Monday, March 9, 2015

More Granularity, On What BMS's NSCLC FDA Opdivo® Nod Might Mean In 2015 Through 2017

An erstwhile anonymous commenter remarked last week that perhaps the FDA nod to Opdivo® would not mean too, too much to Merck's Keytruda® in NSCLC, longer term. I suppose it may be that the world is changing underfoot (wouldn't be the first time that's happened to me!), but it had always been my perception that -- in oncology at least -- it tends to be "winner take all". The below reiterates that view.

Of course, I do think there will be perhaps $5 to $7 billion in Keytruda market proceeds for Merck (per year), working into 2018 and beyond. However, I do think in the near term, BMS has scored a vast win, here -- by nailing an inroad to NSCLC first -- by as much as 9 to 12 months, over Kenilworth.

And I do think -- as the below Bloomberg article intones, oncology is. . . different. Both as to price points -- and as to prescribing patterns -- where (as here) there is a clear survival benefit. A bit, then -- from the Bloomberg story of this afternoon:

. . . .That’s because the FDA’s practice of approving drugs by each cancer type and stage of disease. So even if two cancer drugs are similar on paper, they may still not compete directly because they are approved for slightly different uses.

Another factor that helps keeps pricing up is that cancer doctors tend to exclusively prescribe the drug that is perceived to have the most efficacy for each particular cancer type, even if the advantage is narrow.

In oncology, it tends to be winner take all,” Evans said. “Whoever has the best efficacy will get all the sales, and that really preserves the pricing power. . . .”

I still think the commenter has a fine longer term (circa 2018 and beyond) point. And, as much as I hate to say it, once Opdivo starts posting results in lung cancer, inside the oncology wards, day by day -- those docs are reasonably likely to write off label for it -- and second line vs. third line will become a blurred line, at best. In sum, I just think it is hard to overestimate the significance of Opdivo's FDA NSCLC nod, last week. For what it is worth.


Anonymous said...

Hi Condor - I am the original commenter. You are correct in pointing out that I was taking the longer view, but my view is also colored by an understanding of how cancer is treated outside the US. There is much less non-indicated usage as payers and reimbursers generally only reimburse for labeled indications. BMY will have the edge in the US as non-indicated usage is far more common, but in the EU and other developed markets the broader indication that MRK is pursuing may end up providing an advantage. I do not disagree with your analysis. You have an uncanny ability to hit the sweet spot in your analyses in general.

Condor said...

Hello, good friend --

I agree with all you wrote.

And most of all -- the human race is. . . the winner.

As Derek Lowe wrote this morning, we will collectively look back decades from now, at the this moment, and say that's when we -- as a matter of applied science -- turned the corner, on cancer.

Heady stuff -- do stop back!


Anonymous said...

Hi Condor - You provide a wonderful source of information and insight and I will continue to visit and learn. I fully agree with you that with this class of treatments we may be on the verge of seeing cancer become a long-term manageable disease for many patients, like HIV is now. The real winners will be patients, their families and friends, and the human race. Well said.

Anonymous said...

An update - Today I read the label BMS received for Opdivo for lung cancer from the FDA. The FDA accepted the 2L data (from Checkpoint-017?) along with the 3L data. So, the rapid approval is more advantageous for BMS than I indicated in my initial comment. Again, even better news for patients.