20-372 Stay Up to Date with Medication Trend Updates and Preferred Drug List Changes - 2nd Quarter 2020

Date: 05/08/20

This information applies to Physicians and Participating Physician Groups (PPGs).

This information applies to Medi-Cal in Fresno, Kings and Madera counties.

 

Review changes for oral, inhalable and injectable drugs

Stay up to date with information about:

• Safety communication alert on gabapentin and pregabalin.
• Alternative sites of infusion care.
• Prior authorization requests for Humira^®.
• Changes to the guidelines for provision of methadone and buprenorphine for treating opioid use disorder (OUD)^† related to the COVID-19 emergency.
• Changes to the CalViva Health Medi-Cal Preferred Drug List (formulary) for the second quarter of 2020.

Safety communication alert about gabapentin and pregabalin

The U.S. Food and Drug Administration (FDA) is warning that serious breathing difficulties may occur in patients with respiratory risk factors using gabapentin (Neurontin^®, Gralise^®, Horizant^®) or pregabalin (Lyrica^®, Lyrica^® CR). These FDA-approved medications are used to treat a variety of conditions, including seizures, postherpetic neuralgia (pain following shingles), neuropathic pain associated with diabetic neuropathy, fibromyalgia, generalized anxiety disorder, and restless legs syndrome. The FDA is requiring new warnings to be added to the prescribing information of these medications, which are often referred to as gabapentinoids.

The warning is for individuals who have concurrent respiratory risk factors, which include combined use of opioids or other drugs that depress the central nervous system (CNS), conditions, such as chronic obstructive pulmonary disease (COPD), that reduce lung function, and older age. Gabapentinoids are often being combined with CNS depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. Fewer breathing complications were seen in healthy individuals taking gabapentinoids alone. The new warnings are based on a review of data from numerous sources, including case reports, observational studies, human trials and animal studies.

The FDA recommends that health care professionals start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when gabapentinoids are prescribed with an opioid or other CNS depressants. Individuals with underlying respiratory disease and the elderly are also at increased risk and should be managed similarly.

Alternative sites of infusion care

The health plan has options available for members who are being treated with any of the infusion products listed in the table below. Members have the option to transition infusions from the hospital to the home, an ambulatory infusion suite (AIS) or a nearby physician’s office. Alternate site of infusion care is part of a member's standard benefits.

Health Net*, on behalf of CalViva Health, has partnered with Coram^® CVS Specialty™ Infusion Services as the designated provider for these infusions. Coram provides:

• Experience. More than 30 years of experience in specialized infusion care and demonstrated expertise in the delivery and administration of complex specialty infused medications.
• Safety. Clinicians are certified and specialize in delivery of chronic and complex drug therapy and careful patient monitoring. Experienced nurses stay for the entire infusion duration ensuring patients receive high-level care.
• Convenience. In-home and AIS-based infusions are scheduled directly with patients, enabling flexibility, independence and enhanced quality of life. Clinical support is available to patients 24 hours a day, seven days a week.
• Lower costs. Infusions may be provided at a lower cost to patients promoting compliance to therapy and ultimately improve outcomes and reduce health costs.

For patient referrals or additional information, contact Peter Tran, PharmD, at (714) 934-3362, Monday through Friday, from
9 a.m. to 4 p.m., and reference the Site of Care Optimization of Therapeutic Infusion (SCOTI) Program.

The following table lists products eligible for alternate site of infusion care.

Products eligible for alternate site of infusion care

Disorder	Product	Disorder	Product
Alpha-1 antitrypsin deficiency	Aralast™ NP, Glassia®, Prolastin®-C, Zemaira®	Lysosomal storage disorders	Aldurazyme®, Cerezyme®, Elaprase®, Elelyso®, Fabrazyme®, Kanuma®, Lumizyme®, Naglazyme®, Vimizim®, Vpriv®
Amyloidosis	Onpattro®	Movement disorders	Radicava®
Autoimmune disorders	Actemra®, Entyvio®, Inflectra®, Orencia®, Remicade®, Renflexis®, Simponi Aria®	Multiple sclerosis	Lemtrada®, Ocrevus®, Tysabri®
Hereditary angioedema	Cinryze®	Paroxysmal nocturnal hemoglobinuria	Soliris®, Ultomiris®
Immune deficiencies and related disorders	Asceniv®, Bivigam®, Carimune®, Cutaquig®, Cuvitru®, Flebogamma®, Gammagard® Liquid, Gammagard® S/D, Gammaked™, Gammaplex®, Gamunex®-C, Hizentra®, Hyqvia®, Octagam®, Panzyga®, Privigen®, Xembify®
		Rare disorders	Crysvita®
		Systemic lupus erythematosus	Benlysta®

Prior authorization requests for Humira

Note the following changes to the PA requirements for Humira. For Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, and uveitis, Humira remains a preferred medication.

Indication	Preferred medication(s)*
Rheumatoid arthritis	Two of the following, each used for at least three months: Enbrel®, Kevzara®, Xeljanz®/Xeljanz XR®
Polyarticular juvenile idiopathic arthritis	Enbrel used for at least three months
Psoriatic arthritis	Three of the following, each used for at least three months: Enbrel, Otezla®, Simponi®/Simponi Aria, Taltz®, Xeljanz/Xeljanz XR
Ankylosing spondylitis	Two of the following, each used for at least three months: Cimzia®, Enbrel, Taltz
Plaque psoriasis	Taltz used for at least three months

*Prior authorization (PA) is required to verify member eligibility and that the member satisfies clinical protocols to ensure appropriate use of the medication.

