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- 1. Feb 2020 High Council for Health Insurance, I.R.Iran Revision of Health Insurance Benefits Package 2nd Round for Consultation to review and advice for selection of health interventions and procedures to be included in the benefit package for the UHC in the I.R. of Iran Dr. Mojtaba Nouhi
- 2. The first round of the consultation مشاورین حضورزمینه در المللی بین خدمات بندی اولویتدانشگاه از سالمت هلند نایمخن(۱۸تا۲۴می ماه۲۰۱۹)
- 3. Actions (from May 2019 up to Jan 2020) Develop a value assessment framework Develop a collection of conditional coverages Design process for the appeal Design a process to harmonize HTA agencies to support evidence-informed decision making make a plan to involve patient representatives in decision making process Develop a plan for adapting general framework (scoping, assessment, and appraisal) of health technologies coverage Approved the actions by the High Council for Health Insurance (HCHI) Planning initial steps to start revision of services package of six diseases (breast cancer, hypertension management, diabetes(type2), M.S, schizophrenia treatment, COPD) using MCDA/EDP methodology
- 4. Zero draft version of theVAF * The first mission report. Page 24.
- 5. * DevelopValue Assessment Framework (VAF) 1. Identify social values related to revision HIBP 2. Identify criteria that represent the social values 3.Weight the criteria 4. Hierarchical structure of value framework * Pilot theVAF Layout
- 6. *Rashidian A, Arab M, Vaez Mahdavi M, Ashtarian K, Mostafavi H. Which social values are considered in Iranian health system? Arch Iran Med. 2018;21(5):199–207.
- 7. ValueVS criterion * Shams L, Akbari Sari A, Yazdani S. Values in health policy – a concept analysis. Int J Health Policy Manag. 2016;5(11):623–630. doi:10.15171/ijhpm.2016.102 * Nouhi M. It is time to develop a values hierarchy in the health system. Arch Iran Med. 2019;22(5):277.
- 8. Cost-effectiveness Clinical effectiveness Relative effectiveness Number of population Cost per patient Severity of health condition Budget impact analysis uncertainty Magnitude of effectiveness Quality of evidence Rarity of disease fairness Type of targeted population Practice variation Need assessment Local production Availability of comparators Type of disease Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity solidarity Human dignity Financial sustainability availability Patient satisfaction Price availability of guidelines Ease of use Quality of life Generic or brand Burden of disease (step 1)
- 9. Cost-effectiveness Clinical effectiveness Relative effectiveness Number of population Cost per patient Severity of health condition Budget impact analysis uncertainty Magnitude of effectiveness Quality of evidence Rarity of disease fairness Type of targeted population Practice variation Need assessment Local production Availability of comparators Type of disease Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity solidarity Human dignity Financial sustainability availability Patient satisfaction Price availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Viyanchi et al (2015) (step 1)
- 10. Cost-effectiveness Clinical effectiveness Relative effectiveness Number of population Cost per patient Severity of health condition Budget impact analysis uncertainty Magnitude of effectiveness Quality of evidence Rarity of disease fairness Type of targeted population Practice variation Need assessment Local production Availability of comparators Type of disease Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity solidarity Human dignity Financial sustainability availability Patient satisfaction Price availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Mohamadi et al (2016) (step 1)
- 11. Cost-effectiveness Clinical effectiveness Relative effectiveness Number of population Cost per patient Severity of health condition Budget impact analysis uncertainty Magnitude of effectiveness Quality of evidence Rarity of disease fairness Type of targeted population Practice variation Need assessment Local production Availability of comparators Type of disease Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity solidarity Human dignity Financial sustainability availability Patient satisfaction Price availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Rajabzadeh et al (2016) (step 1)
- 12. Cost-effectiveness Clinical effectiveness Relative effectiveness Number of population Cost per patient Severity of health condition Budget impact analysis uncertainty Magnitude of effectiveness Quality of evidence Rarity of disease fairness Type of targeted population Practice variation Need assessment Local production Availability of comparators Type of disease Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity solidarity Human dignity Financial sustainability availability Patient satisfaction Price availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Dehnavieh et al (2010) (step 1)
- 13. Cost-effectiveness Clinical effectiveness Relative effectiveness Number of population Cost per patient Severity of health condition Budget impact analysis uncertainty Magnitude of effectiveness Quality of evidence Rarity of disease fairness Type of targeted population Practice variation Need assessment Local production Availability of comparators Type of disease Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity solidarity Human dignity Financial sustainability availability Patient satisfaction Price availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Secretariat of the HCHI (2009) (step 1)
