better data gathering on supply/demand what is needed? · 2019-02-19 · ec workshop: medical...
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EC workshop: Medical Radioisotopes in the Future, 7th February 2019
EC workshop - Medical Radioisotopes in the Future
7th February 2019
Better data gathering on supply/demand
What is needed?
Nicolas MARIO
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
NucAdvisor has an experience in research reactors, radionuclides supply chain and nuclear medicine applications
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SAMIRA Study
European Study on Medical, Industrial and Research
Applications of Nuclear and Radiation Technology
Final report – July 2018
SMER study
Study on Sustainable and Resilient Supply of Medical
Radioisotopes in the EU
Final report under review
Owner Engineer Services for new build research reactors projects
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
1. Challenges & limitations when assessing medical radioisotopes supply
a. Supply chain specificities and limitations
b. Supply capacity: current knowledge level
c. What can be improved?
2. Challenges & limitations when assessing medical radioisotopes demand
a. Medical radioisotopes demand specificities
b. How to precisely assess the demand?
c. Good practices supporting a better understanding of the demand
Better data gathering on supply/demand, what is needed?
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EC workshop: Medical Radioisotopes in the Future, 7th February 2019
1. Challenges & limitations when assessing medical radioisotopes supply
a. Supply chain specificities and limitations
b. Supply capacity: current knowledge level
c. What can be improved?
2. Challenges & limitations when assessing medical radioisotopes demand
a. Medical radioisotopes demand specificities
b. How to precisely assess the demand?
c. Good practices supporting a better understanding of the demand
Better data gathering on supply/demand, what is needed?
4
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Radionuclides supply chain specificities make it difficult to precisely assess supply capacity
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Each radionuclide has a single or different specific supply chain, relying on different types of equipments with different timeframes;
Supply capacity must be considered as a whole, as radionuclides production are impacting each other.
In the case of research reactors, they must be considered as multi-purpose facilities
Supply capacity must be assessed at each step of the supply chain to identify the “weakest link” among complex processes.
Each player has its own limiting factors;
- Irradiation positions;- Neutron flux;- Availability;- Irradiation duration
- Production lines capacity;- Availability;
- Production batch per week;- Production lines capacity
per production batch; MARIA irradiation services (1995-2016)
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Data regarding supply capacity are limited to Mo-99 but their representativeness can be questioned…
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- Literature on supply capacity is extremely limited;
- Mo-99 is the most used medical radionuclides; Supply chain studies are focused on Mo-99, almost no assessment can be found for others radionuclides, demand being more limited with few players. Security of supply considerations are the results of past issues (Mo-99 crisis);
- Overcapacity needed to cope with unexpected shutdown of supply chain players;
- For other radionuclides, industry has specific and confidential agreements with limited numbers of suppliers;
- Only reliable source of information for Mo-99 production capacity is OECD-NEA / AIPES, whereas supply capacity is self-defined by research reactors/MPF owners and based on “theoretical maximum production capacity”;
- Worldwide supply capacity assessments are based on:
- theoretical maximum irradiation capacity per week;
- availability of the reactor;
Is such approach representative of the reality?
Are improvements needed and possible?
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Unexpected events in the supply chain may hinder reliable previsions
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Supply models foresee no shortage
During 1st quarter 2018, no production was achieved by NTP, Versailles model (based on maximum weekly
production capacity) planned no shortage.
Industry experienced continuous shortages
OECD/NEA could identify long shortage period for various generator manufacturer over first quarter 2018 through
direct surveys.
During 1st quarter 2018, 10% of the supply chain was affected by Mo-99 shortages
Challenge: how to better define supply capacity ? Should it be defined on the lowest production available on a specific week? Shall it be extended to all radionuclides?
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
How to better assess the radioisotope supply chain capacity?
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Supply capacity models must be multi-radioisotopes based
Supply capacity models should take into account economic factors
Supply capacity models should consider the minimal weekly production capacity achievable(security of supply)
- Production tools are mutualized (research reactors, cyclotrons…) and contractually linked (back-up agreements);
- Near future developments in therapeutics could impact the supply chain (produce more RI with same production capacity)
- Radioisotopes producers compete for most lucrative radioisotopes business with their production capacity;
- Radioisotopes supply chain players favour most economical production paths (preferred installations for production);
- Supply capacity evaluation should not be limited to maximal production achievable. Security of supply considerations should lead to systematically integrate minimal production achievable.
It leads to complex supply chain
models
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
1. Challenges & limitations when assessing medical radioisotopes supply
a. Supply chain specificities and limitations
b. Supply capacity: current knowledge level
c. What can be improved?
2. Challenges & limitations when assessing medical radioisotopes demand
a. Medical radioisotopes demand specificities
b. How to precisely assess the demand?
c. Good practices supporting a better understanding of the demand
Better data gathering on supply/demand, what is needed?
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EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Medical radionuclides demand is difficult to assess
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Demand can be assessed at different steps of the supply chain using different physical quantities and units;
Target manufacturer
Irradiator (reactor,
cyclotron)
ProcessorGenerator
manufacturer
Radio-pharmacy
Hospital
Patient
Demand is closely connected to supply
• Origin of supply and supply chain structure impact demand (e.g. US demand increase after NRU production switch to EU/RoW);
• Supply shortages impacts demand of others radioisotopes (e.g. some SPECT procedures being replaced by PET in case of Tc-99m shortage);
Demand Supply
User reserve and decay represent a non negligible share of the demand.
