ModifiedBlue Cross Blue Shield - MassachusettsPolicy 257

Growth hormones and insulin-like growth factors prior authorization

Prior authorization, formulary status, and medical necessity criteria for growth hormone products and related agents for BCBSMA commercial members; affects prescribers and pharmacy/medical benefit reviewers.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyGrowth hormones and insulin-like growth factors prior authorization

Policy CodePolicy 257

Change TypeFormulary and coverage revisions

Effective Date

Next Review Date

Key ActionSubmit a Massachusetts Standard Form (eForm) or fax form #434 with supporting clinical documentation to request prior authorization.

SourceLink

POLICY UPDATE CHANGES

Moved Humatrope to Non-Formulary, Non-Covered and removed Zorbtive due to manufacturer discontinuation.

Moved Norditropin to Preferred status and removed prior step requirement for Skytrofa and Sogroya; added new indication for Skytrofa.

~20document chunks extracted

PA requiredmost listed products require prior authorization

Commercial plansapplies to

numerousNOT MEDICALLY NECESSARY indications

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supporting documentation

Coverage Criteria for Growth Hormone and Related Agents

Egrifta (tesamorelin) — MEDICALLY NECESSARY

Covered when ALL of the following are met:

Egrifta criteria: 1. Documented HIV infection; 2. Used for the reduction of excess abdominal fat due to lipodystrophy due to antiretroviral therapy

Serostim (somatropin) — MEDICALLY NECESSARY for HIV wasting/cachexia

Covered when ALL of the following are met:

Serostim criteria: 1. Documented HIV infection; 2. Wasting or cachexia to increase lean body mass and body weight, and improve physical endurance

Norditropin and Genotropin — Initial therapy

May be covered and considered MEDICALLY NECESSARY for ANY of the following indications:

Pediatric GHD: Children with proven growth hormone deficiency (GHD)

Prader-Willi: Children with growth failure due to Prader-Willi syndrome who do not have contraindications (history of upper airway obstruction, sleep apnea, or severe respiratory impairment)

Chronic renal insufficiency: Children with height below the 3rd percentile for chronologic age with chronic renal insufficiency

Turner syndrome: Children with Turner syndrome

Noonan syndrome: Children and young adults with short stature due to Noonan syndrome

SHOX deficiency: Children with short stature due to SHOX deficiency

Wound healing/burns: Promotion of wound healing in patients with third-degree burns

Prevent growth delay in severe burns: Prevention of growth delay in children with severe burns

HIV/AIDS wasting: Patients with HIV/AIDS wasting syndrome who meet all of: a) weight loss ≥10% from baseline or BMI <20 kg/m2; b) wasting not due to malnutrition, mental illness, endocrine disease, or other causes; c) concomitant antiretroviral therapy for duration of treatment

Short bowel syndrome: Patients with short bowel syndrome receiving specialized nutritional support in conjunction with optimal management

Adult GHD: Adults with proven growth hormone deficiency as defined in policy (abnormal response to two provocative stimulation tests, or one test in specified clinical contexts, or low IGF‑I in complete hypopituitarism)

Continuation criteria — Pediatric (<18 years)

May be covered for continuation when ALL of the criteria below are met:

Open epiphyses as determined within the last year by radiographic evidence

No active neoplasm: No evidence of active neoplasm

Growth velocity > 2 cm/year

Absence of significant side effects

Compliance with therapy

No combination somatropin: Not used in combination with another somatropin agent (e.g., Serostim, Zorbtive or any other product covered by this policy)

Humatrope, Nutropin variants, Omnitrope, Saizen, Zomacton — Restricted coverage

May be covered and considered MEDICALLY NECESSARY only after:

Trial of two formulary alternatives: Treatment failure with, limiting side effects of, or contraindication to at least TWO formulary alternatives (see drug chart)

Skytrofa — Pediatric and adult criteria

May be considered MEDICALLY NECESSARY when ALL of the following are met:

Skytrofa — pediatric criteria: 1. Age ≥ 1 year; 2. Weight ≥ 11.5 kg (25.3 lbs); 3. Epiphyses confirmed open; 4. Proven growth hormone deficiency

Skytrofa — adult criteria: 1. Patient is 18 years or older; 2. Proven adult growth hormone deficiency

Sogroya — Pediatric criteria

May be considered MEDICALLY NECESSARY and covered when ALL of the following are met:

