The obscure advisory committees at the heart of the U.S. drug pricing debate – Reuters – by Caroline Humer – April 2019
Expectations were high last year for three new migraine drugs hitting the market from Amgen Inc, Eli Lilly and Co and Teva Pharmaceutical Industries.
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
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.
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.
Their identities are only secret to the general public. I’m sure the pharmaceutical companies have found out who they are and finding ways to influence them. Money opens many doors to reveal information that remains unavailable to the rest of us.
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.
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.
FROM “BREAKTHROUGH” TO “OPTIONAL”
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.
It’s ridiculous to believe that these Pharmacy Benefit Managers “lowered prescription drug costs” in any way in any time. Prices are high and keep getting higher. Why?
Because they can. As long as people are buying them (to save their lives in some cases), there’s little incentive to NOT raise prices sky-high. That’s the free market at work.
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.
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.
The committee’s verdict: All three drugs should be considered “optional” treatments that provide no unique benefit.
All these decisions are made on the basis of statistical analysis of studies and trials that calculate benefits for the “average patient”, that mythical creature with one breast and one testicle.
Using such “standardization” of patients and drugs moves medicine even further from finding solutions patients like those with still undiagnosed EDS.
“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.