TOPIC:

My GP told me today that these drugs are S100 medications and so she could not prescribe them. She referred me to a doctor who is trained in prescribing S100 medications. Was this accurate information?

At the moment, in Australia a private prescription would be the only way to access the medications, although as far as I know nobody has any stock.

The proposed and pending PBS listing is and S100 listing.

S100 is not a - do the S100 course and you can prescribe S100 medications.

It is a do the S100 HIV prescriber course and you can prescribe S100 HIV medications (but not any other S100 medications).

So when the PBS listing happens it will be under S100 - well at least that's what the PBAC suggested. At that moment Infectious Disease Physicians and Gastroenterologist will probably be "grandfathered" ie given S100 rights because of experience/qualifications.

GPs will need to do a specific course, pass an exam, and then (probably) spend X days/consults with an approved S100 prescriber to get their ticket.

This process is exactly what was required for me to be able to prescribe methadone. A 2 day course at Sydney University. An exam. And then to actually get the ticket you have to sit in with someone and see some patients.

Only after doing all that can a GP get their ticket to prescribe.

It's a good process that makes sure people prescribing know what they are doing, but it is also a barrier.

Hep C patients are unusual in that as a group they are very, very well informed about the best treatment, but with things like Daclatasvir that have a lot of interactions to consider it's a little more complicated than meets the eye.

I've been fortunate to have experts offer me personal advice. For example one expert pointed me to

www.hep-druginteractions.org/checker

Which is a great tool for checking drug interactions. At his unit they use it all the time and file it in the notes.

Now I know about it I use it all the time, but it was important need to know stuff that when I met patient zero I simply did not know.

I'm still a bit confused on this topic. I'll summarise what I'm perhaps understanding:

1. At present the new HepC drugs are not listed at all, so they are not S100 medications. Therefore, right now, any medical practitioner can legally prescribe them.
2. If the drugs are listed in November, they will be S100 medications, and thus prescribing of them will be greatly restricted.
3. Therefore, if you want to get a prescription for the drugs now to use for the Buyers Club, it's best to do it before the end of November, because any (kind and brave) doctor can do it now, but that might not be the case in December.

Is all of this correct?

Is all of this correct?

No.

1 Is correct however...

A doctor can prescribe anything clinically indicated on a private script.

Our PBS is a subsidy scheme that typically has restrictions about what medications can be prescribed by which doctors to which patients for which conditions.

2. Is correct in that if these medications are listed as S100 (they may not be). Most PBS medications can be prescribed by any doctor. S100 medications are an exception where only S100 approved doctors can prescribe.

However for patients who don't meet the criteria, or doctors who are not S100 approved, private scripting will remain entirely possible. These private prescriptions will however not allow access to the PBS subsidised medication

3. We have historically rarely (?never) seen open slather access of newly listed PBS medications. Usually the restrictions are lifted over time as prices fall.

While it would be wonderful for all patients to have simple access to these medications via their GP there are several hurdles:

1. Agreeing a price with Gilead
2. Putting that to Cabinet for approval (historically Viagra and Nicotine Replacement Therapy fell over at this point)
3. Actually making the listing on the PBS

As I understand it we are still at 1.

Because of the massive price to government I am less than optimistic about it getting the nod in Cabinet.

At the moment the options for patients are wait and hope, or action a personal import.

PBAC recommend in March 2015 and July 2015 that the new drugs should be s85 not s100, which means they will be able to be prescribed by a regular GP and dispensed at a community pharmacy. This is in recognition of the fact that the current models of care (hospital clinics) will not be able to meet the demand for treatment and the fact that treatment will be much less complex with the new drugs. If you have cirrhosis you will probably still need to be treated at a hospital liver clinic.

PBAC have indicated they are not keen on prioritisation of certain patient groups (by disease progression, treatment history or drug use history) which is great news for Australia. Many other countries are having to fight this battle after access to the drugs was provided.

The earliest possible announcement for PBS is now 1 December 2015, which could mean access in April 2016. The Health Minister has indicated she will not hold back PBAC recommendations once the pricing negotiations are concluded.

All we need now is the successful conclusion to the pricing negotiations.

That is great news. Having GPs able to prescribe could rapidly deliver treatment to all those that need it. I would be sad to see the rationing evident overseas repeated here.