leveringszekerheid-voor-medische-radionucliden-aanvullingen-2020

RIVM-briefrapport 2020-0153

9.2.4

Antwoorden NorthStar (Verenigde Staten) To our knowledge, the most commonly used reactor-produced medical radionuclides are: Yttrium-90 Molybdenum-99/Technetium-99m Iodine-125 Iodine-131 Iridium-192 Holmium-166 Lutetium-177 In the medical world, there is much attention for “upcoming” radionuclides, suitable for cancer therapy by alpha irradiation. To our understanding, the following three nuclides are the main ones under investigation now. Astatine-211 Radium-223 Actinium-225 Company Name Contact details (email)

NorthStar Medical Technologies, LLC jharvey@northstarnm.com

Question 1: In your opinion, is this list of “nuclides of interest” complete? If not: what nuclide(s) are you missing? . Question 2: Your company is currently irradiating medical radioisotopes. Could you please indicate which one, at this moment? Question 3: Could you please indicate whether you have plans to (1) enlarge your capacity for irradiating existing isotopes or (2) building capacity for new isotopes within the coming 5-10 years? In what year will these nuclides be available for the market, in significant amounts? Question 4: Could you

No, “upcoming” should have Cu-67. Cu-67 is neither an alpha emitter nor is it produced via a reactor. Similar to Lu-177 in therapeutic potential and use. It is accelerator produced. Mo-99 on market now Ac-225 & Cu-67 commercially available starting in 2023

Mo-99 is US only at this time; ROW within 5 years Ac-225 & Cu-67 will be available worldwide within 3 years Percentages are business sensitive

Mo-99 we except to show slight growth in US and Pagina 61 van 76

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Company Name please share with us, which nuclides and which percentage of your production goes to the European hospitals? Question 5: looking at the list of nuclides of interest, what trends do you see for the coming years? Will demand for these nuclides grow, decline, or remain stable? Question 6: When thinking about the sustainability of supply of medical radionuclides, what are the opportunities and threats you see for the coming 5 years? Question 7: Is there anything else on this subject you would like to share with us?

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NorthStar Medical Technologies, LLC Europe next 5-10 years. Asia/Pacific + India expected to show modest growth next 5-10 years fuelled mostly by China and possibly India.

Aging reactor infrastructure; challenging supply chain currently in place; use of fission uranium to produce medical isotopes will only get more difficult and more expensive – not sustainable currently and worse at full cost recovery; reimbursement of costs by insurers/governments. New technologies, not dependent on the aging reactor fleet around world and the uranium fission process, which are less costly per unit volume produced, are the future of medical radioisotope production.

RIVM-briefrapport 2020- 0153

9.2.5

Antwoorden SHINE (Verenigde Staten)

MEMORANDUM

TO:

Lars Roobol (RIVM)

FROM: Harrie Buurlage DATE: Friday August 14, 2020 SUBJECT:

SHINE reply to your questions (in blue)

Your RIVM Text in black: To our knowledge, the most commonly used reactor-produced medical radionuclides are: • • • • • • •

Yttrium-90 Molybdenum-99/Technetium-99m Iodine-125 Iodine-131 Iridium-192 Holmium-166 Lutetium-177

In the medical world, there is much attention for “upcoming” radionuclides, suitable for cancer therapy by alpha irradiation. To our understanding, the following three nuclides are the main ones under investigation now. • Astatine-211 • Radium-223 • Actinium-225

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Company Name

SHINE MEDICAL TECHNOLOGIES, LLC

Contact details (e-mail)

harrie.buurlage@shinemed.com

Question 1: In your opinion, is this list of “nuclides of interest” complete?

The nuclides of interest are nuclides that are being used, or are being projected to be used, in clinically relevant studies, clinical treatments, or both. The number of patients, the projected volume trends and the availability of nuclear or non-nuclear alternatives determine the level of interest and the economic value of the nuclides of interest. The projected economic value is a good way of categorizing these nuclides of interest.

If not: what nuclide(s) are you missing?

According to SHINE, the best way of categorizing these nuclides is: • • • •

High level of interest: Mo-99, Lu-177, Ac-225 Medium level of interest: I-131, Y-90, Ir-192, Xe-133 and possibly Ho- 166.

