Bye Bye Warfarin?

SomeDose

Ok so the title is somewhat exaggerated, but now that dabigatran (Pradaxa) has gained a license for prevention of stroke & thromboembolism in patients with AF, it's likely that a large number of these patients will now be treated with the new drug instead. Dabigatran, a direct Factor II inhibitor, gained its approval on the back of the RELY study (available here if anyone is interested) which claimed reduced rates of stroke compared to warfarin (ARR 0.58%, NNT 172), with similar rates of bleeding. When used at a lower dose, it showed similar rates of stroke as with warfarin, but with less risk of major bleeds. I'm not the world's greatest study appraiser, but overall it looks fairly robust. One thing I'm not too sure about though is how tightly the warfarin group were kept within a therapeutic INR range. Maintaining a therapeutic INR for longer would obviously improve rates of stroke reduction.

For most patients, the most significant practical difference will be the lack of monitoring required i.e. no more blood tests to check INR. Dabigatran also has fewer interactions with food/drink and other meds.

Downsides? Well, long-term safety is obviously still a work in progress. In terms of bleeding, the main concern with dabigatran is that it cannot be reversed (unlike warfarin). This also causes problems for patients undergoing unplanned ot emergency surgery.

Cost, as always, will also be a huge issue. In the UK, where it will cost just over £900 per patient P.A., NICE are expected to give it the green light in the coming months but will attach restrictions to its use in NHS patients. AFAIK they will only fund it in those patients with contra-indications to warfarin or in those already at increased risk of intra-cranial haemorrhage.
Trouble is, I can't imagine many patients electing to start or remain on warfarin and patient demand for dabigatran is expected to be strong.

I'd be interested to hear other people's views on this, especially how they think it will pan out in Ireland. No doubt patients will start asking about it once word gets around. Will the GPs be eager to switch their patients to the new agent straight away? And will the HSE agree to fund it on the medical card, or maybe impose some kind of consultant-only / high-tech restriction on it's use?

bleg

Hopefully it won't go short like a certain brand of warfarin!

palmcut

Many GPs do not get paid for INR testing of GMS patients. Many GPs would like to see the switch from Warfarin.
Because of the cost factor the HSE may not be too keen on the switch.

RobFowl

palmcut wrote: »

Many GPs do not get paid for INR testing of GMS patients. Many GPs would like to see the switch from Warfarin.
Because of the cost factor the HSE may not be too keen on the switch.

No GP's are actually paid for INR testing on GMS patients. Some were in a pilot program some years ago but despite being successful it was discontinued.

I'd be cautious about this new drug but very optimistic in the medium to long term. Changing too quickly can be a mistake as the Cox2 class of drugs showed.

jimmydec

Potentially fantastic development! Hours and hours of practice nurse time, huge inconvenience and worry for patient and family,cautiously await progress,very exciting but agree with rob fowl

Traumadoc

It may already be yesterdays drug?

http://www.nejm.org/doi/full/10.1056/NEJMoa1107039


Apixaban FTW.

(OK it is a funded study .... I know)

jimdeans

Don't think there are many drug trials (certainly in novel antivirals) that aren't industry sponsored.

I actually know one of the authors from years back in England. Stand up guy.

Traumadoc

The other thing is compliance, warfarin by its nature and follow up ensures high rates of compliance, in the real world outside a rigorous trial, I doubt compliance with these newer drugs will be as high as with warfarin

Mucco

The NICE review of pradaxa for AF is due out any day now.

In the meantime, you might have spotted that Apixaban failed to meet it's end-points against heparin:
http://www.nejm.org/doi/full/10.1056/NEJMoa1110899

Vorapaxar seems to have flunked too.

Sitric

From the end of this month, Pradaxa will no longer be covered by the medical card.

Sardonicat

Sitric wrote: »

From the end of this month, Pradaxa will no longer be covered by the medical card.

Or the refund scheme (whatever it's proper name is) according to my pharmacist.

