Cabenuva

[Pirata]

Has anyone tried this medicine? This is the monthly injection.

[Mightysure]

I have. I'm in the clinical trial and today is my 3 year anniversary.

It is a life changer. No more pill bottles, no more remember if you've taken your pill, worrying about if you ate enough for the meds that require food. No more worrying about pills bottles and airport security.

You just get two and go on with life.

Now everything isn't peachy keen. The injections, at least initially, do come with some injection site pain.  You do have to go into the clinic every month for the shots (for the time being anyway).

I'm currently in the trial to test the effectiveness of bi-monthly injections. So hopefully soon, people can live with only 6 doses per year.

I hope that helps

[PozChilean]

I have. I'm in the clinical trial and today is my 3 year anniversary.

It is a life changer. No more pill bottles, no more remember if you've taken your pill, worrying about if you ate enough for the meds that require food. No more worrying about pills bottles and airport security.

You just get two and go on with life.

Now everything isn't peachy keen. The injections, at least initially, do come with some injection site pain.  You do have to go into the clinic every month for the shots (for the time being anyway).

I'm currently in the trial to test the effectiveness of bi-monthly injections. So hopefully soon, people can live with only 6 doses per year.

I hope that helps

That's a good point you make about traveling; I'd never thought about it.

I don't know if I could put up a with monthly date with needles... I hate them! 

[Mightysure]

That's a good point you make about traveling; I'd never thought about it.

I don't know if I could put up a with monthly date with needles... I hate them! 

Yea. It's two needles every month. However, they are seeking approval for dosing every other month, if that makes a difference.

I will say that you get used to it after a while.  The ripilvirine used to burn like hell going in at first, but now it's just a normal routine.

It's just a god-send for me. I found an old Genvoya bottle from years ago and thought how easier my life is now.

[leatherman]

they are seeking approval for dosing every other month

speaking of travel, it'll be good to see if every other month works out. A shot (or two) a month would be great after nearly 3 decades of HIV meds; however for my husband and me, it's at least an hour trip or more (about 45 miles) to travel from our rural state to the metro area in the neighboring state for us to reach our doctor. Until this becomes a DIY shot, or at least bi-monthly (every 2 months), a number of patients will have travel as an access issue.

[Loa111]

However, they are seeking approval for dosing every other month, if that makes a difference.

One shot every 2 months would be amazing & such a freedom.

Until this becomes a DIY shot, or at least bi-monthly (every 2 months),

Or even better, a DIY self-administered shot (like diabetics have).

I was asking my ID Doc about the monthly shot a few weeks back. He said it is not approved for Ireland yet, though he expected it will be at some point in the future. I'll wait for the ever 2 months option, might take several years, but will be worth it if it becomes available.

[Mightysure]

Yes. My life has had so much freedom for these years of the clinical trial. I understand that some things will become my responsibility once the trial ends (dealing with insurance and the pharmacy), but the mental freedom of not having to be reminded every day of HIV is the biggest freedom.


As for the 2 month option, I do want to let folks know that the 2 month dose is 1.5x more than the monthly dose. That will likely impact any injection site reactions such as intial discomfort people often experience with the first few injections.

I'm not sure how drug approval works in Europe because I know that Cabenuva has been approved by the EU. Does each member country still have to approve drugs?

[Jim Allen]

I'm not sure how drug approval works in Europe because I know that Cabenuva has been approved by the EU. Does each member country still have to approve drugs?

Yes, No, depends. Red tape and costs.

There are two for a med to be approved within the EU, they are listed here: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines

In the example of this drug though for it to roll out in Ireland, the medication would need additional approval from the Health Products Regulatory Authority (HPRA). Once approved though it does not mean a medication would be available, we see this with other meds held up depending on the costs to the state, budgets and cheaper treatment options available etc.

I do think this injection option monthly or bi-monthly will suit some people, not sure we have the capacity in clinics here yet. When we do get it like everything it will not be everyone's cup of tea but it gives people more choices and that's okay.

For example, I'm loving my current treatment, the normality in my life and the freedom from it, understand for others this is not the case. Injections every month or two months would mean visiting the clinic and next to managing all my other issues it would add a additional burden I am not sure I could cope with.

