Are You Paying Too Much for Pregabalin?

By Pat Anson, PNN Editor

It didn’t take long for cheaper generic versions of pregabalin to take a bite out of Pfizer’s monopoly of Lyrica, a drug widely used to treat fibromyalgia, diabetic neuropathy and other types of chronic pain.

Last month the U.S. Food and Drug Administration gave approval to rival drug makers to begin selling generic pregabalin after Pfizer’s patent on Lyrica expired. According to FiercePharma, Pfizer lost about a third of the market for pregabalin to 16 competitors by the end of July.  

It’s not hard to see why. According to Healthcare Bluebook, a 60-day supply of 75mg Lyrica sells for a “fair price” of $472. That compares to generic versions that sell for about $28.

“The price that most patients pay is set by insurers. The cost difference for patients between brand-name Lyrica and generic pregabalin may vary depending on the patients’ insurance plan, the state in which their prescription is filled, or the pharmacy where they pick up their prescription,” said Steven Danehy, a Pfizer spokesman.

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As of August 9, Lyrica still had about 43% of the market for pregabalin, but that’s likely to change as patients, doctors and insurers became more aware of the significant difference in price.

Pregabalin is approved by the FDA for the treatment of pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy. It is also commonly prescribed "off label" for other types of chronic pain.

Pregabalin is a Schedule V controlled substance, which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed.

The drugs, which belong to a class of nerve medication called gabapentinoids, were originally developed to treat epilepsy, not pain. Prescriptions for gabapentinoids have tripled over the past 15 years as more doctors prescribed them as “safer” alternatives to opioids.

Deaths involving gabapentinoids have increased in the UK, Australia and Canada, where some addicts have learned the drugs can heighten the euphoric effect of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

FDA Approves First Generics for Lyrica

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Lyrica (pregabalin), a medication widely prescribed for the treatment of fibromyalgia, diabetic neuropathy and other types of chronic pain.

Lyrica has been a blockbuster drug for Pfizer since its approval in 2004, generating revenue of $4.6 billion annually. The recent expiration of Pfizer’s patent on Lyrica opened the door to much cheaper generic competitors.

A one year supply of Lyrica currently costs about $2,800 in the United States, according to Healthcare Bluebook, while a similar dose of pregabalin under the UK’s National Health Service costs about $74.

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“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

The FDA granted approvals for generic pregabalin to 9 drug makers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Pfizer’s patent for Lyrica CR — an extended released version of Lyrica — remains in effect until April, 2021.

Side Effects

The most common side effects for Lyrica are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and difficulty concentrating. Lyrica’s warning label also cautions users that the drug may cause suicidal thoughts in about 1 in 500 people.

Pregabalin is classified as Schedule V controlled substance in the U.S., which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed. The drugs were recently classified as controlled substances in the UK.

Pregabalin and gabapentin were originally developed to prevent epileptic seizures, but their use has tripled over the past 15 years as more doctors prescribed them off-label as “safer” alternatives to opioids.

A recent study in the British Medical Journal found the drugs increase the risk of suicide, overdose and traffic accidents in younger people. The risks were strongest for those taking pregabalin and were most pronounced among adolescents and young adults aged 15 to 24. Patients aged 55 and older taking gabapentinoids were not at greater risk.



Drug Maker Payments May Influence Gabapentinoid Prescribing

By Pat Anson, PNN Editor

There is growing attention being paid to doctors who accept money from pharmaceutical companies. A recent study, for example, found that doctors who receive direct payments from opioid manufacturers tend to prescribe more opioid medication than doctors who receive no such payments.

But another new study shows the same is true for doctors who prescribe an expensive class of non-opioid drugs that are widely used “off label” to treat chronic pain.

Researchers at Yale University and the University of Connecticut looked at Medicare Part D prescribing data for gabapentinoids from 2014 to 2016, comparing it with payments made to doctors from gabapentin manufacturers. Over the study period, about 51,000 physicians received $11.5 million from the drug makers, mostly for meals, beverages and gifts.

