Health Technology Assessment.

Transcription

1 BROUGHT TO YOU BY Health Technology Assessment. Part 2: Health Economics and Outcome Research Created by Pfizer This learning module is intended for UK healthcare professionals only. Job bag: PP-GEP-GBR-1021 Date of preparation March 2018

2 Agenda I. Introduction II. Value of a medicine III. Value impacts on product reaching market IV. Health economics and outcomes research

3 Introduction

4 Learning Objectives This module will improve your understanding of the value of medicines and medical devices You will learn examples of stakeholder groups and their priorities for value Example of Health Technology Assessments (HTA), in practice, will be given This module will also cover the factors that Health and value is used to evaluate The results of HTA will also be covered, with focus on clinical and patient outcomes

5 Value of a medicine 1

6 Value What is the value of a medicine or medical device? The answer to this question can vary depending on what stakeholder you were to ask. If you spoke to a patient, they may not care what cost the treatment was to the NHS if it could halt disease progression to a chronic condition they have been suffering with The concept of global health and value begins early in product development, through gathering data and insights that allow the value to be justified Balancing the stakeholders wants must be carried out with the main aim of achieving high value healthcare for patients, with value being defined as the health outcomes achieved per pound spent This goal is what matters for patients, payers, providers and suppliers so that they can all benefit while the economic sustainability of health care system increases

7 Value As economic growth slow and demand increases we need ways to calculate the true value medicines will bring to our health service Clinical differentiation and cost-effectiveness are no longer sufficient; True value of medicines is increasingly debated These ways must balance stakeholders wants with the inclusion of the aim to achieve high value healthcare for patients, with value being defined as the health outcomes achieved per pound spent This goal is what matters for patients, payers, providers and suppliers so that they can all benefit while the economic sustainability of health care system increases Health technology assessment as introduced in module 1 is being used as a method of calculating the value of a medicine

8 Refresh from HTA part 1 HTA The World Health Organisation defines Health Technology as the application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life's This includes the pharmaceuticals, devices, procedures and organizational systems used in health care Health Technologies Drugs Medical devices Diagnostics Surgical procedures accessed on 02/11/2017

9 Refresh from HTA part 1 Good HTA Health Technology Assessment (HTA) should place appropriate demands on the level and type of evidence, use proper assessment methods, and makes a fair decision

10 Global health and value However, when a medicine is being developed it has to show that it has worth in different countries and in many different factors, termed as global health and value of a medicine Clinical need Health Economics Clinical study outcomes Real word data Pricing model Global health and value

11 Global health and value To ensure patients have access to novel treatments, producers have to validate the need for this treatment and they do so by: Generating clinical data and evidence Health technologies and economic evaluations Setting list and net price Industry Gaining reimbursement / funding from payers Product value to the health system Patient access Demand of the product

12 Global health and value There are several different stakeholders involved in working out the price of a medication/treatment Stakeholder type Responsibility Role National Regional Hospital Entire country Subsection of a country Responsible for pricing and reimbursement decisions for the entire population within a country Responsible for decisions that apply to entire population within a specific geographic region within a country Responsible for decisions that apply to all patients being treated at a specific hospital Medicine / treatment Private insurer Responsible for decisions that apply to a specific population who have selected to join a particular insurance scheme Patient Individual An individual patient who is paying for the full or partial cost of their treatment themselves Patient Access

13 Examples of stakeholder groups Medical community Advocacy groups Health technology agencies Distribution stakeholders, retailers, wholesalers etc Stakeholders Medical guideline committees Industry & trade associations Governments politicians, policy makers

14 Different stakeholders priorities Stakeholder evidence needs vary even within country and also within asset type (generic, biosimilar, innovative drugs) Differentiation of the evidence specific for each stakeholder/payer type will make it easier for local affiliates to use relevant information from the strategy documents or value dossier Government Patient value Costs Burden of illness Public health impact Societal value Holistic value Unmet needs Regulators Safety Efficacy Effectiveness Incremental benefit vs SOC Manufacturing / purity Promotional, labelling, opportunity Payers / HTA Economics value Incremental benefit vs SOC Patient unmet needs Healthcare medical cost offset Comparative effectiveness Product value Physicians / Providers Comparative effectiveness (efficacy and safety) Adherence Product differentiation / incremental benefit vs SOC Hospital cost offset, LOS, readmission Patients Stronger advocacy Personal impacts of disease and treatment Healthcare and products benefit to patient Patient preference

