Medical Benefit Pharmaceutical Policies for Providers
See the latest updates to our medical benefit pharmaceutical policies.
MBP 209.0 Padcev (enfortumab vedotin-ejfv)
Padcev (enfortumab vedotin-ejfv) is an antibody-drug conjugate consisting of human IgG1-kappa antibody, anti-Nectin-4, attached to a microtubule disrupting agent, monomethyl auristatin E (MMAE), by a cleavable maleimidocaproyl valine-citrulline linker. The antibody-drug conjugate binds to the Nectin-4 adhesion protein found on the cell surface and the entire complex is internalized. MMAE is cleaved from the complex resulting in the disruption of the microtubule network within the cell, leading to cell cycle arrest and apoptotic cell death.
MBP 168.0 Parsabiv (etelcalcetide)
Parsabiv (etelcalcetide), a calcium-sensing receptor agonist, is a synthetic peptide calcimimetic agent that allosterically binds and activates the calcium-sensing receptor (CaSR) on parathyroid chief cells. This action on the parathyroid gland sensitizes CaSR to promote negative feedback, thus decreasing PTH secretion and serum calcium and phosphorus levels.
MBP 275.0 Pedmark (sodium thiosulfate)
Cisplatin-induced ototoxicity is caused by irreversible damage to hair cells in the cochlea hypothesized to be due to a combination of reactive oxygen species (ROS) production and direct alkylation of DNA leading to cell death. Pedmark (Sodium thiosulfate) interacts directly with cisplatin to produce an inactive platinum species. In addition, sodium thiosulfate can enter cells through the sodium sulfate cotransporter 2 and cause intracellular effects such as the increase in antioxidant glutathione levels and inhibition of intracellular oxidative stress. Both activities may contribute to the ability of sodium thiosulfate to reduce the risk of ototoxicity. Concurrent incubation of sodium thiosulfate with cisplatin decreased the in vitro cytotoxicity of cisplatin to tumor cells; delaying the addition of sodium thiosulfate to these cultures prevented the protective effect.
New Policy 3/21/23
MBP 233.0 Pepaxto (melphalan flufenamide)
Pepaxto (melphalan flufenamide) is a peptide-drug conjugate that is highly lipophilic and is therefore rapidly and passively distributed into cells and then enzymatically hydrolyzed to the alkylating agent melphalan. Melphalan flufenamide's antitumor activity involves crosslinking of DNA; it inhibits proliferation and induces apoptosis of hematopoietic and solid tumor cells and (with dexamethasone) has demonstrated synergistic cytotoxicity in multiple myeloma cell lines, including melphalan-resistant and nonresistant cell lines
MBP 263.0 Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
Lutetium Lu 177 (177Lu) vipivotide tetraxetan is a radioligand therapeutic agent. The active moiety of lutetium 177Lu vipivotide tetraxetan is the radionuclide lutetium-177, which is linked to a moiety that binds to prostate-specific membrane antigen (PSMA), a transmembrane protein that is expressed in prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC). Upon binding of lutetium 177Lu vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from 177Lu delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage, which can lead to cell death.
MBP 200.0 Polivy (polatuzumab vedotin-piiq)
Polivy (polatuzumab vedotin-piiq) is an antibody drug conjugate (ADC) directed at CD79b which consists of 3 components: 1) a CD79b-specific humanized IgG1 antibody; 2) a microtubule-disrupting agent, monomethylauristatin E (MMAE); and 3) a protease cleavable linker (which covalently conjugates MMAE to the polatuzumab antibody). The conjugate binds to CD79b (B-cell specific cell surface protein commonly expressed in mature B cell lymphomas, and forms a complex which is internalized within the cell and releases MMAE. MMAE binds to the tubules and disrupts the cellular microtubule network, inducing cell cycle arrest (G2/M phase) and apoptosis.
MBP 142.0 Portrazza (necitumumab)
Portrazza (necitumumab) is a recombinant human IgG1 EGFR monoclonal antibody that binds (with a high affinity) to the ligand binding site of the EGFR receptor to prevent receptor activation and downstream signaling.
Portrazza is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).
MBP 185.0 Poteligeo (mogamulizumab-kpkc)
Poteligeo (mogamulizumab-kpkc) is a first-in-class defucosylated, humanized IgG1 kappa monoclonal antibody which selectively binds to C-C chemokine receptor 4 (CCR4). CCR4 mediates cell trafficking of lymphocytes to skin and various organs and is consistently expressed on the surface of T-cell malignancies (eg, mycosis fungoides, Sézary syndrome, adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma) (Kim 2018). Mogamulizumab-kpkc binding to CCR4 targets a cell for antibody-dependent cellular cytotoxicity (ADCC), resulting in target cell depletion.
MBP 143.0 Praxbind (idarucizumab)
Praxbind (idarucizumab), a specific reversal agent for Pradaxa (dabigatran), is a humanized monoclonal antibody fragment (Fab) that binds specifically to dabigatran and its acylglucuronide metabolites with an affinity for dabigatran that is approximately 350 times greater than that of thrombin, and neutralizes the anticoagulant effect within minutes.
Praxbind is indicated for reversal of the anticoagulant effects of dabigatran for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
MBP 177.0 Prevymis IV (letermovir)
Prevymis IV (letermovir) is an antiviral agent that inhibits cytomegalovirus (CMV) replication by targeting the CMV DNA terminase complex (pUL51, pUL56, pUL89), which is required for viral DNA processing and packaging. Letermovir affects production of genome unit lengths and alters virion maturation.
MBP 58.0 Prialt (ziconotide intrathecal infusion)
Prialt (ziconotide intrathecal infusion) is a non-opioid analgesics categorized as an N-type calcium channel blocker (NCCB). Prialt is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus. Research in animals suggests that Prialt works by targeting and blocking N-type calcium channels on nerves in the spinal cord that ordinarily transmit pain signals.
Prolia (denosumab) is a human IgG2 monoclonal antibody (fully human, lab-produced antibody) that inactivates the body's bone-breakdown mechanism by targeting a chemical signal called RANK ligand, an essential part of the body's natural process for breaking down bone.
MBP 79.0 Provenge (sipuleucel-T)
Provenge (sipuleucel-T) is an immunotherapy product consisting of autologous dendritic cells loaded ex vivo with a recombinant fusion protein. The goal of therapy is to induce therapeutic immunity against prostate cancer cells by targeting the PAP tumor antigen, which is expressed on greater than 95% of prostate cancer cells.
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