Prior authorization required for molluscum contagiosum

Prior authorization is required for berdazimer requests for molluscum contagiosum. The request must document diagnosis of molluscum contagiosum, be prescribed by or in consultation with a dermatologist, and show trial and failure (≥3 months) of at least one conventional therapy (cantharidin, silver nitrate, cryotherapy, or curettage).

• Document dermatologist prescriber or documented specialist consultation.
• Document ≥3 months trial and failure of ≥1 conventional therapy (cantharidin, silver nitrate, cryotherapy, curettage).

Vykat XR prior authorization — document clinical criteria

Vykat XR (diazoxide choline) is subject to prior authorization; requests must include the same clinical eligibility documentation required for listed treatments (e.g., qualifying clinical condition, age) and adhere to the policy's quantity limit.

• Quantity limit: 1 kit (31 grams) per month.
• Patient must meet package-insert minimum age and other clinical criteria as specified for MC decisions.

PA requires documentation of qualifying clinical condition

Prior authorization requires documentation that the patient meets one of the listed qualifying clinical conditions (atopic dermatitis, immunocompromised status, or concomitant bacterial infection), is not on concurrent MC treatment, and meets the product package‑insert minimum age.

• Document presence of atopic dermatitis OR immunocompromised status OR concomitant bacterial infection.
• Document patient is not receiving concurrent treatment for molluscum contagiosum.
• Document patient meets package‑insert minimum age (1 year or older).

PA — confirm no concurrent MC treatment and age per PI

Prior authorization must include evidence the patient is not on concurrent treatment for molluscum contagiosum and that the patient meets the package‑insert minimum age for the indication.

• Confirm and document no concurrent MC therapy.
• Confirm and document age per package insert (document lists 1 year of age or older).

Prior authorization duration — Vykat XR: 12 months

Approval duration for Vykat XR prior authorization is reported as 12 months for both initial and renewal approvals in the policy.

• Documented approvals are issued for 12 months (initial and renewal) per policy language.

Prior authorization — Vykat XR (12 months, age limit noted)

Vykat XR requires prior authorization with documented eligibility and is listed with a 12‑month initial and renewal approval duration and policy-stated age limit.

• Age limit referenced in multiple chunks as 1 year of age or older.
• Quantity limit 1 kit (31 grams) per month.

PA — Tryptyr and Andembry approval durations

Tryptyr (acoltremon) and Andembry (garadacimab‑gxii) require prior authorization with specified initial and renewal durations per product: Tryptyr initial 3 months / renewal 12 months; Andembry initial 6 months / renewal 12 months.

• Tryptyr: Approval duration 3 months initial, 12 months renewal.
• Andembry: Approval duration 6 months initial, 12 months renewal.

PA and limits — initial 6 months, renewal 12 months; qty & age limits

Prior authorization for certain agents (example: Andembry) includes limits: initial approval 6 months, renewal 12 months, and a quantity limit of 60 vials per 30 days; age requirements are specified in the policy language.

• Initial approval: 6 months; renewal: 12 months.
• Quantity limit: 60 vials per 30 days.
• Policy-specified age limit: 18 years of age or older (for DED entries).

PA and duration — initial 6 months / renewal 12 months; qty 60 vials/30 days

Prior authorization includes specific duration and quantity limits: initial 6 months and renewal 12 months, with a policy quantity cap of 60 vials per 30 days noted for certain agents.

• Quantity limit: 60 vials per 30 days.
• Initial approval: 6 months; renewal: 12 months.

Policy-specified age limit (18+ for some approvals)

The policy operationally specifies an age limit of 18 years or older for approval in sections addressing certain products, despite manufacturer labeling indicating 12 years and older for some agents.

• Policy age limit: 18 years (stated in multiple chunks for DED/Andembry lines).
• Manufacturer/FDA indication referenced as 12+ in other sections.

PA duration — Andembry: 6 months initial / 12 months renewal

Andembry prior authorization is described with an initial approval duration of 6 months and renewals of 12 months when criteria are met.

• Initial approval: 6 months; renewal: 12 months.
• Apply required eligibility and documentation criteria for approval.

PA requirements — HAE: confirmed diagnosis, prophylactic intent, specialist, no concurrent prophylactics

Prior authorization for HAE therapies requires documented HAE diagnosis, prophylactic intent, specialist prescriber or consultation, and absence of concurrent alternative prophylactic agents.

• Confirm HAE diagnosis with complement testing OR C1‑INH protein and functional tests.
• Document therapy is for prophylactic use and prescribed by or in consultation with an immunologist, hematologist, or HAE specialist.
• Confirm patient is not receiving concurrent prophylactic HAE agents.

