Prior Authorization Required

Pharmacy Benefit Dimensions requires prior authorization (PA) for drugs listed with a 'PA' on the Pharmacy Benefit Dimensions PDP Part D formulary. If prior authorization is not obtained for a PA-designated drug, coverage may be denied.

• PA drugs are identified by 'PA' on the formulary and require approval before dispensing.
• Contact Medicare Member Services for questions: 1-800-667-5936 (TTY 711).

Cablivi — PA specifics

Cablivi (caplacizumab) will only be authorized when the request documents the diagnosis of aTTP and confirms caplacizumab will be administered with plasma exchange and immunosuppressive therapy. If the request is for subsequent use, submit prior aTTP recurrences while on caplacizumab; coverage will not be authorized for >2 recurrences while on therapy. Initial coverage duration is 3 months; prescribers restricted to cardiology, hematology, or immunology; patient age ≥18.

• Must document concomitant plasma exchange and immunosuppressive therapy.
• If not first use, submit prior aTTP recurrences on caplacizumab; >2 recurrences while on therapy = no authorization.
• Coverage duration: 3 months initial.

Prior authorization — required documentation

Most products in this section require prior authorization. Requests must include the diagnosis and the specific required clinical documentation (labs, genetic or mutation testing where applicable). Failure to provide required information may delay or deny coverage.

• Submit current or previous therapies used to treat the condition where requested.
• Provide pregnancy status for females of childbearing potential when noted.
• Include baseline labs or testing specified for the product (e.g., LFTs, CBC, mutation testing).

CHOLBAM — prior authorization requirements

CHOLBAM prior authorization requires a diagnosis of the covered use and submission of liver function testing. Prescriber specialties limited to gastroenterology, hepatology, and pediatric gastroenterology. Initial coverage is 3 months, then 1 year for subsequent authorizations. For first reauthorization, document liver function improvement without complete biliary obstruction or persistent/worsening cholestasis; annual LFTs are required thereafter.

• Initial authorization: 3 months; subsequent: 1 year.
• Required: liver function testing at initial request and updated LFTs for reauthorization.
• Prescriber restriction: gastroenterology/hepatology/pediatric gastroenterology.

ROS1-positive therapy — prerequisite and documentation

For ROS1-positive tumor therapies, submit a test confirming ROS1-positive status and pregnancy status for females of childbearing potential. For initial authorization, the patient must have tried and failed to have an adequate response to, or had intolerance/contraindication to, either crizotinib or entrectinib unless contraindicated.

• Submit documentation of ROS1-positive tumor testing.
• Attestation of prior trial/failure or intolerance to crizotinib or entrectinib, or documentation of contraindication to both.
• Prescriber restriction: oncology; age ≥18.

LIVTENCITY — authorization requirements

LIVTENCITY authorization requires documentation of diagnosis and a documented history of hematopoietic stem cell or solid organ transplant when applicable. The patient must have tried and failed at least one of cidofovir, foscarnet, ganciclovir, or valganciclovir prior to approval. Prescribers must be in hematology, infectious diseases, oncology, or transplant specialty. Coverage duration is 8 weeks.

• Submit history of transplant when applicable.
• Document prior failure of at least one of cidofovir, foscarnet, ganciclovir, or valganciclovir.
• Prescriber restriction: hematology, infectious disease, oncology, or transplant specialty; age ≥12.

GLP-1 agonists — off‑label exclusion for weight management

GLP-1 agonists and related products will not be approved for weight management under Medicare Part D (off-label exclusion). When covered uses apply (e.g., diabetes), submit documentation of the covered diagnosis and attest the patient is not receiving another GLP-1 agonist for the treatment of any condition if required by the product-specific criteria.

• Off-label use for weight management is excluded under Medicare Part D.
• For diabetes indications, provide diagnostic evidence (medical record, ICD-10, or lab results such as A1c).
• Attestation if required that the patient is not receiving another GLP-1 agonist for treatment.

VOQUEZNA/vonoprazan — prior PPI trial requirement and denial risk

VOQUEZNA/vonoprazan (TAVNEOS/vanoprazan entries) — for erosive esophagitis and non-erosive GERD prior authorization requires documentation that the patient tried and failed two different proton pump inhibitors (PPIs) unless contraindicated. Failure to document these prior PPI trials may delay or result in denial of coverage.

• Initial authorization for erosive esophagitis/non-erosive GERD: trial/failure of two different PPIs required.
• Non-erosive GERD initial coverage 4 weeks with option to extend; H. pylori treatment limited to a single 14-day course when applicable.
• Risk: missing documentation of prior PPI trials may delay or deny coverage.

PAH documentation — right heart catheterization and related data

Pulmonary arterial hypertension (PAH) therapy PA requests must include right heart catheterization data: mean pulmonary arterial pressure (mPAP), pulmonary arterial wedge pressure (PAWP), and pulmonary vascular resistance (PVR). Also submit WHO Group classification, creatinine clearance (or serum creatinine with weight/height), pregnancy status, and current or previous therapies used to treat the condition.

