Delaware – Highmark BCBSDE Coverage Criteria Revisions for Certain Medical Policies
February 2018 ~
Highmark Blue Cross Blue Shield Delaware (Highmark BCBCDE) has revised its coverage criteria for several medical policies, scheduled to take effect April 2nd.
These changes, applying to both professional provider and facility claims, are as follows:
Ustekinumab (Stelara®)
Coverage criteria added:
- For the treatment of moderately to severely active Crohn’s disease for individuals 18 years of age or older.
- For the treatment of moderate to severe plaque psoriasis for individuals 12 years of age or older.
Alpha1-Proteinase Inhibitor Infusions
Coverage criteria added:
- Prolastin-C Liquid may be considered medically necessary for the treatment of emphysema due to Alpha-1 antitrypsin deficiency when coverage criteria are met.
- A1AT inhibitor augmentation therapy may be considered medically necessary when
- EITHER of the following is present:
- Moderate airflow obstruction is evidenced by forced expiratory volume (FEV1)of 30-65% of predicted value, prior to initiation of therapy; or
- Individual has a rapid decline in lung function as measured by a change inFEV1 greater than 120 ml/year.
Coverage criteria removed:
- Progressive panacinar emphysema is present with a documented rate of decline in FEV1.
Belimumab (Benlysta®)
Coverage criteria added:
- Positive anti-nuclear antibody (ANA) titer (greater than or equal to 1:80) or anti-double-stranded DNA antibody (anti-dsDNA) greater than or equal to 30 IU/ml.
- Insufficient response to two standard of care drug classes:
- Corticosteroids (e.g. prednisone); or
- Antimalarials (i.e. hydroxychloroquine); or
- Immunosuppressives (e.g. azathioprine, mycophenolate mofetil, ormethotrexate).
Coverage criteria removed:
- Non-steroidal anti-inflammatory drugs from the concomitant standard of care for treatment of systemic lupus.
Eculizumab (Soliris®)
Coverage criteria added:
- For the treatment of an individual 18 years of age or older with documented paroxysmal nocturnal hemoglobinuria.
Vedolizumab (Entyvio®)
Coverage criteria added:
- Primary Non-responders to adalimumab (Humira) or infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis)
- Treatment with infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) for at least fourteen weeks was ineffective, not tolerated, or is contraindicated in patients with moderate to severe disease activity of ulcerative colitis (UC) or Crohn’s disease (CD).
- Primary Responders to adalimumab (Humira) now relapsing:
- Treatment with infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) for at least fourteen weeks was ineffective, not tolerated, or is contraindicated.
- Primary Responders to infliximab (Remicade) now relapsing:
- Vedolizumab (Entyvio) may be considered medically necessary for moderate to severe disease activity of UC or CD in patients who initially achieved remission in their disease with infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) and have lost response as evidenced by a relapse in their symptoms during treatment.
Coverage criteria removed:
- For new or current members established on vedolizumab (Entyvio) therapy, for the treatment of moderate to severe disease activity of UC or CD, continued treatment may be considered medically necessary.
Chimeric Antigen Receptor T-Cell Therapy
Highmark DE has revised its coverage criteria for tisagenlecleucel (Kymriah™) from patients 3 to 26 years of age to patients 25 years of age or younger. Additionally, the insurer has established new coverage criteria for axicabtagene ciloleucel (Yescarta™).
Coverage criteria added:
Axicabtagene ciloleucel (Yescarta™) may be considered medically necessary for individuals18 years of age or older when all the following criteria are met:
- Individual has a diagnosis of any one of the following aggressive forms of NHL:
- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified; or
- High-grade B-cell lymphoma; or
- Double hit lymphoma; or
- Primary mediastinal large B-cell lymphoma (PMBCL); or
- Transformed follicular lymphoma (TFL); and
- For the treatment of DLCBL, High-grade B-cell lymphoma, double hit lymphoma, or PMBCL individual meets either of the following criteria:
- Axicabtagene ciloleucel (Yescarta™) is additional therapy for individuals with intention to proceed to high-dose therapy who have partial response, no response, or progressive disease following second-line therapy for relapsed or refractory disease; or
- Treatment of disease in second relapse or greater (if not previously given); or
- For the treatment of TFL individual meets either of the following criteria:
- For individuals who have received minimal or no prior chemotherapy prior to histologic transformation to DLBCL and have partial response, no response, relapsed, or progressive disease (only after treatment with greater than or equal to two (2) chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated); or
- For individuals who have received multiple therapies (not including axicabtagene ciloleucel) prior to histologic transformation to DLBCL (only after treatment with greater than or equal to two (2) chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated); and
- No active or latent hepatitis B or active hepatitis C, human immunodeficiency virus(HIV) positive or any uncontrolled infection; and
- No active central nervous system involvement by malignancy; and
- No prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy, or gene therapy; and
- An Eastern Cooperative Oncology Group (ECOG) scale of performance status less than or equal to one (1); and
- No live vaccination within two weeks prior to initiation of lymphodepleting chemotherapy; and
Apheresis product received and accepted by manufacturing site.
Source(s): Highmark Blue Cross Blue Shield Delaware;
