Prior Authorization, Quantity Limits, Step Therapy — follow PA/ST/QL process

Sharp Health Plan uses common formulary controls: Prior Authorization (PA), Quantity Limits (QL), and Step Therapy (ST). Prescribers must request PA or Step Therapy Exceptions when a drug row is marked with PA, PA**, or ST. PA requests will be approved or denied within 72 hours for non‑urgent requests (24 hours for urgent/exigent).

• Request PA by phone, fax, or electronic PA form and include supporting clinical information.
• If PA/Step Therapy Exception is incomplete, the plan will request missing information within 72 hours (24 hours exigent).
• If Sharp fails to respond within the timelines for a completed request, the request is deemed granted.

PA required for drugs marked 'PA' or 'PA**'

Prior Authorization is required before Sharp Health Plan will cover drugs labeled 'PA' on the formulary; PA** denotes PA if Step Therapy is not met (providers may still request PA when medically necessary).

• Providers must submit PA when a product row shows 'PA' or 'PA**'.
• PA decisions: 72 hours non‑urgent, 24 hours urgent/exigent.

Obtain PA for Brand‑Name or reference biologic when generic/interchangeable available

When a generic equivalent exists, the dispensing pharmacy must dispense the generic unless the prescriber obtains prior authorization for the Brand‑Name; similarly, pharmacies may be required to dispense an interchangeable biologic unless PA for the reference biologic is obtained.

• If requesting the Brand or reference biologic instead of the generic/interchangeable product, submit PA demonstrating medical necessity.
• Failure to obtain PA may result in the pharmacy dispensing the generic/interchangeable product.

PA required to dispense Brand‑Name or reference biologic

Prior authorization is required to dispense Brand‑Name drugs in lieu of an available generic or to receive a reference biologic instead of an interchangeable biological product; pharmacies are required to substitute unless PA is obtained.

• Prescribers seeking Brand or reference biologic must submit PA supporting medical necessity.
• Pharmacy will fill generic/interchangeable if PA not approved.

Amphetamine/stimulant prescriptions: PA, QL, and age documentation

Many amphetamine and stimulant products require prior authorization and are subject to quantity limits; PA is commonly required for members age ≥19 and prescribers must document patient age in PA requests.

• Examples of QL: 360 tabs every 75 days, 180 caps every 75 days, 540 tabs every 75 days for certain methylphenidate formulations.
• PA documentation must include the patient's age when age‑based PA applies (age ≥19).

Opioid ER: Step Therapy prior use requirement

Certain extended‑release opioid (OPIOID ER) products require step therapy: coverage is provided only when the member has prior opioid exposure (cumulative ≥7 days IR within past 90 days OR cumulative ≥30 days ER within past 90 days) or when step criteria are otherwise met.

• If step criteria are not met, prescribers must submit PA/Step Therapy Exception with documentation of prior opioid use per the specified timeframe.
• Opioid ER claims may be denied without prior exposure documentation.

PA required for many listed stimulant and anti‑obesity products

Prior authorization is required for the majority of listed amphetamine, anti‑obesity, ADHD, and related products; review each formulary row and submit PA when the COVERAGE REQUIREMENTS field shows 'PA'.

• Providers should confirm QL and age limits on the product row when submitting PA.
• PA decisions follow standard timelines (72/24 hours).

WAKIX: Specialty pharmacy routing + PA + QL (2 tabs/day)

WAKIX (pitolisant) is designated SP (specialty), requires prior authorization, and is subject to a quantity limit of 2 tablets per day; dispense only via specialty channel unless authorized otherwise.

• Submit PA for WAKIX and ensure specialty pharmacy routing.
• Quantity limit: 2 tabs every 1 day as listed.

Methylphenidate/stimulant PA and QL for adults (age ≥19)

Many methylphenidate formulations require prior authorization for members age ≥19 and are subject to quantity limits; prescribers must include age and supporting information in PA requests.

• QL examples for methylphenidate: 540 tabs/75 days, 270 tabs/75 days, 90 tabs/75 days, and liquid mL limits (e.g., 5400 mL/75 days).
• PA required for members age greater than or equal to 19.

Specialty drugs: SP designation requires specialty routing + PA (+ QL)

Specialty products (SP) require specialty pharmacy routing and prior authorization; many SP products also carry quantity limits and must be dispensed through the plan’s specialty channel (e.g., tobramycin nebulizer solutions, upadacitinib, apremilast).

• Submit PA and follow specialty pharmacy site‑of‑care requirements (30‑day supply limits per specialty policy).
• Include documentation to satisfy QL and SP routing in the PA request.

PA required for many opioid ER/patch/high‑strength formulations

Prior authorization is required for many extended‑release, patch, and high‑strength opioid formulations; high‑strength products are specifically labeled 'High Strength Requires PA' on product rows.

• Prescribers must document prior opioid therapy and clinical justification when requesting PA for high‑strength products.
• Some ER/patch strengths are also subject to step therapy (ST) or PA**.

