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Formulary prior authorization and step therapy coverage criteria (pharmacy)

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HealthPartners Commercial 2026 formulary document describing prior authorization and step therapy requirements for prescription drugs under the pharmacy benefit; applies to providers prescribing and pharmacies dispensing medications for affected members.

Policy Summary

PayerHealthPartners

PolicyFormulary prior authorization and step therapy coverage criteria (pharmacy)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document required prior trials, allergies/contraindications, or provider attestations per product-specific prior authorization criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+drug entries in this section (A-B range)

multipleentries referencing external PA documents/URLs

commonreserved for allergy/inadequate response

links providedentries link to PA PDFs/web pages

1 yrtypical approval duration example

Coverage Criteria and Product-Level Rules

General PA/Step Therapy criteria (A-B listings)

Common coverage logic applied to many individual drug entries in this chunk:

Standard step therapy/PA conditions: Coverage for many listed products is allowed only when ALL of the following are met: (1) the patient has an inadequate response to one or two preferred alternatives as specified for the product; AND (2) the patient has a documented medical contraindication or documented allergy to preferred/generic alternatives when applicable; AND (3) where referenced, the patient meets detailed criteria in the external PA document URL.see product-specific notes

Some products require documentation of clinical benefit in literature if used despite multiple preferred failures.

General step therapy/reservation criteria

Covered when the specific reservation condition is met for each product

All products reserved for documented allergic reaction: Coverage for listed brand or non-preferred products is reserved for patients with a documented allergic reaction to the equivalent preferred generic or brand, as specified per product.

Policy Summary

PayerHealthPartners

PolicyFormulary prior authorization and step therapy coverage criteria (pharmacy)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document required prior trials, allergies/contraindications, or provider attestations per product-specific prior authorization criteria.

SourceLink

On This Page

documented allergic reaction

applies to multiple entries

All products reserved for inadequate response: Coverage is reserved when patients have had an inadequate response to one or more preferred alternatives; many entries specify 'two preferred alternatives' as the required failures.inadequate response to preferred alternatives

number of alternatives varies by product; often two

Products reserved for FDA-approved indications or specialist prescribing: Certain medications are reserved for FDA-approved indications and/or require prescribing by or consultation with a specialist (e.g., behavioral health prescriber for CAPLYTA, cystic fibrosis center for CAYSTON).FDA-approved indication and specialist involvement

see specific product entries

Opioid attestation

Opioid-specific requirement

Long-acting opioid attestation: Long-acting opioids require provider attestation that therapy is being managed per standard opioid prescribing guidelines and that the patient had an inadequate response to a recent adequate trial (minimum 30 days) with a short-acting opioid.30 days short-acting opioid trial

applies to long-acting opioids such as buprenorphine and butrans

CAYSTON (aztreonam inhalation) criteria

Cystic fibrosis inhaled antibiotic criteria

CAYSTON approval criteria: Aztreonam inhalation (CAYSTON) will be approved for cystic fibrosis patients with documented Pseudomonas aeruginosa, when prescribed and managed by specialists from a cystic fibrosis treatment center, and limited to one 28-day package per month. Initial approvals for 12 months; renewals annually with documentation that the patient has been seen within the last 12 months at the CF center and the medication is effective.one 28-day package per month; initial 12 months

specialty prescribing and CF center follow-up required

General coverage criteria for listed pharmacy products

Products listed are reserved for coverage when one or more of the following product-specific conditions are met

Allergy to preferred/generic: Coverage reserved for patients with a documented allergic reaction to the equivalent generic or preferred alternative as specified per product.

Frequently cited across many entries

Inadequate response to preferred products: Coverage reserved for patients with an inadequate response to one or more preferred products or to two or more preferred products as specified; number of required failures varies by product.1-3 failed preferred products depending on product

Examples include entries requiring two or three failed preferred alternatives

FDA-approved indication: Coverage reserved for FDA-approved indications for some products; others explicitly require FDA-approved uses.

Applies where product listing specifies FDA indication

Agent-specific monitoring/attestation: Certain agents require additional attestation or monitoring documentation (e.g., DALFAMPRIDINE ER requires neurologist prescribing, ambulation attestation, and demonstrated improvement for continuation).initial approval 6 months then annual renewals with improvement documentation

See product-specific entries

General coverage criteria patterns from listed products

Covered when requirements in each product-specific entry are met (examples below represent patterns in this excerpt).

General two-preferred-step requirement: Patient has an FDA-approved indication (if applicable) AND has had inadequate response to two preferred products OR has medical contraindication to the preferred products.two failed preferred products

Many product entries use this exact logic

Allergic reaction exception: Patient has a documented allergic reaction to the equivalent generic or preferred alternative.documented allergic reaction

Several brand products reserved for allergy to generic

Product specific limits: Some products have specific limits or requirements (e.g., DIFICID suspension requires diagnosis of C. difficile and prior inadequate response or contraindication to vancomycin; Diskets long-acting opioids require attestation and 30-day prior short-acting opioid trial).as specified per product

See product entry for details

General coverage conditions (E–G excerpt)

Coverage reserved or subject to prior authorization when ALL of the following typical conditions apply:

Typical PA/Step criteria: Drug is reserved for FDA-approved indications OR patient has inadequate response to preferred alternatives OR patient has medical contraindication to preferred alternatives OR documented allergic reaction to equivalent generic (varies by product).as specified per product

Some products require one preferred alternative; others require two; links provided for drug-specific details.

Gattex coverage conditions

Gattex-specific initial approval and reauthorization conditions:

Gattex initial approval: Adult patients with short bowel syndrome significantly impaired in functional capacity due to chronic parenteral nutrition requirements (e.g., >=4 L daily) who have been dependent on parenteral nutrition for at least one year AND at least three or more days per week.>=1 year dependence; >=3 days/week; sometimes >=4L/day as an example

Initial approvals for 3 months; reauthorizations up to 1 year with documented reduction in parenteral nutrition.

Opioid products

Long-acting fentanyl products:

Long-acting fentanyl PA: Reserved for patients with inadequate response to preferred generic fentanyl patches or with medical contraindications; long-acting opioids require provider attestation of opioid management per guidelines including prior trial (>=30 days) of a short-acting opioid.30 days

Fentanyl citrate reserved for breakthrough cancer pain in opioid-tolerant patients who have tried and failed two preferred products or have medical contraindications.

Reserved / Step Therapy Conditions

Covered only under specific reservation criteria

Reserved for documented allergic reaction to equivalent generic/biosimilar: Coverage reserved when patient has documented allergic reaction to the equivalent generic or biosimilar.documented allergic reaction

appears for multiple products

Reserved after inadequate response to preferred products: Coverage reserved for patients with an inadequate response to one or more preferred products (often two preferred products), or medical contraindication to preferred products.failure of 1-2 preferred products as specified

documentation and literature support may be required

Reserved for FDA-approved indications only: Some products are reserved strictly for FDA-approved indications.FDA-approved indication

used for imaging or specialty products

Gattex (short bowel syndrome) coverage

Gattex (teduglutide) reservation criteria

Gattex: adult short bowel syndrome criteria: Adult patients with short bowel syndrome significantly impaired in functional capacity due to chronic parenteral nutrition requirements (e.g., >= 4L daily) who have been dependent on parenteral nutrition for at least one year and at least three or more days per week.>=1 year dependence; >=3 days/week; sometimes >=4L/day as an example

Initial approvals for 3 months; reauthorization up to 1 year with documented reduction in parenteral nutrition volume; doses up to 5 mg daily approved; other doses case-by-case.

