Andexxa - for real?

[owlegrad]

So I am getting caught up on my CEs (no judging!) and just came across this agent. Holy crap, $50,000???

Has anyone actually seen this medication used?

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[ValeRx]

Harvoni is pretty expensive too. Something like 30k for a bottle of 28 tabs.

 

[Rouelle]

So I am getting caught up on my CEs (no judging!) and just came across this agent. Holy crap, $50,000???

Has anyone actually seen this medication used?

I went to a drug rep dinner funded by the Andexxa rep. The steak was phenomenal.

 

[ornithoptor]

Radicava, 750K the first year. That is the cost without any markups.


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[PolarPop]

I heard it wasn’t even that great for $50k. Something about a short half-life and Kcentra being cheaper and maybe as good. That’s all I can remember from our office freaking out when the request came in.

 

[owlegrad]

I heard it wasn’t even that great for $50k. Something about a short half-life and Kcentra being cheaper and maybe as good. That’s all I can remember from our office freaking out when the request came in.

According to PL I should expect to continue seeing Kcentra used off label. Apparently they are correct as usual.


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[Stella14]

We’ve used it 3 or 4 times since it became available


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[awval999]

I heard it wasn’t even that great for $50k. Something about a short half-life and Kcentra being cheaper and maybe as good. That’s all I can remember from our office freaking out when the request came in.

That is list price for the highest dose (the double dose)
Regular dose is $25000, with a $12,500 Medicare NTAP payment, so net net $12,500.
Andexxa is also the recommended standard of care in CHEST.

Andexxa binds directly to the Xa inhibitor and inactivates the drug.
Kcentra is literally Factors II, VII, IX and X, trying to overwhelm the drug by adding coagulation proteins, which risks re-bound clotting in these patients who were put on Xa inhibitors for a pro-thrombotic state.

The short half life of Andexxa is a benefit.

 

[owlegrad]

That is list price for the highest dose (the double dose)
Regular dose is $25000, with a $12,500 Medicare NTAP payment, so net net $12,500.
Andexxa is also the recommended standard of care in CHEST.

Andexxa binds directly to the Xa inhibitor and inactivates the drug.
Kcentra is literally Factors II, VII, IX and X, trying to overwhelm the drug by adding coagulation proteins, which risks re-bound clotting in these patients who were put on Xa inhibitors for a pro-thrombotic state.

The short half life of Andexxa is a benefit.

Apparently Andexxa also has a risk of rebound clotting though. Not sure how big a risk compared to Kcentra though.


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[lane one]

That is list price for the highest dose (the double dose)
Regular dose is $25000, with a $12,500 Medicare NTAP payment, so net net $12,500.
Andexxa is also the recommended standard of care in CHEST.

Andexxa binds directly to the Xa inhibitor and inactivates the drug.
Kcentra is literally Factors II, VII, IX and X, trying to overwhelm the drug by adding coagulation proteins, which risks re-bound clotting in these patients who were put on Xa inhibitors for a pro-thrombotic state.

The short half life of Andexxa is a benefit.

Thrombosis rate was 18% 12hr post infusion for Andexxa. $50K pile of garbage.

 

[PharmDBro2017]

Thrombosis rate was 18% 12hr post infusion for Andexxa. $50K pile of garbage.

Link to study?

Let em die from bleeding out rather than an 18% chance of developing a thrombus, solid idea.

 

[Pharmacy is a Scam]

So I am getting caught up on my CEs (no judging!) and just came across this agent. Holy crap, $50,000???

Has anyone actually seen this medication used?

How else is pharma supposed to recoup their “R&D costs”? 7-10 years of drug discovery and development, clinical trials testing and tv ad development not to mention free samples at doctors’ offices and free steak dinners to sell a drug for $100 a pop? I don’t think so.

 

[spacecowgirl]

And yet, people will still give vit K infusions.

IIRC, the reversal agent isn't indicated to reverse the Xa made by the same company that makes Andexxa

 

[PolarPop]

That is list price for the highest dose (the double dose)
Regular dose is $25000, with a $12,500 Medicare NTAP payment, so net net $12,500.
Andexxa is also the recommended standard of care in CHEST.

Andexxa binds directly to the Xa inhibitor and inactivates the drug.
Kcentra is literally Factors II, VII, IX and X, trying to overwhelm the drug by adding coagulation proteins, which risks re-bound clotting in these patients who were put on Xa inhibitors for a pro-thrombotic state.

The short half life of Andexxa is a benefit.

It’s not my field so I don’t personally have an opinion on this drug. I know the P&T decision has been tough for many places. It was written about in JAMA the other day.
Reducing the Expert Halo Effect on Pharmacy and Therapeutics Committees

 

[njac]

That is list price for the highest dose (the double dose)
Regular dose is $25000, with a $12,500 Medicare NTAP payment, so net net $12,500.
Andexxa is also the recommended standard of care in CHEST.

Andexxa binds directly to the Xa inhibitor and inactivates the drug.
Kcentra is literally Factors II, VII, IX and X, trying to overwhelm the drug by adding coagulation proteins, which risks re-bound clotting in these patients who were put on Xa inhibitors for a pro-thrombotic state.

The short half life of Andexxa is a benefit.

We still didn’t add it to formulary.


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[Rockinacoustic]

Wow, a clinical topic on these forums?

Apparently Andexxa also has a risk of rebound clotting though. Not sure how big a risk compared to Kcentra though.


