In brief
- Ten new entries in the price catalogue. Entries no. 7254-7263 are inserted after entry no. 7253 in Annex no. 1 to Order of the Minister of Health no. 5.994/2024, the list in which the state fixes the maximum legal price of every medicinal product for human use.
- Eight of the entries are one and the same cancer treatment. IMDYLLTRA (tarlatamab), used in extensive-stage small cell lung cancer, takes up entries 7254-7261, in two strengths. A 10 mg box has a retail price, VAT included, of 107,049.12 lei, and a 1 mg box one of 10,874.73 lei.
- Nine of the ten entries are imports under special needs authorisations. They are brought in by CN Unifarm S.A. under authorisations no. 1.284/2026 to no. 1.292/2026, for fixed quantities adding up to 112 boxes. At the retail price, those 112 boxes are worth 11,476,506.10 lei.
- The prices apply from 12 October 2026. The table declares them valid until 30 September 2027 for eight entries, 1 October 2027 for one and 31 March 2027 for the last, yet a second order published on the same day caps the validity of catalogue prices at 30 June 2027.
Published: Official Gazette of Romania, Part I, no. 855 of 12 October 2026, pages 12-13
In force from: 12 October 2026, the date of publication, since Article II does not set a later date and Article 12(3) of Law no. 24/2000 on legislative drafting rules ties the entry into force of ministerial orders to the date of publication in the Official Gazette of Romania (Monitorul Oficial)
The national medicines price catalogue has grown by ten entries, and the most expensive of them costs 111,976.12 lei a box. Order of the interim minister of health no. 1.733/2026, published in the Official Gazette of Romania, Part I, no. 855 of 12 October 2026, inserts entries no. 7254-7263 after entry no. 7253 in Annex no. 1 to Order no. 5.994/2024. That annex is the catalogue in which the Ministry of Health sets, for every presentation of a medicinal product, three ceiling prices: the manufacturer price, the maximum wholesale price excluding VAT and the maximum retail price, VAT included. No marketing authorisation holder, no wholesale distributor and no supplier in a contractual relationship with the ministry, with the health insurance houses or with the public health directorates may go above the figures in this table.
The ten entries cover three medicinal products. The first, and the one that takes up eight of the ten rows, is IMDYLLTRA, with the active substance tarlatamab, listed in the catalogue under the international nonproprietary name TARLATAMABUM and ATC group L01FX33. It treats extensive-stage small cell lung cancer in adults whose disease has progressed during or after first-line platinum-based chemotherapy, and in the European Union it holds orphan medicine status, meaning that it is intended for a rare disease. The catalogue prices two strengths, 1 mg and 10 mg, both powder for concentrate and solution for solution for infusion. The 1 mg box, code W71922001, has a manufacturer price of 9,540.00 lei, a maximum wholesale price excluding VAT of 9,665.40 lei and a maximum retail price including VAT of 10,874.73 lei. The 10 mg box, code W71921001, has a manufacturer price of 94,476.37 lei, a wholesale price of 95,451.14 lei and a retail price of 107,049.12 lei. The ratio between the two quantities that were priced, 6 boxes of 1 mg against 93 boxes of 10 mg, shows that the small form covers the opening doses and the large one the rest of the treatment.
The second medicinal product is OGSIVEO, with nirogacestat, listed as NIROGACESTATUM, ATC group L01XX81, at entry no. 7262. It treats progressing desmoid tumours in adults who need systemic therapy, that is, a medicine that travels through the whole body rather than a local procedure. Desmoid tumours are rare, aggressively growing formations that start in the soft supporting tissues, and this medicine too holds orphan status in the European Union. The box, code W72069001, contains 4 blisters of 14 film-coated tablets each, that is 56 tablets of 150 mg, and carries the highest price in the whole order: 98,827.65 lei at the manufacturer, 99,845.93 lei wholesale and 111,976.12 lei retail. Per tablet, the retail price works out at 1,999.57 lei.
The third, at entry no. 7263, is VYVGART, with efgartigimod alfa, listed as EFGARTIGIMODUM ALFA, ATC group L04AA58, the only entry flagged in the catalogue with the status „orfan”, orphan. It is given in generalised myasthenia gravis, an autoimmune disease in which the command travelling from nerve to muscle is blocked and the patient tires muscularly to the point of being unable to lift an eyelid or breathe normally, in adults with anti-acetylcholine receptor antibodies, alongside standard therapy. The presentation that gets a price is the pre-filled syringe with 5 ml of 200 mg/ml solution for injection, that is 1,000 mg, code W71198001, at 59,906.57 lei at the manufacturer, 60,535.63 lei wholesale and 67,905.35 lei retail.
