Table 26: Antidiabetic Agents
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: Endocrine/Metabolic
Medication Class/Individual Agents: Antidiabetic Agents
I. Prior-Authorization Requirements
Antidiabetic Agents - Anti-CD3 antibodies |
Clinical Notes |
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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.
Alpha-glucosidase inhibitors:
Biguanides:
Insulin:
Meglitinides:
Sulfonylureas:
Thiazolidinediones:
Pregnancy/lactation:
Phentermine Contraindication The following are acceptable contraindications to phentermine:
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Antidiabetic Agents – Alpha-Glucosidase Inhibitors |
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Antidiabetic Agents – Biguanides |
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Antidiabetic Agents – Combination Products |
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Antidiabetic Agents – Dipeptidyl Peptidase (DPP)-4 Inhibitors |
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Antidiabetic Agents – Glucagon Like Peptide (GLP)-1 Agonists and GLP-1 Combination Products |
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Antidiabetic Agents – Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon Like Peptide (GLP)-1 Agonist |
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Antidiabetic Agents – Insulin |
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Antidiabetic Agents – Meglitinides |
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Antidiabetic Agents – Not Otherwise Classified |
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Antidiabetic Agents – Sodium Glucose Cotransporter (SGLT)-2 Inhibitors |
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Antidiabetic Agents – Sulfonylureas - Second Generation |
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Antidiabetic Agents – Thiazolidinediones |
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# | This designates a brand-name drug with FDA “A”-rated generic equivalents. PA 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. |
PD | Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. |
M90 | Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply. |
II. Therapeutic Uses
FDA-approved, for example:
- Diabetes mellitus (Admelog, Afrezza, Basaglar, Basaglar Tempo, Fiasp, Humalog Tempo, Humulin N, Lyumjev, Lyumjev Tempo)
- Heart failure (Inpefa)
- Type 1 diabetes mellitus, Stage 2 (Tzield)
- Type 2 diabetes mellitus (alogliptin, alogliptin/metformin, alogliptin/pioglitazone, Bydureon Bcise, glimepiride/pioglitazone, Glyxambi, Invokana, Invokamet, Invokamet XR, metformin extended-release, gastric tablet (generic Glumetza), metformin extended-release, osmotic tablet (generic Fortamet), metformin immediate-release 625 mg tablet, metformin immediate-release solution, miglitol, Mounjaro, Onglyza, Ozempic, Qtern, repaglinide/metformin, Riomet ER, Rybelsus, saxagliptin/metformin extended-release, Segluromet, sitagliptin (generic Zituvio), Soliqua, Steglatro, Steglujan, Trijardy XR, Xultophy)
- Type 2 diabetes mellitus and chronic kidney disease (Inpefa)
- Type 2 diabetes mellitus and diabetic nephropathy with albuminuria (Invokana)
non-FDA-approved, for example:
- Gestational diabetes (metformin extended-release, gastric tablet (generic Glumetza), metformin extended-release, osmotic tablet (generic Fortamet), metformin immediate-release solution, Riomet ER)
- Obesity (Bydureon Bcise, liraglutide [generic Victoza], Mounjaro, Ozempic, Rybelsus)
- Oligomenorrhea related to polycystic ovarian syndrome (PCOS) (metformin extended-release, gastric tablet [generic Glumetza], metformin extended-release, osmotic tablet [generic Fortamet], metformin immediate-release solution, Riomet ER)
- Overweight (Bydureon Bcise, liraglutide [generic Victoza], Mounjaro, Ozempic, Rybelsus)
- Prediabetes (Bydureon Bcise, metformin extended-release, gastric tablet [generic Glumetza], metformin extended-release, osmotic tablet [generic Fortamet], metformin immediate-release solution, Ozempic, Riomet ER, Rybelsus)
- Prevention of diabetes related to PCOS (metformin extended-release, gastric tablet [generic Glumetza], metformin extended-release, osmotic tablet [generic Fortamet], metformin immediate-release solution, Riomet ER)
Note: The above lists may not include all FDA-approved and non-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, and frequency.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
Admelog and Apidra
- Documentation of both of the following is required:
- appropriate diagnosis; and
- inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to one of the following: insulin aspart (Novolog or therapeutically equivalent generic), insulin lispro (Humalog or therapeutically equivalent generic).