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Short answer: lower thrombosis but higher 30-day mortality in this study: Management of rivaroxaban- or apixaban-associated major bleeding with prothrombin complex concentrates: a cohort study

 

[CetiAlphaFive]

So I am getting caught up on my CEs (no judging!) and just came across this agent. Holy crap, $50,000???
Has anyone actually seen this medication used?

Nope

 

[owlegrad]

Wow, a clinical topic...[/URL]

Sorry, that’s my bad.



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[awval999]

Thrombosis rate was 18% 12hr post infusion for Andexxa. $50K pile of garbage.

Interim Report on the ANNEXA-4 Study: Andexanet For Reversal of Anticoagulation in Factor Xa – Associated Acute Major Bleeding

Read the interim report.

The vast majority of thrombotic events are due to not restarting anticoagulation.

It has a ~2% thrombotic rate for the first 72 hours.

This drug is for real. It should have heavy restrictions and be used only for life-threatening ICH / GI bleeds / traumas after confirmation of recent Xa use. But it's life saving.

 

[lane one]

Interim Report on the ANNEXA-4 Study: Andexanet For Reversal of Anticoagulation in Factor Xa – Associated Acute Major Bleeding

Read the interim report.

The vast majority of thrombotic events are due to not restarting anticoagulation.

It has a ~2% thrombotic rate for the first 72 hours.

This drug is for real. It should have heavy restrictions and be used only for life-threatening ICH / GI bleeds / traumas after confirmation of recent Xa use. But it's life saving.

The data I saw presented from ANNEXA-4 wasn't compelling, but I guess I need to revisit the topic.

 

[sakigt]

Its only available at our main campus for now. Just another expensive drug for me to police. Not looking forward to it.

Pharmacy directors want passive Pharmacists that follow their every wish without question then sit those same Pharmacists in a busy department then tell ER docs their $40k Icatibant wont work for ACEI Angioedema and that $50k Andexxa probably isn't appropriate for mild GI bleed. Sheesh.

 

[awval999]

Its only available at our main campus for now. Just another expensive drug for me to police. Not looking forward to it.

Pharmacy directors want passive Pharmacists that follow their every wish without question then sit those same Pharmacists in a busy department then tell ER docs their $40k Icatibant wont work for ACEI Angioedema and that $50k Andexxa probably isn't appropriate for mild GI bleed. Sheesh.

I'm a hospital pharmacy manager.

That's not true.

Please do your job. Those drugs are life saving antidotes. By all means, please police them. That's what you're paid to do. The ED pharmacists at my facility are the smartest, more important clinical specialists in the entire hospital.

 

[sakigt]

Don't be surprised when theyre also the spiciest, just sayin.

 

[ldiot]

I've seen it used. The hospital I was at was part of an early access program or something and carried one dose on-site

 

[lane one]

Anyone have a link to the actual data and methodology from Annexa-4? All I can find are the slides from the interim report which leave quite a bit to be desired. For example, how were their secondary endpoint of effective hemostasis defined (excellent, good, poor etc.)?

Edit: Nevermind. Just noticed they cited the Sarode study for their methodology.

 

[awval999]

Full results from Annexa-4 released this week.

 

[awval999]

I heard it wasn’t even that great for $50k. Something about a short half-life and Kcentra being cheaper and maybe as good. That’s all I can remember from our office freaking out when the request came in.

Apparently Andexxa also has a risk of rebound clotting though. Not sure how big a risk compared to Kcentra though.

Thrombosis rate was 18% 12hr post infusion for Andexxa. $50K pile of garbage.

We still didn’t add it to formulary.

The data I saw presented from ANNEXA-4 wasn't compelling, but I guess I need to revisit the topic.

https://www.nejm.org/doi/full/10.1056/NEJMoa1814051?query=featured_home

Boom. Lives are saved with this drug. Life threatening ICH or GI bleed mortality rate reduced to 14% when standard of care is 50%. Zero thrombotic events when Xa's restarted.

RESULTS
Patients had a mean age of 77 years, and most had substantial cardiovascular disease. Bleeding was predominantly intracranial (in 227 patients [64%]) or gastrointestinal (in 90 patients [26%]). In patients who had received apixaban, the median anti–factor Xa activity decreased from 149.7 ng per milliliter at baseline to 11.1 ng per milliliter after the andexanet bolus (92% reduction; 95% confidence interval [CI], 91 to 93); in patients who had received rivaroxaban, the median value decreased from 211.8 ng per milliliter to 14.2 ng per milliliter (92% reduction; 95% CI, 88 to 94). Excellent or good hemostasis occurred in 204 of 249 patients (82%) who could be evaluated. Within 30 days, death occurred in 49 patients (14%) and a thrombotic event in 34 (10%). Reduction in anti–factor Xa activity was not predictive of hemostatic efficacy overall but was modestly predictive in patients with intracranial hemorrhage.

Within 30 days of enrollment, thrombotic events occurred in 34 patients (9.7 percent) and death occurred in 49 patients (13.9 percent), consistent with previous ANNEXA-4 trial results and with the high background thrombotic risk of the enrolled patient population. The majority of thrombotic events occurred in patients who delayed or did not re-start anticoagulation therapy with a Factor Xa inhibitor during the follow-up period. Among the 100 patients who re-started oral anticoagulation therapy, no thrombotic events were observed.

 

[Rockinacoustic]

Cost aside, I'm still not seeing the huge advantage of this over 4-Factor-PCC. Especially when I can mix and get KCentra to the bedside faster than this cumbersome drug.