The short answer is yes. The special access program has been in operation for a long time and, as I mentioned earlier, it requires a dialogue with physicians, so the physician has to determine that specific therapy is the best choice for their patient.
They submit a request; it's assessed in the program and then it's ultimately authorized. There may, at times, be problems with documentation or lack of documentation, so there may be a further dialogue. If there isn't a response, it may ultimately be cancelled. If the dialogue with the physician is such that it is determined that it's not the best therapy, then it may be withdrawn.
Actually, formal denials are 0.3%. Last year there were 13,000 requests for the special access program, and only 48 were denied, so it's very rare.
Speaking to your question about process improvements, one of the things we've done is to look at when denials happen and ask how we can make that better. In the last year or two we've actually hired additional resources with clinical expertise, so we have a clinical pharmacist who actually works in the health care system as well as working for Health Canada. Before we make any denials, currently this individual, or someone with similar skills, will contact the physician and have a dialogue. Putting this in place has dropped our denials from about 1.5% to 0.3%, so there is a conversation.
You mentioned the situation with the drugs for the skin condition, larva migrans. We can't speak to specific requests, because that is private information, but I would just say that one of the bars that used to be met is that the request has to explain why the condition is serious and life threatening, and have the documentation on the use and safety and efficacy.
Sometimes requests will come in where that isn't clear. If you have certain conditions, like infectious diseases or the type of conditions that can be self-limiting or there can be aspects where it becomes life threatening, it requires a dialogue to determine whether the situation is serious and life threatening when it's approved.
Putting in place these additional clinical contacts I think will go a long way to avoiding situations where the problem is more clarity of information between the program and the practitioner.
As for other improvements, the communication is there. We've added clinical expertise. We've actually increased the collaboration across directorates and with the bureaus involved with approving drugs. You mentioned drugs that have been on the program for a long time, and this is an area where we are focusing and we've had dialogue with industry on why these drugs aren't coming in. Is it low volume or is it marketing decisions? We're putting in place a series of incentives to try to get companies that have had their drug on the program for so long to actually come in and market the drug.
We've had some success in the last year. We've had three of the top 10 drugs that were on the program for a number of years actually come in and get market approval, so that's a lot of help for pharmacists, for physicians and for hospitals, and we continue to work on that.
The other challenge you mentioned was patients who are on drugs for a long time on the program. Again, we've looked at this and we are changing some of our processes around situations where it's likely there will be a repeat request where the authorization period could be extended.
Having said that, the program is providing access to unapproved therapies that haven't gone through a formal assessment by the regulator to look at safety, quality, and efficacy. Some of these drugs are well known, and some are not, so the hesitancy to provide a long period of approval is that really they're not at the same bar. We don't have the same understanding as we do with approved drugs on the market in Canada.