- 14. Cost-effectiveness Clinical effectiveness Relative effectiveness Number of population Cost per patient Severity of health condition Budget impact analysis uncertainty Magnitude of effectiveness Quality of evidence Rarity of disease fairness Type of targeted population Practice variation Need assessment Local production Availability of comparators Type of disease Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity solidarity Human dignity Financial sustainability availability Patient satisfaction Price availability of guidelines Ease of use Quality of life Generic or brand Burden of disease (step 1)
- 15. Cost-effectiveness Clinical effectiveness Relative effectiveness Cost per patient Severity of health condition Budget impact analysis Quality of evidence Type of targeted population Local production Availability of comparators Patient safety Type of health condition Level of evidence Decision process Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity Patient satisfaction availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Price (step 1)
- 16. Cost-effectiveness Clinical effectiveness Relative effectiveness Cost per patient Severity of health condition Budget impact analysis Quality of evidence Type of targeted population Availability of comparators Patient safety Type of health condition Level of evidence Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity Patient satisfaction availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Price Local production Decision process (step 1)
- 17. Cost-effectiveness Clinical effectiveness Relative effectiveness Cost per patient Severity of health condition Budget impact analysis Quality of evidence Type of targeted population Availability of comparators Patient safety Type of health condition Level of evidence Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity Patient satisfaction availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Price Local production Decision process (step 1)
- 18. Cost-effectiveness Clinical effectiveness Relative effectiveness Cost per patient Severity of health condition Budget impact analysis Quality of evidence Type of targeted population Availability of comparators Patient safety Type of health condition Level of evidence Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity Patient satisfaction availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Price Local production Decision process (step 1)
- 19. Cost-effectiveness Clinical effectiveness Relative effectiveness Cost per patient Severity of health condition Budget impact analysis Quality of evidence Type of targeted population Availability of comparable Patient safety Type of health condition Level of evidence Decision in other countries Time of utilization Unbiased evidence Catastrophic cost efficiency equity Patient satisfaction availability of guidelines Ease of use Quality of life Generic or brand Burden of disease Price Local production Decision process SustainabilityNecessityQuality of care کارایی Cost-effectiveness Budget impact Local production Price/tariffs Decision in other countries Generic and brand Decision process Availability of comparators Out-of pocket Burden of disease Type of population Number f population type of health condition Severity of disease عدالت Clinical effectiveness Patient safety Quality of evidence Ease of use Time od utilization Availability of guidelines Quality of life (step 1)
- 20. کارایی Cost-effectiveness Budget impact Local production Price/tariffs Decision in other countries Generic and brand Decision process Availability of comparators Out-of pocket Burden of disease Type of population Number f population type of health condition Severity of disease عدالت Clinical effectiveness Patient safety Quality of evidence Ease of use Time od utilization Availability of guidelines Quality of life SustainabilityNecessityQuality of care (step 1)
- 21. step 2: identifying criteria Value First Criteria Final Criteria Necessity Size of the targeted population Size of the targeted population Probability of death or major disability Probability of death or major disability Patient out-of-pocket payment Patient out-of-pocket payment Prioritized diseases Prioritized diseases Availability of comparators Availability of comparators Type of target population Type of target population Type of requested service Total score Quality of care Effectiveness Relative effectiveness Safety Relative safety Quality of evidence Quality of evidence Patient satisfaction Availability of practice guidelines Cost-effectiveness Patient satisfaction Local production Cost-effectiveness Total score sustainability Cost-effectiveness Size of the targeted population Budget impact Budget impact Cost/tariffs per each service Cost per patient Local production Local production Cost-effectiveness Total score Each participant separately determined appropriateness of criteria to defining the values. They were allowed to add/remove criteria in/from of the retrieved list. In cases of disagreement between participants, at the first they explained the reasons in favor of their claims. If the disagreement was not resolved, the discussion continued to reach consensus.
