CurrentWashington State Health Care AuthorityPolicy 27.15.00-1

Amylin Analogs

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This policy governs medical necessity, initial authorization, reauthorization, and quantity limits for pramlintide products used as an adjunct to mealtime insulin in members with type 1 or type 2 diabetes. Coverage requires inadequate glycemic control despite optimal insulin therapy and satisfaction of specified clinical criteria.

Policy Summary

PayerWashington State Health Care Authority

PolicyAmylin Analogs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization and document optimal insulin therapy, inadequate glycemic control, and satisfaction of all clinical criteria for initial pramlintide coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Diabetes types addressed

>9%HbA1c exclusion threshold

6 monthsInitial approval duration

12 monthsReauthorization duration

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CurrentWashington State Health Care AuthorityPolicy 27.15.00-1

Amylin Analogs

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Policy Summary

PayerWashington State Health Care Authority

PolicyAmylin Analogs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization and document optimal insulin therapy, inadequate glycemic control, and satisfaction of all clinical criteria for initial pramlintide coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Diabetes types addressed

>9%HbA1c exclusion threshold

6 monthsInitial approval duration

12 monthsReauthorization duration

Quantity limit per 28 days

Coverage Criteria

Initial Therapy Criteria

Pramlintide (Symlin or SymlinPen) may be covered when all eligibility criteria are met and none of the exclusion conditions apply.

Initial therapy

Diagnosis and treatment history: The member has type 1 or type 2 diabetes; has failed to achieve desired glycemic control despite optimal insulin therapy; and is currently receiving optimal mealtime insulin or continuous insulin infusion through an insulin pump.
Exclusions absent
- Gastroparesis or gastrointestinal motility medication: Diagnosis of gastroparesis or requirement for medication to stimulate gastrointestinal motility, including metoclopramide or erythromycin.
  Must be absent.
- Hypoglycemia unawareness, including inability to detect and act upon the signs or symptoms of hypoglycemia.
  Must be absent.
- Insulin regimen compliance: Poor compliance with the current insulin regimen.
  Must be absent.
- Blood-glucose monitoring compliance: Poor compliance with self-blood-glucose monitoring.
  Must be absent.
- HbA1c greater than 9% within the period specified by the policy.>9%
  Must be absent.
- Severe hypoglycemia: Recurrent severe hypoglycemia requiring assistance during the past 6 months.Required assistance during the past 6 months
  Must be absent.

Reauthorization Criteria

Symlin may be continued when all of the following are met.

Continuation therapy: The member is currently receiving optimal mealtime insulin or continuous insulin infusion through an insulin pump, and documentation demonstrates positive clinical benefit from Symlin.

Coverage requires no gastroparesis and no requirement for medication to stimulate gastrointestinal motility, including metoclopramide or erythromycin.

Hypoglycemia unawareness must be absent, including an inability to detect and act upon the signs or symptoms of hypoglycemia.

The member must not have poor compliance with the current insulin regimen.

The member must not have poor compliance with self-blood-glucose monitoring.

The member must not have an HbA1c greater than 9% within the period specified by the policy.

The member must not have recurrent severe hypoglycemia requiring assistance during the past 6 months.

Clinical Thresholds and Coding Details

HbA1c threshold

MeasureHbA1c (hemoglobin A1c)

ThresholdGreater than 9%

Policy applicationMust be absent for initial coverage

Recurrent severe hypoglycemia

EventRecurrent severe hypoglycemia

RequirementAssistance required

Lookback periodPast 6 months

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required for Initial Coverage

Prior authorization is required before initial coverage of pramlintide (SYMLIN® or SYMLINPEN®). Submit documentation demonstrating that all initial-approval criteria are met.

Applies to initial pramlintide coverage.

Prior Authorization

Reauthorization Criteria

For reauthorization, document that the member continues to receive optimal mealtime insulin or continuous insulin infusion through an insulin pump and has experienced positive clinical benefit from Symlin.

Required for continued coverage.

Documentation Required

Background

Pramlintide is an amylin analog used with mealtime insulin in patients with type 1 or type 2 diabetes who have not achieved desired glycemic control despite optimal insulin therapy. It slows gastric emptying, suppresses postprandial glucagon, and reduces food intake to help regulate postprandial glucose. Pramlintide is administered before major meals and titrated as tolerated; it carries a boxed warning for severe hypoglycemia.