Does anyone know if cost is the only reasoning behind that decision?

Sid_Justice

so does this mean all px will be back on warfarin?

bleg

Sid_Justice wrote: »

so does this mean all px will be back on warfarin?

Yes. Unless they want to pay for it themselves.

locum-motion

Sardonicat wrote: »

...Does anyone know if cost is the only reasoning behind that decision?

Absolutely. 100%.

Sardonicat

bleg wrote: »

Yes. Unless they want to pay for it themselves.

Indeed. My family have decided to pay the €120 per month for my father's script as he really does not want to go back on Warfarin. Not everyone is the a position to do that.

bleg

Sardonicat wrote: »

Indeed. My family have decided to pay the €120 per month for my father's script as he really does not want to go back on Warfarin. Not everyone is the a position to do that.

I thought it was more than that. Is it covered on DPS?

Sardonicat

bleg wrote: »

I thought it was more than that. Is it covered on DPS?

I hope it isnt more than that! The pharmacist was just doing a quick mental estimation over the phone when she very kindly phoned to tell me that his medical card wouldn't cover it next month. And no, it's not covered on DPS, according to the same pharmacist.

spence101

My pharmacist told me that the 150mg Pradaxa pills were not covered by the drug payment scheme but the 75mg ones were so she put the order through as 75mg.

My mam is very sensitive to drugs and Pradaxa has had the least side effects of Heperin, Clexane and especially warfarin.

Would anyone know the price if these were not included on the drug payment scheme at all?

bleg

Sardonicat wrote: »

I hope it isnt more than that! The pharmacist was just doing a quick mental estimation over the phone when she very kindly phoned to tell me that his medical card wouldn't cover it next month. And no, it's not covered on DPS, according to the same pharmacist.

Ah yea, I was wondering. It's just when you said €120 alarm bells started ringing.

locum-motion

bleg wrote: »

I thought it was more than that. Is it covered on DPS?

You thought right, and it's not covered.

Sardonicat wrote: »

I hope it isnt more than that! The pharmacist was just doing a quick mental estimation over the phone when she very kindly phoned to tell me that his medical card wouldn't cover it next month. And no, it's not covered on DPS, according to the same pharmacist.

It's closer to €140.

spence101 wrote: »

My pharmacist told me that the 150mg Pradaxa pills were not covered by the drug payment scheme but the 75mg ones were so she put the order through as 75mg...

Pradaxa is covered under GMS and DPS for its licenced indications; short term prevention of blood clots following hip or knee replacement. It is not licensed for use as a replacement for warfarin for AF patients. Since it is licenced for short term use, the pharmacy will be paid for it for any given patient for a short period of time, namely one month. After that, the PCRS have said that they won't pay any pharmacy for supplying it to any patient. Your pharmacist will get a nasty surprise when they submit a claim for the second month's treatment, no matter what strength is dispensed.

spence101

locum-motion wrote: »

Pradaxa is covered under GMS and DPS for its licenced indications; short term prevention of blood clots following hip or knee replacement. It is not licensed for use as a replacement for warfarin for AF patients. Since it is licenced for short term use, the pharmacy will be paid for it for any given patient for a short period of time, namely one month. After that, the PCRS have said that they won't pay any pharmacy for supplying it to any patient. Your pharmacist will get a nasty surprise when they submit a claim for the second month's treatment, no matter what strength is dispensed.

ah, thanks for the info. It'll save me from getting a shock next month!

My Mam was actually prescribed Pradaxa for dvt, which after a quick google I realised its not registered for that purpose. It really was a last resort for doctors as she is hypersensitive to any other anticoagulants she has tried and the pradaxa has the least amount of side effects and her bloods and inr came back perfect for the first time in 6 weeks.

