Date
Insurance Company
RE:
John Doe
ID no.
Service: Adalimumab 80 mg./week
Date of service: prior authorization
Dear Sir/Madam
I am writing on behalf of Mr. Doe to request prior authorization of increased weekly
dosing of Adalimumab and to provide you with detailed medical information to support
the increase dosage.
I am requesting an increased dosage of Adalimumab from 40 mg per week to 80 mg per
week in an effort to recapture Mr. Doe’s remission. Enclosed are his (1)
accompanying medical records and (2) medical journal articles.
The increasing the dosage from the current 40 mg per week to 80 mg per week for a
defined period of time will likely result in significant improvement in Mr. Doe’s
symptoms. Mr. Doe has been on 40 mg per week of Adalimumab for nearly x years with
truly outstanding results. He has been in a complete remission, having only one formed
stool per day.
Now, Mr. Doe is losing his response to Adalimumab at 40 mg per week and, thus, he is
suffering the beginning of a flare of his Crohn’s colitis, having roughly two to three loose
stools per day. In my medical opinion and based on x years of experience, I believe that
the most conservative course of action would be a trial of a higher dosage of
Adalimumab for long enough to recapture his remission. I would like to try an increased
dose for six months, and then try to reduce Mr. Doe’s dosage to its current level.
I.
The Most Conservative Course of Action Would be a Trial of An Increased
Dosage of Adalimumab
Although the prescribed dose is high, this is a conservative approach because we would
be utilizing a medication that we already know is safe for Mr. Doe, and works for him,
too. Rather than changing medications and having to try several alternatives before
identifying one that works despite potentially harmful side-effects, my approach would
stay with what works, just at a higher dosage for a trial period. Because of the positive
effect Adalimumab has had on Mr. Doe’s illness for the past x years, increasing the
dosage in an attempt to recapture remission is a conservative, sensible approach.
II.
Other Treatments Are Ineffective or Carry Significant Risks
Medical literature pertaining to Adalimumab including three studies that support
evaluated Adalimumab at a dose higher than that recommended on the FDA label report
success in recapturing remission.
It is equally important, though, to explain why the other available options are riskier
and/or less likely to be effective.
III
5-ASAs
First, Mr. Doe was on Medication Y for an extended period, as reflected in my office
notes. It did not work. There is no reason to believe that a different 5-ASA would work
better. Mr. Doe has Crohn’s colitis, so Pentasa, which is released in the small intestine,
would not work.1 Medication Z can be harder to absorb than Medication Y; Mr. Doe
typically noted un-dissolved caplets of Medication A in his stool. Thus, if any 5-ASA
were expected to work, it would be Medication Y, and that has been tried and failed.
VI.
Azathioprine/6MP
Mr. Doe was also on azathioprine for a significant period of time and it did not bring with
it any results. Indeed, although azathioprine comes in 50 mg. tablets and the usual dose
is 100 mg or less, Mr. Doe was on 200 mg and not obtaining any result.
In addition, of course, azathioprine and 6-mercaptopurine can be toxic. They are, in
essence, chemotherapy drugs designed to weaken the immune system. Especially for
someone as public as Mr. Doe, the risk of taking an immunosuppressant is unacceptably
high.
Thus, since even a high dose of azathioprine was not effective for Mr. Doe, and this class
of drugs would more severely weaken the immune system in ways that Adalimumab has
not done to Mr. Doe, this class of drugs is inadvisable in this case.
V.
Infliximab
Mr. Doe has tried infliximab and quickly lost an initial response. We have cited to
voluminous literature in our initial appeal documenting the efficacy of Adalimumab in
cases in which patients have lost their response to infliximab.
In addition,
[i]ntravenous use of infliximab, a chimeric monoclonal antibody to TNF-α
is, however, limited by the occurrence of adverse events, infusion
reactions, infectious complications, aggravation of heart failure, the
Where information such as this is contained in the FDA labeling for a drug discussed here, we
have not included a copy of that labeling. However, we would be pleased to provide that
labeling upon request.
1
2
occurrence of neurological demyelinating conditions and induction of rare
malignancies.
T.A. Winter, et al., “Treatment of Crohn’s disease with certolizumab pegol,” Expert
Review of Clincal Immunology Sept. 2007; 3(5): 683-694.
Further, patients build up antibodies to infliximab. Often that precludes them from trying
it a second time. Mr. Doe would need to undergo expensive blood testing to determine
whether a further trial of infliximab was safe.
VI.
Corticosteroids
Corticosteroids have been used as first-line treatment of IBD for many years. “Systemic
corticosteroid treatment causes disfiguring cosmetic side effects during short-term use
and bone demineralization as well . . . .” P. Mamula, et al., Pediatric Inflammatory
Bowel Disease 363 (2008). Long-term steroid use not only weakens bones, but it can be
the cause of cataracts, steroid dependence, and even mood changes severe enough to be
called steroid psychosis. T.P. Warrington, et al., “Psychiatric Adverse Effects of
Corticosteroids,” May Clin Proc. 2006;81(10):1361-1367. Mr. Doe has already been on
prednisone, as stated in my notes.
Mr. Doe knows Adalimumab works and has had no negative effects after nearly x years.
On the other hand, little is known about the long-term use of newer biologic therapies.
Staying with a known drug – one that is safe and effective – is the more conservative
choice for a patient who has been as stable as Mr. Doe has for as long a period of time.
VII.
Conclusion
Although there are options, each option carries with it a possibility or even likelihood of
either non-responsiveness or adverse effects. Adalimumab is tried and tested, inducing
and maintain remission in Mr. Doe for nearly x years. Based on my professional
experience, with administration of a boosted dosage for six months, remission may be
recaptured. If that does not occur, other options will have to be explored. However,
there is no question that the best result would be achieved if relatively short-term use of
an increased dosage of Adalimumab re-induces remission and allows Mr. Doe another x
years of symptom-free existence.
Please let me know if any additional information will help clarify this request. I would
like to proceed as soon as possible with increased dosing.
Sincerely,
Dr. XXXX
Address
Contact Info
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