Table 8: Opioids and Analgesics
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Pain and Inflammation
Medication Class/Individual Agents: Opioids and Analgesics
I. Prior-Authorization Requirements
Opioids and Analgesics – Long-Acting Opioids |
Clinical Notes |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself. Please note: PA will be required if it is determined that the member is stable on opioid dependence therapy (≥ 60 days of therapy within the last 90 days of an oral opioid dependence agent, or Probuphine in the past 210 days, or ≥ 56 days of Sublocade in the last 84 days) for any long-acting opioid agent, any short-acting opioid agent > 7 days supply, and any short-acting opioid agent if there is ≥ 7 days of a short-acting opioid agent in the last 30 days.
Acetaminophen Hepatotoxicity:
Aspirin Dose Limit:
Ibuprofen Dose Limit:
Duplicate Opioid Therapy:
Allergy:
Renal Dysfunction:
Constipation:
Hydrocodone and oxycodone in combination with acetaminophen:
Please click on the link below to see the Opioid and Pain Initiative. MassHealth Pharmacy Initiatives and Clinical Information
For additional information about Opioids (e.g., Letters to Prescribers), go to the following link.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Opioids and Analgesics – Other Analgesics |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Opioids and Analgesics – Short-Acting Opioids |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
# | This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. |
BP | Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent. |
* | The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization. |
^ | This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy. |
II. Therapeutic Uses
FDA-approved, for example:
- acute pain
- chronic pain
Note: The above list may not include all FDA-approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
- All PA requests must include clinical diagnosis, drug name, dose, frequency, and formulation.
- A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
- For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
- Additional criteria may apply, depending upon the member's condition, requested medication, and Duplicate Therapy, High Dose, High Dose Short-Acting Monotherapy, and Quantity Limit restrictions (see below).
- If MassHealth pharmacy claims history of required trials is not available, medical records documenting such trials may be required.
Please note: PA will be required if it is determined that the member is stable on opioid dependence therapy (≥ 60 days of therapy within the last 90 days of an oral opioid dependence agent, or Probuphine in the past 210 days, or ≥ 56 days of Sublocade in the last 84 days) for any long-acting opioid agent, any short-acting opioid agent > seven days supply, and any short-acting opioid agent if there is ≥ seven days of a short-acting opioid agent in the last 30 days.
Abstral (fentanyl sublingual tablet), fentanyl buccal tablet
- Documentation of the following is required:
- indication of breakthrough cancer pain; and
- adverse reaction or contraindication to all of the following:
- hydromorphone immediate-release; and
- morphine immediate-release; and
- oxycodone immediate-release; and
- fentanyl transmucosal system (generic Actiq) (requires PA - see criteria below); and
- member is maintained on a long-acting opioid regimen; and
- prescriber is an oncologist or pain specialist.
Belbuca
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- adverse reaction or contraindication to long-acting morphine sulfate that cannot be expected or managed as a part of opioid therapy; or
- medical necessity for buccal formulation; or
- prescriber wants to avoid using a full opioid agonist; and
- dose does not exceed 1,800 mcg/day.
benzhydrocodone/acetaminophen, dihydrocodeine/acetaminophen/caffeine, dihydrocodeine/aspirin/caffeine, hydrocodone/acetaminophen 300mg, hydrocodone 5 mg, 10 mg/ibuprofen, oxycodone/acetaminophen 300 mg, oxycodone/ibuprofen, Xartemis XR (oxycodone/acetaminophen extended-release)
Please refer to table in Section I. Prior-Authorization Requirements: Clinical Notes above for hydrocodone/acetaminophen and oxycodone/acetaminophen strengths that do not require PA within dose limits.
- For strengths and formulations that require PA, documentation of the following is required:
- appropriate diagnosis; and
- medical records documenting an inadequate response, adverse reaction, or contraindication to all of the following:
- codeine/acetaminophen; and
- hydrocodone/acetaminophen; and
- hydrocodone/ibuprofen; and
- oxycodone/acetaminophen.
