CurrentExecutive Office of Health and Human ServicesPolicy N/A

Pharmacy & Therapeutics Committee formulary recommendations and edits — coverage criteria

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Meeting minutes documenting P&T Committee decisions on therapeutic class reviews, formulary additions/changes, step edits, and communication actions affecting Medicaid drug coverage and prior authorization processes.

Policy Summary

PayerExecutive Office of Health and Human Services

PolicyPharmacy & Therapeutics Committee formulary recommendations and edits — coverage criteria

Policy CodePolicy N/A

Change TypeFormulary changes and step therapy updates

Effective Date

Next Review DateJun 3, 2014

Key ActionProvide prior authorization with documented medication history demonstrating required prior therapy or failure within specified look-back windows.

SourceLink

POLICY UPDATE CHANGES

SGLT-2 class (Invokana) was reviewed and accepted as a new class for P&T review with no preferred agents.

MS agents review: look-back for failure of preferred agent changed from 90 days to 360 days for Tecfidera.

Insulin formulary changed: added Levemir and removed Novolin/Novalog with a 90-day sundown and 60-day look-back for new prior authorization requests.

Victoza (liraglutide) will require step therapy: failure of Byetta within past 60 days unless patient is grandfathered.

Prolia (bone resorption inhibitor) has a new indication and will be added to a step edit requiring prior bisphosphonate use for a specified duration.

Multiple

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CurrentExecutive Office of Health and Human ServicesPolicy N/A

Pharmacy & Therapeutics Committee formulary recommendations and edits — coverage criteria

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Policy Summary

PayerExecutive Office of Health and Human Services

PolicyPharmacy & Therapeutics Committee formulary recommendations and edits — coverage criteria

Policy CodePolicy N/A

Change TypeFormulary changes and step therapy updates

Effective Date

Next Review DateJun 3, 2014

Key ActionProvide prior authorization with documented medication history demonstrating required prior therapy or failure within specified look-back windows.

SourceLink

POLICY UPDATE CHANGES

SGLT-2 class (Invokana) was reviewed and accepted as a new class for P&T review with no preferred agents.

MS agents review: look-back for failure of preferred agent changed from 90 days to 360 days for Tecfidera.

Insulin formulary changed: added Levemir and removed Novolin/Novalog with a 90-day sundown and 60-day look-back for new prior authorization requests.

Victoza (liraglutide) will require step therapy: failure of Byetta within past 60 days unless patient is grandfathered.

Prolia (bone resorption inhibitor) has a new indication and will be added to a step edit requiring prior bisphosphonate use for a specified duration.

Multiple

360dTecfidera look-back

90dTransition period

Coverage Criteria and Definitions

Initial coverage criteria by agent/class

Covered when ALL of the following prior therapy/step criteria are met (per agent/class as specified):

SGLT-2 class (Invokana): Coverage requires documentation of treatment with two concurrent antidiabetic agents within the prior 6 months; no grandfathering for existing patients.6 months look-back; two concurrent agents

No preferred agents designated; accepted by committee.

Victoza (liraglutide): Coverage requires documented failure of Byetta within the past 60 days unless the patient is grandfathered from prior coverage.60 days look-back

Current Victoza patients are grandfathered.

MS agent Tecfidera: Coverage requires failure of preferred agent(s) as demonstrated over a 360-day look-back period.360 days look-back

Changed from prior 90-day look-back.

Prolia (bone resorption inhibitor): Coverage requires prior bisphosphonate therapy for a specified duration (committee discussion referenced months of bisphosphonate use) before Prolia; Prolia added to step edit.specified months on bisphosphonate

Implement step edit to require prior bisphosphonate use as amended by committee.

Insulin formulary change (Novolin/Novolog): Novolin/Novolog removed from preferred listing; current patients allowed a 90-day transition (sundown); new prior authorization requests must include a 60-day medication history for Novolin/Novolog use.90-day transition; 60-day look-back for new PAs

Levemir was added to the formulary.

Coverage of SGLT-2 class agents (e.g., Invokana) requires documentation that the member has been treated with two concurrent antidiabetic agents within the prior 6 months. There is no grandfathering for patients newly started on SGLT-2 agents; new prior authorization requests must meet the step therapy look-back requirement. The committee did not designate any preferred agents in this class.

