Jason Douglas of Dow Jones reports that:
" The U.K's National Institute for Health and Clinical Excellence said Thursday that Roche Holding AG's (RHHBY) drug Tarceva has been turned down as a treatment for non-small cell lung cancer because it's too expensive.
NICE said Tarceva could not be considered a cost-effective use of the U.K.'s state-run National Health Service's resources compared to Sanofi-Aventis's (SNY) Taxotere.
NICE, which determines whether drugs should be available on the NHS in England and Wales on the basis of their effectiveness and value for money, said the cost of Tarceva was considerably higher than acceptable. It found Tarceva was GBP 2,100 more expensive to buy per patient than Taxotere and said it was not persuaded that Roche had proved its drug, known generically as erlotinib, had an equivalent survival benefit to Taxotere, or docetaxel.
Professor Peter Littlejohns, Clinical and Public Health Director, said NICE has yet to make a final decision on Tarceva and won't issue final guidance to the NHS until June.
Tarceva is licensed in Europe for the treatment of patients with advanced or metastatic non-small cell lung cancer, for whom other drugs have failed."
So let's get this straight. It's not just a "crazy" patent busting country like India that has issues with the price of Tarceva--it turns out that a richer and more patent friendly nation like the UK has a problem as well! And we might add that the UK boasts of a nationwide health insurance scheme. For our previous posts on the Roche vs CIPLA patent litigation in India, please see here.
I am now trying to investigate the price of Tarceva in the US and UK, so that we can compare with the price in India. If anyone has data on this or pointers in this, please write to me at. If you permit me, I will also share this information with all our readers on the blog.
Thus far, I have found only one cancercommunity group and a NY Times article that seems to suggest that the price of Tarceva in the US is the same (or even slightly higher) than the price in India! I reproduce the message below:
"How are all of you affording the cost of Tarceva?
My mother was just prescribed Tarceva. She is 89 years old and on a limited income. After the insurance pays 1/3 the cost of Tarceva, she will have to pay $2,400.00 out of pocket for a 30 day supply. She can't afford this."
From the above message, it is clear that the total monthly cost of this drug in the US is USD 3600 (or 1.44 lakhs Indian Rupees). Justice Bhat in his judgment found that the monthly cost in India was Rs 1.4 lakhs. In other words, the cost of the drug in India may be slightly more expensive than in the US!
Of course, what is quoted here is a 2006 price--which may have changed since then. However, it is unlikely that the change would have been significant.
It is notewothy that a NY times article pegs the price of Tarceva in the US at 2700 a month. Which means that the price is higher in India (USD 3600) than it is in the US!
See also this Forbes article in 2004, and this BBC article in 2006 which lamented the increasingly high costs of cancer drugs, including Tarceva.
Interestingly, the cancercommunity group that I mentioned earlier has a message from someone in India:
"hello, my mom was diagnoised with lung cancer 6 months back. She has finished 5 cycles of chemo treatment consisting of Carboplatin/gemcite. We are unable to give further chemo treatments becasue of her low blood counts. Under this conditions, i am exloring the usage of Terceva for her. But it seems to be very costly. We are uanable to afford for such high cost for treatment. Moreover in India , we dont have insurance which cover diseases like this .
I would be glad if you could guide me , as to how to procure Terceva from some cherity or any type of NGO or any type of social instituation . Hoping to hear from you.
Rajiv"
Recall our earlier post, where we attempted to debunk the use of terms such as "patent busting" to describe Justice Bhat's nuanced judgment. The above prices in the Western and more "developed" markets indicate that Justice Bhat was right to be concerned about the price and to build in this "public interest" factor into the injunction jurisprudence in India.
The question we ask our readers is this:
From a policy perspective, isn't it only fair that a country like India be given the freedom to derogate from a patentee's exclusive rights, when the patentee's price in India (a much poorer country with no universal health insurance coverage) is the same that it charges in the US? Particularly, when the validity of the patent is in issue?
On another note, why don't innovative pharmaceutical companies take more meaningful steps towards a differential pricing model? What stands in the way? Threat of parallel imports? The fear that lower prices in India would cause their own home consumers to begin demanding lower prices back home? See our previous posts on the parallel imports issue here and here.
" The U.K's National Institute for Health and Clinical Excellence said Thursday that Roche Holding AG's (RHHBY) drug Tarceva has been turned down as a treatment for non-small cell lung cancer because it's too expensive.
NICE said Tarceva could not be considered a cost-effective use of the U.K.'s state-run National Health Service's resources compared to Sanofi-Aventis's (SNY) Taxotere.
NICE, which determines whether drugs should be available on the NHS in England and Wales on the basis of their effectiveness and value for money, said the cost of Tarceva was considerably higher than acceptable. It found Tarceva was GBP 2,100 more expensive to buy per patient than Taxotere and said it was not persuaded that Roche had proved its drug, known generically as erlotinib, had an equivalent survival benefit to Taxotere, or docetaxel.
