New Drugs for Expiring Patents

[sdn1977]

New drugs are ahead which will be marketed to try to replace those with expiring patents. They are metabolites or isomers of existing drugs with the pitch that they will give better efficacy or fewer side effects.

Some live up to their pitch, some won't....but this is what's ahead:

Invega (paliperidone) - the active metabolite of risperidone. It is sustained release, so its dosed just once a day. Studies show it works as well, but will not require dose titration??? Also, less concern about drug interactions with drugs that inhibit CYP2D6 (paroxetine, fluoxetine)

Pristiq (desvenlafaxine) - the major metabolite of venlafaxine. Has comparable efficacy & tolerability. It will be approved for depression & hot flashes, but also has been used off-label for fibromyalgia & neuropathic pain.

Don't know exactly when the release dates are, but they're expected in 2007. So....you've got a jump on the reps !

Finally, Focalin (dexmethylphenidate) was marketed to cause fewer side effects than methylphenidate....but, so far, no conclusive post-marketing proof.

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[OldPsychDoc]

It's sad really...there is nothing more pathetic than a drug rep who is trying to convince you that "Oh yes this really IS better than the last one...". Was sitting at a table with several other attendings as the poor Invega rep was trying to push his pill to blank faces...bad enough trying to push atypicals with CATIE out there, but this...?

 

[Milo]

We've got the Invega in the sample cabinet now, and oddly enough they've stopped sampling the 1mg and 2mg Risperdal. What a shock!

 

[Anasazi23]

New drugs are ahead which will be marketed to try to replace those with expiring patents. They are metabolites or isomers of existing drugs with the pitch that they will give better efficacy or fewer side effects.

Some live up to their pitch, some won't....but this is what's ahead:

Invega (paliperidone) - the active metabolite of risperidone. It is sustained release, so its dosed just once a day. Studies show it works as well, but will not require dose titration??? Also, less concern about drug interactions with drugs that inhibit CYP2D6 (paroxetine, fluoxetine)

Pristiq (desvenlafaxine) - the major metabolite of venlafaxine. Has comparable efficacy & tolerability. It will be approved for depression & hot flashes, but also has been used off-label for fibromyalgia & neuropathic pain.

Don't know exactly when the release dates are, but they're expected in 2007. So....you've got a jump on the reps !

Finally, Focalin (dexmethylphenidate) was marketed to cause fewer side effects than methylphenidate....but, so far, no conclusive post-marketing proof.

I was involved in the naming of Invega in a focus study a long time ago. They make you read endless lists of possible marketable drug names, and call their answering machine and read them to see if physicians can easily pronounce them. Sort of interesting. Finally it's coming out. We'll have to see the ne literature to see if its got any advantage over conventional risperdal. If they're smart, they'll test dosing on children. They use Risp a lot there.

 

[OldPsychDoc]

Isn't it an ethical violation to test new drugs on expiring patients?

Oh.

never mind....

 

[Anasazi23]

Isn't it an ethical violation to test new drugs on expiring patients?

Oh.

never mind....

When I first read the thread title, I saw the same thing (briefly). Glad I wasn't the only one.

We probably need therapy.

The sickest part was that I thought that was a really interesting and needed pharmacological field.

 

[maranatha]

When I first read the thread title, I saw the same thing (briefly). Glad I wasn't the only one.

We probably need therapy.

The sickest part was that I thought that was a really interesting and needed pharmacological field.

Oh crap...I thought the same thing when I read the post. And I'm not yet a burned-out-resident or cynical attending....I'm doomed!

 

[OldPsychDoc]

Oh crap...I thought the same thing when I read the post. And I'm not yet a burned-out-resident or cynical attending....I'm doomed!

Fear not.
I was this way BEFORE I was a burned-out resident or cynical attending.
It just means that you've got what it takes to make it to this level!

 

[Hurricane]

We were visited by the Invega rep last week. The most interesting thing to come of our questioning was this: Invega's sustained release delivery system is the same that's used for Concerta. Which means the patients poop out the empty "ghost" pill capsule. Something you might want to warn your more paranoid patients about. Otherwise they might mistake it for proof of alien implanted tracking devices

 

[MBK2003]

Invega (paliperidone) - the active metabolite of risperidone. It is sustained release, so its dosed just once a day.

