CurrentMolina HealthcarePolicy C14599-A

Keveyis (dichlorphenamide) Coverage Criteria

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Prior authorization and pharmacy benefit coverage for oral dichlorphenamide products used to treat primary hyperkalemic or hypokalemic periodic paralysis and related variants, subject to clinical, prescriber, age, quantity, and safety requirements.

Policy Summary

PayerMolina Healthcare

PolicyKeveyis (dichlorphenamide) Coverage Criteria

Policy CodePolicy C14599-A

Change TypeNo material change

Effective DateSeptember 24, 2026

Next Review DateJuly 1, 2027

Key ActionPrior authorization is required for dichlorphenamide products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

200 mg/dayMaximum dosage

4 tablets/dayMaximum quantity

6 monthsInitial authorization

12 months

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CurrentMolina HealthcarePolicy C14599-A

Keveyis (dichlorphenamide) Coverage Criteria

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Policy Summary

PayerMolina Healthcare

PolicyKeveyis (dichlorphenamide) Coverage Criteria

Policy CodePolicy C14599-A

Change TypeNo material change

Effective DateSeptember 24, 2026

Next Review DateJuly 1, 2027

Key ActionPrior authorization is required for dichlorphenamide products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

200 mg/dayMaximum dosage

4 tablets/dayMaximum quantity

6 monthsInitial authorization

12 months

Continuation authorization

85%Continuation adherence

Covered Uses and Safety Requirements

Initial Therapy

Covered when ALL of the following criteria are met:

ALL of the following

Documented diagnosis of primary hyperkalemic periodic paralysis or primary hypokalemic periodic paralysis.
Prescriber documents a baseline disease activity evaluation and goals for treatment to evaluate efficacy at renewal, such as number of attacks per week or month, severity of attacks, or Short Form-36 assessment.
Documentation of inadequate response (no change in attack rate per week from baseline) after 3 months of adherent therapy, serious side effects, or an FDA-labeled contraindication to oral acetazolamide at the recommended dosage of 250 to 375 mg/day PO in divided doses.
ONE of the following
- For hyperkalemic periodic paralysis: Documentation of inadequate response, serious side effects, or contraindication to a thiazide diuretic.
- For hypokalemic periodic paralysis: Documentation of inadequate response, serious side effects, or contraindication to a potassium-sparing diuretic.
Applicable disease-specific counseling requirement
- For hyperkalemic periodic paralysis: Prescriber attests that the member has been counseled on implementing and maintaining dietary and lifestyle changes to help prevent episodes, including eating meals rich in carbohydrates and avoiding potassium-rich medications and foods, fasting, strenuous work, and exposure to cold.
- For hypokalemic periodic paralysis: Prescriber attests that the member has been counseled to avoid triggers; follow a low-sodium, low-carbohydrate, high-potassium diet; and take oral potassium supplementation.
Prescriber attests, or the clinical reviewer has found, that the member does not have any FDA-labeled contraindications that have not been addressed by the prescriber in the submitted documentation, including concomitant use with high-dose aspirin (greater than 100 mg per day), severe pulmonary disease or obstruction such as severe COPD, hepatic insufficiency, or hypersensitivity to dichlorphenamide or other sulfonamides.

Continuation Therapy

Continuation coverage requires ALL of the following criteria:

ALL of the following

Adherence to therapy at least 85% of the time as verified by the prescriber or member medication fill history, OR adherence less than 85% of the time due to surgery or treatment of an infection causing temporary discontinuation.
Documented positive response from baseline in periodic paralysis symptoms, including a decrease in the frequency or severity of paralytic attacks.
Per the FDA label, evaluate response and the need for continued therapy after 2 months of treatment.
Prescriber attests, or the clinical reviewer has found, that the member does not have concomitant use with high-dose aspirin (greater than 100 mg per day), severe pulmonary disease or obstruction such as severe COPD, or hepatic insufficiency.
Prescriber attests that the member has continued to maintain dietary and lifestyle changes to help prevent episodes.