- 22. step 3: weighting criteria Category Criterion Weight Necessity Size of the target population 15 Probability of death or major disability 17 Patient out-of-pocket payment 16 Prioritized diseases 16 Availability of comparators 23 Type of the target population 13 Total score of necessity 100 Quality of service Relative effectiveness 18 Relative safety 13 Quality of evidence 16 Availability of practice guidelines 15 Patient satisfaction 9 Local production 10 Cost-effectiveness 19 Total score of quality of care 100 Sustainability Size of the target population 13 Budget impact 35 Cost per patient 16 Local production 12 Cost-effectiveness 24 Total score sustainability 100 The weight of each value was taken to be 100 scores, and each participant was asked to share the 100 scores among related criteria. The average of scores for each criteria was regarded as the final weight.
- 23. SustainabilityNecessityQuality of care step 4: hierarchical structure
- 24. Ignoring financial sustainability Legal obligation to balance budget Ignoring quality of care may exacerbate technical & allocative efficiency SustainabilityNecessityQuality of care step 4: hierarchical structure
- 25. Diverging from UHC goals May hurt financial protection Legal obligation to balance budget SustainabilityNecessityQuality of care step 4: hierarchical structure
- 26. Delay important health need of patients Considerable social and political pressure on the government Limit responsibility of the health insurance organizations sustainabilityNecessityQuality fo care step 4: hierarchical structure
- 27. Quality of care Sustainability Necessity (step 4)step 4: hierarchical structure
- 28. 100 90 80 70 60 50 40 30 20 10 0 Quality of care Sustainability Necessity 100 90 80 70 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 step 4: hierarchical structure
- 29. 100 90 80 70 60 50 40 30 20 10 0 Quality of care Sustainability Necessity 100 90 80 70 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 The service must score a minimum 50% of the insurance coverage capacity score and, on average, a minimum 50% of the insurance coverage necessity and quality of service score step 4: hierarchical structure
- 30. Test virtual scenarios Metformin Value Criterion Scores Very low Low Medium High Very high 0 10 20 30 40 50 60 70 80 90 100 Necessity Size of the targeted population Probability of death or major disability Patient out-of-pocket payment Prioritized diseases Availability of comparators Type of target population Total score Quality of care Relative effectiveness Relative safety Quality of evidence Availability of practice guidelines Patient satisfaction Local production Cost-effectiveness Total score Sustainability Size of the target population Financial burden Cost per patient Local production Cost-effectiveness Total score
- 31. Value Criterion Scores Very low Low Medium High Very high 0 10 20 30 40 50 60 70 80 90 100 Necessity Size of the targeted population Probability of death or major disability Patient out-of-pocket payment Prioritized diseases Availability of comparators Type of target population Total score Quality of care Relative effectiveness Relative safety Quality of evidence Availability of practice guidelines Patient satisfaction Local production Cost-effectiveness Total score Sustainability Size of the target population Financial burden Cost per patient Local production Cost-effectiveness Total score
- 32. Name of service Category of service Disease/health condition Scores obtained Deicision Necessity Sustainability Quality Metformin Drug Diabetes type 2 80 67 70 Accepted Atorvastatin Drug Chronic heart disease 62 66 93 Accepted Laronidase Drug MPS1* 53 25 19 Rejected – proposed to cover by governmental support Open heart surgery Surgery Acute heart disease 91 71 83 Accepted PET scan Imaging Breast cancer 80 67 70 Accepted Rhinoplasty Surgery Cosmetic procedure 17 30 25 Rejected Test virtual scenarios
- 33. ThankYou
- 34. Feb 2020 High Council for Health Insurance-WHO office country, I.R.Iran Revision of the Health Insurance Benefits Package 2nd Round for Consultation to review and advice for selection of health interventions and procedures to be included in the benefit package for the UHC in the I.R. of Iran Development of conditional coverages policies
- 35. Actions (from May 2019 up to Jan 2020) Develop a value assessment framework Develop a collection of conditional coverages Design process for the appeal Design a process to harmonize HTA agencies to support evidence-informed decision making make a plan to involve patient representatives in decision making process Develop a plan for adapting general framework (scoping, assessment, and appraisal) of health technologies coverage Articles 8 to 15 Tables 2 to 8
- 36. ValueAssessment Framework 50 50 100 100 Mean of Q&N scores Sustainability scores Q= Quality of care N= Necessity
- 37. ValueAssessment Framework 50 50 100 100 Mean of Q&N scores Sustainability scores
- 38. ValueAssessment Framework 50 50 100 100 Mean of Q&N scores Sustainability scores
- 39. ValueAssessment Framework 50 50 100 100 Mean of Q&N scores Sustainability scores .. . . .... . . .. .. .. . .. . .
