Cost of Mis-Diagnosis

Cost of Mis-Diagnosis

Audience

Health economists, physicians and pharmacists, carers, those suffering, journalists

Keywords

Mis-diagnosis, healthcare costs, economic appraisal, NHS cost, social care cost

Failure to recognise B12 deficiency may be costing the country billions of pounds in lost tax, lost quality of life, and costs to the NHS. As only the costs to the NHS can be calculated with any accuracy, let's look at these.

For the purposes of the calculations we’ve used the 2007/08 census and prevalence figures, and only used the number of patients suffering from specific named conditions, i.e. 2 million, so the actual benefits may be much higher.

In simple terms, the cost of screening 2 million people from B12 deficiency would be around £6.7 million (one off cost), and assuming that 30% of these required injections and the rest oral tablets, treatment costs would be £118.3 million per year.

This would save at least £854 million per year, specifically on medication costs to the NHS (i.e. not including social services or care costs and all of the other more nebulous costs), and even then we've excluded a lot of savings which we considered "too difficult to estimate" so this is a very conservative figure. This only represents around 5% of the total NHS medicines budget, which is reassuring considering the number of patients being treated (perhaps around 15% of the "active patients").

Vitamin B12 deficiency symptoms are common witha number of other conditions, some of which may share these symptoms simply because they are caused by deficiency of this important vitamin.  Many diseases are a description of the symptoms, not of the potential cause.

Some treatment prescribed for these mis-diagnosed conditions may at best stabilise the condition and reduce side effects.  Misdiagnosis can be dangerous – during the September 2009 Swine Flu crisis, at least one person nearly died from meningitis because they were diagnosed with swine flu and treated for the wrong thing.

Most people want to get better, and where the symptoms can be relieved by Vitamin B12 replacement therapy this may even lead to the physician declaring the condition ‘resolved’ (the disease cured).

Misdiagnosis has a cost.

There’s a cost to the person suffering, their carers and friends, their employer, and society.  Depression, lack of self-worth, neuroses, days lost sick because nothing seems to work.  Pain, fatigue and inability to work.  These are very real to the sufferer, but I won’t try to quantify them because

1                     it’s very easy to come up with valuations that, whilst fully justified, start to look too big to be believable for policy-makers

2                     it’s insulting to put a low value on pain, and difficult to put a high one

Cost to NHS and social care

Let’s look at the direct and measurable NHS costs of some commonly diagnosed conditions which could be Vitamin B12 deficiency :

Although figures are given for renal disfunction and diabetes, there are so many causes for these conditions that their figures are not included in any totals.  For the other conditions only a proportion of the figures are included

  • Crohns & Irritable Bowel Syndrome – one hospital estimates cost of care at £757,433 over a 6 month period at 2004 prices (for a hospital catchment population of 330,000)[1].  Assuming this hospital is typical, this would multiply to £230million over whole of England per year.  What proportion would benefit from B12 treatment?  Crohns disease is almost certainly associated with Vitamin B12 deficiency but IBS could appear for a variety of reasons.  Estimate 50% of this total is used
  • Multiple Sclerosis (MS) affects around 100,000 people in UK.  MS is termed a ‘relapsing remitting’ condition (at least for the bulk of sufferers who don’t have primary progressive MS) which means that the symptoms appear (relapse) and then fade away (remission).  Currently it is considered untreatable although some disease modifying drugs are prescribed to alleviate the symptoms, therefore the costs of treatment are nearly impossible to estimate.  For example if a treatment costs £150 per month, then we still need to understand on average how many months of any given year and for how many people.  For this reason, MS costs have been excluded from the calculations.
  • ME/CFS/Fibromyalgia – the society “Action for ME” (www.AFME.org.uk) estimates cost of treatment at £787 per person per year at 2006 prices (Sheffield Hallam Univ)[2] based on prescribed drug costs of £410 (2006 prices) and consultation/ intervention activity costs of £376 (2006 prices).  These figures are calculated from lifetime costs / 6.8 years (the average length of time people suffer).  They also estimate that there are 75,000 people diagnosed and receiving treatment, which amounts to £59million.  A study using MHRA’s GPRD database suggests 750,000 present with any fatigue symptom in any given year, although some of these will not receive diagnosis treatment directly for fatigue.  What figure do you use for the prevalence (anywhere between 75,000 and 750,000)?  What price do you put on the cost of “other fatigue” drugs especially those purchased by the sufferer?  We observed a strong result for people addressing fatigue with Vitamin B12 replacement therapy therefore have used 80% of the figure for 75,000 patients, which would represent a much smaller proportion of the total if prevalence were 750,000
  • Dementia/ Alzheimers’ –Dementia UK reported [3] 574,717 people were suffering from dementia in its various forms in England, some with mild, some moderate, and some severe symptoms.  They calculate approx £1,362million (yes £1.3billion) per year NHS costs, and estimate twice this again in Social Services costs.  They also detail other social costs which have not been included. Given the association documented between Vitamin B12 deficiency and dementia[4-7], can we use 50% cost of NHS treatment as a very conservative approximation of the cost?

