An Assessment of the Impact of Guidelines on the Management of Coronary Heart Disease in the United

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An Assessment of the Impact of Guidelines on the
Management of Coronary Heart Disease in the
United Kingdom, Germany and the United States
A Case Study - Comparing and contrasting
physician prescribing of CHD agents

• Presentation to PBIRG 2003 Conference
• 19th May 2003
• Linda MacMillan, PhD, Mary Thompson, PhD, Marion
  Gaskin, MA (IMS Health, Pinner, UK) Heather von
  Allmen, BA, Scott Henderson, MS (IMS Health
  Consulting, USA)

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Background to the analysis

• In the UK, perceived inequalities in health and
  preventative care based on region (post code
  prescribing) led to a need to standardize
  patient care.
• In the UK, guidelines for patient care were
  introduced (National Service Framework - NSF),
  starting with the NSF for coronary heart disease
  in 2001.
• The intent of guidelines was to reduce the risk
  of complications and death country-wide (with the
  added longer term benefit of a reduction of
  burden on the health care system)
• GPs now have to keep a practice register of
  patients who have and are at high risk of
  coronary heart disease. They will undergo
  clinical audit.

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Background to the analysis

• A panel of GPs supplying IMS with longitudinal
  patient data requested help with benchmarking
  against the parameters covered by the initial UK
  guidelines.
• A methodology was produced, with input from panel
  members.
• The data for these physicians were analyzed
  pre-NSF to assist them in identifying patients
  where treatment standards were not being met, in
  order to help them meet targets.

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Background to the analysis

• As the effect of guidelines in the UK appeared to
  be less than complete, it was decided to extend
  the study to other countries to see if there was
  a similar level of response to guidelines.
• In the US, ACC/AHA introduced guidelines in 1999
  for the Management of Patients with Acute
  Myocardial Infarction, and published an update in
  2001 for Secondary Prevention for Patients with
  Coronary and Other Vascular Disease
• In Germany, science-based guidelines for
  diagnostics and therapy were last updated in 1998
  (AWMF) K (019 Kardiologie), 019/001Koronare
  Herzkrankheit

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Objectives of analysis

• Perform analyses parallel to those performed in
  the UK, using data from Germany and the United
  States, to benchmark the clinical management and
  recording strategies of physicians before the
  publication of national management guidelines for
  CHD, and to measure the subsequent changes in
  prescribing and recording behavior for CHD
  patients following publication

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Objectives of analysis

• Investigate and compare the impact of guidelines
  within each country to examine the effect they
  have on disease treatment.
• Illustrate how this type of data can allow
  pharmaceutical industry to align more closely
  with physicians and payors through a deeper
  understanding of current practice and the trends
  caused by guidelines and other factors.

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IMS Disease Analyzer - Mediplus is a
longitudinal database of patients who consult
their GPs and who are treated or not treated for
their illnessLifeLinkTM Integrated Claims
Solutions is a longitudinal database containing
integrated medical and pharmacy claims from
employer-based indemnity and PPO health insurance
plansin the United States
Data Sources
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IMS longitudinal data patient populations
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Methodology Patient Selection

• Patients were classified as CHD or MI via ICD-10
  codes (Germany and UK) or ICD-9-CM codes (US)
• Pre-guidelines Diagnosis recorded in 12-month
  period before guidelines were introduced
• Post-guidelines Diagnosis recorded 12-month
  period after guidelines or most recent 12 months
  of available data

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Methodology Patient Selection

• From the cohort of patients with CHD or
  myocardial infarction (MI) available for
  treatment in the pre- and post-periods we
  identified the proportion of those patients
  remaining untreated with recommended therapies.
• Pre-guidelines Examined prescriptions from the
  four month period before guidelines were
  introduced
• Post-guidelines Examined prescriptions from the
  last four months of the post-guideline period

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Methodology Observation Period

• Actual observation periods (for pre- vs.
  post-guidelines) were defined for each country,
  since the timing of the release of guidelines
  differed for the US and Germany

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Methodology Recommended Therapies

• Evaluated the proportions of available patients
  reported remaining untreated with recommended
  therapies included in guidelines
• aspirin (or anticoagulants / antiplatelets),
• ß- blockers (or contraindication e.g.
  bronchiospastic disease),
• statins/cholesterol reducing therapy
• estrogen replacement therapy in post-menopausal
  women (US only)
• anti-hypertensives (US only)

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Results
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Germany CHD

• Pre-guidelines aspirin ( aspirin or
  alternative), 25 treated
• Current aspirin, 38 treated
• Pre-guidelines statins, 11 treated
• Current statins, 20 treated

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US CHD

• Pre-guidelines cholesterol reducers, 45.1
  treated
• Current cholesterol reducers, 49.6 treated,
  increased use of combination therapy
• Pre-guidelines anti-coagulants/anti-platelets,
  16.7 treated
• Current anti-coagulants/anti-platelets, 19.8
  treated

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US CHD

• Pre-guidelines antihypertensives, 39.8 treated
• Current anti-hypertensives, 44.7 treated
• Pre-guidelines ß-blockers, 32.8 treated
• Current ß-blockers, 36.6 treated

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Germany MI

• Pre-guidelines, ß-blockers 30 treated
• Current ß-blockers, 46 treated
• Pre-guidelines statins, 19 treated
• Current statins, 33 treated

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US MI

• Pre-guidelines, ß-blockers 46.6 treated
• Current ß-blockers, 50.9 treated
• Pre-guidelines cholesterol reducers, 43.1
  treated
• Current cholesterol reducers, 49.4 treated,
  increased use of combination therapy

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US MI (continued)

• Pre-guidelines, Anti-coagulant/Anti-platelets
  25.3 treated
• Current Anti-coagulant/Anti-platelet, 28.1
  treated
• Pre-guidelines Estrogen Replacement Tx (in
  post-menopausal women), 3.4 treated
• Current Estrogen Replacement Tx 4.0 treated

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Discussion

• Results from longitudinal patient data do show a
  rise in the proportion of the target populations
  who were treated appropriately, compared with
  prior to guidelines, in all countries studied.
• Despite this, a number of patients remain
  untreated (although the reasons are unknown and
  could be clinical).

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Discussion

• The data indicated that treatment levels in the
  UK were higher than those in both the US and
  Germany. This may be due in part to the UK
  government requirement that GPs now have to keep
  a practice register of patients who have and are
  at high risk of CHD. Increased oversight may be
  causing increased adherence to the guidelines.
• Increased awareness of the level of response to
  guidelines among physicians and consumers could
  increase adherence to guidelines and increase
  product use in these markets.

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Possible next steps

• Having established through the use of
  longitudinal databases that there may be
  prescribing issues amongst physicians, industry
  executives can direct their finite resources at
  addressing the whys? of the situation.
• What type of patient remains untreated?
• Are there clinical reasons for this?
• Is it an age-related issue?
• Are there co-morbidities which mean that
  treatment is not appropriate?
• What are the cost implications of these patients
  being without treatment long-term?