Skip to Content

Table 83: Renal Disorder 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: Renal Disorder Agents

Medication Class/Individual Agents: Renal Disorder Agents

I. Prior-Authorization Requirements

 Renal Disorder Agents – Hyperphosphatemia Agents
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes
tenapanor 20 mg, 30 mg tablet Xphozah PA  
  • Xphozah (tenapanor) is FDA-approved to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
  • Xphozah (tenapanor) is dosed as 30 mg twice daily before morning and evening meals.
 

 Renal Disorder Agents – Immunoglobulin A Nephropathy Agents
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes
atrasentan Vanrafia PA  
  • Filspari (sparsentan) and Tarpeyo (budesonide are FDA-approved to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
  • Vanrafia (atrasentan) received accelerated approval from the FDA to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.
  • Filspari (sparsentan) is initially dosed as 200 mg once daily for 14 days then titrated to 400 mg once daily if tolerated for maintenance dosing.
  • Tarpeyo (budesonide) is recommended for a total of nine months of therapy at a dose of 16 mg once daily. The dose should be reduced to 8 mg once daily for the last two weeks of therapy.
  • Vanrafia (atrasenta) is dosed as 0.75 mg once daily for initial and maintenance dosing.
 
budesonide 4 mg delayed-release capsule Tarpeyo PA  
sparsentan Filspari PA  

 Renal Disorder Agents – Mineralocorticoid Receptor Antagonists
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes
finerenone Kerendia PA  
  • Kerendia (finerenone) is FDA-approved to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage renal disease (ESRD), cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure (HF) in adult patients with CKD associated with type 2 diabetes (T2DM).
  • Kerendia (finerenone) is initially dosed as 20 mg once daily in patients with eGFR ≥ 60, 10 mg once daily in patients with eGFR ≥ 25 and < 60, and not recommended in patients with eGFR < 25. Maintenance dosage adjustments are required based on the current serum potassium concentration and current dose.
 

 Renal Disorder Agents – Potassium Binding Agents
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes
patiromer Veltassa PA   - > 1 unit/day
  • Lokelma (sodium zirconium cyclosilicate) and Veltassa (patiromer) are both FDA-approved for the treatment of hyperkalemia in adults. Veltassa (patiromer) is additionally FDA-approved for the treatment of hyperkalemia in pediatric patients 12 years of age and older.
  • Lokelma (sodium zirconium cyclosilicate) is initially dosed as 10 g three times daily for up to 48 hours, with reduction to maintenance dosing ranging from 5 g every other day to 15 g daily.
  • Veltassa (patiromer) adult dosing is initially 8.4 g once daily and can be titrated by 8.4 g increments at weekly or longer intervals up to a maximum of 25.2 g once daily.
  • Veltassa (patiromer) pediatric dosing is initially 4 g once daily and can be titrated by 4 g increments at weekly or longer intervals up to a maximum of 25.2 g once daily.
 
sodium polystyrene sulfonate test  
sodium zirconium cyclosilicate Lokelma PA   - > 1 unit/day

 Renal Disorder Agents – Potassium Supplements
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes
potassium bicarbonate test   A90

potassium chloride powder for oral solution1,2:

  • FDA-approved for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
  • The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance; volume status; electrolytes, including magnesium, sodium, chloride, phosphate, and calcium; electrocardiograms; and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate.
  • Administration of oral potassium salts rarely causes serious hyperkalemia in persons with normal potassium excretion. Serious hyperkalemia is characterized by electrocardiographic changes, and potentially muscle paralysis or cardiovascular collapse in the most severe cases.
  • For members who have difficulty swallowing capsules or tablets, some potassium chloride capsules may be opened and sprinkled on soft food and some potassium chloride tablets may be split in half or dissolved in water. See specific product information for further information on food and liquids compatible with capsule or tablet contents.

1Lexicomp Online Database [database on the Internet]. Hudson (OH): Lexicomp Inc.; 2024 [cited 2025 June 13]. Available from: http://online.lexi.com. Subscription required to view.

2Pokonza [package insert]. Hazlet (NJ): Carwin Pharmaceutical Associates, LLC; 2024 Mar.

 
potassium chloride extended-release capsule test   A90
potassium chloride extended-release tablet K-Tab test   # , A90
potassium chloride injection test  
potassium chloride oral solution test   A90
potassium chloride powder for oral solution Pokonza PA  
potassium chloride powder packet, extended-release tablet Klor-Con test   # , A90

 Renal Disorder Agents – Vasopressin Antagonists
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes
tolvaptan-Jynarque Jynarque PA  
  • Tolvaptan (Jynarque) is FDA-approved to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
  • Tolvaptan (Jynarque) is initially dosed as 60 mg per day as 45 mg in the morning and 15 mg eight hours later, then titrated up to a maximum of 90 mg plus 30 mg per day as tolerated.
  • Tolvaptan (Samsca) is FDA-approved for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
  • Tolvaptan (Samsca) is initially dosed as 15 mg once daily and can be titrated up to a maximum of 60 mg once daily as needed to achieve the desired level of serum sodium.
 