·         Pernicious anaemia (PA) – PRIMIS+ (an analysis system based on MIQUEST data, developed by NHS Information Centre and Connecting for Health and hosted by University of Nottingham) records 190,073 people diagnosed with PA and 251,555 receiving injections of hydroxocobalamin (usually only administered with a diagnosis of PA)[8].  The cost of administering hydroxocobalamin (a manufactured form of B12) is approx £10 per injection (representing £1.50 for the medication and a charge for nursing time) at a frequency of one per 3 months = £10,062,200.  Of course this doesn’t include any care needs such as special diets, home care support, nor any of the social costs.

  • Chronic Kidney Disease (CKD) is present in around 2.9% of the population of England (1,589,353 people in 2007/08 census)[9], and many more have milder forms of renal disfunction which affect their lives in different ways.  Many of these patients also have co-morbidities, the most common of which is diabetes.  Of the costs estimated for treatment of CKD (£1.3billion), 93% are in secondary care – hospitals – leaving around 7% or £91million in primary care[10].  However it should be noted that this £19million excludes the main costs in primary care: GMS/PMS costs associated with renal failure and prevention budgets. Renal failure is associated with a number of conditions especially diabetes, therefore for the sake of maintaining defensible and conservative estimates of the cost of mis-diagnosis the costs of treating CKD in primary care are excluded from the calculations.
  • Diabetes is present in around 3.9% of the population of England (2,088,335 people 2008 figures)[11-12]. It cannot be cured, and the cost of treatment is estimated at £9billion (10% of NHS budget) of which £561.4million is for drugs (7% of drugs budget)[13].  Type 1 diabetes (approx 15% of the population with diabetes) is caused by an autoimmune condition[14], and vitamin B12 deficiency has been linked with other autoimmune conditions although its association with diabetes has not been shown.  The sheer volume of diabetes patients means that for the sake of retaining conservative estimates of cost, we have excluded these numbers from the total.

Condition

Total cost to NHS (see above) (£million)

Proportion of total cost used for calculation

National cost figure used (see above) (£million)

Crohns and IBS

230

50%

115

ME/CFS/Fibromyalgia and other fatigue

59

80%

48

Dementia, Alzheimers

1,362 + estimate for Social Services

50%

681

Pernicious Anaemia

10

100%

10

Multiple Sclerosis

Not possible to calculate

Costs Not included

Costs Not included

Renal disfunction, Chronic Kidney Disease

91 (primary care excluding GMS & Public Health)

Costs Not included

Costs Not included

Diabetes

9,000

Costs Not included

Costs Not included

Totals

 

 

854

 

£854,000,000.  £0.8billion.  This figure is a conservative estimate in a population of 54million (2007/08 census which is the date for most of the prevalence data).

It’s also big in terms of numbers of people suffering:

75,000 with Crohns/IBS.

75,000 with ME/CFS and perhaps 10x this number with all forms of fatigue.

574,000 with dementia.

251,000 receiving treatment for PA (whether diagnosis recorded or not)

Millions with renal imbalance and diabetes. 

The numbers are huge. Lets put a round number on it, say 2million

 

Citations

 

1.            Bassi, A., et al., Cost of illness of inflammatory bowel disease in the UK: a single centre retrospective study. Gut, 2004. 53(10): p. 1471-8.

2.            Action for ME and M. Atkinson, RE: Finding out about ME/ CFS/ Fibromyalgia, 2009, www.AFME.org.uk.

3.            Knapp, M. and M. Prince, Dementia UK - The Full Report. 2007, Alzheimer's Society: London.

4.            Clarke, R., et al., Folate, Vitamin B12, and Serum Total Homocysteine Levels in Confirmed Alzheimer Disease. Arch Neurol, 1998. 55(11): p. 1449-1455.

5.            Nilsson-Ehle, H., Age-related changes in cobalamin (vitamin B12) handling. Implications for therapy. Drugs Aging, 1998. 12(4): p. 277-92.

6.            Nilsson, K., et al., Treatment of cobalamin deficiency in dementia, evaluated clinically and with cerebral blood flow measurements. Aging (Milano), 2000. 12(3): p. 199-207.

