The Medicines Company’s PCSK9 Inhibitor Strategy: More Heart Patients Via Lower Pricing | Forbes

However, in a recent conversation, Meanwell shared that he doesn’t plan to compete solely on these benefits of inclisiran. Rather, he plans to broaden access to inclisiran via a significantly lower price as compared to the established agents. Part of his move to this position was based on studying the changes in the top ten selling drugs of 2000 vs. those of 2015. The former group, which included drugs like Lipitor, Celebrex and Zoloft, generated sales of $34 billion (inflation adjusted). The 2015 list, which included Humira, Harvoni and Embrel, amassed $84 billion. These data are not all that shocking. But what surprised him was that the $34 billion spent in 2000 benefited a target population of 413 million patients, whereas the top ten selling drugs of 2015 only benefited 54 million. Basically, the top ten drugs of 2015 are targeting one-eighth of the 2000 population at 2.5X the cost. He believes that such a trend is unsustainable for healthcare in America.

So, what does he plan to do about it? Meanwell believes that inclisiran can be a very successful drug at a much lower price than Repatha and Praluent. Before dosing a single patient with inclisiran, The Medicines Company generated data to know exactly the type of profile the drug needed to have in order to be able to do this. Its phase 2 data from the ORION 1 study supports Meanwell’s view. Assuming this profile holds through the recently started phase 3 program, inclisiran would be positioned to be the PCSK9 inhibitor for the masses – a drug priced so that anyone with documented atherosclerotic cardiovascular disease and anyone who has already had a heart attack would have access to inclisiran.

It’s unusual for a company to develop a first-in-class drug and then compete on price. In the past, companies have priced new drugs at a similar level that existing agents enjoyed. Mimicking such past practices, inclisiran on FDA approval would have been priced in the range that Amgen and Sanofi/Regeneron have negotiated with payers. After all, inclisiran’s ultimate clinical profile will likely be similar to their drugs, so why not enjoy a similar price? Instead, Meanwell plans to succeed by charging a much lower price thereby gaining greater payer acceptance and access to a much larger patient base. While not unprecedented, this is not a common practice.

Meanwell wasn’t willing to give a specific price being contemplated for inclisiran. He’ll have a better idea on that once the phase 3 data for inclisiran begin to roll out. But he was quite confident that it would be significantly less than that for currently marketed PCSK9 inhibitors, certainly low enough to get payers on board. In fact, The Medicines Company has already opened up a dialogue with payers to factor their views into these key decisions.

Read complete article here:

The Medicines Company’s PCSK9 Inhibitor Strategy: More Heart Patients Via Lower Pricing.