The coordination group Medicines Evaluation Network of the National Health System (RevalMed) has published a document on the issues raised during the meeting of 30. In it he announced that it was agreed to start work on the Therapeutic positioning reports (IPT) of six new medicines with a positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
As already mentioned, it was agreed to start work on the IPT by: Pepaxti (melphalanflufenamide) for the treatment of adult patients with multiple myeloma who have received at least three prior lines of treatment radiance vow (Lasmiditan) indicated for the acute treatment of the pain phase of migraine attacks, with or without aura, in adults and Rooctavian (valoctocogene roxaparvovec), indicated for the treatment of severe haemophilia A in adults with no history of factor VIII inhibitors and no detectable antibodies to adeno-associated virus serotype 5.
In the same way it has also announced in a report skemblix (asciminib) for the treatment of adult patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia who have been previously treated with two or more tyrosine kinase inhibitors.
The report for Sunlenca (Lenacapavir), is being pilot manufactured under the new REvalMed Plan process. In its injectable form, it is indicated in combination with other antiretroviral medicinal products for the treatment of adults with multidrug-resistant HIV-1 infection for whom a suppressed antiviral regimen cannot otherwise be established. In tablet form, including in combination, it is indicated for the treatment of adults with multidrug-resistant HIV-1 infection for whom a suppressive antiviral regimen cannot otherwise be established, for oral administration prior to parenteral administration of lenacapavir.
Likewise, the REvalmed Coordinating Group will conduct the IPT of Vyvgart (Efgartigimod alfa), indicated for the treatment of adult patients with generalized myasthenia gravis with positive antibodies to the acetylcholine receptor.
It was also announced that the CG will carry out the IPT for the new indications or indication extensions crysvita (burosumab), Enhertu (trastuzumab deruxtecan), Imbruvica (ibrutinib), Lynparza (olaparib) and Rinvoq (Upadacitinib).
Under the terms of the REvalMed plan, all IPTs agreed upon by the CG will be conducted with a request for their prioritization Criteria approved by the Standing Pharmacy Commission.
On the other hand, the Spanish Medicines and Health Products Agency has reported that it has finalized the reports on the following medicines: verquvo (vericiguat) for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction, Edistride/Forxiga (dapagliflozin) in chronic kidney disease, Trodelvy (Sacituzumab Govitecan) in unresectable or metastatic triple negative breast cancer (mTNBC) who have received two or more prior systemic therapies, Ngenla (Somatrogon) in children and adolescents from the age of 3 years with growth disorders due to insufficient growth hormone secretion, Eighth (zanamivir) for complicated influenza A or B virus infection, neck (mepolizumab) for relapsing remitting or refractory eosinophilic granulomatosis with polyangiitis (AGEP), Ontozry (cenobamate) for partial seizures with or without secondary generalization in adults with epilepsy and Venclyxto (venetoclax) in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
Also updating the report quarziba (Dinutuximab beta), formerly Dinutuximab beta EUSA and Dinutuximab beta Apeiron, for the treatment of high-risk neuroblastoma in patients 12 months and older who have received prior induction chemotherapy and have achieved at least a partial response followed by myeloablative and myeloablative treatment stem cell transplantation and in stem cell transplantation Patients with a history of relapsed or refractory neuroblastoma with or without residual disease.
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