Buprenex (buprenorphine injection)
- Documentation of the following is required:
- appropriate diagnosis; and
- clinical rationale why oral pain medications cannot be used; and
- adverse reaction or contraindication to fentanyl transdermal that cannot be expected or managed as a part of opioid therapy; and
- adverse reaction or contraindication to buprenorphine transdermal.
butorphanol nasal spray
- Documentation of the following is required:
- diagnosis of acute pain; and
- quantity is ≤ two canisters/month; and
- medical records documenting one of the following:
- adverse reaction or contraindication to all other generic short-acting opioids: codeine, hydromorphone, morphine, and oxycodone; or
- medical necessity for nasal spray formulation and adverse reaction or contraindication to both morphine immediate-release solution and oxycodone immediate-release solution.
codeine products for members < 12 years old
- Documentation of one of the following is required:
- CYP2D6 genotyping confirms member is not an ultra-rapid CYP2D6 metabolizer; or
- member has previously utilized a codeine-containing product without adverse effect that prevents repeat use.
fentanyl 37.5 mcg/hr, 62.5 mcg/hr, 87.5 mcg/hr transdermal system
- Documentation of the following is required:
- clinical rationale why two patches cannot be combined to obtain the equivalent strength requested.
fentanyl transmucosal system (Actiq)
- Documentation of the following is required:
- indication of breakthrough cancer pain; and
- adverse reaction or contraindication to all of the following:
- hydromorphone immediate-release; and
- morphine immediate-release; and
- oxycodone immediate-release; and
- member is maintained on a long-acting opioid regimen; and
- prescriber is an oncologist or pain specialist.
hydrocodone extended-release capsule, hydrocodone extended-release tablet, hydromorphone extended-release, Morphabond ER (morphine extended-release tablet), Nucynta ER (tapentadol extended-release), oxymorphone extended-release, Xtampza (oxycodone extended-release capsule)
- Documentation of the following is required:
- appropriate diagnosis; and
- adverse reaction or contraindication to all of the following that cannot be expected or managed as a part of opioid therapy:
- fentanyl transdermal; and
- morphine extended-release; and
- oxycodone extended-release tablet (requires PA - see criteria below).
levorphanol tablet
- Documentation of the following is required:
- adverse reaction or contraindication to all of the following that cannot be expected or managed as a part of opioid therapy:
- fentanyl transdermal; and
- morphine extended-release; and
- oxycodone extended-release tablet (requires PA - see criteria below); and
- clinical rationale for use of the requested agent over all other long-acting opioids.
- adverse reaction or contraindication to all of the following that cannot be expected or managed as a part of opioid therapy:
meperidine
- Documentation of the following is required:
- appropriate diagnosis; and
- allergy to morphine; and
- member has not used morphine derivatives since documented date of morphine allergy.
methadone injection
- Documentation of the following is required:
- appropriate diagnosis; and
- clinical rationale for use over oral formulations of methadone.
methadone tablet
- Documentation of the following is required:
- appropriate diagnosis; and
- member is not opioid naive; and
- baseline ECG showing normal QTc interval; and
- one of the following:
- adverse reaction or contraindication to long-acting morphine sulfate and fentanyl transdermal that cannot be expected or managed as a part of opioid therapy; or
- clinical rationale for the use of oral methadone over other long-acting opioids.
morphine extended-release capsules (Kadian, generics)
- Documentation of the following is required:
- appropriate diagnosis; and
- clinical rationale for use in place of long-acting generic morphine tablets.
Nucynta (tapentadol), Opana IR (oxymorphone immediate-release)
- Documentation of the following is required:
- appropriate diagnosis; and
- adverse reaction or contraindication to all of the following:
- hydromorphone immediate-release; and
- morphine immediate-release; and
- oxycodone immediate-release.