Changes to guidelines for provision of methadone and buprenorphine for the treatment of OUD

The Substance Abuse and Mental Health Services Administration (SAMHSA) has released a set of FAQs about changes to the guidelines for provision of methadone and buprenorphine for OUD in light of the COVID-19 emergency. To view the FAQs, visit www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.

Also, the Department of Health Care Services (DHCS) has released FAQs pertaining to medication-assisted treatment and telehealth. To view the FAQs, visit www.dhcs.ca.gov/provgovpart/Documents/COVID-19-FAQ-MAT-and-Telehealth_CSD.pdf.

CalViva Health Medi-Cal Preferred Drug List changes

The Pharmacy and Therapeutics (P&T) Committee, which includes practicing physicians, pharmacists and other health care professionals, reviews medications on the CalViva Health Medi-Cal Preferred Drug List each quarter to determine medications to stay on or be moved to a different status. A list of some recent changes is provided in the table below. A complete    CalViva Health Medi-Cal Preferred Drug List is available on the provider website at provider.healthnet.com under Pharmacy Information.

Additional information

Providers are encouraged to access the provider portal online at provider.healthnet.com for real-time information, including eligibility verification, claims status, prior authorization status, plan summaries, and more.

If you need additional information regarding the CalViva Health Medi-Cal Preferred Drug List, contact the Pharmacy Department by telephone at 1-800-867-6564, press option #2, or by fax at 1-800-977-8226. For all other questions contact CalViva Health at 1-888-893-1569.

^†Any transfer of information or data between providers and/or facilities about a member's OUD or SUD must first be authorized by the member before transferring the information or data between providers and/or facilities. This can be done by having the member sign an Authorization for Disclosure (AFD) form and designating the provider or entity that will be reviewing the member's data.

CalViva Health Medi-Cal Preferred Drug List changes

Oral medications

Medication	Status	Formulary alternative(s)	Comments
Mayzent® (siponimod) tablet	F*	Oral formulation: Gilenya®*,**, Tecfidera®*,** Injectable formulation: glatiramer (Copaxone)*,**, Glatopa®*,**, Avonex®*, Plegridy®*,**	Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS), in adults
Nourianz™ (istradefylline) tablet	NF	entacapone, pramipexole, ropinirole	As adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes
Pretomanid tablet	NF		Treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) as part of a combination regimen with bedaquiline and linezolid
Trikafta™ (elexacaftor/  ivacaftor/ tezacaftor; ivacaftor) tablet	F*	Kalydeco®*, **, Orkambi®*, **, Symdeko®*, **	Treatment of cystic fibrosis (CF) in patients age 12 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Oral Vyndaqel® (tafamidis 20 mg) and Vyndamax™ (tafadimis 61 mg) capsule	F* QL		Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization Quantity limit is 4 capsules per day (Vyndaqel) and 1 capsule per day (Vyndamax).
Wakix® (pitolisant) tablet	NF	armodafinil (Nuvigil®)*, modafinil (Provigil®)* Stimulants: amphetamine immediate-release (IR), amphetamine/dextroamphetamine (Adderall®), dextroamphetamine (Dexedrine®), methylphenidate (Ritalin®)	Treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy
Xenleta™ (lefamulin) tablet	NF	azithromycin, erythromycin, clarithromycin, doxycycline, amoxicillin, amoxicillin/clavulanate, cefdinir, cefpodoxime,  cefuroxime, levofloxacin	Treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumonia

Inhalation preparations

Medication	Status	Formulary alternative(s)	Comments
Breo® Ellipta® (fluticasone furoate and vilanterol inhalation powder) inhaler	F (ST)	fluticasone/salmeterol (Advair Diskus®), Symbicort®	Step therapy requires a trial of fluticasone/salmeterol (Advair Diskus) or Symbicort first. Quantity limit is one inhaler per month.
Dulera® (mometasone furoate and formoterol fumarate dihydrate) inhaler	F (ST)	fluticasone/salmeterol (Advair Diskus), Symbicort	Step therapy requires a trial of fluticasone/salmeterol (Advair Diskus) or Symbicort first. Quantity limit is one inhaler per month.
Symbicort (mometasone furoate and formoterol fumarate dihydrate) inhaler	F		Quantity limit is one inhaler per month.

Injectable preparations

Medication	Status	Formulary alternative(s)	Comments
Beovu® (brolucizumab) single-dose vial	Medical benefit	Lucentis®*,**	Treatment of patients with neovascular (wet) age-related macular degeneration (nAMD)

*Prior authorization (PA) is required to verify member eligibility and that the member satisfies clinical protocols to ensure appropriate use of the medication.

**CCS = California Children’s Services: refer to www.dhcs.gov for the local telephone number to determine member’s coverage eligibility.

• F indicates formulary.
• NF indicates nonformulary. These medications require member-specific medical reasons why formulary medications cannot be considered. Requests are reviewed via the plan’s prior authorization process.
• QL indicates quantity limit.
• ST indicates electronic step therapy