Professor Peter Littlejohns, Clinical and Public Health Director, said NICE has yet to make a final decision on Tarceva and won't issue final guidance to the NHS until June.
Tarceva is licensed in Europe for the treatment of patients with advanced or metastatic non-small cell lung cancer, for whom other drugs have failed."
So let's get this straight. It's not just a "crazy" patent busting country like India that has issues with the price of Tarceva--it turns out that a richer and more patent friendly nation like the UK has a problem as well! And we might add that the UK boasts of a nationwide health insurance scheme. For our previous posts on the Roche vs CIPLA patent litigation in India, please see here.
I am now trying to investigate the price of Tarceva in the US and UK, so that we can compare with the price in India. If anyone has data on this or pointers in this, please write to me at
Thus far, I have found only one cancercommunity group and a NY Times article that seems to suggest that the price of Tarceva in the US is the same (or even slightly higher) than the price in India! I reproduce the message below:
"How are all of you affording the cost of Tarceva?
My mother was just prescribed Tarceva. She is 89 years old and on a limited income. After the insurance pays 1/3 the cost of Tarceva, she will have to pay $2,400.00 out of pocket for a 30 day supply. She can't afford this."
From the above message, it is clear that the total monthly cost of this drug in the US is USD 3600 (or 1.44 lakhs Indian Rupees). Justice Bhat in his judgment found that the monthly cost in India was Rs 1.4 lakhs. In other words, the cost of the drug in India may be slightly more expensive than in the US!
Of course, what is quoted here is a 2006 price--which may have changed since then. However, it is unlikely that the change would have been significant.
It is notewothy that a NY times article pegs the price of Tarceva in the US at 2700 a month. Which means that the price is higher in India (USD 3600) than it is in the US!
See also this Forbes article in 2004, and this BBC article in 2006 which lamented the increasingly high costs of cancer drugs, including Tarceva.
Interestingly, the cancercommunity group that I mentioned earlier has a message from someone in India:
"hello, my mom was diagnoised with lung cancer 6 months back. She has finished 5 cycles of chemo treatment consisting of Carboplatin/gemcite. We are unable to give further chemo treatments becasue of her low blood counts. Under this conditions, i am exloring the usage of Terceva for her. But it seems to be very costly. We are uanable to afford for such high cost for treatment. Moreover in India , we dont have insurance which cover diseases like this .
I would be glad if you could guide me , as to how to procure Terceva from some cherity or any type of NGO or any type of social instituation . Hoping to hear from you.
Rajiv"
Recall our earlier post, where we attempted to debunk the use of terms such as "patent busting" to describe Justice Bhat's nuanced judgment. The above prices in the Western and more "developed" markets indicate that Justice Bhat was right to be concerned about the price and to build in this "public interest" factor into the injunction jurisprudence in India.
The question we ask our readers is this:
From a policy perspective, isn't it only fair that a country like India be given the freedom to derogate from a patentee's exclusive rights, when the patentee's price in India (a much poorer country with no universal health insurance coverage) is the same that it charges in the US? Particularly, when the validity of the patent is in issue?
On another note, why don't innovative pharmaceutical companies take more meaningful steps towards a differential pricing model? What stands in the way? Threat of parallel imports? The fear that lower prices in India would cause their own home consumers to begin demanding lower prices back home? See our previous posts on the parallel imports issue here and here.
Two quick points: 1, The decision by NICE was not welcomed by many patients as Tarceva was found useful to them.Roche did reduce the price of Tarceva. It may not be
ReplyDeletecost effective according to NICE but can drugs be assessed soley on the basis of 'cost effectiveness'
when they are life saving/life extending. In this case what are the alternatives to Tarceva in India other than the generic one
produced by CIPLA and are they available in India and if so at
what prices.
2, Who defines 'public interest' and on what paramters
in patent litigation, particularly when there is a case on infrignment.
Thanks Ravi,
ReplyDeleteFirstly, it was not just cost effectiveness, but there appears to be a substitute, as indicated in teh news item itself i.e. Taxotere.
I have to admit though that I'm not sure whether or not Taxotere is a perfect substitute and whether or not Tarceva works well on patients or not --and cannot state anything conclusive on this, till I see more data. But I'm very interesting in seeing your references for this, if you have any.
Also, you state that patients did not welcome the NICE decision. where did you get this statement from? Please do share. Some of the user lists that I browsed through seemed to suggest that not all of them were happy with Tarceva. Some admitted that it extends life by a couple of months, but comes with some serious complications.
2. As to who defines "public interest" is an issue that courts are struggling with not just in IP, but in several other areas of law. as you'll appreciate, we cannot have a rigid formula here and will have to wait for courts to work this out from case to case. But the absence of a set formula does not mean that courts refrain from incorporating this factor into our injunction jurisprudence at all...