Letters of Medical Necessity by Drug
Payer-specific LMN templates, denial reasons, and appeal strategies for the most-prescribed specialty drugs in the United States.
Humira (adalimumab) prior authorization denials are among the most common in specialty pharmacy. Most denials are reversible with a properly written L...
Stelara (ustekinumab) is frequently denied on first submission due to step therapy requirements that mandate failure of a TNF inhibitor. A well-constr...
Dupixent (dupilumab) prior authorization requests routinely require detailed documentation of severity scoring and prior topical/oral therapy. Missing...
Ozempic (semaglutide) denials almost always cite A1c thresholds, metformin trial documentation, or off-label weight-loss use. A precise LMN that addre...
Mounjaro (tirzepatide) is a newer dual GIP/GLP-1 agonist that frequently faces step therapy hurdles requiring failure of a single-mechanism GLP-1 firs...
Enbrel (etanercept) is a first-generation TNF inhibitor that remains widely prescribed but increasingly faces biosimilar substitution pressure. A targ...
Cosentyx (secukinumab) denials commonly cite step therapy, missing severity scoring, or IBD history. A successful LMN addresses each criterion explici...
Skyrizi (risankizumab) is increasingly used as a high-efficacy IL-23 option but typically requires documented failure of preferred therapies. LMNs sho...
Otezla (apremilast) is often a non-injectable alternative for patients who cannot tolerate or prefer to avoid biologics. LMNs should highlight patient...
Rinvoq (upadacitinib) carries a JAK class boxed warning that drives strict prior authorization criteria. LMNs must explicitly address age, cardiovascu...
Wegovy (semaglutide 2.4mg) prior authorization requires meticulous BMI and comorbidity documentation. Many plans categorically exclude weight-loss age...
Zepbound (tirzepatide) prior authorization typically requires documented BMI, weight-related comorbidities, and step therapy through Wegovy on many fo...
Trulicity (dulaglutide) is often a step therapy alternative when Ozempic is preferred. LMNs should address prior treatment, A1c targets, and CV risk i...
Jardiance (empagliflozin) has multiple guideline-endorsed indications across cardiometabolic disease. PA denials are usually fixable by clarifying whi...
Farxiga (dapagliflozin) prior authorization may require documentation of indication and prior step therapy through preferred SGLT2 inhibitors like emp...
Eliquis (apixaban) is one of the most prescribed DOACs but faces significant prior authorization friction on Medicare Part D plans. A targeted LMN can...
Xarelto (rivaroxaban) prior authorization is typically driven by formulary preference for Eliquis. LMNs should address why rivaroxaban is preferred fo...
Jakafi (ruxolitinib) requires confirmed hematologic diagnosis with cytogenetic/molecular workup and risk stratification. LMNs must include the diagnos...
Imbruvica (ibrutinib) is increasingly facing step therapy through second-generation BTK inhibitors with better cardiac safety profiles. A clinical rat...
Keytruda (pembrolizumab) prior authorization is highly indication-specific. The LMN must specify the exact tumor type, line of therapy, and biomarker ...
Opdivo (nivolumab) PA decisions hinge on tumor-specific biomarker results, line of therapy, and the specific regimen requested. Precise documentation ...
Tagrisso (osimertinib) requires confirmed EGFR mutation status. The LMN should include the specific mutation, testing methodology, and line of therapy...
Ibrance (palbociclib) prior authorization requires documentation of HR+/HER2- status and the planned combination partner. Newer CDK4/6 inhibitors may ...
Verzenio (abemaciclib) is the only CDK4/6 inhibitor approved for adjuvant therapy in high-risk HR+/HER2- early breast cancer. PA criteria differ betwe...
Darzalex (daratumumab) prior authorization requires precise specification of the regimen, line of therapy, and clinical rationale for the chosen combi...
Revlimid (lenalidomide) requires REMS program enrollment due to teratogenicity. With generic lenalidomide now available, PAs increasingly require just...
Biktarvy (bictegravir/FTC/TAF) is a guideline-recommended first-line ARV regimen. PA denials are usually correctable with baseline labs and resistance...
Descovy (FTC/TAF) PA for PrEP often requires step therapy through generic Truvada. Patient-specific renal or bone health concerns can justify Descovy ...
Vyvanse (lisdexamfetamine) PA decisions are increasingly driven by generic availability. LMNs should specify the indication and clinical rationale for...
Concerta (OROS methylphenidate ER) PA challenges typically center on brand vs generic equivalence concerns and adherence to delivery system specificat...
Lyrica (pregabalin) PA denials are usually correctable with documentation of indication, prior gabapentin trial, and severity of symptoms....
Restasis (cyclosporine ophthalmic) PA typically requires documented failure of artificial tears and objective dry eye disease severity measures....
Xolair (omalizumab) prior authorization requires specific clinical and laboratory criteria including IgE level, weight, and prior controller therapy t...
Nucala (mepolizumab) requires documented blood eosinophilia and severe disease despite high-dose controller therapy. Missing eosinophil counts is the ...
Fasenra (benralizumab) PA decisions often hinge on eosinophil count, prior biologic trials, and exacerbation history....
Tezspire (tezepelumab) is the only severe asthma biologic without a phenotype/biomarker restriction, making it useful for non-T2 high patients. PAs re...
Tysabri (natalizumab) carries PML risk and requires JCV antibody monitoring under the TOUCH program. PAs require comprehensive risk documentation....
Ocrevus (ocrelizumab) is the only approved therapy for primary progressive MS. PAs require diagnosis confirmation and pre-treatment screening document...
