SHOULD NUTRITIONAL PRODUCTS BE EVALUATED AND REIMBURSED IN THE SAME WAY PHARMACEUTICALS ARE? Issue Panel Session (IP25) 14 th November 2018

Transcription

1 SHOULD NUTRITIONAL PRODUCTS BE EVALUATED AND REIMBURSED IN THE SAME WAY PHARMACEUTICALS ARE? Issue Panel Session (IP25) 14 th November 2018

2 Outline Issue panel session Nutrition Economics Challenges & complexities Nutrition Economics Discrepancies in current reimbursement policies Dr. Karen Freijer Irene Lenoir-Wijnkoop Moreno Perugini Debate shared & opposing viewpoints All 2

3 Health Economics & Nutrition Economics Karen Freijer, PhD, BSc 14th November 2018 Chair ISPOR Nutrition Economics SIG

4 Disclosure Dept Health Services Research CAPHRI School for Public Health and Primary Care Founder & Chair Nutrition Economics Advisor Physician & (Nutrition) Lifestyle Education Commission Freijer4Food & health care Consultancy

5 Nutrition Economics Freijer K. Nutrition Economics: DRM & Economic value of medical nutrition-phdthesis 2014, Maastricht Univeristiy NL

6 Nutrition Economics Merging of nutrition and health economics discipline Interdependency between nutritional habits, health and public expenses To illustrate health and economic aspects of specific changes in the daily nutrition and nutrition recommendations through the lens of costeffectiveness Nutrition economics is defined as "a discipline dedicated to researching and characterizing health and economic outcomes in nutrition for the benefit of society 1 1. BJN 2011;105:

7 NUTRITION Difference healthy person - patient Healthy: death after approx. 70 days Ill: death after approx. 28 days Loss of muscle mass > 40% = death

8 NUTRITION Difference healthy person - patient Healthy: death after approx. 70 days Ill: death after approx. 28 days Loss of muscle mass > 40% = death

9 (Medical) Nutrition Novel synergistic combinations of nutrients Pharma (New) Chemical Entity (one compound) Nutrients focus on multiple fysiological systems, safety has been proven Focus on single intervention, adverse events

10 Health & Nutrition Overall population Conventional food Functional food Infant formula/food General nutrition Expert Meetings 1 & 2 British Journal of Nutrition 2011;105: British Journal of Nutrition 2013;108: Survival, energy, health, pleasure Targets specific body functions/risk factors Age specific needs Expert meeting 1 A rational exists for developing the field of Nutrition Economics, defined as a discipline dedicated to researching and characterising health and economic outcomes in nutrition for the benefit of society. Expert meeting 2 There is a need of up-to-date knowledge on the role of nutrition and to assess impacts for the individual, the healthcare system and society as a whole.

11 Health & Nutrition Overall population Diseased population (= patients) Medical nutrition Expert meeting 3 Specific characteristics of medical nutrition do need special attention: study design, study population, sample size, comparator, clinical research outcomes (endpoints) Enteral nutrition Parenteral nutrition Special enteral medical nutrition for all ages Special parenteral (intravenous) medical nutrition for all ages Expert Meeting 3 European Journal of Clinical Nutrition 2015;69:

12 Health & Nutrition Nutrition Economics Overall population Diseased population (= patients) General nutrition Medical nutrition Conventional food Survival, energy, health, pleasure Enteral nutrition Special enteral medical nutrition for all ages Functional food Infant formula/food Targets specific body functions/risk factors Age specific needs Parenteral nutrition Special parenteral (intravenous) medical nutrition for all ages Expert Meetings 1 & 2 Expert Meeting 3 British Journal of Nutrition 2011;105: British Journal of Nutrition 2013;108: European Journal of Clinical Nutrition 2015;69:

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14 DEPARTEMENT PHARMACEUTICAL SCIENCES 14 November 2018 Challenges & Complexities in Nutrition Economics IRENE LENOIR-WIJNKOOP

15 Challenges & Complexities in Nutrition Economics The integral role that food and nutrients play in the disease etiology and progression puts a heavy burden on healthcare expenditures and should prompt decisionmakers to consider the cost and value of nutrition interventions ILW 11 November 2018

16 Common conditions of ill health British Journal of Nutrition Extension of nutritional strategies for managing civilization diseases would considerably reduce healthcare expenditures ILW 11 November 2018

17 Common conditions of ill health British Journal of Nutrition Extension of nutritional strategies for managing civilization diseases would considerably reduce healthcare expenditures ILW 11 November 2018

18 Diet, Nutrition and the prevention of chronic diseases Although nutrient deficiency diseases are still prevalent in some countries, and are an important cause of ill-health and premature death, nutrient-associated chronic diseases due to incorrect balance or an excess of nutrients are now of significant importance in virtually all countries, developing and developed alike. Factors needed for successful nutrition and food policies: Food and nutrition policies must have the credibility provided by scientific and epidemiological evidence, have political and technical support, and be regarded as necessary and convenient by the consumer [citizen]. ILW 11 November 2018

