NFMCPA Position on Step-Therapy

Jan Chambers, president and founder of the NFMCPA, will be discussing more about this issue during the NFMCPA’s newly launched bi-weekly online radio program on BlogTalkRadio. "Step-Therapy Fails for Fibromyalgia Patients” will air live on Friday, October 14 at 9:00 am MT.  For additional details to hear the program, go to www.blogtalkradio.com/nfmcpa.

The position paper is detailed below:

National Fibromyalgia & Chronic Pain Association

Position Paper on Access to Care for Step-Therapy, Fail-First, and Special Tiers

Acute and chronic pain management is unique to each patient.  It is not a repetitive process nor a technique applied for relief in the same manner from patient to patient for a similar beneficial outcome.  Whereas removing an appendix, treating a strep throat or common medical occurrences can be effectively treated by a standardized process repeated with patients, a standardized process is inappropriate for patients with pain.  Pain patients need direct interaction with a treating physician who is aware of patient history and current condition. Disparities and increased vulnerability to pain are found in:

  • having English as a second language
  • race and ethnicity
  • income and education
  • sex and gender
  • age group
  • geographic location
  • military veterans
  • cognitive impairments
  • surgical patients
  • cancer patients, and
  • the end of life.1

Turning a necessary interpersonal relationship between a patient and a physician into a process approved by a removed decision-making body through step-therapy, fail-first, and special tiers is not in the best interests of patients.  Additionally, there is strong potential for harmful effects.

Pain can be a disease unto itself.  The Institute of Medicine’s June 2011 Report, Relieving Pain in America, calls for “a recognition of the complexity of the pain experience.”2 Most researchers and clinicians use the “biopsychosocial model” for pain which recognizes the interrelation of biological, psychological, and social/family/cultural contexts of pain to understand and treat pain.3 Pain is part of a  symptom cycle where inappropriately addressed pain decreases psychological wellbeing, disrupts essential sleep, increases anxiety, decreases the patient’s resiliency and quality of life, and is linked to suicide.4,5,6,7,8 Inadequate pain management causes harm to patients.

Under step- and fail-first therapies, patients are required to fail on lower-cost medications and treatments before insurance companies will cover the cost of medications originally prescribed by physicians.  Often these lower-cost medications include over-the-counter drugs that are insufficient treatment options.  Step-therapy was instituted to minimize cost burdens; however, the practice has been shown to potentially produce the opposite effect.  While pharmacy costs may go down under step-therapy, research indicates that overall medical expenses increase due to resulting increased inpatient and emergency room costs. 9

Using special tiers designed by insurance companies shifts the expense of medications to their insured by requiring them to pay a percentage of cost rather than a co-pay.  This places access to front-line medications out of reach for most patients.  Simply put, creating an insurmountable barrier to care is not an acceptable purpose of insurance.

Physical and emotional costs are associated with step-therapy, fail-first, and special tiers practices.  Patients who must fail first before receiving the appropriate care for their conditions are left to suffer for longer than necessary.  A study on the effects of step-therapy for treatment of depression indicated that complications, such as drug resistance, recurrences, and chronicity resulted with each failed treatment.10 People who experience acute pain may go on to develop chronic, intractable pain.11 Step-therapy also increases the burden placed on physicians’ time with the increased approvals they must complete.

The negative effects of step-therapy expand over a number of diseases and conditions.  The Epilepsy Foundation asserts their position against step-therapy practices.  They state that seizures can result in injury to the patient and others as well as cause lasting brain damage and should therefore be prevented if at all possible.  Patients who must fail first on inadequate medications are at increased risk for seizures and their consequences.

Fibromyalgia patients are subject to severe chronic pain and numerous overlapping conditions.  It is inappropriate to institute any policy that requires FM patients to needlessly suffer longer than necessary or that increases risk for complicating conditions.

SUMMARY: The National Fibromyalgia & Chronic Pain Association (NFMCPA) feels it is not in the best interests of patients, and additionally that there is strong potential for harmful effects, to have step-therapy, fail-first, and special tiers in health care.  We urge necessary laws and policies be enacted to cease their continuance.

  1. Institute of Medicine, Relieving Pain in America:  A Blueprint for Transforming Prevention, Care, Education and Research.  2011.  National Academies Press p 2-9.
  2. Ibid., p 1-15.
  3. Gatchel R J, et al. 2007. The biopsychosocial approach to chronic pain:  Scientific advances and future directions.  Psychological Bulletin 133(4);581-624.
  4. Brennan F, et al. 2007.  Pain management: A fundamental human right. Anesthesia & Analgesia 105:205-221.
  5. Sinatra R. 2010. Causes and consequences of inadequate management of acute pain. Pain Medicine 11:1859-1871.
  6. Stanford Patient Education Research Center.  2006. Chronic Disease Self-Management Program. 1:4, p 11.
  7. Bair M, et al. 2008.  Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients. Psychosomatic Medicine 70(8); 890-897.
  8. Ilgen M A, et al. 2008.  Pain and suicidal thoughts, plans, and attempts in the United States. General Hospital Psychiatry 30(6):521-527.
  9. Mark T, et al.  2010. The effects of antidepressant step therapy protocols on pharmaceutical and medical utilization and expenditures. American Journal of Psychiatry167(10), 1202-1209. doi:10.1176/appi.ajp.2010.09060877

10.  Greden J.  2010. Does antidepressant step therapy fuel the law of unintended consequences? American Journal of Psychiatry167(10), 1148-1151. doi:10.1176/appi.ajp.2010.10081158

11.  Institute of Medicine, Relieving Pain in America:  A Blueprint for Transforming Prevention, Care, Education and Research.  2011.  National Academies Press p 1-9.