Download Multiple Myeloma

Policy Number: MEDS79
JOHNS HOPKINS HEALTHCARE
Subject: Medications for Multiple Myeloma
Department: Pharmacy
Lines of Business: PPMCO, EHP, USFHP
Effective Date: 07/01/2013
Review Date: 10/01/2013
Page 1 of 4
POLICY:
Select oral and injectable medications commonly-used for multiple myeloma will require prior
authorization to ensure appropriate use. The process for initiating a prior authorization request can be
found in policy PHARM 20.

PPMCO members are subject to the Priority Partners formulary, available at www.ppmco.org.

USFHP members are subject to prior authorization criteria, step-edits and days-supply limits
outlined in the Tricare Policy Manual. Tricare Policy supersedes JHHC Medical/Pharmacy
Policies. Tricare limits may be accessed at:
http://pec.ha.osd.mil/formulary_search.php?submenuheader=1
POLICY CRITERIA
All prior authorization requests for oral and injectable medications for multiple myeloma will be
reviewed against the most recent version of the NCCN guidelines for multiple myeloma. Initial therapy
will be approved if the treatment regimen is listed as preferred OR the treatment regimen is listed as
other and the patient has a clinical contraindication to a preferred regimen in the applicable treatment
category.
Concurrent Prophylaxis
Antithrombotic therapy is essential in patients receiving an immunomodulatory drug (such as
thalidomide, lenalidomide or pomalidomide) with dexamethasone due to the high risk of
thromboembolism. Patients should receive concurrent aspirin, warfarin or low molecular weight heparin
unless they have an absolute contraindication to antithrombotic therapy.
Herpes zoster prophylaxis is recommended for patients treated with bortezomib or carfilzomib.
Carfilzomib (Kyprolis) & Pomalidomide (Pomalyst)
In addition to the criteria above, the following medication-specific criteria apply:
At least two prior therapies for recurrent multiple myeloma have been ineffective or not tolerated. These
prior therapies must have included both of the following medications unless contraindicated:
1. Bortezomib.
AND
2. An immunomodulator (lenalidomide or thalidomide).
Privileged and Confidential
Policy Number: MEDS79
JOHNS HOPKINS HEALTHCARE
Subject: Medications for Multiple Myeloma
Department: Pharmacy
Lines of Business: PPMCO, EHP, USFHP
Effective Date: 07/01/2013
Review Date: 10/01/2013
Page 2 of 4
AUTHORIZATION PERIOD/LIMITATIONS:
Initial approval will be for six months at the guideline-recommended dosage. Approval for continuation
of therapy can be extended for six month intervals. Approvals will be based on an efficient dose to
maximize patient adherence and cost-effective therapy.
USFHP patients are subject to Tricare days-supply limits. Tricare limits may be accessed at:
http://pec.ha.osd.mil/formulary_search.php?submenuheader=1
EXCLUSIONS:
If the request is for a diagnosis not listed above, a letter may be sent to the requesting physician to
provide additional information.
Pomalidomide is considered not medically necessary when used in combination with bortezomib
(Velcade) or carfilzomib (Kyprolis). Pomalidomide is considered investigational when used for all other
conditions, including but not limited to myelofibrosis.
CODES:
CPT Copyright 2013 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical
Association.
Note: The following CPT/HCPCS codes are included below for informational purposes. Inclusion or exclusion of a
CPT/HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. The member's specific
benefit plan determines coverage. All inpatient admissions require pre-authorization.
Medication
Bortezomib (Velcade)
Carfilzomib (Kyprolis)
HCPCS/CPT Code
J9041 (Injection, bortezomib, 0.1 mg)
C9295 (Injection, carfilzomib, 1 mg)
Notes
No prior auth required
Prior auth required
Lenalidomide (Revlimid)
n/a
Thalidomide (Thalomid)
n/a
carmustine
Pomalidomide (Pomalyst)
J9050
n/a
Prior auth required
Tricare limit for USFHP
Prior auth required
Tricare limit for USFHP
No prior auth required
Prior auth required
Privileged and Confidential
Policy Number: MEDS79
JOHNS HOPKINS HEALTHCARE
Subject: Medications for Multiple Myeloma
Department: Pharmacy
Lines of Business: PPMCO, EHP, USFHP
Effective Date: 07/01/2013
Review Date: 10/01/2013
Page 3 of 4
BACKGROUND/DEFINITIONS:
Multiple myeloma is a malignancy of plasma cells characterized by the production of abnormal immune
globulins. The malignant plasma cells lead to anemia, leukopenia and bone loss. The goals of therapy
are to relieve symptoms, prevent disease progression or relapse, and improve overall survival.
There are several therapeutic options for patients who receive treatment and, despite treatment advances
in recent years, no currently available treatment is considered curative. Initial therapy is based on the
patient’s age, comorbidities and prognosis at time of diagnosis. Newly diagnosed MM patients who are
transplant candidates can receive induction therapy followed by high-dose chemotherapy and autologous
stem cell transplant (ASCT). Induction regimens consist of bortezomib, lenalidomide or thalidomide in
combination with dexamethasone. In recent year, newer bortezomib- and lenalidomide- based regimens
have approached the same rates of progression-free survival as ASCT. ASCT is not curative, but may
extend overall survival for newly-diagnosed patients and for relapse. Allogenic stem cell transplant may
be curative for some patients, but is associated with a 5-10% mortality rate and most patients are not
candidates. After initial therapy, maintenance therapy with thalidomide, bortezomib or lenalidomide
reduces tumor burden and improve progression-free survival.
Evidence demonstrates that patients who receive treatment earlier in their disease and those who remain
on therapy longer achieve better outcomes. A variety of new regimens are being studied to reduce side
effects, particularly peripheral neuropathy, and avoid treatment discontinuation.
Patients who are refractory to their initial course of therapy or have experienced relapse can often
undergo a new course of therapy. The choice of regimen for salvage therapy is dictated by the context of
the clinical relapse. The regimen can repeat the primary induction therapy or consist of a different
medication. The two newest agents, carfilzomib and pomalidomide, have demonstrated improved
outcomes in progressive, refractory disease. In clinical trials, carfilzomib demonstrated 24% response
rate with duration of response greater than 8 months. Likewise, patients refractory to lenalidomide or
bortezomib who received treatment with pomalidomide experienced 25% partial response rate.
Among oral medications for MM, thalidomide and lenalidomide are most commonly used. A recent
analysis demonstrated that 32% of claims for these medications are dosed inefficiently. For example,
patients were using two 50 mg thalidomide capsules per day instead of a single daily 100 mg capsule.
Other than during dose titration, inefficient doses of oral medications can decrease patient adherence and
introduce unnecessary costs for the health plan.
POLICY APPROVED BY:
Signature on file at JHHC
Privileged and Confidential
Policy Number: MEDS79
JOHNS HOPKINS HEALTHCARE
Subject: Medications for Multiple Myeloma
Department: Pharmacy
Lines of Business: PPMCO, EHP, USFHP
DATE OF REVISION
REFERENCES:
1. NCCN Guidelines Version 2.2013: Multiple Myeloma
2. Palumbo A et al. J Clin Oncol 2011; 29: 986-993.
3. Managed Care Oncology, Quarter 3 2011
Privileged and Confidential
Effective Date: 07/01/2013
Review Date: 10/01/2013
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SUMMARY OF CHANGE