New pharmacy policies
No updates this month.
Revised pharmacy policies
Effective September 1, 2024
C3 and C5 Complement Inhibitors, 5.01.571 PBC | Premera HMO
Drug added
Medical necessity criteria added
Piasky (crovalimab-akkz)
- Added coverage for treatment of paroxysmal nocturnal hemoglobinuria in individuals aged 13 years or older
- Must have completed at least 3 months of therapy with Soliris or Ultomiris
- Must have experienced residual anemia (hemoglobin
<10.5 g/dL and lactic acid dehydrogenase level 1.5 times the upper limit) while undergoing treatment on Soliris or Ultomiris
- Must have received Streptococcus pneumoniae, Neisseria meningitis, and Hemophilus influenzae at least 2 weeks prior to first does
Drug removed
- Removed Ultomiris SC on body injector since it is removed from the market
Hereditary Angioedema, 5.01.587 PBC | Premera HMO
Medical necessity criteria updated
Berinert (pdC1-INH) IV
- Added requirement that individual must have tried and had an inadequate response or intolerance to generic icatibant or Sajazir (icatibant)
Cinryze (pdC1-INH) IV
- Removed requirement for males 18 years and older to have tried and had an inadequate response or intolerance to Danocrine or another androgen
Haegarda (pdC1-INH) SC
- Removed requirement for males 18 years and older to have tried and had an inadequate response or intolerance to Danocrine or another androgen
Kalbitor (ecallantide) SC
- Removed requirement for males 18 years and older to have tried and had an inadequate response or intolerance to Danocrine or another androgen
Orladeyo (berotralstat) oral
- Removed requirement for males 18 years and older to have tried and had an inadequate response or intolerance to Danocrine or another androgen
Ruconest (rhC1-INH) IV
- Added requirement that individual must have tried and had an inadequate response or intolerance to generic icatibant or Sajazir (icatibant)
Takhzyro (lanadelumab-lyo) SC
- Removed requirement for males 18 years and older to have tried and had an inadequate response or intolerance to Danocrine or another androgen
Immune Checkpoint Inhibitors, 5.01.591 PBC | Premera HMO
Medical necessity criteria updated
Imfinzi
- Added treatment of primary advanced or recurrent endometrial cancer that is mismatch repair deficient when administered as a single agent following combination therapy with carboplatin and paclitaxel
Keytruda (pembrolizumab) IV
- Added treatment of hepatocellular carcinoma secondary to hepatitis B in individuals who have received prior systemic therapy other than a PD-1/PD-L1 containing regimen
- Added treatment of primary advanced or recurrent endometrial carcinoma when administered as a single agent following combination therapy with carboplatin and paclitaxel
Pharmacologic Treatment of Hemophilia, 5.01.581 PBC | Premera HMO
Drugs added
Medical necessity criteria added
Beqvez (findanacogene elaparvovec-dzkt)
- Added coverage for treatment of hemophilia in individuals aged 18 years and older who are assigned male at birth
- Must have severe or moderately severe hemophilia B as defined by a plasma Factor IX (FIX) activity level of 2% or less
- Must have either current or historical life threatening hemorrhage OR repeated serious spontaneous bleeding episodes OR is currently receiving a FIX prophylaxis that will be discontinued following Beqvez administration
- Must not have a history of FIX inhibitors or a positive screen result of 0.6 or greater Bethesda Units
- Must have received a liver health assessment including enzyme testing and an hepatic ultrasound and elastography
- Must have been assessed by an hepatologist if radiological liver abnormalities or sustained liver enzyme elevations are present
- Must be human immunodeficiency virus (HIV) negative or have HIV controlled infection
- Must not have an active hepatitis B or hepatitis C infection
- Must not have neutralizing antibodies to adeno-association virus serotype Rh74var capsid
- Must be prescribed by or in consultation with a physician specializing in hemophilia B or a hematologist
Investigational criteria updated
Beqvez (findanacogene elaparvovec-dzkt)
- Considered investigational for all other uses not outlined in policy or for repeat treatment
