ModifiedmhnPolicy CP.PHAR.198

Clinical Policy: Tadalafil (Adcirca, Alyq, Tadliq)

Covers medical necessity and prior authorization criteria for tadalafil products (Adcirca, Alyq, Tadliq) for treatment of pulmonary arterial hypertension (PAH) for Centene-affiliated health plans across listed lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Tadalafil (Adcirca, Alyq, Tadliq)

Policy CodePolicy CP.PHAR.198

Change TypeMaterial updates (step therapy bypass, approval duration, formulation added)

Effective Date03.16

Next Review Date

Key ActionSubmit prior authorization with documentation showing PAH diagnosis, prescriber specialty, prior calcium channel blocker failure (unless exception), and that requested dose/quantity do not exceed plan limits.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

Added requirement that request does not exceed health-plan approved quantity limit.

Extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

Newly approved oral suspension formulation Tadliq added to policy.

Criteria clarified to also apply to brand Adcirca, Alyq, and Tadliq.

Removed commercially unavailable branded products from Appendix B.

40 mg/daymaximum daily dose

12 monthsapproval duration (Medicaid/HIM)

WHO Group 1indicated population

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial PAH approval criteria: 1. Diagnosis of pulmonary arterial hypertension (PAH). 2. Prescribed by or in consultation with a cardiologist or pulmonologist. 3. Failure of a calcium channel blocker (see Appendix B), unless member meets one of the following: (a) inadequate response or contraindication to acute vasodilator testing; (b) contraindication to or clinically significant adverse effects from calcium channel blockers. 4. If request is for brand Adcirca, Alyq, or Tadliq, member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced, or for Tadliq requests the member is unable to swallow tablets (Illinois HIM Tadliq step therapy exception per IL HB 5395). 5. Request does not exceed the health-plan approved quantity limit. 6. Dose does not exceed one of the following: (a) Adcirca or Alyq: i. 40 mg per day; ii. 2 tablets per day; (b) Tadliq: i. 2 bottles per month; ii. 300 mL per month.

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: 1. Member is currently receiving medication via Centene benefit, has previously met initial approval criteria, or is enrolled in a state/product with continuity of care regulations. 2. Member is responding positively to therapy. 3. If request is for brand Adcirca, Alyq, or Tadliq, member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced, or for Tadliq requests the member is unable to swallow tablets (Illinois HIM Tadliq step therapy exception per IL HB 5395). 4. Request does not exceed the health-plan approved quantity limit. 5. If a dose increase is requested, the new dose does not exceed one of the following: (a) Adcirca or Alyq: i. 40 mg per day; ii. 2 tablets per day; (b) Tadliq: i. 2 bottles per month; ii. 300 mL per month.

inv-03: Other diagnoses/indications

Other diagnoses/indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, new dosing), refer to either: (a) the no coverage criteria policy for the relevant line of business for drugs on the formulary/PDL (CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, CP.PMN.255 for Medicaid); or (b) the non-formulary policy for the relevant line of business for drugs NOT on the formulary/PDL (CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, CP.PMN.16 for Medicaid). 2. If the requested use (diagnosis, age, dosing) is not specifically listed under Section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Non–FDA approved uses of tadalafil that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

Commercially unavailable branded tadalafil products that were removed from Appendix B during the 1Q 2024 annual review are not considered for coverage. Requests should be evaluated against the remaining referenced branded and generic formulations included in the policy.

Coding and Referenced Products

Referenced Products and formulationsmixed

Adcirca	Tablet: 20 mg
Alyq	Tablet: 20 mg
Tadliq	Oral suspension: 20 mg/5 mL in 150 mL bottle

inv-07: Maximum daily dose — 40 mg/day

Maximum daily doseAdcirca/Alyq/Tadliq: 40 mg per day (equivalent to 2 tablets/day for Adcirca/Alyq; Tadliq 40 mg [10 mL] PO QD)

Alternate expression40 mg/day (listed as maximum dose for Adcirca, Alyq, and Tadliq)

Dose limit contextDose not to exceed specified maximums for initial and continuation approvals per policy

inv-08: Initial approval duration (Medicaid and HIM) — 12 months

Initial approval duration (Medicaid and HIM)12 months (Medicaid and HIM initial approval duration extended from 6 months to 12 months)

Typical review noteApplied for maintenance medication for chronic condition per policy revision

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests of tadalafil (including Adcirca, Alyq, and Tadliq). Provider must demonstrate that the member meets the policy’s approval criteria (diagnosis, prescriber specialty, prior therapies/step requirements, dosing and quantity limits).

Prior authorization required for initial and continuation requests
Prescriber: cardiologist or pulmonologist or in consultation with one

Documentation Required

Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, consultation notes, prior trial documentation) that shows the member meets all approval criteria. Failure to provide adequate documentation may result in denial of the request.

Include evidence of diagnosis, prior vasoreactivity testing or reason for bypass, prior trial of calcium channel blocker when applicable, and documentation justifying brand use if requested

Definitions

inv-18: PAH — Pulmonary arterial hypertension (WHO Group 1) definition and context

DefinitionPulmonary arterial hypertension (PAH) is WHO Group 1 pulmonary hypertension treated with targeted therapies including PDE5 inhibitors (tadalafil)

Indication statementAdcirca, Alyq, and Tadliq are indicated to improve exercise ability in PAH (WHO Group 1)

Clinical study populationStudies establishing effectiveness included predominantly patients with idiopathic/heritable PAH and connective tissue disease–associated PAH

inv-19: NYHA/WHO Functional Class — classification used in PAH studies (e.g., Class II-III)

Functional class used in studiesNYHA/WHO Functional Class II–III were predominantly enrolled in studies establishing tadalafil efficacy

Purpose of classification

Background

Tadalafil is a phosphodiesterase‑5 (PDE5) inhibitor indicated to improve exercise capacity in pulmonary arterial hypertension (WHO Group 1). Clinical trials establishing effectiveness primarily enrolled patients with NYHA/WHO Functional Class II–III disease and etiologies such as idiopathic/heritable PAH or connective tissue disease–associated PAH. Formulations referenced in this policy include branded tablets and the newly added oral suspension (Tadliq).