NICE gives tentative broad approval to both Repatha, Praluent


Sanofi and Regeneron put a list price of about $5,780 on their new-gen cholesterol lowering drug Praluent when they took it to the U.K., as did Amgen with its Repatha. That is less than half of the roughly $14,000 they have on the drugs in the U.S. But that was still not good enough for the U.K. price watchdog, which has extracted further discounts from the companies for consideration of its approval.

In draft guidance today,  NICE reversed itself and said that it will recommend the drugs to the National Health Service for people who cannot get their cholesterol under control using standard treatments, so long as the lower price is in place.  It ealier had approved Repatha for much more limited use. 

“However, both drugs are relatively expensive, costing over £4000 per patient per year compared with about £350 for ezetemibe,” Carole Longson director of the NICE Centre for Health Technology Evaluation, said in a statement. “Therefore the draft guidance recommends alirocumab and evolocumab as a cost effective use of NHS resources only with the discounts agreed with the companies ....”

It is not as if the drugs have had an easy time in the U.S., While both drugs came to market with very high analyst expectations, they have faced resistant payers who are concerned about a very high price for the injected drugs that would be used along with the inexpensive generic statins that millions of people currently take for lowering cholesterol. Instead of allowing doctors carte blanche authority to prescribe them, payers are requiring they and their patients go through a document-intensive pre-approval process to get them.

Sanofi CEO Olivier Brandicourt addressed the difficulty last week during a call with analysts. “Both physicians and patients are confronted with significant administrative hurdles which are imposed by payers before providing access to this important new therapy,” he said according to the news service.

Those difficulties have kept a lid on sales so far.  Analysts have forecast that both drugs could generate about $3 billion in annual sales by 2022. But as Bloomberg points out, Repatha was forecast to have about $185 million in sales this year and Praluent as much as $265 million, yet in the first quarter both turned in only about $20 million.

Amgen’s executive VP of global commercial operations, Tony Harper, told analysts last week the situations has been extremely frustrating to cardiologists, Bloomberg reports, not to mention Amgen execs. “We are spending quite a bit of time with payers at the moment, and helping them see the -- what I would imagine are the -- unintended consequences of a rather onerous paper-based prior-authorization system, which is resulting in so many patients not getting access to drug when they should,” Harper said.

-here’s the NICE press release 
- read the Bloomberg story 

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