PBM: What Doesn’t Kill You Makes Us Money
“Potential Signal of a Serious Risk / New Safety Information: Drug-induced lupus.” – FDA
Vertical integration “creates perverse incentives for PBMs to shut out independent pharmacies at the expense of the American public.” – Earl Leroy “Buddy” Carter, Republican U.S. Representative, Georgia
Cut or dice it however you like, patients are getting the raw end of “sweetheart deals” between PBM, Physician, and Pharma.
Pharmacy Benefit Manager (PBM) vertical integration of Pharmacy and Insurance allows for control of the 3 Ps – Pharma, Physician, and Patient. As Pharma prices soared at the height of 1990, PBMs set themselves up for the 21st century → Key roles of negotiating drug prices and authorizing drugs.
REPURPOSING VACCINES
Vaccines Proposals: If your interests and research lie in biotechnology, genetic engineering, and the use of Chinese hamster ovary (CHO) cells for recombinant protein therapeutics you may wish to visit my spacedefcommand.com and read my paper EMCV and SARS Vaccines: Interferon beta 1-alpha (mammalian cells) and Natural Killer Cells.
A formulary taken for MS is described as an Interferon beta-1a using “genetically engineered Chinese Hamster Ovary cells” while another, interferon beta-1b is produced in modified E. coli.” MS formularies are priced between $5,000 – 7,500 on average for a month’s supply.
It seems plausible to develop a vaccine where once injected, the body sees the genetically engineered virus as a makeshift bait and/or bacteria. Let’s say “Pharma X” comes up with an inexpensive vaccine ($50.00) for SARS-COV-2 (inoculation or yearly therapy).
It seems probable that the same inexpensive SARS-COV-2 vaccine can be repositioned for the expensive auto-immune disease MS formulary. Hmm, $50 or $5,000?
Not a chance! Drug Repurposing is typically done with the bottom line in mind.
PBMs Exclusive Drug Deals
PBMs have become the Negotiator and Closer of your drug. Brian S. Feldman’s March 17, 2016 article, “Big pharmacies are dismantling the industry that keeps US drug costs even sort-of under control” points to its beginnings and administrations “greenlighting” their deals.
Feldman adds, “When a pharmacy owns a PBM, explains Bob Zebroski, a professor at the St. Louis College of Pharmacy, “it’s a sweetheart deal—the two entities no longer have an incentive to negotiate with each other.”
Right, but are we overlooking deals between the pharmacy/PBM and the drug dealers otherwise known as Big Pharma?
A German company Merck KGaA, (NOT to be confused with the American Merck & Co.), appears to have been give the “green light” to contract with an American PBM.
A PR Newswire 2016 news release headline reads, “EMD Serono Takes on Exclusive Promotion of Rebif® (interferon beta-1a) in the US.”
Two questions: Who is EMD Serono and who is the deal with?
→“EMD Serono, the biopharma business of Merck KGaA, Darmstadt, Germany”
→“Rebif, the number one prescribed interferon for relapsing MS in patients new to therapy in the US*, is now the exclusive interferon beta-1a on CVS Caremark™ National Formulary and will also continue to be covered on most major national formulary plans.”
Yet, according to the same PR Newswire
“The efficacy and safety of Rebif in controlled clinical trials beyond 2-years has not been established.”
“Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.”
“Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients.”
“Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy.”
“There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”
Was CVS reported Rebif exclusivity a way to compete? Recall that “Centene acquired Health Net in March 2016 for $6 billion. As a result of this acquisition, Centene became the largest Medicaid managed-care provider in the United States.”
A Valparaiso University Law Review 2007 “Leveling the Playing Field in the Pharmacy Benefit Management Industry” by Allison Dabbs Garrett and Robert Garis argues that:
“Lack of transparency has created an environment in which PBMs may engage in practices that involve self-dealing or that are prohibited under various laws. Examples of these practices include drug switching, channeling certain prescriptions to the PBMs’ own mail order or specialty pharmacies, and certain rebate and pricing practices. The PBMs, which are ostensibly hired by health plans as the agents for those plans to negotiate with manufacturers and retail pharmacies, hide from their own clients what they pay for prescriptions and often fail to disclose appropriate information.”
WHY IMPORTANT? For employers not contracted with CVS, it means zilch. For employers who are, it may mean patients on other formularies will be required to take Rebif. Family and friends in Europe may have no choice in what their state run health system prescribes, but they’ll likely not pay high drug prices.