FDA-Approved Indications

Dichlorphenamide is covered for the following FDA-approved indications:

ALL of the following

Treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
The associated diagnosis may be coded as G72.3 (Periodic Paralysis) or G71.19 (Other specified myotonic disorders).

No compendial approved off-label uses are listed for dichlorphenamide.

All other uses of dichlorphenamide are considered experimental or investigational and follow Molina Healthcare's Off-Label policy.

Dichlorphenamide is contraindicated or excluded in members with hepatic insufficiency, severe pulmonary disease or obstruction (including severe chronic obstructive pulmonary disease), hypersensitivity to dichlorphenamide or other sulfonamides, or concomitant use with high-dose aspirin (greater than 100 mg per day).

Diagnosis, Product, and Policy Limits

FDA-Approved Uses Diagnosis CodesICD-10Covered

G72.3	Periodic Paralysis
G71.19	Other specified myotonic disorders

Diagnosis CodesICD-10

G72.3	Periodic Paralysis
G71.19	Other specified myotonic disorders

HCPCSHCPCS

N/A

Acetazolamide trial

Prior medicationOral acetazolamide

Recommended dosage250 to 375 mg/day by mouth in divided doses

Trial duration3 months of adherent therapy when inadequate response is claimed

Continuation adherence

Required adherenceAt least 85% of the time

Permitted exceptionAdherence below 85% is permitted when surgery or treatment of an infection causes temporary discontinuation

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation showing the qualifying diagnosis, baseline assessment and treatment goals, required prior therapies, disease-specific counseling, safety review, neurologist involvement, age eligibility, and quantity limits. Molina may request additional information to determine medical necessity.

Documentation Required

Document Baseline Disease Activity

Before initiating therapy, document baseline disease activity and goals so efficacy can be evaluated at renewal. Examples include attack frequency, attack severity, and a Short Form-36 assessment.

Medication and Policy Context

Keveyis (dichlorphenamide) is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

Clinical Terms

Periodic paralysis and related variants

Disorder categoryPeriodic paralysis and related variants

Included subtypePrimary hyperkalemic periodic paralysis

Included subtypePrimary hypokalemic periodic paralysis

Related conditionsRelated variants of primary periodic paralysis

Primary periodic paralysis

DefinitionA group of rare hereditary disorders

Core episodesEpisodes of muscle weakness or paralysis

Initial Therapy Requirements

Initial Therapy Criteria

Initial therapy requires all applicable clinical, prior-treatment, counseling, and safety criteria.

Initial therapy

Qualifying diagnosis
- Documented diagnosis of primary hyperkalemic periodic paralysis.
- Documented diagnosis of primary hypokalemic periodic paralysis.
Baseline assessment
- The prescriber documents a baseline disease activity evaluation and treatment goals for use in evaluating efficacy at renewal.
  Examples include the number of attacks per week or month, attack severity, or a Short Form-36 assessment.

Continuation Therapy Requirements

Continuation Therapy Criteria

Continuation therapy requires all listed renewal criteria.

Continuation therapy

Adherence
- Adherence to therapy is at least 85% of the time as verified by the prescriber or the member's medication fill history.At least 85%
- Adherence is less than 85% because surgery or treatment of an infection caused temporary discontinuation.
Clinical response
- There is a documented positive response from baseline in periodic paralysis symptoms, including a decrease in the frequency or severity of paralytic attacks.

Required Prior Treatment Steps

Step	Required therapy	Criteria for advancing to dichlorphenamide
1	Oral acetazolamide at 250 to 375 mg/day by mouth in divided doses	Document inadequate response after 3 months of adherent therapy, serious side effects, or an FDA-labeled contraindication

Step	Required therapy	Criteria for advancing to dichlorphenamide
2	Thiazide diuretic for hyperkalemic periodic paralysis	Document inadequate response, serious side effects, or contraindication

Step	Required therapy	Criteria for advancing to dichlorphenamide
2	Potassium-sparing diuretic for hypokalemic periodic paralysis	Document inadequate response, serious side effects, or contraindication

Dosage and Quantity Restrictions

Dichlorphenamide products

ProductsDichlorphenamide products

Maximum dosage200 mg/day

Limit typeMaximum daily dosage

Dichlorphenamide products

ProductsDichlorphenamide products

Maximum quantity4 tablets/day

Limit typeMaximum daily tablet quantity

Administration Setting

Billing Rule

Use the pharmacy benefit and home setting

Oral medication is recommended for pharmacy benefit coverage and patient self-administration at home.