PA required for buprenorphine/belbuca and other opioid products

Prior authorization (PA or PA**) is required for many opioid and related products including specific strengths of buprenorphine/belbuca patches and films; high‑strength buprenorphine products also require PA.

• BUprenorphine patches/films: check product row for ST/PA/PA** and QL before dispensing.
• Provide documentation of medical necessity for high‑strength buprenorphine products when submitting PA.

Submit PA where the formulary row indicates 'PA'

Medications labeled with 'PA' in the Coverage Requirements and Limits column require prior authorization before coverage; review product rows (examples include testosterone products and others) and submit PA when indicated.

• Examples: methyltestosterone 10 mg and several testosterone gels list PA and MO.
• Follow the PA submission process and include requested supporting documentation.

PA required for select antiarrhythmics (e.g., dofetilide)

Select antiarrhythmic agents (e.g., dofetilide) carry specialty (SP) and prior authorization flags; submit PA and anticipate specialty routing for these agents.

• Dofetilide capsule strengths (125, 250, 500 mcg) require SP and PA.
• Include clinical justification and any site‑of‑care instructions in the PA.

PA required when requests exceed quantity limits or MO notes

Several products include explicit quantity limits (QL) or 'MO' notes; requests that exceed QL or initial supply limits require prior authorization and may be denied if limits are not met.

• Examples: inhalers QL (e.g., 180 inhalations/75 days), methylphenidate QLs, and OTEZLA QL (55 tabs/28 days).
• If requesting quantities beyond QL, submit PA documenting medical necessity.

PA/SP/QL required for vigabatrin (VIGADRONE)

Vigabatrin (powder pack/tab 500 mg; VIGADRONE) is designated SP, requires prior authorization, and is subject to a quantity limit (6 packets/tabs every 1 day); submit PA with specialty routing and documentation.

• VIGADRONE and generic vigabatrin rows: SP, PA, QL (6 packets or tabs every day).
• Specialty PA submission required for coverage.

PA/SP/QL required for zuranolone (ZURZUVAE) caps

Zuranolone (ZURZUVAE) products are designated SP, require prior authorization, and are subject to quantity limits (1–2 caps per day depending on listing); submit PA including specialty routing and requested QL.

• ZURZUVAE 20 mg: SP, PA, QL = 2 caps every 1 day; other ZURZUVAE listing: SP, PA, QL = 1 cap every 1 day.
• Include clinical justification in the PA for zuranolone.

PA and QL requirements for select neuroactive and injectable specialty drugs

Certain neuroactive agents and select specialty products require PA plus QL and specialty routing (e.g., zuranolone, vigabatrin, selected incretin mimetics); submit PA with documentation of indication and requested quantity limits.

• GLP‑1/dual agonists (tirzepatide, semaglutide, dulaglutide) list PA (and often MO); submit PA for these injectable agents.
• Provide required clinical documentation and route to specialty pharmacy when SP is indicated.

PA required for many GLP‑1 receptor agonists and tirzepatide

Many GLP‑1 receptor agonists and tirzepatide products (e.g., MOUNJARO, OZEMPIC, RYBELSUS, TRULICITY) require prior authorization per the formulary listings; submit PA for these incretin mimetic agents.

• Injectable GLP‑1s are often also labeled MO; include documentation if medical override applies.
• Prescribers should follow PA process for all listed GLP‑1/dual agonist strengths.

Step Therapy: follow ST rules and submit exceptions when justified

Formulary contains step therapy rules and class‑specific tables; drugs marked 'ST' require trial of preferred alternatives first and providers may request Step Therapy Exceptions with clinical justification.

• Step Therapy Exception requests follow the PA process and are reviewed within 72 hours (24 hours exigent).
• Continuity of care from a prior insurer may exempt a member from Step Therapy.

Weight‑loss drugs: enrollment in weight‑loss program may be required

Enrollment in a comprehensive weight‑loss program may be required as a Step Therapy requirement prior to or concurrent with coverage of certain weight‑loss drugs when medically necessary for Class III obesity.

• When coverage is provided for Class III obesity, include evidence of enrollment in the weight‑loss program in the PA or Step Therapy Exception request.
• Examples: WEGOVY and phentermine/topiramate products list PA and may require program participation per formulary notes.

Formulary is subject to change — confirm current coverage and PA/ST/QL flags

Document is subject to change and previous versions are no longer in effect; providers should verify current formulary status online (sharphealthplan.com/search-drug-list) to confirm PA/QL/ST requirements before prescribing.

• Sharp will provide 60 days’ notice to members for negative formulary changes.
• Providers should reference the electronic formulary for the most current coverage flags and limits.

Denial risk if PA is not obtained

Failure to obtain required prior authorization when the formulary indicates 'PA' may result in denial of coverage.

• Denials may be appealed; appeal and grievance processes are described in the formulary.
• If PA is denied, the member or provider may file an appeal.