Sogroya pediatric: 1. Age ≥ 1 year; 2. Weight ≥ 11.5 kg (25.3 lbs); 3. Epiphyses confirmed open; 4. Proven growth hormone deficiency

Sogroya - Pediatric coverage

Sogroya (somapacitan) covered when ALL of the following are met:

Sogroya pediatric criteria: 1. Age ≥ 1 year; 2. Weight ≥ 11.5 kg (25.3 lbs); 3. Epiphyses open; 4. Proven growth hormone deficiency

Ngenla - Pediatric coverage

Ngenla covered when ALL of the following are met:

Ngenla pediatric demographic and weight: 1. Age ≥ 1 year; 2. Weight ≥ 11.5 kg (25.3 lbs)

Ngenla step/therapeutic trial requirement: Trial and failure or treatment‑limiting adverse effects of two formulary growth hormone products (examples: Norditropin, Genotropin, Skytrofa, or Sogroya)

Children with growth failure due to Prader‑Willi syndrome may be eligible for growth hormone therapy only when they do not have the specified respiratory contraindications. Specifically, therapy is contraindicated in members with a history of upper airway obstruction, sleep apnea, or severe respiratory impairment; these conditions must be absent for coverage to be considered.

The policy explicitly lists several FDA‑approved uses that are considered NOT MEDICALLY NECESSARY and are not covered. Examples include: pediatric patients born small for gestational age who fail to show catch‑up growth by age 2 years, and children with idiopathic short stature defined as height SDS ≤ -2.25 without documented growth hormone deficiency. Additional non‑covered examples include familial short stature, growth hormone insensitivity (Laron syndrome), constitutional growth delay, growth failure caused by glucocorticoids, short stature associated with chronic disease when not GH deficient, functioning renal transplants, most chromosomal/genetic disorders (other than the specific covered syndromes listed), enhancement of body mass/strength for nonmedical reasons, use to counteract non‑AIDS catabolic illness, treatment of altered body habitus or lipodystrophy except for abdominal lipodystrophy in HIV (see Egrifta), treatment of precocious puberty with GnRH analogs for GH indication, obesity, cystic fibrosis, idiopathic dilated cardiomyopathy, juvenile idiopathic arthritis, congestive heart failure, and adults with age‑related GH deficiency without organic cause or childhood origin.

The references cited in the policy document include systematic reviews, cohort studies, registry analyses and case reports that document adverse events and, in some instances, deaths associated with growth hormone treatment in specific populations. Notably, the literature on Prader‑Willi syndrome includes systematic reviews and registry data addressing both benefits and safety concerns, and reports of sudden death in growth hormone–treated children with Prader‑Willi syndrome are cited as a population‑specific safety signal to inform coverage decisions.

The policy enumerates specific pediatric and adult indications that are explicitly NOT MEDICALLY NECESSARY and therefore excluded from coverage. These exclusions include (but are not limited to): pediatric SGA without catch‑up by age 2, idiopathic short stature without documented GHD, familial short stature, GH insensitivity (Laron syndrome), constitutional growth delay, glucocorticoid‑induced growth failure, short stature related to chronic disease when not GH deficient, functioning renal transplant recipients, most chromosomal/genetic disorders (except Turner, Noonan, Prader‑Willi, or SHOX deficiency where specified), body mass/strength enhancement for nonmedical reasons, treatment for non‑AIDS catabolic illness, altered body habitus or lipodystrophy except abdominal lipodystrophy in HIV, obesity, cystic fibrosis, idiopathic dilated cardiomyopathy, juvenile idiopathic arthritis, congestive heart failure, and adult age‑related GHD without organic cause or childhood origin.

The policy cites multiple systematic reviews, meta‑analyses and Cochrane reviews to support the evidence base for various indications. Examples include Cochrane and systematic reviews of growth hormone in short bowel syndrome, burns, HIV wasting, and idiopathic short stature, as well as meta‑analyses and randomized controlled trials addressing growth outcomes and safety. These references are used to inform which indications are considered medically necessary versus not medically necessary or investigational.

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization required for the growth hormone and related products listed in this policy. Providers must use the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or Formulary Exception/Prior Authorization form and may call, fax, or mail the form to Pharmacy Operations. Contact Pharmacy Operations: Phone: 1-800-366-7778; Fax: 1-800-583-6289. Pharmacy benefit (SPBO) applies to specialty-listed products.