- 40. ValueAssessment Framework 50 50 100 100 Mean of Q&N scores Sustainability scores . . . . . . . . . . . . The services outside of the green area 8-1) the service has an appropriate alternative in the package, with limited relative effectiveness. 8-2) the service has an appropriate alternative in the package, but is not cost-effective. 8-3) the service has an appropriate alternative in the package, but does not have appropriate safety. 8-4) the service has an appropriate alternative in the package, with a very small patient out-of-pocket payment. 8-5) the service has no alternative in the package, has limited relative effectiveness, and is not cost-effective
- 41. ValueAssessment Framework 50 50 100 100 Mean of Q&N scores Sustainability scores . . . . . . . . . . . The services outside of the green area RISK (more budge impact OR inefficiency) . 8-1) the service has an appropriate alternative in the package, with limited relative effectiveness. 8-2) the service has an appropriate alternative in the package, but is not cost-effective. 8-3) the service has an appropriate alternative in the package, but does not have appropriate safety. 8-4) the service has an appropriate alternative in the package, with a very small patient out-of-pocket payment. 8-5) the service has no alternative in the package, has limited relative effectiveness, and is not cost-effective
- 42. ValueAssessment Framework 50 50 100 100 Mean of Q&N scores Sustainability scores . . .. . . The services inside of the green area Inclusion of some services with: • Small clinical effectiveness • Unfavorable cost-effectiveness • Considerable cost per patients • Considerable budget impact RISK (more budge impact OR inefficiency)
- 43. Conditional coverage policies (purchasing policies) Yes No Conditional coverage
- 44. Conditional coverages taxonomy Walker S, Sculpher M, Claxton K, Palmer S. Coverage with evidence development, only in research, risk sharing, or patient access scheme? A framework for coverage decisions. Value in Health. 2012 May 1;15(3):570-9.
- 45. Conditional coverages taxonomy Carlson JJ, Sullivan SD, Garrison LP, Neumann PJ, Veenstra DL. Linking payment to health outcomes: a taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health policy. 2010 Aug 1;96(3):179-90.
- 46. Conditional coverages taxonomy Morel et al.: Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries. Orphanet Journal of Rare Diseases 2013 8:198.
- 47. Conditional coverages taxonomy Garrison Jr LP, Towse A, Briggs A, de Pouvourville G, Grueger J, Mohr PE, Severens JH, Siviero P, Sleeper M. Performance-based risk-sharing arrangements—good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force. Value in Health. 2013 Jul 1;16(5):703-19.
- 48. Conditional coverages taxonomy Two challenges • The first: focus heavily on new technologies (specifically new medicine) • The second:There is not clear which policies would be appropriate for which services
- 49. Iran conditional coverages taxonomy Conditional coverages Outcome-based policies Financial-based policies Coverage with Evidence Development Performance-Based Agreements Price-Volume Agreements Internal Reference Pricing Patient Access Determination Collective Purchasing (Tendering ) The first challenge
- 50. Iran conditional coverages taxonomy Conditional coverages Outcome-based policies Financial-based policies Coverage with Evidence Development Performance-Based Agreements Price-Volume Agreements Internal Reference Pricing Patient Access Determination Collective Purchasing (Tendering ) The first challenge Coverage decision is conditioned upon the collection of additional population-level evidence.
