Skeletal System

PA Criteria:Tier 1 products are covered with no authorization necessary.Tier 2 authorization criteria:

• Previous use of at least two Tier 1 NSAIDs (from different product lines) plus a PPI within the last 120 days, or
• For those with prior GI bleed who must have an NSAIDs, a Tier 2 product may be approved (Celebrex should also be taken with a PPI)

Special PA approval criteria:

• A unique indication for which a Tier-1 or Tier-2 medication is not appropriate, such as the diagnosis of gout for indomethacin; or
• Previous use of at least two Tier-1 NSAID products (from different product lines); and
• A patient-specific, clinically significant reason why a special formulation is needed over a Tier-1 product.
• Additionally, use of Tivorbex™ will require a patient-specific, clinically significant reason why member cannot use other available generic indomethacin products.

• NOTE: In order for previously utilized Tier 1 medications to count as trials toward a Tier 2 authorization, the member's NSAID therapy must have been continuous. Dates and dosing information for Tier 1 trials must be included on petition for authorization. Trials with OTC formulations of Tier 1 products must be dosed at full prescription strength.

• naproxen sodium (Anaprox®)
• flurbiprofen (Ansaid®)
• diclofenac potassium (Cataflam®)
• sulindac (Clinoril®)
• oxaprozin (Daypro®)
• etodolac (Lodine®)
• etodolac ER (Lodine XL®)
• meclofenamate (Meclomen®)
• meloxicam (Mobic®)
• ibuprofen (Motrin®)
• naproxen (Naprosyn®)
• naproxen EC (Naprosyn EC®)
• ketoprofen (Orudis®)
• nabumetone (Relafen®)
• tolmetin (Tolectin®)
• diclofenac ER (Voltaren XR®)
• diclofenac sodium (Voltaren®)

• diclofenac sodium/misoprostol (Arthrotec®)
• celecoxib (Celebrex®)
• fenoprofen (Nalfon®)

• ketoprofen 200mg xr 24hr
• ibuprofen/famotidine (Duexis®)
• piroxicam (Feldene®)
• diclofenac epolamine (Flector®)
• indomethacin (Indocin®)
• naproxen sodium (Naprelan®)
• diclofenac sodium drops (Pennsaid®)
• mefanamic acid (Ponstel®)
• indomethacin (Tivorbex™)
• esomeprazole/naproxen (Vimovo®)
• meloxicam (Vivlodex™)
• diclofenac sodium gel (Voltaren Gel®)
• diclofenac potassium (Zipsor®, Cambia®)
• diclofenac (Zorvolex™)

PA Criteria:

• Tier 1 products are covered with no authorization necessary.

Tier 2 authorization requires:

• Documented trial of two Tier 1 medications within the last 90 days with no beneficial response after a minimum of 2 weeks of continuous therapy during which time the medication has been titrated to the recommended dose.

• cyclobenzaprine (Flexeril®)
• baclofen (Lioresal®)
• orphenadrine (Norflex®)
• chlorzoxazone (Parafon Forte, Paraflex®)
• methocarbamol (Robaxin®)
• tizanidine (Zanaflex®)

• metaxolone (Skelaxin®)

• carisoprodol 350mg w/aspirin
• carisoprodol 350mg, ASA, codeine
• cyclobenzaprine ER (Amrix®) Caps
• cyclobenzaprine 7.5mg (Fexmid®) Tabs
• chlorzoxazone (Lorzone™)
• carisoprodol (Soma®) 250mg, 350mg
• tizanidine (Zanaflex®) Caps

PA Criteria:

• A cumulative 90 therapy day window per 365 days will be in place for these products, further approval will be based on the following:
• An additional approval for 1 month will be granted to allow titration or change to a Tier1 muscle relaxant. Further authorizations will not be granted.
• Clinical exceptions may be made for members with the following diagnosis and approvals will be granted for the duration of one year:
  • Multiple Sclerosis
  • Cerebral Palsy
  • Muscular Dystrophy
  • Paralysis
• A quantity limit of 120 per 30 days will also apply for the carisoprodol and carisoprodol combination products.

Soma 250

Approval for coverage is based on the following criteria:

• Documentation regarding member's inability to use other skeletal muscle relaxants including carisoprodol 350 mg, and specific reason member cannot be drowsy for even a short time period. Member must not have other sedating medications in current claims history.
• A diagnosis of acute musculoskeletal pain, in which case, the approval will be for 14 days per 365 day period. Conditions requiring chronic use will not be approved.

PA criteria:

• Approval requires FDA approved indication and clinical documentation of inability to take other generically available forms of cyclobenzaprine hydrochloride.
• A quantity limit of 30 capsules for 30 days placed on Amrix.
• A quantity limited of 90 tablets for 30 days placed on Fexmid.