Americans may find that other than paying high drug prices they’ll also have to contend with obtaining their formularies from a PBM that has contracted with said German pharmaceutical and chemical company or other foreign drug companies.
MS: Aunt Esty’s Lived Experience
My favorite German philosopher, Frederick Nietzsche, is known for saying “What doesn’t kill you makes you stronger.” I think he was referring to a persons’ character in facing adversity not man-made formularies, vaccines or chemical compounds.
Viruses, vaccines, and auto immune diseases brings to mind my Aunt Esther, or as I have called her, Aunt Esty. Aunt Esty has lived with Multiple Sclerosis (MS) for twenty years. Do you have a loved one or friend with an autoimmune disease like MS?
Auto-immune diseases are where the body’s own immune system “goes on the attack.” Depending on the disease, it targets specific cells or tissues of the body. Research points to two likely causes: genetics and/or environment.
As a young teen, I recall accompanying my Grandmother to get her flu shot. I asked her why she was being “shot” with flu. As I understood it then it was a way to boost the body’s immunity to the flu. I must admit it seemed strange to me, but it was no stranger than years later overhearing my Aunt attempt to explain to my Mother of how her immune system attacks cells in her brain.
I realized Aunt Esty had a special system. Simply put, her immune system was naturally on overdrive. No surprise, I later found out her medicine was classified as a “specialty drug” (expensive & temperature sensitive). I was told her medicine required she take weekly injections. The idea of simply using one injection a year like a flu shot occurred to me. In time, I shared my ideas with my Father:
Auto-immune response in people with MS can metaphorically be compared to that of SPECIAL FORCES vs Police Officers. It seems plausible that if a person’s immune system is already in full force, then the moment their body comes into contact with a foreign antigen, their system responds accordingly and attacks it instead of the body’s cells or tissues. Basically, flu vaccines or viruses can be used as bait for the forces to attack.
At the next family get together, Father shared my ideas with Aunt Esty. She approached me with a heart warm smile and said, “Like Father, like Daughter.” But my special task force and mission to help my Aunt had not yet been accomplished.
Years later, in the heat of summer, Aunt Esty noted how terrible she felt on account of the weather (heat can exacerbate symptoms of MS). I asked her, how do you get over such a condition? I’ll never forget her response, “You don’t get over it. You get through it. This is my lived experience.”
A feeling of shame came over me. Here I was sharing with her the history of women’s lived experiences around the world and the injustices we’ve suffered, being patronized and doctors dismissing our painful symptoms, only to blindly overlook hers. Noticing my blushing, Aunt Esty said, “I am proud of how you’ve connected with friends globally learning and working together with your Brothers and Sisters.”
At the time, I did not fully grasp the extent of my Aunt’s health situation only that it would be with her for the rest of her life. As her Niece, it’s become my mission in life to be there for her and do everything I can to help her get through it.
Nature v Nurture
There has been a rising interest in the study of epigenetics, how the environment acts on genes. Scientists are known for saying, “genes are not destiny.” I find that for better or worse, just because something is in our nature doesn’t mean it cannot be altered by nurture.
Health Advocates know as much if not more about their loved ones’ health condition and the painstaking work in contacting doctors, insurance and pharmacy reps. I not only became informed on my Aunt’s disease and her prescribed therapy/drug/formulary. I took it a step further. I became her Guardian. I spoke to friends and colleagues – scientists and physicians, specifically those specializing in immunology and epidemiology, as well as nutritionists.
I shared with Aunt Esty what I had learned. It was important to know everything from her clinical history, genetic makeup, diet, supplements, exercise routine, and epigenetic factors which may have provoked the onset of MS. As some physicians have noted, I pointed to the implications of how in addition to high temperatures, stress can exacerbate symptoms of the disease. Additionally, steering away or reducing certain foods or drinks.
LET ME BE CLEAR. Recommendations were tailored to my Aunt specifically. Still, I am compelled to share them with you. Fortunately, my Aunt has a great memory. She remembered what she ate before her first symptoms, mushrooms (fungicides). She removed it from her diet along with those her body no longer tolerated (soft cheeses, oats, pure maple syrup, barley…
Reengineering Medicine: Effective Risk
A stickler for keeping records, Aunt Esty keeps journals documenting adverse side effects along with notable changes in her lab work. If there were any changes to her prescribed formulary or from her pharmacy she was to inform us.
