Skeletal System

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.
• Prior Authorization form

Allopurinol 200mg Tablet Approval Criteria:

• An FDA approved diagnosis; and
• A patient-specific, clinically significant reason why the member cannot use 2 allopurinol 100mg tablets in place of allopurinol 200mg must be provided. 

colchicine capsules (Mitigare™) and colchicine oral solution (Gloperba®) Approval Criteria:

• A quantity of 6 capsules for a 3-day supply is available without prior authorization for treatment of acute gouty attacks; AND
• Failure of allopurinol after 6 months of treatment defined by persistent gouty attacks with serum urate levels greater than 6.0mg/dL; AND
• Patient-specific, clinically significant reason why colchicine tablets (generic Colcrys^®) or colchicine/probenecid would not be a viable option for the member; AND
• For authorization of Gloperba®, a patient-specific, clinically significant reason why the member cannot use colchicine tablets or capsules must be provided; AND
• A quantity limit of 60 capsules per 30 days or 300 mL per 30 days will apply for gout; AND   
• Members with the diagnosis of Familial Mediterranean Fever verified by genetic testing will be approved for up to 2.4mg per day.

pegloticase (Krystexxa®) Approval Criteria:

• An FDA approved diagnosis of gout; AND  
• Member must have symptomatic gout with:
  • ≥3 gout flares in the previous 18 months; OR
  • ≥1 gout tophus; OR
  • Gouty arthritis; AND
• Failure of the following urate lowering therapies: allopurinol, febuxostat, AND probenecid titrated to the maximum tolerable dose for at least 3 months; AND
• Pegloticase must be administered in a health care setting by a health care provider prepared to manage anaphylaxis; AND
• Prescriber must attest that the member will be pre-medicated with antihistamines and corticosteroids to reduce the risk of anaphylaxis; AND
• Prescriber must document that member does not have glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting pegloticase; AND
• Member must discontinue oral urate-lowering agents prior to starting pegloticase; AND
• Member must receive gout flare prophylaxis with non-steroidal anti-inflammatory drug(s) (NSAIDs) or colchicine at least 1 week before initiation of pegloticase therapy and continue for at least 6 months unless medically contraindicated or member is unable to tolerate therapy.
• Approvals will be for the duration of 6 months. Reauthorizations may be granted if the prescriber documents the member is responding well to treatment, and member has not exceeded >4 consecutive weeks without therapy.  

febuxostat (ULORIC®) Approval Criteria:

• Failure of allopurinol defined by persistent gouty attacks with serum urate levels greater than 6.5 mg/dL
• Clinical Reason why allopurinol is not a viable option for the member.
  
• Quantity limit of 30 per 30 days will apply.

lesinurad (Zurampic™) Approval Criteria:

• Member must be 18 years of age or older; AND
  
• An FDA approved diagnosis of gout in patients who have not achieved target serum uric acid (sUA) levels with a xanthine oxidase inhibitor (XOI) alone; AND
• Failure of allopurinol or febuxostat alone defined by serum urate levels greater than 6.0mg/dL; AND
• Prescriber must verify that member has a creatinine clearance greater than 45mL/min prior to initiating treatment and for continued approval; AND
• Prescriber must verify that member will take Zurampic™ concomitantly with a XOI; AND
• Prescriber must document member is not taking more than 325mg of aspirin per day and member is not taking any epoxide hydrolase inhibitors; AND 
• Prescriber must document member has no contraindications for use of Zurampic™ including any of the following: Tumor lysis syndrome or Lesch-Nyhan syndrome, severe renal impairment (CrCl less than 30mL/min), end stage renal disease, kidney transplant recipients, or patients on dialysis.
• A quantity limit of one tablet daily will apply.

Prior Authorization form

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
• Prior Authorization form  

 

