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 Priced around $7,000 each, the drugmakers called them "breakthrough"
treatments designed to prevent migraines when taken year-round, and
estimated that millions of patients could benefit. The U.S. Food &
Drug Administration said Amgen's Aimovig – the first of the three
drugs approved – was an "important addition" to available
treatments.
But a small group of external medical experts who quietly advise
U.S. health insurers on new drugs was not impressed, according to a
private meeting held at UnitedHealth Group's OptumRx offices in
Chicago that was attended by Reuters.
They concluded that all three medicines offered no clear benefit
over drugs already on the market and that insurers could consider
them optional when it came to health coverage. They advised putting
limits into place on their use.
While these experts do not discuss drug costs, their view of the
clinical value of the new migraine drugs emboldened OptumRx, which
manages prescription drug benefits, to demand steep discounts from
the three manufacturers. Similar "pharmacy and therapeutics" (P&T)
committees at rivals CVS Health Corp and Cigna Inc's Express Scripts
came to the same conclusion.
The impact of their rulings will be on display on Tuesday, when
Amgen, which co-markets the drug with Novartis AG, and Lilly report
on their quarterly financial performance.
When asked by Reuters about the OptumRx committee decision, the
three drugmakers said the new therapies represent an important
advance to patients who are not helped by existing treatments, or
who have struggled to stay on their medications. They stress that
for some patients, the new migraine drugs cut by half the number of
days they experience headaches each month.
These relatively unknown expert committees have been involved in
drug coverage decisions for decades. Their identities are kept
secret due to federal regulations aimed at preventing pharmaceutical
industry interference. The committees make their decisions based on
a drug's clinical value, independent of cost, pharmacy benefit
managers say. But their power has grown more recently with the
consolidation of most of the U.S. pharmacy benefits business under
OptumRx, CVS and Express Scripts. Taken together, their three
advisory committees now guide drug coverage for more than 90 million
Americans.
P&T committees also hold sway over record numbers of novel and
expensive medicines introduced into the U.S. market each year, more
often with less evidence of effectiveness or safety than in the
past.
New drugs that may fall under their scrutiny in the next year
include potentially life-saving therapies for spinal muscular
atrophy and Duchenne muscular dystrophy as well as oral treatments
for migraine, diabetes and multiple sclerosis.
Their decisions have new consequences as the pharmacy benefits
companies they advise are more likely to exclude a new treatment
from coverage if it is deemed on par with existing therapies. Or
they can demand discounts - or rebates - from drugmakers in exchange
for the coverage.
"If the committee says (a treatment) is no better than the existing
drug, there is a very decent possibility that it might get a less
preferred status or not be included" for reimbursement, said Jack
Hoadley, a health policy expert at Georgetown University.
OptumRx's ability to call the shots on drug coverage for more than
30 million people make it a formidable negotiator for clients like
Ben Johnson, a pharmacy director for a health plan in Utah that
covers about 20,000 railroad union workers. Johnson once relied on
his own P&T committee to determine whether a drug was effective and
worth the price.
Now he is often among the dozens of OptumRx clients and consultants
invited to observe the quarterly P&T committee meetings in Chicago.
Handing that role to OptumRx has tripled the value of rebates that
his plan receives, Johnson said.
FROM "BREAKTHROUGH" TO "OPTIONAL"
Drugmakers say pharmacy benefit managers such as OptumRx are
middlemen that take too great a cut of the discounts they negotiate
and ultimately drive prices higher.
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U.S. Congress and President Donald Trump have taken up that
criticism, and the administration has proposed banning rebates in
government health programs unless benefits managers hand over the
savings to patients.
OptumRx, Express Scripts and CVS say that their method of reviewing
a drug's benefit and subsequent price negotiations has lowered
prescription drug costs, and that 95 to 98 percent of the discounts
they receive are passed on to their clients.
In the case of the migraine drugs, Amgen, Lilly and Teva were quick
to advertise the potential benefits directly to U.S. consumers once
they were approved, months before the pharmacy benefits companies
made decisions on how to cover the drugs.
Television commercials from the drugmakers highlighted how some
patients had their headache days cut in half, or more. The
manufacturers offered the drugs to commercially insured migraine
sufferers for free for up to a year or even longer to entice people
to try them. Their primary competition is older, cheaper generic
drugs.
Migraines affect more than 39 million Americans, mostly women, and
Amgen estimated 8 million could be candidates for the preventative
therapies, which are delivered by injection every month or few
months. Analysts forecast $4 billion in annual sales by 2026 in
major global markets.
OptumRx convened its advisory committee of a dozen doctors and
pharmacists last November to review the new migraine drugs.
These experts pointed to clinical trial data showing that patients
taking the new drugs experienced an average of 1 to 2.5 fewer
migraine days a month than those treated with a placebo, and said
that was on par with existing therapies, though there were no
clinical studies directly comparing the two groups of medicines.
The committee acknowledged that some patients saw a much bigger
benefit from the new drugs, but said the data did not show who might
be helped the most. They questioned the limited safety data and the
unknown long-term effects on the body.
"Let's be cautious and see how it all plays out, but we need to look
at these studies with a jaundiced eye," one of the members said. The
committee's verdict: All three drugs should be considered "optional"
treatments that provide no unique benefit. OptumRx Chief Medical
Officer Sumit Dutta said the decision, based on available clinical
data, provided balance to the drugmakers' claims.
"There are plenty of examples of drugs that have a lot of enthusiasm
in the beginning," but that later turned out to be problematic,
Dutta said.
Because OptumRx could choose not to cover any of the new migraine
drugs, it could push aggressively for discounts. On February 1, it
began to cover Amgen's Aimovig and Lilly's Emgality. Teva's Ajovy
would only be covered if patients did not benefit from the other two
drugs.
Leerink biotech analyst Ami Fadia estimates manufacturer rebates on
the drugs are as high as 50 percent.
Amgen said 200,000 U.S. patients have been prescribed Aimovig, with
about half of prescriptions being filled for free. Teva and Lilly
have not provided figures on patient use. Teva said in February it
expects 2019 sales for Ajovy of $150 million.
For its part, Express Scripts estimates that only 128,000 of its
covered patients will be good candidates for the new therapies, and
has a program to closely manage who receives them. OptumRx and CVS
declined to provide similar forecasts.
(Additional reporting by Deena Beasley in Los Angeles; Editing by
Michele Gershberg and Edward Tobin)
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