General product coverage qualifiers

Coverage for listed pharmacy products is determined individually; common qualifying conditions include ALL of the following in many entries:

Common qualifiers: (1) Product is for an FDA‑approved indication when required; (2) Patient has had an inadequate response or intolerance to one or more preferred alternatives (often 1 or 2); (3) Patient has a documented allergic reaction to equivalent generic when brand is requested; (4) Documentation of clinical benefit over preferred alternatives may be required for certain products.varies by product

See product-specific linked prior authorization criteria for exact requirements

General Step Therapy / Prior Authorization Criteria (L–M list excerpt)

Covered when ALL of the following are met (general/recurring rules in this excerpt):

GeneralStepTherapy: Member has tried and had an inadequate response to one or two preferred alternatives as specified for the product, or has documented medical contraindication to preferred alternatives.failure of 1-2 preferred products

Many entries specify two preferred alternatives; some specify one.

FDAApprovedIndication: Use is for an FDA‑approved indication when specified by the product listing.NA

Some specialty agents are limited to FDA‑approved indications or clinical trial criteria.

DocumentationRequired: Provider must submit clinical rationale and documentation of prior therapy failures or contraindications, and supporting literature when superiority over preferred alternatives is claimed.NA

Used for select products per listings.

General Step Therapy / Prior Authorization

Covered when product-specific step therapy or PA criteria are met

General step/PA requirements: For many listed products coverage is reserved for: (1) FDA-approved indications OR (2) documented inadequate response to two preferred alternatives (three for some NSAIDs) OR (3) documented allergic reaction/contraindication to equivalent preferred generics.two preferred alternatives (commonly)

Specific products vary; see individual entry or referenced PA document

Opioid-specific criteria

Specific opioid-related criteria

Long-acting opioid attest: Long-acting opioids require a provider attestation that therapy is being managed per standard opioid prescribing guidelines AND reserving for patients with an inadequate response to a recent adequate trial (minimum 30 days continuous) with a short-acting opioid.minimum 30 days

Applies to methadone formulations, morphine ER formulations, MS Contin, and other long-acting opioids referenced.

Nexletol / Nexlizet criteria

Lipid-lowering agents (Nexletol/Nexlizet)

Nexletol/Nexlizet coverage: Reserved for FDA-approved indications AND inadequate response to standard therapy (high-intensity statins) with LDL >= 70 mg/dL OR medical contraindication to statins, AND inadequate response to ezetimibe or documented allergy/contraindication to ezetimibe. Approvals given for one year; reauthorization requires reduction in LDL per provider attestation.LDL >= 70 mg/dL

Reauthorization: documentation of LDL reduction per provider attestation.

Testosterone therapy criteria

Testosterone products (e.g., Methitest, Methyltestosterone, Natesto)

Testosterone product coverage: Reserved for patients with: (1) FDA-approved indication with documented testosterone deficiency <300 ng/dL and inadequate response or contraindications to two or more preferred alternatives; OR (2) diagnosis of gender dysphoria per plan benefits with inadequate response or contraindications to two or more preferred products.< 300 ng/dL

Applies to Methitest, Methyltestosterone, Natesto and similar entries.

Nexlizet — Initial Therapy

Nexlizet coverage is allowed when ALL of the following are met

Nexlizet initial approval criteria: 1) FDA-approved indication; 2) inadequate response to standard therapy (high-intensity statins) or documented contraindication to statins; 3) inadequate response to ezetimibe or allergy/contraindication to ezetimibeLDL >= 70 mg/dL

Approvals are given for one year; re-authorization requires provider attestation of LDL reduction.

Nuzyra — Initial Therapy

Nuzyra coverage requires ALL of the following

Nuzyra initial criteria: 1) FDA-approved indication; 2) prescribed by or in consultation with Infectious Disease providers; 3) inadequate response to standard treatments, or medical contraindication to them; culture and sensitivity results required

Standard treatments include quinolones for CAP and linezolid for ABSSSI.

Nuplazid — Time-limited approval

NUPLAZID coverage (example of time-limited approval)

Nuplazid initial and continuation: 1) FDA-approved indication for Parkinson's disease psychosis; 2) frequent psychotic symptoms severe enough to warrant antipsychotic therapy

Initial approvals for 3 months; continued coverage up to 12 months requires medical chart documentation of improvement.

General product coverage criteria (O–P segment)

Covered when ALL of the following generalized conditions are met (applies per listed product unless a specific product URL indicates alternate criteria):

General PA/ST conditions: 1) Drug is prescribed for an FDA‑approved indication; AND 2) Member has had an inadequate response to two preferred alternatives, or documented medical contraindication to those alternatives, or documented allergic reaction to equivalent generic when specified; AND 3) For certain specialty products, provider must submit supporting documentation or follow specific PA forms linked by URL; AND 4) For long‑acting opioids, provider attestation of management per opioid guidelines and prior 30‑day short‑acting opioid trial when required.two failed preferred alternatives (commonly)

Individual products may have product‑specific modifications; see product URL when provided.

PEGASYS (peginterferon) coverage

Covered when ALL of the following are met for PEGASYS (example):

PEGASYS coverage: (1) Prescribed by gastroenterology, hepatology, or infectious disease specialist; AND (2) Treatment of hepatitis B or C; AND (3) If for HCV: documentation of genotype and viral load; AND (4) documentation of intolerance to or adverse effects from prior Peg‑Intron; AND (5) use in combination with specified agents for regimens meeting HealthPartners criteria.Hepatitis B up to 48 weeks; HCV genotype 1 up to 48 weeks; genotypes 2/3 up to 24 weeks

Duration limits specified in document.

General Step Therapy / Prior Authorization Criteria

Covered when ALL of the following are met (applies per-product as specified):

General ST/PA logic: (1) The request is for a listed product; AND (2) Patient has inadequate response or intolerance to specified preferred alternatives OR has a documented allergic reaction to the equivalent generic/biosimilar OR the use is for an FDA‑approved indication when specified; AND (3) Product-specific documentation or specialty center follow-up provided when required.

Applies variably per product; see product-specific PA PDFs where linked

Common coverage criteria patterns (R–S segment)

Coverage/authorization conditions captured in this segment (by repeated patterns):

FDA indication with step/failure requirement: Coverage reserved for FDA-approved indications and typically requires inadequate response to one or two preferred alternatives or medical contraindication to preferred alternatives.failure of 1-2 preferred alternatives

Many entries state 'inadequate response to two preferred alternatives' or similar.

Allergy to generic: Coverage reserved for patients with a documented allergic reaction to the equivalent generic.documented allergic reaction

Numerous branded products list this as the criterion.

Specialty prescribing or consultation: Some products require prescribing by or consultation with a specialist (e.g., infectious disease for Sirturo, behavioral health for Secuado).specialty prescriber

Explicit in several entries.

Product-specific prior authorization via external criteria: Several entries direct to HealthPartners prior authorization PDFs/links for full criteria.see linked PA document

Links provided for multiple products.

Initial approval durations for select agents: Certain long-acting or specialty agents have specified initial approval periods (e.g., Signifor initial 3 months, Signifor LAR initial 6 months, Somatuline Depot initial 6 months) with annual renewals for responders.initial approvals 3-6 months

Specified in the text.

General reservation and step therapy conditions (excerpt)

Coverage/reservation rules summarized for listed products

Reservation reasons: Products in this excerpt are reserved for one or more of the following: documented allergic reaction to equivalent generic, inadequate response to one or two preferred alternatives or dosage forms, medical contraindication to preferred products, or FDA-approved indications with additional criteria.

Examples across entries specify 1 or 2 failed alternatives or intolerance/allergy; some require documentation in literature for superiority.

