Omega3 polyunsaturated fatty acids

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• Omega-3 polyunsaturated fatty acids
• The health economic case of Omacor in secondary
  prevention after myocardial infarction

Solvay Pharmaceuticals February 2008
Birgit Gradl Global Health Economist
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Points to cover

• 1. Evidence base for omega-3 fatty acids
• 2. Case-study UK Health-economic model for
  decision making
• Results
• Summary and recommendation

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Evidence Base for omega-3 fatty acids a
meta-analysis

• Meta-analysis by Yzebe D, Lievre M (2004)1
• Ten RCTs with 14.727 patients included in total
• Results of daily intake of omega-3 fatty acids
• decrease of all causes of mortality by 16
  (relative risk 0.84 95 confidence interval
  0.76 0.94)
• decrease of incidence of death due to MI by 24
  (relative risk 0.76 95 confidence interval
  0.66 0.88)
• 1 Yzebe D, Lievre M. Fish oils in the care of
  coronary heart disease patients a meta-analysis
  of randomized controlled trials. Fundamental
  Clinical Pharmacology 2004 18 581-592.

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Evidence Base for omega-3 fatty acids the
GISSI-P trial

• Omega-3 fatty acids efficacy proven by GISSI-P
  trial1
• 11,324 patients post MI, 3.5-yr follow-up, 4
  arms
• (1) n-3 PUFA (n2,836) (3) vitamin E
  (n2,830)
• (2) n-3 PUFA vitamin E (n2,830) (4) no
  supplement (n2,828)
• Results
• Decreased risk of cardiovascular death Relative
  risk reduction RRR 17 (2-way analysis), 30
  (4-way analysis)
• 1 GISSI-Prevenzione Investigators. Dietary
  supplementation with n-3 polyunsaturated fatty
  acids and vitamin E after myocardial infarction
  results of the GISSI-Prevenzione trial. Lancet
  1999 354447-55.
• 2-way-analysis2 groups analysed (n-3
  PUFA-group versus non-n-3 group)
• 4-way-analysis each group analysed seperately

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Further clincial evidence

• Din JN et al. Omega 3 fatty acids and
  cardiovasular disease fishing for a natural
  treatement. BMJ 200432830-35.
• Weber HS et al. Prevention of Cardiovascular
  Diseases and Highly Concentrated n-3
  Polyunsaturated Fatty Acids (PUFAs). Herz 2006
  924-30.
• Schacky C. Omega-3 fatty acids and cardiovascular
  disease. Current Opinion in Clinical Nutrition
  and Metabolic Care 2007 10129-135.
• Fedacko J et al. n-3 PUFAs From dietary
  supplements to medicines. Pathophysiology 2007
  (in press).

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Case study Omacor UKA health economic model
for decision making
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2. Health economic model for decision making
Is Omacor worth funding for the UK NHS?

• Cost-utility analysis of Omacor for myocardial
  infarction survivors
• Health economic model for decision making
• Based on the GISSI-P trial with extrapolated
  survival to evaluate the cost-effectiveness of
  Omacor treatment as a standard prevention
  measure after myocardial infarction

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2. Health economic model for decision making
Impact of MI for England and Wales

• 64,000 get first MI each year1
• 30 die before reaching the hospital, 70
  survive2
• ? 45,000 new eligible patients for secondary
  MI prevention each year

1 Volmink JA, Newton JN, Hicks NR, Sleight P,
Fowler GH, Neil HA. Coronary event and case
fatality rates in an English population results
of the Oxford myocardial infarction incidence
study. The Oxford Myocardial Infarction Incidence
Study Group. Heart 19988040-4. 2 World Heart
Organisation. Death Rates from CHD, Men and Women
aged 35-74, Selected countries. www.who.org.
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2. Health economic model for decision making
Impact of MI in Russia

• Year 2006 191.108 patients with registered
  diagnosis acute MI and recurrent MI1
• Mortality rate in MI patients 391

1 Chazov E.I., Congress for Acute Coronary
Syndrome, St.-Petersburg, May 2007.
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2. Health economic model for decision making
Omacor cost-utility model features

• Health economic model developed combining a
  survival model and a Markov model to estimate
  costs
• Yearly cycle length
• Model assumes Omacor treatment is stopped after
  4 years
• Life time model
• No patient-level data but model is based on
  GISSI-P 4-way analysis (comparing n-3 PUFA with
  no supplement treatment)
• First events of GISSI-P were recreated in model
  (3.5 years)
• Extrapolation for 41 years (I.e. until patients
  had died or were 100 years of age)
• NHS perspective no indirect costs included
• Cost level 2004
• Outcome measures cost (GBP) per QALY gained/per
  life year gained /per death avoided

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2. Health economic model for decision making
Omacor cost-utility model technical structure
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2. Health economic model for decision making
Omacor cost-utility model inputs and outputs
input output
clinical part
HE part
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3. Results cost-utility model

• Base case results comparing Omacor treatment
  for 4
• years with no treatment
• Patients in both arms are receiving other
  standard
• post-MI prophylactic treatments
• Results are below GBP 20-30.000 cost/QALY

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3. Results NICE-guideline
Chapter 1, page 8
http//guidance.nice.org.uk/CG48/niceguidance/pdf/
English
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3. Results NICE-guideline timelines

• 2004 Scoping meetings at NICE
• 17 Dec 2004 Submission of evidence to NICE
• 14 Aug 2006 Consultation guideline published
• 9 Oct 2006 End of consultation period
• 7 March 2007 Additional evidence submitted to
  NICE
• 3 May 2007 Final guideline released

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4. Summary and recommendation

• HE-assessments of pharmaceuticals are appropriate
  and well-established tools for local
  reimbursement decisions in many countries
• International GOPs in place

http//www.ispor.org/publications/PROR.asp
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Back-up HE-publications

• Quilici S., Martin M., McGuire A., Zoellner Y. A
  cost - effectiveness analysis of n-3 PUFA
  (Omacor) treatment in post - MI patients. Int J
  Clin Pract 2006 60 922-932
• Lamotte M., Annemans L., Kawalec P., Zoellner Y.
  A Multi-Country Health Economic Evaluation of
  Highly Concentrated N-3 Polyunsaturated Fatty
  Acids in Secondary Prevention after Myocardial
  Inaraction. Pharmacoeconomics 2006 24 783-79