Stupid cost-cutting strategies harm patients

The Exceptional Access Program (EAP) provides a valuable service to Ontarians on expensive life-saving medications, such as biologic drugs. Unfortunately, cost-cutting is a fact of life these days, and, of course, as a taxpayer and a (temporarily) unemployed person, I can understand the concept. But by cutting funding to effective programs — in some cases, halting the insurance coverage of Remicade that allows Crohn’s sufferers to stay in the workforce — can cause more harm than good. There are better ways to trim health care expenditures than to reduce payments for biologic medications because denying patients already on biologics the medicines they need actually costs the health care system more in the long run — not to mention harming patients physically and financially.

Trying to cut costs by restricting eligibility for Remicade, overriding specialists’ opinions, does not work

One way that the EAP has been trying to hold costs down has been to restrict which patients are eligible for having their biologic medicines covered. The EAP’s guidelines about which patients are eligible for Remicade, the most commonly prescribed biologic in Ontario, are more restrictive than the guidelines used by the Canadian Association of Gastroenterology, the body of doctors most qualified to judge how to best care for patients on Remicade for Crohn’s. This means that many patients who, in the opinions of their treating physicians, would be best treated by Remicade, are ineligible for Remicade funding according to the EAP. This group of patients includes — and may even be mostly composed of — patients already on Remicade who require an increase in dose or frequency in order to stay well. There are so many patients falling through the gaps in coverage now that gastroenterologists are drowning in paperwork — nearly every patient on Remicade requires extra letters on his or her behalf in order to obtain coverage [Footnote 1]. Patients themselves are exposed to financial hardship (each dose of a biologic costs > $3,000) and many have to plead with politicians, the media, and the Ontario Ombudsman in order to persuade the EAP to pay for their medicine.

I explain some of the unfortunate results of the way that pressure to cut expenditures has played out at the EAP — and my suggestions of how to fix these problems — in my position statement. I will explain some of the details of what the EAP’s actions meant for me here.

Out-of-synch guidelines harm patients

I mentioned in my introduction to this blog that I’ve been on Remicade since 2004, and also that going on Remicade was not something I had wanted to do. But, despite my initial fears, Remicade has worked really well for me and has allowed me not only to stay alive, but also to do things such as finish a postgraduate degree and work full time for 4 years in the private sector. During my time on Remicade, though, I needed to have the dose increased from the standard initial dose of 5 mg/kg every 8 weeks, first to 5 mg/kg every 7 weeks, and then to 7 mg/kg every 7 weeks. This was done over a period of 6 years; I’ve been stable on 7 mg/kg every 7 weeks for 2 years now. The dose is important because the EAP’s objections to paying for my Remicade had to do with the dose I was on.

The Canadian Association of Gastroenterology’s guidelines for using Remicade and related drugs for treating Crohn’s disease (2009) rate different methodologies according to the principles of evidence-based medicine, that is, “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. . .  integrating individual clinical expertise with the best available external clinical evidence from systematic research” (link).

These guidelines suggest that, for a patient on Remicade for maintenance therapy, a dose of 5 mg/kg every 8 weeks is standard (Statement 8). For patients who start to get breakthrough symptoms on that treatment regimen, as I did, “I. shortening the interval between infliximab [Remicade] dosing; or II. increasing the dose to 10 mg/kg” are advised, with extremely strong expert support (Statement 9).

Just to point out, 7 mg/kg every 8 weeks is obviously less than 10 mg/kg every 8 weeks, and 7 mg/kg every 7 weeks works out to less Remicade per year than 10 mg/kg every 7 weeks, as well, keeping my treatment regimen well within the guidelines [Footnote 2].

The EAP also recently released a new version of the criteria it uses in determining whether to renew coverage of Remicade for treating Crohn’s in May 2012. Normal maintenance therapy is defined as a dose of 2 to 5 mg/kg every 6 to 8 weeks (page 20). 5 mg/kg every 7 weeks, the dose I was on before the flare-up I’m about to discuss, was within these guidelines. In cases where the Crohn’s is ongoing and severe enough to meet certain criteria, other standards apply. The most important of them here are that:

Renewal will be considered [only] for patients with 50% reduction in HBI from pre-treatment as well as improvement of symptoms (e.g., absence of bloody diarrhea and weight stabilization or increase) and no longer using steroids.  . . . .