• Required hemodynamics: mean PAP >20 mm Hg, PAWP ≤15 mm Hg, and PVR >2 Woods units for WHO Group 1 PAH.
• For CTEPH (WHO Group 4) provide PVR >3 Woods units and evidence of chronic pulmonary embolism with attestation of inoperable or persistent/recurrent disease after surgery.
• Prescriber restrictions: cardiology or pulmonology; age ≥18.

CERDELGA — required testing and exclusions

CERDELGA (eliglustat) PA requests must include diagnosis, CYP2D6 metabolizer status from genotype testing, and liver function testing or a Child‑Pugh score. Exclusions include ultrarapid CYP2D6 metabolizers, pre-existing cardiac disease, moderate/severe hepatic impairment, long QT syndrome, and coadministration with Class Ia or Class III antiarrhythmics. Annual reauthorization requires updated LFTs or Child‑Pugh score.

• Submit CYP2D6 genotype and metabolizer status.
• Provide baseline and updated liver function testing or Child‑Pugh score for reauthorization.
• Do not approve for ultrarapid CYP2D6 metabolizers or those with listed cardiac/hepatic exclusions.

EoHILIA — diagnostic and prior-therapy documentation

EoHILIA (eosinophilic esophagitis therapy) PA requires diagnostic confirmation by upper endoscopy with biopsy showing ≥15 eosinophils per high-power field (or 60 eosinophils/mm2), documentation of relevant signs/symptoms, and evidence the patient tried and failed at least an 8‑week course of PPI therapy. Age minimum is 11; prescribers restricted to allergy, gastroenterology, immunology, or ENT. Coverage limited to 12 weeks (one course per 365 days).

• Submit upper endoscopy biopsy demonstrating required eosinophil count.
• Document symptoms (e.g., dysphagia, food impaction, reflux, chest/abdominal pain, nausea/vomiting).
• Confirm prior 8‑week PPI trial and that EoE is unrelated to GERD.

Ensacove — required tumor testing and attestation

Ensacove (ALK‑targeted agent) PA requires submission of a test confirming an ALK‑positive tumor, attestation that the patient has not previously received an ALK inhibitor, and pregnancy status for females of childbearing potential. Prior ALK‑inhibitor use and certain drug interactions are exclusionary.

• Submit ALK testing confirming ALK‑positive tumor.
• Attest patient has not received prior ALK‑inhibitor therapy.
• Prescriber restriction: oncology; age ≥18.

Baseline thiamine and platelet requirements

For agents with risks related to thiamine depletion or platelet effects (example: INREBIC/Imkeldi), submit baseline thiamine level and baseline platelet count. If thiamine is low, coverage will be delayed until repletion is documented.

• Baseline thiamine level required and baseline platelet count where specified.
• If thiamine deficiency is detected, provide documentation of repletion prior to approval.

RIVFLOZA — diagnostic documentation and reauthorization

RIVFLOZA prior authorization requires documentation of AGXT mutation confirmed by liver enzyme analysis or genetic testing, submission of 24‑hour urinary oxalate excretion (≥0.7 mmol, normalized for BSA if under 18), eGFR, and attestations that the patient has not received a prior kidney or liver transplant and will not use RIVFLOZA with lumasiran. Initial coverage is 6 months then 1 year; first reauthorization requires evidence of clinically relevant response.

• Submit AGXT mutation confirmation (enzyme analysis or genetic testing).
• Provide 24‑hour urinary oxalate excretion ≥0.7 mmol (normalize for BSA if <18).
• Attest no prior kidney/liver transplant and no concomitant lumasiran use.

Somavert — baseline labs and reauthorization attestations

Somavert (pegvisomant) PA requires documentation that surgery/radiation was not curative or is not an option, submission of baseline IGF‑1 and baseline liver function testing including bilirubin with transaminases ≤3× ULN. For first reauthorization submit IGF‑1 improvement from baseline, LFTs with transaminases <5× ULN, and attestation of no signs/symptoms of liver injury; annual reauthorization requires documented maintenance/improvement of IGF‑1.

• Baseline IGF‑1 and baseline LFTs including bilirubin required; transaminases must be ≤3× ULN at baseline.
• First reauthorization: updated IGF‑1 showing improvement and LFTs with transaminases <5× ULN; attest no clinical liver injury.
• Prescriber restriction: endocrinology; age ≥18.

Teriparatide — high fracture‑risk documentation required

Teriparatide (and similar anabolic agents) PA requires documentation the patient is at high risk for fracture. Provide fracture history, T‑scores, FRAX score, or other evidence supporting high fracture risk. For reauthorization beyond recommended durations, submit updated serum calcium and ongoing high‑risk evidence.

• Document high‑risk criteria: prior fragility fracture, T‑score thresholds, or FRAX risk supporting anabolic therapy.
• For annual reauthorization beyond 2 years, submit serum calcium and evidence the patient remains high risk.

