MAVENCLAD (cladribine)

MAVENCLAD (cladribine)

SELF ADMINISTRATION- ORAL

Indications for Prior Authorization: 

• Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults
  • Because of its safety profile, use of Mavenclad® is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS
• Limitations of Use:
  • Mavenclad® is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile

Coverage Criteria:

• Patient is 18 years of age or older, AND
• Patient weighs at least 40 kg, AND
• Medication is prescribed by or in consultation with a neurologist, AND
• Patient has a diagnosis of relapsing forms of multiple sclerosis as confirmed by chart note documentation, AND
• Patient has experienced an inadequate response, contraindication, or intolerable side effect to two different preferred agents (e.g., Avonex®, Betaseron®, dimethyl fumarate [Tecfidera®], Gilenya®, glatiramer/Glatopa® [Copaxone®], Plegridy®, Rebif®/Rebif Rebidose®, Vumerity™), AND
• This drug may not be used in combination with any other disease modifying therapy for MS either oral or injectable (e.g. Aubagio®, Avonex®, Betaseron®, Copaxone®, Extavia®, Gilenya®, Glatopa®, Rebif®, Tecfidera®, Tysabri®, or mitoxantrone), AND
• Member has been assessed prior to starting each Mavenclad® treatment course (assessments to include: cancer screening, pregnancy, CBC, infections [e.g. HIV, TB, HBV, HCV, acute infections, immunization status (immunize 4-6 weeks prior to starting Mavenclad®), baseline MRI-due to risk of PML (progressive multifocal leukoencephalopathy)], liver injury)
   
  • Contraindicated in patient with:
    • Current malignancy
    • Pregnant woman and women/men of reproductive potential who do not plan to use effective contraceptive during Mavenclad® dosing and for 6 months after the last dose in each treatment course.
    • HIV infection
    • Active chronic infection
    • History of hypersensitivity to cladribine.
    • Women intending to breastfeed on a Mavenclad® treatment day and for 10 days after the last dose.
• Not recommended in patients with moderate to severe renal impairment (CrCL < 60 mL/min)
• Not recommended in patients with moderate to severe hepatic impairment (Child-Pugh Score >6)

Reauthorization Criteria:

• Detailed documentation of response to the first treatment is required

Dosing:

• Recommended cumulative dose is 3.5 mg/kg divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). Each treatment course is divided into 2 treatment cycles:
   
  • First Treatment Course:
    • First course/first cycle: start any time
    • First course/second cycle: administer 23 to 27 days after the last dose of First course/first cycle.
  • Second Treatment Course: 
    • Second course/first cycle: administer at least 43 weeks after the last dose of First course/second cycle.
    • Second course/second cycle: administer 23 to 27 days after the last dose of Second course/first cycle. 

*The use of Mavenclad® in patients weighing less than 40 kg has not been investigated.

• Administer the cycle dosage as 1 or 2 tablets once daily over the 4 or 5 consecutive days. Do not administer more than 2 tablets daily
• Following the administration of 2 treatment courses, do not administer additional Mavenclad® treatment during the next 2 years. Treatment during these 2 years may further increase the risk of malignancy. The safety and efficacy of reinitiating Mavenclad® more than 2 years after completing 2 treatment courses has not been studied

Coverage Duration:

• Initial: 1 treatment course
• Reauthorization: 1 treatment course (maximum of 2 treatment courses per lifetime)

Authorization is Not Covered for the Following: 

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Contraindicated in patients with:
  • Current malignancy
  • Pregnant woman and women/men of reproductive potential who do not plan to use effective contraceptive during Mavenclad® dosing and for 6 months after the last dose in each treatment course.
  • HIV infection
  • Active chronic infection
  • History of hypersensitivity to cladribine.
  • Women intending to breastfeed on a Mavenclad® treatment day and for 10 days after the last dose
• Additional warnings for: malignancies, risk of teratogenicity, lymphopenia, infections, hematologic toxicity, Graft-Versus-Host Disease with blood transfusion, liver injury, hypersensitivity, cardiac failure
• Prior to starting each Mavenclad® treatment course assess for: cancer screening, pregnancy, CBC, infections (e.g. HIV, TB, HBV, HCV, acute infections, immunization status [immunize 4-6 weeks prior to starting Mavenclad®], baseline MRI-due to risk of PML), liver injury
• Avoid concomitant use with compounds that require intracellular phosphorylation to become active (e.g., lamivudine, zalcitabine, ribavirin, stavudine, and zidovudine) could interfere with the intracellular phosphorylation and activity of cladribine
• Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day Mavenclad® treatment cycles. If this is not possible, consider selection of alternative concomitant drugs with no or minimal ENT1, CNT3, or BCRP transporter inhibiting properties. If this is not possible, dose reduction to the minimum mandatory dose of drugs containing these compounds, separation in the timing of administration, and careful patient monitoring is recommended
• Pregnancy: Mavenclad® is contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception
• Lactation: Mavenclad® is contraindicated in breastfeeding women because of the potential for serious adverse reactions in breastfed infants
• The safety and effectiveness in pediatric patients (below 18 years of age) have not been established. Use of Mavenclad® is not recommended in pediatric patients because of the risk of malignancies
• Not recommended in patients with moderate to severe renal impairment (CrCL < 60 mL/min)
• Not recommended in patients with moderate to severe hepatic impairment (Child-Pugh Score >6)

Review History:

• 11/17/20- Class review, no change to criteria
• 9/8/20- Annual review, format updated
• 9/12/19- Original review

References: 

• Mavenclad [package insert]. Rockland (MA): EMD Serono, Inc.; 2019.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.