Companies tussle over market share for anti-cholesterol drug Lipitor® and its generic equal

Anti-cholesterol drug Lipitor has come off patent and faces tough competition from generic versions. The.Comedian/Flickr

Anti-cholesterol drug Lipitor® (atorvastatin) has been estimated to generate Pfizer revenues of more than $130bn worldwide. Australian taxpayers’ share of this is about $7bn, through subsidies from the Pharmaceutical Benefits Scheme (PBS).

On April 1, 2012, the first generic version of atorvastatin became available on the PBS – Trovas® sponsored by Ranbaxy Australia Pty Ltd. In response, Pfizer produced its own generic version of atorvastatin while continuing to market Lipitor®.

More generic competitors to Lipitor®, (14 in all) are poised to enter the Australian market. And, not surprisingly, a promotional war has broken out. Originally it targeted pharmacists but, more recently, it’s moved into the public domain.

On May 6, 2012, Pfizer ran a full-page advertisement in the Sunday Telegraph and other media headed, “A message to the more than 1 million patients prescribed Lipitor®.” It went on to say, “Pfizer has received many inquiries from patients who have been informed that Lipitor is no longer available. This is not true. Lipitor is and will continue to be available. If you have any concerns please contact your doctor or pharmacist.”

Dr Bill Ketelbey, medical director for Pfizer Australia, said “Patients have been variously told that Lipitor is ‘no longer available,’ ‘not manufactured anymore,’ or that it ‘has been replaced.’ It is a very serious matter for patients to be misled about the availability of their medication.”

Ketelbey said Pfizer had also written to GPs, specialists and pharmacists to reassure them about Lipitor’s continuing availability.

Pfizer’s “educational” notice in the Sunday Telegraph.

A spokesperson for the Pharmacy Guild of Australia said the organisation was aware of reports that consumers had been given conflicting advice about the availability of Lipitor, but believed it was restricted to a limited number of pharmacies.

“We know that there is some confusion regarding atorvastatin, because Pfizer have their own generic version,” the spokesperson said. “We believe the problem that has been identified relates to a tiny minority of pharmacies who have been written to and remedial action undertaken.”

Another pharmacist commented, “Pharmacists who outright lie to their customers for the sake of generic discount should be brought before the Pharmacy Board of Australia and made to go through a professional ethics refresher course.”

So what discounts or deals are available? Since July 1, 2010, pharmacists have received a $1.53 (indexed annually) generic substitution fee from the government every time they convinced a patient to move from an originator brand to a generic.

More recently, Ranbaxy Australia Pty Ltd has offered pharmacists supporting their product $14,647.98 worth of free Trovas® (generic atorvastatin) stock and a 90% discount for subsequent orders. In addition, this discount is backed by a “Ranbaxy Lowest Price Guarantee”. This means that if a competitor offers a lower everyday price Ranbaxy will match it.

Is this Ranbaxy offer ethical? Section 6.8.4 of the 2010 Generic Medicines Industry Association’s (GMiA) Code of Conduct says: “Members take all reasonable steps to ensure their behaviour does not lead to actual or potential conflicts of interest or interfere with or impede the independence of Healthcare Professionals or their professional judgement.”

In addition, Section 9.12 of the 2010 Medicines Australia code says: “No gift, benefit in kind or pecuniary advantage shall be offered or given to healthcare professionals or to administrative staff as an inducement to recommend, prescribe, dispense or administer a Company’s product(s).”

But it appears Ranbaxy Australia Pty Ltd is neither a member of the GMiA or Medicines Australia or any other local self-regulatory industry association and so isn’t bound by the their codes. This lacuna was highlighted in the report of the government’s Working Group on Promotion, which has yet to be addressed.

What about Pfizer’s appeal to the public about Lipitor? Pfizer is a member of Medicines Australia whose Code says (Section 12.3): “…prescription products must not be promoted to the public. Any information provided to members of the general public must be educational. Any activity directed towards the general public which encourages a patient to seek a prescription for a specific prescription only product is prohibited.”

Pfizer argues that notices placed in the press were not advertisements but “educational” community service announcements designed to counter “misleading and false information” being spread about the availability of its drug. An alternative view is that the advertisements were part of a Pfizer strategy to maintain market share of a product now exposed to competition.

It could be argued that any misinformation promulgated could have been legitimately corrected by Pfizer responding to individual patient queries and communicating to doctors and pharmacists (as was done).

The fact that these extensive (and expensive) advertisements were directed to the general public suggests the aim was to reinforce the brand name of Lipitor® and its popularity (“more than 1 million patients prescribed”) in the minds of the patients who had been prescribed the drug in the hope that they would question why they have been prescribed or recommended a generic alternative.

If the advertisement was truly educational, it could have pointed out that Lipitor® is now off-patent. And that this has provided the opportunity for generic companies to compete on price and such competition results in lower drug prices for the PBS, taxpayers and consumers.

Patients are likely to find their doctors prescribing generic atorvastatin (or pharmacists recommending a generic substitute) not because Lipitor® is unavailable but because this helps the sustainability of the PBS.

A complaint about the Pfizer advertisements will be heard on June 18, 2012 by Medicines Australia Code of Conduct Committee. But who will hear the complaint about Ranbaxy Australia Pty Ltd?