PA and limits — HAE agents: 6 months initial, 12 months renewal; qty limits noted

Prior authorization for HAE agents often includes approval durations of 6 months initial and 12 months renewal and a quantity limit of 60 vials per 30 days in policy examples.

• Initial approval: 6 months; renewal: 12 months.
• Quantity limit: 60 vials per 30 days where specified.

PA requirements — confirmatory HAE testing and specialist involvement

Prior authorization requires confirmatory diagnostic testing for HAE (complement testing OR C1 inhibitor protein and functional tests), specialist prescribing/consultation, prophylactic intent, and no concurrent alternative prophylactic agent; approvals are typically 6 months initially and 12 months on renewal.

• Confirmatory testing: complement testing OR C1‑INH protein and functional assays.
• Document prophylactic use and specialist involvement.
• No concurrent prophylactic HAE agents permitted.

PA and approval durations — HAE agents: 6 months initial / 12 months renewal; renewal attestation required

Prior authorization for HAE agents requires the initial criteria (confirmed diagnosis, prophylactic use, specialist prescribing/consultation, no concurrent prophylactic agent, age per package insert) and is granted for 6 months initially with 12‑month renewals.

• Initial approval: 6 months; renewal: 12 months.
• Renewal requires prescriber attestation of improvement compared to baseline.

PA requirements — diagnostic confirmation and prophylactic prescribing

Prior authorization requires diagnosis confirmation for HAE (complement testing or C1 inhibitor protein and functional tests), documentation of prophylactic intent, specialist prescribing/consultation, absence of concurrent alternative prophylactic agents, and that the patient meets package‑insert age requirements.

• Confirm diagnosis via complement testing OR C1‑INH protein and functional tests.
• Document prophylactic intent and specialist involvement.
• Confirm no concurrent prophylactic HAE agents (examples listed).

PA requirements — HAE: confirm diagnosis, specialist, prophylaxis, no concurrent agents

Prior authorization requires documentation of HAE diagnosis, specialist prescribing or consultation, use for prophylaxis, absence of concurrent prophylactic HAE agents, and appropriate patient age; approvals are initial 6 months and renewals 12 months.

• Document confirmatory testing (complement or C1‑INH assays).
• Document specialist prescriber or consult and prophylactic intent.
• Confirm patient is not on concurrent alternative prophylactic agents.

Step therapy — trial/failure ≥3 months of conventional therapy required

Step therapy requires documentation of trial and failure (≥3 months) of at least one conventional therapy (examples include cantharidin, silver nitrate, cryotherapy, curettage) before approval for molluscum contagiosum.

• Record duration and outcome of prior conventional therapy (≥3 months).
• Include which conventional therapy was tried (cantharidin, silver nitrate, cryotherapy, or curettage).

Referenced treatment options — conventional therapies listed

The policy references standard procedural and topical treatment options as alternatives/trials prior to approval, including cantharidin, silver nitrate, cryotherapy, and curettage.

• These options should be documented as prior attempts when applicable.

Alternatives noted — procedures mentioned without explicit sequence

The guideline notes alternative procedures (cryotherapy, curettage) are mentioned as options, but no explicit sequential step‑therapy flow beyond the required trial/failure is provided in the excerpts.

• Document which alternative procedures were attempted if claimed.

Concurrent therapy consideration — no concurrent MC treatment when required

Some recommendation lines specify the patient should not be on concurrent treatment for molluscum contagiosum; prior authorization will require confirmation the patient is not receiving another MC therapy when that condition is part of the decision.

• Document absence of concurrent MC therapy when required by the decision line.

Step therapy — Tryptyr requires prior trials of lubricating drops and preferred agents

For dry eye agent Tryptyr, step therapy requires a trial and failure of preservative‑free, nonprescription lubricating eye drops and at least a 1‑month trial and therapeutic failure/intolerance of two preferred agents documented prior to approval.

• Document trial of preservative‑free artificial tears.
• Document ≥1 month trial and failure/intolerance/allergy/contraindication of two preferred agents.
• Document objective DED sign (CFS ≥2 in any field OR Schirmer 1–10 mm/5 min).

No concurrent prophylactic agents — HAE therapy exclusion

The policy repeatedly excludes concurrent prophylactic HAE agents: the patient must not be on concurrent prophylactic therapies (examples listed) at the time of approval; presence of such agents will preclude approval.