PA Criteria:

• Trizanidine tablets must be tried prior to consideration of the capsules. The capsules maybe considered for approval if there is supporting information as to why the member cannot take the tablets

PA Criteria:

• Generic chlorzoxazone 500mg tablets must be tried prior to consideration of Lorzone™; AND
• A patient-specific, clinically significant reason why the member cannot use generic chlorzoxazone 500mg tablets must be provided; AND
• The following quantity limits apply:
  • Lorzone™ 375mg tablets: 120 tablets for 30 days
  • Lorzone™ 750mg tablets: 120 tablets for 30 days

Tier 1 products are available with no authorization necessary.

PA Criteria:

*Calcitonin and raloxifene are not included as Tier-1 trials.

• Must be used at recommended doses in conjunction with Tier-1 bisphosphonate for trial to be accepted unless member has a recent laboratory result showing adequate Vitamin D or member is unable to tolerate calcium. OTC Calcium and Vitamin D are only covered for members with osteoporosis. See a list of covered calcium products.

Criteria for Moving to Higher Tiers:

• Treatment failure with all lower tiered products, or
• Contraindication to all lower tiered products, or
• Allergic reaction to all lowered tiered products, or
• Specific indication not covered by a lower tiered product.
• No concomitant use of bisphosphonate therapy will be approved. No additional bisphosphonate therapy may be approved for 365 days following zoledronic acid infusion.

Clinical Exceptions/Additional Criteria:

• Risedronate may be approved for members with high risk for gastric side effects.
• Zoledronic acid may be approved for members with a diagnosis of Paget’s disease or for osteoporosis if secondary diagnosis meets criteria below:
• Severe esophageal disease (e.g., ulcerations, strictures)
• Inability to take anything by mouth
• Inability to sit or stand for prolonged periods
• Inability to take an oral bisphosphonate for other special medical circumstances that justify the method of administration

•  
• alendronate (Fosamax®)
• calcium + vitamin D

•  
• alendronate +D (Fosamax +D®)
• lbandronate (Boniva®)
• risedronate (Actonel®)

•  
• risedronate delayed release (Atelvia®)
• alendronate (Binosto^TM )
• ibandronate (Boniva^TM )
• conjugated estrogens/bazedoxifene (Duavee®)
• teriparatide (Forteo®)
• denosumab (Prolia®)
• zoledronic acid (Reclast®)

PA Criteria:

• A Bone Mineral Density test (T-score at or below -2.5) within the last month, AND
• A minimum 12 month trial with a bisphosphonate plus adequate calcium and vitamin D, OR
• A 12 month trial of Prolia™ (Denosumab), unless contraindicated, intolerant, or allergic, that did not yield adequate results. Quantity Limits apply bases on FDA maximum doses.

Consideration for approval will be based on the following criteria:

• An FDA approved indication of prevention of skeletal-related events in patients with bone metastases from solid tumors OR treatment of adults and skeletally mature adolescents with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.

Prior Authorization Criteria:

• A minimum 12 month trial with a Tier 1 or Tier 2 bisphosphonate plus adequate calcium and vitamin D, or
• Contraindication to or intolerable adverse effects with Tier 1 and Tier 2 products.
• Clinical exceptions may apply for members with
  • Severe esophageal disease (e.g., ulcerations, strictures)
  • Inability to take anything by mouth
  • Inability to sit or stand for prolonged periods
  • Inability to take bisphosphonates orally for other special medical circumstances that justify the method of administration

Consideration for approval will be based on the following criteria:

• An FDA approved diagnosis of moderate to severe vasomotor symptoms associated with menopause or for prevention of postmenopausal osteoporosis; AND
• Member must be a female with an intact uterus; AND
• For a diagnosis of moderate to severe vasomotor symptoms associated with menopause:
  • Member must have at least 7 moderate to severe hot flushes per day or at least 50 per week prior to treatment; AND
• For a diagnosis of prevention of postmenopausal osteoporosis:
  • A trial of Fosamax® (alendronate), Actonel® (risedronate), Boniva® (ibandronate) or Reclast® (zoledronic acid) compliantly used for at least 6 months concomitantly with calcium + vitamin D, that failed to prevent fracture or improve BMD scores; OR
  • Contraindication to, hypersensitivity to, or intolerable adverse effects with all bisphosphonates indicated for prevention of postmenopausal osteoporosis; and
• Member must not have any of the contraindications for use of Duavee®; AND
• Members greater than 65 years of age will generally not be approved without supporting information.
• Approvals will be for the duration of 6 months to ensure the need for continued therapy is reassessed periodically and the medication is being used for the shortest duration possible.
• A quantity limit of 30 tablets per 30 days will apply.