In brief

  • The National Health Insurance House (CNAS) has added three new specific forms, positions 327, 328 and 329: one for nivolumab in operable bronchopulmonary cancer and two for pembrolizumab, in advanced renal carcinoma and in endometrial carcinoma. Without the form filled in by the doctor, the reimbursed prescription for these treatments cannot be issued.
  • Another 13 existing forms have been rewritten in full, from brentuximab vedotin and daratumumab to teduglutide for short bowel syndrome, bulevirtide for hepatitis delta and vosoritide for achondroplasia. The 16 forms take up 52 pages of the Official Gazette of Romania (Monitorul Oficial).
  • The order sets no later date of application, so it applies from 3 September 2026, the day of publication. Doctors have no transition period in which the old forms remain valid.
Act: Order of the President of the National Health Insurance House no. 1.442 of 4 August 2026
Published: Official Gazette of Romania no. 747 of 3 September 2026, the annexes in no. 747 bis
In force from: 3 September 2026, the date of publication

Three oncology immunotherapies received, as of 3 September 2026, the form without which the reimbursed prescription is not issued. Order of the President of the National Health Insurance House no. 1.442/2026, published in Official Gazette of Romania no. 747 of 3 September 2026, adds three new positions to the table of specific forms and replaces another thirteen forms already in use. It is the administrative half of the same mechanism through which the Ministry of Health and CNAS updated the prescribing protocols for dozens of medicines in July 2026: the protocol says who is entitled to treatment, the specific form is the piece of paper on which the doctor shows that the patient in front of him meets the conditions. In the same national programmes, the reimbursement prices were rewritten a few days later, through MS Order no. 1.212/2026 and CNAS Order no. 1.566/2026.

The forms are not printed in the ordinary edition of the Gazette. The 16 annexes appear separately, in issue no. 747 bis of the same day, on pages 3 to 54. The order was signed on 4 August 2026 by the president of CNAS, Horațiu-Remus Moldovan, on the basis of approval memorandum no. DG 8.694 of the same date, and reached publication a month later.

The three new positions, as they appear in the table, are: position 327, form code L01XC17-NSCLC.1, for nivolumab in bronchopulmonary cancer, neoadjuvant and adjuvant treatment; position 328, code L01XC18.17, for pembrolizumab in advanced renal carcinoma, first line, in combination with axitinib; position 329, code L01XC18.18, for pembrolizumab in endometrial carcinoma. The codes and the names in the table of the order match, letter for letter, the headings of Annexes nos. 14, 15 and 16, which is not always the case with acts of this kind.

A specific form has two sections and asks different things in each. Section I, the general data, is filled in with the medical unit, the insurance house and the contract number, the doctor’s stamp code, the patient’s name and personal identification number, the number of the medical record, the type of assessment, that is initiation, continuation or discontinuation, the classification of the medicine in the list, the administration period of 3, 6 or 12 months and confirmation that the patient has signed the declaration on his or her own responsibility. The second section, the medical data, contains the approved indication and four or five groups of criteria, for inclusion, exclusion, continuation and discontinuation, of which the doctor circles those matching the patient’s situation at the time of completion. Underneath, the doctor signs a sentence that binds him personally: he is answerable for the truthfulness and accuracy of the way the form has been filled in.

The three new forms also require a mandatory diagnosis code from the international classification of diseases, the variant with 999 disease codes: 111 for nivolumab, 137 for pembrolizumab in renal carcinoma and 128 for pembrolizumab in endometrial carcinoma. Checked against the official list of codes, all three correspond exactly to the indications: 111 is malignant tumour of the bronchus and lung, 137 is malignant tumour of the kidney except the renal pelvis, and 128 is malignant tumour of the corpus uteri, that is precisely the area from which endometrial carcinoma starts.

The forms being replaced cover a far wider range of diseases than the word „oncology” would suggest. Rewritten are the forms for brentuximab vedotin in Hodgkin lymphoma, blinatumomab in acute lymphoblastic leukaemia, daratumumab in multiple myeloma, abemaciclib in breast cancer, apalutamide in prostate cancer, gilteritinib in acute myeloid leukaemia, selpercatinib in two separate forms, lung cancer and thyroid cancer, acalabrutinib in mantle cell lymphoma, plus rituximab and avacopan for ANCA positive vasculitis. Three of the thirteen leave the field of cancer altogether: teduglutide for short bowel syndrome, bulevirtide for chronic infection with the hepatitis delta virus and vosoritide for achondroplasia, a treatment that can be started from the age of 4 months.

