Council for Medical Schemes
Therapeutic Algorithms for the Chronic Disease List Conditions
December 2002
This first daft of the Therapeutic Algorithms for the Chronic Disease List Conditions was developed by Bettina Taylor with the support of Medscheme Integrated Care Division. The document is provided as an Appendix to the following report:
The Costing of the Proposed Chronic Disease List Benefits in South African Medical Schemes in 2001
By Professor Heather McLeod, Professor Alan Rothberg,
Leslie Pels, Sean Eekhout, Deus Bazira Mubangizi and Dr Therese Fish
December 2002
Centre for Actuarial Research
(CARE)
A Research Unit of the University of Cape Town
Centre for Actuarial Research
University of Cape Town
Private Bag
Rondebosch
7701 SOUTH AFRICA
Medscheme Integrated Care Division
Private Bag X124
Bryanston
2021 SOUTH AFRICA
Introduction to the First Draft
The Regulations dated 4 November 2002 that introduced the Chronic Disease List state:
Treatment: Diagnosis, medical management and medication, to the extent that this is provided for by way of a therapeutic algorithm for the specified condition, published by the Minister by notice in the Gazette.
It is the intention that these therapeutic algorithms be discussed with stakeholders and published in the course of 2003 for implementation on 1 January 2004.
The Standard Treatment Guidelines and Essential Drugs List published by the Department of Health in 1998 forms the basis of this document. All guidelines relevant to the diseases included in the CDL conditions have been collated without any change to the content of information. Editorial changes have focused on layout and consolidation of information.
The clinical staff of Medscheme Integrated Care identified a number of problem areas and have suggested the following solutions:
· Some of the clinical information is outdated e.g. ACE-inhibitors have become the standard of care in patients with congestive cardiac failure. It is important that all guidelines are revised by a team of experts from a clinical perspective.
· Certain key diseases are not adequately covered in the Standard Treatment Guidelines. Of particular concern is the lack of information pertaining to the treatment of hyperlipidaemia and multiple sclerosis. These diseases should be addressed as a matter of urgency.
· Although the guidelines focus on maintenance management of chronic diseases, some do refer to acute intermittent therapies that may be indicated for the respective diseases. It is important that the final CDL document clearly states which acute/intermittent therapies are expected to be covered. The administrative complexities and financial risks that may arise from including some of these must be carefully considered in the final decision-making process.
It is suggested that a task team be appointed to be responsible for documenting and maintaining the treatment algorithms for the CDL conditions. Ideally this team should work closely with the Standard Treatment Guidelines and the EDL committee. The task team should have representation from private funders, relevant clinical disciplines and the public sector.
Actuarial and pricing expertise should be sought once initial clarity has been achieved in order to estimate the price of the algorithms. This may result in an iterative process of refining the algorithms and sufficient time needs to be allocated to this possibility. A project manager should be identified to ensure that the process moves forward in time for schemes to incorporate the benefits in their pricing in August 2003, in order to ensure a smooth introduction of benefits from 1 January 2004.
Preliminary recommendations for a package of tests, equipment and visits in respect of each CDL condition were costed in the report and the spreadsheet is provided separately.
Table of Contents
Introduction to the First Draft 3
Table of Contents 4
1. Cardiovascular Disease 6
1.1. Hypertension 6
1.1.1. Paediatrics 6
1.1.2. Adults 7
1.2. Hyperlipidaemia 10
1.3. Coronary Artery Disease 11
1.4. Cardiac Failure / Cardiomyopathy 12
1.4.1. Paediatrics 12
1.4.2. Adults 12
1.5. Dysrhythmias 15
2. Respiratory Disease 16
2.1. Asthma 16
2.1.1. Paediatrics 16
2.1.2. Adults 17
2.2. Chronic Obstructive Pulmonary Disease 19
2.3. Bronchiectasis 20
2.3.1. Paediatrics 20
2.3.2. Adults 21
3. Endocrine Disease 22
3.1. Diabetes Mellitus Type 1 22
3.1.1. Paediatrics 22
3.1.2. Adults 23
3.2. Diabetes Mellitus Type 2 24
3.3. Hypothyroidism 25
3.3.1. Paediatrics 25
3.3.2. Adults 25
3.4. Addison’s Disease 26
4. CNS Disease 27
4.1. Epilepsy 27
4.1.1. Paediatrics 27
4.1.2. Adults 27
4.2. Parkinson’s Disease 29
4.3. Multiple Sclerosis 30
5. Psychiatric Disease 31
5.1. Bipolar Mood Disorder 31
5.2. Schizophrenia 32
6. Musculoskeletal Disease 33
6.1. Rheumatoid Arthritis 33
7. Immunological Disease 35
7.1. Systemic Lupus Erythematosus 35
8. Gastro-Intestinal Disease 36
8.1. Crohn’s Disease 36
8.1.1. Paediatrics 36
8.1.2. Adults 36
8.2. Ulcerative Colitis 38
8.2.1. Paediatrics 38
8.2.2. Adults 38
9. Renal Disease 40
9.1. Chronic Renal Disease 40
9.2. Chronic Renal Failure 40
9.2.1. Paediatrics 40
9.2.2. Adults 41
9.3. Nephrotic Syndrome 42
9.3.1. Paediatrics 42
9.3.2. Adults 43
9.4. Pyelonephritis and Obstructive/ Reflux Nephropathy 44
9.4.1. Paediatrics 44
9.5. Renal Calculi 45
10. Haematological Disease 46
10.1. Haemophilia A and B 46
11. Opthalmological Disease 47
11.1. Glaucoma 47
1. Cardiovascular Disease
1.1. Hypertension
1.1.1. Paediatrics
Definition
Elevation of systemic blood pressure beyond the 95th blood pressure centile for age on at least three different occasions at weekly to monthly intervals (excluding acute hypertensive states).