Policy Summary

PayerMolina Healthcare

PolicyKeveyis (dichlorphenamide) Coverage Criteria

Policy CodePolicy C14599-A

Change TypeNo material change

Effective DateSeptember 24, 2026

Next Review DateJuly 1, 2027

Key ActionPrior authorization is required for dichlorphenamide products.

SourceLink

On This Page

Prescriber attests, or the clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity, such as skin rash, persistent metabolic acidosis, or falls.

Prescriber verification or member medication fill history

Maximum dosage

MedicationDichlorphenamide products

Maximum dosage200 mg/day

Limit typeMaximum daily dosage

Maximum tablet quantity

MedicationDichlorphenamide products

Maximum quantity4 tablets per day

Limit typeMaximum daily tablet quantity

High-dose aspirin contraindication

Contraindicated medication combinationConcomitant use of dichlorphenamide with high-dose aspirin

Aspirin thresholdGreater than 100 mg/day

Applies duringInitial and continuation therapy review

Minimum age

Minimum age18 years

Eligibility requirementMember must be 18 years of age or older

Restriction typeAge restriction for dichlorphenamide coverage

Billing Rule

Initial Authorization Period

The initial authorization period is 6 months. Although authorization extends for 6 months, response to dichlorphenamide should be evaluated after 2 months of treatment.

Billing Rule

Renewal Authorization Period

Continuation authorization is granted for 12 months when renewal criteria are met. Document adherence, improvement from baseline, continued counseling and treatment, safety, and the absence of intolerable adverse effects or toxicity.

Unsupported block type: billing_rule

Step Therapy

Prior Acetazolamide Therapy

Document that the member had an inadequate response after 3 months of adherent therapy at the recommended acetazolamide dosage, experienced serious side effects, or has an FDA-labeled contraindication to oral acetazolamide.

Step Therapy

Hyperkalemic Paralysis Diuretic Step

For primary hyperkalemic periodic paralysis, document inadequate response, serious side effects, or a contraindication to a thiazide diuretic.

Step Therapy

Hypokalemic Paralysis Diuretic Step

For primary hypokalemic periodic paralysis, document inadequate response, serious side effects, or a contraindication to a potassium-sparing diuretic.

Documentation Required

Medical-Necessity Documentation

Molina may request additional records, test results, and credentials of the provider ordering or performing the drug or service. Inadequate documentation may support denial of reimbursement or other appropriate action.

Documentation Required

Initial Clinical Documentation

The initial request must document a qualifying diagnosis, baseline disease activity and treatment goals, prior treatment response or intolerance, and all other applicable clinical requirements.

Documentation Required

Continuation Documentation

For renewal, verify adherence of at least 85% or document an allowable temporary interruption for surgery or infection, and provide evidence of positive response from baseline, including reduced frequency or severity of paralytic attacks.

Documentation Required

Neurologist Documentation

The drug must be prescribed by, or in consultation with, a board-certified neurologist. If prescribed in consultation, submit the consultation notes with both the initial request and reauthorization requests.

Documentation Required

Counseling and Contraindication Attestations

Submit the applicable prescriber attestations: counseling for hyperkalemic periodic paralysis on dietary and lifestyle changes and avoidance of potassium-related triggers; counseling for hypokalemic periodic paralysis on trigger avoidance, a low-sodium/low-carbohydrate/high-potassium diet, and oral potassium supplementation; and confirmation that FDA-labeled contraindications have been addressed.

Documentation Required

Illinois Medical Exception Documentation

For an Illinois off-formulary medical exception, submit evidence that the formulary drug was contraindicated, failed, or was not tolerated, or document that the member is stable on the requested drug under a current or previous plan.