Medical Necessity Criteria for Pharmacy Edits, 5.01.605 PBC | Premera HMO
Medical necessity criteria updated
Motpoly XR (lacosamide extended release)
- Added treatment of primary generalized tonic-clonic seizures in individuals weighing at least 50 kg
Sirturo (bedaquiline)
- Update criterion to indicate diagnosis requirement of pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid
Palforzia [peanut (arachis hypogaea) allergen powder-dnfp]
- Age requirement updated from those aged 4 years or older to those aged 1 year and older
Drug added
Medical necessity criteria added
Vigafyde (vigabatrin)
- Added coverage for treatment of infantile spasms when used alone in individuals aged 1 months to 2 years
- Must have tried and had inadequate response or intolerance to generic vigabatrin, Vigpoder (vigabatrin), or Vigadrone (vigabatrin)
Drugs added
Medical necessity criteria added
Durysta (bimatoprost)
- Added coverage for use to reduce intraocular pressure in individuals diagnosed with open-angle glaucoma or ocular hypertension
- Must have tried and had an inadequate response or intolerance to two generic ophthalmic prostaglandin analogs
Envarsus XR (tacrolimus extended-release)
- Added as a transplant agent for individuals who have received a kidney transplant
- Must have tied generic immediate-release tacrolimus
- Must be prescribed by or in consultation with a nephrologist or transplant specialist
Opill (norgestrel)
- Added to Contraceptives with a quantity limit of 30 tables per 30 days
Drugs added
Brand Oral NSAIDs
- Anaprox (naproxen)
- Arthrotec (diclofenac-misoprostol)
- Celebrex (celecoxib)
- Daypro (oxaprozin)
- Feldene (piroxicam)
- Lodine (etodolac)
- Mobic (melaxicam)
- Naprosyn (naproxen)
- Voltaren (diclofenac)
Miscellaneous Oncology Drugs, 5.01.540 PBC | Premera HMO
Drugs added
Medical necessity criteria added
Casodex (bicalutamide)
- Added coverage for the treatment of metastatic carcinoma of the prostate in individuals aged 18 years and older
- Must be used in combination with gonadotropin releasing hormone (GnRH) analogs
- Must have tried and had inadequate response or intolerance to generic bicalutamide
- Must limit dosing to 50 mg daily
Eulexin (flutamide) oral
- Added coverage for the treatment of locally confined or metastatic carcinoma of the prostate in individuals aged 18 years and older
- Must be used in combination with gonadotropin releasing hormone (GnRH) analogs
- Must have tried and had inadequate response or intolerance to generic bicalutamide
- Must limit dosing to 750 mg daily
Nilandron (nilutamide) oral and generic nilutamide oral
- Added coverage for the treatment of metastatic prostate cancer in individuals aged 18 years and older
- Must be used in combination with a bilateral orchiectomy
- Must have tried and had an inadequate response or intolerance to generic bicalutamide
- Must limit dosing to 300 mg daily for 30 days followed by 150 mg daily
Dacogen (decitabine) IV
- Added coverage for the treatment of myelodysplastic syndromes (MDS) in individuals aged 18 years and older
- Must have been diagnosed with MDS, including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes
- Must have tried and had an inadequate response to generic decitabine
- Added coverage for generic decitabine IV for the treatment of myelodysplastic syndromes (MDS) in individuals aged 18 years and older
- Must have been diagnosed with MDS, including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes
Elitek (rasburicase) IV
- Added coverage for the initial management of plasma uric acid levels in individuals with leukemia, lymphoma, or solid tumor malignancies
- Must be receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid
Imdelltra (tarlatamab-dlle) IV
- Added coverage for the treatment of extensive stage small cell lung (ES-SCLC) cancer in individuals aged 18 years and older
- Must have relapsed or refractory ES-SCLC
- Must have had disease progression on or after treatment with platinum-based chemotherapy
- Must be prescribed by or in consultation with an oncologist
Pharmacologic Treatment of Atopic Dermatitis, 5.01.628 PBC | Premera HMO