Olinvyk (oliceridine)
- Documentation of the following is required:
- diagnosis of acute moderate to severe pain; and
- inadequate response, adverse reaction or contraindication to all of the following:
- fentanyl injection; and
- hydromorphone injection; and
- morphine injection; and
- appropriate dosing; and
- total course of therapy is limited to 48 hours.
opioid powders
- Documentation of the following is required:
- appropriate diagnosis; and
- clinical rationale why other commercially available alternatives cannot be used.
Oxaydo (oxycodone immediate-release)
- Documentation of the following is required:
- clinical rationale as to why the generically available 5 mg tablets cannot be used.
oxycodone extended-release tablet
- Documentation of the following is required:
- appropriate diagnosis; and
- adverse reaction or contraindication to long-acting morphine sulfate or fentanyl transdermal that cannot be expected or managed as a part of opioid therapy.
pentazocine/naloxone
- Documentation of the following is required:
- appropriate diagnosis; and
- adverse reaction or contraindication to all of the following:
- one nonsteroidal anti-inflammatory drug (NSAID); and
- hydromorphone immediate-release; and
- morphine immediate-release; and
- oxycodone immediate-release; and
- tramadol; and
- dose does not exceed 600 mg/day of pentazocine.
tramadol 100 mg
- Documentation of the following is required:
- appropriate diagnosis; and
- medical necessity for the use of the 100 mg tablets instead of the 50 mg tablets; and
- medical records documenting an inadequate response or adverse reaction to tramadol 50 mg tablet (two 50 mg tablets).
tramadol/acetaminophen
- Documentation of the following is required:
- appropriate diagnosis; and
- clinical rationale for use of the combination product over the commercially available separate agents.
tramadol extended-release capsule, tablet
- Documentation of the following is required:
- appropriate diagnosis; and
- medical records documenting an inadequate response or adverse reaction to generic tramadol immediate-release; and
- clinical rationale for use of an extended-release formulation.
tramadol products for members < 12 years old
- Documentation of the following is required:
- individual drug PA criteria must be met first where applicable; and
- one of the following:
- CYP2D6 genotyping confirms member is not an ultra-rapid CYP2D6 metabolizer; or
- member has previously utilized a tramadol-containing product without adverse effect that prevents repeat use.
In addition to individual drug PA criteria above, some opioids are subject to additional Duplicate Therapy, Concurrent Therapy with Opioid Dependence Agents, High Dose, High Dose Short-Acting Monotherapy, and Quantity Limit restrictions.
Duplicate Therapy and Concurrent Therapy with Opioid Dependence Agents
The following opioids require PA if there is concurrent use of two long-acting or two short-acting opioids for at least 60 days out of any 180-day period. In addition, PA will be required if it is determined that the member is stable on opioid dependence therapy, for any long-acting opioid agent, any short-acting opioid agent > seven days supply, and any short-acting opioid agent if there is ≥ seven days of a short-acting opioid agent in the last 30 days.
Long-acting |
Short-acting |
Belbuca (buprenorphine buccal film) |
Abstral, Actiq, Fentora |
Butrans (buprenorphine transdermal) |
Apadaz (benzhydrocodone/acetaminophen) |
Conzip (tramadol extended-release capsule) |
Buprenex (buprenorphine injection) |
Dolophine, Methadose (methadone) |
butalbital/aspirin/caffeine/codeine |
Duragesic (fentanyl transdermal system) |
butorphanol nasal spray |
hydromorphone extended-release |
carisoprodol/aspirin/codeine |
Hysingla ER (hydrocodone extended-release tablet) |
codeine |
Kadian (morphine extended-release capsule) |
Demerol (meperidine) |
levorphanol tablet |
dihydrocodeine/acetaminophen/caffeine |
Morphabond ER (morphine extended-release tablet) |
Dilaudid (hydromorphone) |
morphine extended-release capsule |
hydrocodone/acetaminophen |
MS Contin (morphine controlled-release) |
hydrocodone/ibuprofen |
Nucynta ER (tapentadol extended-release) |
MSIR (morphine immediate-release) |
Oxycontin (oxycodone extended-release tablet) |
Nucynta (tapentadol) |
oxymorphone extended-release |
Opana IR (oxymorphone immediate-release) |
Ultram ER (tramadol extended-release tablet) |
Oxaydo (oxycodone immediate-release) |
Xtampza (oxycodone extended-release capsule) |
oxycodone/aspirin |
Zohydro ER (hydrocodone extended-release capsule) |
oxycodone/ibuprofen |
Percocet, Xartemis XR (oxycodone/acetaminophen) |
|
pentazocine/naloxone |
|
|
Synalgos-DC (dihydrocodeine/aspirin/caffeine) |
|
Tylenol/Codeine (acetaminophen/codeine) |
|
Ultracet (tramadol/acetaminophen) |
|
Ultram (tramadol) |
- If PA is required for duplicate therapy, documentation of the following is required:
- appropriate diagnosis; and
- individual drug PA criteria must be met first where applicable; and
- clinical rationale for not maximizing opioid monotherapy.
