Lipitor Going Generic

If you work in pharmacy, this has been on your radar since Zocor went generic years ago. Lipitor has been the biggest drug worldwide, and I believe the spend in the US is still almost $7B a year even with generic Zocor available. (See Consumer Reports on statins)

Now, it appears that generic Lipitor (atorvastatin) will be available 11/30/11 according to the Pfizer site. It looks like Ranbaxy who was first to file the ANDA will get the 180-day exclusivity (but I know several other generic manufacturers have challenged the patent).

So, what does this mean?

1. Lipitor will likely move to the 3^rd tier either immediately or at the next formulary update period once the generic is available on the market.
2. Atorvastatin will become a part of statin step therapy programs.
3. Pharmacies in states that have mandatory generic laws will begin auto-substitution of atorvastatin for Lipitor prescriptions unless there the script has a Dispense As Written (DAW) indication.
4. Depending on the pricing of the generic, PBMs and pharmacies will be very aggressive about encouraging use of the generic version (as allowed with the AG settlements from years ago).

We’ve already seen Pfizer take some action which is to promote a $4 copay card (or 30-day sample) for patients. This is to protect market share, but it also makes me wonder if they won’t do something like Merck did by pricing the generic below the Ranbaxy price (see WSJ article).

Given that Pfizer owns a generic company (Greenstone), I have to imagine that they plan to sell atorvastatin thru that company. But, I think the big question that I would be focused on is whether there will be an “authorized generic” (look at the FTC interim report on this topic). This is a big topic in the industry. It allows the manufacturer who owns the patent to allow a generic manufacturer to make and produce a generic version outside of the ANDA process. Right now, it appears that Watson may get to bring an authorized generic of Lipitor to market.

Will you see the same energy around this as you did around Zocor? I remember having a whole “control room” that we developed at Express Scripts to encourage utilization of generic Zocor. It was built around several key things:

1. What were all the channels that a patient communicated with the PBM and how did we educate them around the new generic? [And which could we do at what time so as not to limit the short term rebates that our clients were getting on brand Zocor which kept the prices down until the generic was available?]
   1. Member portal
   2. Mail order invoices / stuffers
   3. Inbound IVR messaging while on hold
   4. FAQs
   5. Training call center reps
   6. Formulary notification programs
2. How did we inform physicians?
   1. Academic detailing – fax, letter, phone consultations, face-to-face visits
3. What plan design changes did we encourage?
   1. Step therapy
4. What could be done at the POS with the retail pharmacies?
5. What could be done at mail?
6. How would we track success?

Personally, as a PBM or pharmacy, I’d be trying to lock in a period of exclusivity with Watson or Pfizer to have the limited distribution of the generic Lipitor for a period of time. That would be a huge deal (if it could be pulled off).