- 51. Iran conditional coverages taxonomy Conditional coverages Outcome-based policies Financial-based policies Coverage with Evidence Development Performance-Based Agreements Price-Volume Agreements Internal Reference Pricing Patient Access Determination Collective Purchasing (Tendering ) The first challenge payment is directed towards those patients that satisfy eligibility criteria for a treatment.
- 52. Iran conditional coverages taxonomy Conditional coverages Outcome-based policies Financial-based policies Coverage with Evidence Development Performance-Based Agreements Price-Volume Agreements Internal Reference Pricing Patient Access Determination Collective Purchasing (Tendering ) The first challenge The unit price of a service is linked to the expected volume sold, so that it declines when volume increases.
- 53. Iran conditional coverages taxonomy Conditional coverages Outcome-based policies Financial-based policies Coverage with Evidence Development Performance-Based Agreements Price-Volume Agreements Internal Reference Pricing Patient Access Determination Collective Purchasing (Tendering ) The first challenge Establishes a benchmark or reference price within a country which is the maximum level of reimbursement for a group of services.
- 54. Iran conditional coverages taxonomy Conditional coverages Outcome-based policies Financial-based policies Coverage with Evidence Development Performance-Based Agreements Price-Volume Agreements Internal Reference Pricing Patient Access Determination Collective Purchasing (Tendering ) The first challenge Determine level of access to health centers (e.g. special hospital or general hospital or clinics) and prescribers (e.g. physician or specialist)
- 55. Iran conditional coverages taxonomy Conditional coverages Outcome-based policies Financial-based policies Coverage with Evidence Development Performance-Based Agreements Price-Volume Agreements Internal Reference Pricing Patient Access Determination Collective Purchasing (Tendering ) The first challenge announcing to buying an specific basket of services in healthcare market
- 56. Iran conditional coverages taxonomy The second challenge Qualitative MCDA
- 57. Iran conditional coverages taxonomy s Criteria Layers budget impact unclear amount of budget impact small budget impact considerable budget impact relative effectiveness considerable impact on the quality of life or lifetime of the patient. small magnitude of impact on the quality of life or lifetime of the patient. unclear relative effectiveness risk of ethical hazard The risk of induced demand, fee splitting, smuggling, and other ethical hazards is high. The risk of induced demand, fee splitting, smuggling, and other ethical hazards is small. There is not risk of induced demand, fee splitting, smuggling, and other ethical hazards. size of the targeted population The target population is small. The target population is considerably large. The size of the target population is unclear frequency of use Frequency of utilization of the service/drug is considerable. Frequency of utilization of the service/drug is limited. Frequency of utilization of the service/drug is unclear. geographic distribution of the patients The patients are distributed across the country. The population of patients has considerable density in some regions. The geographical distribution of patients is not known. cost per patient The cost per patient is considerable. The cost per patient is acceptable. The cost per patient is small. safety complication The risk of safety complications for the patient is considerable. The risk of safety complications for the patient is small. No safety complications will occur for the patient. need to patient follow-up There is a need for gathering of medical records of patients There is no need for gathering medical records of patients availability of evidence The evidence is sufficient (the level and quality of evidence is acceptable). The evidence is limited (the level and quality of evidence is insufficient). off-label use There is a high risk of of-label use. There is a small risk of off-label use. mathing evidence with real world The evidence matches the reality of service provision. The evidence does not match the reality of service provision. total number of providers/producers The number of providers/suppliers is considerable. The number of providers/suppliers is limited. alternative services Alternative service is available. Alternative service is not available.
