Rachel Ostrom has been using an opioid pain control patch for several years to help her cope with the chronic pain of fibromyalgia. Her doctor prescribed the Butrans patch, which releases controlled doses of a milder, less addictive opioid known as buprenorphine.

But after the 24-year-old woman moved from Massachusetts to Maine this year, a company called Express Scripts – which manages the pharmacy benefits for her Maine insurance company – refused to cover the Butrans patch.

Express Scripts told Ostrom that her insurance would only cover patches using fentanyl or similar opioids – which are more addictive than buprenorphine and more likely to result in overdoses. If she wanted the Butrans patch – which is more expensive – she’d have to pay for it herself, at a cost of $800 a month.

Rachel Ostrom’s Butrans pain control patch.

The company was keeping its own costs down while exposing Ostrom to a highly addictive drug that her doctor had specifically avoided.

Ostrom appealed the decision – with guidance from her father, who is a retired doctor – and her insurance company eventually agreed to cover the safer Butrans patch. But the Biddeford woman’s case is emblematic of a system that critics say increasingly prioritizes profit over patient safety.

“These are decisions not based on medicine, but what deals they (pharmacy benefit managers) can get from the pharmaceutical industry,” said Dr. Noah Nesin, a pain control and addiction specialist at Penobscot Community Health Center in Bangor. “The moment they find a better deal, they’ll switch these lists. I don’t know that for a fact in this case, but I would bet my retirement on it.”

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The stakes are especially high for patients taking opioid painkillers, powerful drugs that fueled the epidemic of substance use disorder that is sweeping the country, driving thousands of people into the clutches of heroin and other illicit drugs. More than 115 people die in the U.S. every day from an opioid overdose, according to the National Institute on Drug Abuse, while Mainers are dying from drug overdoses at the rate of more than one a day.

The pharmacy benefit manager is usually a large, behind-the-scenes corporation like Express Scripts that has the power to exclude drugs from coverage. The pharmacy benefit managers create the formulary, a list of permitted medications and those excluded from coverage.

Concerns about pharmacy benefit managers have started to be raised nationally by industry experts, health care advocates and politicians, but it’s still a relatively new topic and not much research has been done yet on how they affect the health care system. But specific issues have begun to surface, including the imposition of “gag rules” that prohibit doctors from discussing less expensive options for obtaining prescribed drugs.

‘THE RIGHT MEDICINE FOR ME’

Drugs on the pharmacy benefit manager’s list of excluded medications can still be prescribed, but the patient must bear the entire cost of the drug.

Ostrom had been using the Butrans patch for several years, but after she moved to Maine and switched to a Maine insurance carrier, she had to fight with the company, Community Health Options, and Express Scripts, to continue the patch.

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“It was a very frustrating process. It was really outrageous,” said Ostrom.

She said she was greatly helped by her father, David Ostrom, a retired doctor who knows the ins-and-outs of the insurance system and the differences in medications. He paid $800 out of pocket while waiting for the appeal to be resolved so that his daughter could continue to use Butrans. With insurance, the monthly cost is about $130.

“If I had tried to do this on my own, I don’t know what I would have been able to achieve,’ said Rachel Ostrom.

She said Butrans is “safer long term, and there’s so much proof of that. It’s the right medicine for me at this time.”

Ostrom said she would be worse off if she had been forced to use another opioid patch, such as the fentanyl patch that Express Scripts offered to cover, because her risk of overdose would have been higher.

A spokeswoman for Express Scripts told the Maine Sunday Telegram that other opioid patches are “better clinical options” than Butrans, which is why Butrans is excluded from the list of covered drugs.

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But two federal agencies, and three Maine doctors interviewed by the Telegram, contradict that.

Dr. Jeffrey Barkin, a Maine physician who helps administer the Medicaid pharmacy benefit for 16 states, including Maine, said that excluding Butrans patches while allowing fentanyl and other opioid patches “clinically does not make a lot of sense.”

Butrans is also much more expensive than fentanyl and other opioid patches. While prices vary, the opioid patches that are not Butrans typically cost less than $100 per month.

In Maine, about one in every six opioids prescribed is either a patch or an extended-release pill. About 750,000 opioids were prescribed in Maine in 2017, according to federal data.

Street fentanyl – which is the same drug but more dangerous than prescription-grade fentanyl – is being mixed with heroin or in some cases replacing heroin. Street fentanyl is much more powerful than heroin and is fueling the most recent increases in drug overdose deaths, toxicology experts have said.

‘INCREASING INFLUENCE’ TROUBLING

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Missouri-based Express Scripts is a Fortune 100 company and one of the three largest pharmacy benefit managers in the country. Many companies use Express Scripts for employer-based health insurance. In Maine, the company manages pharmacy benefits for state employees and Community Health Options, an insurer in the Affordable Care Act’s individual marketplace.