Am I the only one who prescribes Risperidone once daily?

 

[sdn1977]

Oh gosh!!!!! Did I say patients????? I meant patents ! Kind of weirdly funny though - I'm embarrassed to say! Not much post-marketing surveillance on that group of pts (gallows humor ).

Hmm...studies - not so much with the whole pedi population studies...those are expensive & not done so much. Too much cost & liability! There has to be a clear reason for them and lots of regulatory hoops to jump thru & if the drug is used off label for that population, its not such an issue...altho becoming moreso with these drugs. Oddly enough...the only prescriber who I've had give risperdal in a child less than 8 was a private practice FP - worrisome, particularly since I'm within 15 miles of a child/adolescent pschiatry inpt/outpt center......can't judge since I'm not in that business - just observation.

But...naming studies can be cool to do - I've done about 20 & they're interesting!

Sorry again about the expiring patients - that is waaaay too weird! I'm just trying to keep you posted about your new "stuff" out there. And..yeah - lots of daily risperdal....but...less & less risperdal at all (I've actually discarded both my 1mgs & 2mgs due to lack of use) - my pts say they're too tired in the day. The elderly still get it at bedtime - but fewer & fewer active adults.

 

[OldPsychDoc]

Oh gosh!!!!! Did I say patients????? ...Sorry again about the expiring patients - that is waaaay too weird! I'm just trying to keep you posted about your new "stuff" out there. And..yeah - lots of daily risperdal....but...less & less risperdal at all (I've actually discarded both my 1mgs & 2mgs due to lack of use) - my pts say they're too tired in the day. The elderly still get it at bedtime - but fewer & fewer active adults.

No, actually, you didn't say 'patients', but a substantial number of us read it that way nonetheless. THAT is the scary part!

 

[Anasazi23]

No, actually, you didn't say 'patients', but a substantial number of us read it that way nonetheless. THAT is the scary part!

To this day, I still keep reading it like that...

 

[Chewbacca Jung]

so, now what's the consensus? is this a good thing or a bad thing that I think giving drugs to expiring patients is funny?

 

[kugel]

Am I the only one who prescribes Risperidone once daily?

I keep trying to think of something Invega actually solves.
- qDay dosing. I Rx about 80% risperidone qHS. Those that get a second dose seem to NEED a pulse of medicine earlier in the day. Invega can't provide that.
- Less P450 interaction. Has that been a big problem for a large # patients (or patents) on Risperdal?
- No doing adjustment req'd in liver failure. a big problem with risperidone? don't have all that many overt liver failure pt's in clinic. Janssen's own PI on Risperdal says there was no dosing adj needed in liver failure.
- Less side effects. If you look at Janssen's own data on most SE's of each drug, you'll find that the increase in each side effect above placebo is about the same in both drugs. If Side Effect A was ~200% that of placebo for Risperdal, it's about the the same % above placebo in Invega.

When one of Janssens' Principle Investigators was asked about these things, he said, "Well, that may be true but I have to tell you that it seems to work better in my patients," for which he's getting a LOT of $ to his clinic.
Very Scientific!

Also, why is this the only med for which the reps can't/won't provide reprints of the actual journal articles? Something is rotten in Denmark. or in New Jersey.

Clinically, Invega is an answer in search of a question.

 

[MBK2003]

I keep trying to think of something Invega actually solves.

When one of Janssens' Principle Investigators was asked about these things, he said, "Well, that may be true but I have to tell you that it seems to work better in my patients," for which he's getting a LOT of $ to his clinic.
Very Scientific!

Also, why is this the only med for which the reps can't/won't provide reprints of the actual journal articles? Something is rotten in Denmark. or in New Jersey.

Clinically, Invega is an answer in search of a question.

Bravo!
I'm training at a program with lots of pharma money flowing in the doors, and yet have a strong interest in public sector psychiatry and public policy, so I get into this debate a lot. When we use more expensive on-patent medications without clear advantage over the off-patent meds, we are running into an issue of the tragedy of the commons, namely the Medicaid funding. Both the president and many governors are targeting reductions in Medicaid spending as their stopgap measures for budget shortfalls. This is not just an issue in psychiatry, look at all the new diabetes meds which provide no additional glycemic benefit compared with sulfonylureas and metformin, much higher potential side effects, and yet are seeing significant gains in numbers of new prescriptions. Medicaid is unlikely to continue being the cash cow ("best 3rd party payer we have") and this should impact our decisions around prescribing.

