In brief

  • The Ministry of Health and the National Health Insurance House (CNAS) have updated, through Joint Order no. 824/1,313/2026, the therapeutic protocols that set the prescribing conditions for dozens of reimbursed medicines.
  • The changes cover treatments in oncology, haematology, rare diseases, diabetes, psychiatry, pulmonology, gastroenterology, hepatology and dermatology, including therapies for breast cancer, multiple myeloma, leukaemias, amyloidosis, Crohn’s disease, hepatitis B, severe psoriasis and COPD.
  • The technical annex, over 300 pages long, containing the full text of every revised protocol, was published separately, in Official Gazette of Romania (Monitorul Oficial) no. 586 bis of the same day.

Who is affected: patients currently being treated for the conditions mentioned, the doctors who prescribe these therapies (specialists and, for continuation, family doctors), and the health insurance houses that approve reimbursement.

Entry into force: 17 July 2026, the date of publication in the Official Gazette of Romania.

What’s new in the order

The Ministry of Health and the National Health Insurance House (CNAS) amended, through Joint Order no. 824/1,313/2026, annexes no. 1 and 2 to Order MS/CNAS no. 564/499/2021, the act that approves the therapeutic protocols for prescribing reimbursed medicines within the social health insurance system. In practice, these protocols are the “official recipe” that every doctor must follow when prescribing a medicine from a national list, either at state expense or with a reduced personal contribution: for each disease and each active substance, they set out who can start the treatment, what criteria must be met, what doses are used, and how the patient is monitored.

The order was signed on 10 July 2026 by Stela Firu, State Secretary, by delegation from the acting Minister of Health, and on 14 July 2026 by Horațiu-Remus Moldovan, President of CNAS, then published in the Official Gazette of Romania, Part I, no. 586 of 17 July 2026. The actual amendment, i.e. Articles I and II of the order, takes up less than a page. The real content, the more than 25 fully revised therapeutic protocols, was published separately, as an annex, in Official Gazette of Romania no. 586 bis of the same day, a technical volume of over 300 pages.

For these two substances CNAS later introduced specific eligibility forms for nivolumab and pembrolizumab, alongside another 13 revised forms.

What it changes in practice

The practical effect is that, for each of the substances involved, the old protocol (indications, inclusion criteria, doses, monitoring, criteria for discontinuing treatment, prescribing doctors) is entirely replaced by a new one. The order doesn’t add new medicines to the reimbursed list and doesn’t change prices; it updates the clinical rules under which treatments already in the system are prescribed, generally to align them with the latest medical evidence, international recommendations, or the expanded indications approved by the European Medicines Agency.

Based on an analysis of the technical annex, the revised protocols cover a wide range of conditions:

  • Oncology and haematology: protocols for brentuximab vedotin (Hodgkin lymphoma), nivolumab, pembrolizumab (immunotherapies used in several cancer types), blinatumomab (acute lymphoblastic leukaemia), daratumumab (multiple myeloma), abemaciclib (breast cancer), apalutamide (prostate cancer), gilteritinib (acute myeloid leukaemia), acalabrutinib (chronic lymphocytic leukaemia), selpercatinib (RET-mutant cancers) and aflibercept.
  • Rare and genetic diseases: tafamidis (transthyretin cardiac and neurological amyloidosis), vosoritide (achondroplasia, a form of dwarfism), vutrisiran (hereditary transthyretin amyloidosis), bulevirtide (chronic hepatitis D), avacopan (ANCA-associated vasculitis) and asciminib (chronic myeloid leukaemia resistant or intolerant to other therapies).
  • Diabetes and metabolic diseases: alpha-lipoic acid (sensory disorders in diabetic polyneuropathy), benfotiamine (neuropathy) and dapagliflozin (diabetes mellitus, heart failure and chronic kidney disease).
  • Pulmonology: fixed inhaled combinations for asthma and COPD (beclometasone/formoterol/glycopyrronium and formoterol/glycopyrronium/budesonide), plus a dedicated protocol for dupilumab in eosinophilic COPD, alongside the general protocol for dupilumab.
  • Psychiatry: aripiprazole (schizophrenia, bipolar affective disorder) and vortioxetine (major depressive disorder).
  • Gastroenterology and hepatology: the protocol for chronic inflammatory bowel disease (Crohn’s disease and ulcerative colitis, biologic therapies) and the protocol for chronic viral hepatitis and cirrhosis caused by hepatitis B virus.
  • Dermatology: the protocol for severe chronic plaque psoriasis, treated with biologic agents and small-molecule intracellular therapies.