Kesimpta (ofatumumab) is a self-administered subcutaneous anti-CD20 for MS. PAs may require step therapy through preferred DMTs....
Aimovig (erenumab) requires documented migraine frequency and failure of two oral preventives per most payer policies. A headache diary is essential....
Ajovy (fremanezumab) PA criteria are similar to Aimovig: documented migraine frequency and failure of multiple oral preventives....
Emgality (galcanezumab) is approved for both migraine and episodic cluster headache prevention. PA documentation differs by indication....
Spravato (esketamine) requires REMS-certified administration and documented treatment-resistant depression. PAs require detailed prior treatment histo...
Caplyta (lumateperone) typically requires step therapy through generic atypical antipsychotics. LMNs should address tolerability concerns or specific ...
Rexulti (brexpiprazole) PA criteria differ by indication. For dementia agitation, the boxed warning acknowledgment and behavioral non-pharmacologic tr...
Eylea (aflibercept) prior authorization is often challenged because off-label bevacizumab (Avastin) is dramatically cheaper. LMNs should address prior...
Lucentis (ranibizumab) PA increasingly requires step therapy through bevacizumab or a ranibizumab biosimilar. LMNs should justify originator selection...
Spinraza (nusinersen) PA requires genetic confirmation of SMA, functional baseline, and documentation of intrathecal administration plan....
Evrysdi (risdiplam) is the oral SMA therapy. PAs require genetic confirmation, weight, and clarification on concurrent or prior SMA-modifying therapy....
Xeljanz (tofacitinib) carries a JAK class boxed warning stemming from the ORAL Surveillance trial, leading to stringent prior authorization criteria t...
Nurtec ODT (rimegepant) is the only CGRP therapy approved for both acute and preventive migraine treatment. Prior authorization commonly requires docu...
Entyvio (vedolizumab) prior authorization typically requires step therapy through a TNF inhibitor and documentation of moderate-to-severe disease acti...
Tremfya (guselkumab) is an IL-23 inhibitor with strong long-term efficacy data in psoriasis and psoriatic arthritis. PAs typically require step therap...
Taltz (ixekizumab) prior authorization commonly requires step therapy through a TNF inhibitor and documented severity scores. When secukinumab is pref...
Calquence (acalabrutinib) is a second-generation BTK inhibitor with improved cardiac safety over ibrutinib. PAs require diagnosis confirmation, cytoge...
Trikafta (elexacaftor/tezacaftor/ivacaftor) is the standard of care for cystic fibrosis patients with at least one F508del mutation. PA requires CFTR ...
Repatha (evolocumab) prior authorization requires rigorous documentation of maximally tolerated statin therapy, ezetimibe trial, and residual LDL-C ab...
Praluent (alirocumab) PA criteria mirror Repatha requirements but may additionally require step therapy through the formulary-preferred PCSK9 inhibito...
Xtandi (enzalutamide) prior authorization requires documentation of castration resistance, disease stage, and line of therapy. Formulary preference fo...
Kisunla (donanemab) is an anti-amyloid antibody for early Alzheimer's disease. Prior authorization is highly restrictive, requiring confirmed amyloid ...
Cobenfy (xanomeline/trospium) represents the first novel mechanism for schizophrenia in decades. Prior auth often requires documentation of atypical a...
Winrevair (sotatercept) is a first-in-class treatment for pulmonary arterial hypertension added to background therapy. Prior authorization requires do...
Omvoh (mirikizumab) is an IL-23 inhibitor for ulcerative colitis and Crohn's disease. Prior auth typically requires TNF inhibitor failure documentatio...
Columvi (glofitamab) is a bispecific antibody for relapsed DLBCL after two or more prior therapies. Prior authorization requires detailed documentatio...
Jaypirca (pirtobrutinib) is indicated for MCL patients who have progressed on a prior covalent BTK inhibitor. Documentation of prior BTK inhibitor use...
Blincyto (blinatumomab) is a bispecific T-cell engager for B-cell ALL, used in both relapsed/refractory and MRD-positive settings. Prior authorization...
Botox (onabotulinumtoxinA) is one of the highest-volume prior authorization drugs in the country, with denial patterns varying sharply by indication. ...
Actemra (tocilizumab) is denied at high rates when payers require failed TNF inhibitor therapy first or when site-of-care policies redirect infusions....
Orencia (abatacept) frequently faces step-therapy denials requiring prior TNF inhibitor failure. Citing seropositive RA with extra-articular features ...
Cimzia (certolizumab pegol) is uniquely positioned for patients who are pregnant or planning pregnancy due to its minimal placental transfer. Letters ...
Hemlibra (emicizumab-kxwh) is an extremely high-cost specialty therapy ($400K+ annually) with stringent prior authorization requirements. A complete L...
Soliris (eculizumab) carries one of the highest annual costs in pharmacy ($500K+) and faces uniformly strict prior authorization. Many payers now pref...
Vraylar (cariprazine) is commonly denied via step-therapy requirements that mandate two generic atypical antipsychotic trials. Letters of Medical Nece...
Mavyret (glecaprevir/pibrentasvir) prior authorization is highly state-Medicaid- and payer-specific, with sobriety, fibrosis-stage, and specialist req...
Tecfidera (dimethyl fumarate) faces frequent denials in favor of authorized generics or Vumerity. A Letter of Medical Necessity citing prior intoleran...
Zolgensma (onasemnogene abeparvovec-xioi) is the highest-priced one-time therapy in U.S. healthcare (~$2.1M) and prior authorization requirements are ...