Download mecasermin - Rocky Mountain Health Plans

UNIFORM PHARMACY PRIOR AUTHORIZATION REQUEST FORM
CONTAINS CONFIDENTIAL PATIENT INFORMATION
Complete this form in its entirety and send to Rocky Mountain Health Plans at 858-357-2538
Urgent 1
Non-Urgent
Requested Drug Name: Increlex® (mecasermin) SubQ Inj.
Patient Information:
Prescribing Provider Information:
Patient Name:
Member/Subscriber Number:
Policy/Group Number:
Patient Date of Birth (MM/DD/YYYY):
Patient Address:
Prescriber Name:
Prescriber Fax:
Prescriber Phone:
Prescriber Pager:
Prescriber Address:
Patient Phone:
Patient Email Address:
Prescriber Office Contact:
Prescriber NPI:
Prescriber DEA:
Prescriber Tax ID:
Specialty/Facility Name (If applicable):
Prescriber Email Address:
Prescription Date:
Prior Authorization Request for Drug Benefit:
New Request
Reauthorization
Patient Diagnosis and ICD Diagnostic Code(s):
Drug(s) Requested (with J-Code, if applicable):
Strength/Route/Frequency:
Unit/Volume of Named Drug(s):
Start Date and Length of Therapy:
Location of Treatment: (e.g. provider office, facility, home health, etc.) including name, Type 2 NPI (if applicable), address and
tax ID:
Clinical Criteria for Approval, Including other Pertinent Information to Support the Request, other Medications Tried, Their
Name(s), Duration, and Patient Response:
Increlex® (mecasermin) SubQ Inj.
Diagnosis (documentation of diagnosis and lab results supportive of growth failure required)
Child with severe, primary insulin-like growth factor deficiency (Primary IGFD)
Child with growth hormone gene deletion who has developed neutralizing antibodies to growth hormone
Other (please state): ________________________________________________________________________________
Clinical Consideration (for approval, please indicate and provide documentation of the following):
Child (age ≥ 2 years old) meets the definition of severe Primary IGFD if:
Height standard deviation score ≤ -3.0 AND
Basal IFG-1 standard deviation score ≤ -3.0 AND
Normal or elevated growth hormone (GH)
Updated 12/8/15
Physician Specialty
Physician experienced in the diagnosis and management of patients with growth disorders
Other: ______________________________________________________________________________________________
For use in clinical trial? (If yes, provide trial name and registration number):
Drug Name (Brand Name and Scientific Name)/Strength:
Dose:
Quantity:
Route:
Number of Refills:
Product will be delivered to:
Patient’s Home
Frequency:
Physician Office
Other:
Date:
Prescriber or Authorized Signature:
Dispensing Pharmacy Name and Phone Number:
Approved
Denied
If denied, provide reason for denial, and include other potential alternative medications, if applicable, that are found in the
formulary of the carrier:
1. A request for prior authorization that if determined in the time allowed for non-urgent requests could seriously jeopardize the life or
health of the covered person or the ability of the covered person to regain maximum function, or subject the person to severe pain that
cannot be adequately managed without the drug benefit contained in the prior authorization request
RMHP Formulary Coverage Policy
THIS INFORMATION IS NOT ALL-INCLUSIVE AND IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY
Increlex® (mecasermin [rDNA origin] injection)
CLASSIFICATION
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Endocrine Metabolic Agent
DESCRIPTION
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Mecasermin is a recombinant form of human insulin-like growth factor I (rhIGF-I) that mediates
anabolic and growth-promoting effects of growth hormone. Endogenous Insulin Growth Factor1
(IGF-1) is required for normal growth and brain development. IGF-1 is in part directed towards
stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports
growing tissues.
Endogenous IGF-1 increases in insulin sensitivity; mimics some actions of insulin (has a 6 to 11%
of glucose-lowering effect) and therefore has hypoglycemic potential.
Indicated for the long-term treatment of children with severe primary insulin-like growth factor
deficiency (Primary IGFD) or with growth hormone gene deletion who have developed
neutralizing antibodies to growth hormone
Severe Primary IGFD is defined by: height standard deviation score ≤ -3.0 and basal IGF-1
standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH)
Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR
signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot
be expected to respond adequately to exogenous GH treatment. Increlex is not a substitute for GH
treatment.
Increlex is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH
deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of antiinflammatory steroids.