19 Highly interconnected physiological & metabolic processes related to nutrients intake Frontiers Endocrinology 2018 ILW 11 November 2018

20 ILW 11 November 2018

21 OECD Data. Health resources - Health spending. ILW 11 November 2018

22 Conclusion In spite of an increasing number of nutritional strategies, the burden of nutrition-related illness gets skyrocketing Most health assessors do still not have nutrition on their radar, it is time to get off the beaten track of the 20th century (Medical) nutrition is essential to nourrish sustainable health care systems ILW 11 November 2018

23 Announcement

24 DISCLAIMER The information in this presentation has been compiled with the utmost care, but no rights can be derived from its contents. Utrecht University

25 The tough pathway to reimbursement for Medical Nutrition interventions Moreno Perugini Head Medical Affairs and Market Access, Nestle Health Science November 2018

26 Increasing evidence on the health outcome of Medical Nutrition Interventions Patient perspectives on nutrition,

27 Malnutrition is a big issue for the HealthCare system 30

28 Major hurdles need to be address to ensure the patient has access to medical nutrition Clinical development Regulatory framework 31

29 Regulatory framework in the US: the need to demonstrate Distinctive Nutritional Requirement Pregnancy is not a condition for which a medical food could be labeled and marketed given the requirement of DNR can be managed by modification of the diet alone. Generally the levels of micronutrients necessary for pregnancy can be achieved by the modification the normal diet alone (1) Medical Food cannot be sold for diabetes because diet therapy is the mainstay of diabetes management and that a regular diet can be modified to meet the needs of an individual affected by Diabetes Mellitus (along with appropriate drug therapy if necessary) (2) 32 (1) Draft guidance for Industry. Frequently Asked Questions about medical food 2 nd edition (2013). Question #24 (2) Draft guidance for Industry. Frequently Asked Questions about medical food 2 nd edition (2013). Question #26

30 Major hurdles need to be address to ensure the patient has access to medical nutrition Clinical development Regulatory framework Coverage policy 33

31 Coverage policy in the US Medicare: NCD Enteral and parenteral therapy (1) limits the coverage to beneficiaries Who have a permanent functional impairment of the GI tract Who require tube feeding to maintain weight and strength, and For whom enteral nutrition is reasonable and necessary Commercial coverage landscape for CD (2) Commercial plans: The situation varies plan by plan but on average most of the plans recall Medicare determination for coverage 34(1) CMS National Coverage Determination NCD for Enteral and Parenteral Nutritional Therapy (2) Extrapolation of coverage distribution from sampled regional payers to all regional commercial payers. Focus on oral medical food coverage for Crohn s disease. Quorum consulting 2014

32 35 Since the product is oral it will not be reimbursed by Medicare

33 Coverage policy in EU Different provisions market by market Most of the markets do not follow drug reimbursement pathway Provisions usually include nutritionally complete Medical Nutrition interventions that are sole source of nutrition Reimbursement criteria based on specific compositional criteria according to local regulation 36

34 Major hurdles need to be address to ensure the patient has access to medical nutrition Clinical development Incentives for innovation Regulatory framework Coverage policy 37

35 Which incentives for innovation? Different methodologies exist but in general for NCE : Price of a drug is correlated to the health outcomes that the product has demonstrated, within available budget For Medical Nutrition Interventions price is generally defined by: Common lines of reimbursement By units of ingredients (e.g. protein, energy level, fibers, etc.) By calories count 38

36 Is calories count the best way to reward health outcome? Phenylketonuria (PKU) is an inborn error of metabolism that results in decreased metabolism of the amino acid phenylalanine PRODUCT COMPARISON EXPLICATIVE PRODUCT A Unit PRODUCT B Unit Daily Consumption (units) 4 Packet 0.5 Tub Perspective of the costs for one adult PKU patient requiring 60g of protein equivalent /day Calculations assume a reimbursement rate of $4/100 calories from Payer to Provider Product A and Product B deliver the same amount of Protein Equivalent Monthly Consumption (g) 3000 g 6000 g Calories / Day 296 Cals 820 Cals Daily Cost to Payer ($11.84) ($32.80) Monthly Cost to Payer ($355.20) ($984.00) Monthly Cost to Provider $ $ Monthly Reimbursement to Provider $ $ Provider Net Profit ($344.80) $

37 Major hurdles need to be address to ensure the patient has access to medical nutrition Clinical development Incentives for Innovation Regulatory framework Coverage policy 40

38 Debate view points 1. Can the rise of medical foods tackle unsustainable public healthcare costs? 2. How should reimbursement policies evolve? What is needed to have (medical) nutrition valued as a health care intervention? - Awareness? - Knowledge? - Evidence? - Stakeholders? - Frameworks?

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