DRUG AGENDA - May 2015

ADASUVE  (Loxapine)

      Request to establish a new Level II HCPCS code to identify loxapine, Trade Name: 
Adasuve.  Applicant’s suggested language:  “JXXXX Loxapine, inhalation powder, 10 mg.

Background/Discussion:
     Teva Pharmaceuticals requests a new Level II HCPCS code to identify for loxapine.  According
to the requester, loxapine is an atypical antipsychotic drug supplied as a powder for oral
inhalation, indicated for the acute treatment of agitation associated with schizophrenia or bipolar
I disorder in adults.  “Psychomotor agitation” is defined in DSM - IV as “excessive motor activity
associated with a feeling of inner tension.”  Patients experiencing agitation often manifest
behaviors that interfere with their care (e.g., threatening behaviors; escalation or urgently
distressing behavior; self - exhausting behavior), leading clinicians to use a rapidly absorbed
antipsychotic medication to achieve immediate control of the agitation.  To limit the risk of
serious side effects such as bronchospasm, use of Adasuve must only be used in healthcare
facilities enrolled in the Adasuve Risk Evaluation and Mitigation Strategy (REMS) Program
that have immediate (on-site) access to equipment and personnel trained to manage acute
bronchospasm, including advanced airway management (intubation and mechanical ventilation). 
Adasuve is administered in a single breath inhalation via a single - use, disposable, handheld
inhaler that contains the drug.  Patients are instructed to hold the inhaler away from their mouth
and exhale fully, then put the mouthpiece of the inhaler between their lips, close their lips and
inhale with a single steady, deep breath, remove the mouthpiece and hold their breath for up to
10 seconds.

The applicant comments that a new code is warranted because there are no existing “J”
codes to describe this formulation and delivery method of loxapine. 

Preliminary Decision:
     A national program operating need was not identified by Medicare, Medicaid or Private Insurers
to establish another Level II HCPCS code to identify Adasuve.  Existing code C9497 “Loxapine,
inhalation powder, 10 mg” is available for assignment by insurers if they deem appropriate.  

VIZAMYL (Flutemetamol)

         Request to establish a unique Level II HCPCS code to identify Flutemetamol F18 Injection,
Trade Name:  Vizamyl. 

Background/Discussion:
GE Healthcare submitted a request to establish a new Level II HCPCS code to identify
Flutemetamol F18 Injection (Vizamyl).  According to the requester, Vizamyl is
a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging
of the brain to estimate Beta Amyloid neuritic plaque density in adult patients with
cognitive impairment who are being evaluated for Alzheimer’s disease (AD), or other causes
of cognitive decline.  A negative Viazmyl scan indicates sparse to no neurotic plaques,
and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition.
 A negative scan reduces the likelihood that a patient’s cognitive impairment is a result of AD. 
A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques;
neuropathological examination has shown this amount of neuritic plaque is present in patients with A
D, but may also be present in patients with other types of neurologic conditions,
as well as older people with normal cognition.  Vizamyl is an adjunct to other diagnostic evaluations. 
There are, however; some limitations of use. 
A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder. 

Recommended dose is 185 megabecquerels (MBq) [5 millicuries (mCi)]; maximum mass dose
20 micrograms] in a maximum dose volume of 10 mL, administered as a single intravenous
bolus within 40 seconds, followed by an intravenous flush of 0.9% sterile sodium chloride
injection.  It is supplied in a 10 mL or a 30 mL multi-dose vial with 1 -10 mL and 1-30 mL fill
volume respectively.  Each vial is enclosed in a radiation shield.  The total concentration is 150
MBq/mL (4.05 mCi/mL) of flutemetamol F 18 at reference date and time.The applicant comments that a new code
is warranted because no existing HCPCS code accurately describes this product. 


Preliminary Decision:
   Existing code A9599 “Radiopharmaceutical, diagnostic, for beta - amyloid positron emission
tomography (PET) imaging, per study dose” adequately describes the product that is the subject
of this request.

NEURACEQ (Florbetaben)

   Request to establish a unique Level II HCPCS code to identify florbetaben F 18, Trade
Name:  Neuraceq.  Applicant’s suggested language:  “AXXXX Injection, florbetapen F 18,
diagnostic, per study dose, up to 8.1 millicuries”.

Background/Discussion:
   Piramal Pharma, Inc., submitted a request for a new code to identify Neuraceq (florbetaben F 18).
According to the applicant, Neuraceq is a radioactive diagnostic agent indicated for Positron
Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density
in adult patients with cognitive impairment who are being evaluated for AD and other causes of
cognitive decline. Florbetaben binds to β-amyloid plaques in the brain. This produces a position
signal that is detected by a PET scanner. Neuraceq is administered by intravenous injection.
Recommended dosage is a single IV bolus of 300 MBq of Neuraceq followed 45-130 minutes afterwards
by brain PET imaging for 15 - 20 minutes in duration. Neuraceq is supplied in 30 mL multi-dose vial
s containing 50 to 5000 MBq/mL (1.4 to 135 mCi/mL) florbetaben F 18 at EOS. 
At time of administration, 300 MBq (8.1 mCi_ are contained in up to 10 mL of solution for injection.  

The applicant claims that there is a significant therapeutic distinction between Amyvid and Vizamil
–and Neuraceq.  All three of these products have different dosages; there is also a difference between
the mean effective radiation dose of Neuraceq and Vizamyl and the mean effective radiation dose of Amyvid.  
The applicant claims that, as per prior CMS HCPCS coding determination, existing code A9599,
Radiopharmaceutical, diagnostic, for beta-amyloid positron emission tomography (pet) imaging , per study dose
does not accurately describe Neuraceq, because the descriptor is not specific to the active ingredient, florbetaben F 18.


Preliminary Decision:
Existing code A9599 “Radiopharmaceutical, diagnostic, for beta-amyloid positron emission
tomography (PET) imaging, per study dose” adequately describes the product that is the subject of this request.


Ref: http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/May-7-2015-DrugAgenda.pdf