Health Care Resource Use and Costs of H.P. Acthar® Gel (Repository Corticotropin Injection) for Multiple Sclerosis Relapse
"This study adds to the body of data discussing Acthar," said
"Managing relapses is a central concern for the overall management of MS, yet there are few studies that compare these three treatment options for multiple relapses," said Principal Investigator
The cohort analysis titled, "Health Care Costs and Resource Utilization in Multiple Sclerosis Relapse Patients," aimed to describe and generate hypotheses related to health care utilization, outcomes and costs among patients with MS who experienced multiple relapses. Researchers reviewed 12- and 24-month health care utilization and costs among patients who received Acthar (n=213 and n=96, respectively) compared to patients who were treated with PMP/IVIG (n=226 and n=132, respectively), in a commercially insured U.S. population. Claims data from the Truven Health Analytics MarketScan® Commercial Claims and Encounters Databases were examined between
Findings from this retrospective, observational study among MS patients include:
- 12-month outcomes: Compared to PMP/IVIG, Acthar had lower hospitalizations (0.2 vs. 0.6, p=0.0002), outpatient services (31 vs. 48, p<0.0001), inpatient (
$15,300lower, p=0.001) and outpatient costs ( $54,100lower, p<0.0001) with similar total costs ( $5,000higher, p=0.69).
- 24-month outcomes: Compared to PMP/IVIG, Acthar had lower hospitalizations (0.5 vs. 1.0, p=0.04), outpatient services (56 vs. 87, p<0.0001), inpatient (
$17,400lower, p=0.03) and outpatient costs ( $121,000lower, p<0.0001) with similar total costs ( $33,400lower, p=0.13).
- The costs of medications were increased in the group that received Acthar prescriptions, these costs were offset by 93% (among the cohort with 12 months of follow-up) and 132% (among the cohort with 24 months of follow-up) by the relative decrease in inpatient and outpatient costs among the group that received Acthar prescriptions.
Limitations of the Study
- Exposure to Acthar was defined as using outpatient prescription claims data, so some patients may be subject to misclassification as they did not actually inject the medication.
- This was an observational retrospective study and not a randomized controlled trial, so unmeasured factors may still confound the associations reported.
- Since the study included only patients who experienced multiple relapses and who received treatments besides intravenous methylprednisolone (IVMP) for their subsequent relapses, the sample size was relatively small and results are not generalizable to the broader MS population that responds to IVMP.
- Information on procedures or health care resource utilizations for which patients paid out-of-pocket are not included in the data
- As with any claims-based study, data may include coding errors with diagnoses or procedures.
The manuscript can be accessed here.
MS is neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord). Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.4 More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.
About MS Relapse
MS is an autoimmune disorder with large annual costs. On average, annual direct health care costs for MS patients have been shown to be about
About H.P. Acthar Gel (repository corticotropin injection)
H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the
- As an orphan monotherapy medication for the treatment of infantile spasms ("IS") in infants and children under 2 years of age.
- Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
- Treatment of acute exacerbations of MS in adults.
- Use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.
- Use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).
- Use as adjunct therapy for short-term administration in select cases of rheumatoid arthritis.
The company is also exploring the possibility of developing other approved indications and the possibility of pursuing
Important Safety Information
- Acthar should never be administered intravenously.
- Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.
- Acthar is contraindicated where congenital infections are suspected in infants.
- Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins.
- The adverse effects of Acthar are related primarily to its steroidogenic effects.
- Acthar may increase susceptibility to new infection or reactivation of latent infections.
- Suppression of the hypothalamic–pituitary–adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Cushing's Syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms.
- Monitor patients for elevation of blood pressure, salt and water retention, and hypokalemia.
- Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and following discontinuation.
- Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer with an increased risk for perforation with certain GI disorders. Monitor for signs of bleeding.
- Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, depression, and psychosis. Existing conditions may be aggravated.
- Patients with comorbid disease may have that disease worsened. Caution should be used in patients with diabetes and myasthenia gravis.
- Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections.
- Acthar is immunogenic and prolonged use may increase the risk of hypersensitivity reactions.
- There is an enhanced effect in patients with hypothyroidism and those with cirrhosis of liver.
- Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients.
- Decrease in bone density may occur. Monitor during long-term therapy.
- Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
- Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.
Please see full Prescribing Information here for additional important safety information.
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 Gold, L., Suh K., Schepman P. and Hansen, R. Healthcare Costs and Resource Utilization in Patients with Multiple Sclerosis Relapses Treated with H.P. Acthar Gel®. Advances in Therapy, June, 2016, p. 1. Available at http://link.springer.com/article/10.1007%2Fs12325-016-0363-0
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 Owens GM, Olvey EL, Skrepnek GH, Pill MW. Perspectives for managed care organizations on the burden of multiple sclerosis and the cost-benefits of disease-modifying therapies. J Manag Care Pharm. 19 (1 Suppl A), S41-53 (2013).
 Carroll CA, Fairman KA, Lage MJ. Updated cost-of-care estimates for commercially insured patients with multiple sclerosis: retrospective observational analysis of medical and pharmacy claims data. BMC Health Serv Res. 14 286 (2014).
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