The difference of regime between the entries matters as much as the prices. Nine of the ten entries, all eight for IMDYLLTRA plus OGSIVEO, carry in the remarks column a special needs authorisation and a precise quantity. A special needs authorisation is the instrument through which a medicine without a marketing authorisation in Romania can still be brought in and used here, for an identified need and for a given quantity. The numbers run consecutively, from 1.284/2026 to 1.292/2026, and the quantities range from a single box to 27 boxes. The importer, in all nine cases, is CN Unifarm S.A., the state-owned company through which medicines missing from the Romanian market are brought in. The only entry without a special needs authorisation and without a quantity is 7263, VYVGART, for which the holder listed in the catalogue is Argenx BV, of Belgium.
What it changes in practice
From 12 October 2026, the three price columns are enforceable ceilings, not negotiating marks. The manufacturer price is the one above which the authorisation holder or its representative cannot sell on to distribution. The maximum wholesale price excluding VAT is the one above which the wholesale distributor cannot invoice further. The maximum retail price including VAT is the one above which the medicine cannot be dispensed to the patient. Each of them is read off the exact catalogue entry, not off the brand name: IMDYLLTRA has two different prices, by strength, and eight entries that repeat them.
The margin these ceilings leave can be read straight off the figures. On the 10 mg box of IMDYLLTRA, 974.77 lei are left for the distributor between the manufacturer price of 94,476.37 lei and the wholesale price of 95,451.14 lei. Between the wholesale price and the retail price excluding VAT, 989.51 lei are left for the pharmacy. The rest up to 107,049.12 lei, that is 10,608.47 lei, is the 11% value added tax collected by the state. On the 1 mg box, the same links take 125.40 lei and 131.65 lei, and VAT takes 1,077.68 lei. In other words, on a box costing more than 100,000 lei, the distributor and the pharmacy share around 1,960 lei, while the state collects more than five times as much.
For the nine entries brought in under special needs, the price does not come on its own: it comes tied to a quantity. The authorisations cover 1, 12, 27, 27, 27, 1, 2, 2 and 13 boxes, 112 boxes in all. At the retail price, that volume is worth 11,476,506.10 lei. The largest single entry, any one of the three authorisations for 27 boxes of 10 mg IMDYLLTRA, is worth 2,890,326.24 lei on its own. Once the authorised quantity runs out, the price stays in the catalogue but has nothing left to cover: a new patient needs a new authorisation and, very probably, a new catalogue entry, hence another order published in the Official Gazette of Romania.
One effect that does not occur deserves saying just as plainly: the order reimburses nothing. Entering the price catalogue is the condition for a medicine to be invoiced lawfully within the public system, not the decision to pay for it from public money. Payment is settled separately, through the lists of reimbursed medicines and through the national health programmes, which this order leaves untouched. A patient who reads that tarlatamab has a price in Romania learns that the medicine may circulate here at a capped price, not that he will receive it free of charge.
What has changed compared with the previous situation
Until 12 October 2026, Annex no. 1 to Order no. 5.994/2024 ended at entry no. 7253, and the three medicinal products had no maximum price in Romania for the presentations covered by this order. Without a catalogue price, a medicine brought in under a special needs authorisation has no figure at which to be invoiced in the contractual relationship with the ministry, with the insurance houses or with the public health directorates. The supplement clears exactly this administrative blockage, for 112 boxes and for one pre-filled syringe.
The time horizon has changed too, and here matters are not simple. The validity column of the table gives three different deadlines: the prices of entries 7254-7261 are declared valid until 30 September 2027, that of entry 7262 until 1 October 2027, and that of entry 7263 until 31 March 2027. On the same day, in the Official Gazette of Romania, Part I, no. 853 of 12 October 2026, the same ministry published Order no. 1.742/2026, which rewrites Article 32 of Order of the Minister of Health no. 368/2017: the maximum prices approved in the catalogue remain valid until the entry into force of the order approving the prices resulting from the annual correction, „but no later than 30 June 2027”. For eight of the new entries, the deadline in the table runs three months longer than the ceiling set in the same day of the Gazette.