15 Value impact on products reaching market 2

16 Several factors depend on a product becoming available The body of clinical evidence on a product e.g., safety, efficacy, relative effectiveness outcomes etc., Data The cost of a medicine, patient volume it reaches and the associated economic implications to the patient or health system Cost Demand Stakeholder buy in that the medicine funding is appropriate and beneficial for the need e.g., treatment guideline

17 HTA in practice an example The statins in hyperlipidemia. Strong clinical evidence and economic value drove patient access. Data Strong clinical evidence showing a reduction in low density lipoprotein (LDL) Impactful outcomes data (e.g., reduction of myocardial infarction and stroke) Advocacy None Cost High budget impact for payers but Cost-effective economic value Cost Data Patient access to medicine Demand The powerful clinical and economic value proposition positively impacted payer perception

18 Health economics and outcomes research (HEOR) 3

19 Health economics and outcome research Health economics - a discipline that analyses the economic aspect of health and healthcare and that usually focuses on costs (inputs) and consequences (outcomes) of healthcare interventions Outcomes research - the scientific discipline that evaluates the effect of healthcare interventions on patients related, if not patient-specific, clinical, humanistic and economic outcomes Various factors contribute to health economics such as; Clinical research Clinical epidemiology (incidence / prevalence / burden of illness) Health service research (claims database analyses) Policy service research (claims database analyses) Health economic evaluation (models / studies) Policy research (policy impact) Health economic evaluation (models / studies) Clinical outcome assessments (patient reported outcomes, health related quality of life, treatment satisfaction, preference etc.,)

20 Health economics and outcome research Healthcare expenditures are growing As the population ages there is more resource utilization Cost containment measures are being enforced worldwide Scientific evidence is needed for decision- makers to prioritise healthcare use and define Value: What do we get for what we are paying?

21 Health economics and outcome research One size does NOT fit all Different populations and different patient characteristics Different physician practice patterns and treatment management Different systems, cost and resources

22 Health and value is used to evaluate many factors Health and value can be used to evaluate the burden of illness and the epidemiology of the disease Three types of burden- Clinical, economic and patient Clinical Comorbidities Mortality Function Economic Burden of illness Resource utilisation Cost-effectiveness Absenteeism / presentism Humanistic Clinical outcomes Health related QoL Preference Caregiver burden

23 Health economic models A model is a simplified mathematical representation of the disease or healthcare delivery process used to enhance our understanding of systems and make predictions about their behaviour Models combine effectiveness data with local standards of practise, epidemiology and cost Clinical Comorbidities Mortality Function A well-constructed model can help decision makers assess the impact of a product in a variety of settings Models are often used to aid in internal and external decision making Economic Burden of illness Resource utilisation Cost-effectiveness Absenteeism / presentism Humanistic Clinical outcomes Health related QoL Preference Caregiver burden

24 Outcomes within HTA 4

25 Cost considerations When calculating the economic burden of illness aspect for the HTA models we need to gather information related to all the costs associated with the condition which would not otherwise be incurred if the disease did not exist Examples of costs considered are: Direct medical costs Those costs involving monetary exchange, such as- Physicians services, medications, hospital services and the medications themselves Indirect costs Reflect economic value of health state consequences such asdays off work, lost productivity etc., Intangible costs Value of decreased enjoyment of life because of illness

26 Patient outcome consideration The overarching aim of HTA models is to help provide patient access to good value medication. There are many ways this can be calculated. Patient reported outcomes (PROs) - is one of the main ways that we glean the value of a medicine. PROs are any report of the status of a patient s health condition that comes directly from the patient without interpretations of the patients response by a clinical or anyone else PROs are different from the safety and efficacy outcomes collected in a clinical trial PROs is an umbrella terms that includes a whole host of subjective outcomes such as -Symptoms (pain, fatigue nausea and vomiting etc.,) -Functioning (physical, emotional, social) -Health-related quality of life (HRQoL) -Utility measures -Treatment satisfaction / preference -Productivity