For most of these conditions, the act doesn’t change whether the patient has access to treatment, but rather the clinical details of the protocol: for example, asciminib now has an explicit dose-adjustment schedule for managing adverse reactions, and pembrolizumab has a table with recommendations on modifying treatment based on individual tolerability.

What has changed compared with the previous situation

Compared with the form of the protocols approved by Order MS/CNAS no. 564/499/2021, published in Official Gazette of Romania no. 474 and 474 bis of 6 May 2021, as subsequently amended, the more than 25 items listed above are entirely replaced with new versions. The technical annex in Official Gazette of Romania no. 586 bis contains, for each protocol, the full text: indications, inclusion and exclusion criteria, doses and method of administration, monitoring, adverse reactions, and which doctors can start or continue the treatment.

Because the annex is so large (over 300 pages, with highly precise medical wording, dose tables and detailed clinical criteria for each disease), this article does not reproduce the protocols word for word. The full, complete text of each amended protocol can be consulted directly in the Official Gazette of Romania, Part I, no. 586 bis of 17 July 2026.

Advantages and disadvantages

What it improves

  • The updated protocols align Romanian medical practice with the latest clinical evidence and internationally approved indications for modern, often expensive therapies, which can widen the group of patients eligible for reimbursed treatment.
  • The existence of explicit dose-adjustment schedules (as with asciminib) or clear monitoring tables gives doctors a more precise decision-making framework, with direct benefits for patient safety.
  • Updating protocols periodically, instead of a rare, large-scale overhaul, lets the system respond faster to medical progress.

What remains a problem

  • The sheer technical volume of the change (over 300 pages) makes it almost impossible for an ordinary patient to understand exactly what changes in their own case without their doctor’s help.
  • The order doesn’t explain, in the part published in the base edition of the Official Gazette of Romania, the medical reasons behind each change, so the justification for every modification has to be inferred by directly comparing the old and new protocol texts.
  • Successive protocol updates, without an easily consultable consolidated version, can create confusion even for medical practices, which have to carefully track every amending order.

Practical advice

  1. If you’re being treated for one of the conditions mentioned above, ask your doctor at your next appointment whether your protocol has changed and whether the change affects the dose, monitoring, or conditions for continuing therapy.
  2. Don’t stop or change a reimbursed treatment on your own based on this article. The protocol update is applied through the specialist doctor’s decision, not automatically at the patient level.
  3. For full technical details about the protocol for a specific disease, ask your doctor or pharmacist for the updated version, or consult Official Gazette of Romania no. 586 bis of 17 July 2026 directly.

A week later, the same two institutions signed a second joint order, through which sick-leave allowances for ordinary illnesses received separate reporting lines for the three tiers of 55%, 65% and 75%.

The order of 17 July 2026 is part of a series of medicine-related legislative acts from the summer of 2026: two weeks earlier, the Ministry of Health had extended the validity of maximum prices for human medicines through Order MS no. 707/2026, and a week after the therapeutic protocols, it also updated the National Catalogue of Medicine Prices through Order MS no. 895/2026.

Frequently asked questions

What is a therapeutic protocol?
It’s the official document that sets out, for a given disease and active substance, who can prescribe the treatment, what criteria the patient must meet to be eligible, what doses are used, how progress is monitored, and under what conditions the treatment can be stopped. Protocols are part of the social health insurance system and are mandatory for doctors who prescribe reimbursed medicines.
Does Order 824/1,313/2026 introduce new medicines or change prices?
No. The order updates the clinical prescribing rules for active substances already in the reimbursement system; it doesn’t add new medicines to the list and doesn’t change prices.
Which diseases are affected by the change?
More than 25 protocols, covering conditions in oncology and haematology (breast cancer, prostate cancer, multiple myeloma, several types of leukaemia, Hodgkin lymphoma), rare diseases (amyloidosis, achondroplasia, hepatitis D), diabetes, respiratory diseases (asthma, COPD), psychiatry (schizophrenia, depression), Crohn’s disease and ulcerative colitis, chronic hepatitis B, and severe psoriasis.
Where can I find the full text of the protocol for my disease?
The full text of all amended protocols is published in the Official Gazette of Romania, Part I, no. 586 bis of 17 July 2026, a technical document of more than 300 pages.
From when do the new protocols apply?
From 17 July 2026, the date the order was published in the Official Gazette of Romania.

This article is for informational purposes only and does not constitute legal or medical advice. For specific situations related to a treatment, consult your specialist doctor.

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. 586 of 17 July 2026 (annex in no. 586 bis) 16 pages PDF, 113 KB the act starts on page 9

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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.