In this week’s JAMA Health Forum, Dr. Angela Liu and colleagues (disclaimer: I’m working on a couple of projects & grants with Dr. Kelly Anderson and I have a grant with Dr. Dan Polsky (among others) under review), examine how prescription drug use patterns change after one insurer institutes a step therapy requirement in Medicare Advantage integrated drug plans. Step therapy is a requirement that a certain drug is used first before other options are allowed.
They find decent size but not absolute effects:
For the first administration of a treatment episode, the control group was prescribed bevacizumab 63.5% and 63.7% of the time, before and after implementation of macular degeneration step therapy (to which they were not subjected), respectively. Within the treatment group, bevacizumab was prescribed 61.2% and 69.2% of the time in the before and after periods, respectively, demonstrating an 8.0−percentage point increase in bevacizumab prescribing after step therapy implementation (Table 1 and Figure 1).
An 8 percentage point increase in bevacizumab is about a 13% percent increase in the use of this drug as a first treatment.
I was slightly surprised that the effect of step therapy institution was not higher. I would have thought that a credible threat to not pay would have changed clinician behaviors. The researchers note that the behavior changes were bigger in the HMO product than the PPO product. This makes sense to me as PPO clinicians have a much more credible threat to go out of network so the insurer has less effective leverage and control.
This Is Very Tim Walz
Capri
Have you looked at Administrative Harm at all? The effects in outcomes from (presumably) cost-based coverage decisions?
edgefigaro
Anecdotal, I’ve read stories about insurance insisting on step therapy for drugs the patient has previously used to no effect and doctor isn’t in perscribing.
It really gives an “insurance in the way” vibe.
Gvg
Yes, my sister the doctor used to have to spend a bunch of time overriding insurance on drugs because there were good reasons for the choices she made, such as interactions with other drugs, known allergies, previous use ineffectiveness and sometimes the generic has a different coating or other slight difference that the patient doesn’t tolerate. There is just a whole bunch of things going on.
What made her mad was that sometimes the difference was life threatening to the patient.
It has actually gotten better though.
Gretchen
Is the first drug less effective in treating the condition than the later drugs?
I’m in a Blue Cross Medicare Advantage plan and was regretting the choice when Blue Cross decided to get out of my market so I get to go with traditional Medicare! I’m pretty happy about that.
TBone
@Gretchen: I’m happy for you, too.
gene108
Unless I misunderstood what you wrote, in my experience physicians have no clue about my network’s coverage of prescriptions.
I have to inform them that my new prescription costs $500 to get an alternative.
It’s usually the pharmacist who alerts me to something like a step treatment option implemented by my insurer, when I go to pick up my prescription and am informed it’s $500.
Mel
@edgefigaro: I agree wholeheartedly. I was forced to go back on an immunosuppressive med that had previously damaged my liver, then forced to go on high dose steroids again (which cause me to develop pancreatitis and iatrogenic Cushing Syndrome every time), before my insurance would cover a biologic. Things were so bad that my doctor told me to throw away the rest of the prednisone and just wait out the rest of the required “step therapy period”.
i suffered for decades because of insurance companies gaming the system. After 20+ years of utter suffering and total disability, I have finally gotten access to the medications that I needed all along, and they are working. However, they can’t repair the years of damage (to my heart, my vascular system, my cognitive function, my gastrointestinal system, my eyes, my bladder – the whole shebang- caused by not having access to the proper medications, thus alllowing my autoimmune diseases to progress constantly. Nor can they repair the lasting damage caused by being forced to try and re-try meds that caused more harm than improvement.
I had several doctors tell me very directly that they just didn’t have the time or the resources to do endless battle with insurance companies’ denials , even when the meds are clearly the best choice, because already difficult insurance companies have gotten dramatically more obstructive over the past two years.
For example, my autoimmune disease causes severe vasculitis, including ulcerative vasculitis in the GI tract. I was coughing up dried blood, running a daily fever, bloated, having to do a largely liquid diet, had daily upper and lower abdominal pain, became severely anemic. An endoscopy showed multiple bleediing ulcers, but we needed to make sure that there weren’t additional bleeding ulcers, fistulas or infection in the small intestine. Despite a swallowed camera study being obviously indicated, it took nearly four MONTHS to get approval. My insurance company denied it, the specialist appealed, insurance denied again, my specialist escalated it and appealed again, the insurer sent it to third party for-profit assessment service. It was so obviously needed that the third party approved it upon receiving and reviewing it, but the insurance company initially lied and refused to tell me or the specialist’s office what the result of that assessment was, saying, “We don’t have any answer from them yet.”
When the specialist’s office finally threatened to report the insurance company, they gave them the name of third party assessor, but stated that they didn’t have any way to contact the assessor by phone, and no phone number to give to my doctor or his representative . My doctor’s staff called numerous other practices and finally found a billing employee who had gotten an active contact number for the third party assessor from a different insurance company. And yes, my specialist’s practice has to pay several full time employees just to deal with insurance nightmares like this.