About four years ago, in 2016, Aunt Esty had what physicians term a “flare up.” It appeared to be Musculoskeletal related. Her right arm and leg became partly numb and stiffened making it somewhat difficult to walk. Two MRIs were ordered by her physician. As soon as I heard, I took the next flight to the U.S.
Fearing she had had a stroke, my aunt went through with the MRIs only to read later the radiologist’s findings and conclusions as “unremarkable and consistent with MS.” She didn’t have a stroke but ended up paying the deductible of $3,000.00 + $3,400.00. The MRIs were pointless, except for the hospital that profited. As with her initial onset symptoms of MS, it endured for about a month.
Interestingly, while physicians are quick to order MRIs, most overlook a particular manufacturer’s drug information on MRI Results: “The exact relationship between MRI findings and the clinical status of MS patients is unknown. The prognostic significance of MRI findings in these studies has not been evaluated.”
Moreover, MRI findings stats table in the drug pamphlet points to “cumulative increase in newer or enlarging lesions” for both the Placebo and “Drug X.” In other words, drug or no drug, lesions will appear in some people. It begs the question, how useful are MRIs? Moreover, can you afford taking images of your brain just to see the diseases’ “footprints?”
Oh, and let’s not forget the MRI contrast agents pumped into her veins leaving her kidneys and liver to filter out the gadolinium-based compound. The toxicity endured from one MRI may be negligible but what of dozens throughout her lifetime?
In early 2018, in placing an order she was asked a series of questions: “Is the medication working? Have you developed any adverse symptoms, etc.?” She notified and keeping me updated added that this new line of questioning became the norm every time she placed an order.
Last year, she suddenly felt extremely weak, nauseous, with loss of control in walking. Again, she contacted me. I contacted my colleagues. Describing her symptoms, she appeared to be experiencing peripheral neuropathy. Scared but recalling her MRI experience, she decided to sit this one out. And like the last “flare up” the symptoms receded in about a month.
The two new “flare ups” were concerning. In her next order, she noticed the formulary packages included additional literature highlighting serious side effects. She contacted me.
After reading and scanning some medical documentation, I forwarded copies to friends and colleagues familiar with MS in New York and California. We discovered that the original formulary Aunt Esty had been prescribed twenty years ago had changed.
Reading the formulary description dated 1999 and comparing it to the more recent drug description dated 2016, we found that the Interferon beta-1a “produced by mammalian cells (Chinese Hamster Ovary cells)” was replaced with one produced “using genetically engineered Chinese Hamster Ovary cells.”
Another key difference was the number of pages of info appeared to have increased from about 25 to 40, and most focused on adverse symptoms.
NOTE: Interferon beta 1-a is said to be “produced by mammalian cells, while interferon beta-1b is produced in modified E. coli.” Adverse effects listed in the drug description including those exhibited in Aunt Esty’s two “flare ups” can also be found in other drugs, like HYDRALAZINE.
According to medicines.org.uk “Prolonged treatment with hydralazine (i.e. usually for more than 6 months) may provoke a systemic lupus erythematosus (SLE)-like syndrome, especially where doses exceed 100 mg daily.”
“FDA Adverse Event Reporting System (FAERS)”
Government research provided by my colleagues in the U.S. confirmed one of my two fears, drug-induced diseases and drug-induced death. In this case it was potential “drug-induced lupus.”
An April-June 2016 report stressed the “Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS).”
Beta Interferons:
•Avonex (interferon beta-1a) injection
•Betaseron (interferon beta-1b) subcutaneous injection
•Extavia (interferon beta-1b) subcutaneous injection
•Plegridy and Plegridy PEN (peginterferon beta-1a) subcutaneous injection
•Rebif and Rebif Rebidose (interferon beta-1a) subcutaneous injection
Potential Signal of a Serious Risk / New Safety Information: Drug-induced lupus
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling for Betaseron and Extavia were updated April and May 2016 to include drug-induced lupus.
FDA decided that no action is necessary at this time for Avonex, Plegridy or Rebif based on available information.
Medicine Denied: Getting the Raw End of the Drug Deals
Aunt Etsy is one of those Americans. Her prescription for Avonex was denied twice on appeal. According to the PBM:
“A qualified health care professional has determined that your request for this medicine is not medically necessary or is experimental or investigational based on the documentation submitted.”