SHINE is monitoring the R&D in theranostics and TAT for other promising nuclides and this could result in adjustment of the above-mentioned categorization. Note 1: We believe that I-125 should be categorized as a nuclide with a low level of interest given the available non-nuclear alternatives. I-125 cannot be considered a standard of care given the very limited number of hospitals that decide to use I-125 for patients with early stage prostate cancer, for instance.

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Note 2: Most of the promising nuclides for TAT (including As-211 and Ac-225) are being produced by making use of accelerators instead of research reactors. Question 2: Your company is currently planning to build, or building, an irradiation facility. Could you please indicate (according to present plans) which of the above nuclides your facility will be able to irradiate in the coming 5-10 years, and when (in what year) these nuclides would be available for the market, in significant amounts?

SHINE plans to have its U.S. accelerator-driven, uraniumfission plant commercially operational in 2022. This facility will be able to produce at least one-third of the global demand for Mo-99. Mo-99 produced in this plant will be available for export to the EU from the start. This facility also will produce I-131 soon after. The facility also will produce other fission isotopes like Y-90 (as daughter of Sr-90) and Xe133, conditioned on a solid business case. In fact, SHINE’s technology can be used for all U-235 fission products and most of the trans-mutational neutron activation products. SHINE also is in the process of selecting a site in Europe for its European production facility. The site selection will be concluded this year. Construction of the EU plant is planned to start in 2023. This facility will be a copy of the USA facility and could be serving European patients as early as 2025. Both the USA and the EU facilities will be equipped with additional irradiation ports, allowing for the production of a broad range of neutron activation products including Lu-177, Ho-166 and, if needed, I-125. SHINE is also focusing on Ac-225 from a therapeutics perspective, but at this stage time-to-market is unclear.

Note on Lu-177: The production of Lu-177 does not only require a neutron source (like a reactor or the SHINE accelerator), it also needs enriched target material and a very complex radiochemistry process, post-irradiation. SHINE is active in all of these three

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critical steps in this supply chain and is likely to become the first and only vertically integrated Lu-177 supplier soon. First Lu-177 sales are expected early next year. Question 3: Do you foresee that a share of your irradiated material will be available for the European market?

SHINE’s USA facility will be exporting significant quantities of Mo-99 and (soon thereafter) other key nuclides to Europe as of the start of commercial operations in the USA. This will last until the SHINE EU plant takes over.

If yes: could you please share your expectation with us, i.e. which nuclides and which percentage of your production would be available for Europe?

SHINE has firm plans to install more than sufficient production capacity in Europe for European patients. Our planned EU infrastructure will be more than sufficient to supply all EU patients with Mo-99, I-131, and Lu-177. Y-90 and, if needed, Ho-166 and I-125 also will be produced in Europe, if a solid business case justifies it. Note 1: SHINE intends to utilize reactors initially for Lu-177 irradiations and to transition using our own accelerator system over time. Note 2: Most medical isotopes with a medium to low level of interest (like Ir-192) are eligible for centralized production. As an example, Ir-192 can be produced all over the world with enough time for transportation (decay time of Ir-192 is 74 days). Furthermore, the production of these isotopes benefits from the freed-up European and global reactor capacity caused by the introduction of SHINE Mo-99. Note 3: SHINE will not limit her product portfolio to utilization of its current innovative technology but will invest in other non-

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reactor key technologies like cyclotrons if a solid business case justifies such an investment. Question 4: looking at the list of nuclides of interest, what trends do you see for the coming years? Will demand for these nuclides grow, decline, or remain stable?

The growing development of theranostics will not only drive significant growth in Lu-177 and other potential therapeutics such as Ac-225, but also their companion diagnostic radionuclides. Mo-99 usage also will grow, mostly driven by increased Asia-Pacific (APAC) needs. While some TAT applications are promising, it is too early to make reliable growth assumptions.

Question 5: When thinking about the sustainability of supply of medical radionuclides, what are the opportunities and threats you see for the coming 5 years?

