REvalMed Completes IPTs for Six New Drugs

The REvalMed coordinating group has finalized reports on Blincyto (blinatumomab) in adults in monotherapy for the treatment of CD19-positive and refractory or relapsed B-precursor acute lymphoblastic leukemia (ALL), Vazkepa (ethyl icosapent) in reducing the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk, Bylvay (odevixibat) in progressive familial intrahepatic cholestasis (PFIC), Tepmetko (tepotinib) in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC), Inbrija (levodopa) in the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) and Imfinzi (durvalumab) in the first-line treatment of adults with extended-stage small-cell lung cancer (SCLC-EE).

At its latest meeting, held July 28th, REvalMed group has agreed to start work on the Therapeutic Positioning Reports (TPRs) for vutrisiran, voclosporin, tirzepatide, fosdenopterin, relatlimab / nivolumab, teclistamab, tezepelumab and faricimab, which have a positive opinion from the EMA’s Committee for Medicinal Product Assessment (CHMP).

Amvuttra (vutrisiran), from Alnylam Netherlands, is indicated for the treatment of hereditary transthyretin amyloidosis (ATTRh) in adult patients with stage 1 or 2 polyneuropathy. Lupkynis (voclosporin), from Otsuka Pharmaceutical Netherlands, is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active lupus nephritis class III, IV, or V (including mixed classes III/V and IV/V). Mounjaro (tirzepatide), developed by Eli Lilly Nederland, indicated for the treatment of adults with inadequately controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, both in monotherapy, when metformin is not considered appropriate due to intolerance or contraindications and as an addition to other drugs for the treatment of diabetes.

Nulibry (fosdenopterin), from Comharsa Life Sciences, is indicated for the treatment of patients with type A molybdenum cofactor deficiency. Opdualag (relatlimab / nivolumab) was developed by Bristol-Myers Squibb Pharma EEIG, and is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years and older with PD-L1 expression < 1% in tumor cells.

Tecvayli (teclistamab), from Janssen-Cilag International, is a monotherapy treatment for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who have had disease progression to the last treatment.

The licensee of Tezspire (tezepelumab) is AstraZeneca. The drug is indicated as additional maintenance therapy in adults and adolescents 12 years and older with severe asthma who are not adequately controlled despite the administration of high-dose inhaled corticosteroids in combination with another drug for maintenance therapy.

Roche’s Vabysmo (faricimab) is indicated for the treatment of adult patients with neovascular (exudative) age-related macular degeneration and visual impairment due to diabetic macular edema.

The group will perform the IPTs for the new indications or indication extensions for Imcivree (setmelanotide), Retsevmo (selpercatinib), Tecartus (brexucabtagene autoleucel) and Ultomiris (ravulizumab).

In accordance with the REvalMed Plan, all the agreed IPTs will be carried out, applying the criteria approved by the Standing Committee on Pharmacy for their prioritization.

Likewise, it was agreed to initiate the following IPT as a pilot project in accordance with the new procedure of the REvalMed Plan: Tezspire (tezepelumab).

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In general, IPTs of combinations of already authorized active ingredients will not be carried out, except in those cases in which the AG considers it necessary

The AG reminds that, in order to maximize the available resources, and until a definitive procedure is established, authorization holders of drugs with a positive opinion from the CHMP are requested to contact the group’s secretariat, indicating whether or not they intend to market in Spain the new drugs that have obtained a positive opinion by centralized procedure prospectively since the publication of this document, and also providing a contact point for the holder for aspects related to the AG. If no marketing confirmation is received, the preparation of the report will not begin.

Similarly, in the event of withdrawals of the marketing authorization, changes in the ownership of the drug, or in the intention to market it, the information should be communicated to the e-mail addresses indicated above.

The next AG meeting will take place on September 22, 2022.

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(Featured image by jarmoluk via Pixabay)

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