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HARVARD PILGRIM HEALTH CARE
RECOMMENDED MEDICATION REQUEST GUIDELINES
SUMATRIPTAN NON-ORAL
Generic
Brand
HICL
GCN
Exception/Other
SUMATRIPTAN
ONZETRA XSAIL
40608
ROUTE = INTRANASAL
SUMATRIPTAN
ZEMBRACE
40811
ROUTE = SUBCUTANEOUS
NOTE: To determine if a member is on a Closed Formulary, check the benefit description
associated with the benefit code. If the word 'CLOSED' is in the benefit description then it
is a closed benefit.
GUIDELINES FOR USE
INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
1. Is the patient between the ages of 18 and 65?
If yes, continue to #2.
If no, do not approve. Please use status code #238 and the provided denial text.
DENIAL TEXT: Per your health plan's sumatriptan (non-oral) guideline, ____________
is only covered for members between the ages of 18 and 65. Your physician indicated
that you are not between the ages of 18 and 65 and therefore your request was not
approved.
2. Does the patient have a diagnosis of migraine headaches?
If yes, continue to #3.
If no, do not approve. Please use status code #238 and the provided denial text.
DENIAL TEXT: Per your health plan's sumatriptan (non-oral) guideline, ____________
is only covered for members with a diagnosis of migraine headaches. Your physician
did not indicate that you have a diagnosis of migraine headaches and therefore your
request was not approved.
3. Does the patient have any of the following contraindications to treatment?
• History of coronary artery disease or coronary spasm
• Wolff-Parkinson-White Syndrome
• History of stroke, transient ischemic attack, or hemiplegic, or basilar migraine
• Peripheral vascular disease
• Ischemic Bowel Disease
• Uncontrolled hypertension
If yes, do not approve. Please use status code #238 and the provided denial text.
DENIAL TEXT: Per your health plan's sumatriptan (non-oral) guideline, _____________
is contraindicated in patients with certain medical conditions [history of coronary artery
disease or coronary spasm, Wolff-Parkinson-White Syndrome, history of stroke,
transient ischemic attack, hemiplegic migraine, basilar migraine, peripheral vascular
disease, Ischemic Bowel Disease, uncontrolled hypertension]. Your physician indicated
that you have one or more of these medical conditions and therefore your request was
not approved.
If no, continue to #4.
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HARVARD PILGRIM HEALTH CARE
RECOMMENDED MEDICATION REQUEST GUIDELINES
SUMATRIPTAN NON-ORAL
INITIAL CRITERIA (CONTINUED)
4. Is the request for Onzetra Xsail?
If yes, continue to #5.
If no, continue to #6.
5. Did the provider provide clinical rationale for why the patient cannot use the preferred
formulary intranasal triptan products [e.g., sumatriptan (Imitrex) and zolmitriptan (Zomig)
Nasal Spray]?
If yes, continue to #7.
If no, do not approve.
DENIAL TEXT: Per your health plan's sumatriptan (non-oral) guideline, Onzetra is only
covered for members who cannot use the preferred formulary triptan nasal sprays, (e.g.,
sumatriptan and zolmitriptan (Zomig). Your physician did not indicate there is a clinical
reason why you cannot use the covered alternatives and therefore your request was not
approved.
6. Did the provider provide clinical rationale for why the patient cannot use the preferred
formulary sumatriptan injectable products [e.g., sumatriptan 4 mg/0.5ml and 6 mg/0.5ml
prefilled syringes or cartridges for auto-injectors or 6mg/0.5ml vials]?
If yes, continue to #7.
If no, do not approve.
DENIAL TEXT: Per your health plan's sumatriptan (non-oral) guideline, Zembrace is
only covered for members who cannot use the covered formulary sumatriptan injectable
products, (e.g., sumatriptan 4 mg/0.5ml and 6 mg/0.5ml prefilled syringes or cartridges
for auto-injectors or 6mg/0.5ml vials). Your physician did not indicate there is a clinical
reason why you cannot use the covered alternatives and therefore your request was not
approved.
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HARVARD PILGRIM HEALTH CARE
RECOMMENDED MEDICATION REQUEST GUIDELINES
SUMATRIPTAN NON-ORAL
INITIAL CRITERIA (CONTINUED)
7. Approve as follows:
For members on an Open formulary, approve for 12 months by GPID.
