways of offering the drug.