Afrezza
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- medical necessity for the use of an inhaled insulin product instead of an injectable or prefilled insulin syringe.
alogliptin and saxagliptin
- Documentation of all of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with Januvia or Tradjenta; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Januvia or Tradjenta; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Januvia or Tradjenta; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Januvia and Tradjenta; and
- one of the following:
- requested quantity is ≤ one tablet/day; or
- clinical rationale for exceeding FDA-approved dosing.
SmartPA: Claims for alogliptin and saxagliptin within the quantity limit (described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and Januvia or Tradjenta for at least 90 days within the last 120-day time period.†
alogliptin/metformin, alogliptin/pioglitazone, glimepiride/pioglitazone, Glyxambi, Invokamet, Invokamet XR, Qtern, repaglinide/metformin, saxagliptin/metformin extended-release, Segluromet, Steglujan, and Trijardy XR
- Documentation of all of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to combination therapy with metformin used in combination with at least one of the non-metformin agents in the requested combination; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to at least one of the non-metformin agents in the requested combination; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to at least one of the non-metformin agents in the requested combination; and
- for Trijardy XR, medical necessity for use of the combination product instead of the commercially available separate agents.
Basaglar and Basaglar Tempo
- Documentation of all of the following is required:
- appropriate diagnosis; and
- inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to insulin glargine prefilled syringe or vial (branded or unbranded Lantus solostar or Lantus vial); and
- inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to one of the following: insulin glargine-yfgn prefilled syringe or vial, Rezvoglar prefilled syringe; and
- for Basaglar Tempo, medical necessity for use of Tempo pen formulation instead of Kwikpen formulation (i.e., documentation that member has access to the Tempo smart button and accompanying app).
Bydureon Bcise, Ozempic, Rybelsus
- Documentation of all of the following is required for the diagnosis of prediabetes or type 2 diabetes:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with Byetta, liraglutide (generic Victoza), or Trulicity; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Byetta, liraglutide (generic Victoza), or Trulicity; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Byetta, liraglutide (generic Victoza), or Trulicity; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Byetta, liraglutide (generic Victoza), or Trulicity; and
- if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
- requested agent will not be used in combination with another GLP-1 receptor agonist.
- Documentation of all of the following is required for diagnosis of obesity or overweight:
- appropriate diagnosis; and
- one of the following:
- for Ozempic and Rybelsus, member is ≥ 18 years of age; or
- for Bydureon Bcise, member is ≥ 12 years of age; and
- member weight (dated within the 90 days prior to treatment initiation); and
- member has been counseled to continue reduced-calorie diet and increased physical activity; and
- if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
- the requested agent will not be used in combination with another GLP-1 receptor agonist; and
- one of the following*:
- inadequate response to phentermine with or without topiramate defined as all of the following:
- member is adherent to phentermine (defined as ≥ 90 days out of 120 days)**; and
- one of the following:
- insufficient clinical response defined as < 5% reduction in bodyweight from baseline despite initial trial of ≥ three months of treatment with the maximally tolerated dose of phentermine; or
- plateaued clinical response defined as no weight loss for at least ≥ three months of treatment with the maximally tolerated dose of phentermine; and
- member's current BMI is ≥ 27 kg/m2; or
- medical records documenting adverse reaction to phentermine that is allergic in nature or cannot be expected or managed as part of weight loss therapy; or
- medical records documenting contraindication to phentermine; and
- inadequate response to phentermine with or without topiramate defined as all of the following:
- one of the following:
- member BMI is ≥ 30 kg/m2 (dated within the 90 days prior to treatment initiation); or
- for Bydureon Bcise, both of the following:
- member is ≥ 12 years of age and <17 years of age; and
- BMI is in the 95th percentile or greater (dated within the 90 days prior to treatment initiation); or
- both of the following:
- member BMI is ≥ 27 kg/m2 (dated within the last 90 days); and
- one of the following weight-related comorbid conditions:
- coronary heart disease or other atherosclerotic disease; or
- dyslipidemia; or
- hypertension; or
- non-alcoholic steatohepatitis (NASH); or
- obstructive sleep apnea; or
- polycystic ovarian syndrome; or
- prediabetes; or
- systemic osteoarthritis; or
- type 2 diabetes mellitus.