The opportunities are clearly the therapy applications (Lu177 and TAT) and the increased use of Mo-99. The main threat is the non-existence of a level playing field caused by the continuation of national governments financially supporting research reactor technology only. This continues despite clear direction from international organizations like the OECD stating that the supply of nuclear medicine can only become stable if national governments decide to withdraw their subsidies so that privately funded innovation can take over. The introduction and expansion of non-research reactorbased innovations like SHINE is hindered strongly because of this lack of a level playing field. The Dutch government should publicly state that they will withdraw its financial support for research reactors used for the production of nuclear medicine. As an alternative, national governments could decide to equalize public financial support over all promising initiatives fairly.

Question 6: Is there anything else on this subject you would like to share with us?

The production of medical isotopes asks for much more than just the availability of a neutron source. In fact, four critical steps must be taken care of and SHINE is managing all these steps internally with its two plants (USA and EU).

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1. Availability of enriched target material 2. Irradiation with a neutron source (like SHINE or PALLAS) 3. The radiochemical separation process postirradiation 4. The radiopharmaceutical process assuring the elimination of unwanted impurities and the assurance that the final product meets all other quality specifications The reliability of supply is dictated by all four steps and simply having a neutron source does not guarantee the supply of medical isotopes, especially when steps three or four, or both, are taken care of by other organizations than the neutron source providers. SHINE advises RIVM and the Dutch ministries to review the supply of medical isotopes holistically, meaning taking all four steps into their considerations.

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RIVM-briefrapport 2020- 0153

9.2.6

Antwoorden Pallas (Nederland) To our knowledge, the most commonly used reactor-produced medical radionuclides are: Yttrium-90 Iodine-125 Iodine-131 Iridium-192 Holmium-166 Lutetium-177 In the medical world, there is much attention for “upcoming” radionuclides, suitable for cancer therapy by alpha irradiation. To our understanding, the following three nuclides are the main ones under investigation now. Astatine-211 Radium-223 Actinium-225 Company Name Contact details (email) Question 1: In your opinion, is this list of “nuclides of interest” complete? If not: what nuclide(s) are you missing? .

PALLAS (Stichting Voorbereiding PALLASreactor) Titus Tielens, Director Strategy Most commonly used reactor isotopes is accurate, with a few comments: Molybdenum-99 must be added of course I believe the list is pretty accurate, except Ho166 is still early phase, and not yet used very much, with perhaps a few hundred treatments per year (There are some more traditional isotopes that are being phased out: Sr-89, Er-169, Sm-153, Pd-103, Au-198 – these are now of lesser interest, so good to exclude from the list.) As for upcoming isotopes, terbium-161 should definitely be added, a potential successor to Lu177, as it seems to have better medical properties and the terbium family includes also alpha and auger electron emitters – allowing for a single chemistry across a range of nuclides.

Question 2: Your company is currently irradiating medical radioisotopes. Could you please

Other upcoming radionuclides, currently of slightly lesser interest, include: Phosphor-32, see Oncosil Lead-212 (alpha), see Orano Med Rhenium-186 and 188 (e.g., the focus of the Meander hospital) Stannum-117m The PALLAS reactor is being designed to mass produce a wide range of isotopes. As long as there is demand for any of the isotopes on the list (or yet other ones), it is the intention that PALLAS will produce them. There are only a few Pagina 69 van 76

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Company Name indicate which one, at this moment? Question 3: Could you please indicate whether you have plans to (1) enlarge your capacity for irradiating existing isotopes or (2) building capacity for new isotopes within the coming 5-10 years? In what year will these nuclides be available for the market, in significant amounts?

Question 4: Could you please share with us, which nuclides and which percentage of your production goes to the European hospitals?

PALLAS (Stichting Voorbereiding PALLASreactor) exceptions based on technical limitations: At211, Ra-223, P-32. The PALLAS reactor will be able to supply a large percentage (20-40%) of global demand. It is expected that the majority of output will be supplied to radiopharmaceutical production sites in Europe, for the purpose of mass production of registered medicines (such as Lutathera), as well as to European University Medical Centres (UMCs, academische ziekenhuizen), for the purpose of clinical trials and small scale use (in manu medici, compassionate use, ‘magistrale bereiding’). It is difficult to foresee exactly what volumes and percentages will be available for Europe, but you may assume anywhere between 50 and 80%. PALLAS will be able to supply 5080% of European demand. These are ballpark numbers. Looking at current trends in the supply chain, a likely end state will be that each major pharma company will have 2 or 3 production sites globally, e.g., one in North America, one in Europe and one in Asia. Likewise, each region will have a few production hubs. It is expected that the PALLAS-reactor will sit at the heart of the main hub for Europe, perhaps together with the Belgian infrastructure (BR2, IRE, …).

