Evidence from the literature in this section is provided for informational use only, and is not intended for use by healthcare providers to make treatment decisions for individual patients.

ITB therapy has been shown to be cost effective compared to other medical management of severe spasticity in multiple studies. While the initial cost of ITB therapy is high, there is evidence that over time, healthcare utilization and resource costs may offer savings. One retrospective study that followed 409 patients with severe spasticity over 3 years pre- and postimplant showed that ITB therapy was less expensive over time than conventional medical management. The break-even point occurred between 2 and 3 years post-implant, and the per patient savings for a year relative to conventional medical management was $8009.  The majority of savings were the result of reduced inpatient admissions, reduced office visits, and fewer ambulatory surgical events, even in the face of the costs of treating catheter complications ($2307). Thus, over time, ITB Therapy℠ with Lioresal® Intrathecal could offer patients cost savings.1

Cost comparison of conventional medical management and ITB Therapy1

Time From Implant

Discounted Cumulative Costa

Costs/Savings Per Patient (Cumulativeb)

Costs/Savings Per Patient (Per Year)

Year Post-Implant

Conventional Therapy (Projection)

ITB Therapy

0 (month of implant) 4,575 34,682 30,107 30,107
1 61,922 88,297 26,375 26,375
2 122,683 133,327 10,644 5,322
3 186,180 166,242 (19,937) (6,646)
4 251,611 203,463 (48,148) (12,037)
5 318,084 250,315 (67,769) (13,554)
6 385,175 363,970 (21,205) (3,534)
7 452,890 430,231 (22,659) (3,237)
8 521,236 481,273 (39,963) (4,995)
9 590,217 520,256 (69,961) (7,773)
10 659,839 559,861 (99,978) (9,998)
15 1,017,786 894,749 (123,037) (8,202)
20 1,392,693 1,247,070 (145,622) (7,281)
30 2,196,635 1,956,363 (240,272) (8,009)

aAssumes an annual discount rate of 3% and annual medical trend rates of 10.0%, 8.5%, 7.0%, 5.5%, and 4.0% for years 1, 2, 3, 4, and 5+, respectively.

bValues not in parentheses are costs. Values in parentheses are savings.

In a retrospective longitudinal analysis of medical and pharmacy claims in 38,951 patients (2004-2010), patients receiving ITB therapy for spasticity (n=973 for spasticity alone; n=14,257 for spasticity and pain) showed a mean annualized postimplant societal cost ranging from $12,233 (spasticity patients) to $20,049 (spasticity + pain patient cohort). Two-thirds of these societal costs were shown to be due to inpatient events from a small number of patients (representing high costs for medical encounters).2

Two studies analyzed the incremental cost saving in quality-adjusted life years (QALY).  The first study evaluated a cohort of children with cerebral palsy treated with ITB therapy or conventional medical management. In the base case model, ITB therapy cost on average $49,000 more than conventional medical management over a 5-year period, but the average patient gained 1.2 QALY, bringing the net incremental cost-effectiveness ratio (ICER) for ITB

therapy to approximately $42,000 QALY. Keep in mind that it is widely assumed that a treatment that provides an additional QALY is at a cost <$50,000. When considering potential annual risk of developing a complication of 25%, the ICER was $45,700 for ITB therapy. When assuming that the cost of conventional medical management can increase 10% annually due to increasing complexity of treatment, the ICER was $31,500.3

In a second study, ITB therapy resulted in functional benefits in selected patients with severe spasticity. Benefits were particularly pronounced in patients who were bedridden and then were able to sit in a wheelchair or in a small number of patients who were wheelchair bound and then became ambulatory. The cost per QALY ranged from $10,550 to $19,560, an acceptable ratio compared to other interventions.4


Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension and paresthesias. Priapism may develop or recur if treatment with intrathecal baclofen is interrupted. Signs of overdose may appear suddenly or insidiously, and a massive overdose may present as coma. Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma. Should overdose appear likely, the patient should be taken immediately to a hospital for assessment and emptying of pump reservoir. Except in overdose related emergencies, the dose of Lioresal® Intrathecal should ordinarily be reduced slowly if the drug is discontinued for any reason.

  1. Saulino M, Guillemette S, Leier J, Hinnenthal J. Medical cost impact of intrathecal baclofen therapy for severe spasticity. Neuromodulation. 2015;18(2):141-149; discussion 149.
  2. Thrasher TA, Fisher S. Societal costs of intrathecal drug delivery systems−an administrative analysis based on patient claims. Neuromodulation. 2013;16(3):261-265; discussion 265.
  3. de Lissovoy G, Matza LS, Green H, Werner M, Edgar T. Cost-effectiveness of intrathecal baclofen therapy for the treatment of severe spasticity associated with cerebral palsy. J Child Neurol. 2007;22(1):49-59.
  4. Sampson FC, Hayward A, Evans G, Morton R, Collett B. Functional benefits and cost/benefit analysis of continuous intrathecal baclofen infusion for the management of severe spasticity. J Neurosurg. 2002;96(6):1052-1057.
  5. Becker WJ, Harris CJ, Long ML, Ablett DP, Klein GM, DeForge DA. Long-term intrathecal baclofen therapy in patients with intractable spasticity. Can J Neurol Sci. 1995;22(3):208-217.
  6. Bensmail D, Ward AB, Wissel J, et al. Cost-effectiveness modeling of intrathecal baclofen therapy versus other interventions for disabling spasticity. Neurorehabil Neural Repair. 2009;23(6):546-552.
  7. Hattori N, Hirayama T, Katayama Y. Cost-effectiveness analysis of intrathecal baclofen therapy in Japan. Neurol Med Chir (Tokyo). 2012;52(7):482-487.
  8. Hoving MA, Evers SM, Ament AJ, van Raak EP, Vles JS, Dutch Study Group on Child S. Intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a cost-effectiveness analysis. Dev Med Child Neurol. 2008;50(6):450-455.
  9. Meythaler JM, Steers WD, Tuel SM, Cross LL, Haworth CS. Continuous intrathecal baclofen in spinal cord spasticity. A prospective study. Am J Phys Med Rehabil. 1992;71(6):321-327.
  10. Nance P, Schryvers O, Schmidt B, Dubo H, Loveridge B, Fewer D. Intrathecal baclofen therapy for adults with spinal spasticity: therapeutic efficacy and effect on hospital admissions. Can J Neurol Sci. 1995;22(1):22-29.
  11. Ordia JI, Fischer E, Adamski E, Spatz EL. Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticity. J Neurosurg. 1996;85(3):452-457.
  12. Postma TJ, Oenema D, Terpstra S, et al. Cost analysis of the treatment of severe spinal spasticity with a continuous intrathecal baclofen infusion system. Pharmacoeconomics. 1999;15(4):395-404.
  13. Vidal J, Slof J, Serrano D, Marques T, Kumru H, Benito-Penalva J. Cost-effectiveness of Intrathecal Baclofen Therapy in severe refractory non-focal disabling spasticity: a Spanish hospital perspective. Expert Rev Pharmacoecon Outcomes Res. 2017;17(1):67-76.

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage


Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.