MBK2003

 

[Milo]

You can tell your patient that the laser drilled osmotic pump casing they poop out daily is actually them shedding their imbeded monitors!

 

[sdn1977]

Bravo!
I'm training at a program with lots of pharma money flowing in the doors, and yet have a strong interest in public sector psychiatry and public policy, so I get into this debate a lot. When we use more expensive on-patent medications without clear advantage over the off-patent meds, we are running into an issue of the tragedy of the commons, namely the Medicaid funding. Both the president and many governors are targeting reductions in Medicaid spending as their stopgap measures for budget shortfalls. This is not just an issue in psychiatry, look at all the new diabetes meds which provide no additional glycemic benefit compared with sulfonylureas and metformin, much higher potential side effects, and yet are seeing significant gains in numbers of new prescriptions. Medicaid is unlikely to continue being the cash cow ("best 3rd party payer we have") and this should impact our decisions around prescribing.

MBK2003

I may be too tired & it may be too late for me to understand what the last part is saying....

In my state, CA.....surprisingly...I HAVE to dispense Pravachol on Medicaid - not pravastatin. Until last Sept - I HAD to dispense Glucophage on Medicaid rather than metformin on Medicaid.......who was getting the kickback??? I'm thinking the state of CA perhaps??? Is that what you're meaning by prescribing decisions? Those are rarely your decisions, unless you have significant medical justification which allows me to obtain a treatment authorization request or do a DAW-1, which even then may need a TAR. I may have read your statement completely wrong - I've been working for 13 hrs...

As for Invega - no...not much market in the outpt setting. However, as a pharmacist who also does inpt (altho not much mhu, to be sure...) - if there is not dose titration required it does get the pt out faster. So, it might get past the P&T committee based on length of stay needs only. Then...it puts the outpt folks in a dilemma. Medicaid allows 10 days of post hospitalization coverage only, generally...then we have to get it changed to a covered medication. Few, if any, private insurers will cover this as a first tier - the PBM's have become too smart!

 

[MBK2003]

I'm not in California and unfortunately am fairly ignorant of the general practice in CA around generics vs. patented meds for Medicaid. I am much more familiar with the situation in New York City, where Medicaid has been to some extent corrupted by the pharmaceutical industry- e.g. Ambien CR is the new 1st line sedative hypnotic on MCD formulary, so I'm not so naive as to believe that all decisions made by the medicaid PBM are simply in the interest of patient care, evidence-based medicine, and overall cost to the system. I personally don't chafe at the idea of a tiered Medicaid formulary that requires I give a patient trials of lower cost, soon-to-be generic antipsychotics or mood stabilizers, before moving on to much higher cost 2nd generation antipsychotics with little demonstrated effectiveness compared with first generation drugs or lower cost second generation drugs. I do this in my outpatient practice with SSRIs, why should antipsychotics and mood stabilizers be any different?

MBK2003

 

[sdn1977]

I'm not in California and unfortunately am fairly ignorant of the general practice in CA around generics vs. patented meds for Medicaid. I am much more familiar with the situation in New York City, where Medicaid has been to some extent corrupted by the pharmaceutical industry- e.g. Ambien CR is the new 1st line sedative hypnotic on MCD formulary, so I'm not so naive as to believe that all decisions made by the medicaid PBM are simply in the interest of patient care, evidence-based medicine, and overall cost to the system. I personally don't chafe at the idea of a tiered Medicaid formulary that requires I give a patient trials of lower cost, soon-to-be generic antipsychotics or mood stabilizers, before moving on to much higher cost 2nd generation antipsychotics with little demonstrated effectiveness compared with first generation drugs or lower cost second generation drugs. I do this in my outpatient practice with SSRIs, why should antipsychotics and mood stabilizers be any different?

MBK2003

Ok yes - thats what I thought you meant! Thanks for the clarification and - I agree completely.

