EXHIBIT 1010 
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1010
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01797
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`Prior Authorization Approval Criteria
`Subsys (fentanyl sublingual spray)
`
`Generic name:
`
`Brand name:
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`fentanyl
`
`Subsys
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`Medication class:
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`Opioid analgesic
`
`FDA-approved uses:
`
`Management of breakthrough cancer pain in patients who are receiving
`and who are tolerant to opioid therapy for underlying persistent cancer
`pain
`
`Available dosage forms:
`
`Sublingual Spray-100, 200, 400, 600 and 800mcg single spray units.
`
`Usual dose:
`
`Individually titrate to an effective dose starting at 100mcg to 200mcg to
`400mcg, and up to a maximum of 1600mcg. If pain is not relieved after
`30 minutes, patients may take only one additional dose of the same
`strength for that episode. No more than two Subsys doses should be
`used per episode. Patients must wait at least 4 hours before treating
`another episode.
`
`Duration of therapy:
`
`Indefinite
`
`Cost (based on AWP 2012): based on 100mcg qid- 800mcg qid: $102.88-$300/day
`
`•
`
`Criteria for use (bullet points below are all inclusive unless otherwise noted):
`•
`The indicated diagnosis (including any applicable labs and /or tests) and medication
`usage must be supported by documentation from the patient’s medical records.
`• Only approved for management of breakthrough cancer pain in patients who are
`already receiving and who are tolerant to opioid therapy for underlying persistent
`cancer pain
`Patients considered opioid-tolerant are those who are taking at least 60 mg
`morphine/day or an equianalgesic dose of another opioid for a week or longer.
`• Must be 18 years of age or older.
`• Must be prescribed by oncologist or pain specialist.
`• Must be able to comply with instructions to keep medication out of the reach of
`children and to discard open units properly.
`• Must try and fail an adequate dose of a formulary immediate release narcotic for
`breakthrough pain.
`• Must be on an adequate dose of a long-acting (maintenance, around-the-clock) opioid.
`
`Criteria for continuation of therapy:
`•
`Patient is tolerating and responding to medication and there continues to be a medical
`need for the medication
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`Contraindications:
`• Contraindicated in the management of acute or post-operative pain
`• Contraindicated in opioid non-tolerant patients.
`•
`Intolerance or hypersensitivity to fentanyl, Subsys, or its components.
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`Fallon Community Health Plan Department of Pharmacy Services
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`Page 1 of 2
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`Not approved if:
`• Patient has any contraindications to the use of fentanyl.
`• Patient does not meet above requirements.
`• Patient has received an MAO-I within 14 days.
`• Patient has known past or current substance abuse potential.
`• Patient is being treated for substance abuse (including treatment with buprenorphine or
`buprenorphine-naloxone).
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`
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`FCHP Pharmacy and Therapeutics Committee approval: __________________________________________
`Date: ______________________
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`
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`Adopted: 03/14/12
`Revised 12/18/12
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`Fallon Community Health Plan Department of Pharmacy Services
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`Page 2 of 2