The researchers found that doctors who received the payments were more likely to prescribe a brand name gabapentinoid such as Lyrica (Pfizer), Gralise (Assertio) or Horizant (Arbor). These brand name drugs cost several hundred dollars for a one-month supply, compared to less than $20 for a one-month supply of a generic version. 

“Among physicians who prescribed gabapentinoids, receipt of payments from industry was associated with a higher likelihood of prescribing brand-name products than generic gabapentin,” researchers reported in JAMA Internal Medicine.

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“Our findings raise concerns about the reasons some physicians prescribe brand-name gabapentinoids and not less-expensive generic alternatives.”

Generic drugs are generally just as effective as brand name drugs, but the differences in cost can be significant. For a Medicare beneficiary in 2016, about $2,500 a year was spent on a brand name gabapentin vs. just $89 for a generic version of the same drug.

“All of these studies have essentially the same finding -- that marketing to physicians is associated with increased sales of a company’s product and increased Medicare expenditures,” Robert Steinbrook, MD, UC San Francisco School of Medicine, wrote in a JAMA editorial.

“Association studies do not establish cause and effect, they do not account for other influences on prescribing, such as direct-to-consumer advertising, and they do not assess the appropriateness of prescriptions for individual patients. Nonetheless, the pattern is indisputable.”

Does your doctor accept industry payments? You can see for yourself on Medicare’s Open Payments database.

In addition to the costs involved, there is growing awareness that gabapentinoids are over-prescribed and not as effective for some chronic pain conditions.

The drugs were originally developed to prevent epileptic seizures, but their use has tripled over the past 15 years as more doctors prescribed them off label for a wide variety of pain conditions.

Our findings raise concerns about the reasons some physicians prescribe brand-name gabapentinoids and not less-expensive generic alternatives.
— JAMA Internal Medicine study

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” wrote Christopher Goodman, MD, and Allan Brett, MD, University of South Carolina School of Medicine, in a recent clinical review in JAMA Internal Medicine.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

Goodman and Brett said the 2016 CDC opioid guideline reinforces “an inflated view of gabapentinoid effectiveness” by asserting they are “first-line drugs” for neuropathic pain. Many patients who take gabapetinoids have side-effects such as dizziness or drowsiness, and there are increasing reports that the drugs are being abused and sold on the street.   

Gabapentinoids Raise Risk of Suicide and Overdose in Younger People

By Pat Anson, PNN Editor

Gabapentinoids – a class of nerve medication widely prescribed to treat chronic pain – increase the risk of suicide, overdose, traffic accidents and head or body injuries in younger people, according to a large new study published in The British Medical Journal.

Sales of the two main gabapentinoids, pregabalin (Lyrica) and gabapentin (Neurontin), have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.

A team of researchers followed nearly 192,000 people enrolled in the Swedish Prescribed Drug Register who filled prescriptions for gabapentinoids on at least two consecutive occasions from 2006 to 2013. That information was compared to data in the Swedish Patient Register, which collects information on hospital admissions and outpatient care, as well as the Swedish Cause of Death Register.

Over the study period, researchers found that patients taking gabapentinoids had higher rates of suicide or suicidal behavior (5.2%), unintentional overdose (8.9%), traffic accidents (6.3%) and head or body injuries (36.7%) than the general population.

The risks were strongest for people who were prescribed pregabalin and were most pronounced among adolescents and young adults aged 15 to 24.  Patients aged 55 and older taking gabapentinoids were not at greater risk.

Researchers believe the drugs may have more impact on younger people because they have faster metabolisms, which could lead to withdrawal problems that affect their impulsivity and emotions.

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“Overall, gabapentinoids seem to be safe for a range of outcomes in older people. However, the increased risks found in adolescents and young adults prescribed gabapentinoids, particularly for suicidal behaviour and unintentional overdoses, warrant further research,” said lead author Seena Fazel, MD, of the University of Oxford in England.

“If our findings are triangulated with other forms of evidence, clinical guidelines may need review regarding prescriptions for young people, and those with substance use disorders. Further restrictions for off-label prescription may need consideration.”

Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries; while gabapentin is approved for epilepsy and post-herpetic neuralgia. Both drugs are also widely prescribed off-label to treat back pain, depression, migraine and other chronic conditions.

Gabapentinoids are increasingly being used recreationally by addicts who have found the medications enhance the effects of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

Gabapentin is not currently scheduled as a controlled substance by the DEA, while Lyrica is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A recent clinical review found little evidence the drugs should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The CDC’s controversial opioid guideline, for example, calls gabapentin and pregabalin “first-line drugs” for neuropathic pain.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Out-of-Pocket Costs for Neurology Drugs Rise Sharply

By Pat Anson, PNN Editor

Out-of-pockets costs for medications to treat multiple sclerosis, peripheral neuropathy and other neurologic conditions rose sharply over 12 years, according to a new study that found the average monthly cost to patients for MS drugs rose nearly 2,000 percent.

One in six people lives with a neurologic disease or disorder, according to the American Academy of Neurology. The annual cost of treating neurologic disorders in the United States is more than $500 billion.

“With many new, high-priced neurologic drugs coming to market and a recent rise in use of high-deductible insurance plans, which shift costs to patients, it is likely out-of-pocket costs will continue to increase,” said lead author Brian Callaghan, MD, of the University of Michigan in Ann Arbor.

The study was published online in the journal Neurology.

Callaghan and his colleagues examined out-of-pocket costs for over 912,000 people with MS, neuropathy, epilepsy, dementia or Parkinson’s disease who were privately insured from 2004 to 2016.

Researchers found that out-of-pocket costs for MS drugs showed the steepest monthly increase. Patients paid an average of $309 a month in 2016, compared to just $15 in 2004. Costs for MS patients in high-deductible health plans were even higher, averaging $661 per month or nearly $8,000 a year.

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Co-pays and deductibles for brand name medications for neuropathy, dementia and Parkinson’s disease also rose considerably.

“Everyone deserves affordable access to the medications that will be most beneficial, but if the drugs are too expensive, people may simply not take them, possibly leading to medical complications and higher costs later,” said Ralph Sacco, MD, President of the American Academy of Neurology.

Researchers said neurologists and other physicians usually do not know the cost of drugs they prescribe, so they don’t discuss alternative medications based on a patient’s disease, insurance plan, pharmacy and deductible.

“Out-of-pocket costs have risen to the point where neurologists should be able to consider the potential financial burden for the patient when prescribing medication, but they do not have this information available to them,” Callaghan said. “Neurologists need access to precise cost information for these drugs in the clinic so when they meet with patients to make treatment decisions, they can help minimize the financial burden.”

Even when a generic version of a drug becomes available, it can take years for out-of-pocket costs to drop substantially. It took five years for out-of-pocket costs for gabapentin, for example, to drop to those of other tricyclic anti-depressants after gabapentin went generic in 2004.

A 2015 study found an “alarming” increase in costs for MS drugs and suggested the price increases were coordinated by drug companies.

A Pained Life: Fearful Fortunes

By Carol Levy, PNN Columnist

I love fortune cookies, but have no faith in the fortunes themselves. I opened a cookie recently and out came this message: “Listen to what you know instead of what you fear.”

I am going through a bad time recently. For 19 years I have had a spontaneous remission of the worst of my trigeminal neuralgia pain.

The trigeminal nerve now seems to be regenerating and it worries me. I get sporadic tingling sensations in the numbed areas of my face, the result of a procedure done in 1979. Within the last few months, the spontaneous pain has also started coming back, not in the same way, and only one or two flares were horrific.

I am very fearful all the pain will return.

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My new neurologist specializes in headaches. My situation is an unknown to him. He is very nice but is essentially throwing drugs at me, a new one each time the one he just prescribed doesn't help or gives me terrible side effects. He is throwing things at the wall and hoping something will stick. I fear nothing will.

I finally found someone who specializes in trigeminal neuralgia and facial neuropathy, my disorders. She asked for a copy of my medical records so she can decide if she will accept me as a patient.  I fear she will refuse. Or if she agrees to see me will be unable to help — like almost all the others.