Five clinical studies (4 open-label and one double-blind, placebo controlled) were conducted in 71
pediatric patients with severe Primary IGFD. The dose of mecasermin ranged from 0.06 to 0.12
mg/kg subcutaneously twice daily. Patient enrollment was based on extreme short stature, slow
growth rates, low IGF-1 serum concentrations, and normal growth hormone secretion. The data
from all 5 trials was pooled to allow a global efficacy and safety analysis. 61 patients completed
at least one year of treatment and 13 patients completed 8 years of treatment. Fifty-three (87%)
had Laron Syndrome; 7 (11%) had growth hormone gene deletion; and 1 (2%) had neutralizing
antibodies to growth hormone. Pre-treatment height velocity was available for 58 patients and
after 1 year of treatment the change from pre-treatment was significant (p< 0.0001). Significant
results in height velocity continued through year 6 (p = 0.0009) of treatment and by year 8 the
mean (SD) for change from pre-treatment was +0.7 (2.5) resulting in a p-value of 0.3059. The
evaluation of bone age advancement was conducted in 49 patients on mecasermin. The mean SD
change in chronological age was 4.9 +/- 3.4 years and the change in bone age was 5.3 +/- 3.4
years.
Increlex can be self-administered.
FORMULARY COVERAGE
Prior authorization: Required
Good Health Formulary: Tier 5; Age limit restriction of 2 years of age and older
Commercial Formulary: Tier 6; Age limit restriction of 2 years of age and older
Medicare Part D coverage: Tier 3; Age limit restriction of 2 years of age and older (effective 1/1/2015)
COVERAGE CRITERIA
Increlex® (mecasermin) meets the definition of medical necessity for the following:
 Long-term treatment of children with severe primary insulin-like growth factor deficiency
(Primary IGFD) or with growth hormone gene deletion who have developed neutralizing
antibodies to growth hormone.
o Documentation required supportive of diagnosis, Severe Primary IGFD, as defined as:
 Height standard deviation score ≤ -3.0 and
 Basal IGF-1 standard deviation score ≤ -3.0 and
 Normal or elevated growth hormone (GH)
 Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR
signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, that cannot
be expected to respond adequately to exogenous GH treatment. Increlex is not a substitute for GH
treatment.
Increlex® (mecasermin) is considered experimental for the following:
 Any condition or diagnosis not FDA approved or Compendia supported including:
 Secondary forms of IGF-1 deficiency (e.g., GH deficiency, malnutrition, hypothyroidism,
or chronic treatment with pharmacologic doses of anti-inflammatory steroids)
 Amyotrophic lateral sclerosis
 Adjuct in Diabetes mellitus type 2
Required Provider Specialty:
 Approval is limited to physicians who are experienced in the diagnosis and management of
patients with growth disorders
DOSAGE/ADMINISTRATION
Pediatric Dosing (safety and efficacy has not been determined for pediatric patients less than 2 years):
 Primary IGF-1 deficiency (Severe): The dosage of mecasermin should be individualized for each
patient. The recommended initial dose is 0.04 to 0.08 mg/kg subQ twice daily. Once mecasermin
is well tolerated for at least 1 week, the dose may be increased by 0.04 mg/kg per dose, to a
maximum of 0.12 mg/kg subQ twice daily. Patients should monitor their preprandial glucose at
the initiation of therapy, if frequent symptoms of hypoglycemia occur and until a well-tolerated
dose is established. Mecasermin should always be given shortly before or after (+/- 20 minutes) a
meal or snack. If the patient cannot eat a meal or snack before or after administration, the dose of
mecasermin should be omitted. Subsequent doses of mecasermin should never be increased to
make up for omitted doses. If hypoglycemia occurs despite adequate food intake, the dose of
mecasermin should be decreased and careful monitoring of glucose levels should continue.
PRECAUTIONS
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Contraindications:
o Allergy or severe hypersensitivity to mecasermin (rhIGF-1) or any component of the formulation
o Growth promotion in patients with closed epiphyses
o Intravenous administration
o Active or suspected neoplasia - discontinue therapy if evidence of malignancy subsequently
develops
Precautions:
o High-risk activities (e.g., driving or operating machinery) due to hypoglycemic effect. Limit
activities within 2 to 3 hours after dosing, particularly when therapy is initiated.
o Hypersensitivity and allergic reactions, including anaphylaxis, have been reported.
o Hypoglycemic effect, especially in small children. Administer shortly before or after a meal or
snack. Monitoring is recommended. Mecasermin may require dose adjustmen.t
o Intracranial hypertension has occurred. Perform funduscopic examinations at initiation and
intermittently during therapy
o Lymphoid tissue (e.g., tonsillar and adenoidal) hypertrophy has occurred. Monitoring is
recommended.
o Neonates: gasping syndrome and neurologic toxicity due to benzyl alcohol preservative can occur.
o History of scoliosis: progression may occur with rapid growth due to mecasermin therapy.
Monitoring is recommended.
o Slipped capital femoral epiphysis may occur with rapid growth due to mecasermin therapy.
Evaluate limp or complaints of hip or knee.
Billing/Coding information
CPT Coding:
96372
Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
HCPCS Coding:
J 2170
Injection, mecasermin, 1mg
COST
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AWP (July 2014): Increlex 40mg/4ml (4ml): $3,198.12
GUIDELINE UPDATE INFORMATION
July 2014
Prior Authorization and Coverage Policy created
REFERENCES
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DRUGDEX®, accessed 07/16/2014.