Jim

[Mightysure]

Yes, No, depends. Red tape and costs.

There are two for a med to be approved within the EU, they are listed here: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines

In the example of this drug though for it to roll out in Ireland, the medication would need additional approval from the Health Products Regulatory Authority (HPRA). Once approved though it does not mean a medication would be available, we see this with other meds held up depending on the costs to the state, budgets and cheaper treatment options available etc.

I do think this injection option monthly or bi-monthly will suit some people, not sure we have the capacity in clinics here yet. When we do get it like everything it will not be everyone's cup of tea but it gives people more choices and that's okay.

For example, I'm loving my current treatment, the normality in my life and the freedom from it, understand for others this is not the case. Injections every month or two months would mean visiting the clinic and next to managing all my other issues it would add a additional burden I am not sure I could cope with.

Jim

I understand.  As you know in the US, the state is not the primary payer for medical costs, it is on us and our insurance companies. For those on state-provided health insurance, there may be restrictions based on costs more so than private insurance carriers.

But I think that's why the 2 month option will be the big push it needs to get support from insurance companies, especially the state.

And I recognize that Cabenuva won't be for everyone. No treatment is. I thought I'd scare my experience with it for those who have questions about it since there aren't too many people who are on it. 

And even though it has been approved by the FDA in the US, there's still logistical things they still have to iron out, i.e. if pharmacists will be trained to administer, if clinical visits will be an additional cost to patients, guidelines on setting criteria for patients to qualify for it, etc. 

But as with anything that is different from the current paradigm, it has kinks to be worked out.

[Pirata]

I asked my doctor for it and he said it’s hard to get into the process. He said only two people here in NC have been approved by the insurance and that the company has not figured out the copay process. I decided to wait until my next appointment in August to see if there has been any changes, he also mentioned the trials for bimonthly injections. Thank you for your feedback!! And I will see if I make the change in August

[Mightysure]

I asked my doctor for it and he said it’s hard to get into the process. He said only two people here in NC have been approved by the insurance and that the company has not figured out the copay process. I decided to wait until my next appointment in August to see if there has been any changes, he also mentioned the trials for bimonthly injections. Thank you for your feedback!! And I will see if I make the change in August

Thanks for that update. This is a concern for us on the trial once it ends. My study doctor expressed similar cocnerns with the logistics and how it has to be worked out.

If the bi-monthly trials are still enrolling, that is a great way to get it and not have to hassle with insurance.

So there's no copay assistance from the manufacturer?

[Pirata]

I think it’s but is like you pay and then then send you a gift card to pay you back. I think that was what my doctor said

[Matths]

A comment to the co-pay and manufacturer reimbursement: the procedure you describe that you have to pay whatever the co-pay is and that you get a gift card or anything like that as “reimbursement” is flat out wrong. You should not disseminate such ideas but get accurate information from the company.

All medicines from this company (and I assume other companies that produce HIV treatments) have patient support programs in place assuming that your insurance covers part of the cost for the treatment. The annual amount of company support is set by the company. If your co-pay is as an example 20% of what the medicine costs, your insurance pays 80% and you are responsible for 20%. You/your doctor/the pharmacy can apply for support from the manufacturer and they will reimburse the pharmacist directly up to the maximum allowable amount per year. Once this amount has been maxed out, if there is a remainder you would be responsible for it. However, you/your doctor/the pharmacist can reach out to the manufacturer to ask for additional support into cover this remaining balance. Therefore, for many of us, ie for me got example, my treatment costs me $0 out of pocket.

This is how this generally works. It’s a very well established process and every patient can access this system to be able to afford the treatment they need. Hope this helps, best Matt

[bocker3]

I have actually used a copay assistance in the past where I paid it myself and was sent a check directly to me by the copay assistance company.

This was a way to get around the fact that, at a time, copay assistance money didn't count toward your deductible and/or total out of pocket costs.  It was a bit of a hassle, with the paperwork (they often found a reason to send it back for "correction") - but it ensured that I hit my deductible and out of pocket max, relatively early.  Thus saving me (and them) money.

My state now mandates that copay assistance be included in deductible and out of pocket costs now, so I no longer do it that way.  I simply have my pharmacy deal with getting the money from them.

Mike