tolvaptan-Samsca Samsca PA   A90
Table Footnotes
# 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.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Autosomal dominant polycystic kidney disease (ADPKD) – tolvaptan (generic Jynarque)
  • Chronic kidney disease associated with type 2 diabetes – Kerendia
  • Euvolemic hyponatremia (SIADH) – tolvaptan (generic Samsca)
  • Hyperkalemia – Lokelma, Veltassa
  • Hyperphosphatemia in chronic kidney disease on dialysis for ≥ three months – Xphozah
  • Hypervolemic hyponatremia (CHF) – tolvaptan (generic Samsca)
  • Hypokalemia – Pokonza
  • Immunoglobulin A nephropathy (IgAN) – Filspari, Tarpeyo, Vanrafia

Note: The above lists may not include all FDA-approved indications.

Back to top

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.

  

Filspari

Documentation of all of the following is required:

  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a nephrologist or consult notes from a nephrologist are provided; and
  • medical records documenting one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days:
    • urine protein-to-creatinine ratio (UPCR) ≥0.5 g/g; or
    • proteinuria >0.5 g/day; and
  • both of the following:
    • requested initial dose of 200 mg daily for two weeks followed by 400 mg daily for maintenance treatment; and 
    • requested quantity is ≤ one unit/day; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; or
    • both of the following:
      • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
      • medical records documenting intolerance to an ACE inhibitor or ARB at a dose above the maximally tolerated dose.

 

Kerendia

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • concurrent therapy with an ACE-Inhibitor or ARB; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: dapagliflozin, Inpefa, Invokana, Jardiance, Steglatro; and
    • requested quantity ≤ one unit/day.

 

Lokelma and Veltassa > one unit/day

  • Documentation of all of the following is required:
    • diagnosis of hyperkalemia; and
    • medical necessity for exceeding the quantity limit.

 

Pokonza

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following: potassium bicarbonate, potassium chloride oral solution; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to potassium chloride 20 mEq powder packet at an equivalent requested dose; or
      • requested dose cannot be achieved without using Pokonza; and
    • for members ≥ 13 years of age, inadequate response, adverse reaction, or contraindication to both of the following: potassium chloride extended-release capsule, potassium chloride extended-release tablet.
  • For recertification, documentation that the member meets the criteria above is required.

 

Tarpeyo

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • prescriber is a nephrologist or consult notes from a nephrologist are provided; and
    • one of the following:
      • both of the following:
        • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
        • adverse reaction to the ACE inhibitor or ARB at a dose above the maximally tolerated dose; or
      • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; and
    • one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days:
      • urine protein-to-creatinine ratio (UPCR) ≥0.5 g/g; or
      • proteinuria >0.5 g/day; and
    • medical necessity for the delayed-release formulation instead of other glucocorticoid formulations available without PA.

 

tolvaptan (generic Jynarque)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years and < 56 years of age; and
    • prescriber is a nephrologist or consultation notes from a nephrologist are provided; and
    • estimated glomerular filtration rate (eGFR) ≥ 25 mL/min (e.g., within the last 6 months).
  • For recertification, documentation of positive response to therapy and that eGFR continues to be ≥ 25 mL/min (e.g., within the last 6 months) is required.

tolvaptan (generic Samsca)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member is currently taking and stabilized on the requested agent; and
    • one of the following:
      • for 15 mg tablet, requested quantity is ≤ one unit/day; or
      • for 30 mg tablet, requested quantity is ≤ two units/day; or
      • clinical rationale for exceeding FDA-approved dosing.

 

Vanrafia

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a nephrologist or consult notes from a nephrologist are provided; and
    • one of the following:
      • both of the following:
        • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
        • adverse reaction to the ACE inhibitor or ARB at a dose above the maximally tolerated dose; or
      • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; and
    • one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days:
      • urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g; or
      • proteinuria >1.0 g/day; and
    • requested quantity is ≤ one unit/day.

 

Xphozah

  • Documentation of all of the following is required:
    • diagnosis of hyperphosphatemia in chronic kidney disease on dialysis for ≥ three months; and
    • member is ≥ 18 years of age; and
    • prescriber is a nephrologist or consult notes from a nephrologist are provided; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: calcium acetate, ferric citrate, lanthanum, sevelamer hydrochloride or sevelamer carbonate, Velphoro; and
    • requested quantity is ≤ two units/day.

Original Effective Date: 10/2025

Last Revised Date: 10/2025

Clinical Criteria Main Page | Back to top |  Previous  |  Next

Last updated 11/10/25

Feedback