We expect that Lu-177 will indeed prove to be the main workhorse for the coming 10-20 years for beta emitting medicines, while the other isotopes fulfil niche positions. Over time, Tb-161 could replace Lu-177 thanks to more convenient medical and chemical properties. Y-90 will likely remain popular, Ho-166 will probably be used more widely (with the acquisition of Quirem by Terumo), I-131 will probably grow in use (with 3 new medicines in the pipeline, e.g., by Actinium Pharmaceuticals and Cellectar) At the same time, Targeted Alpha Therapy is attracting a lot of research attention for its closerange tumour search-and-destroy power. But alpha based medicines are not as advanced yet, as they have significant challenges (e.g., on how to handle recoil and daughter decay effects), and production routes have not been settled. So it is well possible that alpha therapies will become popular say ten years from now. It is not clear what the winning alpha isotope will be. Currently

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Company Name

Question 5: looking at the list of nuclides of interest, what trends do you see for the coming years? Will demand for these nuclides grow, decline, or remain stable?

Question 6: When thinking about the sustainability of supply of medical radionuclides, what are the opportunities and threats you see for the coming 5 years? Question 7: Is there anything else on this subject you would like to share with us?

PALLAS (Stichting Voorbereiding PALLASreactor) most attention is paid to Ac-225, but Pb-212 or another one could be more attractive in the long run. Setting up robust supply chains for medical radionuclides will be key in order to support expected demand for the very promising new nuclear medicines that are now in the pipeline. As you can see from a recent PALLAS presentation at an IAEA conference, there are two or three critical elements that need to be in place: Sufficient irradiation capacity, both from reactors and cyclotrons. PALLAS will significantly improve the robustness of global production capacity, but other research reactors remain needed, also in Europe. Efficient post-irradiation processing supply chains – these are needed to increase capacity, and reduce the time between irradiation and administration to a patient. If the supply chain can be reduced by a few days, then capacity grows by tens of percentage points, while waste per unit is reduced. Supply of target material, particularly of ytterbium-176 for Lu-177. Feel free to come by to discuss any topic further.

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10

Bijlage B: Vragen aan stakeholders: ziekenhuizen

10.1

Vragen aan gebruikers (afdelingen nucleaire geneeskunde) Toelichting Het RIVM is gevraagd om de actuele situatie te beschrijven m.b.t. leveringszekerheid van medische radionucliden en de rol die de Pallasreactor hierin kan gaan spelen. In 2019 heeft het RIVM hierover een rapport gepubliceerd [3]. De conclusie van dit rapport is, dat wanneer de HFR in Petten sluit zonder dat de Pallasreactor wordt gerealiseerd, Nederland haar positie binnen de leveringsketen verliest. Zowel de werkgelegenheid als de nucleaire kennisinfrastructuur zullen hieronder te lijden hebben. Radionuclide

Gebruik (veel, weinig, niet)

Hoeveel besteld in 2019

Aantal patiënten behandeld in 2019

Tc-99m I-131 I-125 Lu-177 Y-90 Ho-166 Ra-223 …

Verwachte trend voor komende jaren (groei, onveranderd, krimp)

Vraag 1 In de bovenstaande tabel staat een opsomming van reactorgeproduceerde radionucliden. Zijn dit in uw centrum de meest gebruikte reactor-geproduceerde radionucliden? Als er veelgebruikte radionucliden in de tabel ontbreken, wilt u de tabel dan hiermee aanvullen? Kunt u voor deze radionucliden invullen: Hoe vaak hiervan gebruik wordt gemaakt (veel, weinig, niet) Hoeveel hiervan in 2019 besteld werd (bijv. doses of vials of Bq) Hoeveel patiënten hiermee in 2019 behandeld werden Wat uw verwachting is voor de komende jaren wat betreft gebruik (groei, krimp, onveranderd) Vraag 2 Heeft uw centrum in 2019 leveringsproblemen van reactorgeproduceerde radionucliden ondervonden? Zo ja, hoe vaak? En wat waren hiervan de 2 meest voorkomende oorzaken? Vraag 3 Welke kansen, risico’s of bedreigingen ziet u wat betreft leveringszekerheid voor de komende jaren? Pagina 72 van 76