What it changes in practice

The immediate effect is that three treatments which until now had no form of their own can be reimbursed from the single national health insurance fund. The specific form is the link through which the insurance house checks, after the event, that the medicine reached a patient who met the criteria of the protocol. Without it the pharmacy has nothing to rely on, and reimbursement can be refused at an audit.

The second effect touches prescribing doctors. From 3 September 2026, the thirteen old forms are no longer the approved ones. A doctor who fills in the earlier version for daratumumab or for apalutamide is working on a document that no longer exists in Annex no. 1 to Order no. 141/2017. The order contains no clause saving forms already filed in the days immediately after publication.

The third effect is less visible and concerns the patient’s file. Each form repeats, at the end, that the original file together with all the documents attached to it, clinical assessments, laboratory or imaging results, the informed consent and the declaration on own responsibility, is the source document against which the audit is carried out. In other words, the completed form does not stand on its own: if the tests underpinning the circled criteria are missing at an audit, the form is worth nothing.

What has changed compared with the previous situation

Until 3 September 2026, the table in Annex no. 1 to Order no. 141/2017 stopped at position 326. Nivolumab had forms for other indications, but not for the neoadjuvant scheme followed by adjuvant treatment in operable bronchopulmonary cancer, and pembrolizumab had no form either for the combination with axitinib in first line renal carcinoma or for advanced or recurrent endometrial carcinoma in combination with carboplatin and paclitaxel. In practice the protocol could exist, but the administrative instrument for proving eligibility was missing.

The form for nivolumab brings in a numerical threshold that did not exist before in this shape: eligible patients are those whose tumour shows PD-L1 expression of at least 1%, with stages from IIA over 4 centimetres up to IIIB, T3 and N2 only, under the eighth AJCC edition, without EGFR mutations or ALK rearrangements and with ECOG performance status 0 or 1. It is a tighter filter than in the other two new forms, where ECOG from 0 to 2 is accepted.

What has also changed is the treatment of patients coming from another source of financing. The form for endometrial carcinoma says explicitly that patients previously given pembrolizumab from other financial sources, without progressive disease, may benefit from continuation of treatment. This bridge is missing from the form for renal carcinoma, although the financing mechanism is identical.

The comparison with the basic act says something about pace. Order no. 141/2017 was published on 28 February 2017 and, through Article 6, set its own entry into force for 1 March 2017, that is, it gave itself one day of breathing space. Order no. 1.442/2026 contains no such provision, so it applies from publication, under Article 12(3) of Law no. 24/2000, which states that legal acts other than laws and ordinances enter into force on the date of publication unless they provide for a later date.

Advantages and disadvantages

What it improves

  • Three oncology indications that had no form of their own become reimbursable, among them a complete treatment scheme around surgery for operable lung cancer.
  • The form codes and the names in the table match the headings of the annexes exactly, so the doctor does not have to guess which document is being asked for.
  • The diagnosis codes imposed, 111, 137 and 128, are correct against the official list of 999 codes, so the prescription does not get stuck in the platform because of a wrong reference.
  • The four forms from outside oncology, for short bowel syndrome, hepatitis delta, achondroplasia and ANCA positive vasculitis, show that updating is not confined to the areas under heavy commercial pressure.
  • The form for endometrial carcinoma expressly settles the position of patients who began treatment on another source of financing.

What remains a problem

  • Zero days of transition. The old forms cease to apply on the very day of publication, and the order sat for a month between signature and appearance in the Gazette.
  • The annexes appear only in edition no. 747 bis, and the footnote sends the reader off to buy that issue from the Public Relations Centre.
  • The annexes do not carry the number of the position they replace, only the form code, so matching them up is a matter of counting in order.
  • The note to the exclusion criteria in the two pembrolizumab forms contradicts the inclusion criteria in the same form, on ECOG status and on brain metastases.
  • There is nowhere a consolidated version of Annex no. 1, even though the table has reached 329 positions and is amended several times a year.