Drug added
Medical necessity criteria added
Zoryve (roflumilast) 0.15% cream, topical
- Added coverage for treatment of atopic dermatitis in individuals aged 6 years and older
- Must have tried and had an inadequate response or intolerance to one topical corticosteroid medication
- In individual is aged 2 years and older, must have tried and had an inadequate response or intolerance to one topical calcineurin inhibitor medication
- Considered investigational for all other conditions
Pharmacologic Treatment of Chronic Non-Infectious Liver Diseases, 5.01.615 PBC | Premera HMO
Drug added
Medical necessity criteria added
Iqirvo (elafibranor) oral
- Added coverage for treatment of primary biliary cholangitis (PBC) when used in combination with ursodeoxycholic acid (UDCA) in individuals aged 18 years and older who have had inadequate response to UDCA, or as monotherapy in those unable to tolerate
UDCA
- Must have PBC without cirrhosis or PBC with compensated cirrhosis and no evidence of portal hypertension
- Must have confirmed diagnosis by consistently elevated alkaline phosphatase for at least 6 months AND positive antimitochondrial (AMA) test OR presence of sp100 or gp210 autoantibodies if AMA-negative OR liver biopsy consistent with PBC
- Must not be a diagnosis associated with cholestatic drug reaction, complete biliary obstruction, sarcoidosis, or primary sclerosing cholangitis
- Must have tried and had inadequate response to at least 1 year of UDCA therapy or had intolerance to UDCA therapy
- Must not be used in combination with Ocaliva (obeticholic acid)
- Must be prescribed by or in consultation with a gastroenterologist or hepatologist
- Must not exceed 80 mg once daily
Investigational criteria updated
- Added Iqirvo (elafibranor) as investigation for all other conditions not outlined in policy
Medical necessity criteria updated
Ocaliva (obeticholic acid)
- Added requirement that must be prescribed by or in consultation with a gastroenterologist or hepatologist
- Must not be used in combination with Iqirvo (elafibranor)
- Must not exceed 10 mg once daily
Pharmacologic Treatment of Interstitial Lung Disease, 5.01.555 PBC | Premera HMO
Drug added
- Add Tyenne (tocilizumab-aazg) IV/SC for treatment of moderate to severe rheumatoid arthritis with current criteria for Actemra (tocilizumab) IV
Pharmacologic Treatment of Sleep Disorders, 5.01.599 PBC | Premera HMO
Medical necessity criteria updated
Wakix (pitolisant)
- Age requirement updated from adults to those aged 6 and older
Pharmacotherapy of Arthropathies, 5.01.550 PBC | Premera HMO
Drugs added
First-line IL-6 Inhibitors
- Added Tyenne (tocilizumab-aazg) IV/SC for treatment of polyarticular juvenile idiopathic arthritis with current criteria for Actemra (tocilizumab) IV
- Added Tyenne (tocilizumab-aazg) IV/SC for treatment of systemic juvenile idiopathic arthritis with current criteria for Actemra (tocilizumab) IV
- Added Tyenne (tocilizumab-aazg) IV/SC for treatment of moderate to severe rheumatoid arthritis with current criteria for Actemra (tocilizumab) IV
Second-line IL-6 Inhibitors
- Added Kevzara (sarilumab) SC for treatment of polyarticular juvenile idiopathic arthritis with current criteria for Actemra (tocilizumab) IV
- Must have had inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine
- Must have had an inadequate response or intolerance to two of the drugs as listed within the policy
- Must be prescribed by or in consultation with a rheumatologist
Second-line T-Cell Costimulation Modulators
- Orencia (abatacept) IV/SC: Updated list of drugs which individual must have inadequate response or intolerance to include Tyenne and Rinvoq or Rinvoq LQ
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563 PBC | Premera HMO
Drug added
- Add Tyruko (natalizumab-sztn) for treatment Crohn’s disease with current criteria for Tysabri (natalizumab)
Drug added
Medical necessity criteria added
- Site of service review is added to Skyrizi (risankizumab-rzaa) IV and Skyrizi (risankizumab-rzaa) SC on-body injector
- Add Skyrizi (risankizumab-rzaa) IV for treatment of ulcerative colitis prescribed by or in consultation with a gastroenterologist and used only for induction therapy
