SciGuy: CVS/Caremark Formulary Changes

[anonymous]

What is the net impact of the CVS/Caremark Formulary changes just announced?

Specifically ...

Removal of Lilly's Cymbalta (5 alternative choices)

vs​

Removal of Pfizer's Viagra (1 remaining choice, Lilly's Cialis).

Is this a net "win", given Cialis still on patent for a few years?

 

[anonymous]

What is the net impact of the CVS/Caremark Formulary changes just announced?

Specifically ...

Removal of Lilly's Cymbalta (5 alternative choices)

vs​

Removal of Pfizer's Viagra (1 remaining choice, Lilly's Cialis).

Is this a net "win", given Cialis still on patent for a few years?

I'd give that a net win, due to the current patent protection of Cialis; Cymbalta revenues went to zero, in essence, when that patent expired, coupled with ample other generics to compete. Now, if some bolt-from-the-blue were to take out...

 

[anonymous]

Agreed. Your analysis holds, if and only if the patent remains valid.

 

[anonymous]

What is the net impact of the CVS/Caremark Formulary changes just announced?

Specifically ...

Removal of Lilly's Cymbalta (5 alternative choices)

vs​

Removal of Pfizer's Viagra (1 remaining choice, Lilly's Cialis).

Is this a net "win", given Cialis still on patent for a few years?

YOU REALLY want to know what eye think?

Eat a lot of BEETS... you will solve all those problems and get nutrients to boot

How's that, Patent Guy?

 

[anonymous]

Sales ($ billions)

Cymbalta Viagra Cialis
2013 5.1 1.9 2.2
2014 1.6 1.7 2.3
Change - 68% - 10% + 5%

In a simple world, would expect Viagra Rx's to migrate to Cialis in 2015, at least for CVS/Caremark patients ...

Cialis U.S. patent reportedly expires in May 2018 ... or earlier?

At a 30% share of PBM market, should see at least a $0.5B (or 20-25%) bump in Cialis sales.

 

[anonymous]

Sales ($Billion)

Cymbalta Viagra Cialis
2013 5.1 1.9 2.2
2014 1.6 1.7 2.3
Change - 68% - 10% + 5%

CVS/Caremark has about 33% PBM market share.

So should expect a $0.5B (20-25%) bump in Cialis sales, barring any screwups on Lilly's part.

Of course, that's unlikely to make up for further erosion in Cymbalta sales due to patent loss and getting dropped from CVS/Caremark Formulary.

Still, its a ray of sunshine.

 

[anonymous]

YOU REALLY want to know what eye think?

Eat a lot of BEETS... you will solve all those problems and get nutrients to boot

How's that, Patent Guy?

Beets... have an odd, dirt-like flavor to me. Like them roasted, then converted to their preferred embodiment--borscht! With much dill and sour cream.

 

[anonymous]

I think the Poles, Slavs, Russians and other peoples of that part of the world must have recognized, for generations, the very high betaine content of beets, thus deploying them in many regional variants of borscht. Perhaps the lipid content of sour cream acts as delivery means; although I'm sceptical that it crosses the B-B barrier as a charged species, perhaps a demethylation occurs, and then it becomes a precursor to ACh...or perhaps it acts on receptors in the gut. We all have, essentially, a second brain in our gut if you look at the distribution of receptors, ion channels, etc. found elsewhere only in the brain!

 

[anonymous]

Is this a net "win", given Cialis still on patent for a few years?

Oh Dear...
Lilly's Tadalafil Particle Size Patent - IPR Granted
Lilly's tadalafil '975 particle size patent is now in a full IPR. The PTAB granted the IPR petition on the grounds that it was probably obvious to reduce particle size for poorly soluble drugs.

The petitioner was Actelion.

For those that are litigating particle size patents, the Institution decision has the rationales for reducing particle size. An argument raised was that the rationale was a poorer choice (i.e., a worse alternative). The PTAB said this, which I thought was interesting (the quote from In Re Mouttet):

Moreover, even if co-precipitation methods like that of Butler
“represent[] the ultimate in size reduction,” it does not compel us to ignore
evidence of record (Ex. 1011, 3:6467) indicating that micronization of drug
substances for the purposes of improving dissolution rate was a conventional
method known in the art. In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir.
2012)(“[J]ust because better alternatives exist in the prior art does not mean
that an inferior combination is inapt for obviousness purposes.”).
Furthermore, we note that there is no evidence on the current record to show
that providing tadalafil in free drug particulate form was uniquely
challenging or difficult for one of ordinary skill in the art.

 

[anonymous]

Oh my...

Lilly's Tadalafil Particle Size Patent - IPR Granted
Lilly's tadalafil '975 particle size patent is now in a full IPR. The PTAB granted the IPR petition on the grounds that it was probably obvious to reduce particle size for poorly soluble drugs.

The petitioner was Actelion.

For those that are litigating particle size patents, the Institution decision has the rationales for reducing particle size. An argument raised was that the rationale was a poorer choice (i.e., a worse alternative). The PTAB said this, which I thought was interesting (the quote from In Re Mouttet):

Moreover, even if co-precipitation methods like that of Butler
“represent[] the ultimate in size reduction,” it does not compel us to ignore
evidence of record (Ex. 1011, 3:6467) indicating that micronization of drug
substances for the purposes of improving dissolution rate was a conventional
method known in the art. In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir.
2012)(“[J]ust because better alternatives exist in the prior art does not mean
that an inferior combination is inapt for obviousness purposes.”).
Furthermore, we note that there is no evidence on the current record to show
that providing tadalafil in free drug particulate form was uniquely
challenging or difficult for one of ordinary skill in the art.