• Examples of excluded concurrent prophylactic agents: Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo.
• Document discontinuation of alternative prophylactic agents prior to approval.

Concurrent prophylactic therapy restriction — HAE agents disallowed concurrently

Concurrent therapy with alternative prophylactic HAE agents is not allowed; requests will be denied if the patient is receiving another prophylactic agent (examples provided) at the time of the request.

• Confirm and document absence of concurrent prophylactic HAE therapy.

Therapy sequencing requirement — no overlapping prophylactic HAE agents

Policy language indicates that concurrent alternative prophylactic agents for HAE preclude approval; no explicit required sequencing is provided, but exclusivity is enforced.

• If prior prophylactic therapy was used, document cessation before starting the requested agent.

Concurrent agent restriction — no overlapping HAE prophylactics at approval

The policy restates that concurrent alternative prophylactic agents for HAE will disqualify the request; approval expects no overlapping prophylactic therapy.

• Document discontinuation of alternative prophylactic agents (examples listed) before approval is considered.

Required documentation — MC diagnosis, specialist involvement, prior trials

Required documentation for molluscum contagiosum requests includes confirmation of the MC diagnosis, specialist (dermatologist) prescribing or consultation, and evidence of prior trial and failure (≥3 months) of one or more conventional therapies.

• Confirm and document MC diagnosis.
• Document dermatologist prescriber or consultation.
• Provide records of prior conventional therapy trials and outcomes (≥3 months).

Required clinical documentation — qualifying condition, no concurrent therapy, age

Clinical documentation must show the patient meets at least one qualifying condition (AD, immunocompromised, or concomitant bacterial infection), confirm absence of concurrent MC treatment, and document that the patient meets the package‑insert minimum age.

• Document which qualifying condition is present (AD OR immunocompromised OR concomitant bacterial infection).
• Document no concurrent MC therapy when required.
• Document patient age per package insert (1 year or older).

Required clinical documentation — specify qualifying condition and eligibility elements

Clinical documentation must explicitly state which qualifying clinical condition the patient meets (atopic dermatitis, immunocompromised status, or concomitant bacterial infection) and confirm other eligibility elements such as no concurrent MC treatment and age per package insert.

• State the qualifying clinical condition and supporting clinical notes.
• Confirm and document no concurrent MC treatment.
• Record patient age consistent with package insert minimum.

Vykat XR required documentation — genetic confirmation & baseline labs

Vykat XR‑specific documentation must include genetic confirmation of Prader‑Willi syndrome (abnormal DNA methylation of chromosome 15q11.2‑q13), baseline fasting plasma glucose and HbA1c, and prescriber attestation of monitoring (FPG/HbA1c and signs/symptoms of edema).

• Provide genetic test confirming PWS (abnormal DNA methylation of 15q11.2‑q13).
• Include baseline FPG and HbA1c and plan/attestation to monitor during treatment.

Tryptyr required documentation — prior trials and objective DED signs

Tryptyr required documentation includes prior trial of preservative‑free nonprescription lubricating eye drops and documentation of at least a 1‑month trial and therapeutic failure/intolerance of two preferred agents, plus objective DED signs.

• Document trial of preservative‑free artificial tears.
• Document ≥1 month trial and failure/intolerance/allergy/contraindication of two preferred agents.
• Document objective sign: CFS ≥2 in any field OR Schirmer 1–10 mm/5 min.

Required clinical documentation — baseline and follow‑up objective DED measures

For dry eye therapies, documentation must show baseline and follow‑up objective measures demonstrating improvement (decrease in corneal fluorescein staining score or increase in Schirmer tear test mm/5 min); age and quantity limits should also be documented.

• Provide baseline and follow‑up CFS or Schirmer measurements.
• Document age and adherence to stated quantity limits.

Required documentation — confirmatory HAE testing and specialist prescribing

Documentation for HAE therapies must confirm diagnosis via complement testing OR C1 inhibitor protein and functional tests, document that therapy is for prophylactic use, and show prescribing by or consultation with an immunologist, hematologist, or other HAE specialist.

• Include complement testing OR C1‑INH protein and functional assay results.
• Document that use is prophylactic.
• Provide evidence of specialist prescribing or documented consultation.

Required diagnostic documentation and renewal attestation — HAE

Required diagnostic documentation for HAE approval is confirmation via complement testing or C1 inhibitor protein and functional tests; renewal requires prescriber attestation of improvement compared to baseline (reduction in attack frequency or severity).

• Submit confirmatory diagnostic test results (complement OR C1‑INH protein/function).
• On renewal, provide prescriber attestation of clinical improvement vs baseline.