Tobramycin (inhalation) initial and renewal criteria

Tobramycin inhalation products — specific criteria

Tobramycin inhalation initial approval: Coverage reserved for cystic fibrosis patients known to have Pseudomonas aeruginosa in the lungs AND prescribed and managed by specialists from a cystic fibrosis treatment center AND quantity up to one 56-count carton per 56 days. Initial approvals provided for 12 months; renewals annually with documentation of CF center visit and effectiveness.quantity <= 56-count per 56 days; initial 12 months; annual renewals

Specialty center management and documentation required

Tramadol coverage criteria and opioid stewardship requirements

Tramadol products — coverage conditions

Tramadol ER: Requires provider attestation that opioid therapy is managed per standard opioid prescribing guidelines and that patient had an adequate recent trial (minimum 30 days continuous) with a short-acting opioid; age limits apply (reserved for adults and children 12 years and older for some forms). IR opioids new users limited to a 7-day supply first fill and 14-day total per episode without PA; longer therapy requires prior authorization.short-acting opioid trial >= 30 days for long-acting opioids; IR new user limits 7/14 days

Quantity and age edits apply

Some products in this formulary are listed as not medically necessary when there is insufficient evidence that they are superior to less costly alternatives. Examples cited in the policy include AGAMREE and other agents where the document states the product will be considered not medically necessary absent demonstration of clinical benefit over preferred options.

Many entries are reserved for FDA‑approved indications; off‑label uses are not covered unless an external prior authorization document explicitly permits them. Several product lines explicitly state coverage is limited to FDA‑approved uses and require the patient meet those indication criteria.

For some non‑preferred or branded products, coverage requires supporting evidence from the medical literature that the product provides clinical benefit over preferred alternatives. The policy specifies that documentation of superiority in the literature may be required before coverage will be granted.

DEFLAZACORT (generic) is identified in the formulary as not medically necessary because the policy states there is insufficient evidence to show superiority to much less costly alternatives. Brand formulations are reserved only when a member has a documented allergic reaction to the equivalent generic.

EMFLAZA (brand deflazacort) is treated similarly to other deflazacort brands: the policy indicates it will be considered not medically necessary when no documented allergic reaction to the generic exists and when evidence of superiority is lacking. Brand coverage is limited to patients with documented allergy to the generic equivalent.

Certain fentanyl formulations are reserved specifically for breakthrough cancer pain in opioid‑tolerant patients. Long‑acting fentanyl products require a provider attestation that opioid therapy is managed per standard opioid prescribing guidelines and that the patient had an inadequate response to a recent adequate trial (minimum 30 days) of a short‑acting opioid.

The policy does not present broad categorical exclusions. Instead, many products are reserved to limited scenarios — for example, coverage only for FDA‑approved indications, only after failure of preferred alternatives, or only when the member has a documented allergic reaction to an equivalent generic or biosimilar.

JAYTHARI (a deflazacort brand) is listed as not medically necessary in the absence of evidence showing superiority to much less costly alternatives; like other deflazacort brands, JAYTHARI is reserved only for patients with a documented allergic reaction to the equivalent generic.

Across many product entries, branded or non‑preferred products are reserved for patients with a documented allergic reaction to the equivalent generic or for members who have failed required preferred alternatives. These allergy‑ or failure‑based restrictions are recurrent in the formulary.

Multiple products are explicitly reserved for FDA‑approved indications or require documentation of prior trials (often one or two preferred alternatives) before coverage. Some entries also require laboratory thresholds or specialist involvement as part of the approval criteria.

The policy contains specific directives to discontinue certain products: for example, clinicians are instructed to stop prescribing Ocaliva and to contact patients regarding stopping and starting other treatments per the Primary Biliary Cholangitis policy; similarly, the document states that health care professionals should stop prescribing Oxbryta.

Oxbryta is included in the policy with an explicit directive that health care professionals should stop prescribing the product; the formulary notes patients and caregivers should contact their provider about discontinuation and alternative options.

Relyvrio is not eligible for coverage through HealthPartners as of 4/4/2024 because the product has been withdrawn from the market; the formulary explicitly states coverage ineligibility effective that date.

Certain products require involvement of a specialty clinician or prior therapies before coverage will be considered. Examples include psychiatric agents that must be prescribed by or in consultation with a behavioral health provider (e.g., CAPLYTA, SECUADO) and inhaled antibiotics/specialty pulmonary agents that must be prescribed and managed by a cystic fibrosis treatment center (e.g., CAYSTON, PULMOZYME).

There is no single, explicit complete‑list of exclusions in this excerpt. Instead, many entries limit coverage by reserving products to specific circumstances (FDA‑approved indications, documented allergy to generics, failure of preferred alternatives) or by directing prescribers to separate prior authorization documents for full criteria.

AGAMREE is specifically noted in the policy as being not medically necessary because there is insufficient evidence to demonstrate superiority to less costly alternatives; the formulary lists AGAMREE among items where noncoverage is cited for lack of supporting comparative evidence.

Long‑acting opioid coverage typically requires provider attestation that therapy is managed according to standard opioid prescribing guidelines and documentation that the patient had an adequate recent trial of a short‑acting opioid (minimum 30 days continuous use). Without the attestation and trial documentation, requests for long‑acting opioids may be denied.

DEFLAZACORT is identified in multiple entries as not medically necessary absent evidence of superiority to less costly alternatives; brand products are reserved only for documented allergy to the equivalent generic.

EMFLAZA (brand deflazacort) is again noted as being considered not medically necessary when no documented allergic reaction to the generic exists; the formulary repeats the requirement that brands be reserved for documented allergies to generics.

JAYTHARI (deflazacort brand) is called out as not medically necessary absent evidence of superiority to less costly alternatives; the brand is reserved for patients with documented allergy to the generic equivalent.

KYMBEE (a deflazacort brand) is listed as not medically necessary when evidence of superiority to less costly alternatives is lacking; consistent with other deflazacort brand entries, the brand is reserved for patients with a documented allergic reaction to the generic equivalent.

Branded products throughout the formulary are commonly reserved for use only when a patient has a documented allergic reaction to the equivalent generic or biosimilar, or when required prior trials of preferred alternatives have failed. These allergy/failure exceptions are used to limit branded product coverage.

Products that lack documentation of clinical benefit over preferred alternatives may not meet coverage criteria. The policy states that for some items, medical literature demonstrating superiority or added clinical benefit is required before approval will be granted.

PYQUVI (a deflazacort product reference) is noted in the formulary as being considered not medically necessary when there is insufficient evidence of superiority to less costly alternatives; brand coverage is limited to documented allergy to the generic equivalent.

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for many products listed on the HealthPartners drug list. Providers must request prior authorization (PA) when prescribing these non‑preferred, specialty, long‑acting opioids, age/quantity edited agents, or products with product‑specific PA criteria. See the HealthPartners Drug List and the plan's PA pages for the current list of products requiring PA.

Refer to the HealthPartners online Drug List and individual drug PA documents for product‑specific requirements and forms.
PA may be required for non‑preferred brand products, specialty drugs, and many products listed alphabetically in the formulary.

Prior Authorization

Prior Authorization — General Requirement and External References

Some products have general prior authorization rules applying across multiple agents: PA is required when a) the requested product is non‑preferred or specialty, b) the member has not tried required preferred alternatives (step therapy), or c) the clinical situation meets a product‑specific exception such as documented allergy or contraindication. External PA documentation or separate product policy PDFs are referenced where noted.

Common external PA documents and specialty PDFs are linked from the formulary (e.g., CFTR modulators, biologic or infusion agent PDFs).
When a product page links to a separate PA document, follow the steps and documentation instructions in that referenced document.

