Safe and Effective Medication Use - NC Standard

Criteria for Approval of Restricted Product(s):

1. The requested medication is for a pramoxine containing product; AND
   1. The medication is being used to treat corticosteroid-responsive dermatoses; AND 
   2. The patient has tried and failed over-the-counter products containing hydrocortisone and/or pramoxine; AND 
   3. The provider acknowledges that the use of hydrocortisone/pramoxine was not considered effective for any indication by the FDA¹ ; OR
2. The requested medication is Demerol (meperidine) or pentazocine/naloxone; AND 
   1. The patient is NOT being treated for cancer Pain² ; AND
   2. If the request is for Demerol (meperidine),
      1. The patient is NOT being treated for chronic pain³ ; AND
   3. The patient has had a trial and failure of up to three alternative opioid analgesics; OR
   4. The patient has a documented allergy, intolerance, or contraindication to all oral analgesic alternatives; OR
3. The requested medication is Zyflo (zileuton) or Zyflo CR (zileuton ER)⁴ ; AND 
   1. The patient is 12 years of age and older; AND 
   2. The medication is being used for the prophylaxis and long-term treatment of persistent asthma; AND
   3. The patient has tried and failed an inhaled corticosteroid regimen consistently for a 12 month period; AND
   4. The patient has tried and failed a long-acting beta agonist regimen consistently for a 6 month period; OR
   5. The patient has tried and failed theophylline consistently for a 6 month period; OR
   6. The patient has tried and failed an alternative leukotriene receptor antagonist consistently for a 6 month period; OR
   7. The patient has a documented allergy, intolerance, or contraindication to all of the above guideline-specific alternatives; OR
4. The requested medication a carisoprodol containing product; AND 
   1. The medication is being used for the short-term relief of discomfort associated with acute, painful musculoskeletal conditions; AND
   2. The patient will only be taking the medication for up to 3 weeks for the musculoskeletal condition; AND
   3. The patient has tried and failed two other muscle relaxants; AND
   4. The patient has been assessed for a history of substance abuse; AND 
   5. If the above criteria is not met and the patient has been stable on the requested medication for an extended period of time, then a one-time, 12 week authorization will be granted to allow tapering off of the medication or to meet criteria; AND 
      1. Individualized tapering authorizations may be granted beyond 12 weeks based on review by the Blue Cross NC clinical review team; OR
5. The request is for meprobamate; AND
   1. The medication is being used for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety; AND
   2. The patient is stable on therapy; OR 
   3. The provider acknowledges that the use of meprobamate containing products are not supported in clinical guidelines for anxiety and that meprobamate is a last line therapy for the patient; AND
   4. The patient has been assessed for a history of substance abuse; OR
6. The requested medication is Nefazodone or Thioridazine; AND 
   1. The patient is currently stable on Nefazadone or Thioridazine; OR
   2. If the medication is Nefazodone;
      1. The medication is being used to treat depression; AND
      2. The patient has tried and failed two other antidepressants within the selective serotonin reuptake inhibitor (SSRI) or selective serotonin/norepinephrine reuptake inhibitor (SNRI) class (4 week trial required of each); OR
   3. If the medication is Thioridazine;
      1. The medication is being used to treat schizophrenia; AND
      2. The medication is not the first line treatment for the patient; OR
7. The requested medication is Halcion (triazolam);
   1. The patient will be using to aid in sleep onset; AND
   2. The patient will not be using for more than 7 to 10 days; AND
8. The requested medication is Librax (clidinium and chlordiazepoxide); AND 
   1. The medication is written by or in consultation with a gastroenterologist; AND
   2. The patient has a diagnosis of peptic ulcer; AND
      1. The patient has failed therapy or has a clinical contraindication/intolerance to proton pump inhibitors (omeprazole, pantoprazole, rabeprazole, etc.); AND
      2. The patient has failed therapy or has a clinical contraindication/intolerance to H2 receptor antagonists (ranitidine, famotidine, cimetidine, etc.); AND 
      3. The patient has failed therapy or has a clinical contraindication/intolerance to sucralfate; OR
   3. The patient has a diagnosis of irritable bowel syndrome ^5,6;
      1. The patient has failed therapy or has a clinical contraindication/intolerance to alosetron; AND
      2. The patient has failed therapy or has a clinical contraindication/intolerance to Xifaxan (rifaximin); AND
      3. The patient has failed therapy or has a clinical contraindication/intolerance to tricyclic or SSRI antidepressants; AND
      4. The patient has failed therapy or has a clinical contraindication/intolerance an antispasmodic (dicyclomine); AND
   4. The provider acknowledges that clidinium and chlordiazepoxide (Librax) are not considered effective for any indication by the FDA¹

Duration of Approval: 365 days (1 year); Titration taper: 84 days

Quantity Limitations: quantity limitations apply to brand and associated generic products*.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year) 

References:

all information referenced is from FDA package insert unless otherwise noted below. 

¹FDA Drug Efficacy Study Implementation (DESI) process deemed these medications less than effective for all indications.

²National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Adult Cancer Pain. Version 2.2019. 2019 Mar 15; National Comprehensive Cancer Network. Abstract available at https://www.nccn.org/professionals/physician_gls/pdf/pain.pdf 

³Manchikanti L, Kaye AM, Knezevic NN, McAnally H, et. al. Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician 2017;20:S3–s92.

⁴National Asthma Education and Prevention Program: Expert panel report III: Guidelines for the diagnosis and management of asthma. Bethesda, MD: National Heart, Lung, and Blood Institute, 2007. www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

⁵Weinberg DS, Smalley W, Heidelbaugh JJ, et al. American Gastroenterological Association Institute Guideline on the pharmacological management of irritable bowel syndrome. Gastroenterology 2014; 147:1146.

⁶Ford AC, Moayyedi P, Lacy BE, et al. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol 2014; 109 Suppl 1:S2. 

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

July 2024: Criteria update: Updated carisoprodol step requirement from “up to two” to “two” other muscle relaxants.

May 2024: Criteria update: Removed obsolete products meperidine 100mg, Butisol, and carisoprodol/ASA from policy.

October 2021: Criteria update: Removed Ketoconazole from policy.

July 2021: Criteria update: Criteria applied to Essential and Net Results formularies.

July 2019: Original utilization management criteria issued