- If PA is required for concurrent therapy with opioid dependence agents, documentation of the following is required:
- individual drug PA criteria must be met first where applicable; and
- clinical rationale why concurrent therapy with buprenorphine is clinically appropriate.
High-Dose
The following opioids and analgesics require PA for high-dose if used at doses exceeding the limits listed below.
Long-acting |
Short-acting |
||
Belbuca (buprenorphine buccal film) |
> 1,800 mcg/day |
acetaminophen products |
> 4 grams/day |
Butrans (buprenorphine transdermal system) | > 20 mcg/hr |
acetaminophen with codeine products |
> 4 grams acetaminophen/day > 360 mg codeine/day |
Conzip (tramadol extended-release capsule) | > 300 mg/day |
Apadaz (benzhydrocodone/acetaminophen) |
> 65.28 mg/day |
Dolophine, Methadose (methadone) | > 30 mg/day |
codeine products |
> 360 mg/day |
Duragesic (fentanyl transdermal system) | > 50 mcg/hr |
Dilaudid (hydromorphone) |
> 32 mg/day |
hydromorphone extended-release | > 32 mg/day |
hydrocodone/acetaminophen |
> 80 mg/day |
Hysingla ER (hydrocodone extended-release tablet) |
> 80 mg/day |
hydrocodone/ibuprofen |
> 80 mg hydrocodone/day > 3.2 grams ibuprofen/day |
Kadian (morphine extended-release capsule) |
> 120 mg/day |
morphine immediate-release |
> 120 mg/day |
levorphanol tablet | > 4 mg/day |
Opana (oxymorphone immediate-release) |
> 40 mg/day |
Morphabond ER (morphine extended-release tablet) | > 120 mg/day |
Oxaydo (oxycodone immediate-release) |
> 80 mg/day |
morphine extended-release capsule | > 120 mg/day |
oxycodone/acetaminophen |
> 80 mg/day |
MS Contin (morphine controlled-release) | > 120 mg/day |
oxycodone/aspirin |
> 4 grams aspirin/day |
Oxycontin (oxycodone extended-release tablet) | > 80 mg/day |
oxycodone/ibuprofen |
> 80 mg oxycodone/day > 3.2 grams ibuprofen/day |
oxymorphone extended-release | > 40 mg/day | Ultracet (tramadol/acetaminophen) |
> 4 grams acetaminophen/day > 400 mg tramadol/day |
Ultram ER (tramadol extended-release tablet) | > 300 mg/day |
Ultram (tramadol) |
> 400 mg/day |
Xtampza (oxycodone extended-release capsule) | > 72 mg/day |
|
|
Zohydro ER (hydrocodone extended-release capsule) | > 80 mg/day |
|
|
- If exceeding 4 grams/day of an acetaminophen- or aspirin-containing product, or 3.2 grams/day of an ibuprofen-containing product, documentation of the following is required:
- appropriate diagnosis; and
- individual drug PA criteria must be met first, where applicable; and
- clinical rationale for utilizing greater than 4 grams of acetaminophen or aspirin, or greater than 3.2 grams of ibuprofen per day.