Prior Authorization

DIFICID-Specific Prior Authorization

DIFICID (fidaxomicin) has specific PA rules: the oral suspension/tablet forms are reserved for patients with a diagnosis of Clostridioides difficile infection and evidence of inadequate response or medical contraindication to one or more courses of oral vancomycin. Approvals are limited to a 10‑day course for the suspension; tablet requests follow allergy/generic rules when applicable.

DIFICID Suspension: diagnosis of C. difficile infection AND inadequate response or contraindication to ≥1 course of vancomycin; approvals limited to 10 days.
DIFICID Tablet: reserved for patients with documented allergy to equivalent generic where noted.

Documentation Required

Long‑Acting Opioid Prior Authorization Attestation

Long‑acting opioids and certain ER opioid products require a provider attestation. The attestation confirms that opioid therapy is being managed per standard opioid prescribing guidelines and that the patient had an inadequate response to a recent adequate trial (minimum 30 days of continuous use) with a short‑acting opioid when required by the policy.

Provider attestation must state therapy is managed per standard opioid prescribing guidelines.
Attestation must document an inadequate response to a recent adequate short‑acting opioid trial (minimum 30 continuous days) when required.
This attestation requirement appears on multiple long‑acting opioid agents (e.g., fentanyl patches, methadone, morphine ER, oxycontin, tapentadol ER, etc.).

Prior Authorization

Refer to Drug‑Specific PA Documents

Refer to the drug‑specific PA documents linked from the formulary for detailed criteria, required supporting clinical documentation, and any quantity/age edits. Many agents (specialty medications, biologics, infused therapies) have separate PDFs that outline initial approval and reauthorization documentation and timeframes.

Follow the product‑specific link(s) on the formulary entry to access the PA criteria PDF when available.
Product PDFs specify initial approval durations, reauthorization requirements, and clinic/specialist documentation expectations (e.g., Gattex, CFTR modulators).

Prior Authorization

Prior Authorization — Common Rule

A common PA rule across many entries: reserved use when a) the request is for FDA‑approved indications, and b) the patient has had inadequate response to a set number of preferred alternatives OR has documented contraindications/allergy. Documentation of prior trials or contraindications is required for coverage determination.

Many entries require failure of two preferred alternatives before approval; others require failure of one preferred alternative depending on drug/class.
When documentation of superiority is claimed, literature support may be requested.

Prior Authorization

Prior Authorization via Referenced Documents

Some formulary entries reference prior authorization via a separate referenced document or specialty criteria set. When an entry points to a referenced document, the referenced document governs the PA process and required documentation.

Examples include specialty coverage PDFs for immune thrombocytopenia, CFTR modulators, interleukin inhibitors, and infusion/biologic administration policies.
If the formulary entry links to an external PA PDF, submit documentation per that PDF.

Documentation Required

External Prior Authorization Documentation Referenced

External PA documentation and specialty PDFs are commonly referenced for complex products. Providers should include the specified clinical notes, test results, or specialist attestation indicated by those external documents when submitting PA requests.

External documents may require lab values, viral/genotype data, culture and sensitivity results, or specialty clinic visit notes.
Specialty drug PDFs often list initial approval lengths and reauthorization expectations (e.g., Gattex reauthorization documentation).

Note

Coverage Ineligibility/Market Withdrawal Notices

Coverage ineligibility: some products are specifically noted as not eligible for coverage or withdrawn from the market. Check the formulary entry for coverage status; for example, Relyvrio is listed as not eligible for coverage and withdrawn from the market as of 4/4/2024.

Relyvrio — not eligible for coverage through HealthPartners and withdrawn from the market (effective 4/4/2024).
Ocaliva and Oxbryta entries include plan‑level safety/coverage advisories—follow linked policy for more information.

Billing Rule

Tramadol Prior Authorization, Quantity, and Age Edits

Tramadol ER and some tramadol combinations require prior authorization with provider attestation and are subject to quantity and age edits. Short‑acting tramadol/IR opioid edits restrict new users to limited first‑fill days supply; longer therapy requires PA with attestation.

Tramadol ER: provider attestation required that therapy is managed per standard opioid prescribing guidelines and documents an inadequate trial of tramadol IR (≥30 days) when required.
Tramadol age edits: reserved for adults and children ≥12 years; IR opioid new‑user limits (first fill 7 days; episode 14 days) — longer therapy requires PA.

Step Therapy

Step Therapy — Required Trials and Denial Risk

Step therapy requires failure of preferred alternatives or documented contraindication/allergy. If step therapy criteria (required prior trials or contraindication) are not met, PA will be denied. Providers must document prior trials, dates, reasons for failure, or contraindications.

Document the specific preferred products tried, duration, clinical response, and reason for discontinuation or failure.
Denials commonly occur when step therapy failure requirements or documented contraindications are not supplied.

Documentation Required

Gattex Reauthorization Requirement

Gattex (teduglutide) has defined reauthorization requirements: initial approvals for a limited duration (e.g., three months) with reauthorization provided for up to a year when clinical response is documented and parenteral nutrition volume reduction is shown. Submit documentation of parenteral nutrition dependence and volume changes per the Gattex PA PDF.

Initial approval: short duration (example: three months) for patients meeting criteria (dependent on parenteral nutrition).
Reauthorization: up to one year with documentation of reduced parenteral nutrition volume per provider attestation and clinical notes.

Documentation Required

Opioid Attestation and Prior Trial Requirement

Opioid attestation and prior short‑acting opioid trial requirements apply broadly to long‑acting opioid approvals. Providers must attest that long‑acting therapy is being managed per guidelines and document a sufficient short‑acting opioid trial when required.

Attestation must reference guideline‑based opioid management and prior trial of short‑acting opioid (minimum 30 days continuous use) when requested by policy.
This requirement is repeated across many long‑acting opioid entries (e.g., fentanyl, morphine ER, oxycodone ER, methadone, tapentadol ER).

Documentation Required

Clinical Benefit and Response Documentation Required

Clinical benefit and response documentation are necessary for many specialty agents and reauthorizations. Providers should submit objective clinical measures, lab results, imaging, chart notes, or validated scoring to support continued use or superiority claims versus preferred agents.

Examples: CFTR modulators, biologics, and enzymes often require specialist visit notes and objective response measures (e.g., reduced PN volume for Gattex, CF center visits for inhaled tobramycin).
When requesting brand products due to claimed superiority, provide literature support documenting improved outcomes versus preferred alternatives.

Denial Risk

Denial Triggers — Missing Required Justification

Failure to meet step‑therapy failure requirements, missing prior trials, absent attestation, or insufficient clinical documentation are frequent denial triggers. Ensure the PA submission contains all required elements from the formulary entry or referenced PA PDF to avoid denial.

Common denial triggers include: missing documentation of prior trial durations, no provider attestation when required (e.g., long‑acting opioids), lack of lab or specialist documentation requested by the product PDF.
If documentation is incomplete, the request may be denied or returned for additional information, delaying therapy.

Documentation Required

Required Documentation for Prior Authorization

Required documentation for PA varies by product but generally includes medical history, prior medication trials (drug names, doses, dates, reasons for failure), relevant labs or imaging, and specialist notes when indicated.

Submit prior trial details (drug, dose, start/stop dates, reason for discontinuation) and clinical rationale for prescribing the requested product.
Include supporting test results (e.g., culture/sensitivity, LDL levels for lipid agents, viral genotype/viral load for hepatitis agents) when requested.

Documentation Required

Required Documentation for Select Agents

Some select agents have specific documentation templates or stricter documentation requirements (examples include DALFAMPRIDINE ER, tobramycin inhalation products, PULMOZYME, and certain specialty biologics). Follow the product‑specific PA PDF for the exact documentation required.

