Standardization of MS care: advantages and needs

ECTRIMS Congress 2021

October 14, 2021

Professor of Neurology, American University of Beirut

President, MENACTRIMS

Director, Neurology Institute and MS center- Harley Street MC

Abu Dhabi-UAE

Disclosures

Speaker honoraria: Bayer, Biogen, Merck, Novartis, Roche and Sanofi

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Research grants: Bayer, Biogen, Merck, Novartis and Pfizer

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Advisory board honoraria: Bayer, Biogen, Merck, Novartis, Roche and Sanofi

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The impact of MS as a disease�

*Calculated using EQ-5D. EDSS, Extended Disability Status Scale. 1. Orme M et al. Value Health 2007; 2. Reproduced from J Neurol Neurosurg Psychiatry. Costs and quality of life of patients with multiple sclerosis in Europe. Kobelt G, Berg J, Lindgren P, Fredrikson S, Jönsson B. 77: 918-926. ©2006 with permission from BMJ Publishing Group Ltd; 3. Sobocki P, Pugliatti M, Lauer K, Kobelt G. Sobocki P. Mult Scler. Estimation of the cost of MS in Europe: extrapolations from a multinational cost study. 13(8):1054-64. ©2007. Reproduced by permission of SAGE; �4. Pfleger CC et al. Mult Scler 2010; 5. Capkun G et al. Poster P779 presented at ECTRIMS 2013 (analysis of the US Department of Defence database)

Quality of life

• EDSS and utility have shown a significant inverse relationship^1,2

Employment^2,4

• ~50% of patients with MS are unemployed when they reach EDSS 3.0 and/or 10 years after diagnosis⁴

Survival shortened by 7-10 years

Disease severity (Function, EDSS)

Utility*

Disease severity (EDSS)

Proportion of patients working or on long-term sick leave

Healthcare costs

• Bulk of cost attributed to direct medical costs (56%) and long-term sick leave / early retirement (22%)³

Distribution of costs (Europe)�Mean cost per patient €31k / year

(Hordaland County, Western Norway, 1953-2003)

Among the twelve most common disorders of the brain, Multiple Sclerosis has the second lowest prevalence but the second highest costs�

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MS: A Rare & Expensive Condition

5

10

15

20

25

30

35

40

45

Number of cases (million)

Anxiety disorders

Migraine

Affective disorders

Addiction

Dementia

Psychotic disorders

Epilepsy

Parkinson's disease

Stroke

Trauma

Multiple Sclerosis

Brain tumour

0

5 000

10 000

15 000

20 000

25 000

30 000

35 000

40 000

Cost per patient (€ 2004)

tumour

multiple sclerosis

stroke

dementia

psychotic disorders

parkinson

epilepsy

affective disoders

trauma

addiction

anxiety disorders

migraine

Andlin-Sobocki P et al. European Journal of Neurology 2005;12 ;1-27

Definition: What is standardization in healthcare?

• Standardization in healthcare is often defined as the process by which healthcare products and services are chosen by a committee of key stakeholders, considering evidence-based results, to reduce variation in clinical treatment and patient outcome and thus improve quality of patient care

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• Standardization represents an effort to eliminate unnecessary complexity of care processes so that patients can receive the correct treatment in a safer environment

Standardization of MS healthcare: Advantages (1)

• Standardization of healthcare ensures reliable, high-quality clinical outcomes which makes it a key issue for providers, payers, and patients.

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• Evidence-based standards and guidelines can provide support to doctors in making complex decisions, help them avoid medical errors and omissions, and help ensure that all patients get a consistently high quality of treatment.

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• Implementing evidence-based interventions and best practices in a uniform way is one of the main contributors to improved patient safety in MS.

Standardization of MS healthcare: Advantages (1)

• In view of rising costs and the existing differences in quality of care in MS, reliable quality standards improve cost effectiveness of medical interventions, which is crucial for governmental agencies, insurance companies and patients’ organizations. This issue becomes crucial in low to middle income countries.

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• Finally, standardization will help advance clinical research in MS by providing data that can be processed, understood and compared across different systems, users, registries, platforms and countries. A globally aligned, standardized protocol that allows the capture, quantification and documentation of clinical data in MS is crucial for analyzing patient data both longitudinally (between different visits) and cross- sectionally (between different centers).

Standardization of healthcare improves patients outcomes

• Introduction of the National Surgical Quality Improvement Program was associated with decreases in mortality of 27% and 30-day morbidity of 45%.

