CurrentMass General Brigham Health PlanPolicy N/A

Kynamro (mipomersen) prior authorization

Defines prior authorization, benefit, and coverage criteria for Kynamro (mipomersen sodium) under the pharmacy benefit for Mass General Brigham Health Plan Commercial/Exchange members; includes specialty pharmacy and quantity limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyKynamro (mipomersen) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date02/01/2022

Next Review DateN/A

Key ActionSubmit prior authorization and documentation confirming HoFH by genetic/laboratory testing and evidence of required prior therapies or contraindications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial/Exchangeplan applicability

≥18minimum age

3 moinitial duration

12 moreauthorization

4 syr/28dquantity limit

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Initial/continuing member coverage criteria

Authorization may be granted for members with homozygous familial hypercholesterolemia (HoFH) when ALL of the following are met

HoFH diagnosis: Diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by laboratory/genetic testing for mutations (LDLR, PCSK9, familial defective apo B)

Age: Member is ≥ 18 years of age≥ 18 years

Applies to criteria block for continuing members

Diet adherence: Member is adherent to a low-fat diet (< 20% of energy supplied by dietary fat intake)< 20% energy from fat

Prior statin therapy: Documented side-effect, allergy, inadequate response, treatment failure, or contraindication to high-potency HMG Co-A reductase inhibitor (e.g., atorvastatin or rosuvastatin), including use in combination with ezetimibe, a fibric acid derivative, and/or cholestyramine

Must document intolerance/failure/contraindication

Lipid apheresis: Inadequate response, treatment failure, or contraindication to lipid apheresis therapy

PCSK9 inhibitor: Inadequate response, treatment failure, or contraindication to a PCSK9 inhibitor (e.g., Praluent or Repatha)

Pregnancy test: If female, negative pregnancy test prior to initiation of treatment with Kynamronegative pregnancy test

Applies prior to initiation

Kynamro (mipomersen sodium) is designated a specialty medication for Mass General Brigham Health Plan Commercial/Exchange members and is covered under the pharmacy benefit. Prior authorization is required. Per the policy, the drug must be filled at a contracted specialty pharmacy.

Use of Kynamro is not supported for members who do not meet ALL of the policy criteria. Required elements include documented genetic/laboratory confirmation of homozygous familial hypercholesterolemia (HoFH), age and diet adherence criteria, and documentation of intolerance, contraindication, treatment failure, or inadequate response to prior therapies (high‑potency statin ± ezetimibe, fibric acid derivative, and/or cholestyramine), lipid apheresis, and a PCSK9 inhibitor. For females, a negative pregnancy test prior to initiation is required.

Prior Authorization, Documentation, and Prior Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kynamro (mipomersen sodium) under the pharmacy benefit for Commercial/Exchange members. Specialty pharmacy dispensing is required — this medication has been designated specialty and must be filled at a contracted specialty pharmacy.

Plan: Commercial/Exchange (pharmacy benefit)
Program type: Prior Authorization
Specialty pharmacy dispensing required — fill at contracted specialty pharmacy
Pharmacy benefit contact: Phone 800-711-4555; Fax 844-403-1029

Step Therapy

Prior Therapy Requirements

Documented intolerance, contraindication, treatment failure, or inadequate response to specified prior therapies is required before Kynamro may be authorized. This includes failure or contraindication to a high-potency statin (e.g., atorvastatin or rosuvastatin) used in combination with ezetimibe, and failure/inadequate response to other lipid-lowering therapies as specified.

High-potency HMG Co-A reductase inhibitor (e.g., atorvastatin or rosuvastatin) plus ezetimibe — documented side-effect, allergy, inadequate response, treatment failure, or contraindication
Inadequate response, treatment failure, or contraindication to lipid apheresis therapy
Inadequate response, treatment failure, or contraindication to a PCSK9 inhibitor (Praluent or Repatha)

Documentation Required

Required Documentation

Documentation must support the diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by laboratory/genetic testing (e.g., LDLR, PCSK9, or familial defective apo B mutations) and show adherence to adjunct requirements.

Genetic or laboratory confirmation of HoFH (LDLR, PCSK9, or apo B mutation)
Evidence of adherence to a low-fat diet (<20% of energy from fat)
Pregnancy test negative for females prior to initiation

Denial Risk

Denial Triggers for Coverage Criteria

Coverage will be denied if ALL listed HoFH criteria are not met. Common denial triggers include: lack of genetic/laboratory confirmation of HoFH, age <18 years, no documentation of adherence to a low‑fat diet, absence of documented intolerance/contraindication/failure to high‑potency statin plus ezetimibe, no evidence of inadequate response or contraindication to lipid apheresis or PCSK9 inhibitor, or missing pregnancy test for females prior to initiation.

No genetic or laboratory confirmation of HoFH
Member < 18 years of age
No documentation of low‑fat diet adherence (<20% calories from fat)
No documented intolerance, contraindication, inadequate response, or treatment failure to high‑potency statin (atorvastatin or rosuvastatin) plus ezetimibe
No documented inadequate response, treatment failure, or contraindication to lipid apheresis
No documented inadequate response, treatment failure, or contraindication to a PCSK9 inhibitor (Praluent or Repatha)
For females, missing negative pregnancy test prior to initiation

OpenPayer

Kynamro (mipomersen) prior authorization

Coverage Criteria for Kynamro (mipomersen)

Product Codes and Quantity Limits

Prior Authorization, Documentation, and Prior Therapy Requirements

Key Definitions

Background on Kynamro (mipomersen)