DALFAMPRIDINE ER: neurologist attestation, walking ability documentation, physician attestation of difficulty walking, and dosing limits.
Tobramycin inhalation products: CF center specialist prescribing and annual CF center visit documentation for renewals.
PULMOZYME: specialty follow‑up documentation and annual CF center visit notes for renewals.

Documentation Required

Literature Support for Superiority Claims

When requesting a product based on claimed superiority over preferred alternatives, provide literature support. The plan may request published evidence or clinical trial data demonstrating superiority to justify coverage of non‑preferred or reserved products.

Provide peer‑reviewed literature, clinical studies, or evidence demonstrating clinical benefit over preferred therapies when the formulary requests such support.
Lack of literature support may result in denial if the product is reserved pending documented superiority.

Documentation Required

Specialty Follow‑Up and Chart Documentation Examples

Specialty and clinical response documentation examples include pulmonary specialist notes for inhaled antibiotics, chart documentation for behavioral health agents (example: Secuado), and specialist attestation for enzyme or infusion therapies. Ensure chart notes explicitly document prior stability, adverse effects, or reasons for switching therapies as required.

Secuado: chart documentation stating prior stability on asenapine sublingual tablets and specific adverse effect (mouth sores) required.
Pulmozyme and inhaled tobramycin: CF specialist prescribing and documentation of effectiveness plus annual CF center visit notes for renewals.
Enzyme/infusion agents: infusion center or specialty clinic notes and relevant lab/imaging results as requested in product PA PDFs.

Step Therapy

Step Therapy — Summaries and Reserved‑Use Rules

Step therapy summaries and reserved‑use rules: many formulary entries specify the number of preferred alternatives required to be tried (commonly one or two) or reserved use only (e.g., documented allergy to generics). Review the specific product entry for exact step counts, reserved‑use language, and any age or dosage form restrictions.

Some entries: 'Reserved for patients with a documented allergic reaction to the equivalent generic.'
Others: 'Reserved for patients with an inadequate response to two preferred alternatives' or 'Reserved for patients with an inadequate response to one preferred alternative.'

Step Therapy

Step Therapy — Failure/Reserved Rules and Exceptions

Step therapy failure/reserved rules and exceptions: if a patient has a contraindication, allergy, or lacks access to preferred therapies, document the exception clearly. Provider statement or chart notes should explain the medical necessity for bypassing step therapy.

Document medical contraindications, allergies, or clinical rationale for bypassing step requirements.
Provide specialist support when requested (e.g., cardiology for Multaq, gastroenterology for PEGASYS, CF center for CF products).

Definitions and Key Terms

Step Therapy (ST) definition

DefinitionA utilization management process requiring patients to try one or more specified formulary-preferred alternatives first; coverage of the non-preferred agent is allowed only after documentation of trial and inadequate response (or documented contraindication/allergy) to the required preferred product(s).

Typical requirementNumber of required prior trials varies by product (commonly one or two preferred alternatives; sometimes three).

ExceptionsExceptions to step therapy include documented medical contraindication or documented allergic reaction to the preferred alternative(s).

Prior Authorization (PA) definition

DefinitionA payer requirement that certain medicines meet HealthPartners' prior authorization criteria before being covered under the pharmacy benefit; providers must submit required clinical documentation for approval.

Where to find detailsMany drug-specific PA criteria are provided via HealthPartners prior authorization PDFs or web links referenced in the formulary entries.

Denial riskCoverage may be denied if PA criteria are not met or required documentation (e.g., prior trials, contraindications) is not provided.

Preferred alternative definition

DefinitionA formulary-preferred product that must be tried and shown to provide inadequate clinical benefit (or be contraindicated/allergic) before coverage of a non-preferred product is approved.

Role in step therapyPreferred alternatives are the required earlier-step medications whose failure or intolerance justifies approval of the requested non-preferred agent.

DocumentationRequests must document trials and inadequate response to the specified preferred alternatives, per product-specific rules.

Reserved definition

Definition'Reserved' indicates coverage is limited to specific circumstances (for example: documented allergic reaction to the equivalent generic, inadequate response to preferred alternatives, specialist-prescribed indications, or FDA‑approved indications only).

ImplicationWhen an agent is labeled 'Reserved' the PA will only be approved if the member meets the stated reservation condition(s).

Common reservation reasonsAllergy to generic, inadequate response to preferred alternatives, or FDA‑approved indication per product listing.

What's Step Therapy (ST)? short label

Short labelStep Therapy (ST)

PurposeRequires trying specified preferred medicines first before covering non-preferred agents.

OutcomeNon-preferred drug covered only after documented failure/intolerance or contraindication to required preferred alternatives.

Step Therapy (ST) definition variant

Definition variantA utilization management tool where patients must try and fail preferred therapies (or have documented contraindication/allergy) before coverage of a non-preferred product is authorized.

Variation by productNumber of required failed preferred therapies varies by product (one, two, or three as specified).

DocumentationProvider must submit clinical rationale and evidence of prior trials or contraindication per product-specific PA rules.

Inadequate response definition

DefinitionImplied requirement that prior trials of preferred products failed to provide sufficient clinical benefit; specific duration or objective measure of failure may be specified by product (e.g., laboratory values, symptom persistence).

Common measureFor some products (e.g., lipid therapies) inadequate response may be defined by lab thresholds (see product-specific rules).

Documentation neededProvider must document prior trials and reason(s) for considering them inadequate in PA submission.

Documented allergic reaction / medical contraindication definition

DefinitionProvider-documented evidence that the patient cannot use the preferred generic or dosage form due to an allergic reaction or medical contraindication, qualifying them for an alternative under PA/step therapy rules.

Acceptable documentationClinical notes describing the allergic reaction or contraindication and reason the preferred alternative is inappropriate.

Effect on step therapyA documented allergic reaction or contraindication often waives the requirement to trial the preferred product(s).

Reserved for FDA-approved indications

DefinitionCoverage limited to FDA‑approved indications; off‑label uses are generally not covered unless a specific PA document allows otherwise.

Implication for PAWhen a product is reserved for FDA‑approved indications, PA will be approved only for those indications and with required supporting documentation.

ReferenceSome product entries point to external PA documents for full indication and documentation requirements.

Inadequate response to preferred alternatives

DefinitionPatient has failed or had insufficient clinical benefit from one or more formulary-preferred agents before approval of the listed product; commonly requires failure of two preferred alternatives as specified by product.

DocumentationPA requests must include documentation of prior therapies and clinical rationale for failure or intolerance.

Variable numeric requirementNumber of required failed alternatives varies by product — often one or two, sometimes three for certain drug classes.

Step Therapy (ST) definition repeat

Definition (repeat)A utilization management process requiring patients to try specified preferred alternatives before coverage of a non-preferred product; approval contingent on documented inadequate response or valid exception (allergy/contraindication).

Common consequenceFailure to meet step therapy requirements may result in denial of coverage.

Where specifiedDrug-specific step therapy rules and linked PA documents provide exact required steps per product.

Step Therapy (ST) definition repeat

Definition (repeat)Step therapy is a formulary management approach requiring trial and inadequate response to preferred alternatives or documentation of contraindication/allergy before a non-preferred product is covered; initial approvals often limited in duration (e.g., 3–6 months) with renewals for responders.

Typical initial durationSome approvals are initially time-limited (examples: 3 months for certain agents; 6 months for others) with annual renewals for responders.

Provider actionSubmit prior therapy history and clinical rationale per product-specific PA criteria.

inadequate response (Nexlizet example)

Inadequate response (Nexlizet example)For Nexlizet inadequate response is defined as LDL cholesterol level >= 70 mg/dL despite standard therapy (high-intensity statin) or when statins are contraindicated, and inadequate response to ezetimibe if required.

