better data gathering on supply/demand what is needed? · 2019-02-19 · ec workshop: medical...

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

[email protected]

mailto:[email protected]


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


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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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)


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?


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?


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











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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)


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


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)

https://dosreg.ssm.se/Isotopstatistik/RegistreringPublik


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

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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


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);


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

better data gathering on supply/demand what is needed? · 2019-02-19 · ec workshop: medical...

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