Skytrofa Health Insurance Denial

• Received a Skytrofa Health Insurance Denial? Contact Us
• What is Skytrofa?
• What Causes Growth Hormone Deficiency?
• What are the Symptoms of Growth Hormone Deficiency?
• How is GHD Diagnosed and Treated?
• Is Skytrofa Successful?  
• How Much Does Skytrofa Cost?
• Is There a Biosimilar or Generic for Skytrofa?
• Do Insurance Companies Cover Skytrofa As a Treatment for Growth Hormone Deficiency?
• What You Must Know About the Terms Medically Necessary, Medically Beneficial, Experimental, and Investigational
• How Do Insurance Companies Evaluate Skytrofa Coverage Requests?
• What Duty Do Insurance Companies Have to Members Submitting Claims?
• Contact the Law Offices of Scott Glovsky if You Receive a Skytrofa Health Insurance Denial

Received a Skytrofa Health Insurance Denial? Contact Us

Skytrofa became the first once-weekly prescription medication for the treatment of pediatric patients aged one year and older with growth failure due to inadequate endogenous growth hormone production. It was commercially launched in October 2021, and in September 2024, Ascendis submitted a supplemental Biologics License Application to use Skytrofa for the treatment of adults with growth hormone deficiency. Skytrofa is approved and marketed in Europe under the name Lonapegsomatropin. 

This article addresses Skytrofa health insurance coverage claims and denials, explaining how insurance companies make determinations regarding medical necessity. If you have received a Skytrofa coverage claim denial, it is essential to consult with a skilled legal advocate who has a comprehensive background in health insurance denials, such as the Law Offices of Scott Glovsky. 

What is Skytrofa?

Skytrofa treats growth failure due to inadequate endogenous growth hormone production, also known as growth hormone deficiency (GHD). This is a condition in which the pituitary gland fails to produce sufficient growth hormone (GH, also known as somatotropin) for normal growth and development. 

What Causes Growth Hormone Deficiency?

The causes of GHD are genetic defects, underdevelopment of the pituitary gland, pituitary tumors, radiation therapy to the head or brain, certain head injuries, lack of blood flow to the pituitary gland, and central nervous system infections. 

What are the Symptoms of Growth Hormone Deficiency?

The most notable symptoms of GHD are slow height growth each year, short stature with normal body proportions, a younger-looking face, delayed puberty, chubby body build, and impaired hair growth. 

How is GHD Diagnosed and Treated?

An MRI of the brain can reveal abnormalities in the pituitary gland or hypothalamus. The treatment typically involves daily injections of synthetic growth hormone (somatropin) or the use of one of the newer drugs designed to treat GHD, such as Skytrofa or Sogroya, which are administered weekly rather than daily. 

Patients with severe IGF-1 deficiency who fail to respond well to GHD therapy may be placed on Increlex. Early treatment for GHD is essential; the earlier the condition is diagnosed and treated, the higher the chances the child has of reaching near-normal adult height. Patients with severe or permanent pituitary dysfunction may require lifelong GHD therapy. 

Is Skytrofa Successful?  

In clinical trials, Skytrofa showed a higher growth rate as compared to daily somatropin in children with GHD. In 2024, Skytrofa held a 6.5 percent market share of the overall U.S. growth hormone market and an 18 percent market share in pediatric patients with GHD. Skytrofa continues to demonstrate positive clinical outcomes and strong market increases as the manufacturer works to expand its indications. 

How Much Does Skytrofa Cost?

Co-pays for Skytrofa can range from approximately $900 per month to more than $8,000 per month. Skytrofa’s list price is $13,151.87 for four injections. The company offers financial assistance for Skytrofa in some cases. For more information, check out the Skytrofa FAQs here.  

Is There a Biosimilar or Generic for Skytrofa?

Biosimilar drugs are similar to brand-name biologic drugs and are typically developed after the patent for the biologic drug has expired. The manufacturer of a biologic drug can sell it for up to 12 years before other manufacturers are legally allowed to create biosimilar versions. Skytrofa is currently only available as a brand-name biologic with no generic or biosimilar versions available, however, there are other FDA-approved drugs that are similar to Skytrofa and are used to treat pediatric GHD, including:

• Somatropin (Norditropin, Genotropin, Omnitrope)
• Somatrogon (Ngenla)
• Somapacitan (Sogroya)

Do Insurance Companies Cover Skytrofa As a Treatment for Growth Hormone Deficiency?

