Health launches six new IPTs and will review five more

Aemps headquarters.

The Coordination Group of the National Health System Drug Evaluation Network (Revalmed) has announced six new Therapeutic Positioning Reports (IPT) for drugs indicated for multiple myeloma, migraine, hemophilia A, myeloid leukemia, HIV and myasthenia gravis. In addition, he agreed to carry out, as a pilot, the IPT of Sunlenca (lenacapavir), according to the new model, that is to say the one with an economic evaluation.

The first of the drugs for which an IPT will be established is Pepaxti, (active ingredient, melphalan flufenamide), of Oncopeptides AB, which is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three previous lines of treatment. Similarly, an IPT of the drug will be performed Rayvow (lasmiditan), from Eli Lilly and which is indicated for the acute treatment of the painful phase of migraine attacks, with or without aura, in adults.

will also prepare octave (valoctocogene roxaparvovec), from BioMarin International Limited, and is indicated for the treatment of severe hemophilia A (congenital factor VIII deficiency) in adults with no history of factor VIII inhibitors and no detectable antibodies against adeno-associated virus of serotype 5.

On the other hand, they announced an IPT for Semblix (asciminib), from Novartis Europharm and indicated for the treatment of adult patients with chronic phase Philadelphia chromosome positive chronic myeloid leukemia previously treated with two or more tyrosine kinase inhibitors.

Pilot program for a new process in IPT

The report for sunlenca (lenacapavir), from Gilead Science, will be prepared as a pilot according to the new procedure of the Revalmed Plan. In its injectable form, in combination with other antiretrovirals, it is indicated for the treatment of adults infected with multidrug-resistant HIV-1 for whom suppressed antiviral treatment cannot otherwise be established. In its tablet form, also in combination, it is indicated for the treatment of adults with multidrug-resistant HIV-1 infection for whom suppressive antiviral therapy cannot otherwise be established, for oral loading prior to parenteral administration of lenacapavir.

Ultimately, Vyvgart (efgartigimod alfa), from Argenx, which is indicated for the treatment of adult patients with generalized myasthenia gravis with positive antibodies against the acetylcholine receptor, will also have IPT.

IPT review and completion

On the other hand, from Revalmed, they have announced that the IPT will be carried out for new indications or indication extensions of the following drugs: Crisvita (burosumab), Enhertu (trastuzumab deruxtecan), Imbruvic (ibrutinib), Lynparza (take) y Renew (upadacitinib).

From health, they announced the completion of nine more reports. In this case, they correspond to the drugs of Well done (vericiguat) in the treatment of chronic heart failure; With Edistride/Forx (dapagliflozin) in chronic kidney disease; Trodelvy (sacituzumab govitecan) in unresectable or metastatic triple-negative breast cancer; To go up (somatrogon) in children and adolescents from 3 years of age with growth disorders due to insufficient secretion of growth hormone; Dectova (zanamivir) in infections complicated by influenza A or B virus; Nucala (mepolizumab) in eosinophilic granulomatosis with relapsing-remitting or refractory polyangiitis; Ontozry (cenobamate) in focal epileptic seizures with or without secondary generalization in adults with epilepsy; Yes Venclyxto (venetoclax) in combination with a hypomethylating agent, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.

Also, the update is complete. Qarziba report (dinutuximab beta), formerly Dinutuximab beta EUSA and Dinutuximab beta Apeiron.

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