- 58. Iran conditional coverages taxonomy Price-Volume Agreements Criteria Layers budget impact unclear amount of budget impact small budget impact considerable budget impact relative effectiveness considerable impact on the quality of life or lifetime of the patient. small magnitude of impact on the quality of life or lifetime of the patient. unclear relative effectiveness risk of ethical hazard The risk of induced demand, fee splitting, smuggling, and other ethical hazards is high. The risk of induced demand, fee splitting, smuggling, and other ethical hazards is small. There is not risk of induced demand, fee splitting, smuggling, and other ethical hazards. size of the targeted population The target population is small. The target population is considerably large. The size of the target population is unclear frequency of use Frequency of utilization of the service/drug is considerable. Frequency of utilization of the service/drug is limited. Frequency of utilization of the service/drug is unclear. geographic distribution of the patients The patients are distributed across the country. The population of patients has considerable density in some regions. The geographical distribution of patients is not known. cost per patient The cost per patient is considerable. The cost per patient is acceptable. The cost per patient is small. safety complication The risk of safety complications for the patient is considerable. The risk of safety complications for the patient is small. No safety complications will occur for the patient. need to patient follow-up There is a need for gathering of medical records of patients There is no need for gathering medical records of patients availability of evidence The evidence is sufficient (the level and quality of evidence is acceptable). The evidence is limited (the level and quality of evidence is insufficient). off-label use There is a high risk of of-label use. There is a small risk of off-label use. matching evidence with real world The evidence matches the reality of service provision. The evidence does not match the reality of service provision. total number of providers/producers The number of providers/suppliers is considerable. The number of providers/suppliers is limited. alternative services Alternative service is available. Alternative service is not available.
- 59. Iran conditional coverages taxonomy Performance-based Agreements Criteria Layers budget impact unclear amount of budget impact small budget impact considerable budget impact relative effectiveness considerable impact on the quality of life or lifetime of the patient. small magnitude of impact on the quality of life or lifetime of the patient. unclear relative effectiveness risk of ethical hazard The risk of induced demand, fee splitting, smuggling, and other ethical hazards is high. The risk of induced demand, fee splitting, smuggling, and other ethical hazards is small. There is not risk of induced demand, fee splitting, smuggling, and other ethical hazards. size of the targeted population The target population is small. The target population is considerably large. The size of the target population is unclear frequency of use Frequency of utilization of the service/drug is considerable. Frequency of utilization of the service/drug is limited. Frequency of utilization of the service/drug is unclear. geographic distribution of the patients The patients are distributed across the country. The population of patients has considerable density in some regions. The geographical distribution of patients is not known. cost per patient The cost per patient is considerable. The cost per patient is acceptable. The cost per patient is small. safety complication The risk of safety complications for the patient is considerable. The risk of safety complications for the patient is small. No safety complications will occur for the patient. need to patient follow-up There is a need for gathering of medical records of patients There is no need for gathering medical records of patients availability of evidence The evidence is sufficient (the level and quality of evidence is acceptable). The evidence is limited (the level and quality of evidence is insufficient). off-label use There is a high risk of of-label use. There is a small risk of off-label use. matching evidence with real world The evidence matches the reality of service provision. The evidence does not match the reality of service provision. total number of providers/producers The number of providers/suppliers is considerable. The number of providers/suppliers is limited. alternative services Alternative service is available. Alternative service is not available.
- 60. Iran conditional coverages taxonomy Internal Reference Pricing Criteria Layers budget impact unclear amount of budget impact small budget impact considerable budget impact relative effectiveness considerable impact on the quality of life or lifetime of the patient. small magnitude of impact on the quality of life or lifetime of the patient. unclear relative effectiveness risk of ethical hazard The risk of induced demand, fee splitting, smuggling, and other ethical hazards is high. The risk of induced demand, fee splitting, smuggling, and other ethical hazards is small. There is not risk of induced demand, fee splitting, smuggling, and other ethical hazards. size of the targeted population The target population is small. The target population is considerably large. The size of the target population is unclear frequency of use Frequency of utilization of the service/drug is considerable. Frequency of utilization of the service/drug is limited. Frequency of utilization of the service/drug is unclear. geographic distribution of the patients The patients are distributed across the country. The population of patients has considerable density in some regions. The geographical distribution of patients is not known. cost per patient The cost per patient is considerable. The cost per patient is acceptable. The cost per patient is small. safety complication The risk of safety complications for the patient is considerable. The risk of safety complications for the patient is small. No safety complications will occur for the patient. need to patient follow-up There is a need for gathering of medical records of patients There is no need for gathering medical records of patients availability of evidence The evidence is sufficient (the level and quality of evidence is acceptable). The evidence is limited (the level and quality of evidence is insufficient). off-label use There is a high risk of of-label use. There is a small risk of off-label use. matching evidence with real world The evidence matches the reality of service provision. The evidence does not match the reality of service provision. total number of providers/producers The number of providers/suppliers is considerable. The number of providers/suppliers is limited. alternative services Alternative service is available. Alternative service is not available.