Requests that do not meet the committee‑specified prior therapy or look‑back requirements are not supported for coverage. Examples include failure to demonstrate a history of two concurrent antidiabetic agents within the required 6‑month look‑back for SGLT‑2 agents, or failure to document prior agent use within the look‑back windows specified for other step edits. Such requests should be considered not meeting coverage criteria and may be denied.

Prior Authorization, Step Edits, and Provider Notifications

Prior Authorization

Prior authorization and required prior-therapy evidence

Prior authorization is required for certain agents and classes with supporting evidence of prior therapy or failure within the specified look-back windows. Examples include SGLT-2 agents (Invokana) which require documentation of two concurrent antidiabetic agents within the prior 6 months, Victoza which requires documented failure of Byetta within the past 60 days (unless patient is grandfathered), and Tecfidera which requires failure of preferred MS agent(s) over a 360-day look-back period.

SGLT-2 (Invokana): prior authorization requires documentation of two concurrent antidiabetic agents within the prior 6 months.
Victoza (liraglutide): prior authorization requires documented failure of Byetta within the past 60 days unless the patient is grandfathered.
Tecfidera (MS agent): prior authorization requires failure of preferred agent(s) demonstrated over a 360-day look-back period.

Step Therapy

Step therapy requirements (Prolia, Victoza, SGLT-2)

Initial Therapy Requirements and Step Edits

Initial therapy requirements

Initial coverage rules and step edits established by the committee for specific agents — coverage requires meeting ALL applicable initial therapy conditions below.

Victoza initial therapy: Require documented failure of Byetta within the prior 60 days unless the patient is grandfathered.60 days

Grandfather current Victoza patients per committee motion.

SGLT-2 initial therapy (Invokana): Require documentation of treatment with two concurrent antidiabetic agents during the prior 6 months before coverage of an SGLT-2 agent.6 months look-back; two concurrent agents

No grandfathering for these patients; no preferred agents designated.

Tecfidera initial therapy:

Look-back Periods and Step Edit Table

Look-back period	Applies to (agent / class)	Requirement / notes
60 days	Victoza (liraglutide) / Byetta (exenatide)	Coverage requires documented failure of Byetta within the past 60 days unless the patient is grandfathered (current Victoza patients are grandfathered).
360 days	MS agent Tecfidera	Coverage requires failure of preferred agent(s) demonstrated over a 360-day look-back period (revised from prior 90-day look-back).
6 months	SGLT-2 class (e.g., Invokana / canagliflozin)	Coverage requires documentation of two concurrent antidiabetic agents within the prior 6 months; no grandfathering for existing patients; no preferred agents designated.

Key Terms and Abbreviations

SGLT-2 class definition (e.g., canagliflozin / Invokana)

Class nameSGLT-2 (sodium‑glucose co‑transporter‑2) inhibitors — example: Invokana (canagliflozin)

Coverage step requirementRequires documentation of treatment with two concurrent antidiabetic agents within the prior 6 months before coverage is approved

GrandfatheringNo grandfathering allowed for patients newly started on SGLT‑2 agents; new requests must meet the 6‑month look‑back requirement

Formulary statusReviewed and accepted as a new class by P&T with no preferred agents designated

Related provider actionPrior authorization required with medication history demonstrating two‑agent use over the prior 6 months

Preferred Drug List (PDL) definition

Background and Committee Review Summary

The P & T Committee reviewed multiple therapeutic classes and voted on formulary placement, step edits, and prior authorization actions. Key decisions included: acceptance of the new SGLT‑2 class (Invokana) with a 6‑month step therapy look‑back requiring two concurrent antidiabetic agents and no grandfathering; a step edit for Victoza (liraglutide) requiring failure of Byetta within 60 days (with current Victoza patients grandfathered); addition of Levemir and removal of Novolin/Novolog with a 90‑day transition (sundown) for current patients and a 60‑day medication history requirement for new prior authorization requests; and addition of Prolia to a step edit requiring prior bisphosphonate therapy for a specified duration. These actions establish the prior authorization and step therapy expectations that providers must follow.

