Obscure advisory committees at the heart of the debate over US drug pricing

CHICAGO (Reuters) – The expectations of Amgen Inc., Eli Lilly and Co and Teva Pharmaceutical Industries, regarding the arrival of three new drugs for migraine in the market have been high.

At a cost of about $ 7,000, drug manufacturers call them "breakthrough" treatments designed to prevent migraines throughout the year, and believe that millions of patients could benefit. The US Food & Drug Administration has declared Amgen's Aimovig – the first of three approved drugs – to be an "important addition" to available treatments.

But a small group of medical experts who discreetly advise US insurers on new drugs has not been impressed, according to a private meeting held at the UnitedHealth Group's OptumRx offices in Chicago, which was attended by Reuters.

They concluded that the three drugs had no clear advantage over drugs already on the market and that insurers could view them as optional with respect to health care coverage. They advised setting limits on their use.

While these experts do not discuss the cost of drugs, their vision of the clinical value of new migraine medications has emboldened OptumRx, which manages the benefits of prescription drugs, to demand substantial discounts from all three manufacturers. Similar "Pharmacy and Therapeutics" (P & T) committees at CVS Health Corp and Express Scripts of Cigna Inc. have reached the same conclusion.

The impact of their decisions will be exposed Tuesday, when Amgen, which co-sells the drug with Novartis AG, and Lilly report their quarterly financial results.

Asked by Reuters about the OptumRx committee's decision, the three drug companies said the new treatments represent a significant step forward for patients who are unaided by existing treatments or who have trouble staying on their medications. They point out that for some patients, new migraine medications halve the number of headache days each month.

These relatively unknown expert committees have been involved in decisions about drug coverage for decades. The identity of their members is kept secret because of federal regulations to prevent interference by the pharmaceutical industry.

But their power has grown more recently with the consolidation of most US drug benefit activities under OptumRx, CVS and Express Scripts. Together, their three advisory committees are now guiding drug coverage for more than 90 million Americans.

P & T committees also influence the record number of new and expensive drugs introduced into the US market each year, most often with less evidence of efficacy or safety than in the past.

New drugs that could be under scrutiny in the coming year include potentially life-saving treatments for spinal muscular atrophy and Duchenne muscular dystrophy, as well as oral treatments for migraine, diabetes and multiple sclerosis.

Their decisions have new consequences because the pharmaceutical companies they advise are more likely to exclude a new coverage treatment if it is judged to be equal to existing treatments. They can also claim discounts – or discounts – from drug companies in exchange for coverage.

"If the committee says (a treatment) is not better than the existing drug, there is a very decent possibility that it will get a less privileged status or be not included," said Jack Hoadley, expert in health policy at Georgetown University. .

OptumRx's ability to convince more than 30 million people to get drug coverage makes them a great negotiator for clients such as Ben Johnson, the pharmacy director of a Utah health care plan that covers about 20,000 unionized railway workers. Johnson once used his own P & T committee to determine if a drug was effective and cost-effective.

Now, he is often one of the dozens of OptumRx customers and consultants invited to attend the quarterly meetings of the P & T Committee in Chicago. Assigning this role to OptumRx has tripled the value of the rebates his plan receives, Johnson said.

FROM "BREAK" TO "OPTIONAL"

Drug manufacturers say that drug benefit managers such as OptumRx are middlemen who over-cut the discounts they negotiate and, ultimately, drive up prices.

The US Congress and President Donald Trump have taken up these criticisms and the administration has proposed banning rebates in government health programs unless benefit managers hand over savings to patients.

OptumRx, Express Scripts and CVS explain that their method of reviewing the benefit of a drug and the price negotiations that followed lowered the cost of prescription drugs and that 95-98% of the rebates they received were passed on to their customers.

In the case of migraine medications, Amgen, Lilly and Teva quickly announced the potential benefits directly to US consumers once they had been approved, several months before drug benefit distribution companies made decisions on the subject. way to cover the drugs.

The TV commercials of drug manufacturers have highlighted the fact that some days of headaches had been halved or more. Manufacturers have been offering drugs to commercially insured migraine sufferers for a year or more to encourage people to try them. Their main competition is older, cheaper generic drugs.

Migraines affect more than 39 million Americans, mostly women, and Amgen estimates that 8 million could be candidates for preventive treatments, which are given by injection every month or every month. Analysts expect annual sales of $ 4 billion by 2026 in key global markets.

In November, OptumRx convened its advisory committee of a dozen doctors and pharmacists to review new migraine medications.

These experts cited clinical trial data showing that patients taking new medications had an average of 1 to 2.5 fewer days of migraine per month than those taking placebo, and said it was consistent with existing, although no clinical study has been conducted directly. compare the two groups of drugs.

The committee acknowledged that some patients saw the benefits of the new, much larger drugs, but said the data did not indicate who could be the most helpful. They questioned limited safety data and unknown long-term effects on the body.

"Let's be careful and see how it all goes, but we need to look at these studies with a yellowish eye," said one of the members.

The committee's verdict: all three drugs should be considered "optional" treatments that do not provide any particular benefit. Sumit Dutta, Chief Medical Officer at OptumRx, said the decision, based on available clinical data, balances drug manufacturers' claims.

"There are many examples of drugs that are very exciting at first," but that turned out to be problematic afterwards, Dutta said.

As OptumRx could choose not to cover any of the new migraine medications, it could aggressively push for discounts. On February 1, he started covering Aimovig from Amgen and Lilly's Emgality. Ajovy de Teva would only be covered if patients did not benefit from the other two drugs.

Ami Fadia, an analyst at Leerink Biotech, estimates that the discounts granted by manufacturers on these drugs could reach 50%.

According to Amgen, 200,000 American patients have been prescribed at Aimovig, of which about half of the prescriptions are dispensed free of charge. Teva and Lilly did not provide figures on patient use. Teva said in February that he was counting on sales of $ 150 million for Ajovy in 2019.

For its part, Express Scripts estimates that only 128,000 of its covered patients will be good candidates for new treatments and has a program to closely manage who receives them. OptumRx and CVS refused to provide similar forecasts.