GOSNELL, Ark. (KAIT) – Jen Holifield has multiple myeloma, an incurable blood cancer. Her doctor prescribed Lenalidomide — brand name Revlimid — to treat it. She has not been able to fill that prescription in more than two months because of its price and what her insurance is willing to pay.
Holifield is on Medicare. While her insurance covers the generic version of the drug, she said the cost has made it impossible to obtain.
“I went to get my prescription refilled, and for a 30-day supply of it, they told me that my co-pay was going to be $3,271.66,” Holifield said.
Having to deal with finding financial sources for her medication by herself has been hard. This is a treatment she will need to take for the rest of her life.
Why the drug costs so much
Dr. Charles Bennett, a lead author of Congressional Investigation of RevAssist-Linked and General Pricing Strategies for Lenalidomide, published in the JCO Society of Clinical Oncology Journal, said the high price is tied to the history of Lenalidomide’s predecessor, Thalidomide — a drug known to cause life-threatening birth defects.
Because of that history, the safety label for Revlimid requires women who can become pregnant to complete two negative pregnancy tests before taking the drug and to use two forms of birth control while on it.
“Multiple myeloma patients, like your patient that you have in Arkansas, they’re usually in their forties or fifties,” Bennett said. “They’re not likely to get pregnant.”
Revlimid and its generics are only available through a restricted, patented distribution program known as REMS.
“The question at the policy level we’ve asked for in the paper that I wrote is, if you believe in this requirement for the REMS program, why not make it generic rather than brand it? And why not drop the price of the REMS program, which means drop the price of Revlimid,” Bennett added.
A history of price increases
According to Bennett’s article, the price of Lenalidomide has been raised 22 times since 2005, from $215 per pill to $763 per pill by 2019. By the end of 2020, a one-month supply of Revlimid cost $16,000.
Manufacturer Celgene, now Bristol Myers Squibb, generated $53 billion in revenue between 2009 and 2018.
Bennett said the restricted distribution model contributes directly to the price.
Due to Revlimid’s restricted distribution, few pharmacies can fill the prescription. Pharmacies in Arkansas have attempted to gain access to the drug for years. According to Layton Kelley, PharmD, associate chief pharmacy officer at the University of Arkansas for Medical Sciences, the hospital tried to obtain the brand-name drug for its in-house specialty pharmacy for 12 years without success.
Pharmacist and Arkansas State Representative Brandon Achor helped sponsor two bills — Act 624 and Act 630 — in part, because of Revlimid.
“When you limit the distribution of something, you limit the number of areas that can purchase it. You create an artificial shortage,” Achor said. “That’s what allows that price to remain stagnant.”
Act 624 addresses pharmacy benefit managers setting high prices. Act 630 requires manufacturers to allow pharmacies that meet the same credentials as mail-order pharmacies to purchase those same medications.
“What bothers me about this tremendously is that drug, Revlimid, was one of the primary reasons I sought to help rectify this. We have a multiple myeloma clinic at UAMS that is known around the entire nation, and they can’t purchase that medication,” Achor added.
Both pieces of legislation are currently being challenged in court.
The issue hits close to home for Rep. Achor. His wife is in six months post-recovery from stage three triple-negative breast cancer.
The cancer medication Kisqali has been open access for a decade, but it was recently assigned for limited distribution.
“When you take a medication that’s been safely distributed for the last decade, and then all of a sudden assign it to be limited distribution, there is no motive other than to control pricing,” Achor said.
Drug can extend lifespan from two years to 20
Dr. Bennett said the stakes for patients are significant.
“Before Thalidomide and Revlimid, the average lifespan of a patient with myeloma would be two or three years. Now, it’d be 20 years,” he said.
John Vinson is the chief executive officer for The Arkansas Pharmacy Association. He wants pharmacies in the state to have access to the drug.
With limited distribution, less access and less competition means a higher price. When more generics come out, more companies can produce those generics, driving down the cost of the drug.
Drugs with common brand names, Accutane and Clozapine, were both expensive from the start due to REMS distribution, but over time they dropped in price as more generics were produced and the drug became more widely available.
But it’s not just medication cost that concerns Vinson. Right now, when a patient is prescribed Revlimid, they have to obtain the prescription from a mail-order pharmacy.
“If everything goes to heck and there’s a tornado or an ice storm that takes down the supply chain, or China or North Korea takes down our logistics infrastructure, patients who have multiple myeloma can’t afford to have delays in treatment,” Vinson said.
Experts suggest patients in similar situations speak with a local insurance agent about switching Medicare plans to one with a lower deductible.
One option for patients who are in a similar situation to Holifield is to disenroll from their Medicare plan and enroll in one with a more affordable deductible.
Vinson also recommends reaching out to a local, trusted insurance agent or pharmacist for guidance.
BMS has financial support options, but they do not apply to those with Medicare, Medicaid, or TRICARE.
Holifield said she has exhausted her options. She’s applied for medication assistance, she’s been denied assistance on multiple occasions, and she doesn’t want to change her Medicare plan since she says she’s paying beyond her means already.
She said she’s out of options.
“It’s really hard when it’s just you, you’re living on disability, and you’re trying to take care of everything,” Holifield said. “Plus, going through the stress of getting your own funding for this disease. It’s just too much sometimes.”
Dr. Bennett is pushing to meet with Arkansas Attorney General Tim Griffin to find a permanent solution. When asked for a comment, Griffin’s office said it is representing the state in active litigation and cannot discuss specifics at this time.
A Bristol Myers Squibb spokesperson released statements regarding this story.
K8 News reached back out to Bristol Myers Squibb to ask why Revlimid has not been approved for distribution in Arkansas pharmacies equipped to handle specialty medications. The company had not responded at the time of publication.
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