CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Photofrin (porfimer) — Photodynamic Therapy Coverage Criteria

Defines accepted indications, contraindications, exclusions, coding, and authorization expectations for Photofrin (porfimer) use in cancer treatment for Neighborhood Health Plan of Rhode Island members; applies to providers submitting medication requests to Evolent for authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPhotofrin (porfimer) — Photodynamic Therapy Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit medication requests for Photofrin to Evolent for prior authorization; continuation may be approved if member has not progressed, prior use was within one year with ≤30-day lapse, and no additional drugs are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9600HCPCS code listed

4Indication groups

2 mg/kgSingle-dose limit

PorphyriaContraindication

Coverage Criteria for Photofrin (porfimer)

Related Billing Codes

HCPCS-J9600-PORFIMER-SODIUM-75MG-INJECTION

HCPCS J9600: Injection, Porfimer Sodium 75 mg

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Basal or Squamous Cell Skin Cancer (photodynamic therapy)

Covered when ALL of the following are met for superficial skin malignancies:

Basal/Squamous cell skin cancer criteria: Member has low-risk superficial basal cell carcinoma, actinic keratoses, or squamous cell carcinoma in situ (Bowen's disease)

Treatment candidacy: Member is not a candidate for surgery or radiation therapy

NSCLC and Esophageal Cancer (palliation)

Covered when ALL of the following are met for endobronchial NSCLC or esophageal cancer:

Palliative photodynamic therapy criteria: Member has obstruction due to endobronchial non-small cell lung cancer (NSCLC) or esophageal cancer

Treatment candidacy: Member is not a candidate for surgery or radiation therapy

Photofrin (porfimer) is considered investigational or off‑label for any indication that lacks sufficient supporting evidence as defined by this policy. Specifically, uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature will be treated as investigational. The policy evaluates sufficiency of evidence by whether (1) the patient and cancer clinical characteristics are represented in the published evidence, (2) the oncologic treatment regimens used in studies mirror the proposed regimen, (3) reported outcomes are clinically meaningful, and (4) the experimental design is appropriate to the question being asked; failure to meet these standards supports an investigational determination.

Use of Photofrin (porfimer) will be deemed not medically necessary (NMN) when supporting evidence is inadequate. Examples of insufficient evidence cited by the policy include case reports (generally uncontrolled and anecdotal), meeting abstracts without a full peer‑reviewed article, and studies that do not adequately represent the relevant clinical populations, regimens, or clinically meaningful outcomes. Requests relying on these types of evidence should be denied as NMN per the policy criteria.

Regimen	Indication	Notes
Photofrin (porfimer) with appropriate light activation per prescribing information
Low‑risk superficial basal cell carcinoma; actinic keratoses; squamous cell carcinoma in situ (Bowen's disease)
Covered when the member is not a candidate for surgery or radiation; administered as photodynamic therapy with light activation per prescribing information

Provider Requirements, Authorization, and Exclusions

Prior Authorization

Prior Authorization Required

Medication requests for Photofrin (porfimer) must be authorized by Evolent prior to initiation. Continuation requests may be approved without re‑review only when all continuation conditions are met.

All initial and renewal requests require prior authorization from Evolent.
Continuation (renewal) is allowed if: member has no disease progression on Photofrin; therapy was used within the last 12 months with no gap >30 days in active authorization; and no additional medications are being added to the continuation request.

Documentation Required

Provide Supporting Evidence

Ordering providers must supply clinical documentation supporting the requested use. Acceptable sources of supporting evidence include FDA labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

FDA approved product labeling (Photofrin prescribing information).
CMS‑recognized compendia (e.g., NCCN Drugs & Biologics compendium, AHFS, Micromedex, Clinical Pharmacology).
NCCN or ASCO clinical guidelines.
Peer‑reviewed literature that meets CMS criteria (full articles preferred; abstracts alone generally insufficient).

Denial Risk

Exclusion / Denial Triggers

Requests meeting any exclusion criteria should be denied. Common triggers for exclusion are listed below.

Disease progression while receiving Photofrin.
Dosing that exceeds the single‑dose limit of 2 mg/kg.
Investigational or off‑label indications that lack sufficient evidence or are not generally accepted (e.g., unsupported by CMS compendia or acceptable peer‑reviewed literature).
Insufficient supporting literature (case reports, abstracts without full peer‑reviewed publication, or studies not representative of the patient population or concurrent therapies).

Documentation Required

Provider Submission Requirements

When submitting a request, include clinical notes, treatment history, prior authorization identifiers (if continuation), dosing calculations (weight and mg/kg), and citations to the supporting evidence used to justify the request.

For continuation requests, include the prior authorization number and documentation showing no >30‑day lapse and absence of disease progression.
Provide patient weight and exact dosing rationale to demonstrate dosing ≤2 mg/kg.
Attach copies or citations of supporting guideline or peer‑reviewed evidence.

Definitions and Therapy Types

Photodynamic therapy / palliation

DefinitionPhotodynamic palliation therapy: use of Photofrin (porfimer) with light activation to relieve obstruction from endobronchial non-small cell lung cancer (NSCLC) or esophageal cancer in members who are not candidates for surgery or radiation.

Contraindications relevant to palliationPorphyria; existing tracheoesophageal or bronchoesophageal fistula; tumors eroding into a major blood vessel; esophageal or gastric varices; esophageal ulcers >1 cm; emergency treatment when 40–50 hour interval between injection and light activation cannot be observed.

Clinical contextIntended for palliation of obstructing tumors to restore airway or esophageal patency when surgery/radiation are not options; timing requires 40–50 hours between Photofrin injection and laser light treatment, limiting emergency use.

Regimen	Indication	Administration notes
Photofrin (porfimer) with appropriate light activation per prescribing information
Palliative photodynamic therapy for obstruction from endobronchial non‑small cell lung cancer (NSCLC)
Covered when the member is not a candidate for surgery or radiation; follow prescribing information for timing of drug administration and light activation

Background

Photofrin (porfimer) is a photosensitizing agent used in photodynamic therapy where the drug is activated by light to produce a cytotoxic effect. In oncology practice, it is applied for photodynamic therapy of superficial skin malignancies (e.g., low‑risk basal cell carcinoma, actinic keratoses, squamous cell carcinoma in situ) and for palliative photodynamic palliation of obstructing endobronchial non‑small cell lung cancer or esophageal tumors in patients who are not candidates for surgery or radiation. Treatment requires coordination of drug administration and timed light activation per the prescribing information, and certain safety considerations and contraindications (for example, porphyria) apply.