The calculation mechanism is unchanged. The order does not amend the Norms in Order no. 368/2017 that it invokes in the preamble and it does not change the structure of the catalogue either: every entry keeps the same fields, from code and brand name through to ATC group and remarks. What has been added are rows, not rules.
Advantages and disadvantages
What it improves
- Three treatments for serious and rare diseases have, from 12 October 2026, a public price ceiling in Romania, checkable by anyone, entry by entry and presentation by presentation.
- The regulated commercial margin is tight and easy to read: 974.77 lei for the distributor and 989.51 lei for the pharmacy on a box costing 94,476.37 lei, that is around 1% at each link.
- Medicines brought in under a special needs authorisation receive a price, so imports through CN Unifarm S.A. can be invoiced within the public system without case-by-case negotiation.
- The information published is complete on every row: code, brand name, strength, pharmaceutical form, pack, international nonproprietary name, ATC group, holder, country, authorisation number and quantity.
- The catalogue covers both strengths of tarlatamab, 1 mg and 10 mg, hence the opening doses as well, not only the large continuation doses.
What remains a problem
- A price does not bring reimbursement. Anyone reading only this order may believe the treatment becomes affordable, when in fact the source of funding is decided in other acts.
- The validity deadline in the table, 30 September 2027 for eight entries and 1 October 2027 for one, runs past the 30 June 2027 ceiling set on the same day by Order no. 1.742/2026. A reader of the catalogue has no way of learning this from the table.
- The fixed quantities tie the price to an authorisation. One more patient means a new authorisation, a new entry and another published order, with all the administrative time this route demands.
- Eight entries for a single product, with only two distinct prices between them, inflate the catalogue with identical rows. Entries 7255-7258 share the same code, the same pack and the same figures, and differ only by authorisation number and quantity.
- Entry 7263 appears without the „N” status marker that the other nine carry, even though the annex introduces all of them as new entries.
- The order says nothing about who pays the 11.47 million lei that the authorised quantities come to at retail price.
Practical advice
- Look up the entry, not the name. IMDYLLTRA has eight entries and two prices, by strength. Code W71922001 marks the 1 mg form, at 10,874.73 lei retail, and W71921001 the 10 mg form, at 107,049.12 lei.
- When checking a distribution invoice, compare it with the maximum wholesale price excluding VAT, not with the retail price. On the 10 mg box that is 95,451.14 lei against 107,049.12 lei, a gap of almost 11,600 lei that comes almost entirely from VAT.
- Treat the quantity in the special needs authorisation as a ceiling, not as an estimate. On entries 7254-7262, the price comes with an exact number of boxes, from 1 to 27.
- If access to treatment is what you care about, do not stop at this order. Ask the treating doctor or the insurance house under which mechanism the medicine is funded, because entering the price catalogue is not a payment decision.
- Note 30 June 2027 as the real date on which catalogue prices are reset, not the dates in the validity column, and 31 March 2027 for entry 7263, where the deadline of its own is shorter.
- If you work with OGSIVEO, calculate per tablet rather than per box: 111,976.12 lei for 56 tablets means 1,999.57 lei apiece, and the 13 authorised boxes come to 728 tablets.
Frequently asked questions
What do the three catalogue prices mean?
Can I buy IMDYLLTRA from a pharmacy at 107,049.12 lei?
Does a catalogue price mean the medicine is reimbursed?
How long are the new prices valid?
What is a special needs authorisation?
Why are there eight entries for the same medicine?
When does the order enter into force?
Editorial analysis
Nowhere does the order explain how the figures in the table were arrived at, but the figures can be reconstructed. Add 1% plus 30 lei to the manufacturer price and you get the maximum wholesale price; add 1% plus 35 lei to that and apply 11% VAT and you get the retail price. This rule reproduces all ten retail prices to the last ban, and eight of the ten wholesale prices. At entries 7255-7258, the published wholesale price of 95,451.14 lei is one ban higher than the calculated one, and at entry 7263 the 60,535.63 lei are one ban lower. Both deviations carry correctly into the next column, so there is no contradiction between the published figures, only a rounding that goes up once and down once. What matters for the reader is something else: on a box costing 94,476.37 lei, the ceiling leaves the distributor 974.77 lei and the pharmacy 989.51 lei, roughly 1% each, because the fixed sums of 30 and 35 lei all but vanish against such a base. The mark-up scale was designed for medicines costing a few tens of lei, not for boxes costing more than 100,000, and at this level it works as an almost proportional and very tight ceiling.