27 Clinical outcomes Clinical outcomes assessment Sources and examples Patient-reported outcomes Observer-reported outcomes Clinician-reported outcomes Performancereported outcomes Patient Caregiver, spouse, teacher Physician, nurse Tests with patient participation Symptoms e.g., pain Functioning HRQoL Utility measures Tx satisfaction Productivity Frequency of cough Activity level Self-care Global impression of change of severity Performance status ECOG MMSE FEV1 Visual acuity Gait speed Neurocognitive test

28 Patient burden Patient burden is the patient assessment and impact of the disease and can be measured directly by the patient as a patient recorded outcome (seen in the table on the next slide) or clinical outcome assessments Clinical outcome assessments may come from Physicians or HCPs Caregivers Observers

29 Patient burden Type of Measure Symptom measures Disease/ Condition Specific Measures Generic Measures Utility Measures Dimension- Specific Measures Definitions Examples Assesses patient symptoms (severity and frequency) - Patient Acromegaly Symptom Questionnaire (PASQ) - Sign and symptom Checklist for HIV (SSC-HIVrev) - MD Anderson Symptom Inventory (MDASI) Better able to detect changes with treatment - Quality of Life in Short Stature Youth (QoLISSY) - International Index of Erectile Function (IIEF) - Asthma Quality of Life Questionnaire - EORTC QLQ- C30 + cancerspecific module (e.g. EORTC QLQ- OV28) Assesses health status and general quality of life. Benchmarking relative to other diseases and normal populations - Short-form 36 (SF-36) - Health Assessment Questionnaire (HAQ) - Nottingham Health Profile (NHP) - Pediatric Quality of Life (PedsQoL) Provides utility values for economic analyses and benchmarking relative to other diseases and normal populations - EuroQoL 5 Dimensions (EQ-5D) - EuroQoL Visual Analog Scale (EQ- VAS) - Health Utilities Index 3 (HUI-3) Short form 6D (SF-6D) Assesses specific dimensions such as convenience, satisfaction, work Productivity: - Work Productivity Activity Impairment (WPAI), WPAI-IBS Treatment satisfaction: - Treatment Satisfaction Questionnaire for Medication (TSQM) - Cancer Treatment Satisfaction Questionnaire (CTSQ) - Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)

30 Calculating QALYs The quality adjusted life-year (QALYs) can also be used as a method of calculating the value of a medicine. Since health is function of life and quality of life, the QALY was developed as am attempt to combine the value of these attributes into a single number

31 Drug cost vs medical costs Below is an example of how if we only considered the actual cost of a drug and not the other factors the HTA takes into consideration, then we may not pursue with a treatment that could lower overall costs

32 Summary The true value of a medicine has to take many factures into consideration before in can be quantified The use of health technology assessments has because come practise in calculating whether a new medicine will provide adequate value to patients whilst being affordable for our health service These models will need to become more sophisticated as treatment evolves with time

33 Registration Sign up Thank you for completing this module. Please click here to sign up for updates and new modules.

34 Contact Us For general inquiries or information about Pfizer medicines, you can contact Pfizer on This learning module is intended for UK healthcare professionals only. Job bag: PP-GEP-GBR-1021 Date of preparation March 2018

35 Test your knowledge 8

36 Question 1 Global health and value only concerns the clinical need of the product True False 3 6

37 Question 2 Please select all the correct examples of stakeholders for a medicines health and value -Advocacy groups -Medical guidelines -Industry -Medical community -Health technology agencies -Government 3 7

38 Question 3 PROs is an umbrella terms that includes a whole host of subjective outcomes such as -Symptoms (pain, fatigue nausea and vomiting etc.,) -HCP details -Functioning (physical, emotional, social) -Health-related quality of life (HRQoL) -Utility measures -Treatment satisfaction / preference -Productivity -Date treatment commenced 3 8

39 Question 4 Please select all the examples of direct medical costs -Physicians services -Medications -Hospital services -Days off work -Lost productivity 3 9

40 Question 5 Patient reported outcomes concern tests taken with patients True False 40

41 Certification 8

42 Certificate of completion Name: Completed Health Technology Assessment part 1 and 2