Diagnostic criteria
· The blood pressure values in the table can be regarded as the upper limit of normal (95th centile). All blood values in excess should be treated.
· Hypertension may be asymptomatic or symptomatic. If symptomatic, it usually presents with the clinical features of the underlying disease or the target organ system involved, e.g. hypertensive encephalopathy, pulmonary oedema or renal disease.
Blood pressure values for age – upper limit of normal
Age <12 hours 1 week 6 wks-6 yrs 8yrs 9yrs 10yrs 12yrs 14yrs
Systolic 80 100 115 120 125 130 135 140
Diastolic 50 70 82 84 86 88 90
Referral criteria
· Confirmed hypertension in any child – to determine the underlying cause (if necessary) and to initiate treatment.
· Hypertension not responding satisfactorily to treatment.
Treatment objectives
· Maintain blood pressure at or slightly below the 95th centile for age. (Blood pressure should not be decreased by more than 25% in the acute phase).
· Determine and treat any underlying cause of hypertension.
Non-drug treatment
§ Weight reduction when appropriate.
§ Salt restriction.
§ Aerobic exercise.
§ Identify and treat the underlying cause.
Drug treatment
Essential hypertension
Treat stepwise, beginning with a diuretic.
Hydrochlorothiazide, oral, 0.5-1mg/kg as a single dose. Max. 12.5mg per day.
The subsequent steps correspond to those used in cases of secondary hypertension.
Secondary hypertension
If fluid load is contributory, furosemide, oral, 1-5mg/kg/24 hours in 2-4 divided doses (together with potassium supplementation, as needed). Otherwise, omit the diuretic.
Step 1 - Beta-blockers
Propranolol, oral, 1-8mg/kg/24 hours in 3 divided doses, OR
Atenolol, oral, 1-2mg/kg/24 hours as a single dose or in 2 divided doses.
Beta-blockers contraindicated in asthmatic patients.
Step 2 – Vasodilators
Hydralazine, oral, 1-5mg/kg/24 hours in 3-4 divided doses, OR
Prazosin, oral, 0.1-0.5mg/kg/24 hours in 2 divided doses; max. 20mg per day.
Prazosin should be initiated by paediatrician. Use half the calculated dose for the first 3-5 days to reduce orthostatic hypotension.
Step 3 - ACE-inhibitors
Captopril, oral, 1-6mg/kg/24 hours in 3 divided doses; neonates 0.03-2mg/kg/24 hours, OR
Enalapril, oral, 0.2-1mg/kg/24 hours in 2 divided doses.
Creatinine clearance must be >30-50mL/minute and renal artery stenosis must be excluded. Captopril should be initiated by a paediatrician.
Step 4 - Calcium channel blockers
Nifedipine, oral, 0.2-1mg/kg/24 hours in 3-4 divided doses (6-8 hourly).
1.1.2. Adults
Aim is to reduce blood pressure to <140/90mmHg, and to less than 160/95 in the elderly with no co-morbidity. Patients with diabetic renal disease should have their BP reduced to < 130/80.
Refer
§ if the patient is compliant with therapy and the blood pressure is refractory while on drugs from three different classes, one of which being a diuretic
§ all cases where secondary hypertension is suspected
Drug treatment
Diuretics
Hydrochlorothiazide, oral, 12.5mg daily. In patients with fluid retention, increase to 25mg daily. If unresponsive to latter or if creatinine > 150mmol/l, furosemide, oral, 40-160mg daily.
First line therapy for all patients (except during pregnancy, where diuretics in general are contra-indicated, and high dose diuretics should not be used).
Centrally-acting agents
Reserpine, oral, 0.1mg daily. Continued from primary care as additional therapy.
(For hypertension in pregnancy, methyldopa, oral, 250mg twice daily, increase to maximum dose of 500mg tds)
Beta-blockers
Atenolol, oral, 50mg daily, can be increased to 100mg daily in patients with insufficient beta blockade.
In addition to hydrochlorothiazide may be beneficial in the following conditions:
§ angina/ after myocardial infarction
§ tachydysrhythmias
§ pregnancy.
ACE-inhibitors
e.g. Perindopril, oral, 4mg daily or ramipril 2.5mg – 10mg daily
Use if target blood pressure is not achieved with the above-listed medications. Also for:
§ heart failure
§ left ventricular hypertrophy
§ after myocardial infarction (remodelling prevented)
§ diabetes with micro-albuminuria.
