Non-reimbursable Wegovy: AIFA places new packs in class C

AIFA has placed the new packs of Wegovy, the semaglutide-based medicine for the treatment of obesity, in class C(nn), the section dedicated to drugs not yet evaluated for reimbursement purposes. The decision is contained in Determination no. 1356/2026 of October 1, 2026, signed by the agency’s president Roberto Giovanni Nisticò, and published in the Official Gazette of the Italian Republic, General Series no. 240 of October 15, 2026, on page 46, with the code 26A05342. The measure comes into force the day after publication, therefore from October 16, 2026.

The regulatory framework of the decision

The determination is adopted pursuant to Article 12, paragraph 5, of Law no. 189 of November 8, 2012, which regulates the classification of medicinal products authorized via the centralized procedure. Class C(nn) collects drugs not yet evaluated for reimbursement, pending the submission of a request for a different classification by the holding company.
The opinion on the classification regime was expressed by AIFA’s Scientific and Economic Commission (CSE) during the session of September 7-11, 2026, upon the proposal of the Centralized Procedures Office.

What the measure provides

• The new packs of Wegovy are placed in class C(nn), not reimbursable by the National Health Service.
• The marketing authorization holder is Novo Nordisk A/S.
• The active ingredient is semaglutide, ATC code A10BJ06, European procedure EMA/X/0000296344.
• The medicine remains subject to medical prescription (RR) and additional monitoring.
• If the company does not submit the classification request within thirty days of the reminder from AIFA, pursuant to Article 18 of Law no. 118 of August 5, 2022, alignment to the lowest price within the fourth ATC level will be applied.

Therapeutic indications and obligations for the holder

According to the annex, Wegovy is indicated in addition to a low-calorie diet and increased physical activity for weight management:

• in adults with an initial body mass index equal to or greater than 30 kg/m2 (obesity);
• in adults with a BMI between 27 and 30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity, such as dysglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease;
• in adolescents aged 12 and over with obesity and body weight exceeding 60 kg.
  The holder must communicate to AIFA, prior to the start of commercialization, the ex-factory price, the public price, and the start date of sales for the new packs.

A twin measure in the same Gazette

In the same edition of the Gazzetta Ufficiale (Official Gazette), a parallel determination appears: that which places the new packaging of Sondelbay, a teriparatide-based biosimilar for osteoporosis, owned by Accord Healthcare S.L.U. (code 26A05341), in class C(nn). The two determinations confirm the practice of AIFA to publish the classifications of newly authorized medicines in a single issue.

For Italian patients, the consequence is immediate: the new packaging of Wegovy will not be covered by the National Health Service, and the cost will fall entirely on those who intend to use them. The classification remains provisional, however, as a future application for reimbursement submitted by the company could modify the current placement in class C(nn).

Source: Gazzetta Ufficiale della Repubblica Italiana, General Series no. 240 of October 15, 2026, page 46 — AIFA Determination October 1, 2026, no. 1356/2026, “Classification, pursuant to article 12, paragraph 5, of law 8 November 2012, no. 189, of the medicinal product for human use, based on semaglutide, ‘Wegovy’” (26A05342).