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.
No material clinical or coverage changes in this revision.
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:
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
applies to multiple entries
number of alternatives varies by product; often two
see specific product entries
Opioid attestation
Opioid-specific requirement
applies to long-acting opioids such as buprenorphine and butrans
CAYSTON (aztreonam inhalation) criteria
Cystic fibrosis inhaled antibiotic criteria
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
Frequently cited across many entries
Examples include entries requiring two or three failed preferred alternatives
Applies where product listing specifies FDA indication
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).
Many product entries use this exact logic
Several brand products reserved for allergy to generic
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:
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:
Initial approvals for 3 months; reauthorizations up to 1 year with documented reduction in parenteral nutrition.
Opioid products
Long-acting fentanyl products:
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
appears for multiple products
documentation and literature support may be required
used for imaging or specialty products
Gattex (short bowel syndrome) coverage
Gattex (teduglutide) reservation criteria
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:
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):
Many entries specify two preferred alternatives; some specify one.
Some specialty agents are limited to FDA‑approved indications or clinical trial criteria.
Used for select products per listings.
General Step Therapy / Prior Authorization
Covered when product-specific step therapy or PA criteria are met
Specific products vary; see individual entry or referenced PA document
Opioid-specific criteria
Specific opioid-related criteria
Applies to methadone formulations, morphine ER formulations, MS Contin, and other long-acting opioids referenced.
Nexletol / Nexlizet criteria
Lipid-lowering agents (Nexletol/Nexlizet)
Reauthorization: documentation of LDL reduction per provider attestation.
Testosterone therapy criteria
Testosterone products (e.g., Methitest, Methyltestosterone, Natesto)
Applies to Methitest, Methyltestosterone, Natesto and similar entries.
Nexlizet — Initial Therapy
Nexlizet coverage is allowed when ALL of the following are met
Approvals are given for one year; re-authorization requires provider attestation of LDL reduction.
Nuzyra — Initial Therapy
Nuzyra coverage requires ALL of the following
Standard treatments include quinolones for CAP and linezolid for ABSSSI.
Nuplazid — Time-limited approval
NUPLAZID coverage (example of time-limited approval)
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):
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):
Duration limits specified in document.
General Step Therapy / Prior Authorization Criteria
Covered when ALL of the following are met (applies per-product as specified):
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):
Many entries state 'inadequate response to two preferred alternatives' or similar.
Numerous branded products list this as the criterion.
Explicit in several entries.
Links provided for multiple products.
Specified in the text.
General reservation and step therapy conditions (excerpt)
Coverage/reservation rules summarized for listed products
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
Specialty center management and documentation required
Tramadol coverage criteria and opioid stewardship requirements
Tramadol products — coverage conditions
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 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 — 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.
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.
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.).
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 — 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 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.
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).
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.
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 — 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.
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.
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).
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 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.
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.
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.
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.
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 — 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 — 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
Initial Therapy — Requirements for Initial Authorization
Initial therapy conditions (general)
Initial approval commonly requires trials of preferred products
Specific products may have different numeric requirements as noted per product.
Initial therapy rules
Initial authorization often requires trials of preferred agents
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
Explicitly stated for some agents (e.g., somatostatin analog, other listings).
Initial therapy examples
Representative initial therapy rules from this segment
One-year approvals.
Initial approval 3 months.
Initial therapy for long‑acting opioids
Opioid-specific initial therapy requirements where present:
Applies to OXYCODONE HCL ER, OXYCONTIN, OXYMORPHONE HCL ER and similar long‑acting opioids.
Initial authorization rules
Initial approval examples where specified
Continuation and Reauthorization Requirements
Continuation rules (selected agents)
Continuation criteria for drugs with time-limited initial approvals
Initial approval for six months; renewals up to one year thereafter.
Continuation rules (ocular cystinosis agents)
Continuation criteria for ocular cystinosis agents
Specialist prescribing required for initial approval.
Continuation requirements (examples)
Examples of continuation/re-authorization rules
Approvals are given for one year initially.
Initial approval is 3 months.
Product continuation rules
Renewal/continuation rules when specified
Initial approvals for 12 months.
Authorization durations
Authorization duration examples
Example of specified durations in the policy.
Tobramycin renewal
Renewal requirements for inhaled tobramycin products
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
Quantity Limits and Supply Constraints
Site-of-Care and Specialty Prescribing Requirements
Biosimilar and Preferred Biologic Notes
Authorization Durations, Initial and Renewal Summary
Initial approval duration (summary)
Initial approval duration (summary)
See product-specific entries for exact durations.
Authorization durations (examples)
Authorization durations (examples)
Product-specific PA documents give exact durations.
Continuation rules (selected agents) (repeat)
Continuation rules (selected agents) (repeat)
Repeat of DALFAMPRIDINE ER continuation rules.
Continuation examples (repeat)
Continuation examples (repeat)
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.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.