Download Date - VSL#3

[Date]
[Insurer Name]
[Department]
[Address]
[Fax: Number]
Re: [Patient Name]
Plan # [Enter Plan ID Number]
Member # [Enter Member ID Number]
Date of Birth [Insert DOB]
RE: INSURANCE COVERAGE FOR VSL#3® FOR ULCERATIVE COLITIS PATIENT
To Whom It May Concern:
My patient, [Patient Name] has been diagnosed with ulcerative colitis (UC) and has a
history of treatments including [list all prior treatments, including antibiotic therapy].
I am currently recommending this patient to use VSL#3 for the management of UC.
VSL#3 has proven to be successful in clinical studies and especially for this type of
patient. There has been tremendous improvement in this patient’s health since VSL#3
was started. Because of VSL#3, this patient has been able to return to normal daily
living, which resulted in reducing and/or eliminating the number of days lost from work.
VSL#3 has been shown to be clinically effective in inflammatory bowel related conditions
such as UC and pouchitis1-7. In patients with UC, VSL#3 has been shown to be clinically
effective in one randomised, double blind, placebo controlled study1, two open-label,
non-comparator studies2,3 and one randomized, open-label, multicentre study4. The
double blind placebo controlled study was conducted with children suffering from
moderate to severe newly diagnosed UC; both the number of patients who achieved
remission and the ones who did not relapse in the VSL#3 group were significantly
superior to placebo. In the first open-label, single-centre, non-comparator study, VSL#3
administered for 1 year was effective in maintaining remission in patients with UC unable
to tolerate or allergic to mesalazine2. In the second open-label, multicentre, noncomparator study, VSL#3 was effective in inducing remission or response in patients
with active mild to moderate UC not responding to conventional therapy3. In the
randomized, open-label, multicentre study, VSL#3 in combination with balsalazide (a
drug related to mesalazine but not available in Canada) was more effective than either
mesalazine or balsalazide alone in inducing remission in patients with newly diagnosed
or recently relapsed mild to moderate UC4.
VSL#3 delivers a high concentration of 8 strains of live beneficial bacteria including
lactobacilli and bifidobacteria. VSL#3 is formulated to survive gastric fluid, bile, and
pancreatic secretions, to colonize the gastrointestinal (GI) tract2,3,5-7. The ratio of
individual bacterial strains in VSL#3 is designed to produce an optimal effect on the
composition of the GI microecology.
Patients with UC typically have decreased luminal concentrations of lactobacilli and
bifidobacteria compared with normal individuals8,9. UC patients may benefit from
consuming significantly higher levels of beneficial bacteria so as to maintain the
appropriate quantity and balance of beneficial microflora in their GI tract. This is
particularly important for such patients in view of their frequent and often long-term
antibiotic treatment and recent evidence implicating harmful intestinal bacteria in
inflammatory bowel diseases10,11. Therefore, daily consumption of the beneficial
bacteria in VSL#3 is needed to maintain adequate and balanced colonization in the GI
tract, which cannot be achieved by other means.
Daily intake of VSL#3 is based on results of clinical studies and severity of disease state.
I am recommending a dosage of [X packet(s) per dose, XX times per day].
My patient has tried other products which have not obtained the same benefits as
VSL#3. Without it, my patient’s health, quality of life and productivity at work will all
suffer.
I am writing to ask that due consideration is given to this patient and welcome any
questions that you may have. We look forward to a favourable response.
Sincerely,
[Physician’s Name]
[MD Address]
® Registered trademark of VSL Pharma Inc.
References:
1. Miele E, Pascarella F, Giannetti E et al. Effect of a probiotic preparation (VSL#3) on
induction and maintenance of remission in children with ulcerative colitis. Am J of
Gastro 2009; 104(2):437-443
2. Venturi A, Gionchetti P, Rizzello F et al. Impact on the composition of the faecal
flora by a new probiotic preparation: preliminary data on maintenance treatment of
patients with ulcerative colitis. Aliment Pharmacol Ther 1999;13:1103-1108.
3. Bibiloni R, Fedorak RN, Tannock GW, Madsen KL, Gionchetti P, Campieri M, De
Simone C, Sartor RB. VSL#3 probiotic-mixture induces remission in patients with
active ulcerative colitis. Am J Gastroenterol. 2005 Jul;100(7):1539-46.
4. Tursi A, Brandimarte G, Giorgetti GM, Forti G, Modeo ME, Gigliobianco A. Low-dose
balsalazide plus a high-potency probiotic preparation is more effective than
balsalazide alone or mesalazine in the treatment of acute mild-to-moderate
ulcerative colitis. Med Sci Monit. 2004 Nov;10(11):PI126-31.
5. Gionchetti P, Rizzelllo F, Venturi A et al. Oral bacteriotherapy as maintenance
treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial.
Gastroenterology 2000;119:105-309.
6. Gionchetti P, Rizzello F, Helwig U et al. Prophylaxis of pouchitis onset with probiotic
therapy: a double-blind, placebo-controlled trial. Gastroenterology 2003;124:12021209.
7. Mimura T, Rizzello F, Helwig U et al. Once daily high dose probiotic therapy
(VSL#3) for pouchitis maintaining remission in recurrent or refractory pouchitis. Gut
2004;53:108-114.
8. Fabia R, Ar'Rajab A, Johansson ML, et al. Impairment of bacterial flora in human
ulcerative colitis and experimental colitis in the rat. Digestion 1993;54(4):248-55.
9. Ruseler-van Embden JG, Schouten WR, van Lieshout LM. Pouchitis: result of
microbial imbalance? Gut. 1994 May;35(5):658-64.
10. Gurudu S, Fiocchi C, Katz JA. Inflammatory bowel disease. Best Pract Res Clin
Gastroenterol. 2002 Feb;16(1):77-90.
11. Mahadevan U, Sandborn WJ. Diagnosis and management of pouchitis.
Gastroenterology. 2003 May;124(6):1636-50.