TEPMETKO — diagnostic testing requirement

TEPMETKO prior authorization requires submission of testing confirming the presence of a MET exon 14 skipping mutation and pregnancy status for females of childbearing potential. Prescriber restriction: oncology; age ≥18.

• Submit test confirming MET exon 14 skipping mutation.
• Provide pregnancy status for females of childbearing potential.

Required medical information for oncology and specialty agents

Required medical information across oncology agents includes submitted diagnostic confirmation (e.g., tumor mutation testing such as ALK, ROS1, RET, EGFR where specified), pregnancy status for females of childbearing potential, and documentation of current or previous therapies used to treat the condition. Lack of required medical information may delay or deny approval.

• Submit tumor mutation test results when requested (ALK, ROS1, RET, EGFR, IDH1/2, etc.).
• Provide treatment history and rationale when prior‑therapy requirements apply.
• Include pregnancy status for females of childbearing potential.

Copiktra — prior therapy requirement

COPIKTRA prior authorization requires submission of the diagnosis and documentation that at least two prior systemic therapies were tried and failed. Prescriber restriction: hematology and oncology; patient age ≥18.

• Submit list and dates of at least two prior systemic therapies and reasons for failure/intolerance.
• Attest prophylaxis for PJP and CMV monitoring as required.

Imkeldi / ROS1‑class step requirement

Imkeldi/other ROS1‑style step requirements: for initial authorization of select agents the patient must have tried and failed to have an adequate response to or had an intolerance/contraindication to crizotinib or entrectinib prior to approval unless contraindicated. Prescriber restriction: oncology.

• Document trial/failure or intolerance to crizotinib or entrectinib for ROS1‑targeted agents.
• If contraindicated to those agents, provide rationale and supporting documentation.

Dronabinol — prior therapy requirement for CINV

For dronabinol when used for chemotherapy‑induced nausea and vomiting (CINV), prior authorization requires documentation that the patient has tried and failed or was intolerant to at least one 5‑HT3 receptor antagonist (e.g., granisetron, ondansetron). If the medication will replace IV antiemetic therapy within 48 hours of cancer treatment, indicate Part B coverage intent on the prescription.

• Submit prior antiemetic therapy trial and failure/intolerance (at least one 5‑HT3 antagonist).
• To request Part B coverage, prescribing physician must indicate the medication is a full replacement for IV antiemetic therapy within 48 hours of cancer treatment.

Sickle cell step therapy — l‑glutamine prerequisite

Sickle cell therapy (L‑glutamine) initial authorization requires documentation the patient is using, tried and failed to have an adequate response to, or had an intolerance/contraindication to hydroxyurea. Prescriber restriction: hematology.

• Document hydroxyurea use/trial and failure or intolerance/contraindication.
• Prescriber restriction: hematology.

Nubeqa — step therapy requirement

Nubeqa (darolutamide) authorization requires documentation the patient tried and failed or had intolerance to both Erleada (apalutamide) and Xtandi (enzalutamide) prior to approval for indicated uses.

• Submit prior trials/failures or intolerances to both apalutamide and enzalutamide.
• Prescriber restriction: oncology or urology as applicable.

Opsumit — step therapy requirement

Opsumit (macitentan) authorization requires trial/failure or intolerance to ambrisentan or bosentan prior to approval where step therapy is specified.

• Document trial/failure/intolerance to ambrisentan or bosentan prior to Opsumit approval.
• Provide current PAH therapy history and hemodynamics as required.

Caplyta — step therapy for bipolar I depressive episodes

Caplyta (lumateperone) initial authorization for depressive episodes of bipolar I disorder requires documentation that the patient tried and failed or had intolerance to at least two alternatives (e.g., cariprazine, lurasidone, olanzapine, quetiapine). For other indications, include therapy history per product criteria.

• Submit trials and reasons for failure/intolerance to at least two specified alternatives for bipolar I depression.
• Prescriber restriction: psychiatry; submit prior therapy history.

Sedative‑hypnotics — step requirement for patients ≥65

Sedative‑hypnotics (eszopiclone, zaleplon, zolpidem) PA applies to patients age 65 and older. Documentation must show at least two alternative medications were tried and deemed ineffective or intolerable (e.g., Belsomra, doxepin tablets, ramelteon, trazodone). Failure to provide this documentation may delay or deny authorization.

• PA applies only to patients ≥65 years of age.
• Document trial and failure/intolerance of at least two listed alternatives.
• Explain clinical rationale if alternatives are contraindicated or unsuitable.

Initiate tolvaptan where serum sodium can be closely monitored

For tolvaptan initiation, treatment should occur in a setting where serum sodium can be closely monitored, such as hospital outpatient, to ensure safe initiation and monitoring.

• Initiation site‑of‑care: hospital outpatient recommended for close sodium monitoring

Tolvaptan initiation requires monitored site‑of‑care (hospital outpatient)

Treatment initiation for tolvaptan should occur in a setting where serum sodium can be closely monitored (hospital outpatient) to mitigate rapid sodium changes and liver safety risks.