Please use status code #057 and the following approval language:
APPROVAL TEXT (Onzetra Xsail): Your request has been approved for 12 months
with a quantity limit of one carton (8 doses) per copay per 30 day period.
APPROVAL TEXT (Zembrace): Your request has been approved for 12 months with a
quantity limit of one carton (4 auto-injectors) per copay per 30 day period.
For members on a Closed formulary, approve for 12 months by GPID with the
following quantity limits at the appropriate tier listed in the table below
• Onzetra: 1 carton (8 doses) per 30 days
• Zembrace: 1 carton (4 auto-injectors) per 30 days
Please use status code #056 and the appropriate approval language:
APPROVAL TEXT (Onzetra Xsail): Your request has been approved for 12 months at
the highest cost-share tier with a quantity limit of one carton (8 doses) per copay per 30
day period. Refer to your Harvard Pilgrim ID card for the amount you pay for drugs on
that tier.
APPROVAL TEXT (Zembrace): Your request has been approved for 12 months at the
highest cost share tier with a quantity limit of one carton (4 auto-injectors) per copay for
a 30 day period. Refer to your Harvard Pilgrim ID card for the amount you pay for drugs
on that tier.
Closed Formulary Benefit
3 Tier
4 Tier
5 Tier
Drug Description
All non-formulary
All non-formulary
All non-formulary
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Exception Tier
3
4
5
HARVARD PILGRIM HEALTH CARE
RECOMMENDED MEDICATION REQUEST GUIDELINES
1. Has the patient experienced improvement while on therapy?
If yes, continue to #2.
If no, do not approve. Please use status code #238 and the provided denial text.
DENIAL TEXT: Per your health plan's sumatriptan (non-oral) guideline, authorization for
renewal requires documentation of improvement of symptoms while on therapy. Your
physician did not indicate that your symptoms have improved with this therapy and
therefore your request was not approved.
2. Approve as follows:
For members on an Open formulary, approve for 12 months by GPID. (The quantity
limit is hard-coded.)
Please use status code #057 and the following approval language:
APPROVAL TEXT (Onzetra Xsail): Your request has been approved for 12 months with a
quantity limit of one carton (8 doses) per copay per 30 day period.
APPROVAL TEXT (Zembrace): Your request has been approved for 12 months with a
quantity limit of one carton (4 auto-injectors) per copay per 30 day period.
For members on a Closed formulary, approve for 12 months by GPID with the
following quantity limits at the appropriate tier listed in the table below:
• Onzetra: 1 carton (8 doses) per 30 days
• Zembrace: 1 carton (4 auto-injectors) per 30 days
Please use status code #056 and the following approval language:
APPROVAL TEXT (Onzetra Xsail): Your request has been approved for 12 months at the
highest cost-share tier with a quantity limit of one carton (8 doses) per copay per 30 day
period. Refer to your Harvard Pilgrim ID card for the amount you pay for drugs on that tier.
APPROVAL TEXT (Zembrace): Your request has been approved for 12 months at the
highest cost share tier with a quantity limit of one carton (4 auto-injectors) per copay for a 30
day period. Refer to your Harvard Pilgrim ID card for the amount you pay for drugs on that
tier.
Closed Formulary Benefit
3 Tier
4 Tier
5 Tier
Drug Description
All non-formulary
All non-formulary
All non-formulary
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Exception Tier
3
4
5
HARVARD PILGRIM HEALTH CARE
RECOMMENDED MEDICATION REQUEST GUIDELINES
SUMATRIPTAN NON-ORAL
RATIONALE
To promote the appropriate use of transdermal abortive antimigraine agents.
FDA APPROVED INDICATIONS
Onzetra Xsail is indicated for the acute treatment of migraine with or without aura in adults.
Zembrace is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
• Use only after a clear diagnosis of migraine has been established
• Not indicated for the prevention of migraine attacks
REFERENCES
• Promius Pharma, LLC. Zembrace prescribing information. Princeton, NJ. January 2016.
• Avanir Pharmaceuticals, Inc. Onzetra prescribing information. Aliso Viejo, CA. January
2016.
Created: 09/08/15
Effective: 10/01/16
Client Approval: 08/03/16
P&T Approval: 09/12/16