Use Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or print Form #434 and fax per instructions
Pharmacy Operations Department — Blue Cross Blue Shield of Massachusetts — 25 Technology Place, Hingham, MA 02043; Phone: 1-800-366-7778; Fax: 1-800-583-6289
Specialty products (SPBO) billed via Pharmacy benefit; specialty network requirements may apply

Prior Authorization

Formulary Exception Requirement

For non-formulary medications, in addition to meeting prior authorization clinical criteria, the member must have had prior treatment failure with, or a contraindication to, at least two covered formulary alternatives when available. A higher non-preferred cost share may apply if an exception is approved for a non-formulary drug.

Coding and Age/Threshold Key Facts

Minimum age and weight for Skytrofa and Sogroya (pediatric)

Minimum ageAge greater than or equal to 1 year

Minimum weightWeight at least 11.5 kg (25.3 lbs)

Applies toPediatric use of Skytrofa and Sogroya

Pediatric continuation growth velocity requirement

Required growth velocity for continuationGrowth velocity > 2 cm/year

Other continuation requirements (context)Open epiphyses, no active neoplasm, absence of significant side effects, compliance with therapy

Applicability

Definitions and Background

This policy governs prior authorization, formulary status, and medical necessity criteria for recombinant growth hormone products and related agents for both pediatric and adult indications. It covers treatment of proven growth hormone deficiency in children and adults and specific syndromic or disease‑related indications (for example, Prader‑Willi syndrome, Turner syndrome, Noonan syndrome, SHOX deficiency, short bowel syndrome, HIV wasting/cachexia, and burn‑related indications). The document defines diagnostic standards for adult GHD (provocative stimulation testing or equivalent laboratory criteria), specifies initial and continuation coverage requirements for pediatric patients (including assessment of open epiphyses and growth velocity), and sets prior authorization and step‑therapy expectations consistent with formulary status and referenced clinical guidance.

Definition of proven adult growth hormone deficiency (GHD)

Primary definitionProven adult GHD: abnormal response to TWO provocative stimulation tests (e.g., L-dopa, clonidine, glucagon, arginine, GHRH, insulin)

Alternate single-test exceptionAn abnormal response to ONE provocative stimulation test when there is defined CNS pathology, prior irradiation, multiple pituitary hormone deficiency, or a known genetic defect

Low IGF-I criterionLow IGF-I concentration in patients with complete hypopituitarism can define adult GHD

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyGrowth hormones and insulin-like growth factors prior authorization

Policy CodePolicy 257

Change TypeFormulary and coverage revisions

Effective Date

Next Review Date

Key ActionSubmit a Massachusetts Standard Form (eForm) or fax form #434 with supporting clinical documentation to request prior authorization.

SourceLink

On This Page

Non-formulary coverage requires trial and failure of two covered formulary alternatives (or documented contraindications)
Higher member cost-share may apply for approved non-preferred/non-formulary exceptions

Documentation Required

Required Documentation and Reference Materials

Providers must submit supporting documentation to demonstrate the clinical basis for the request and to show members have met approval criteria. Required materials include chart notes, lab results, medication/treatment history, and clinical references as appropriate. Prescription claims data may be used to establish prior use of formulary alternatives; if claims data is insufficient, the provider must supply additional documentation.

Submit chart notes, lab results, medication/treatment history, and other clinical information to support the request
Include clinical literature or references from compendia (AHFS-DI, Lexi-Drug, Clinical Pharmacology, Micromedex/Drugdex) or relevant guidelines when applicable
If prescription claims do not establish prior use of formulary alternatives or step therapy, provide provider documentation of trials (names, strengths, dates, reasons for failure)

Documentation Required

Provider Documentation Requirements

Provider documentation must specify the name and strength of formulary alternatives tried and failed (including dates if available) and detailed specifics regarding treatment failure or clinical reasons preventing trial/switch. Failure to provide adequate trial documentation or other required clinical information may result in denial.

Document names, strengths, dates, duration, and reason for discontinuation or treatment-limiting adverse effects for each alternative tried
Provide specifics if a formulary alternative was not tried (e.g., contraindication, intolerance) including supporting clinical evidence
Requests based solely on samples will not meet exception criteria — additional clinical information is required

Step Therapy

Step Therapy / Trial Requirements

Step or trial requirements apply for certain non-formulary somatropin products: many non-formulary somatropin agents (for example Humatrope, Ngenla, Nutropin formulations, Omnitrope, Saizen, Saizenprep, Zomacton) require meeting PA criteria and trial and failure of two covered formulary alternatives. For pediatric GH therapy, documented trial and failure or treatment-limiting adverse effects of two formulary growth hormone products (e.g., Norditropin, Genotropin, Skytrofa, or Sogroya) is required where specified.