- For recertification for the diagnosis of obesity or overweight, documentation of all of the following is required:
- member weight (dated within the last 90 days); and
- one of the following:
- weight loss of ≥ 5% from baseline body weight; or
- both of the following:
- improvement in secondary measures; and
- attestation that the improvement in secondary measure is believed to be related to anti-obesity therapy despite lack of reduction in body weight.
- Please note for the quantity limits listed above:
- a 28-day supply should consist of:
- one carton of four 2 mg autoinjectors (Bydureon Bcise)
- one prefilled pen (Ozempic)
- one tablet per day (Rybelsus)
- a 28-day supply should consist of:
*Please note, members who have paid MassHealth pharmacy claims for a GLP-1 agonist within the last 90 days may bypass the phentermine trial. For all other members, documentation of clinical rationale why the member is not new to GLP-1 therapy is required to bypass the phentermine trial.
**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.
SmartPA: Claims for Bydureon Bcise, Ozempic, and Rybelsus within the quantity limit (as described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and Byetta, liraglutide (generic Victoza), or Trulicity for at least 90 days within the last 120-day time period.†
Byetta and Trulicity exceeding quantity limits
- Documentation of all of the following is required:
- appropriate diagnosis; and
- clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
- requested agent will not be used in combination with another GLP-1 receptor agonist.
Fiasp, Lyumjev, and Lyumjev Tempo
- Documentation of all of the following is required:
- appropriate diagnosis; and
- one of the following:
- for Fiasp, member is ≥ two years of age; or
- for Lyumjev, member is ≥ one years of age; and
- inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to one of the following: insulin aspart (Novolog or therapeutically equivalent generic), insulin lispro (Humalog or therapeutically equivalent generic); and
- for Lyumjev Tempo, medical necessity for use of Tempo pen formulation instead of Kwikpen formulation (i.e., documentation that member has access to the Tempo smart button and accompanying app).
Humalog 100 units/mL prefilled syringe, Humalog 100 units/mL vial, Humalog 75/25 prefilled syringe, Novolog, and Novolog 70/30
- Documentation of both of the following is required:
- appropriate diagnosis; and
- medical records documenting an inadequate response or adverse reaction to the therapeutically equivalent generic formulation.
Humalog Tempo
- Documentation of both of the following is required:
- appropriate diagnosis; and
- medical necessity for use of Tempo pen formulation instead of Kwikpen formulation (i.e., documentation that member has access to the Tempo smart button and accompanying app).
Humulin N
- Documentation of both of the following is required:
- appropriate diagnosis: and
- inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to Novolin N prefilled syringe or vial.
Inpefa
- Documentation of all of the following is required for heart failure:
- indication of reduction of risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit; and
- member is ≥ 18 years of age; and
- inadequate response, adverse reaction, or contraindication to both dapagliflozin and Jardiance; and
- requested quantity is ≤ one tablet/day.
- Documentation of all of the following is required for type 2 diabetes and chronic kidney disease:
- indication of reduction of risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in type 2 diabetes mellitus and chronic kidney disease with other cardiovascular risk factors; and
- member is ≥ 18 years of age; and
- inadequate response or adverse reaction to two or contraindication to all of the following: dapagliflozin, Invokana, Jardiance; and
- requested quantity is ≤ one tablet/day.
Invokana
- Documentation of all of the following is required for the diagnosis of diabetic nephropathy with albuminuria:
- indication of risk reduction of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria; and
- member is ≥ 18 years of age; and
- requested quantity is ≤ one tablet/day.
- Documentation of all of the following is required for the diagnosis of type 2 diabetes:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with dapagliflozin or Jardiance; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to dapagliflozin or Jardiance; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to dapagliflozin or Jardiance; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to dapagliflozin and Jardiance; and
- one of the following:
- requested quantity is ≤ one tablet/day; or
- clinical rationale for exceeding FDA-approved dosing.