Approval detailsNexlizet approvals are given for one year; reauthorization requires provider attestation of LDL reduction.

Prior therapiesRequires trial (or contraindication) to high-intensity statin and inadequate response or contraindication to ezetimibe per product criteria.

provider attestation (definition)

Provider attestation (definition)A provider statement documenting clinical findings or outcomes (for example, LDL reduction) or that therapy is being managed according to specified guidelines; used to support re-authorization or PA requests.

UsesRequired for reauthorization for some agents (e.g., LDL reduction attestation for Nexlizet) and attestation of opioid-management for long-acting opioids.

DocumentationAttestation should be included in the PA request or patient chart per product-specific instructions.

Long-acting opioid attestation (definition)

DefinitionA provider attestation specific to long-acting opioid requests stating that opioid therapy is being managed according to standard opioid prescribing guidelines and that the patient had an inadequate response to a recent adequate trial (minimum 30 days continuous) of a short-acting opioid.

When requiredApplies to long-acting opioids (e.g., methadone formulations, morphine ER, fentanyl patches) as specified in PA rules.

Denial riskLack of required attestation or documentation of prior short-acting opioid trial may result in denial of PA.

Reserved for patients with an inadequate response (definition)

Definition'Reserved for patients with an inadequate response' means coverage is limited to members who have failed one or more preferred alternatives as specified by the product listing.

Typical requirementMany entries require documented failure of one or two preferred products before approving the reserved product.

DocumentationProviders must supply prior therapy history showing inadequate response per PA instructions.

Reserved for patients with a documented allergic reaction (definition)

Definition'Reserved for patients with a documented allergic reaction' indicates coverage for branded or non-preferred products only when the member has a documented allergy to the equivalent generic or preferred product.

Documentation standardClinical documentation of the allergic reaction must be provided to justify coverage of the non-preferred product.

Effect on step therapyThis condition commonly waives step-therapy trial requirements for the preferred product when documented.

Reserved for FDA-approved indications (definition repeat)

Definition (repeat)Coverage limited to FDA‑approved indications; when specified, PA is approved only for those FDA‑labeled uses and with required supporting documentation.

Common applicationOften applied to specialty agents or where clinical evidence for off‑label use is insufficient.

Provider guidanceRefer to linked PA documents for product‑specific indication requirements.

Reserved for patients with a documented allergic reaction to the equivalent generic (definition repeat)

Definition (repeat)Coverage is allowed only when there is a documented allergy to the generic equivalent; the branded or non-preferred product is covered as an exception to formulary preference.

Required evidenceProvider must document the allergic reaction to the generic in the PA request or chart notes.

Common useFrequently cited reason for reserving brand-name coverage across multiple product listings.

Treatment failure (CF inhaled antibiotics definition)

DefinitionTreatment failure in cystic fibrosis inhaled antibiotics implies ongoing Pseudomonas aeruginosa infection requiring inhaled tobramycin therapy, with management by a CF treatment center and documented clinical benefit.

DocumentationPA for inhaled tobramycin requires evidence of Pseudomonas aeruginosa in the lungs and specialist management documentation.

Quantity/renewalInitial approvals for 12 months with annual renewals requiring documentation of CF center follow-up and effectiveness.

IR Opioid new user limit definition

DefinitionFor new users of immediate‑release (IR) opioids, initial fills are limited to a 7‑day supply for the first fill and a total of 14 days per episode without prior authorization; longer therapy requires PA and provider attestation per opioid stewardship rules.

Applies toTramadol IR and other immediate‑release opioids for new users as specified in PA listings.

Provider actionLonger therapy requires prior authorization with provider attestation that opioid therapy is managed per standard prescribing guidelines.

Initial Therapy — Requirements for Initial Authorization

Initial therapy conditions (general)

Initial approval commonly requires trials of preferred products

Initial PA conditions: Patient has tried and had inadequate response to required number of preferred alternatives or has documented contraindication/allergy to preferred/generic alternatives; product used within FDA-approved dosing/indication or per external PA document.1-2 failed preferred products (commonly 2)

Specific products may have different numeric requirements as noted per product.

Initial therapy rules

Initial authorization often requires trials of preferred agents

Trials required: Many products are reserved pending trials of preferred alternatives; the number of required failed trials is product-specific (often one to three).1-3 failed trials depending on product

Examples: DICLOFENAC topical requires prior failure of preferred diclofenac 1% gel; DEXLANSOPRAZOLE DR requires three failed preferred alternatives.

Initial approval duration

Typical initial approval rules noted for specific products

InitialApprovalDuration: Initial approvals for certain agents are for six months; annual renewals for responders may be granted.6 months

Explicitly stated for some agents (e.g., somatostatin analog, other listings).

Initial therapy examples

Representative initial therapy rules from this segment

Nexlizet initial: FDA-approved indication AND inadequate response to standard therapy (LDL >= 70 mg/dL) or contraindication to statins AND inadequate response to ezetimibe or contraindication to ezetimibeLDL >= 70 mg/dL

One-year approvals.

Nuplazid initial: FDA-approved indication AND frequent/severe psychotic symptoms warranting antipsychotic therapy

Initial approval 3 months.

Initial therapy for long‑acting opioids

Opioid-specific initial therapy requirements where present:

Long‑acting opioid initial requirements: 1) Trial and failure of two preferred products for long‑acting formulations OR medical contraindication; AND 2) Provider attestation of management per opioid prescribing guidelines and documentation of an adequate recent (minimum 30 days) trial of a short‑acting opioid.30 days

Applies to OXYCODONE HCL ER, OXYCONTIN, OXYMORPHONE HCL ER and similar long‑acting opioids.

Initial authorization rules

Initial approval examples where specified

REYVOW initial approval: Initial authorization provided for 6 months for REYVOW; re-authorization for 12 months.6 months

Continuation and Reauthorization Requirements

Continuation rules (selected agents)

Continuation criteria for drugs with time-limited initial approvals

DALFAMPRIDINE ER continuation: Patients continuing to meet criteria with documented improvements in ambulation after six months will be approved for one year; annual renewals require continued positive response.6 months then annual

Initial approval for six months; renewals up to one year thereafter.

Continuation rules (ocular cystinosis agents)

Continuation criteria for ocular cystinosis agents

CYSTADROPS/CYSTARAN continuation: Initial approvals for three months; renewals require documentation of clinical treatment effect (slit lamp exam notes) and may be provided for up to one year.initial 3 months, renewals up to 1 year

Specialist prescribing required for initial approval.

Continuation requirements (examples)

Examples of continuation/re-authorization rules

Nexlizet re-authorization: Re-authorization granted for patients with documented LDL cholesterol reduction per provider attestation.

Approvals are given for one year initially.

Nuplazid continuation: Continued coverage up to 12 months requires medical chart documentation of improvement

Initial approval is 3 months.

Product continuation rules

Renewal/continuation rules when specified

PULMOZYME continuation: Renewals provided annually with documentation the patient has been seen within the last 12 months at the cystic fibrosis treatment center and the medication is effective.12 months

Initial approvals for 12 months.

Authorization durations

Authorization duration examples

REYVOW authorization durations: Initial authorization provided for 6 months; re-authorization provided for 12 months.6 months initial

Example of specified durations in the policy.

Tobramycin renewal

Renewal requirements for inhaled tobramycin products

Annual renewal for inhaled tobramycin: Renewals provided annually with documentation that the patient has been seen within the last 12 months at the cystic fibrosis treatment center and the medication is effective.annual

Initial approvals for 12 months; quantity limits apply.

