Thank you for the opportunity to provide input on proposal 10-HLTC032.
I have copied the proposal text below and have inserted my comments and relevant research citations and quotes throughout, separated by asterisks like so: *****
ONTARIO PROPOSAL: Funding of Vitamin D Testing Based on Clinical Evidence
Ministry: Ministry of Health and Long-Term Care
Regulation Number(s): 552
Bill or Act: Health Insurance Act
Summary of Proposal: The Ministry of Health and Long-term Care (MOHTLC) will be improving the quality and value of health care based on the best medical evidence available by providing Vitamin D testing as an insured service to Ontarians with the following conditions: Osteoporosis, Rickets, Osteopenia, Malabsorption Syndromes and Renal Disease; or
Ontarians who are on medications that affect Vitamin D metabolism. This proposal is aligned with the Excellent Care for All Act that will improve quality, value and promote evidence-based health care. The Act will ensure that future investments get results and improve health while preserving the health care system for future generations.
MY COMMENTS: Vitamin D testing as an insured service must be provided to Multiple Sclerosis patients. Patients must be able to determine whether their dietary and supplementation regimens are successfully achieving levels above 100 nmol/L, without exceeding 250 nmol/L.
Some cases of Vitamin D3 deficiency or insufficiency are refractory and without testing it is impossible to know whether following a regimen is making the required difference in serum levels.
At the upper end of the scale, concerns regarding Vitamin D3 toxicity issues (such as hypercalcaemia) indicate that patients using therapeutic intakes of Vitamin D3 must be monitored.
On the relevance of Vitamin D3 to MS:
STUDY: Serum 25-Hydroxyvitamin D Levels and Risk of Multiple Sclerosis
Kassandra L. Munger, MSc; Lynn I. Levin, PhD, MPH; Bruce W. Hollis, PhD; Noel S. Howard, MD; Alberto Ascherio, MD, DrPH
"...the highest quintile, corresponding to 25-hydroxyvitamin D levels higher than 99.1 nmol/L..." "The results of our study suggest that high circulating levels of vitamin D are associated with a lower risk of multiple sclerosis."
STUDY: Vitamin D intake and incidence of multiple sclerosis
K. L. Munger, MSc, S. M. Zhang, MD ScD, E. O’Reilly, MSc, M. A. Hernán, MD DrPH, M. J. Olek, DO, W. C. Willett, MD DrPH and A. Ascherio, MD DrPH
"The pooled age-adjusted relative risk (RR) comparing women in the highest quintile of total vitamin D intake at baseline with those in the lowest was 0.67 (95% CI = 0.40 to 1.12; p for trend = 0.03). Intake of vitamin D from supplements was also inversely associated with risk of MS;"
ONTARIO PROPOSAL: Studies of the general population suggest a relatively low prevalence, approximately 5%, of Canadians had Vitamin D deficiency, and between 10% and 25% had low Vitamin D levels. Since 2005, reports have promoted Vitamin D testing and have contributed to the sharp increase in demand for Vitamin D testing in Ontario. Annual billing data shows that Vitamin D testing volumes increased 2500% from 2004/2005 to 2009/2010. If this trend continues, billings could reach up to $155M by 2011/12, for both medically necessary and unwarranted tests.
MY COMMENTS: I would be interested to see which studies are referred to above. How do these terms line up with the following proposed classification?
STUDY: Secondary hyperparathyroidism in the elderly: means to defining hypovitaminosis D.
McKenna MJ, Freaney R.
Osteoporos Int. 1998;8 Suppl 2:S3-6.
STUDY: Vitamin D deficiency: a neglected aspect of disturbed calcium metabolism in renal failure
Jorge B. Cannata‐Andía and Carlos Gómez Alonso
http://ndt.oxfordjournals.org/content/1 ... ull#ref-16
"The following classification has been proposed:
(i) Hypovitaminosis D: concentrations between 20 and 40 ng/ml (50 and 100 nmol/l).
(ii) Vitamin D insufficiency: plasma concentration between 10 and 20 ng/ml (25-50 nmol/l).
(iii) Vitamin D deficiency: 25(OH)D concentrations <10 ng/ml (25 nmol/l)."
MY COMMENTS: Does the literature review include any studies which suggest that levels below 100 nmol/L may actually indicate deficiency, as opposed to hypovitaminosis D?
STUDY: Lessons for nutritional science from vitamin D.
Am J Clin Nutr. 1999 May;69(5):825-6.
"Vieth makes a point that should help us with the needed mental adjustment: individuals exposed to the sun for much of the year in lower latitudes always have blood 25(OH)D concentrations values >100 nmol/L. So, if the true lower limit of the acceptable normal range is, in fact, 100 nmol/L, it could hardly be considered 'high'."
ONTARIO PROPOSAL: Vitamin D testing is currently insured for all Ontarians under OHIP. However, there is no evidence that routine testing of Vitamin D levels encourages adherence to Health Canada’s guidelines. At present, the most efficient way to ensure adequate Vitamin D levels in healthy individuals is to promote Health Canada’s guidelines for maintaining sufficient levels.