SmartPA: Claims for Invokana within the quantity limit (described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and dapagliflozin or Jardiance for at least 90 days within the last 120-day time period.†
liraglutide (generic Victoza) exceeding quantity limits
- Documentation of all of the following is required for the diagnosis of type 2 diabetes or prediabetes:
- appropriate diagnosis; and
- clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
- requested agent will not be used in combination with another GLP-1 receptor agonist.
- Documentation of all of the following is required for the diagnosis of obesity or overweight:
- appropriate diagnosis; and
- appropriate dosing; and
- member is ≥ 12 years of age; and
- member weight (dated within the 90 days prior to treatment initiation); and
- member will be counseled to continue reduced-calorie diet and increased physical activity; and
- requested quantity is ≤ five pens/30 days; and
- the requested agent will not be used in combination with another GLP-1 receptor agonist; and
- one of the following*:
- inadequate response to phentermine with or without topiramate defined as all of the following:
- member is adherent to phentermine (defined as ≥ 90 days out of 120 days)**; and
- one of the following:
- insufficient clinical response defined as < 5% reduction in bodyweight from baseline despite initial trial of ≥ three months of treatment with the maximally tolerated dose of phentermine; or
- plateaued clinical response defined as no weight loss for at least ≥ three months of treatment with the maximally tolerated dose of phentermine; and
- member's current BMI is ≥ 27 kg/m2; or
- medical records documenting adverse reaction to phentermine that is allergic in nature or cannot be expected or managed as part of weight loss therapy; or
- medical records documenting contraindication to phentermine; and
- inadequate response to phentermine with or without topiramate defined as all of the following:
- one of the following:
- member BMI is ≥ 30 kg/m2 (dated within the 90 days prior to treatment initiation); or
- both of the following:
- member is ≥ 12 years of age and < 18 years of age; and
- member BMI is in the 95th percentile or greater (dated within the 90 days prior to treatment initiation); or
- both of the following:
- member BMI is ≥ 27 kg/m2 (dated within the 90 days prior to treatment initiation); and
- one of the following weight-related comorbid conditions:
- coronary heart disease or other atherosclerotic disease; or
- dyslipidemia; or
- hypertension; or
- non-alcoholic steatohepatitis (NASH); or
- obstructive sleep apnea; or
- polycystic ovarian syndrome; or
- prediabetes; or
- systemic osteoarthritis; or
- type 2 diabetes mellitus.
- For recertification for the diagnosis of obesity or overweight, documentation of all of the following is required:
- member weight (dated within the last 90 days); and
- one of the following:
- weight loss of ≥ 5% from baseline body weight; or
- both of the following:
- improvement in secondary measures; and
- attestation that the improvement in secondary measure is believed to be related to anti-obesity therapy despite lack of reduction in body weight.
*Please note, members who have paid MassHealth pharmacy claims for a GLP-1 agonist within the last 90 days may bypass the phentermine trial. For all other members, documentation of clinical rationale why the member is not new to GLP-1 therapy is required to bypass the phentermine trial.
**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.
metformin extended-release, gastric tablet (generic Glumetza) and metformin extended-release, osmotic tablet (generic Fortamet)
- Documentation of all of the following is required for type 2 diabetes, or prevention of diabetes related to PCOS:
- appropriate diagnosis; and
- medical records documenting an inadequate response (defined as ≥ 90 days of therapy) or adverse reaction, at the requested dose, to the metformin extended-release, XR tablet formulation available without PA; and
- for metformin extended-release, gastric tablet, medical necessity for the use of requested product instead of metformin formulations available without PA.
- Documentation of all of the following is required for gestational diabetes:
- appropriate diagnosis; and
- medical records documenting an inadequate response (defined as ≥ 90 days of therapy) or adverse reaction, at the requested dose, to the metformin extended-release, XR tablet formulation available without PA; and
- for metformin extended-release, gastric tablet, medical necessity for the use of requested product instead of metformin formulations available without PA; and
- inadequate response, adverse reaction, or contraindication to insulin therapy.