Denial Risk

Missing Initial Requirements

Initial requests may be denied when the qualifying diagnosis, baseline evaluation or treatment goals, or required prior treatment documentation is absent or insufficient.

Denial Risk

Continuation Criteria Not Met

Renewal requests may be denied when adherence is not adequately verified, improvement from baseline is not documented, or required continuation records and attestations are missing.

Denial Risk

Contraindications or Safety Concerns

Review and address safety concerns before requesting or continuing therapy. Coverage may be denied when applicable contraindications or intolerable toxicity are present or not addressed in the submitted documentation.

Concomitant high-dose aspirin (greater than 100 mg/day)
Severe pulmonary disease or obstruction, such as severe COPD
Hepatic insufficiency
Hypersensitivity or other sulfonamide-related concern
Intolerable adverse effects or drug toxicity, including skin rash, persistent metabolic acidosis, or falls

Denial Risk

Prescriber, Age, and Quantity Limits

The drug must be prescribed by or in consultation with a board-certified neurologist, for members age 18 years or older, and within the maximum dosage and quantity limits.

Minimum age: 18 years
Maximum dosage: 200 mg/day
Maximum quantity: 4 tablets/day

Denial Risk

Other Uses Are Experimental or Investigational

All other uses of dichlorphenamide are considered experimental or investigational and follow Molina's Off-Label policy.

Denial Risk

Contraindications

Contraindications to dichlorphenamide include hepatic insufficiency, severe pulmonary obstruction, hypersensitivity to dichlorphenamide or other sulfonamides, and concomitant use with high-dose aspirin.

Primary formsPrimary hyperkalemic periodic paralysis and primary hypokalemic periodic paralysis

Additional formsRelated variants

Dichlorphenamide

DrugDichlorphenamide

Drug classCarbonic anhydrase inhibitor

Clinical useUsed in the treatment of periodic paralysis

MechanismThe mechanism of therapeutic effect in patients with periodic paralysis is unknown

Prior acetazolamide therapy

Inadequate response to oral acetazolamide therapy at the recommended dosage of 250 to 375 mg/day by mouth in divided doses.3 months of adherent therapy
Inadequate response means no change in attack rate per week from baseline.
Serious side effects from oral acetazolamide therapy at the recommended dosage of 250 to 375 mg/day by mouth in divided doses.
An FDA-labeled contraindication to oral acetazolamide therapy at the recommended dosage of 250 to 375 mg/day by mouth in divided doses.

Subtype-specific diuretic therapy

For hyperkalemic periodic paralysis, documentation of inadequate response, serious side effects, or contraindication to a thiazide diuretic.
For hypokalemic periodic paralysis, documentation of inadequate response, serious side effects, or contraindication to a potassium-sparing diuretic.

Subtype-specific counseling

For hyperkalemic periodic paralysis, the prescriber attests that the member has been counseled on implementing and maintaining dietary and lifestyle changes to help prevent episodes.
Counseling includes addressing carbohydrate-rich meals and avoiding potassium-rich medications and foods, fasting, strenuous work, and exposure to cold.
For hypokalemic periodic paralysis, the prescriber attests that the member has been counseled to avoid triggers, follow a low-sodium, low-carbohydrate, high-potassium diet, and take oral potassium supplementation.

Safety and contraindications

The prescriber attests, or the clinical reviewer finds, that the member has no FDA-labeled contraindications to dichlorphenamide that have not been addressed in the submitted documentation.
Contraindications include concomitant use with high-dose aspirin greater than 100 mg/day, severe pulmonary disease or obstruction, hepatic insufficiency, and hypersensitivity to dichlorphenamide or other sulfonamides.

Per FDA labeling, evaluate response and the need for continued therapy after 2 months of treatment.

Safety and tolerability

The member does not have concomitant use with high-dose aspirin greater than 100 mg/day, severe pulmonary disease or obstruction, or hepatic insufficiency.
There is no evidence of intolerable adverse effects or drug toxicity.
Examples include skin rash, persistent metabolic acidosis, or falls.

Ongoing prevention measures

The prescriber attests that the member has continued to maintain dietary and lifestyle changes to help prevent episodes.