Revealing information was provided by the PBM. The “health care professional” concluded that the “plan criteria” and “current medical literature do not support the use of Avonex over the available formulary alternatives (Rebif and at least two other preferred products: Aubagio, Betaseron, Copaxone, Gilenya, glatiramer, Glatopa, Mayzent, Tecfidera, Tysabri, Vumerity).”
Is this the PBMs formulary biosimilar vendor list with the exclusive one at the top? Good to know. By the way, the last three are said to be manufactured by Biogen, the same company that manufactures Avonex.
The second, Betaseron, was identified by the FDA Adverse Event Reporting System (FAERS) noting “Warnings and Precautions” and “Adverse Reactions” sections of the labeling for Betaseron…to include drug-induced lupus.”
Note: At the bottom of the PBM denial documents, we find “This document contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated…” with said PBM. Not affiliated?
Yet, these same “brand-name prescription drugs” are on the short list of “preferred products” in their denial letter.
Option $ or Option “Free”
Of course, Aunt Etsy was given another option, “You may also choose to purchase this medicine at your own expense.” What I find intriguing is that in denying her a formulary she has been prescribed for twenty years and paid by her insurance and the manufacturer, the PBMs pharmacist hinted that she may be able to obtain it directly from the drug manufacturer, for free through their financial assistance program.
Sound familiar? Recall the PR Newswire for Rebif? “MS LifeLines®, a support service offered by EMD Serono…including a broad range of comprehensive financial assistance programs for eligible people living with relapsing MS, including $0 co-pay or co-insurance for those with commercial insurance coverage.”
Aunt Etsy contacted the manufacturer of her original medicine. Yes, they could arrange to have Aunt Etsy’ prescribed product shipped via their own contracted pharmacy free of charge, assuming she met two criteria: Send the company’s financial assistance program the denial letters and conduct a phone screening to confirm her eligibility. Once confirmed, have her physician fax the prescription to the new pharmacy for them to arrange delivery.
Skeptical and scared, Aunt Esty contacted me. Because the PBM, along with her physician, stringed her along for months blaming the pandemic for their slow response, she had no access to her medicine. In fact, her doctor was more than happy to start her on the “available formulary alternative, Rebif.”
My Aunt’s concern intensified. Her doctor appears to be impeding she obtain her prescription to send to the new pharmacy. On the day the doctor’s assistant had informed my Aunt that he had the prescription ready to send out the next morning, the doctor called and left a message later that evening:
“I’m calling you with regards to the fact that you know I tried to get your Avonex approved. I also spoke to the Medical Director for your insurance but they have not approved it. It’s out of my hands. So we could potentially switch you to a different medication. I can elaborate and explain what other options there are for you. So, please give me a call back or make an appointment so we can discuss this further.”
Sure, doctor. My Aunt already paid you for a “required yearly appointment” where you requested she schedule lab work and MRI. Why would she pay for tests and another appointment when these won’t get her the medicine originally prescribed to her?
The situation went from concern to frustration. The day after the doctor left her message, her assistant, left another. “Hello, I wanted to ask you for your address again. Unfortunately, the prescription that we printed out originally she said it was not going to go through because it was a print out from the computer. So she went ahead and reordered it to a triplicate so that it could go through without any problems…” His voice sounded confused and nervous.
The recent scenario at her doctor’s office does not inspire confidence. Doctors too are gaining the PBM system. After speaking with our family doctor, friends and colleagues, Aunt Etsy was advised to contact the manufacturer to obtain the product as suggested as soon as she receives the prescription.
HOWEVER, she was to do two things: 1. Confirm the product being shipped was her prescribed medication; and 2. Upon receiving the product she is to scan and send me copies of all information attached to the shipment, especially the drug pamphlet. My Aunt is keeping me apprised.
Our concerns dealt with biosimilar formulary changes and/or drug production. Why? Visiting the website of the new pharmacy, I came across list of dozens of products. Several were from the same drug manufacturers as those on the PBMs “vendor list.” IT BEGS THE BIG QUESTION. WHY WOULD A PBM DENY A PRESCRIBED DRUG WHEN THE MANUFACTURER OF THE DRUG CAN SUPPLY IT FOR FREE?
PBM’s actions shine light in how they practice and profit from notifying people that their “medicine is not medically necessary or is experimental or investigational.”
It readily appears people are being put in the position of taking part in experiments by being required to use biosimilar products or request theirs for free inadvertently taking part in “clinical trials” as drug companies compete, sometimes with themselves, vying for FDA approval. In access data clinical studies are pointed out in FDA drug comparisons. And PBMs facilitate the process.
