Payers are already looking for ways to forestall spending on new, high-priced PCSK9 drugs--and that could mean good things for AstraZeneca's ($AZN) high-powered statin, Crestor. But it's the soon-to-hit Crestor generics that could prove an even bigger thorn in the sides of PCSK9 drugmakers.
The British pharma's blockbuster is one drug that stands to gain if payers mandate that patients exhaust existing options before graduating to pricey PCSK9s. And while it's all speculation for now, that's a situation that "wouldn't surprise me," AstraZeneca's Marc Ditmarsch, the global development lead for Brilinta, told FiercePharmaMarketing at the European Society of Cardiology Congress in London.
Right now, list prices for newly approved Praluent from Sanofi ($SNY) and Repatha from Amgen ($AMGN) stand at $14,600 and $14,100, respectively--jumping off points for the payer negotiations that are sure to follow. But according to a report from the Institute for Clinical and Economic Review, the meds' benefits justify prices between $3,615 and $4,811 per year--a 67% discount that payers aren't likely to score.
Express Scripts ($ESRX), for one, is ready to go with its Cholesterol Care Value (CCV) Program, launched before PCSK9s hit the scene. The program uses a "a rigorous clinical documentation process to preserve access to the PCSK9 inhibitors for the right patients," company spokesman David Whitrap told FiercePharmaMarketing via email, noting that for the "large majority" of high-cholesterol patients, statins are the "clinically appropriate, tried-and-true therapy."
If payer tactics do end up pushing more patients Crestor's way, AstraZeneca certainly wouldn't complain. The company has had some lofty sales goals to meet ever since it set about defending against last spring's Pfizer takeover effort.
But Crestor may not have much time left to rake in diverted PCSK9 sales. The med loses U.S. patent protection in 6 months, and its European shield is set to expire in 17 months. After that, it'll be facing generic competitors--which could appeal to payers even more than Crestor itself, and potentially frustrate Sanofi and Amgen further. Within the statin class, "we will prefer the generics and the lower-priced branded options," Whitrap said of the CCV effort.
Payers aside, there are other reasons docs may not want to prescribe PCSK9s over Crestor and its generics, AZ Brilinta team member David Ginivan told FiercePharmaMarketing at ESC--and adherence is among them, he noted. Crestor is a pill, which is easier for some patients to keep up with than injections.
There are tradeoffs to getting patients to their cholesterol goals, he said--"whether they stay on their pill, is injection worth the cost--there's a multi-factorial kind of decision-making that has to be there for the physician on that one," he said. "You've got a fantastic drug in Crestor delivering great lipid management, then going generic--that's going to be a challenge for PCSK9 drugs."
Special Reports: Top 10 Cardio Drugs 2012 - Crestor | Top 15 pharma companies by 2014 revenue - Sanofi - AstraZeneca - Amgen