Definitions

Hypoglycemia unawareness

TermHypoglycemia unawareness

DefinitionAn inability to detect and act upon the signs or symptoms of hypoglycemia

Coverage applicationMust be absent for initial coverage

Continuous insulin infusion

TermContinuous insulin infusion

DefinitionContinuous insulin delivery through an insulin pump

Coverage applicationQualifies as current insulin therapy when specified criteria are met

Initial Symlin Approval

Symlin may be covered when all of the following are met.

Initial Symlin approval

Diagnosis and treatment history: The member has type 1 or type 2 diabetes; has failed to achieve desired glycemic control despite optimal insulin therapy; and is currently receiving optimal mealtime insulin or continuous insulin infusion through an insulin pump.
Exclusions absent
- Gastroparesis or gastrointestinal motility medication: Diagnosis of gastroparesis or requirement for medication to stimulate gastrointestinal motility, including metoclopramide or erythromycin.
  Must be absent.
- Hypoglycemia unawareness, including inability to detect and act upon the signs or symptoms of hypoglycemia.

Symlin Reauthorization

Symlin may be continued when all of the following are met.

Quantity Limits

Symlin vial quantity limit

ProductSymlin vial

Maximum quantity4 vials (20 mL)

PeriodPer 28 days

SymlinPen 60 quantity limit

ProductSymlinPen 60

Maximum quantity4 pens (6 mL)

PeriodPer 28 days

Policy Summary

PayerWashington State Health Care Authority

PolicyAmylin Analogs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization and document optimal insulin therapy, inadequate glycemic control, and satisfaction of all clinical criteria for initial pramlintide coverage.

SourceLink

On This Page

Initial Clinical Documentation

Initial authorization requests must document the qualifying diagnosis, inadequate glycemic control despite optimal insulin therapy, and current optimal mealtime insulin therapy or continuous insulin infusion.

Type 1 or Type 2 diabetes diagnosis.
Failure to achieve desired glycemic control despite optimal insulin therapy.
Current optimal mealtime insulin or continuous insulin infusion (insulin pump).

Documentation Required

Continuation Documentation

Continuation requests must include documentation of ongoing optimal mealtime insulin therapy or continuous insulin infusion through an insulin pump, together with documentation of positive clinical benefit.

Document both ongoing insulin treatment and positive clinical benefit.

Denial Risk

Core Eligibility Not Met

Deny initial coverage when the member does not have Type 1 or Type 2 diabetes or has not failed to achieve desired glycemic control despite optimal insulin therapy.

Qualifying diagnosis is required.
Failure of optimal insulin therapy is required.

Denial Risk

Clinical Exclusion or Safety Risk

Do not authorize pramlintide when any listed clinical exclusion or safety risk is present.

Diagnosis of gastroparesis or need for medication to stimulate gastrointestinal motility, including metoclopramide or erythromycin.
Hypoglycemia unawareness, including inability to detect and act upon signs or symptoms of hypoglycemia.
Poor compliance with the current insulin regimen.
Poor compliance with self-blood-glucose monitoring.
HbA1C greater than 9% within the applicable review period.
Recurrent severe hypoglycemia requiring assistance during the past 6 months.

Denial Risk

Reauthorization Criteria Not Met

Deny reauthorization when the member is not currently receiving optimal mealtime insulin or continuous insulin infusion through an insulin pump, or when documentation does not show positive clinical benefit.

Both continuation criteria must be met.

Insulin regimen compliance: Poor compliance with the current insulin regimen.

Must be absent.

Blood-glucose monitoring compliance: Poor compliance with self-blood-glucose monitoring.

Must be absent.

HbA1c greater than 9% within the period specified by the policy.>9%

Must be absent.

Severe hypoglycemia: Recurrent severe hypoglycemia requiring assistance during the past 6 months.Required assistance during the past 6 months

Must be absent.

SymlinPen 120 quantity limit

ProductSymlinPen 120

Maximum quantity4 pens (10.8 mL)

PeriodPer 28 days