Express Scripts told Reuters it is pressing them to forego the usual
strategy of setting a high U.S. list price, then lowering the cost
for health plans through hefty rebates. It is also seeking a refund
if the drugs don't work within a defined timeframe. The shift could
help Express Scripts and other pharmacy benefits managers (PBMs)
bring prices down, and deflect growing criticism of their role as
"middlemen" in the drug supply chain.
The Trump administration and members of Congress have demanded that
PBMs pass on more of the rebates they receive to consumers outraged
over rising costs at the pharmacy counter. Many Americans now have
health plans with higher deductibles or co-payments, making them
responsible for more of their medical costs.
Express Scripts is advising drugmakers to take that shift into
account as they launch a new class of migraine drugs.
"If your expectation is that you are not going to actually get that
high list price, then don't do that to patients who have high
co-pays," Chief Medical Officer Steve Miller said in an interview,
describing his message to Amgen and its rivals. "Let's be more
balanced. Let's get back to where gross-to-net is not so different."
Amgen's Aimovig is expected to be approved next month, followed by
similar drugs from Teva Pharmaceutical Industries Ltd and Eli Lilly
& Co that the companies say could benefit up to 4 million people in
the United States.
The injected therapies interfere with the function of a molecule
involved in the processes that kick off a migraine, such as dilation
of blood vessels in the brain.
Wall Street analysts expect Amgen to announce a list price of up to
$10,000 per year for Aimovig once it is approved, setting the tone
for competitors.
But Express Scripts and other PBMs restrict access to new drugs they
deem too expensive, asking doctors to provide detailed evidence of
why a specific patient may benefit, requiring the use of other drugs
for a period of time or favoring cheaper rivals when available.
Drugmakers could face similar issues with the new migraine
treatments, Miller said: "Should they price these things too high
they will probably not be able to achieve much market share."
Express Scripts is also pushing Amgen and its peers to refund
two-thirds of the cost of a migraine drug if a patient stops
treatment within 90 days because it didn't work or caused major side
effects.
Such guarantees are becoming more prevalent for older drugs with
competing products on the market, including diabetes and hepatitis C
therapies. It would be unusual to introduce them for the first drug
in an entirely new class of therapy. Amgen, which will market
Aimovig in partnership with Novartis, declined to comment on talks
with Express Scripts. Research chief Sean Harper said in a recent
interview that payers share blame for the current pricing model.
Their demands for ever-larger rebates has forced manufacturers to
use higher list prices as a benchmark, he said.
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"It is a ridiculous situation that we are in," Harper said. "No one
is paying the list price, but patients are exposed for a period of
time" until they pay off their insurance deductible.
TAKING OUT COSTS
Rising U.S. healthcare costs, the most expensive worldwide, are
straining budgets for families, employers and government agencies.
That has created new pressures within the industry to control costs.
To that end, Express Scripts has agreed to a buyout from health
insurer Cigna Corp, while PBM rival CVS Health Corp plans to buy
insurer Aetna Inc.
In interviews with Reuters, smaller PBM Abarca Health and insurer
Highmark Health said they were adopting similar tactics to Express
Scripts in negotiating coverage for the migraine drugs. CVS declined
comment.
Teva said it was evaluating the pricing environment for its migraine
drug. Officials at Lilly did not respond to a request for comment.
The stakes are high for Amgen, which has struggled to grow revenue
in recent years.
The biotech company's last potential blockbuster, high-priced
cholesterol treatment Repatha, has been stymied by PBMs who
questioned its value compared to generic statins that cost $100 per
year.
Repatha and rival Praluent, sold by Sanofi and Regeneron
Pharmaceuticals, launched in 2015 at list prices near $14,000 a year
and were expected to be billion-dollar products. But Express Scripts
and other payers have rejected most prescriptions written for the
new medicines while awaiting proof that they lower the risk of
death.
As a result, Repatha sales totaled $319 million last year, while
Praluent had sales of $195 million.
"If Amgen and Sanofi had it to do over again, I think they would
have priced at half the list price and made a whole lot more money,"
said Jason Borschow, chief executive officer at Miami-based Abarca.
Aimovig is far more effective at preventing migraines than current
treatments, mainly low cost generic drugs. Recent studies have shown
that Aimovig reduces episodic migraines by at least half in around
50 percent of patients.
The Food and Drug Administration is expected to decide on Aimovig by
May 17. The agency's decision on Teva's treatment fremanezumab had
been expected in June, but that may be delayed due to manufacturing
issues. A ruling on Lilly's galcanezumab is expected later in the
year.
Amgen will report quarterly results on Tuesday afternoon.
(Editing by Michele Gershberg and Edward Tobin)
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