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Tier-1	Tier-2	Tier-3
celecoxib (Celebrex®) caps	diclofenac ER (Voltaren® XR)	celecoxib (Elyxyb®) oral solution
diclofenac potassium (Cataflam®)	diclofenac sodium/ misoprostol (Arthrotec®)	Diclofenac epolamine (generic Flector® Patch)
diclofenac sodium (Voltaren®) 50mg & 75mg tabs	diclofenac sodium (Voltaren®) 25mg tabs	diclofenac potassium (Cambia®) powder pack
diclofenac sodium 1% (Voltaren® Gel)	diflunisal 500mg tabs	diclofenac potassium (Lofena™) tabs
etodolac (Lodine®) tabs	etodolac ER (Lodine® XL)	diclofenac potassium (Zipsor®) caps
ibuprofen (Motrin®)	flurbiprofen (Ansaid®)	diclofenac sodium (Pennsaid®) topical drops
indomethacin (Indocin®) caps	indomethacin (Indocin®) ER caps	diflunisal (Dolobid™) 250mg & 375mg tabs
meloxicam (Mobic®)	mefenamic acid (Ponstel®)	fenoprofen (Nalfon®)
nabumetone (Relafen®)	Naproxen DR (EC-Naprosyn®) 500mg tabs	ibuprofen (Caldolor®) inj
naproxen* (Naprosyn®)	naproxen sodium (Anaprox®) 275mg & 550mg tabs	ibuprofen/acetaminophen (Combogesic® IV) inj+
naproxen DR (EC-Naprosyn®) 375mg tabs	oxaprozin (Daypro®)	ibuprofen/famotidine (Duexis®)
sulindac (Clinoril®)	piroxicam (Feldene®)	indomethacin (Indocin®) supp & susp
		ketoprofen (Orudis®) caps
		ketoprofen ER (Oruvail®)
		ketorolac tromethamine (Sprix®) nasal spray
		meclofenamate (Meclomen®)
		meloxicam (Vivlodex®) caps
		nabumetone 1,000mg (Relafen DS®)
		naproxen sodium ER (Naprelan®)
		naproxen/esomeprazole (Vimovo®)
		tolmetin (Tolectin®)

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), or Wholesale Acquisition Costs (WAC) if NADAC unavailable.
*Naproxen oral suspension is available without prior authorization for members 12 years of age and younger. Members older than 12 years of age require a reason why a special formulation product is needed in place of the regular tablet formulation.
⁺Unique criteria applies.
caps = capsules; DR = delayed-release; ER = extended-release; EC = enteric-coated; inj = injection; ODT = orally disintegrating tablet; PA = prior authorization; supp = suppository; susp = suspension; tabs = tablets

NSAIDs Tier-2 Approval Criteria:

• Previous use of at least 2 Tier-1 NSAID products (from different product lines) plus a proton pump inhibitor (PPI) within the last 120 days.

 

NSAIDs Special Prior Authorization (PA) Approval Criteria:

• A unique indication for which a Tier-1 or Tier-2 medication is not appropriate; or
• Previous use of at least 2 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; and
• Additionally, use of Dolobid™ (diflunisal) 250mg or 375mg tablet will require a patient-specific, clinically significant reason why the member cannot use generic diflunisal 500mg tablets; and
• Additionally, use of Elyxyb^® (celecoxib oral solution) will require a diagnosis of acute migraine treatment in adults 18 years of age and older and a patient-specific, clinically significant reason why the member cannot use Cambia^® (diclofenac potassium powder); and
• Additionally, use of Lofena™ (diclofenac potassium) will require a patient-specific, clinically significant reason why the member cannot use all other available generic diclofenac products.

 

Combogesic^® IV (Ibuprofen/Acetaminophen Injection) Approval Criteria:

• An FDA approved indication in members where an intravenous (IV) route of administration is considered clinically necessary for 1 of the following:
  • Relief of mild-to-moderate pain; or
  • Management of moderate-to-severe pain as an adjunct to opioid analgesics; and
• Member must be 18 years of age or older; and
• A patient-specific, clinically significant reason why the member requires IV administration and cannot use Tier-1 oral and/or topical alternatives must be provided; and
• A quantity limit of 2,000mL (20 vials) per 5 days will apply; and
• A maximum approval duration of 5 days will apply, as Combogesic^® IV is only indicated for short-term use of 5 days or less.

Tier-1	Tier-2	Special PA¥
alendronate tabs (Fosamax®)	alendronate + vitamin D tabs (Fosamax® + D)	abaloparatide inj (Tymlos®)
calcium + vitamin D†	risedronate tabs (Actonel®)	alendronate effervescent tabs (Binosto®)
ibandronate tabs (Boniva®)		alendronate soln (Fosamax®)
zoledronic acid inj (Reclast®)		alendronate 40mg tabs (Fosamax®)
		denosumab inj (Prolia®)
		ibandronate inj (Boniva® IV)
		risedronate 30mg tabs (Actonel®)
		risedronate DR tabs (Atelvia®)
		romosozumab-aqqg (Evenity®)
		teriparatide inj (Forteo®) – Brand Preferred
		teriparatide inj (Bonsity®)

*Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

^†OTC calcium + vitamin D must be used at recommended doses in conjunction with Tier-1 bisphosphonates 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 + vitamin D are only covered for members with osteoporosis who are being treated with a bisphosphonate.