- Add Skyrizi (risankizumab-rzaa) SC on-body injector for treatment of ulcerative colitis when prescribed by or in consultation with a gastroenterologist and individual has received induction therapy with Skyrizi IV
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564 PBC | Premera HMO
Medical necessity criteria updated
- Clarify use of Lupkynis (voclosporin) in policy with no changes to the statement
Drugs added
Giant cell arteritis
- Added Tyenne (tocilizumab-aazg) SC and IV and Tofidence (tocilizumab-bavi) IV for treatment of giant cell arteritis with current Actemra criteria
- Added Tyenne (tocilizumab-aazg) SC and IV and Tofidence (tocilizumab-bavi) IV for treatment of cytokine release syndrome with current Actemra criteria
Drugs added
Medical necessity criteria added
Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Added coverage of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in individuals aged 18 and older
- Must have experienced progressive or relapsing motor and/or sensory symptoms of more than one limb and hyporeflexia or areflexia in affected limbs for at least 2 months
- Must have electrophysiologic findings that meet at least 3 of the 4 American Academy of Neurology criteria indicating demyelinating neuropathy
- Must have excluded any other causes of demyelinating neuropathy
- Must have result of other testing to support diagnosis, if available, and as outlined in the policy
- Must have tried and had an inadequate response or intolerance to intravenous or subcutaneous immune globulin
- Must be prescribed by or in consultation with a neurologist
Sarcoidosis
First-line agents
- Added first-line agents adalimumab-adaz (Hyrimoz unbranded), adalimumab-adbm, (Cyltezo unbranded), adalimumab-ryvk (Simlandi unbranded), Cyltezo (adalimumab-adbm), Humira (adalimumab) (AbbVie) [NDCs starting with 00074], Hyrimoz (adalimumab-adaz),
(Sandoz) [NDCs starting with 61314], and Simlandi (adalimumab-ryvk) for treatment of sarcoidosis when individual has tried and had an inadequate response or intolerance to one corticosteroid
- Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
- Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
- Added first-line TNF-α antagonists Avsola (infliximab-axxq), Infliximab (Janssen-unbranded), and Remicade (infliximab) for treatment of sarcoidosis when individual has tried and had an inadequate response or intolerance to one corticosteroid
- Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
- Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
Second-line agents
- Added second-line TNF-α antagonists Abrilada (adalimumab-afzb), adalimumab-aacf (Idacio unbranded), adalimumab-aaty (Yuflyma unbranded), adalimumab-fkjp (Hulio unbranded), Amjevita (adalimumabatto), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp),
Humira (adalimumab) (Cordavis) [NDCs starting with 83457], Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457], Idacio (adalimumab-aacf), Yuflyma (adalimumabaaty), and Yusimry (adalimumab-aqvh) for treatment of sarcoidosis when individual
has tried and had an inadequate response or intolerance to one corticosteroid
- Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
- Must have inadequate response or intolerance to all agents as listed within the policy
- Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
- Added second-line TNF-α antagonists Renflexis (infliximab-abda) and Inflectra (infliximab-dyyb) for treatment of sarcoidosis when individual has tried and had an inadequate response or intolerance to one corticosteroid
- Must have tried and had an inadequate response or intolerance to one immunosuppressive medication
- Must have inadequate response or intolerance to Avsola (infliximab-axxq), Infliximab (Janssen – unbranded) or Remicade (infliximab)
- Must be prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
Site of Service: Infusion Drugs and Biologic Agents, 11.01.523 PBC | Premera HMO
Drugs added
Site of service review added
- The following will be reviewed for site of service when requested in the inpatient setting:
- Skyrizi (risankizumab-rzaa) IV
- Skyrizi (risankizumab-rzaa) SC on-body injector)