The recommended doses for the treatment of Crohn’s Disease are . . . Infliximab [Remicade] : 5mg/kg/dose at 0, 2 and 6 weeks then 5mg/kg/dose every 8 weeks  (page 33). [My bolding, and my link explaining what the HBI is.]

I meet and I met all of these criteria for being a patient with severe and ongoing Crohn’s, other than the one about being off steroids entirely [Footnote 3]. However, note that, according to the EAP guidelines, an increase in dosing frequency is expected to be a temporary measure, whereas the guidelines put out by the Canadian Association of Gastroenterology recognize that both shortening the treatment interval and increasing the dose on an ongoing basis may be necessary in certain cases.

OK, back to my case history. I was doing all right on 5 mg/kg of Remicade every 7 weeks in 2009 until I had a bad flare-up that landed me in the hospital for a week and on sick leave for 2 months [Footnote 4]. In response to this, my GI increased my dose to 7 mg/kg every 7 weeks, which kept the Crohn’s under control. In the spring of 2010, my doctor wrote the annual letter to the EAP requesting ongoing coverage of Remicade for me, explaining that this increased dose had brought my HBI score down from 8 (moderate disease) to 4 (remission) — a 50% reduction — and that I should stay on Remicade to maintain remission. The letter also stated that I was still on 1 mg/day of prednisone.

This was the start of a many months-long argument with the EAP; the EAP did want to cover Remicade for me because my dose was higher than the standard starting dose and because I was still on steroids. There were several letters back and forth. By the time my July treatment came around, the EAP denied me coverage for Remicade, and I had to pay $4,200 out of pocket in order to get treatment.

More letters flew back and forth. The EAP continued to take issue with my regimen of 7 mg/kg of Remicade every 7 weeks, complaining about both the dosage and the interval. Note that only the dose per kg had increased in the past EAP fiscal year; the treatment interval of every 7 weeks had been ongoing and the EAP had covered it in previous years. The decrease from the standard interval of every 8 weeks had been instituted because on the 8 week schedule, I was getting sick at week 5 every time. Increasing the frequency of treatment to every 7 weeks reduced the amount of time I spent sick at home every treatment cycle. This treatment regimen of 5 mg/kg every 7 weeks was well within both the CAG guidelines and the EAP’s own guidelines. The increase in dose was a subsequent — not simultaneous — deliberate, considered and appropriate decision that was necessary to stop the Crohn’s from flaring up at the lower dose.

Despite all this, the EAP stated that in order for my case to merit “further consideration,” my doctor would have to put me on “either an increased dose (i.e. 7 mg/kg every 8 weeks) or a decreased interval (5 mg/kg every 7 weeks)” of treatment with Remicade. In other words, in order to get coverage for my Remicade costs, I would have to submit to a treatment regimen that I had already tried and that had not controlled my symptoms — I had been on 5 mg/kg every 7 weeks when I had the flare that put me in the hospital more than a year earlier. But at this point, I didn’t know what more we could do to argue with the EAP. The EAP held all the cards. I knew that I could not do the 8 week interval because, whether on 5 mg/kg or 7 mg/kg, I always got symptoms bad enough to cause me to take sick days by the 5th week after treatment. I would have to go with the “option” of 5 mg/kg every 7 weeks. This would be reducing my Remicade dose by 2/7, or nearly 30%, from the dose and interval that were last shown to actually control my disease. I knew there would be serious consequences.

My doctor faxed the EAP a response, letting them know that I had agreed to go on a dose of 5 mg/kg every 7 weeks, and urging them to approve my coverage ASAP for financial as well as health reasons.

Because the EAP took a week to respond to this message, my treatment, when it was approved, was for 7 mg/kg every 8 weeks for one dose (the one in late September that had been delayed by a week) and 5 mg/kg every 7 weeks thereafter, for one year. The EAP added a note to its approval letter that “this dose is above the standard dosing regimen for Crohn’s Disease.” Well, duh. I have above-average symptoms of Crohn’s disease.