Policy Summary

PayerExecutive Office of Health and Human Services

PolicyPharmacy & Therapeutics Committee formulary recommendations and edits — coverage criteria

Policy CodePolicy N/A

Change TypeFormulary changes and step therapy updates

Effective Date

Next Review DateJun 3, 2014

Key ActionProvide prior authorization with documented medication history demonstrating required prior therapy or failure within specified look-back windows.

SourceLink

On This Page

Step therapy edits have been established or amended and must be followed before coverage is approved. Notable requirements include adding Prolia to a step edit requiring prior bisphosphonate therapy for the committee-referenced duration, Victoza requiring failure of Byetta within 60 days (with current Victoza patients grandfathered), and SGLT-2 agents requiring a 6-month look-back demonstrating two concurrent antidiabetic agents.

Prolia: added to step edit; coverage requires prior bisphosphonate use for the months referenced by the committee.
Victoza: step edit requires failure of Byetta within past 60 days; current Victoza patients are grandfathered.
SGLT-2 agents (Invokana): step edit requires evidence of two concurrent antidiabetic agents within the prior 6 months; no grandfathering.

Documentation Required

Medication history documentation required for PA

For prior authorization requests, include a medication history that documents prior agent use and any failures within the policy-specified look-back periods. Ensure the submission specifies dates and agents used to demonstrate concurrent therapy or failure windows (examples: 60 days for Byetta before Victoza; 6 months for two concurrent agents before SGLT-2; 360 days for Tecfidera).

Provide medication names, dates of therapy, and evidence of failure or intolerance as applicable.
For SGLT-2 requests, document two concurrent antidiabetic agents and their use within the prior 6 months.
For Victoza requests, document Byetta use/failure within the prior 60 days (unless grandfathered).
For Tecfidera requests, document failure of preferred agent(s) over the prior 360 days.

Note

Prescriber notification when formulary changes occur

Prescribers will be formally notified when products are removed from the PDL or when formulary changes occur; communications will include the rationale and recommended preferred alternatives and may describe transition allowances.

Letter to prescribers of Victoza notifying them the drug is coming off the PDL, stating the preferred agent and indications for Victoza.
Letter to prescribers of Novolin/Novolog explaining the insulin formulary change and the 90-day transition allowance.

Denial Risk

Denial risk for missing look-back / prior-use evidence

Requests lacking documentation that meets the required look-back or prior-use criteria are at risk of denial. Examples include failure to show Byetta use within 60 days before Victoza, failure to show two concurrent antidiabetic agents within 6 months for SGLT-2 agents, or failure to show preferred-agent failure within 360 days for Tecfidera.

Victoza: denial risk if prior Byetta use/failure within 60 days is not demonstrated (unless patient is grandfathered).
SGLT-2 agents: denial risk if documentation does not show two concurrent antidiabetic agents within the prior 6 months.
Tecfidera: denial risk if failure of preferred agent(s) over the prior 360 days is not documented.

Require documented failure of preferred multiple sclerosis agent(s) over a 360-day look-back period prior to coverage of Tecfidera.

Look-back amended from 90 days to 360 days by committee.

Prolia initial therapy: Require prior bisphosphonate therapy for the duration specified by the committee (months of therapy) before coverage of Prolia; Prolia is added to the step edit.specified months on bisphosphonate

Amend motion to add Prolia to existing bisphosphonate-to-Forteo step edit.

Insulin transition and new PA requests: For patients currently on Novolin/Novolog allow a 90-day sundown (transition). For new prior authorization requests for Novolin/Novolog, include a 60-day medication history look-back.90-day transition; 60-day look-back

Levemir added to the formulary as replacement per committee.

DefinitionPreferred Drug List (PDL): the formulary list identifying preferred products for coverage

Impact of P&T actionsDrugs may be added to or removed from the PDL based on committee recommendations (examples in meeting: addition of Levemir; removal of Novolin/Novolog)

Provider communicationWhen a product is removed or changed on the PDL, prescribers will be notified with rationale and preferred alternatives and may be given transition allowances

Grandfathering/transitionCommittee may specify transition (sundown) periods for current patients when PDL placement changes (example: 90‑day sundown for Novolin/Novolog)