The specialist’s rep called the third party assessor, who informed her that they had sent to my insurer their recommendation to approve it over two months prior to the call, and they faxed her documentation to prove it.
She called us, and my hubby (retired attorney) called and lit up the customer service supervisor to whom he was forwarded. In the meantime, the doctor’s rep called the physician-side customer service and also confronted them. They attempted to lie again, at which point she told them that she had obtained a phone number snd contacted the third party assessor, and had the documentation literally in you hands to prove that the insurer was lying about not having received any word from the assessor.
She also informed them that she was faxing the documents to my husband with my approval, and that we were considering a lawsuit.
Surprise, surprise – within five minutes, they miraculously “found” the “misplaced” approval recommendation.
My father worked in management at a major insurance company for decades. I worked in insurance while in college.
I’ve seen the things that go on inside insurance companies, and I have little doubt that a decent percentage of denials, step therapy demands, etc. are done not in good faith, but dolely with an eye on the bottom line. They are for-profit entities. Profit is their reason for existence, and sadly, that is often in direct opposition to the patient ‘s well-being and the physician’s ability to make the best care decisions for the patient.
And don’t get me started about my brother-in-law, who got denied several times for a CT and Hida scan, until he switched to a doctor who was willing to fight with his insurance company to get them approved. By that time, his pancreatic cancer (diagnosed by the scans, but present for at least six months prior, based upon his symptoms) had metastasized to his spine and his liver. He has maybe four months to live. He and his wife have two older children, and had just adopted two siblings last year whom they had fostered and love dearly.
Would getting the tests and diagnosis two months earlier have saved his life? Honestly, probably not. But it would certainly have allowed for more and better treatment and surgical options, and likely allowed him a year or two more of time with his wife and his children, instead of four months.
So, “stepped options” of trying antacids and then PPIs, and sleeping on a wedge pillow and changing to a high fiber diet for six weeks while his tumors grew and metastasized – well, it did save money. Now they’ll only have to pay for four more months if his care, instead of a couple of years. Not exactly a win for him or the many people who live him, but a win for the insurer’s bottom line, to be certain.
My primary care doctor’s multi-state medical group literally had a series of group-wide meeting to discuss how to attempt to deal with the dramatic increase in blanket denials of clearly necessary procedures and medications.
I know that it isn’t easy for the many decent, caring people who work for insurers to have to be the ones dealing with angry or frightened and very sick insureds, or their frustrated, exhausted doctors. I feel badly for them, too.
Reasonable protocols, reasonable justifications for treatment – these are good practice and good common sense. But good practice doesn’t always maximize profit and please shareholders, hence the problems that will always exist with for profit health insurance. It pays to delay, to be inefficient, to make things as confusing and difficult as possible for doctors and patients. The harder and more time-consuming and dehumanizing that the process is, the quicker that doctors and patients give up.
Barbara
@gene108: Some doctors are much more attuned to this than others. My GI doctor had a table in every room that listed preferred drugs by each major insurer. It’s easier for them because they prescribe a limited number of classes of drugs. It’s harder if your practice is not as specialized.
edgefigaro
@Mel: I hear you. Makes me sad.
I read these missives from our host, and I feel better about being informed about things, but I’m moving further and further away from believing in the Obama care model.
I have higher standards than “better than the republican health care plan.”
TBone
Medicare for every citizen from birth. Our athletes in France now know.
Medicare disAdvantage is a scam, and every time someone calls us to try to get hubby switched, I give them the WHAT FOR!
“You should be ashamed.”
Bodacious
So very interesting- I tried to parse the paper as an arm-chair scientist. Seeing that it did not evaluate outcomes, only usage data, it just reinforces how complex and demanding these issues are for healthcare professionals (who may not know what costs are really being incurred), patients ( who don’t have any idea why the f**k they are getting charged for what), and administrative staff (who are just trying to get reimbursement for their employer). These days I don’t need any encouragement to suspect that the wolf on the room is the insurance company, siphoning of resources and options to pad their back room deals.
Ohio Mom
@Mel: I could hardly bear to read your comment, it’s horrifying the deep damage insurance companies have done to you and your family. I am so sorry.
Ohio Mom
@TBone: Traditional Medicare can be expensive. You have to pay for Parts B and D, and for a Gap Plan.
And you have to wade through a lot of fine print, and do math to figure out which is the best/most affordable for you Part D and Gap Plan.
The complexity no doubt helps to send people over to Medicare Advantage (which as you point out , is a scam, and also a vacuum for tax money).
Traditional Medicaid on the other hand, is easy-peasy and requires nothing out-of-pocket. Ohio Son has had Medicaid as a result of being disabled, and it is the best insurance anyone in our family has ever had.
I think it is the association with poor people that prevents the slogan “Medicaid for All” from being the goal. Too bad!
