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Aug
17
Sandeep Singh Dhillon
A secretive board controls access to prescription drugs for millions of Americans – St Loius Post Despatch
Pharma News
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Each year, Express Scripts releases a list of prescription drugs it will exclude from coverage for the upcoming year, and that list is determined by a secretive board of doctors and a pharmacist.

The nation’s largest pharmacy benefit manager, which is based in St. Louis County, does not disclose the names of the board members or any actual or potential conflicts of interest they may have.

Express Scripts is not alone. Its rivals also exclude drugs from their own annual drug formularies — the list of drugs they will cover — based on the recommendations of unidentified experts.

The reason behind the secrecy is to shield experts from the “tremendous” influences of lobbyists, Express Scripts executives say. But some critics say the process should be more transparent, as it is in many other countries.

The secrecy remains when the rest of the industry is required to publicly disclose its financial relationships. For example, drugmakers and device makers must report how much they pay doctors for perks such as food and beverage, travel and speaking engagements.

“All of us are subject to reporting on what money we receive. These folks should do the same,” said Dr. Adrian Di Bisceglie, co-director of St. Louis University Liver Center.

Express Scripts negotiates the cost of prescription drugs directly with pharmaceutical companies and provides prescriptions to about 85 million Americans each year through their employer-based prescription drug coverage.

The list, or what Express Scripts calls its national preferred formulary, is a major tool to curb the rising costs of prescription drugs. The threat of being excluded pressures drug makers to lower their prices.

Express Scripts recently released its 2017 list of drugs it will cover and those that it will exclude from coverage. The list excludes a total of 85 medications. If a particular drug has a cheaper and clinically equivalent alternative, the original drug is likely to be excluded from the list.

Patients, however, can appeal an exclusion.

“In the instances when a patient has a rare medical need that requires that she be treated with a drug that has been excluded, we have an exception process in place to ensure the patient can have that drug covered,” said David Whitrap, a company spokesman.

For drug manufacturers, being excluded from Express Scripts’ list of preferred drugs has financial consequences.

“Usually the stock drops; usually investors react negatively toward that news,” said Vishnu Lekraj, an analyst covering Express Scripts for Morningstar.

Shares of Gilead Sciences Inc. plummeted 14 percent on Dec. 22, 2014, when Express Scripts moved to exclude the drugmaker’s new, high-cost hepatitis C drug in favor of a different version from Gilead’s rival.

For drugs to make it on the national formulary, they are first reviewed by three different committees during a four-step process.

The committee with the most influence, and the one that makes the final recommendations, is the national pharmacy and therapeutics, or P&T, committee, which Express Scripts describes as independent and objective.

The committee is a 16-member board, comprising almost entirely doctors, half of whom are in academic-based practices and the other half in private practice, said Dr. Steve Miller, Express Scripts’ chief medical officer. They are considered “thought leaders” in their field.

Members serve a three-year term and represent a broad range of medical specialties. To gain a spot on the board, new members are elected by current members.

They are required to disclose their financial relationships with drug and device makers on an annual basis, Miller said.

Members must list the exact dollar amount they receive from those companies and the percentage of their income those payments represent. They also share their stock ownership and research grant awards, according to the company’s own literature.

Miller said it was impossible to find experts who hadn’t received money from the industry.

“If you’re going to have some of the best experts, they’re going to be asked to speak and they’re going to be asked to be in (clinical) trials,” he said. “If they have no conflict at all, are they truly the experts in the field that people are turning to?”

Other countries are much more transparent with this process of selecting drugs, and the secrecy is not common in other parts of the world, said Steve Morgan, professor of health policy at the University of British Columbia and an expert on international pharmaceutical policy.

“I can’t think of an exception to the rule,” Morgan said of countries that name their own panel experts. “The members of the expert advisory committees that make the final decision are typically named,” he said. “You know who they are, you know about their conflict of interest.”

In many countries, such as the United Kingdom, there’s a government-run single-payer health care system, far different from the U.S. health care system of competing, private providers.

The U.K.’s expert panel holds public hearings and publicly publishes its conclusions. But some countries allow the panel to cast their final votes anonymously.

“The professionals who are on these committees are put under enormous pressure — political pressure, lobbying pressure from patient groups and industry,” Morgan said.

For Express Scripts, when formulating its recommendations, the P&T committee does not review any pricing information or potential discounts Express Scripts would receive. It’s focused strictly on clinical analysis.

After reviewing relevant scientific information on particular drugs and a review of its competitors that treat the same issues, the committee either recommends to include or exclude the drug from the annual list.

They can also designate the drug as an optional choice, when there are multiple drugs that treat the same condition.

A majority of drugs are deemed optional because there are many medicines that treat the same ailments without any significant difference among them, Whitrap said.

From there, another committee, comprising Express Scripts’ employees, analyzes the value of a particular drug. The value committee is required to add medications the P&T committee votes to include.

However, the value committee will review the optional drugs and narrow the choices to particular brands that Express Scripts can obtain at cheaper prices.

Then it’s back to the P&T committee for final approval.

For their work, P&T committee members receive a stipend that aims to make up for the revenue they’re losing by taking time out of their regular schedules to work on behalf of Express Scripts.

Fear of lobbying pressure

The P&T committee meets at least every quarter, and Miller said its clients — employers buying the coverage — were invited to the meetings as long as they sign an agreement not to name the doctors publicly. He said his clients were satisfied with the current level of transparency.

The fear is that if the doctors are named, they will be subject to intense lobbying, Miller said.

“Our doctors will tell you, if it’s known who is on the committee they would be under tremendous lobbying efforts by patient care groups, manufacturers and others,” he said.

Meanwhile, the industry has become more transparent. Consumers now can track the flow of money from drug manufacturers to their own physician. The government tracks the dollar value of the perks that manufacturers give physicians, which include trips, food and beverage and promotional speaking fees.

In 2015, about $2.6 billion in general payments were funneled to doctors and teaching hospitals across the United States, according to data from the Centers for Medicare and Medicaid Services. And another $4.8 billion in payments were made for research and ownership or investment interests.

There have been times when a P&T member either voluntarily resigns or they’ve been asked to resign by other members because they became “too involved” in research for a particular product, Miller said.

But because the group of physicians on Express Scripts board are unnamed, it’s not apparent what conflicts they may have. Express Scripts does not disclose that information publicly either.

“You can argue whether that’s wise,” said Arthur Caplan, head of the Division of Medical Ethics at New York University’s Langone Medical Center. “I’d like to see a lot more transparency.”

But analysts say that the formularies are the best way to control drug prices in the country and that there doesn’t need to be more transparency.

For one, Express Scripts’ clients — employers — can customize their own formulary for their employees’ needs. And if a drug is excluded, there is an appeals process if that drug is truly the best treatment for a particular patient.

Express Scripts says its basic national formulary — which hasn’t been tweaked by clients — covers 25 million Americans, but only 0.12 percent, or about 30,000 people, will have switch to medications in 2017 because of the changes.

Analysts point to exclusionary moves in the past that have saved employers and workers billions of dollars.

One of its more widely publicized moves was the exclusion of the controversial drug Sovaldi, manufactured by California-based Gilead Sciences.

The drug was revolutionary because it offered a treatment to quickly cure hepatitis C, a disease that progressively destroys the liver. But Sovaldi came with a significant price tag, and when a competitor introduced an alternative — Viekira Pak, made by Illinois-based AbbVie — in 2015, Express Scripts decided to cover it and exclude Sovaldi. Executives said the move saved the health care system $4 billion in 2015.



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