Suddenly, I recalled my idea of Aunt Etsy using one injection a year like a flu shot. The idea concerned my Aunt. Imagine discovering that you didn’t really need to have taken the medicine weekly for 52 weeks for twenty years.
Labyrinths of Lies and Deceptions: What’s Next?
Why stop with PBMs owning insurance companies? What about PBMs owning doctors? Specifically specialists that prescribe expensive and/or “specialty drugs.” If the American Medical Association (AMA) has made deals with hospitals and pharma, why not PBMs?
Or, the PBM could simply contract with a group of doctors. There’s bound to be plenty more now that the pandemic has negatively affected some physician network groups, especially sole-practitioners. But will they, like their patients, get the raw end of the deal
If the AMA is not willing to deal, there is another obvious option – pharmacists. As it stands, pharmacists are required to have a doctorate and license to practice. But will pharmacists be compelled to deal? And will the AMA grant them the same prescription rights given to MDs?
Recall, Feldman’s article, “PBMs combined with drugstores also pay independent pharmacists lower reimbursement rates for the drugs they sell, then threaten to expel the pharmacists from their network if they complain. Such threats matter, as the three largest PBMs control 78% of the market, and cover more than 180 million people in the US.” Still, people continue to be victims of PBMs cutting corners and Physican deceptive billing practices.
Last fall, Aunt Esty did not receive her insurance statements for medical appointments and lab work. She called. Insurance company/PBM told her they were sent out. But she never received them. This year, again, no statements.
It appears that from their perspective, bills are in the mail. Why should they bother with the expense of mailing statements? Surely after the Pharmacy Benefit Manager did a Cost Benefit Analysis, they figured they’d be saving a fortune. But will they pass along the savings to members?
A few months ago, Aunt Esty received two bills. One from an Orthodontist she had never heard of. The second from her Ophthalmologist. Receiving scam mail is not surprising. Still, Aunt Etsy has never received an identical bill from a doctor a year after paying it.
The office assistant dismissed it as an “accidental mailing.” In a different time this may not have been a concern. But we’re in a pandemic. Given the fact that physicians and those in fields that require physical presence have been restricted in making elective and/or unessential appointments, it would not surprise me that some have engaged in double billing their patients.
Damn Hard Choices: Life or Death?
I recently returned from visiting Aunt Esty. August brings sadness and tears for us both. Mikhail, her Son and my Cousin, died in August twenty years ago. I accompanied her to his gravesite. We exchanged memories of his love of snowboarding and his dream of competing in the Winter Olympics.
She remembered, with a light chuckle, how I pointed out to her that she was fortunate to have had Mikhail before being diagnosed with MS as one of the clinical trials reported potential adverse effects of taking the formulary is infertility. She noted, “Yes, I got lucky, if but for a short time.”
However, she was horrified to discover that one of the required or “preferred products” from the PBM was reported by the FDA as having the potential serious risk of “Drug-induced lupus.” Mikhail died of complications of lupus the same year Aunt Esty was diagnosed with MS. Poetic Injustice?
Now twenty years later, she is being required by the PBM to inject into her body “the number one prescribed interferon” formulary, followed by a series of other drugs, including the one with the lupus warning.
If the first, second, or third drug doesn’t kill Aunt Esty, then her PBM may consider her original prescribed formulary unless the Beta Interferon that the “FDA decided that no action is necessary at this time” changes. If so, she may need to start on a drug therapy for lupus.
Any way you cut or dice the drug and patient, the PBM makes $$$ and Pharma has their test subjects. What’s happening to my Aunt is happening to all across the U.S. with the possible exception of the elite top percent and high-ranking members in Congress, Supreme Court, and the White House.
From auto-immune to chronic to heart to terminal diseases like cancer, people are or will likely be denied their prescribed drug with their doctor resorting to tell their patients, “It’s out of my hands.” Then again, what drug or vaccine is safe and effective for the public at large?
As a businesswoman Aunt Etsy built and ran two businesses while raising a family. Making hard choices is not new for her. But this damn hard choice is literally a matter of life or death. Does she live her life without taking any formulary avoiding potential serious adverse reactions or does she take the “free” formulary and risk a drug-induced disease or worse death?
Aunt Etsy comes from a legacy of strong, confident, brave and intelligent women. Our hearts may be in the past, but our feet are in the present where truth and our work endures for future generations to come.