Elution 1
Elution 2
Elution 3
Elution 4
Elution 5Elution 6
0
20
40
60
80
100
120
140
0 50 100 150
Act
ivit
y (c
i)
Time (hours)
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Almost no assessment of the activity needed per RI can be found in the literature at the exception of Mo-99(OECD/NEA estimate of overall market: 9400 6d Ci EOP in 2018)
Literature information on demand is inhomogeneous and makes it difficult to perform extensive demand assessment
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Data acquisition sources Advantages Drawbacks
Reimbursement data from social security systems and private health insurance(number of NM procedures)
Data exist for almost each country and statistics are already automatically collected
Large uncertainties (precision depends of codification systems and not all the procedures are correctly numbered)
Data coming from national nuclear medicine societies (number of NM procedures)
Data are reliable as compiled by professional of the health sector
Voluntary approach, only exist in some countries
Data from national safety authorities (number of NM procedures and activity injected)
Exhaustive and controlled data, with details per RI
Data coming from dedicated surveys(NM procedures, activities, costs…)
Data gathered on topics where literature does not exist (e.g. SMER study on Tc-99m efficiency of use)
Low coverage rate, representativeness and need for periodic update. Time-consuming approach
Correlations based on other physical quantities (nb of generator, nb of gamma camera…)
Allow rough estimate where data is not available
Large uncertainties (country specificities, reliability of the data used…)
EC workshop: Medical Radioisotopes in the Future, 7th February 2019 12
Source(s): SFMN / CCAM
Large variations can be found among the different set of data: French example
Through surveys, the SFMN (Société Française de MedecineNucléaire) assesses the volume of NM procedures in France every year. Coverage rate of 90%, statistics for SPECT and PET use, per anatomical region.
1 465 229 Nuclear Medicine imaging procedures in 2016
Also in France, Social Security (CCAM) assesses the volume of NM procedures, through reimbursement and health statistics. Theoretical coverage rate of 100%, statistics for SPECT and PET use, per analytical code
1 146 856 Nuclear Medicine imaging procedures in 2016
Code CCAM IntituléNb Actes total en
France 2013
Nb Actes total en
France 2014
Nb Actes total en
France 2015
Nb Actes total en
France 2016
PAQL003Scintigraphie osseuse du corps entier en un temps [temps tardif]
125 030 121 497 129 883 125434
PAQL002Scintigraphie osseuse du corps entier en plusieurs temps
135 350 149 925 163 523 166940
PAQL005
Scintigraphie osseuse du corps entier segment par segment en plusieurs temps, sans acquisition complémentaire par un collimateur sténopé
17 471 14 641 13 580 12612
20% difference between two reliable sources
[…] 78 categories in total
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Extensive database is used in Sweden.Could such approach be generalized over EU-28?
Some good practices in data gathering allow in-depth understanding of RI demand
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Extract of “Isotopstatistik för nukleärmedicinsk verksamhet”https://dosreg.ssm.se/Isotopstatistik/RegistreringPublik
Hospital name Year Procedure type Radioisotope RI deliverance
methodProcedures Activity
(average)
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Large uncertainties can be found when comparing final user demand (activity injected to patient) to demand along the supply chain (e.g. activity received by RI processors)
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Post-Irradiation
Transport
Processing
Transport
Generator Manufacturing
TransportRadiopharmacist
0
20
40
60
80
100
120
140
160
Irradiation Post-Irradiation Transport Processing Transport GeneratorManufacturing
Transport Radiopharmacist Activity Eluted Activity Injected
Mo-99 Tc-99mcumulative
Act
ivit
y (B
q)
bas
e100
Act
ivit
y d
eliv
ered
in
6d
ay C
i E
OP
Activity injected over activity eluted/received by the radiopharmacy?
Type of product delivered to
radiopharmacy ?
Supply chain players, locations and duration
of each step (decay)
Example of Mo-99 supply chain, with generators
Source(s): SAMIRA Final Report
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
How to better assess the medical radioisotopes demand?
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Homogeneity of data among Member States
Automated process for data collection
Improved knowledge of supply chain
- Assessing demand over EU-28 is currently almost impossible in the absence of homogeneous data: absence of statistics for some MS, overall NM procedures for others, details per RI for a limited number…
- To ensure the efficiency of a data collection, process should be fully automatized to avoid using alternative ways such as surveys, data retreatment…
- Having detailed data of final use (activity injected to patients) is not sufficient to assess demand at every step of the supply chain.
- Manufacturing practices, products delivered to radiopharmacies must be known to assess demand at irradiation level.
- Direct surveys of radiopharmacies practices (SMER study);
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
Lack of reliable data hinders important decision-making
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Generally speaking, there is a lack of reliable databases regarding NM globally and in Europe, and even more regarding the radionuclides used in the imaging procedures.
This poor level of databases in Europe has specific causes :
• Radiopharmaceuticals (RP), often generic, have long been considered as a minor aspect of the imaging procedure and do not appear as a drug in almost all European database
• The small amount of RI expenses involved in the patient management has not triggered a warning signal in the global healthcare budget management, except for some RI (FDG for PET);
• The diagnostic status versus the therapeutic status limits the visibility in the healthcare process and insurance data;
• Global reimbursement of NM procedures without individualization of RP drug masks the cost of RP drugs
• Reactor isotope irradiation has been considered, for a long time, as a side activity by reactor operators in Europe
• Radiopharmaceuticals are difficult to define in terms of radioactivity and monodose definition.
As a consequence, there was no real incentive for building reliable databases.
Situation may change in the future with:• the development of NM imaging and therapy;• the necessity of renewing the production
means with “full cost recovery” for all players along the supply chain;
• Security of supply;
EC workshop: Medical Radioisotopes in the Future, 7th February 2019
EC workshop - Medical Radioisotopes in the Future
7th February 2019