MY COMMENTS: By "no evidence", do you mean that no one has investigated testing and adherence yet? If there is a study on this matter which concludes testing does not affect adherence, I would be pleased to read it if you would be so good as to refer me.
In any case, Health Canada's guidelines are insufficient to guarantee serum levels of vitamin D3 at levels associated with least risk of Multiple Sclerosis.
http://www.hc-sc.gc.ca/fn-an/nutrition/ ... bl-eng.php
Health Canada AI = 200 - 600 IU/d, UL 2000 IU/d
The study cited below shows that on 1000 IU/d, the absolute best a patient can do is get up to the cutoff. Even on 4000 IU per day some patients only achieved serum levels between 69 and 100 nmol/L.
This study also demonstrates the wild variability in patients’ serum levels when supplementing identical levels on a daily basis.
[Personal anecdote: my dose-response to one vitamin D3 regimen (a booster, not a maintenance regimen) resulted first in a serum increase of approx 70 nmol/L, and the next time in a serum increase of approx 170 nmol/L, which put me well over 250 nmol/L, the cutoff above which hypercalcemia may occur. Without testing I would have had no idea.]
Vitamin D3 testing is required to ensure that a patient’s daily regimen is successfully getting their serum level above the cutoff, and in some cases it is required to ensure they remain below the upper end of the safe range.
STUDY: Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level
Reinhold Vieth, Pak-Cheung R Chan and Gordon D MacFarlane
American Journal of Clinical Nutrition, Vol. 73, No. 2, 288-294, February 2001
"The minimum and maximum plateau serum 25(OH)D concentrations in subjects taking 25 and 100 microg (1000 and 4000 IU) vitamin D3/d were 40 and 100 nmol/L and 69 and 125 nmol/L, respectively."
STUDY: A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis.
Burton JM, Kimball S, Vieth R, Bar-Or A, Dosch HM, Cheung R, Gagne D, D'Souza C, Ursell M, O'Connor P.
Neurology. 2010 Jun 8;74(23):1852-9. Epub 2010 Apr 28.
"Although there may have been confounding variables in clinical outcomes, treatment group patients appeared to have fewer relapse events and a persistent reduction in T-cell proliferation compared to controls.
CONCLUSIONS: High-dose vitamin D (approximately 10,000 IU/day) in multiple sclerosis is safe, with evidence of immunomodulatory effects."
STUDY: Higher 25-hydroxyvitamin D is associated with lower relapse risk in multiple sclerosis.
Simpson S Jr et al
Ann Neurol. 2010 Aug;68(2):193-203.
"A protective association between higher vitamin D levels and the onset of multiple sclerosis (MS) has been demonstrated; however, its role in modulating MS clinical course has been little studied... Serum 25-OH-D levels were measured biannually, and the hazard of relapse was assessed using survival analysis... higher 25-OH-D levels were associated with a reduced hazard of relapse. This occurred in a dose-dependent linear fashion, with each 10nmol/l increase in 25-OH-D resulting in up to a 12% reduction in risk of relapse. Clinically, raising 25-OH-D levels by 50nmol/l could halve the hazard of a relapse."
ONTARIO PROPOSAL: In June, Ontario’s Health Technology Advisory Committee (OHTAC) concluded that the routine use of Vitamin D testing could not be justified based on current evidence.
OHTAC’s membership consists of a minimum of 12 health experts, including representatives of the Ontario Medical Association and the Ontario Hospital Association.
The proposed amendment seeks to ensure that the testing provided is based on the best medical evidence, increase value for the health care system by eliminating testing that is not deemed medically necessary and promote quality and sustainability by helping to ensure that the health care system is there for future generations.
The Ministry will continue to regulate Vitamin D testing in accordance with the principle of evidence-based healthcare, and it will seek updates as required to incorporate new medical evidence. Testing would continue to be accessible as an uninsured service to Ontarians who do not meet the medical criteria, but who would still like to pay for testing.
MY COMMENTS: The study cited below suggests that Vitamin D3 status should be measured for ALL patients on an annual basis. Based on all the studies provided in this submission, it is my view that at the very least, Ontario's Multiple Sclerosis sufferers must be added to the list of patients who qualify for OHIP coverage of vitamin D3 testing.
I suggest that in the long term, insured testing of vitamin D3 status will reduce spending on tests such as MRI, lumbar puncture, &c for MS patients, and who knows how many tests for the other conditions listed.
STUDY: The Vitamin D Epidemic and its Health Consequences
Michael F. Holick
J. Nutr. 135:2739S-2748S, November 2005
http://jn.nutrition.org/cgi/content/abs ... 5/11/2739S
"There is mounting scientific evidence that implicates vitamin D deficiency with an increased risk of type I diabetes, multiple sclerosis, rheumatoid arthritis, hypertension, cardiovascular heart disease, and many common deadly cancers. Vigilance of one’s vitamin D status by the yearly measurement of 25-hydroxyvitamin D should be part of an annual physical examination."
MY COMMENTS: Thank you again for the opportunity to provide input into this process.
I would be pleased to submit additional literature review and commentary on this proposal, if further evidence is needed to support coverage for vitamin D3 testing for Ontario’s MS patients.