7.            Dogan, et al., Psychotic Disorder and Extrapyramidal Symptoms Associated with Vitamin B12 and Folate Deficiency. Journal of Tropical Pediatrics, 2009. 55(3): p. 205.

8.            PRIMIS+, Drug/Diagnosis ratios, hydroxocobalamin to Pernicious anaemia. 2009, NHS Information Centre.

9.            NHS Choices. Prevalence: Chronic Kidney Disease.  2008  [cited 2009 22 Sept]; Available from: www.nchod.nhs.uk.

10.          O'Donoghue, D. Programme Budgeting Chronic Kidney Disease section 17B.  2009 28 May 2009 [cited 2009 22 Sept]; Available from: http://renaltsar.blogspot.com/2009_05_01_archive.html

11.          Diabetes UK. Diabetes Prevalence 2007.  2007  [cited 2009 21 Sept]; Available from: http://www.diabetes.org.uk/Professionals/Publications-reports-and-resources/Reports-statistics-and-case-studies/Reports/Diabetes-prevalence-2007/.

12.          Diabetes UK. Diabetes Prevalence 2008.  2008; Available from: http://www.diabetes.org.uk/Professionals/Publications-reports-and-resources/Reports-statistics-and-case-studies/Reports/Diabetes-prevalence-2008/.

13.          Diabetes UK, Diabetes in the UK: Key statistics on diabetes. 2009.

14.          DH, National service framework for diabetes: standards, D.o. Health, Editor. 2001.

 

Keywords:

What if it is B12 deficiency? How much would it cost to treat?

Firstly there’s a cost of diagnosis. 

Using the <Chandy diagnostic criteria> takes 2-3minutes which fits easily within a 10 minute consultation.

Blood serum B12 assay for £3.37 (NHS price –  this would be approx £10 through a private laboratory).  The assay may not be definitive (it’s debatable where the threshold point for treatment should be) but blood B12 below 350ng/L should certainly be cause for concern. For 2million people this adds up to less than £7million, and they don’t need testing every year.

Treatment:

Individual vials (1ml of 1mg/ml) of hydroxyl-cobalamin cost £1.50. Depending on the frequency of injection a pack of 5 (£7.50) can last 15 months (over a year) at BNF recommended injections every 3 months – in practice we find people need injections more often (hydroxyl-cobalamin and methyl-cobalamin can be obtained more cost-effectively in bulk).  Even allowing for nurse time to perform the injection the cost of treatment at a GP surgery is unlikely to exceed £10 (simple intramuscular or sub-dermal injection).

For many people, oral B12 in the form of tablets or sub-lingual lozenges are perfectly adequate. We recommend 1mg (1,000µg) per day, which can be purchased from <a health food store> for perhaps £7.99 per 100 tablet dose

Cost of treatment

Injections: assume 1 per month = 12 per year.  Assume 33% of the 2 million need this = 660,000.  Cost £10 per injection = £79.2million.

Oral supplement: assume 1 per day = 365 per year.  Assume remainder = 1,340,000 population.  Cost 8p per dose (no administration cost) = £39.1 million

This total of £125.3million is substantially different from the conservative estimate of £844million above.

(F YOU LIVE IN A COUNTRY WITHOUT GOOD STATE-FUNDED HEALTHCARE, YOUR COSTS ARE LIKELY TO BE BETWEEN 1 ½ AND 2 TIMES THESE)

Will treatment with Vitamin B12 work? How much will it save?

Anecdotally we observe patients with MS restored to full muscular and nervous function, stopping not only their MS drug regime but also reducing their care needs and even returning to work. From mild conditions it takes about 1 year; from severe MS the prognosis is less good although improvements beyond the natural variation and cycles of MS are reported by carers and family.  The improvement is also noted with other motor damage such as single limb paralysis, ataxia, epilepsy, dysphagia.

We observe people who come to the surgery having been prescribed anti-depressants and anti-psychotics, coming off all medication and returning to work.

We observe improvements to patients with Irritable Bowel and Crohns, again allowing people to return to work and cease other medication

Many people report relief from fatigue and better memory/ cognitive ability, reducing care costs and reducing their dependence on the health service.

The plural of anecdote is not data, this is fully accepted[1].  However we believe that Vitamin B12 replacement therapy could have a substantial beneficial effect even when measured purely in terms of direct NHS costs.  If social care costs could be calculated, and if personal costs and the costs of lost activity and lost pleasure factored in, the benefits would be many many times higher.

 

Citations

 

1.            Goldacre, B., Bad science. 2008, London: Fourth Estate. xiii, 338 p.