I dont suppose the PCRS has an appeal system for extraordinary circumstances?

anotherlostie

locum-motion wrote: »

Pradaxa is covered under GMS and DPS for its licenced indications; short term prevention of blood clots following hip or knee replacement. It is not licensed for use as a replacement for warfarin for AF patients. Since it is licenced for short term use, the pharmacy will be paid for it for any given patient for a short period of time, namely one month. After that, the PCRS have said that they won't pay any pharmacy for supplying it to any patient. Your pharmacist will get a nasty surprise when they submit a claim for the second month's treatment, no matter what strength is dispensed.

I don't think you're right there. AFAIK it is licensed now for the non-valvular AF indication, but the NCPE (the HSE version of NICE) have refused to reimburse it based on cost - presumably to get Boehringer to come back with a lower price. I wonder did they include the cost of the INR monitoring in the calculations, never mind the impact it would have on people's life not having to attend for routine monitoring...

I also believe that Vitamin K does not reverse the drug's action, and that there is currently no antidote for this or any of the other DTIs in clinical development? Surely that's worrying!

palmcut

Sardonicat wrote: »

Indeed. My family have decided to pay the €120 per month for my father's script as he really does not want to go back on Warfarin. Not everyone is the a position to do that.

My understanding is that Pradaxa will only be covered on any scheme for a maximum of 30 days.

It appears that you will have to pay the full price of Pradaxa after the first 30 days as it will not be included as part of the drugs payment scheme after those first 30 days. (so Pradaxa will be an additional payment on top of the €120)
Sorry to be the bearer of bad news.

Sitric

It is going to be chaos if everyone on Pradaxa needs to restarted on warfarin at the same time.

Sardonicat

palmcut wrote: »

My understanding is that Pradaxa will only be covered on any scheme for a maximum of 30 days.

It appears that you will have to pay the full price of Pradaxa after the first 30 days as it will not be included as part of the drugs payment scheme after those first 30 days. (so Pradaxa will be an additional payment on top of the €120)
Sorry to be the bearer of bad news.

I am aware that it won't be covered after 30 days, the pharmacist explained that to me. But I don't understand what you mean.

What will we be paying the €120 for? (Or more, as the case may well be) My father has a medical card, as he is 80, and that won't cover the Pradaxa from now on. I know Pradaxa isn't covered on DPS so assumed we would be paying full cost for the script. Why would there be an additional payment on top of the cost of the drug?

palmcut

Sardonicat wrote: »

I am aware that it won't be covered after 30 days, the pharmacist explained that to me. But I don't understand what you mean.

What will we be paying the €120 for? (Or more, as the case may well be) My father has a medical card, as he is 80, and that won't cover the Pradaxa from now on. I know Pradaxa isn't covered on DPS so assumed we would be paying full cost for the script. Why would there be an additional payment on top of the cost of the drug?

Apologies,I did not know your Dad had a medical card. His normal meds will be covered on the Medical Card; if he wants to get Pradaxa for longer than 30 days he will pay as a private patient and not as a DPS patient.

angel01

My Dad has been prescribed Pradaxa and now it is not covered, we are now going to Northern Ireland for this drug, which will now cost us under 100 sterling. He was going to be charged by his local chemist over 400 Euro per month.

If anyone wants the chemist name that we are going to use, please PM me.

WhosUpDocs

http://www.ncpe.ie/u_docs/news_doc_103.pdf

Coincidently the head of the NCPE is one of my lecturers and was very concerned that viable therapies are now being turned down categorically for economic reasons.

locum-motion

spence101 wrote: »

...
I dont suppose the PCRS has an appeal system for extraordinary circumstances?

Everyone who's ever had any reason to deal with the PCRS will have LOL'd at that question!
Do you remember the bit in The Terminator where Reece was explaining what was after her? "It can't be bargained with. It can't be reasoned with. It doesn't feel pity, or remorse, or fear. And it absolutely will not stop, ever, until you are dead."
That's the PCRS. Well, except for the "until you are dead" bit!

George2111

I was quote 3 different prices today 310 .... 283 and 200 euro .... shop around