Whether your insurer will cover Skytrofa will depend on several factors. Government health insurance programs like Medicaid often provide coverage for Skytrofa as a treatment for GHD. Coverage can vary depending on the state. For adults being treated with Skytrofa, Medicare is the federal health insurance program for those 65 and older, often granted through Medicare Advantage Plans (Part C) and Supplemental Plans (Part D). 

Commercial private insurance companies like Kaiser Permanente, Blue Shield, Healthnet, Medi-Cal Managed Care Plans, UnitedHealthcare, Aetna, and Anthem may have widely varying coverage standards provided the company deems Skytrofa as medically necessary. A denial for Skytrofa coverage can be appealed, however, you will need to first determine whether your plan is ERISA (Employment Retirement Income Security Act of 1974) or non-ERISA. ERISA plans are usually provided by private employers with the following exceptions:

• Religious organization plans
• Individual and family plans purchased through private insurance companies like Anthem Blue Cross or Blue Shield of California
• Individual and family plans through Covered California
• Business plans that only cover business owners
• Government employee plans

If you have an ERISA plan, you must exhaust all administrative remedies by filing appeals following a Skytrofa claim denial. If you do not have an ERISA plan, you have other options and can learn more here. 

What You Must Know About the Terms Medically Necessary, Medically Beneficial, Experimental, and Investigational

Insurers often deny claims for Skytrofa and other costly drugs by claiming the drug is not medically necessary or is experimental or investigational. One way they accomplish this is by requiring prior authorization to determine whether a drug is medically necessary for a specific patient with a specific condition. Unfortunately, there are often “catches” in the prior authorization process. 

While a drug can be medically beneficial for a patient, the insurer may claim it is not medically necessary, forcing the patient to try other alternative (typically less expensive) drugs. One form of prior authorization is step therapy, which requires patients to try other less expensive drugs for their symptoms. Step therapy drugs are usually required for at least 60 days, and many companies require that patients try at least two other alternative drugs before re-evaluating the original claim.  

If an insurance company deems a drug not medically necessary, it may also be considered experimental or investigational. When the FDA does not approve a drug for a specific use, it will often be deemed experimental by the insurer. The reality of the situation is that doctors prescribe drugs off-label every single day. Off-label use involves using a drug to treat a different condition, using a different dosage, or using the drug in a different age group than specified on the drug labeling. 

Off-label prescribing is both legal and common, but it can trigger an “experimental” or “investigational” designation by insurance companies to sometimes avoid having to pay for a more expensive drug. The guidelines for determining whether a drug is medically necessary, experimental, or investigational are extremely subjective and vary widely from one insurance company to the next.   

How Do Insurance Companies Evaluate Skytrofa Coverage Requests?

Claim coverage requests are evaluated on internal medical or pharmacy policies, after insurers have their pharmacists, physicians, and/or other practitioners research the drugs and develop those policies. The policies are then brought before a group of external doctors who vote on them. Unfortunately, these doctors may create overly restrictive policies on approving expensive drugs because they are motivated by financial gain or the potential to work for the insurance companies. 

Skytrofa usually requires prior authorization and may also require step therapy. Approval will require evaluation by a physician specializing in the treatment of GHD, and documentation supporting the medical necessity of Skytrofa (including chart notes, lab tests, claim records, and other relevant information. Specifically, insurers may require two growth hormone stimulation tests with peak growth hormone responses less than 10 ng/mL, and evaluation by an endocrinologist. For continued treatment of Skytrofa, the insurer may require documentation of a beneficial response. 

What Duty Do Insurance Companies Have to Members Submitting Claims?

When a member submits a claim, the insurer reviews the claim and determines whether approval or denial is appropriate. The insurer, however, has certain duties, such as thoroughly investigating the claim request, fully inquiring into all possible reasons that might support requests for care, and promptly responding to claim requests. Finally, the insurance company has a duty to appoint and employ qualified medical professionals to make decisions in claim reviews. 

Contact the Law Offices of Scott Glovsky if You Receive a Skytrofa Health Insurance Denial

For the past two decades, the Law Offices of Scott Glovsky has represented injured consumers and victims of wrongful business practices. Our firm focuses on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related litigation. We get justice for our clients and hold the wrongdoers accountable.