Exclusion categories that can trigger denial — confirm indication

Prescriptions for drugs used for excluded purposes (e.g., cosmetic uses, hair loss, sexual dysfunction, athletic performance, anti‑aging for cosmetic purposes, or non‑covered weight loss) may be denied under the outpatient prescription benefit.

• Exceptions apply when use is medically necessary for diagnosed conditions or required by law.
• Confirm indication in PA submission when coverage for such uses is requested.

Opioid ER step therapy denial risk without documented prior exposure

Opioid ER/ST denials: extended‑release opioid coverage may be denied unless prior opioid exposure criteria are documented (cumulative ≥7 days IR within 90 days OR cumulative ≥30 days ER within 90 days).

• If member lacks prior exposure, consider short‑supply allowance for IR combos (up to a 7‑day supply) where applicable and documented.
• Include dispensing history and dates/quantities in PA to meet step criteria.

Amphetamine PA denial risk for patients age ≥19 — include age in PA

Claims for amphetamine products dispensed to members age ≥19 without prior authorization may be denied; prescribers must document patient age in PA requests.

• Many amphetamine entries explicitly state 'PA Required for age greater than or equal to age 19.'
• Include age and clinical rationale when submitting PA for adult stimulant therapy.

Quantity limits and initial supply limits — PA required if exceeding limits

Requests that exceed listed quantity limits (QL) or initial supply limits (initial 7‑day for adults; 3‑day for age ≤19) may be denied or require PA; prescribers should request PA if larger quantities or longer supplies are clinically necessary.

• Initial supply limits: many immediate‑release opioids subject to 7‑day initial limit; age ≤19 subject to 3‑day initial limit.
• Provide justification for continued supplies beyond initial limits in the PA documentation.

PA/SP requirement for select antiarrhythmics (dofetilide)

Dofetilide and other antiarrhythmics flagged SP/PA require prior authorization and specialty routing; coverage may be denied if PA/SP routing is not followed.

• Dofetilide capsule strengths list SP and PA—submit specialty PA with required clinical information.
• Anticipate specialty site‑of‑care instructions when SP is indicated.

Prescription and PA submission content requirements

Prescriptions must include necessary prescription content (prescriber identity and contact, patient name, drug name, quantity, date, and signature if written); include clinical indication when requested by the enrollee or plan.

• Ensure PA submissions include prescriber contact and relevant clinical documentation to avoid incomplete request processing.
• Incomplete PA/Step Therapy Exception requests will trigger a request for additional information within plan timelines.

How to submit PA and handling of incomplete requests

Prescribers must submit Prior Authorization requests by phone, fax, or electronic form and include supporting clinical documentation; if a request is incomplete, the plan will notify the provider what additional information is needed within 72 hours (24 hours exigent).

• Include clinical history, prior therapies, dates/quantities dispensed, and patient age where relevant (e.g., stimulants, opioids).
• Follow up to ensure PA is completed within the stated decision timeframe.

Pharmacy dispensing rules: generic/interchangeable substitution unless PA obtained

Pharmacy must dispense the generic when a generic equivalent exists unless prior authorization for the Brand‑Name drug is obtained; similarly, pharmacy may be required to dispense an interchangeable biological product unless PA for the reference biologic is obtained.

• If prescriber requires Brand or reference biologic, submit PA showing medical necessity for the non‑preferred product.
• Pharmacies follow substitution rules per formulary unless PA authorizes otherwise.

Documentation expectations for high‑strength opioids and continued supplies

Prescribers should expect to provide specific documentation when requesting PA for high‑strength opioids or continued supplies beyond initial limits, including prior opioid exposure history and clinical justification.

• Document prior opioid fills (dates and days supplied) to satisfy opioid ER step therapy criteria.
• Provide rationale for high‑strength dosing and need for quantities beyond QL in the PA.

PA/SP/QL for vigabatrin and zuranolone — include specialty documentation

PA is required for vigabatrin (powder pack/tab 500 mg, VIGADRONE) and zuranolone (ZURZUVAE) as listed, and these products are designated SP with strict QL; submit specialty PA and include required monitoring/justification.

• Vigabatrin: SP, PA, QL = 6 packets/tabs every day.
• Zuranolone: SP, PA, QL = 1–2 caps per day depending on listing.

Respond to coverage flags (PA, PA**, ST, QL, SP, MO) on product rows

Formulary coverage flags (MO, PA, SP, QL) appear next to product listings; when a product is flagged, providers must supply the documentation appropriate to that flag when requesting coverage.

• MO indicates medical/monitoring/medical‑only conditions — include justification in PA when requested.
• SP requires specialty routing; QL indicates the maximum quantity covered per period.

Ensure prescriptions conform to coverage requirements and QL or submit PA

Prescriptions and PA requests should conform to the listed coverage requirements and quantity limits; nonconforming requests (e.g., quantities above QL, missing PA) can be denied or require PA to override.

• If a request exceeds QL, submit PA with medical necessity for the excess quantity.
• If PA is required per the formulary row, obtain authorization prior to dispensing to avoid denial.