- Documentation of all of the following is required for oligomenorrhea related to PCOS:
- appropriate diagnosis; and
- medical records documenting an inadequate response (defined as ≥ 90 days of therapy) or adverse reaction, at the requested dose, to the metformin extended-release, XR tablet formulation available without PA; and
- for metformin extended-release, gastric tablet, medical necessity for the use of requested product instead of metformin formulations available without PA; and
- inadequate response, adverse reaction, or contraindication to combined oral contraceptives.
metformin immediate-release 625 mg tablet
- Documentation of both of the following is required:
- appropriate diagnosis; and
- medical necessity for the requested formulation instead of metformin tablets available without prior authorization.
metformin immediate-release solution ≥ 13 years of age and Riomet ER
- Documentation of all of the following is required for type 2 diabetes, prediabetes, or prevention of diabetes related to PCOS:
- appropriate diagnosis; and
- one of the following:
- medical necessity for the use of a liquid formulation; or
- medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin tablet formulation, or allergic reaction or adverse reaction to the metformin tablet formulation that is not class specific (i.e., nausea, diarrhea); and
- for Riomet ER, medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin immediate-release solution formulation.
- Documentation of all of the following is required for gestational diabetes:
- appropriate diagnosis; and
- one of the following:
- medical necessity for the use of a liquid formulation; or
- medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin tablet formulation, or allergic reaction or adverse reaction to the metformin tablet formulation that is not class specific (i.e., nausea, diarrhea); and
- for Riomet ER, medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin immediate-release solution formulation; and
- inadequate response, adverse reaction, or contraindication to insulin therapy.
- Documentation of all of the following is required for oligomenorrhea related to PCOS:
- appropriate diagnosis; and
- one of the following:
- medical necessity for the use of a liquid formulation; or
- medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin tablet formulation, or allergic reaction or adverse reaction to the metformin tablet formulation that is not class specific (i.e., nausea, diarrhea); and
- for Riomet ER, medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin immediate-release solution formulation; and
- inadequate response, adverse reaction, or contraindication to combined oral contraceptives.
miglitol
- Documentation of all of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with acarbose; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to acarbose; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to acarbose; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to acarbose; and
- one of the following:
- requested quantity is ≤ three tablets/day; or
- clinical rationale for exceeding FDA-approved dosing.
SmartPA: Claims for miglitol within the quantity limit (as described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and acarbose for at least 90 days within the last 120-day time period.†
Mounjaro
- Documentation of all of the following is required for the diagnosis of type 2 diabetes:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with Byetta, liraglutide (generic Victoza), or Trulicity; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Byetta, liraglutide (generic Victoza), or Trulicity; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Byetta, liraglutide (generic Victoza), or Trulicity; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Byetta, liraglutide (generic Victoza), or Trulicity; and
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to Ozempic; and
- the requested agent will not be used in combination with a GLP-1 receptor agonist; and
- if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing.
- Documentation of all of the following is required for diagnosis of obesity or overweight:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member weight (dated within the 90 days prior to treatment initiation); and
- member has been counseled to continue reduced-calorie diet and increased physical activity; and
- medical necessity for the requested agent instead of Zepbound; and
- the requested agent will not be used in combination with another GLP-1 receptor agonist; and
- if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
- one of the following*:
- inadequate response to phentermine with or without topiramate as defined as all of the following:
- member is adherent to phentermine (defined as ≥ 90 days out of 120 days)**; and
- one of the following:
- insufficient clinical response defined as < 5% reduction in bodyweight from baseline despite initial trial of ≥ three months of treatment with the maximally tolerated dose of phentermine; or
- plateaued clinical response defined as no weight loss for at least ≥ three months of treatment with the maximally tolerated dose of phentermine; and
- member's current BMI is ≥ 27 kg/m2 (dated within the 90 days prior to treatment initiation); or
- medical records documenting adverse reaction to phentermine that is allergic in nature or cannot be expected or managed as part of weight loss therapy; or
- medical records documenting contraindication to phentermine; and
- inadequate response to phentermine with or without topiramate as defined as all of the following:
- one of the following:
- member BMI ≥ 30 kg/m2 (dated within the 90 days prior to treatment initiation); or
- both of the following:
- member BMI is ≥ 27 kg/m2 (dated within the 90 days prior to treatment initiation); and
- one of the following weight-related comorbid conditions:
- coronary heart disease or other atherosclerotic disease; or
- dyslipidemia; or
- hypertension; or
- non-alcoholic steatohepatitis (NASH); or
- obstructive sleep apnea; or
- polycystic ovarian syndrome; or
- prediabetes; or
- systemic osteoarthritis; or
- type 2 diabetes mellitus.