- If exceeding the above high-dose limits for other agents, documentation of the following is required:
- appropriate diagnosis; and
- individual drug PA criteria must be met first, where applicable; and
- medical records documenting treatment plan, including clinical rationale for high-dose and titration of medication up to current dose; and
- pain consult from a pain specialist or hematologist/oncologist supporting the high dose of opioid requested; and
- signed and dated patient-prescriber agreement for opioid use.
High-Dose, Short-Acting Monotherapy
The following opioids and analgesics require PA for monotherapy if used at doses exceeding the limits listed below.
Short-acting |
|
acetaminophen with codeine products |
> 4 grams acetaminophen/day > 360 mg codeine/day |
Apadaz (benzhydrocodone/acetaminophen) |
> 65.28 mg/day |
codeine products |
> 360 mg/day |
Dilaudid (hydromorphone) |
> 32 mg/day |
hydrocodone/acetaminophen |
> 80 mg/day |
hydrocodone/ibuprofen |
> 80 mg/day hydrocodone > 3.2 grams/day ibuprofen |
morphine immediate-release |
> 120 mg/day |
Opana (oxymorphone immediate-release) |
> 40 mg/day |
Oxaydo (oxycodone immediate-release) |
> 80 mg/day |
oxycodone immediate-release |
> 80 mg/day |
oxycodone/acetaminophen |
> 80 mg/day |
oxycodone/aspirin |
> 4 grams/day aspirin |
oxycodone/ibuprofen |
> 80 mg/day oxycodone > 3.2 grams/day ibuprofen |
Ultracet (tramadol/acetaminophen) |
> 4 grams acetaminophen/day > 400 mg tramadol/day |
Ultram (tramadol) |
> 400 mg/day |
- If exceeding the above high-dose limits and using as monotherapy, documentation of the following is required:
- individual drug PA criteria must be met first, where applicable; and
- medical records documenting treatment plan, including clinical rationale for high-dose and titration of medication up to current dose; and
- pain consult from a pain specialist supporting the high dose of opioid requested; and
- clinical rationale for not utilizing a long-acting agent in a member requiring high-dose, short-acting opioid therapy for the treatment of chronic pain; and
- signed and dated patient-prescriber agreement for opioid use.
Quantity Limits
The following opioids require PA if used at the quantities listed below.
Long-acting |
|
Butrans (buprenorphine transdermal system) |
> 4 patches/28 days |
Conzip (tramadol extended-release capsule) | > 1 unit/day |
Duragesic (fentanyl transdermal system) | > 10 patches/month |
fentanyl 37.5, 62.5, 87.5 mcg/hr transdermal system | > 10 patches/month |
hydromorphone extended-release |
> 1 unit/day |
Hysingla ER (hydrocodone extended-release tablet) | > 1 unit/day |
Kadian (morphine extended-release capsule) |
> 1 unit/day |
levorphanol tablet | > 2 units/day |
Morphabond ER (morphine extended-release tablet) | > 2 units/day |
morphine extended-release capsule | > 1 unit/day |
Oxycontin (oxycodone extended-release tablet) | > 3 units/day |
oxymorphone extended-release | > 2 units/day |
Ultram ER (tramadol extended-release tablet) | > 1 unit/day |
Xtampza (oxycodone extended-release capsule) | > 2 units/day |
Zohydro ER (hydrocodone extended-release capsule) | > 2 units/day |
- If exceeding the above quantity limits, documentation of the following is required:
- appropriate diagnosis; and
- individual drug PA criteria must be met first, where applicable; and
- requested dose cannot be obtained within the established quantity limits.
Original Effective Date: 08/2002
Last Revised Date: 02/2022
Clinical Criteria Main Page | Back to top | Previous | Next
Last updated 06/21/22