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• The Get With the Guidelines – Stroke program was associated with a 1.18-fold yearly increase in the odds of receiving guideline-recommended care.

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• In 2014 at Xi’an general hospital in China a specific clinical pathway was designed to standardize the treatment processes of partial hepatectomy for patients with hepatocellular carcinoma. Patients who were treated according to the clinical pathway had better outcomes compared to patients who were not, including complications, mortality, and readmissions.

Standardization of MS care: Where is it needed?

• Diagnosis
• Diagnostic criteria
• Clinical assessment
• EDSS, MSFC, NEDA….
• Tests
• LP
• MRI
• Blood tests
• Evoked potentials
• Treatment:
• DMTs
• Symptomatic therapies

Diagnosis

• The Mc Donald criteria for diagnosis of MS are well standardized and accepted internationally. They provide an excellent example of healthcare standardization.
• Making an accurate diagnosis of MS using updated consensus-based criteria is crucial in improving patient outcomes.
• Unfortunately, recent clinical studies have highlighted the frequent problem of misdiagnosis in MS, attributed in a large part to inappropriate application of the McDonald criteria.

Clinical assessments

Clinical assessments

• Most of the clinical tests in current use are not standardized with regard to their place in clinical algorithms (that is, which tests should be used at what time) or their execution (in terms of how to perform the test or examination).
• The EDSS, although far from being perfect, is still the most widely used disability and impairment rating scale in MS and is used in practically all national and international transversal and longitudinal studies, making cross-study comparisons and a common language between neurologists possible.
• The MSFC is gaining ground mostly in clinical trials and is viewed as complementary to the EDSS. It is still not standard in routine clinical practice due to time constraints and familiarity with the test.
• Other clinical assessments need to be integrated into a standard of care such as testing for fatigue, cognition, quality of life, depression and others.
• Standardization of clinical assessments is crucial for adequate evaluation of disease progression, accurate treatment decisions and collaborative clinical research

Laboratory testing in MS

• Except for MRI, there is no standardization for laboratory tests used in MS whether for diagnosis or monitoring of emergent disease activity.
• The MAGNIMS criteria are a good example of standardization of care in MS. They were developed by an international panel of experts to guide the use of MRI for diagnosis and monitoring of disease activity in MS. They enable physicians to make better diagnoses, to specifically monitor the effect of DMTs in MS and to make reliable prognostic assessments.
• Despite the widespread acceptance of standards for use of MRI in MS, there is still a major need to improve their application in routine clinical practice.
• Standardization is also needed for laboratory testing in MS both at time of diagnosis and for disease monitoring and should cover the use of lumbar puncture, evoked potentials and blood tests.

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Treatment

• Multiple treatment guidelines were developed to standardize treatment in MS, including the AAN, EAN/ECRIMS, MENACTRIMS practice guidelines and many other regional or country-specific ones.
• The guidelines aim is to standardize the different aspects of decision making when considering initiating, switching, or stopping DMTs, and provide clear algorithms to help clinicians in routine daily practice.
• Standardization of treatment in MS will obviously have a major impact on patients clinical outcomes, safety and quality of life.
• There is a clear need for widespread education both at the level of individual MS centers and countries to adequately adhere to such practice guidelines.
• Standardization of MS treatment should also cover symptomatic therapies which play a major role in improving patient outcomes especially with advanced disability.

Hurdles facing standardization of MS care

• It is difficult to implement similar standards of care in countries with different levels of income and financial resources, especially when it to comes to expensive therapies.
• With the rapidly changing clinical landscape in MS, both at the level of diagnosis/MRI and treatment, standardized practice guidelines need continuous updating.
• Lack of appropriate training and education for those expected to follow standardized processes: neurologists, nurses, radiologists and other healthcare workers.
• Many doctors fear that standardization will restrict them in their individual treatment decisions.
• Patients are worried that they will not receive individualized, and therefore maybe more expensive, therapy.

Conclusion

• Standardization of care in MS aims at ensuring reliable, high-quality clinical outcomes, improving safety, lowering medical costs, improving data collection and allowing international collaborative research.
• With the rapidly evolving field of MS, existing standards and guidelines should be subjected to regular empirical reviews and adapted to recent advances.
• Many aspects of MS care are currently standardized including diagnostic criteria, MRI use and treatment algorithms. Other aspects such as testing, clinical assessments and monitoring need to be standardized.
• Widespread and continuous education is needed at individual, regional and international levels to insure adherence to existing widely accepted standards of care

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Thank You

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