- For recertification for the diagnosis of obesity or overweight, documentation of all of the following is required:
- member weight (dated within the last 90 days); and
- one of the following:
- weight loss of ≥ 5% from baseline body weight; or
- both of the following:
- improvement in secondary measures; and
- attestation that the improvement in secondary measure is believed to be related to anti-obesity therapy despite lack of reduction in body weight.
- Please note for the quantity limits listed above:
- a 30 day supply should consist of one carton of four prefilled pens.
*Please note, members who have paid MassHealth pharmacy claims for a GLP-1 agonist within the last 90 days may bypass the phentermine trial. For all other members, documentation of clinical rationale why the member is not new to GLP-1 therapy is required to bypass the phentermine trial.
**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.
Rezvoglar and Semglee
- Documentation of both of the following is required:
- appropriate diagnosis; and
- inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction with insulin glargine prefilled syringe or vial (branded or unbranded Lantus solostar or Lantus vial).
sitagliptin (generic Zituvio)
- Documentation of all of the following is required:
- appropriate diagnosis; and
- clinical rationale for the requested agent instead of Januvia; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to combination therapy of metformin used with each of the following: alogliptin, saxagliptin, Tradjenta; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to all of the following: alogliptin, saxagliptin, Tradjenta; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin and adverse reaction or contraindication to all of the following: alogliptin, saxagliptin, Tradjenta; and
- if requested quantity exceeds quantity limits, clinical rationale for exceeding FDA-approved dosing.
Soliqua and Xultophy
- Documentation of all of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with Byetta, liraglutide (generic Victoza), or Trulicity; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Byetta, liraglutide (generic Victoza), or Trulicity; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Byetta, liraglutide (generic Victoza), or Trulicity; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Byetta, liraglutide (generic Victoza), or Trulicity; and
- if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing.
- please note for the quanty limits listed above:
- a 30 day supply should consist of:
- six prefilled pens (Soliqua)
- one carton of five prefilled pens (Xultophy)
- a 30 day supply should consist of:
SmartPA: Claims for Soliqua and Xultophy within the quantity limit (as described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and Byetta, liraglutide (generic Victoza), or Trulicity for at least 90 days within the last 120-day time period.†
Steglatro
- Documentation of all of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with dapagliflozin or Jardiance; or
- adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to dapagliflozin or Jardiance; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to dapagliflozin or Jardiance; or
- inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to dapagliflozin and Jardiance; and
- one of the following:
- requested quantity is ≤ one tablet/day; or
- clinical rationale for exceeding FDA-approved dosing.
SmartPA: Claims for Steglatro within the quantity limit (described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and dapagliflozin or Jardiance for at least 90 days within the last 120-day time period.†
Tzield
- Documentation of all of the following is required for stage 2 type 1 diabetes mellitus:
- appropriate diagnosis; and
- member is ≥ eight years of age; and
- appropriate dosing; and
- prescriber is an endocrinologist or consult notes from a specialist are provided; and
- lab results documenting ≥ two islet autoantibodies; and
- member has not been previously treated with Tzield; and
- one of the following within the last three months:
- fasting plasma glucose (FPG): 100 to 125 mg/dL; or
- 2-hour plasma glucose (2-h PG): 140 to 199 mg/dL; or
- A1C: 5.7% to 6.4%; or
- both of the following:
- 10% increase in A1C in ≤12 months; and
- A1C is ≤ 6.4%.
†Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.
Original Effective Date: 05/2003
Last Revised Date: 01/2025
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Last updated 01/06/25