CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Specialty Drug Prior Authorization Criteria

Defines medical necessity and authorization requirements for specialty and pharmacy drugs for Neighborhood Health Plan of Rhode Island members requesting prior authorization for specialty pharmaceuticals.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySpecialty Drug Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2019

Next Review DateN/A

Key ActionObtain prior authorization confirming FDA-approved or compendia-supported indication, dosing within guidelines, and required prior treatment history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2therapy failures req'd

12 momax duration

FDA/compendiaaccepted sources

01/2024last reviewed

Coverage Criteria

Initial Criteria: (A) The requested drug/product is being used for an FDA-approved indication or a medically accepted indication as defined in a standard reference compendium (AHFS-DI, DrugDex, Clinical Pharmacology, Lexi-Drugs) or peer-reviewed medical literature; (B) The prescribed dose and quantity fall within FDA-approved labeling or compendia-supported dosing guidelines; (C) One of the following: (a) inadequate treatment response or intolerance to two comparable formulary alternatives for the same indication, including generic or biosimilar alternatives if available; (b) if fewer than two comparable formulary alternatives exist, inadequate response or intolerance to all available formulary alternatives, including generic or biosimilar alternatives if available; (c) if no comparable formulary alternatives exist, provide rationale why the requested drug/product is medically necessary.see node text

From section I.

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continuation Criteria: (A) Patient meets all initial criteria in section I; (B) Patient is tolerating treatment and is not experiencing any unacceptable toxicity from the drug; (C) Patient has disease stabilization or improvement in disease as defined by established clinical practice guidelines.clinical improvement or stabilization

From section II.

This policy does not list any explicit coverage exclusions. The document’s approval criteria focus on requirements for initial and continuation authorization (see Section I and II) and do not specify separate categories of services or indications that are explicitly excluded from coverage.

The policy does not provide a standalone list of non-covered items. Instead, treatment that fails to meet the stated authorization requirements in Section I (initial criteria) or Section II (continuation criteria) is considered not medically necessary. In practice, requests that do not demonstrate an FDA-approved or compendia-supported indication, dosing within labeled or compendia-supported ranges, or the required prior treatment history (or ongoing benefit/tolerability for continuation) would be denied as not medically necessary.

Initial Therapy Criteria

inv-11: Initial Therapy

Initial authorization requirements

Initial: Indication must be FDA-approved or supported by a listed compendium or peer-reviewed literature; prescribed dose and quantity must be within FDA labeling or compendia-supported dosing guidelines; and one of: (1) inadequate response or intolerance to two comparable formulary alternatives (including generic/biosimilar if available), (2) if fewer than two comparable alternatives exist, inadequate response or intolerance to all available alternatives (including generic/biosimilar if available), (3) if no comparable alternatives exist, provide rationale why requested drug/product is medically necessary.see text

Section I.

Continuation of Therapy Criteria

inv-12: Continuation of Therapy

Continuation requests must meet the continuation criteria

Continuation: Meets all initial criteria in section I; tolerating treatment without unacceptable toxicity; demonstrates disease stabilization or improvement as defined by established clinical practice guidelines.clinical benefit observed

Section II.

Provider Actions / Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted when the requested drug is for an FDA‑approved or compendia‑supported indication, and dosing/quantity fall within FDA or compendia‑supported ranges. Provide documentation demonstrating indication, dose, and clinical rationale.

Affected: prescription drugs requiring PA per formulary

Step Therapy

Step Therapy / Prior Treatment Requirements

Generally requires inadequate response or intolerance to two comparable formulary alternatives (including generic/biosimilar when available). If fewer than two alternatives exist, failure or intolerance to all available alternatives is required. If no comparable alternatives exist, provide rationale why the requested drug is medically necessary.

Documentation Required

Required Documentation

Provide documentation showing the indication is FDA‑approved or supported by a listed compendium or peer‑reviewed literature; include prescribed dosage, quantity, prior treatment history (names of prior agents, durations, and reasons for discontinuation), and clinical rationale for medical necessity.

Denial Risk

Denial Triggers

Denial may be issued for failure to demonstrate an FDA‑approved or compendia‑supported indication, dosing outside FDA or compendia‑supported ranges, or lack of required prior trials/step therapy documentation.

Step Therapy Requirements

Prior agent(s) tried	Number of trials required	Documented reason(s) for failure or intolerance
Comparable formulary alternatives (including generic and biosimilar if available)	2 (or all available if fewer than two exist)	Inadequate treatment response or intolerance as documented in clinical notes; if no alternatives exist, provide clinical rationale for medical necessity.

Quantity Limits and Coding

Quantity limits — Coverage duration

Maximum duration per authorizationUp to 12 months

Determining authoritiesCoverage duration determined by FDA guidance and internal policies and procedures

Period unitPer authorization / year

Definitions

Medically accepted indication — Definition

DefinitionAn indication supported by one of the listed standard reference compendia (AHFS-DI, DrugDex, Clinical Pharmacology, Lexi-Drugs) or peer-reviewed medical literature.

Accepted compendiaAmerican Hospital Formulary Service Drug Information (AHFS-DI); Thomson Micromedex DrugDex; Clinical Pharmacology; Wolters Kluwer Lexi-Drugs.

Alternative evidencePeer-reviewed published medical literature demonstrating sufficient evidence to support use.

Background

This policy frames prior authorization decisions for specialty pharmaceuticals by aligning coverage with FDA-approved indications or an indication supported by recognized compendia (AHFS-DI, DrugDex, Clinical Pharmacology, Lexi-Drugs) or peer-reviewed literature. Authorization is contingent on dosing consistent with FDA labeling or compendia-supported guidance and demonstration of prior treatment failure/intolerance to formulary alternatives when required.