^¥Unique criteria applies to medications in the Special PA Tier.

DR = delayed-release; inj = injection; PA = prior authorization; soln = solution; tabs = tablets

 

Osteoporosis Medications Tier-2 Approval Criteria:

• A trial of at least 1 Tier-1 bisphosphonate medication, compliantly used for at least 6 months concomitantly with calcium and vitamin D, that failed to prevent fracture or improve bone mineral density (BMD) scores; or
• Hypersensitivity to or intolerable adverse effect(s) with all Tier-1 bisphosphonate medications (including oral and intravenous routes of administration); and
• Quantity limits apply based on FDA approved maximum doses.

 

Actonel^® (Risedronate 30mg Tablets), Atelvia^® [Risedronate Delayed-Release (DR) Tablets], and Binosto^® (Alendronate Effervescent Tablets) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use all other available Tier-1 and Tier-2 bisphosphonate medications must be provided; or
• Members with a diagnosis of Paget’s disease in claims history will not require prior authorization.

 

Boniva^® [Ibandronate Intravenous (IV) Solution], Jubbonti^® (Denosumab-bbdz), and Prolia^® (Denosumab) Approval Criteria:

• A minimum of a 12-month trial with a Tier-1 or Tier-2 bisphosphonate medication plus adequate calcium and vitamin D; or
• Contraindication to or intolerable adverse effects with Tier-1 and Tier-2 bisphosphonate medications (including oral and intravenous routes of administration); and
• For Jubbonti^®, a patient-specific, clinically significant reason why the member cannot use Prolia^® (denosumab) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products. 

 

Bonsity® (Teriparatide) and Forteo^® (Teriparatide) and Teriparatide Approval Criteria:

• Diagnosis of 1 of the following:
  • Treatment of postmenopausal women with osteoporosis at high risk for fracture; or
  • To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture; or
  • Treatment of men and women with osteoporosis associated with sustained systemic corticosteroid therapy at high risk for fracture; or
  • Treatment of non-healing fracture (this indication only pertains to Forteo^®); and
• A minimum 12-month trial with a bisphosphonate plus adequate calcium and vitamin D or a patient-specific, clinically significant reason why the member cannot use a bisphosphonate must be provided; and
• Use of generic teriparatide will require a patient-specific, clinically significant reason why the member cannot use the brand formulation, Forteo^® (teriparatide); and
• Use of Bonsity® (teriparatide) will require a patient-specific, clinically significant reason why the member cannot use Forteo® (teriparatide) or generic teriparatide formulations; and
• The diagnosis of non-healing fracture may be approved for 6 months; and
• Treatment duration including other parathyroid hormone analogs has not exceeded a total of 24 months during the patient’s lifetime; and
• Approval will be for a maximum of 2 years of parathyroid hormone analog therapy.

 

Evenity^® (Romosozumab-aqqg) Approval Criteria:

• An FDA approved diagnosis of osteoporosis in postmenopausal women at high-risk for fracture; and
• Member meets 1 of the following:
  • History of osteoporotic fracture; or
  • Multiple risk factors for fracture (e.g., T-score ≤-2.5 at the total hip or femoral neck, smoking, corticosteroid use, rheumatoid arthritis); or 
  • Failure of or intolerance to other available osteoporosis therapies; and
• Prescriber must verify member has not had a myocardial infarction or stroke within the preceding year; and
• Prescriber must verify calcium levels will be monitored and pre-existing hypocalcemia will be corrected prior to starting therapy; and
• Prescriber must verify that the member will take adequate calcium and vitamin D supplements during treatment with Evenity^® to reduce the risk of hypocalcemia; and
• Evenity^® must be administered by a health care provider; and
• Approval will be limited to a total duration of 1 year of therapy. 

 

Fosamax^® (Alendronate Oral Solution) Approval Criteria:

• An FDA approved diagnosis of osteoporosis or Paget’s disease; and
• A patient-specific, clinically significant reason why the member cannot use the oral tablet formulation must be provided.

 

Fosamax^® (Alendronate 40mg Tablets) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use all other available Tier-1 and Tier-2 bisphosphonate medications including a 35mg alendronate tablet in combination with a 5mg alendronate tablet to achieve a 40mg dose must be provided; or
• Members with a diagnosis of Paget’s disease in claims history will not require prior authorization.