“The increasing influence of (pharmacy benefits managers) is troubling,” said Gordon Smith, executive vice president of the Maine Medical Association, which represents doctors. “The money has trumped good public policy.”

Regulations that put limits on what pharmacy benefit managers can do is either weak or in its infancy, experts say.

In the Maine case and others, at issue is whether pharmacy benefit managers are hampering the ability of doctors to prescribe and pharmacists to dispense medicine.

In some cases, pharmacy benefit managers have issued “gag rules” that forbid pharmacists from telling patients that – depending on the plan and the prescription – some medications would be less expensive for the patient to purchase out-of-pocket than using their health insurance benefits.

That’s because of out-of-sight rebates that pharmacy benefit managers secure from pharmaceutical companies, experts say, making the cost of some drugs cheaper out-of-pocket, depending on a patient’s insurance plan.

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States are starting to take notice and regulate pharmacy benefit managers more closely after a string of complaints. U.S. Sen. Susan Collins, R-Maine, has introduced bipartisan legislation that would forbid the “gag clauses” nationwide.

Collins, during a June health committee meeting in Congress, received support for her bill from Alex Azar, the Trump administration’s Health and Human Services secretary.

Maine passed a law in 2016 that attempted to place some weak limits on maximum amounts on what pharmacy benefit managers could charge for medications. Other states that have recently passed laws that start to rein in pharmacy benefit managers include California, New York, Maryland, Nevada, Oregon, Connecticut and Vermont.

But so far no state appears to have started regulating exclusion lists, according to health insurance experts.

Dr. Stacie Dusetzina, a professor at Vanderbilt University and a national expert on pharmacy benefit managers, said that the exclusion lists occur because the managers make deals with pharmaceutical companies to place their products on permitted lists, and exclude others, steering patients to certain drugs.

That may not have much of an impact on patients if the drugs are equivalent and cost about the same – such as similar antibiotics or medications used to control common ailments.

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But if the drugs are not equivalent or there’s a wide disparity in drug prices, patients could suffer the consequences, Dusetzina said.

DIFFERENCES IN OPIOID PATCHES

The Butrans patch and the fentanyl patch, for instance, are not equivalent, doctors told the Sunday Telegram.

Buprenorphine is categorized as a Schedule III drug by the U.S. Drug Enforcement Administration, while all of the drugs on the list of allowed prescriptions for pain control patches – including the fentanyl patch – are Schedule II, which are considered by the federal government to be more dangerous, more addictive and more likely to cause overdoses.

In this case, the safer drug was excluded from coverage for Ostrom while more dangerous drugs could be easily prescribed.

A second federal agency, the U.S. Substance Abuse and Mental Health Services Administration, lists buprenorphine as a less dangerous drug for pain control compared to stronger opioids. Butrans will “diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings,” and the drug has a better safety record than stronger opioids for overdoses, according to SAMHSA.

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Ostrom wonders about other patients who aren’t questioning why they’re on the fentanyl patch instead of Butrans.

Jennifer Luddy, an Express Scripts spokeswoman, said in an email response to questions that for pain patients who need around-the-clock care, other opioids work better than Butrans.

“We excluded Butrans because scientific guidelines and available data demonstrate there are better clinical options for these patients,” Luddy said.

But Barkin and two other Maine doctors, in addition to the federal agencies, disagreed.

Dr. Stephen Hull, director of medical pain management at Mercy Hospital in Portland, said that buprenorphine is a weaker opioid and it’s also less likely that patients will develop a tolerance to it. Patients who develop tolerance to opioids often end up asking for higher doses, increasing the risk of addiction and overdose.

“As to safety, you essentially cannot overdose on buprenorphine but clearly can on fentanyl,” Hull said.

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According to 2013 research in the scholarly journal Pain Medicine, “buprenorphine and fentanyl transdermal patches, both potent opioids, are considered to be equally efficacious in managing persistent pain” in non-cancer patients.

The study said that buprenorphine patch patients had fewer side effects and better pain outcomes, with 57 percent of fentanyl patch users needing additional pain medications after three months, compared to 31 percent of buprenorphine users.

Nesin said that patches are not inherently safer than taking pills, and there are ways for patients to abuse opioid patches. Furthermore, there’s no evidence opioids are effective in controlling chronic pain, Nesin said.

“All of this begs the question: Why are we using these drugs for chronic pain in the first place?” Nesin said. Scientific studies do indicate that cancer patients may need stronger opioids, such as fentanyl.

Dusetzina said excluding a safer opioid from covered medications is worrisome.

“This is really concerning, especially considering that we as a country are really grappling with opioids,” Dusetzina said.