Applied to the whole authorised volume, the arithmetic says something about who collects what. The 112 boxes for which the order gives both a price and a quantity are worth 10,128,301.86 lei at the manufacturer price and 11,476,506.10 lei at the retail price. Of the 1,348,204.24 lei difference, the combined commercial mark-up of distribution and pharmacies is 210,892.96 lei, and value added tax is 1,137,311.28 lei. From tax alone the state collects 5.39 times more than all the commercial links that carry the medicine from manufacturer to patient earn together. On a chain where the total margin amounts to 2.08% of the manufacturer price, the public debate about pharmacy mark-ups on expensive medicines starts, at these figures, from a false premise.
The second observation comes out of putting together two orders published on the same day by the same ministry. Order no. 1.733/2026 declares the prices of the eight IMDYLLTRA entries valid until 30 September 2027 and that of OGSIVEO until 1 October 2027. Order no. 1.742/2026, in the Official Gazette of Romania, Part I, no. 853 of 12 October 2026, rewrites Article 32 of Order no. 368/2017 and states that maximum catalogue prices remain valid until 30 June 2027 at the latest. The two documents were signed a day apart, on 8 and 9 October 2026, by the same state secretary, for the interim minister. A distributor who draws up a supply plan by reading the validity column will count on three months more than the general rule allows, and a patient who understands the price to be guaranteed until the autumn of 2027 will find it reset in the summer of that year. It is not a contradiction inside the order, and that is why we do not treat it as a drafting error, but it is a mismatch produced by one and the same day of the Gazette.
The third observation concerns what the catalogue looks like after the supplement. Ten new entries cover three medicinal products and four distinct prices. Eight rows describe the same tarlatamab, with the same two codes, and the only thing setting them apart is the special needs authorisation number and the quantity. The authorisation numbers run consecutively, from 1.284 to 1.292, which points to a single wave of decisions taken practically at the same moment, for a small number of patients: three authorisations for 27 boxes of 10 mg IMDYLLTRA, each worth 2,890,326.24 lei at the retail price, one for 12 boxes and four small ones, for 1 or 2 boxes, on the 1 mg strength. For OGSIVEO, the 13 authorised boxes come to 728 tablets, which at two tablets a day is almost a year of treatment for one person, at 1,455,689.56 lei. On these rows the price catalogue thus becomes an indirect record of a few individual cases as well, something its structure was never designed to do.
What should be changed
- The validity column should refer explicitly to the ceiling in Article 32 of Order no. 368/2017, or take over the shorter date outright. The practical effect: whoever reads the catalogue learns the real deadline without comparing two orders from two different issues of the Official Gazette of Romania.
- Entries describing the same product, with the same code and the same price, should be merged into a single row, with the authorisations and quantities in a separate column. The result: the catalogue would carry four rows instead of ten for the same information, and a search by code would no longer return duplicates.
- The status field should be filled in uniformly. Entry 7263 appears without the „N” marker that the other nine carry, even though the annex introduces all of them as new entries. In practice: automated processing of the catalogue would stop treating a new row as a pre-existing one.
- Approval Report no. 1.733R of 8 October 2026, invoked in the preamble, should be published together with the order, with the calculation basis of every price. The practical effect: the mark-up of 974.77 lei or of 1,018.28 lei would no longer have to be deduced from the figures by the reader, as it had to be here.
- The order should indicate, in a note, the mechanism through which medicines brought in under a special needs authorisation are funded. The result: a patient who finds the price in the catalogue would stop mistaking the existence of a ceiling for a right to free treatment.
- The annex should also be published as an open data file, at the same time as the Official Gazette of Romania version. The practical effect: pharmacies, distributors and insurance houses could update all 7,263 entries automatically, instead of transcribing rows by hand from a two-page table.
Original text of the legal act
The text below is reproduced in Romanian, the official form of publication.
The full text, as published in the Official Gazette of Romania
Official Gazette of Romania no. 855 of 12 October 2026, pages 12-13 16 pages PDF, 455 KB the act starts on page 12
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This article is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed attorney or tax advisor.