Step Therapy — Required Trials and Table Summaries

Requirement	Summary
Step therapy requires trial of specified preferred alternatives before coverage of the non-preferred agent	Members must try one or more formulary-preferred products and have documented inadequate response or a documented contraindication/allergy to preferred alternatives unless an exception applies
Number of required trials varies by product (commonly one or two; some products require three)	Exceptions include documented allergy to equivalent generic, FDA‑approved indication restrictions, or product‑specific external PA criteria referenced by URL

Example product	Step therapy / requirement
APEXICON E	Reserved for patients with an inadequate response to two or more preferred products or with medical contraindications to their use; literature support required
APIDRA / APIDRA SOLOSTAR	Reserved for patients with an inadequate response or a medical contraindication to one preferred alternative
ARFORMOTEROL TARTRATE	Reserved for FDA‑approved indications in patients with an inadequate response to two preferred products or with medical contraindications

Required failure type	Examples / notes
Inadequate response to preferred alternatives	CAPEX SHAMPOO: inadequate response to two or more preferred products; CLOBETASOL PROPIONATE CREAM: inadequate response to two or more preferred products
Documented allergic reaction to equivalent generic	Many topical and systemic agents are reserved when patient has documented allergy to equivalent generic (e.g., CLOBEX, CLINDAMYCIN PHOSPHATE)
Contraindication to preferred products	Products may be reserved when medical contraindication to preferred alternatives documented (product-specific)

Product	Typical step therapy condition
CLINDAGEL / CLINDAMYCIN formulations	Reserved for patients with a documented allergic reaction to the equivalent generic or who failed individual active ingredients when given separately
CLOZAPINE ODT	Reserved for patients with an inadequate response to a preferred dosage form or medical contraindication
DALFAMPRIDINE ER	Reserved for patients with MS who can walk 25 feet, neurologist prescribing, physician attestation of walking difficulty, and dose limit 10 mg twice daily; initial 6 months then renewals

Product	Step therapy / additional limits
DICLOFENAC formulations	Reserved for inadequate response to two or three preferred NSAIDs depending on formulation; some topical forms require failure of Voltaren 1% gel
DIFICID (fidaxomicin) suspension	Reserved for C. difficile infection with inadequate response or contraindication to one or more courses of vancomycin; approvals limited to 10 days
DISKETS / long‑acting opioids	Long‑acting opioids require provider attestation of opioid guideline management and inadequate response to recent adequate short‑acting opioid trial (minimum 30 days)

Product group	Step therapy pattern
Topicals and dermatologic agents (example list)	Often reserved after inadequate response to two preferred alternatives or for documented allergy to generic; literature support may be required for some brands
Antibiotics and anti‑infectives	Some agents reserved for FDA‑approved indications and require prior failure of preferred agents or documented contraindication (examples in list)
Specialty biologics and injectables	Many reference external PA documents or require specialist prescribing; reserved for inadequate response to preferred biosimilars or documented allergy to biosimilar

Long‑acting opioid example	Requirement
METHADONE formulations / METHADOSE / MORPHINE ER / MS CONTIN	Long‑acting opioids require provider attestation that therapy is managed per standard opioid prescribing guidelines AND documentation of inadequate response to a recent adequate (minimum 30 days continuous) trial of a short‑acting opioid

General trial requirement	Description
Trial of preferred alternatives	Step therapy commonly requires trial and inadequate response to one or two preferred alternatives prior to coverage of non‑preferred products; number varies by product
Exceptions to trials	Documented medical contraindication or documented allergic reaction to preferred/generic alternatives may exempt step requirements per product-specific criteria

Opioid‑tolerant examples	Requirement / note
FENTANYL long‑acting patches / fentanyl citrate	Reserved for patients with inadequate response to preferred generic fentanyl patches or with contraindications; fentanyl citrate reserved for breakthrough cancer pain in opioid‑tolerant patients after failures
HYSINGLA ER / other long‑acting opioids	Require provider attestation of opioid guideline management and inadequate response to recent adequate short‑acting opioid trial (minimum 30 days)

Reserved entries	Typical reservation reason
Many brand products (examples across list)	Reserved for patients with documented allergic reaction to equivalent generic, inadequate response to preferred alternatives, or limited to FDA‑approved indications
Products referencing external PA documents	Coverage contingent on meeting detailed external PA criteria available via HealthPartners links (see product-specific PA URLs)

Reserved / inadequate response examples	Entry details
ROSUVASTATIN‑EZETIMIBE / ORLISTAT / other metabolic agents	Reserved for FDA‑approved indications and patients with inadequate response to two preferred alternatives or with contraindications
TAPENTADOL / TAPENTADOL ER	Reserved for patients who tried and failed two preferred products or have contraindications; long‑acting forms require opioid attestation and prior short‑acting opioid trial (>=30 days)

Documentation / literature requirement	Examples
Medical literature support may be required	Certain products require documentation in peer-reviewed literature demonstrating clinical benefit over preferred alternatives (stated for multiple entries)
Product‑specific supporting documents	Some products point to external PA PDFs with required documentation (e.g., GLEEVEC, INFLECTRA, others) — consult linked criteria

L–M excerpt summary	Key points
General qualifiers in L–M segment	Coverage often requires FDA‑approved indication (when specified), inadequate response to one or two preferred alternatives, and documentation of prior therapies or contraindications; initial approvals commonly time‑limited (e.g., 6 months)
Brand reserved rules	Brands such as KYMBEE/EMFLAZA are considered not medically necessary absent documented allergy to generic; some brands reserved only for allergy to generic

Opioid attestation	Policy row
Provider attestation requirement	Long‑acting opioids require provider attestation that therapy is managed per standard opioid prescribing guidelines and documentation of an adequate recent short‑acting opioid trial (minimum 30 days) prior to approval
Tramadol ER specifics	Tramadol ER requires provider attestation of opioid stewardship; IR opioids new users limited to 7‑day first fill and 14‑day per episode without PA

Nexlizet initial approval	Criteria summary
Nexlizet (LDL threshold)	Reserved for FDA‑approved indications AND inadequate response to standard therapy (high‑intensity statin) with LDL >= 70 mg/dL AND inadequate response to ezetimibe or contraindication to ezetimibe; approvals given for one year with reauthorization requiring provider attestation of LDL reduction

External PA references	Examples
Multiple products reference external PA PDFs/URLs	Examples include GAMMAGARD, GLEEVEC, GAVRETO, INFLECTRA and many others — see linked HealthPartners prior authorization criteria for full requirements
Specialty product links	Some specialty agents (e.g., ORKAMBI, CFTR modulators) direct to detailed PA documents for cystic fibrosis therapies

Trial documentation requirement	What to provide
Documentation of prior trials and inadequate response	Providers must submit clinical rationale and documentation of prior trials showing inadequate response to specified number of preferred products or documentation of contraindication/allergy
Follow external PA when referenced	When product entry references an external PA URL, follow the linked criteria and provide required documentation (e.g., culture/sensitivity, specialty notes) as specified

Broad application examples	Notes
Many brand and specialty products subject to step therapy	Step therapy is widely applied across the formulary: brands reserved until failure of one or two preferred alternatives, allergy to generic, or other specified conditions
Denial risk when not met	Coverage may be denied if PA/ST criteria are not met or required documentation is missing (e.g., prior trials, attestation, lab thresholds)

R–S excerpt examples	Representative entries
ROMIDEPSIN / ROMVIMZA	Many entries reference external PA documents; reserved or require specialty prescribing per linked criteria
SANDOSTATIN / SANDOSTATIN LAR	Reserved for patients with inadequate response or unable to tolerate generic octreotide; some specialty agents require specialist prescribing
SECUADO	Reserved with product‑specific conditions including prior stability on certain formulations and chart documentation when applicable

Reserved / failure continued	Examples
TALICIA / TAPENTADOL / TAPERDEX	Examples of products reserved for documented treatment failure to first‑line options or two preferred alternatives; TAPENTADOL long‑acting variants require opioid attestation and prior short‑acting opioid trial
TAZVERIK / TECARTUS	Reserved for FDA‑approved indications and often require prior failure of preferred alternatives or specialist documentation

Opioid attestation / prior trial summary	Policy summary
Provider attestation and prior short‑acting trial required	Long‑acting opioids (examples include methadone, morphine ER, oxycodone ER, fentanyl formulations, tapentadol ER) require provider attestation of opioid guideline management AND documentation of an adequate recent short‑acting opioid trial (minimum 30 days continuous use); failure to document may result in denial
Tramadol specifics	Tramadol ER requires attestation; IR opioids for new users limited to 7‑day first fill and 14‑day per episode without PA; age limits apply for some formulations

Key Clinical Thresholds and Coding-Adjacent Values

DALFAMPRIDINE ER ambulation requirement

RequirementMember must be currently able to walk 25 feet to meet DALFAMPRIDINE ER eligibility for improvement in ambulation assessment.