A woman I know has fibromyalgia and Complex Regional Pain Syndrome (CRPS). For years she has been on high dosages of Dilaudid and another strong opioid. Her doctor decided he would halve her dosages of both. She was appropriately fearful of being tapered. But to her astonishment she found she could tolerate the reductions. She is happily doing just as well on the lower dosages as she had been on the higher amounts.

A lot of what we go through is often based on fear. It is legitimate. We know what the pain is like, we know what the medications do, we know what we can and cannot do. A lot of our choices are fear based: It hurts when I do this, so therefore I will never do it again.

I am able to do so much more, feel so much better when I am on this particular medication and this particular dosage, so I will refuse any changes. I am used to this doctor/physical therapist/specialist being involved in my treatment, even though I am not always happy with them, so I will stay anyway.

It is hard to give up the fear. Pain is not like painting a room a new color and then deciding you don’t like it. You can always just repaint. But change what I am used to doing to deal with the pain? That is not so simple. My pain may increase and be even more unbearable, more daunting.

But what if I take the chance and find I am okay?

Our minds and bodies have been programmed to do all we can to avoid pain. Fear is one of the ways we deal with it. As a kid you touch a hot stove and feel the excruciating pain of a burn. You very quickly learn to fear a hot stove, the fear keeping you from hurting yourself in the same way again.

It is almost counter intuitive to heed the fortune: “Listen to what you know instead of what you fear.”

What we know is why we fear. Maybe, at least for us, the fortune should read: “'Listen to what you know, but take the chance of fear anyway.”

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Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

1 in 5 Multiple Sclerosis Patients Misdiagnosed

By Pat Anson, PNN Editor

Nearly one in five patients who are told they have multiple sclerosis are misdiagnosed with the autoimmune disease, according to a new study of patients referred to two MS treatment centers in Los Angeles. The patients spent an average of four years being treated for MS before receiving a correct diagnosis.

MS is a chronic disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision, and fatigue. The symptoms are similar to those of several other chronic conditions – including neuropathy, migraine and fibromyalgia – which often leads to a misdiagnosis.

Researchers at the Cedars-Sinai Multiple Sclerosis and Neuroimmunology Center analyzed the cases of 241 patients who had been diagnosed by other physicians and then referred to the Cedars-Sinai or UCLA MS clinics.

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Their findings, published in the journal Multiple Sclerosis and Related Disorders, indicate that 43 of the 241 patients (18%) with a previous diagnosis of MS did not meet the criteria for the disease.

"The diagnosis of MS is tricky. Both the symptoms and MRI testing results can look like other conditions, such as stroke, migraines and vitamin B12 deficiency," said lead author Marwa Kaisey, MD. "You have to rule out any other diagnoses, and it's not a perfect science."

The most common correct diagnoses was migraine (16%), radiologically isolated syndrome (RIS) (9%), spondylopathy (7%), and neuropathy (7%). RIS is a condition in which patients do not experience symptoms of MS even though their imaging tests look similar to those of MS patients.

The misdiagnosed patients received approximately 110 patient-years of unnecessary MS disease modifying drugs. Nearly half received medications that carry a known risk of developing progressive multifocal leukoencephalopathy, a potentially fatal brain infection.

"I've seen patients suffering side effects from the medication they were taking for a disease they didn't have," Kaisey said. "Meanwhile, they weren't getting treatment for what they did have. The cost to the patient is huge — medically, psychologically, financially."

The cost of disease modifying medications for an MS patient in the U.S. exceeds $50,000 a year. Investigators estimated that the unnecessary treatments identified in this study alone cost almost $10 million. 

Researchers hope the results of the study will lead to new biomarkers and improved imaging techniques to help prevent future MS misdiagnoses.

A similar study in 2016 also found that MS patients were often misdiagnosed. One third of the patients were misdiagnosed for a decade or longer, most took unnecessary and potentially harmful medication to treat a disease they didn't have, and some even participated in clinical trials for experimental MS therapies. About a third suffered from morbid thoughts of death.