ModifiedIndependent HealthPolicy N/A

Keveyis_Formulary_Changes_and_Coverage_Determination_Process

Notifies that Keveyis 5 mg tablets were removed from the pharmacy benefit formulary (Dimensions PDP Tier 5) effective 2024-08-01 with Ormalvi 5 mg tablets listed as the generic alternative, and describes the process for requesting coverage determinations and exceptions for non-formulary drugs.

Policy Summary

PayerIndependent Health

PolicyKeveyis_Formulary_Changes_and_Coverage_Determination_Process

Policy CodePolicy N/A

Change TypeFormulary deletion; generic alternative added

Effective DateAug 1, 2024

Next Review DateN/A

Key ActionSubmit a supporting statement demonstrating medical necessity or that formulary alternatives are less effective or cause adverse effects when requesting a coverage determination or exception.

SourceLink

POLICY UPDATE CHANGES

Keveyis 5 mg tablets removed from Pharmacy Benefit Dimensions PDP Tier 5 formulary.

Ormalvi 5 mg tablets designated as generic alternative to Keveyis.

1Formulary Deletions

1Generic Alternatives Added

2Provider Submission Methods

What changed and scope

This bulletin notifies that Keveyis 5 mg tablets were removed from the Pharmacy Benefit (Dimensions PDP Tier 5) effective 2024-08-01, and that Ormalvi 5 mg tablets are designated as the generic alternative. It describes the plan's process for coverage determinations and exception requests for non-formulary drugs, which require a prescriber's supporting statement demonstrating medical necessity or why formulary alternatives are less effective or would cause adverse effects, and provides submission methods and timelines for review.

Key details

Effective date2024-08-01

StatusMODIFIED

SubjectKeveyis 5 mg formulary deletion and coverage determination process

Scope summaryKeveyis 5 mg tablets removed from Pharmacy Benefit Dimensions PDP Tier 5 formulary effective 8/1/2024; Ormalvi 5 mg tablets listed as the generic alternative; describes process for coverage determinations and exceptions for non-formulary drugs.

Formulary changes

The following material changes are summarized below (document-level changes_list will be populated): this is a material change. First, Keveyis 5 mg tablets were removed from the formulary (Dimensions PDP Tier 5). Second, Ormalvi 5 mg tablets were added/designated as the generic alternative to Keveyis.

Formulary Drug MentionedNDC|mixedNot Covered

Keveyis 5Omg tablets

Formulary deletion from Pharmacy Benefit Dimensions PDP Tier 5; removed effective 8/1/2024

Generic AlternativeNDC|mixedCovered

Ormalvi 5Omg tablets

Listed as generic alternative to Keveyis

Coverage determination & exception criteria

Expedited vs Standard Review Timeframes

Coverage determination or exception requests are allowed when the prescriber provides a supporting statement:

ALL of the following

Requested drug is non-formulary or coverage rule exception is sought
Prescriber provides a supporting statement demonstrating medical necessity OR that formulary alternatives would be less effective or cause adverse effects
For prior authorization or other coverage rule requests, prescriber statement must show the coverage rule is inappropriate or would cause adverse effects for the patient

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What providers must do

Prior Authorization

Coverage determination / exception request submission

Submit a supporting statement demonstrating medical necessity or that formulary alternatives would be less effective or cause adverse effects; for prior authorization or other coverage rule exceptions explain why the rule is inappropriate or would cause adverse effects for the patient.

Effective 8/1/2024
Keveyis removed; Ormalvi designated as the generic alternative

Documentation Required

Supporting statement requirements

Include a supporting statement that: the requested non‑formulary drug is medically necessary because formulary alternatives would be less effective or cause adverse effects; and for prior authorization or other coverage rule exceptions, explain why the coverage rule is inappropriate or would harm the patient.

Prior Authorization

Where to send requests

Mail requests to Independent Health's Pharmacy Department or fax to the numbers listed.

Mail: Independent Health's Pharmacy Department, 511 Farber Lakes Drive, Buffalo, NY 14221
Fax: (716) 631-9636 or 1-800-273-7397

Documentation Required

Expedited request criteria

Request expedited review by indicating that waiting for a standard decision may seriously jeopardize the patient's life, health, or ability to regain maximum function. Expedited decisions are made within 24 hours when that criterion is met.

Expedited: decision no later than 24 hours from receipt
Standard: decision no later than 72 hours from receipt
For exceptions the timeframe begins when the plan obtains the prescriber's supporting statement

Timelines & FAQs

Question: How long will it take to get a decision on a coverage determination or exception? Answer: Expedited requests: decision notified no later than 24 hours from receipt; Standard requests: decision notified no later than 72 hours from receipt; and for exceptions the timeframe begins when the plan obtains the prescriber's supporting statement.

Review timeframes

Expedited decision window24 hours

Standard decision window72 hours

Exception timeframe startsWhen prescriber's supporting statement is received by the plan

Document changes

2024-08-01formulary_removalLatest

Keveyis 5 mg tablets removed from Pharmacy Benefit Dimensions PDP Tier 5 formulary (formulary deletion due to availability of generic alternative).

therapeutic_substitution

Ormalvi 5 mg tablets designated as the generic alternative to Keveyis (listed on therapeutic substitution list).