I was told that I would have to go through at least two treatment cycles at the lower dose before the EAP would allow my doctor to petition for my dosing regimen to be changed; of course, if I stayed well at the lower dose, everything would be fine and dandy, but we knew that wouldn’t be the case. The EAP was putting me in the position of getting seriously ill just to prove that I really needed the higher dose that had already been shown to be the only dose sufficient to control my disease.

Sure enough, during the next six months — 3 treatment cycles — I missed more than 30 days of work because of Crohn’s symptoms. (My doctor had applied for approval for a higher dose of Remicade for me after 2 treatment cycles, but it took until after a third before the approval for coverage came through).

Out-of-synch guidelines are a waste of time, energy and other resources

What benefit to society did this whole stupid dance bring about?

My doctor wrote 6 letters in order for me to stay on the dose of Remicade that had been shown to work for me, instead of the 1 letter she should have needed to have written — this, on top of phone calls and more paperwork, wasted time that she could have spent treating other patients.

The EAP wrote a comparable number of letters and had a consulting physician involved, which wasted its and his/her time as well. Keep in mind that 2010 was the year that the EAP had a 10,000-application backlog. Spending time trying to reduce the dose of Remicade for a patient already doing well on it was not worth the person-hours, especially since the EAP did not have a sound reason for refusing to refund me for the dose that its bureaucratic maneuvering forced me to pay for out of my own pocket.

As for me, I missed 30 days of work being physically ill, suffered considerable stress, and was out $4,200 because of this fiasco. In fact, it took 11 months, and necessitated the involvement of my MPP, before the EAP refunded me the money for the dose of Remicade I received in July; the EAP’s argument against refunding me was that EAP approval for Remicade coverage was not in effect when I got the Remicade, so it was under no obligation to pay, even though the issue between the EAP and my doctor the entire time was not whether I needed to be on Remicade at all, but how much Remicade I needed in order to stay well.

In short, the EAP’s overly restrictive guidelines on who can receive Remicade for Crohn’s ended up costing everyone — the EAP, my specialist, and me — far more in time, money and health terms, than it saved.

Harmonized guidelines would be better for everyone

This short-sighted focus on cost cutting at the expense of patient safety at the EAP is counterproductive and has to stop. The EAP’s guidelines for which patients should receive biologic medications should be brought in line with the guidelines that medical specialists have developed for treating their patients. With harmonized guidelines, fewer patients would fall through the cracks, get ill, or face financial hardship, and the system would be fairer because fewer patients would therefore need to enlist outside advocates (MPPs, journalists, ombudsmen) in order to secure appropriate treatment. Specialists would spend less time on paperwork and more time treating patients, and the overall costs to the health care system would be lower than in the current system as well.

Change the EAP guidelines now!

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[Footnote 1] My specialists and Remicade coordinator, personal communication — for the past 3 years in particular, the paperwork burden has increased dramatically due to the EAP’s overly restrictive definition of which patients merit Remicade coverage.

[Footnote 2] Let’s calculate a “year” as having 56 weeks, since 7 * 8 = 56, and that’s easy to calculate. 7 mg/kg every 7 weeks over 56 weeks = (56 weeks / 7 weeks per treatment cycle ) = 8 treatment cycles per year, or (7 mg/kg/cycle * 8 cycles) = 56 mg/kg per year, whereas 10 mg/kg every 8 weeks over 56 weeks = (56 weeks / 8 weeks per treatment cycle) = 7 treatment cycles per year, or (10 mg/kg/cycle * 7 cycles) = 70 mg/kg per year. Therefore a treatment regimen of 7 mg/kg of Remicade given every 7 weeks is 56/70, or only 80%, of the Remicade that would be used in a treatment regime of 10 mg/kg every 8 weeks.

[Footnote 3] I am pretty sure the requirement to be off steroids entirely was not in at least some previous versions of the criteria because it was not mentioned during the problems I had in with the EAP in 2008. I tried to find the versions of this document that applied in 2008-2011, but they are no longer available.

[Footnote 4] A large part of the reason why I got so ill was that the accommodations for my condition had not been adequately sorted out at my workplace at that time. I was being required to work long hours on consecutive days, making me exhausted and weak, and HR did not want to look at my doctor’s recommendations for a more flexible schedule until after I had already racked up 2 months of sick leave.

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