In renal failure, use ACE-inhibitor only if serum K+ < 5mmol/l.
Alpha blockers
e.g. Prazosin, oral, 1-5mg 2-3 times daily, max. dose 20mg daily.
Start with low dose, titrate upwards. A first dose hypotensive effect can occur.
Consider use for chronic renal failure, heart failure, prostatic hypertrophy and hypertension in pregnancy.
This is a third-line anti-hypertensive drug.
Calcium channel blockers
e.g. Verapamil, oral, 40-80mg 3 times daily, OR
Verapamil sustained release, oral, 120-360mg one or twice daily, OR
Nifedipine long- acting, oral, 30-90mg daily, OR
Amlodipine, oral 2.5mg daily, initially, and up to a maximum of 10mg once daily (dose should only be increased after 10-14 days)
Nifedipine, oral, 5mg, for short term, emergency use only.
Benefits in:
§ angina pectoris
§ peripheral vascular disease
§ in elderly patients
§ systolic hypertension
These drugs are metabolically neutral.
Arteriolar vasodilators
(For hypertension in pregnancy, hydralazine, oral, 25mg tds, increase to 50mg qid)
(For hypertension in pregnancy, aspirin, soluble, oral, 75mg daily may be used).
Preliminary comments:
The adult section is an edited consolidation of three chapters of the SA Treatment Guidelines and Essential Drugs List (Hypertension, Malignant Hypertension, Hypertension in Pregnancy).
The cheapest available agent within a therapeutic group should form the benchmark agent for PMBs, irrespective of whether this agent has been listed as the specific example in the above guideline. For example, perindopril and ramipril are listed as examples of ACE-inhibitors in the current treatment guide, yet an alternative ACE-inhibitor may be the most cost-effective agent available in the private sector. The latter rather than the former should thus form the benchmark for PMB reimbursement in the private sector. This principle should apply to all conditions.
1.2. Hyperlipidaemia
Principles of drug treatment
§ Based on adequate non-drug measures being the cornerstone of treatment initially, and subsequent to drug inclusion.
§ Accurate determination and characterisation of lipid abnormalities.
§ The role of associated risk factors, including lifestyle, race, gender and age.
§ Treatment of underlying and causative secondary conditions.
§ The place of drugs in primary and secondary prevention.
§ The rational use of drugs for associated conditions.
§ The rational use of hypolipidaemic drugs – efficacy, proven effects, cost, side effects, additional benefits and comparisons.
§ Classes of drugs to be used singly or in combination.
§ Therapeutic profiles of all drugs – lipid disorders and for underlying conditions.
Preliminary comments
This is one of the three most expensive chronic conditions to treat, if one considers chronic medication expenditure. Not only is this section covered very poorly in the Standard Treatment Guidelines, but it also appears that no associated drugs are listed on the Essential Drugs Lists. Before PMBs for chronic medication are implemented, it is imperative that an explicit “minimum care” guideline is collated for use of lipid-lowering drugs. The international trend is for higher doses of such drugs being recommended for increasing target populations, a “best practice” trend that could financially cripple health systems. PMBs should probably only mandate reimbursement of lipid-lowering drugs for patients with familial hyperlipidaemia and for those with established atherosclerotic disease and abnormal lipid levels.
1.3. Coronary Artery Disease
Aim of therapy is
§ To identify and aggressively modify risk factors such as smoking, hyperlipidaemia, diabetes mellitus, hypertension, obesity, coagulation risk and menopause.
§ Pain relief
§ Detection and treatment of atherosclerotic progression and complications
Drug treatment
For specific prophylaxis:
Nitrates short acting ,e.g. glyceryl trinitrate, sublingual, 0.5mg, at first indication or before known situation. Repeat if necessary after 5 minutes. OR
Isosorbide dinitrate, sublingual, 5mg when necessary, and repeated at 5 minutes’ intervals if required.
If nitrates are no longer effective, this may be due to deterioration of the coronary artery disease, an unrecognized trigger, or improper storage of the drug.
For long-term prevention of angina:
Nitrates, long acting e.g. isosorbide mononitrate, oral, 10-20mg twice daily OR
Isosorbide dinitrate, oral, 40mg, twice daily, at 8:00 and 14:00 hours.
Adjust to optimal dosage, this also depends on product.
Beta blockers e.g. atenolol, oral, 50-100mg daily (titrate to resting heart rate of approximately 60 beats per minute) PLUS
Aspirin soluble, oral, 75-150mg daily. (long-term prophylaxis for thrombosis)
Calcium channel blocker e.g. verapamil, oral, 120-360mg daily, in 4 divided doses OR
Diltiazem, oral, 180-360mg daily in 2 divided doses (where verapamil is inappropriate).
Caution: contraindicated in-patients with established or borderline cardiac failure and in-patients with intracardiac conduction disturbances.
Use if verapamil is inappropriate.
Preliminary comments
Hormone supplementation is no longer regarded as risk modifying therapy in postmenopausal females, and should as such not form part of PMBs for coronary artery disease.