 

Tymlos^® (Abaloparatide) Approval Criteria:

• Diagnosis of postmenopausal osteoporosis confirmed by the following:
  • History of vertebral fracture(s) or low trauma or fragility fracture(s) (e.g., prior fracture from minor trauma such as falling from standing height or less) within the past 5 years; or
  • A bone mineral density (BMD) test (T-score at or below -2.5) within the last month in the spine, femoral neck, total hip, or 33% radius; or
  • A T-score between -1.0 and -2.5 in the spine, femoral neck, total hip, or 33% radius, with a FRAX^® 10-year probability for major osteoporotic fracture ≥20% or the 10-year probability of hip fracture ≥3%; and
• One of the following [if a 12-month bisphosphonate trial is inappropriate for the member, the member must have a trial of Prolia^® or a selective estrogen receptor modulator (SERM) or a patient-specific, clinically significant reason why Prolia^® or a SERM is not appropriate must be provided]:
  • A minimum 12-month trial with a bisphosphonate medication 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; or
  • A 12-month trial of a SERM, unless contraindicated, intolerant, or allergic, that did not yield adequate results; and
• A patient-specific, clinically significant reason why the member cannot use Forteo^® (teriparatide) must be provided; and
• Treatment duration including other parathyroid hormone analogs has not exceeded a total of 24 months during the member’s lifetime; and
• Approval will be for a maximum of 2 years of parathyroid hormone analog therapy; and
• A quantity limit of 1 pen per 30 days will apply.

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.

Baclofen 5mg Tablet and Baclofen 15mg Tablet Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use other appropriate Tier-1 products including splitting a baclofen 10mg tablet to achieve a 5mg dose must be provided.
  

Chlorzoxazone 250mg Tablet Approval Criteria:

• A patient-specific, clinically specific reason why the member cannot split a 500mg chlorzoxazone tablet to achieve the 250mg dose must be provided.

Fleqsuvy™ 25mg/5mL (Baclofen Oral Suspension), Lyvispah™ (Baclofen Oral Granules) ,Ozobax^® 5mg/5mL (Baclofen Oral Solution), and Ozobax^® DS [Baclofen Double Strength (DS) 10mg/5mL Oral Solution] Approval Criteria:

• An FDA approved indication of spasticity resulting from multiple sclerosis (relief of flexor spasms and concomitant pain, clonus, and muscular rigidity) or spinal cord injuries/diseases; and
• Requests for Fleqsuvy^® ,Ozobax^® ,or Ozobax^® DS will require a patient-specific, clinically significant reason why member cannot use Lyvispah™; and
• Members older than 10 years of age require a patient-specific, clinically significant reason why the member cannot use baclofen oral tablets, even when tablets are crushed.

Norgesic^®, Norgesic^® Forte, and Orphengesic^® Forte (Orphenadrine/ Aspirin/Caffeine) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use all lower-tiered products must be provided.

Prior Authorization form

Tier 1	Tier 2	Special PA
cyclobenzaprine (Flexeril®) baclofen 10mg, 20mg (Lioresal®) orphenadrine (Norflex®) chlorzoxazone (Parafon Forte®) methocarbamol (Robaxin®) tizanidine tabs (Zanaflex®)	metaxolone (Skelaxin®)	baclofen 5mg, 15mg baclofen oral granules (Lyvispah™) baclofen oral suspension (Fleqsuvy™) baclofen 10mg/5mL oral soln (Ozobax® DS) carisoprodol 350mg w/aspirin carisoprodol 350mg, ASA, codeine cyclobenzaprine ER (Amrix®) Caps cyclobenzaprine 7.5mg (Fexmid®) Tabs chlorzoxazone 250mg, 375mg, 750mg  carisoprodol (Soma®) 250mg, 350mg orphenadrine/ASA/caffeine tabs (Norgesic®, Norgesic® Forte, Orphengesic® Forte) 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.

Soma (Carisoprodol) 350mg or Soma (carisoprodol 350mg) Combination Product(s) Approval Criteria:

• Members may receive 3 months of carisoprodol 350mg per rolling 365 days without prior authorization; and
• After the member has the 90 days’ supply, an additional approval for 1 month may be granted to allow titration or change to a Tier-1 muscle relaxant. This additional one-month approval will be granted 1 time only. Further authorizations will not be granted; or
• Clinical exceptions may be made for members with 1 of the following diagnosis and approvals will be granted for the duration of 1 year: multiple sclerosis, cerebral palsy, muscular dystrophy, paralysis, or cancer pain; and
• A quantity limit of 120 tablets per 30 days will apply for carisoprodol and carisoprodol combination products. 

 

• Prior Authorization form

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
• Prior Authorization form