- 61. Iran conditional coverages taxonomy Patient Access Determination Criteria Layers budget impact unclear amount of budget impact small budget impact considerable budget impact relative effectiveness considerable impact on the quality of life or lifetime of the patient. smaal magitude of impact on the quality of life or lifetime of the patient. unclear relative effectiveness risk of ethical hazard The risk of induced demand, fee splitting, smuggling, and other ethical hazards is high. The risk of induced demand, fee splitting, smuggling, and other ethical hazards is small. There is not risk of induced demand, fee splitting, smuggling, and other ethical hazards. size of the targeted population The target population is small. The target population is considerably large. The size of the target population is unclear frequency of use Frequency of utilization of the service/drug is considerable. Frequency of utilization of the service/drug is limited. Frequency of utilization of the service/drug is unclear. geographic distribution of the patients The patients are distributed across the country. The population of patients has considerable density in some regions. The geographical distribution of patients is not known. cost per patient The cost per patient is considerable. The cost per patient is acceptable. The cost per patient is small. safety complication The risk of safety complications for the patient is considerable. The risk of safety complications for the patient is small. No safety complications will occur for the patient. need to patient follow-up There is a need for gathering of medical records of patients There is no need for gathering medical records of patients availability of evidence The evidence is sufficient (the level and quality of evidence is acceptable). The evidence is limited (the level and quality of evidence is insufficient). off-label use There is a high risk of of-label use. There is a small risk of off-label use. matching evidence with real world The evidence matches the reality of service provision. The evidence does not match the reality of service provision. total number of providers/producers The number of providers/suppliers is considerable. The number of providers/suppliers is limited. alternative services Alternative service is available. Alternative service is not available.
- 62. Iran conditional coverages taxonomy Coverage with Evidence Development Criteria Layers budget impact unclear amount of budget impact small budget impact considerable budget impact relative effectiveness considerable impact on the quality of life or lifetime of the patient. smaal magitude of impact on the quality of life or lifetime of the patient. unclear relative effectiveness risk of ethical hazard The risk of induced demand, fee splitting, smuggling, and other ethical hazards is high. The risk of induced demand, fee splitting, smuggling, and other ethical hazards is small. There is not risk of induced demand, fee splitting, smuggling, and other ethical hazards. size of the targeted population The target population is small. The target population is considerably large. The size of the target population is unclear frequency of use Frequency of utilization of the service/drug is considerable. Frequency of utilization of the service/drug is limited. Frequency of utilization of the service/drug is unclear. geographic distribution of the patients The patients are distributed across the country. The population of patients has considerable density in some regions. The geographical distribution of patients is not known. cost per patient The cost per patient is considerable. The cost per patient is acceptable. The cost per patient is small. safety complication The risk of safety complications for the patient is considerable. The risk of safety complications for the patient is small. No safety complications will occur for the patient. need to patient follow-up There is a need for gathering of medical records of patients There is no need for gathering medical records of patients availability of evidence The evidence is sufficient (the level and quality of evidence is acceptable). The evidence is limited (the level and quality of evidence is insufficient). off-label use There is a high risk of of-label use. There is a small risk of off-label use. matching evidence with real world The evidence matches the reality of service provision. The evidence does not match the reality of service provision. total number of providers/producers The number of providers/suppliers is considerable. The number of providers/suppliers is limited. alternative services Alternative service is available. Alternative service is not available.
- 63. 50 50 100 100 Mean of Q&N scores Sustainability scores . . ..... .. .. . . Excluded by cost reduction scenarios (article 8) .. .. .. . . Using right conditional coverage policies to improve efficiency in line with containing budget impact for services outside of the green area
- 64. ThankYou