Specialist prescribing requirement — HAE prophylaxis must involve HAE specialist

Prescriptions for HAE prophylactic agents must be written by, or in consultation with, an immunologist, hematologist, or other HAE specialist; documentation of that specialist involvement is required for approval.

• Document prescriber specialty or include consultant notes from an HAE specialist.

Denial triggers — missing prior trial/failure or required prescriber documentation

Denial triggers include lack of required prior trial/failure of at least one conventional therapy (≥3 months) or absence of required prescriber/specialist documentation; failure to document qualifying clinical eligibility may also result in denial.

• No record of ≥3 months trial/failure of conventional therapy will risk denial.
• Missing dermatologist prescriber or documented consultation may trigger denial.

Clinical eligibility documentation required — missing elements risk denial

Requests that do not document that the patient meets the clinical eligibility (atopic dermatitis, immunocompromised status, or concomitant bacterial infection), or that the patient is not on concurrent MC treatment, or that the patient meets the package‑insert minimum age, risk denial.

• Missing documentation of qualifying condition (AD, immunocompromised, concomitant bacterial infection) may lead to denial.
• Failure to document no concurrent MC therapy or minimum age per PI risks denial.

Primary clinical criteria missing — absence of qualifying condition or concurrent therapy issues

Primary clinical criteria missing (no documentation of AD, immunocompromised status, or bacterial infection), evidence of concurrent MC treatment, or failure to document minimum age per package insert are all explicit triggers for denial.

• Ensure documentation of the specific qualifying clinical criterion.
• Ensure documentation confirming patient is not on concurrent MC therapy.

Denial risks — concurrent MC treatment or age below PI minimum

Requests may be denied if the patient is on concurrent treatment for molluscum contagiosum or does not meet the package‑insert minimum age (document repeatedly states age limit of 1 year or older).

• Document age per package insert (1 year or older) and confirm no concurrent MC therapy.

Possible denial triggers — age below PI or concurrent MC therapy

Possible denial triggers include patient age below the package‑insert minimum and being on concurrent MC treatment—both are repeatedly noted as conditions that may preclude approval.

• If patient is < package‑insert age or on concurrent MC therapy, approval is unlikely.

Denial triggers — Vykat XR missing genetic confirmation or baseline labs

For Vykat XR, denial triggers include missing genetic confirmation of Prader‑Willi syndrome (abnormal DNA methylation of 15q11.2‑q13), absent baseline fasting plasma glucose and HbA1c, or lack of specialist prescribing/consultation.

• Provide genetic confirmation of PWS and baseline FPG/HbA1c to avoid denial.
• Document specialist involvement (endocrinologist/geneticist) per approval criteria.

Denial triggers — Tryptyr missing prior trials or objective DED signs

For Tryptyr, denial triggers include failure to document required prior treatment trials (preservative‑free artificial tears and two preferred agents with ≥1 month trials) and lack of objective DED signs.

• Document prior trials and objective DED measures (CFS or Schirmer) to meet criteria.
• Failure to show these trials/tests may result in denial.

Triggers for denial — lack of objective DED improvement or age/qty noncompliance

Triggers for denial for dry eye treatments include lack of documented improvement in objective DED signs (no decrease in corneal fluorescein staining score or no increase in Schirmer tear test) or failure to meet age/quantity limits.

• Document objective improvement on follow‑up testing for continued coverage/renewal.
• Adhere to age and quantity limits specified in the policy.

Documentation triggers for denial — missing HAE confirmatory tests or specialist documentation

Documentation triggers for denial include absence of confirmatory HAE testing (complement or C1‑INH protein/function assays) or missing documentation that the drug is prescribed for prophylactic use by/in consultation with an immunologist, hematologist, or other HAE specialist.

• Provide confirmatory test results and specialist prescribing/consultation documentation.
• Failure to document prophylactic intent may result in denial.

Concurrent prophylactic therapy exclusion — listed agents disqualify approval

Concurrent prophylactic therapy exclusion: presence of an alternative prophylactic agent for HAE (examples: Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo) is a disqualifying condition that will preclude approval.

• If patient is receiving any listed alternative prophylactic agent, document discontinuation prior to request or denial will be likely.

Concurrent prophylactic therapy — presence of alternative prophylactics may cause denial

Concurrent prophylactic therapy is a basis for denial: requests may be denied if the patient is on alternative prophylactic agents for HAE (examples provided repeatedly).

• Confirm and document that the patient is not on concurrent prophylactic HAE therapy at time of request.