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ForumsInternationalHas anyone dealt with eu ema compounding guidance? Page 2

Has anyone dealt with eu ema compounding guidance?

paul_denver Fri, Oct 25, 2024 at 9:06 AM 26 replies 1,812 viewsPage 2 of 6
VendorMark
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Oct 25, 2024 at 11:56 AM#6

Netherlands (my home country): Ozempic is covered under the basisverzekering (mandatory basic insurance) for T2D. You pay your eigen risico (deductible, currently €385/year) and then it's fully covered.

Wegovy: available since mid-2025, NOT covered by basic insurance. Some aanvullende verzekeringen (supplementary policies) from CZ and Zilveren Kruis have started covering it with prior authorization for BMI 40+ patients.

And to reiterate: compounded semaglutide does not exist as a legal option here. The IGJ (Inspectie Gezondheidszorg en Jeugd) would shut down any pharmacy attempting it within days.

50 2DebRD_ATL, KristenIndy, MarkLI_maint and 47 others
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TinaHashiRN
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Sep 2024
Raleigh, NC
Oct 25, 2024 at 12:13 PM#7

Italy: Interesting case. Ozempic is in Classe A of the AIFA formulary (fully reimbursed by SSN) for T2D. The nota AIFA 100 restricts it to patients who've failed metformin.

But here's the Italian twist: we have significant supply issues. AIFA has had Ozempic on its "carenze" (shortage) list intermittently throughout 2025-2026. When your farmacia doesn't have it, they can't just compound an alternative — you wait, or your doctor switches you to dulaglutide (Trulicity) which is more consistently available.

The Italian pharmacist underground joke: "Ozempic è come il tartufo — prezioso e introvabile." (Ozempic is like truffle — precious and impossible to find.)

47 14mike_mod, SarahChen_PharmD, sarah.morrison and 44 others
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pete_nash
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Aug 2024
Nashville, TN
Oct 25, 2024 at 12:30 PM#8

Great contributions everyone. The summary for EU-based forum members:

  1. Compounding is not a viable option in the EU. Don't try to replicate US approaches.
  2. Brand-name drugs are dramatically cheaper than in the US — even without insurance, you're looking at €175-320/month vs $1,000+ in America.
  3. T2D coverage is universal across essentially all EU member states.
  4. Obesity coverage varies widely — Nordics lead, France and most of Western Europe are pending, Southern/Eastern Europe lags behind.
  5. If you're importing peptides from non-EU sources (US, China), be aware that customs seizure is likely and penalties can include criminal charges in some jurisdictions.
26 6mike_mod, SarahChen_PharmD, sarah.morrison and 23 others
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