Humatrope, Nutropin/Nutropin AQ/Depot, Omnitrope, Saizen, Saizenprep, Zomacton — require PA AND trial and failure of two covered formulary alternatives
Pediatric requirement example: trial and failure or treatment-limiting adverse effects of two formulary GH products (Norditropin, Genotropin, Skytrofa, or Sogroya) where indicated

Step Therapy

Step Requirement for Ngenla

Specifically for Ngenla (somatrogon), authorization requires meeting the PA clinical criteria and documented trial and failure (or treatment-limiting adverse effects or contraindications) of two covered formulary growth hormone products before coverage of Ngenla will be considered.

Ngenla (somatrogon) = NFNC, PA; requires trial and failure of two covered formulary alternatives in addition to meeting PA criteria

Step Therapy

No Formal Step Therapy Protocols Described

There are no formal step therapy protocols described in this policy beyond the trial-and-failure requirements noted for specific non-formulary agents; clinical guidelines and the formulary drug chart may inform sequencing but do not establish additional automatic sequencing rules in this document.

No other formal step therapy protocols are specified in this policy beyond the documented two-alternative trial requirement for certain non-formulary products
Clinical practice guidelines and the drug formulary may be used to guide therapy sequencing

Denial Risk

Denial Triggers

Requests for growth hormone for indications listed as Not Medically Necessary or Investigational (see Non-Covered and Investigational Indications sections) will be denied. Additionally, denials may occur when required documentation (trial history, chart notes, labs, or clinical rationale) is not provided or is insufficient to demonstrate that approval criteria are met.

Denial triggers include: requests for Not Medically Necessary or Investigational indications
Denial triggers include: failure to provide required documentation of prior trials (names, strengths, dates, specifics) or other supporting clinical information
Individual consideration/exception requests may be submitted for atypical patients but must include comprehensive supporting documentation

Documentation Required

Prior Authorization: Reference Materials to Include

Prescribers should include relevant prescribing information and references when submitting PA requests. The policy references Genotropin and other product prescribing information which may be used to support clinical rationale. Examples: Genotropin (Pfizer) Highlights of Prescribing Information; Humatrope (Eli Lilly) Prescribing Information. Cite package inserts, PI links, and relevant peer-reviewed guidelines as appropriate.

Include Genotropin prescribing information (Pfizer PI) when relevant to the request
Include Humatrope prescribing information (Eli Lilly PI) and other product PIs as applicable
References cited in the policy (clinical guidelines, compendia, and PI links) can be provided to support medical necessity

Pediatric patients (age < 18 years) for Norditropin and Genotropin continuation

Minimum age and weight for pediatric somatropin products

Minimum age (somatropin products)Age greater than or equal to 1 year

Minimum weight (somatropin products)Weight at least 11.5 kg (25.3 lbs)

Products referencedApplies to pediatric Skytrofa, Sogroya, Ngenla and other pediatric somatropin formulations per policy

Increlex (mecasermin) severity and diagnostic thresholds

Height SDS thresholdHeight standard deviation score (SDS) less than or equal to -3 for age and sex

Basal IGF-1 SDSBasal IGF-1 standard deviation score (SDS) less than or equal to -3 for age and sex

GH testing criteriaNormal or elevated GH: stimulated GH peak > 10 ng/mL or basal GH > 5 ng/mL

Indication scopeSevere primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH

Diagnostic criteria details for adult GHD and exceptions

Abnormal stimulation responsesAbnormal response to two provocative stimulation tests defines GHD in adults

Central pathology exceptionOne abnormal provocative test is sufficient when central nervous system pathology, irradiation history, multiple pituitary hormone deficiency, or genetic defect is present

IGF-I in hypopituitarismLow IGF-I concentration may establish GHD in patients with complete hypopituitarism

Clinical guidelines and position statements cited

Endocrine Society guidanceHormonal Replacement in Hypopituitarism in Adults: Endocrine Society Clinical Practice Guideline (Fleseriu et al.)

Growth Hormone Research Society / Pediatric guidelinesDiagnosis, Genetics, and Therapy of Short Stature in Children: Growth Hormone Research Society perspective and related consensus statements

Other professional statementsAACE/ACE adult GHD guidelines and NICE guidance on human growth hormone for children