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10.2

Resultaten enquête In totaal zijn er in Nederland 64 ziekenhuizen met een afdeling nucleaire geneeskunde [https://www.nvng.nl/praktijk/afdelingen-nucleairegeneeskunde]. Helaas ontbrak de tijd om via de beroepsvereniging alle afdelingen te peilen. In samenwerking met enkele medisch specialisten zijn 12 ziekenhuizen uitgekozen om te contacteren voor de enquête. Deze ziekenhuizen zijn gekozen op basis van het type verrichtingen dat zij doen (diagnostisch en therapeutisch), en het aantal verrichtingen per jaar. Het betrof alle acht UMC’s en vier perifere ziekenhuizen. Van zeven van de UMC’s en drie perifere ziekenhuizen is de ingevulde enquête terug ontvangen. In tabel 1 en 2 zijn de resultaten weergegeven. De respondenten (ziekenhuizen) zijn hier genummerd 1 tot en met 10. In tabel B.1 staan de opgegeven aantallen behandelde patiënten in 2019 met de meestgebruikte radionucliden. Zoals verwacht is het grootste aandeel onderzoek gedaan met technetium-99m. Twee ziekenhuizen verwachten een lichte groei hiervan en de overige acht een onveranderde of licht krimpend gebruik. Ook voor behandelingen met radioactief jodium wordt weinig groei verwacht, hoewel dit voor jodium125 een vertekend beeld kan zijn, aangezien deze radionuclide als radioactief implanteerbaar jodiumzaadje mogelijk ook via andere afdelingen dan de nucleaire geneeskunde gebruikt wordt.

Het gaat dan bijvoorbeeld om de chirurgie, radiologie of radiotherapie, waarvan nu geen gegevens zijn verzameld. De meeste groei wordt verwacht bij de lutetium-therapie. In tabel B.2 staan beknopt de antwoorden op vraag 2 en 3 van de enquête weergegeven. Hieruit blijkt dat negen van de tien responderende ziekenhuizen in 2019 leveringsproblemen van radionucliden hebben ondervonden, met name van technetium, enkele zelfs meerdere keren in het jaar. Men meldt ook dat hierdoor patiëntprogramma’s moesten worden aangepast. Meermaals genoemde oorzaken zijn een tekort aan beschikbaar molybdeen-99 in Petten en te weinig back-up van andere reactoren. Bijna alle respondenten noemen de sluiting van de HFR zonder structureel alternatief een risico voor de leveringszekerheid en daarmee voor de patiëntenzorg. Ze ervaren op dit moment vaak al enkele malen per jaar leveringsproblemen en zien juist een toename van de vraag naar radionucliden.

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Tabel B.1 Aantallen patiënten in 2019 en verwachting voor de toekomst voor de meestgebruikte reactor-geproduceerde radionucliden. De responderende ziekenhuizen zijn genummerd 1 tot en met 10

1 Technetium-99m Aantal patiënten 1417 in 2019 Verwachting voor Onver de toekomst anderd Jodium-131 Aantal patiënten 95 in 2019 Verwachting voor Onver de toekomst anderd Jodium-125

2

3

4

5

6

7

8

9

10

Totaal aantal patiënten

3072

2995

2471

3000

2272

2190

5200

2500

>5000

>30117

Onveranderd

Lichte krimp

Lichte groei

Onver Onver anderd anderd

Krimp

Onver anderd

3-5%/jaar groei

Geringe afname

178

195

89

108

56

103

20

112

Onveranderd

Lichte krimp

NR

Groei

0 Onbekend, Aantal patiënten loopt via in 2019 chirurgie Verwachting voor Onver de toekomst anderd Lutetium-177 Aantal patiënten 0 451 in 2019 Verwachting voor Sterke Groei de toekomst groei Yttrium-90 Aantal patiënten 7 29 in 2019 Pagina 74 van 76

200

Onver Onver anderd anderd

1156

Onver Stabiel / geringe Onver-anderd anderd afname 900 radiologie, 365 120 radiotherapie Onver3-5%/jaar anderd groei