Timill
@Ohio Mom: Indeed – “Medicaid for All” should be the policy, but you have to sell it under the slogan “Medicare for All”.
Gretchen
@Ohio Mom: yes, I had no idea how insanely complicated Medicare is, which is how we ended up maxing the poor decision to get an advantage plan. The mere fact that navigators exist to help figure out the choices shows that it’s too complicated
EB
@edgefigaro: This does happen … quite frequently. It is not uncommon for insurance to “deny” one medication that I prescribe for patients and to “suggest” using a different medication (not necessarily even one that the patient isn’t already taking!).
These denials then take more work by the patient and practice to “educate” the insurance company that the medication has been tried, is being currently used, or is contraindicated. All of which delays (affordable) treatment. And if the patient is using the suggested alternative, the insurance company should already be paying for it and so should know that it’s not an appropriate substitute!
I always view these as paperwork burdens placed to make it cost (the patient and doctor) more to use medications for which the insurance company hasn’t gotten rebates for (aka what most people would view as unethical kickbacks.) While I personally try my best to excuse individual people when making mistakes as being ignorant rather than malicious, when it comes to insurance denials I often view these policies as malicious first. But that’s only because I’ve seen people permanently lose vision or have to decide between food or medicine (or surgery with its own risks) due to what we view as insurance greed.
EB
@Gretchen: Sometimes the comparative effectiveness is debatable. For avastin vs lucentis, they’re both made by the same company but one is horribly more expensive than the other (but it was developed for the eye and FDA approved for it’s use rather than being used off-label.) So doctors certainly believe that the more expensive drug is safer, more effective, safer, and requires less-frequent treatment. (Yes, safer was listed twice because if I’m injecting your eyeball with a drug you want it to be safe!)
Studies have now been done to assess the benefit difference. And most retina specialists I know (who don’t attend drug-rep-hosted free dinners) would say that the less expensive medication is likely as effective and a good first-line treatment.
EB
@gene108: Sometimes in a field the pattern of drug costs is well known. For anti-VEGF injections, every single ophthalmologist practicing knows that avastin (aka bevacizumab) is the cheapest option … if you can get it. If your eye doctor doesn’t know that, then run away from them because they shouldn’t be practicing.
But although the paper reported that the drug is 1/10 the price, that is lacking a lot of context and associated costs. It assumes that the practice is able to get a compounding pharmacy to make it available in a usable form (because it’s off-label for use in the eye and the drug company would rather you use their expensive drug so they’re not going to make a ready-to-use form.) And despite the cheaper drug cost, the cost of the office visit, macular OCT, and injection procedure is the same and likely are more than the cost of the drug.
EB
Sorry, one last comment. Some of the methodological choices in the paper were puzzling.
First, the 150-day injection-to-injection time window seems odd. Some treat-and-extend treatment protocols might try to push for a long time between intravitreal injections, but 5 months seems like too long (although I’m not a retina specialist.) The paper’s own eTable 2 (supplemental information) lists the dosing schedule as every 4-6 wks. So it doesn’t seem reasonable that an injection in January, nothing in Feb-June, and another injection in July would be part of the same treatment episode. I would have much preferred to see a histogram of the time between injections and time between treatment episodes. Similarly, a histogram showing the number of injections prior to switching medication would show whether docs just gave a single injection of the “cheap” drug prior to using what they wanted to all along (gaming the system.)
Second, many docs don’t care about which insurance provider a patient actually has. If the MD gets a lot of denials due to step-therapy, they may just make it easier on themselves and usually try avastin prior to lucentis. So each provider’s payor-mix is important—probably as important as the patient’s specific insurance. This is shown in eTable 3 where the geographic distribution is massively different between the “control” and “treatment” groups. So even describing these two groups as “control” and “treatment” is likely wishful thinking rather than an actual difference.
Finally, isn’t difference-in-difference analysis known to be rife with statistical problems? The time-to-event model specified in the supplemental methods is sorely lacking. It doesn’t include important variables such as geographic region, disease severity, patient demographics, provider measures, etc. They used some of these as part of their “sensitivity checks” but those should have been present in the base model and all time-dependent models (with 18k patients there is enough data to not be stingy.) Instead, a multi-level generative model could have been used with reasonable priors for the parameters. The presentation by Andrew Gelman last fall probably has a better explanation of what could be done than I can describe (https://statmodeling.stat.columbia.edu/2023/10/11/difference-in-differences-whats-the-difference/ and https://www.youtube.com/watch?v=Sya-s-wibnw).
BarcaChicago
https://apnews.com/article/health-insurance-law-illinois-step-therapy-97d8a8845645f2ce4ad8be01fa153003
The Democrat signed legislation codifying one of his top initiatives of last spring’s legislation session, the Healthcare Protection Act, which outlaws step therapy, prior authorization for mental health crises and junk insurance.
At a Rush University System for Health facility in Chicago, Pritzker said the law is aimed at “empowering” patients and their doctors by “putting medical decisions back in their hands.”