Practical advice

  1. If you are on nivolumab or pembrolizumab for one of the three new indications, ask your treating doctor, at your next visit, whether the specific form has been filled in and registered. Without it, continuing treatment on reimbursement has no administrative cover.
  2. Check what you have signed. Point 12 of section I asks whether the patient has signed the declaration on own responsibility. If the answer is „no”, the form stays incomplete, and the problem surfaces only at an audit.
  3. Keep copies of the tests and imaging assessments on which the decision rested. The order says plainly that the original file with all its annexes is the document against which the audit is carried out, not the form on its own.
  4. If you are a prescribing doctor, get the annexes from no. 747 bis or from cnas.ro before your first prescription after 3 September 2026, for the thirteen positions that have been amended. An old form correctly filled in is still a form that is no longer the approved one.
  5. At reassessment, look at the period ticked at point 10, 3, 6 or 12 months. It determines when the next form has to be completed, and missing the deadline leaves a gap in which the prescription can no longer be issued.
  6. If you do not meet an inclusion criterion, ask for the explanation in writing. The form works on circled criteria, and a missing criterion changes the answer of the insurance house, not the opinion of the doctor.

Frequently asked questions

What exactly is a specific form?
It is a standard document, approved by order of the president of CNAS, through which the treating doctor confirms in writing that the patient meets the eligibility criteria in the therapeutic protocol of the medicine. It has one section with general data, medical unit, insurance house, stamp, patient, type of assessment, and one section with medical data, where the criteria for inclusion, exclusion, continuation and discontinuation are circled.
From when do the new forms apply?
From 3 September 2026, the day of publication in the Official Gazette of Romania. The order provides for no later date, and Article 12(3) of Law no. 24/2000 states that, in the absence of such a provision, the act enters into force on the date of publication.
What happens if the doctor uses the old form after 3 September 2026?
The completed document no longer corresponds to the form approved for that position. The order contains no transitional clause validating old forms filed after publication, so the practical risk is that reimbursement will be challenged at an audit.
Which are the three medicines added?
Nivolumab, for operable bronchopulmonary cancer, in neoadjuvant treatment followed by adjuvant treatment, and pembrolizumab, in two separate indications: advanced renal carcinoma, first line, in combination with axitinib, and primary advanced or recurrent endometrial carcinoma, in combination with carboplatin and paclitaxel.
Where can I find the forms, if the annexes are in a separate edition of the Gazette?
The note in the Official Gazette of Romania points to the Public Relations Centre at Panduri Road no. 1, Bucharest, for the purchase of issue no. 747 bis. There is, however, a free route as well: Article II says that the annexes form an integral part of the order, and Article III requires the order to be published on the CNAS website, at www.cnas.ro. The annexes therefore follow the fate of the order.
Do I have to pay anything for the form to be filled in?
No. Completing the specific form is part of the medical act by which treatment is prescribed within the social health insurance system. The order provides for no fee.
What do the boxes „initiation”, „continuation” and „discontinuation” at point 7 mean?
They are the three moments at which the form is completed. „Initiation” at the start of treatment, „continuation” at each reassessment, at 3, 6 or 12 months, depending on the period ticked at point 10, and „discontinuation” when treatment stops. On discontinuation, point 10 is not filled in.
What do the diagnosis codes 111, 137 or 128 required by the form mean?
They are codes from the international classification of diseases, tenth revision, in the variant with 999 codes used in the insurance system. 111 means malignant tumour of the bronchus and lung, 137 malignant tumour of the kidney except the renal pelvis, and 128 malignant tumour of the corpus uteri. The doctor has to enter them, otherwise the classification in the list remains incomplete.
If I do not meet an inclusion criterion, can I still receive the treatment?
The form works on criteria that are circled, and a criterion that is not met shows. In the two pembrolizumab forms there is nevertheless a note leaving the treating doctor a margin in situations such as HIV infection, hepatitis B or C or active autoimmune disease, if he considers that the benefits outweigh the risks and if the patient has been informed in detail. The note does not, however, cover every criterion.
Does the order change the therapeutic protocol or only the form?
Only the form. Therapeutic protocols are approved by joint order of the minister of health and the president of CNAS, at present Order no. 564/499/2021, as subsequently amended. Order no. 1.442/2026 approves the document by which compliance with those protocols is verified.