PrescriberPrescribing by a Neurologist is required for DALFAMPRIDINE ER PA requests.

Supporting documentationPhysician attestation of walking difficulty and follow-up documentation of improvement are required for continuation/renewal.

DALFAMPRIDINE ER dosage limit

Dosage limitNot more than the FDA‑approved dosage of 10 mg twice daily for DALFAMPRIDINE ER.

Initial approvalInitial approval will be for six months; continuation contingent on documented improvement in ambulation.

Prescriber requirementNeurologist prescribing required.

Gattex parenteral nutrition volume and duration

Volume/duration threshold>= 4 L daily of parenteral nutrition, dependent at least 3 days per week, and dependent on parenteral nutrition for >= 1 year for Gattex eligibility.

Initial approval durationInitial approvals for Gattex are provided for three months; reauthorization may be provided for up to one year with documented reduction in parenteral nutrition needs.

DocumentationPA must include evidence of parenteral nutrition dependence and specialist prescribing/management notes.

Opioid short-acting trial duration

Short-acting opioid trial durationMinimum of 30 days of continuous use of a short-acting opioid constitutes an adequate trial prior to consideration of long-acting opioid therapy.

PurposeRequired to support PA for long-acting opioid formulations and provider attestation of opioid management.

Denial riskLack of documentation of this trial may result in denial of PA for long-acting opioids.

Adequate short-acting opioid trial

Adequate trial definitionAn adequate short‑acting opioid trial is defined as a minimum of 30 days of continuous use prior to initiation of long‑acting opioid therapy.

Applies toLong‑acting opioids such as methadone formulations, morphine ER, MS Contin, and similar agents.

Provider attestationPA requires provider attestation that opioid therapy is managed per standard opioid prescribing guidelines and that the adequate trial occurred.

LDL threshold for Nexletol/Nexlizet step

LDL threshold>= 70 mg/dL is the LDL cholesterol threshold used to define inadequate response for Nexletol/Nexlizet step therapy criteria.

ContextApplies when LDL remains >= 70 mg/dL despite high-intensity statin therapy or when statins are contraindicated, and inadequate response to ezetimibe when required.

AuthorizationInitial approvals are given for one year; reauthorization requires provider attestation of LDL reduction.

Testosterone deficiency threshold

Testosterone deficiency thresholdLaboratory threshold: total testosterone < 300 ng/dL required to meet testosterone deficiency criteria for coverage of certain testosterone products.

Additional requirementsCoverage often requires inadequate response or contraindications to two or more preferred alternatives, or diagnosis-related criteria (e.g., gender dysphoria) per product.

DocumentationProvider must include lab results demonstrating testosterone level <300 ng/dL in the PA request.

LDL cholesterol threshold for Nexlizet (repeat)

LDL threshold (repeat)>= 70 mg/dL is cited again as the LDL criterion for Nexlizet inadequate response to standard therapy.

Re-authorizationProvider attestation of LDL reduction required for reauthorization; initial approval typically one year.

Prior therapiesHigh-intensity statin and ezetimibe trials (or contraindications) are prerequisites per product criteria.

Quantity Limits and Supply Constraints

CAYSTON (aztreonam inhalation) quantity — one 28-day package

Quantity limitOne 28‑day package per month for CAYSTON (aztreonam inhalation).

Clinical requirementsApproved only for cystic fibrosis patients with documented Pseudomonas aeruginosa and prescribed/managed by a CF treatment center.

Approval durationInitial approvals for 12 months; renewals annually with documentation of specialist follow-up and effectiveness.

CIALIS 5 MG and 2.5 MG — up to one tablet

Quantity limitCIALIS 5 mg and 2.5 mg: up to one tablet (quantity/approval follows contract limitations and indication).

Indication notesFor erectile dysfunction: reserved for patients with documented allergic reaction to the equivalent generic; for BPH dosing follows indication-specific rules.

Contract/quantityApproval and quantity limits will follow contract limitations where applicable.

DIFICID (suspension) — 10 days

Duration limitDIFICID (fidaxomicin) suspension: approval limited to 10 days for treatment of C. difficile infection when criteria met.

Clinical prerequisitesRequires diagnosis of Clostridioides difficile infection and inadequate response or contraindication to one or more courses of vancomycin.

Product formsTablet form has separate criteria (e.g., reserved for documented allergic reaction to equivalent generic).

Tobramycin inhalation packaging limit — one 56-count carton

Quantity limitTobramycin inhalation (300 mg ampules/PAK forms): limited to one 56‑count carton per 56 days.

Clinical requirementsReserved for CF patients with documented Pseudomonas aeruginosa and prescribed/managed by a CF treatment center.

RenewalInitial approvals for 12 months; annual renewals require CF center visit documentation and evidence of effectiveness.

Immediate-release opioids (new users) — 7-day first fill; up to 14-day total per episode

Initial fill limitImmediate‑release opioids (new users) — first fill limited to a 7‑day supply; total of up to 14 days per episode without prior authorization.

When PA requiredLonger therapy or quantities beyond these limits require prior authorization with provider attestation of opioid stewardship.

Applies toTramadol IR and other immediate‑release opioid products for new users as specified in PA listings.

Site-of-Care and Specialty Prescribing Requirements

Note

Biosimilar and Preferred Biologic Notes

Note

Authorization Durations, Initial and Renewal Summary

Initial approval duration (summary)

Initial approvals commonly time-limited: Some agents receive initial approvals for a defined period (examples include 3–6 months depending on product) with renewals contingent on documented clinical benefit.3-6 months initial commonly

See product-specific entries for exact durations.

Authorization durations (examples)

Example durations: Representative examples: REYVOW initial 6 months then 12-month reauthorization; some somatostatin analogs initial 6 months; Gattex initial 3 months with reauthorization up to 1 year.3-12 months depending on product

Product-specific PA documents give exact durations.

Continuation rules (selected agents) (repeat)

DALFAMPRIDINE ER continuation (repeat): Patients continuing to meet criteria with documented improvements after six months will be approved for one year; annual renewals require continued positive response.6 months then annual

Repeat of DALFAMPRIDINE ER continuation rules.

Continuation examples (repeat)

Nexlizet re-authorization (repeat): Re-authorization granted for patients with documented LDL reduction per provider attestation; initial approval commonly one year.

Repeat of re-authorization requirements.

Background and Purpose

HealthPartners uses prior authorization and step therapy to ensure that certain medicines meet formulary criteria before coverage. These utilization management tools require trials of preferred alternatives or documentation of medical contraindication/allergy when applicable, and they direct providers to consult product‑specific PA documents for detailed requirements.