I, for the life of me, cannot understand how & why this goes on with Medicaid, which appears to be happening in the greater part of the nation.

Pharmacy Benefit Management companies (PBMs) are very good at negotiating prices, bundling group drug prices, tailoring the bundles & contractual agreements to reflect pt populations (ie Google employees - younger, healthier vs Part D members), etc...They do this by committing $$$ or "units" over a certain # of months to the drug companies - thereby assuring a steady flow - if they don't meet that...there is a penalty which occurs in a variety of forms.

However, Medicaid is, itself, its own PBM (in CA its MediCal) & probably has similar population demographics in most states - from the very, very young to the very, very old with most illness represented. So....it would seem desirable to obtain the lowest price drug available & have the "step" therapies as you suggest. However...here I am - dispensing Pravachol & Prevacid rather than pravastatin & omeprazole.

I'm not normally a politician basher, but I gotta wonder????? Makes me cautious about whose fingers are in the pie with a nationwide uniform drug benefit. It is already a corrupted mess for Part D!

Oh...and watch for generic Ambien soon - late 2007 or early 2008 (which was why Ambien CR was developed - not for the delayed release aspect actually, altho most folks think that.)

 

[kugel]

In CA, when I'm prescribing a med that's not first tier for Medicaid ("Medi-Cal" here), I put the justification right on the script ("failed paxil and lexapro," or "previously stablized on this med," or "cannot medically tolerate side-effect of ______ inherent with ______ brand"). Area pharmacists have been great about putting that info onto a TAR immediately - thus saving the pt up to a week or more of delay. It doesn't always work, but way more than 50% of time, so it's definitely worth the extra 10 seconds it takes to write that on the script. For other situations, I often write, "if needed, please fax TAR to me at ***-**** immediately" and we get the ball rolling quickly that way. I consider the script communication to the pharmacist, and that's been working quite well, thanks to the enormous spirit of cooperation from pharmacists.

Pharmacists are the unsung heros of the medical care team. I simply can't tell you how many times they've saved patients enormous suffering (or worse), sometimes because of my mistakes or misunderstanding. I'm always amazed that someone under such time restriction and scrutiny (esp those at private pharamacies) can cheerfully accept my plea of, "Can you help me figure out what med in this class her insurance WILL cover?" In the hospital, I almost never get as much useful info from a consult as one to the pharmacologist.

I guess this has become my belated Valentine to pharmacists. THANK YOU!

 

[sdn1977]

In CA, when I'm prescribing a med that's not first tier for Medicaid ("Medi-Cal" here), I put the justification right on the script ("failed paxil and lexapro," or "previously stablized on this med," or "cannot medically tolerate side-effect of ______ inherent with ______ brand"). Area pharmacists have been great about putting that info onto a TAR immediately - thus saving the pt up to a week or more of delay. It doesn't always work, but way more than 50% of time, so it's definitely worth the extra 10 seconds it takes to write that on the script. For other situations, I often write, "if needed, please fax TAR to me at ***-**** immediately" and we get the ball rolling quickly that way. I consider the script communication to the pharmacist, and that's been working quite well, thanks to the enormous spirit of cooperation from pharmacists.

Pharmacists are the unsung heros of the medical care team. I simply can't tell you how many times they've saved patients enormous suffering (or worse), sometimes because of my mistakes or misunderstanding. I'm always amazed that someone under such time restriction and scrutiny (esp those at private pharamacies) can cheerfully accept my plea of, "Can you help me figure out what med in this class her insurance WILL cover?" In the hospital, I almost never get as much useful info from a consult as one to the pharmacologist.

I guess this has become my belated Valentine to pharmacists. THANK YOU!

You are sooooo very welcome! I ALWAYS thank you for the dx (the drg helps too in addition to drugs tried & failed for TARs). Even if its not a MediCal pt....I won't go off talking to the pt about the anticonvulsant properties of gabapentin (& I'll tell the pt not to worry about that information which I'm required to provide by law) if I know you're using it to augment a particular dx (& I can access the drgs - so you don't need to actually write the diagnosis if that causes undue anxiety or privacy issues). For the most part, I can tell who is a neurologist & who is a psychiatrist, but for the newer physicians, I can't always tell right away.