Question
Do London patients have to switch from Viramune 400 mg to generic nevirapine 200 mg?
5 August 2013. Related: Access to treatment, All topics, Changing treatment.
I am so so confused right now as I am on nevirapine (Viramune) 400 mg for 2 years or so and my clinic has recently decided WITHOUT CONSULTING ME that I am going to change to nevirapine 200 mg (generic option) of 2 tablets a day taken once.
Their reasoning is the price and I really want to understand if the generic option they want to offer is the same as the slow release I am on right now.
I understand that NHS is trying to cut down the price of meds but what angers me is their lack of planning; why at the first place did they introduced us to the best viramune slow release if they knew it was going to change? It feels like we patients are some kind of bins to take whatever meds they think is cheap. what if tomorrow another company starts producing other cheap generics; Am I going to be asked to change again?
I am angry right now because at my last appointment, my consultant never mentioned this change; it’s when i went to the pharmacy that the pharmacist started explaining the change; I obviously refused to take it as I think any change of meds should be discussed with the doctor.
Another thing I doubt is if the 2 versions of nevirapine are similar, why these pharmaceutical companies can’t produce the latest version that is beneficial to us patients, the science of meds should keep moving forward not go backward. Please email your advice as soon as you can as I have to make my decision as I am running out of meds soon; I really want to stay on the slow release, what are my options?
The thing is I am on my third combination and as this is working. I don’t want anything to mess it up, not just to save money. My life is precious and I pay enough taxes that I deserve to be given the best medicines.
Answer
NOTE: also see updated comment below from 20 September 2013.
Hi
Thanks for your email which brings up important questions about:
- Changing to generic ARVs in the UK
- Specific issues about nevirapine
- Specific issues about HIV treatment in London
I will try to answer these below – and my apologies that the answer is a bit complicated.
1. Changing to generic ARVs in the UK
Firstly, the change to generic ARVs is broadly a good thing. Approximately 60-85% of all NHS prescriptions use generic drugs, and this is how the NHS is able to provide services. Generics drugs have the same active ingredients as the brand name versions and they are just as carefully manufactured and regulated.
However, when changing to a generic version, your doctor should discuss this with you first and you should have the chance to ask any questions that you are worried about.
2. Specific issues about nevirapine
Secondly, nevirapine is a slightly different example because there are two versions:
(i) a 400 mg prolonged release (PR) formulation – you take 1 x 400 mg tablet once a day (daily total 1 x 400 mg tablet); and
(ii) a 200 mg original formulation – you take 1 x 200 mg tablet twice a day (daily total 2 x 200 mg tablets)
Technically, the move to generic formulations in the UK is only recommended when switching exactly the same formulation and dose. So if you currently use the original 200 mg version of nevirapine you will be asked to switch to the 200 mg generic formulation. This would be expected to continue to work in just the same way.
As you are currently using nevirapine 400 mg prolonged release formulation, the London Commissioning Group see this as being different. They are not asking clinics to switch people from the 400 mg version to the original 200 mg formulation. However, individual clinics in London may have their own policy to do this, but if this is the case they need to explain the differences to you and to say that according to the product label the 200 mg is a twice-daily drug. Under these circumstances, you would be able to ask to stay on the same once-daily formulation because changing from a once-daily to a twice-daily combination is not approved just to make financial savings.
This is even more complicated because in the past it was common for people to take the original formulation once daily (2 x 200 mg once-daily). However, this is not how the drug is licensed, so it has never been approved for this dosing. Having said this, taking 2 x 200 mg once-daily is likely to be very similar for most people, especially if they have had an undetectable viral load for several years.
Your situation may be different though becasue you are on your third combination. As there is no data looking at people switching from 400 mg to 2 x 200 mg twice-daily, your doctor may want to be cautious and think there is also a clinical reason why you should stay on 400 mg once-daily.
This is something for you and your doctor to decide and you are right to speak to your doctor before making this change. This could easily be something that the hospital decided as a recent policy though, without having explained this to their doctors.
3. Specific issues about HIV treatment in London
Finally, we have issues about HIV services that are currently specific to London but which are likely to be similar across the country. This is because the NHS is developing a new way of commissioning HIV services and the details are still being worked out.
The London HIV Consortium is responsible for commissioning HIV services including drug purchasing across London. The guidelines that they produce related to cost savings specific that generic HIV drugs have to be “like-for-like”. So anyone using 3TC (lamivudine) will be changing to a generic version. They cannot ask clinics to switch from 400 mg nevirapine to 200 mg nevirapine though because these formulations are different. Even if this saves money and might be safe for most people, they have technically decided not to do this because it requires with off-label prescribing or switching to twice-daily dosing.
However, drug pricing is complex and changeable. The switch to generic versions is based on cost savings without affecting quality of care. If the brand manufacturers reduce their drug costs now that the patents have expired, this would limit the need to switch people anyway. This is likely to become clearing for nevirapine in the next few months as the patent only recently expired for this drug.
UPDATED COMMENT: September 2013
Although only one London clinic originally changed to use the generic 200 mg formulation, other hospitals may may the same decision in different parts of the UK. When this happens your doctor should explain that the formulations are technically different but that there is now evidence that clinical differences have been seen from doing this. It may be that they are both equally safe.
This includes taking two x 200 mg tablets together once-daily, even though this is off label use, because this was such common practice before the 400 mg version became available.
Even though technically the commissioners are not asking clinics to switch back to the 200 mg version, if the clinic does this your only likely option would be to change clinics, but that clinic might also decide to change later.
I don’t think you have a right as a patient to decide which of two formulations you are prescribed unless there is a significant risk, and if this was the case, the hospital is very unlikely to be making the change. However, if you are unhappy, then you have the right to ask for the decision to be explained and perhaps reviewed, and you always have the right to make a formal complaint.
The differences between 200 mg twice-daily, 2 x 200 mg once-daily and 1 x 400 mg once-daily are likely to be so small that even if a study was carried out is might need thousands of patients to see a small difference. This study will never be done because nevirapine is now a generic drug and so there is no financial incentive for a company and such a low safety concern for the NHS not to prioritise this either.
Using the 2 x 200 mg dose once-daily was very common before the 400 mg version became available without any indication that it was any worse than the 400 mg that came later. Also, there is no data showing that the 400 mg has any better outcomes, just a slightly different way of staying in the body for longer.
Although NHS commissioners and drug companies are both prevented from promoting off label uses of a drug but this doesn’t mean they are unsafe.
The are lots of examples where off-label use has been common for HIV treatment and that this can be just as effective or better and can improve quality of life:
- The first protease inhibitors were never approved to either boost or be boosted by other protease inhibitors but it was much safer to use them this when even when the companies didn’t support this.
- Abacavir and 3TC were both twice daily drugs for years – perhaps more than a decade – until it was realised that taking a double dose once-daily was just as effective because the active levels inside cells supported this. Nevirapine may be a similar case.
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