Errors and inconsistencies in the published text

  • Annexes nos. 15 and 16, the inclusion criteria contradict the note to the exclusion criteria. In the form for pembrolizumab in renal carcinoma, inclusion criterion no. 4 requires an ECOG performance status between 0 and 2. In the same form, the note below the exclusion criteria provides that, where ECOG status is above 2, the treatment „poate fi utilizat la acești pacienți”, may be used in those patients, if the treating doctor considers that the benefits outweigh the risks. The same construction appears in the form for endometrial carcinoma, where inclusion criterion no. 6 admits brain metastases only if they are treated and stable, without maintenance corticosteroid therapy above the equivalent of 10 mg of prednisone, while the note to the exclusion criteria places „metastaze active la nivelul SNC”, active metastases in the central nervous system, on the list of situations in which the doctor may nevertheless treat. A doctor in good faith can read two different answers for the same patient: either the form cannot be completed, because an inclusion criterion is missing, or it can, because the note authorises it. The consequence is not theoretical, because the issue of the reimbursed prescription hangs on the form being completed. Since the construction is repeated identically in both new annexes, it is not a drafting slip but a pattern that ought to be corrected at the level of the template, by an express reference from the inclusion criterion to the exception in the note.

Editorial analysis

In substance the order is clean. The three new positions match perfectly between the table in the operative part and the headings of the annexes, the diagnosis codes imposed are the correct ones from the list of 999 codes, and the references to Law no. 95/2006, to the CNAS Statute and to Government Decision no. 720/2008 say what they are cited for. The problem is not in the text, it is in the calendar.

Between 4 August 2026, the date on which the president of CNAS signed the order and the date of approval memorandum no. DG 8.694, and 3 September 2026, the day of publication, exactly 30 days passed. Throughout that time, a patient with operable bronchopulmonary cancer and PD-L1 expression of at least 1% could not receive nivolumab on reimbursement, because the form did not yet exist. The administration took 30 days for the journey from signature to print, and gave the prescribing doctor zero days to move from the old forms to the new ones. The basic act, Order no. 141/2017, had set its entry into force through Article 6 at 1 March 2017, although it had been published on 28 February 2017. One day, but it was there.

The second observation comes from combining two articles which, read separately, look routine. Article II says that Annexes nos. 1 to 16 form an integral part of the order. Article III says that the order is published in the Official Gazette of Romania and on the CNAS website. Put together, the two mean that the 52 pages of forms have to be available free of charge on cnas.ro, not only in edition no. 747 bis, which the footnote invites the reader to buy on Panduri Road. The note in the Gazette is not wrong, but it is the only pointer seen by anyone opening the order, and it leads to the ticket office rather than to the free version the act itself requires.

Finally, a figure about proportions. The table has reached 329 positions, and this single order touches 16 of them, almost 5% of the list, in one day. Of the 16, twelve are oncology or haemato-oncology forms, and four concern rare and autoimmune diseases: short bowel syndrome, hepatitis delta, achondroplasia and ANCA positive vasculitis. For a table growing and changing at this pace, the absence of an officially published consolidated version is no longer a missing convenience but a source of prescribing errors.

What should be changed

  • A short period before entry into force, of 10 or 15 days. It would give hospitals time to replace the printed forms and would remove the days on which a document that has just been superseded is filled in, in good faith.
  • A transitional clause for forms already started. A sentence validating old forms completed in the first days after publication would settle the position of patients between two assessments, without touching the substance of the rules.
  • The number of the position replaced, entered on each annex. Today the annex carries only the form code, and matching it with position 23 or 288 is done by counting in the order set out in the article. A heading reading „ANEXA nr. 4, poziția 149”, Annex no. 4, position 149, would cut off the most likely source of confusion in practice.
  • Alignment of the note to the exclusion criteria with the inclusion criteria. Either the inclusion criterion refers expressly to the exception in the note, or the note is confined to situations not already settled above. Otherwise the decision to treat a patient with ECOG above 2 remains suspended between two sentences in the same form.
  • Publication, on the same day, of a consolidated version of Annex no. 1 on cnas.ro. A single table with all 329 positions, updated at every amendment, would make it unnecessary to reconstruct the list from dozens of successive orders.
  • A statement of the moment when the form becomes available in the IT platform. The order also governs the methodology for transmission into the health insurance platform, but it does not say from when the new form can actually be transmitted. One line would close the gap between the date on which the obligation exists and the date on which it can be met.

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. 747 of 3 September 2026 8 pages PDF, 85 KB the act starts on page 7

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