0

35

70

0

171

0

Onveranderd

Toename

Onveranderd

NR

Groei

6

120

5

0

0

0

45

4

Groei

Toename

Toename

Groei

Groei

Groei

Forse groei

Sterke toename

10

23

20

38

0

7

20

1

1661

NR 631

155

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1

Verwachting voor de toekomst Holmium-166 Aantal patiënten in 2019

3

Onveranderd

Groei

Onveranderd

0

6

0

Groei

Onveranderd

55

23

OnverVerwachting voor anderd de toekomst Radium-223 Aantal patiënten 6 in 2019

Verwachting voor de toekomst Overig

2

Onveranderd

Onveranderd

Onveranderd

I-123: 231 Niet In-111: 8 Aantal patiënten gerapSm-153: in 2019 2 porVerwachting voor teerd Lichte Groei de toekomst krimp

4

5

6

Onveranderd Toena Onvertot me anderd lichte groei 35

0

2

Toena Onver- Onverme anderd anderd 37

60

18

Onveranderd Onver- Onvertot anderd anderd lichte krimp

7

8

9

10

Onveranderd

Onveranderd

Langzame groei

Stabiel

0

0

0

0

Onveranderd 4 Onveranderd

Lichte groei Onverna introductie anderd 2020 11

OnverOnveranderd anderd

I-123: Niet Niet Niet I-123: 63 238 gerapgerap- gerapporporporteerd teerd teerd ToeGroei name

Pagina 75 van 76

10

Ir-192: 200 Onveranderd

Totaal aantal patiënten

43

NR

16

240

Stabiel

Niet gerapporteerd

742

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Tabel B.2 Leveringsproblemen van radionucliden. De responderende ziekenhuizen zijn genummerd 1 tot en met 10, gelijk aan tabel 1.

Leverings Zo ja, welke problemen in 2019 1 Ja Viermaal werden Mo-99/Tc99m generatoren geleverd met te lage activiteit; hierdoor moesten patiëntprogramma's worden aangepast 2 Ja Niet gespecificeerd

3 Ja

4 Ja

5 Nee

Oorzaken

* Bij verminderde leveringscapaciteit bestaat de kans dat patiëntenonderzoek in gevaar komt * Gelet op de verwachting dat de behoefte aan radionucliden voor therapeutische doeleinden zal toenemen, biedt het kansen wanneer dergelijke radionucliden beschikbaar blijven Tweemaal scram * Gezien de leeftijd van de HFR en ook andere medische reactoren (met afgelopen (noodstop) in de jaren al bijbehorende defecten), voorzie ik grote bedreigingen voor de reactor bij Luleveringszekerheid, als geen actie wordt ondernomen 177 * Een nieuwe reactor voor (o.a.) productie van medische isotopen, zou Nederland een leidinggevende rol geven in de productie van en onderzoek naar medische isotopen in de wereld * Sr-89 sinds begin 2019 Niet * Sluiting van de reactor in Petten zal grote nadelige consequenties hebben voor de helemaal niet meer leverbaar gerapporteerd beschikbaarheid van medische isotopen * In maart, mei, juni en sep* Een nieuwe reactor in Petten biedt veel mogelijkheden voor onderzoek naar nieuwe tember geen of minder Tc-99m behandelmogelijkheden, én stelt de beschikbaarheid van Mo-99 veilig Niet gespecificeerd Door onderhoud * Zonder Petten of een vervangende reactor is de leveringszekerheid (en daarmee de aan de reactor diagnostiek en behandeling van duizenden (veelal) kankerpatiënten), direct in het (meer frequent geding vanwege leeftijd * Kansen zijn de grote toename van het

aantal op lutetium-177 gebaseerde van de HFR), behandelingen, en de bedrijvigheid die daarmee samenhangt! voorzien of onvoorzien Niet van toepassing Niet van * Wij voorzien een sterke toename van radionuclidentherapieën, wat vaak een laatste toepassing behandelingsmogelijkheid is voor patiënten * Leveringszekerheid van medische radionucliden is een vereiste voor de Nederlandse zorg

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Tekort aan beschikbaarheid van Mo-99 in Petten

Risico's en kansen voor de toekomst

RIVM De zorg voor morgen begint vandaag