Biotech
Interministerial Commission on Drug Prices Approves New Drugs and Expanded Treatment Funding
The Interministerial Commission on Drug Prices proposed funding six new drugs and four new indications, including two orphan medicines for rare diseases, while easing access to certain topical therapies. Approvals covered hemophilia prophylaxis, HIV prevention, Clostridium difficile infection, IgA nephropathy, and Duchenne muscular dystrophy, plus expanded oncology, vascular, and anti-inflammatory treatment coverage nationwide healthcare improvements.
The Interministerial Commission on Drug Prices (CIPM) proposed at its meeting this month the full or partial funding of six new drugs and four new indications for medications that were already authorized and funded.
Among the new developments at this meeting were the inclusion of two orphan drugs for the treatment of rare diseases and the removal of administrative barriers to accessing certain topical therapies.
Interministerial Commission on Drug Prices Proposes Funding for New Drugs, Rare Disease Treatments, and Expanded Indications
Among the new drugs, the committee approved the inclusion of Alhemo, whose active ingredient is concizumab, in the healthcare system.
This drug is intended for the routine prophylaxis of bleeding in patients 12 years of age and older with hemophilia A with factor VIII inhibitors or severe hemophilia A without inhibitors. It is also indicated for hemophilia B with factor IX inhibitors and for cases of moderate or severe hemophilia B without these inhibitors.
New therapeutic alternatives
In the area of infectious diseases, the CIPM proposed funding for Apretude, composed of cabotegravir, as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection. This treatment targeted adults and adolescents weighing at least 35 kg who were at high risk of exposure. Meanwhile, Vangozyr, based on vancomycin , received approval for the treatment of Clostridium difficile infections in patients 12 years of age and older.
The commission also prioritized access to orphan drugs with the proposal for Filspari, or espasertan. This drug is intended for the treatment of adults with primary immunoglobulin A nephropathy who present with proteinuria equal to or greater than one gram per day. This decision was followed by the approval of Agamree , whose active ingredient is vamorolone, indicated for Duchenne muscular dystrophy in patients from four years of age.
Extension of indications for some drugs
Oncology and hematology were the main areas covered in the new indications section. The CIPM proposed funding Columvi , or glofitamab, in two different scenarios. The first involved its combination with gemcitabine and oxaliplatin for patients with relapsed or refractory diffuse large B-cell lymphoma , not otherwise specified, who are not candidates for autologous transplantation. The second scenario considered its use as monotherapy after two or more lines of systemic treatment.
On the other hand, the combination of the drugs Padcev with Keytruda obtained the funding proposal for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma who can receive platinum-based chemotherapy.
Finally, the committee extended coverage for Rinvoq for giant cell arteritis and for rivaroxaban for the treatment of deep vein thrombosis and pulmonary embolism. Regarding access management, it was agreed to remove the restriction on the reimbursed indication for Klisyri (tirbanibulin), eliminating the prior authorization requirement for the topical treatment of non-hyperkeratotic actinic keratosis in adults.
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(Featured image by James Yarema via Unsplash)
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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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