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LITTLE TRANSPARENCY IN SYSTEM

Pharmacy benefit managers have existed for decades, but in recent years, as the cost of prescriptions has shifted to the patient, their role in the process has started to be more scrutinized, Dusetzina said.

Previously, under most plans, patients would pay a flat co-pay for a prescription, say $10 or $20 per month. If the cost of the prescription went from $100 per month to $500, the patient wouldn’t notice because they were still only paying the flat monthly fee.

Now, many more health insurance plans shift more of the cost of prescriptions to patients, either by having patients pay a percentage or making patients pay a high deductible before the pharmacy benefit kicks in.

Dusetzina said the benefit manager helps keep the overall cost of prescription medication down for its clients, such as employer-based coverage. The pharmacy benefit manager will leverage its buying power to make deals with pharmaceutical companies, and that helps shape the formularies, the place where medications are listed as permitted or excluded.

“It is a black box right now,” Dusetzina said. “We don’t know where the savings are going. It is pretty clear they are not going to the persons using the medications.”

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Pharmacy benefit managers have been blamed for the run-up in drug prices that have made national news, such as the EpiPen controversy in 2017, when the allergy medication’s price ballooned to about $600 per prescription.

Dusetzina said while it’s easy to blame the pharmacy benefit managers, there’s no transparency in the system, so it’s hard to know where the problem lies.

If the price of a drug soars, such as the high-profile EpiPen case, the three major players in the manufacture and delivery of medications – pharmaceutical companies, pharmacy benefit managers and insurance carriers – all blame each other, she said.

Some states – such as North Dakota – are trying to regulate transparency into the system, but Dusetzina said it’s a tall task because of industry lobbying efforts.

Dusetzina said one reason pharmacy benefit managers exist is to help employers keep the cost of prescription drugs in check by leveraging their buying power to extract cost savings from pharmaceutical companies.

She said that may be helping some patients by keeping costs of common prescriptions, such as for diabetes and cholesterol, lower than they would have been.

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But for patients who need specialty drugs or less common medications, the prescription costs could quickly soar, she said.

Barkin is the associate medical director for Change Health Care, which operates pharmacy benefits for Medicaid for 16 states, including Maine. He said except in extremely rare cases, the government health insurance rules make it so that “we don’t have the ability to exclude any drug.”

He said because Change Health Care works for Medicaid, it doesn’t have the same pressures to produce a profit as commercial insurance.

Barkin said in this case, the government has a superior system to the private market.

“What we do is really fair,” Barkin said. “Patients have available to them the whole range of drugs.” Barkin said they encourage the use of generics to keep costs down.

Barkin said because they represent 16 states on behalf of Medicaid, they have negotiating clout with the drug manufacturers, which helps keep costs down.

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Medicare, in contrast, by law is not permitted to use its considerable leverage to negotiate prescription drug costs with drug companies. Giving Medicare that negotiating power is often discussed as a health reform, but so far it hasn’t passed Congress.

A SYSTEM ‘FAR FROM IDEAL’

Kevin Lewis, executive director of Community Health Options, the cooperative in Maine’s ACA marketplace, uses Express Scripts as its pharmacy benefit manager, and he said if it didn’t, prescription costs would be much higher.

Lewis said that if CHO tried to be its own benefit manager, overall prescription costs would skyrocket because it doesn’t have the same negotiating leverage as Express Scripts.

Lewis said the system is “far from ideal” but it’s what they have to work with.

“Sure, PBMs are in the middle and getting a significant share,” Lewis said. “But the drug manufacturers are also making enormous riches.”

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And while CHO does have the power to move medications from the excluded list to the allowed list, “each variation comes with a price,” Lewis said.

Lewis said they would rather carve out exceptions in the appeals process, and take care of situations on a case-by-case basis. Ostrom won her case on appeal.

“We have many alternatives to the Butrans patch,” Lewis said, pointing out that buprenorphine for pain control is also available as pills. Some doctors opt to put their patients on a patch if the pain is constant and if patients are forgetful in taking their medicine, or for other reasons. Ostrom said because she’s getting a steady flow of buprenorphine, she can be on a lower dose.

Dusetzina said insurance carriers and employers purchasing health plans for their workers are making rational choices – using the negotiating power of pharmacy benefit managers to help keep costs down.

But doing so at the same time there’s a fundamental change in how prescription drug benefits are being structured for employees, the system is hurting the pocketbooks of some patients who need certain medications, Dusetzina said.

David Ostrom said it “really bothers me” that Express Scripts’ national policy is to exclude Butrans. He said it’s “absurd” to think that fentanyl and other opioids would be better in a patch for non-cancer pain.

“They throw around a lot of medical terms, but their logic is twisted and incomplete,” Ostrom said. “What is happening simply should not be.”

 


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