Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	1997169
Category:	Medicine
Initiated:	July 1993
Last Review:	July 2023

Photochemotherapy (PUVA)

Description:

Phototherapy, which is defined as the direct use of nonionizing radiation to treat disease, has been used since antiquity. In contrast to phototherapy, photochemotherapy entails the absorption of nonionizing radiation by an exogenous molecule. The activated molecule is then responsible for the therapeutic effect. The photochemotherapy of cutaneous disease usually involves the use of psoralen molecules and ultraviolet A radiation (PUVA). Although this type therapy, using material from plants and UVA from sunlight, has been used in the treatment of skin diseases dating to approximately 1400 BC, it was not until 1974 that use of this treatment of psoriasis was described and photochemotherapy as we know it today had begun. Photochemotherapy has been used for a large number of skin diseases, but fully confirmed data of its usefulness is available in only a relatively few.

PUVA therapy for treatment of psoriasis has been associated with an increased risk of development of melanoma and cutaneous carcinoma.

The oral psoralen products Oxsoralen-Ultra (methoxsalen soft gelatin capsules) and 8-MOP (methoxsalen hard gelatin capsules) have been approved by the FDA; both are made by Valeant Pharmaceuticals. Topical psoralen products have also received FDA approval e.g., Oxsoralen (Valeant Pharmaceuticals).

PUVA for the treatment of vitiligo is addressed in a separate policy #2013024.

PUVA for the treatment of psoriasis is addressed in a separate policy #2002009.

Policy/
Coverage:

Effective January 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Photochemotherapy for the treatment of cutaneous mycosis fungoides, cutaneous mast cell tumors, and cutaneous Sézary's disease meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

Photochemotherapy for the treatment of atopic dermatitis refractory to other treatment, disease induced alopecia, and cutaneous complications of transplanted organs meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of photochemotherapy for any indication not listed above or addressed in a related coverage policy, including any therapy delivered in a tanning bed, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. Therapy using a tanning bed is a contract exclusion in most contracts.

For members with contracts without primary coverage criteria, the use of photochemotherapy for any indication not listed above or addressed in a related coverage policy is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective July 2021 through December 31, 2021

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Photochemotherapy for the treatment of cutaneous mycosis fungoides, cutaneous mast cell tumors, cutaneous Sézary's disease, dermatitis refractory to other treatment, disease induced alopecia, and cutaneous complications of transplanted organs meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Effective Prior to July 2021

Photochemotherapy for the treatment of cutaneous mycosis fungoides, cutaneous mast cell tumors, cutaneous Sézary's disease, dermatitis refractory to other treatment, disease induced alopecia and cutaneous complications of transplanted organs meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

Any other use of photochemotherapy, including any therapy delivered in a tanning bed does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. Therapy using a tanning bed is a contract exclusion in most contracts.

For contracts without primary coverage criteria, any other use of photochemotherapy is considered investigational. Investigational services are an exclusion in the member benefit certificate of coverage.

Effective prior to July 2013

Photochemotherapy meets primary coverage criteria for effectiveness in the treatment of vitiligo or severe, disabling psoriasis which is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light), as well as for the treatment of cutaneous mycosis fungoides, cutaneous mast cell tumors, cutaneous Sézary' s disease, dermatitis refractory to other treatment, disease induced alopecia and cutaneous complications of transplanted organs.

Rationale:

This policy was introduced in 1993 and is based on established indications for photochemotherapy. A review of medical literature in October 2009, including a Medline search using PubMed, did not produce any new information to change the coverage criteria. Thus, the policy remains unchanged.

2012 Update

A literature search of the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.

In 2011, Amirnia and colleagues published a study from Iran in which 88 patients with moderate plaque psoriasis were randomized to receive PUVA or topical steroids (Amirnia, 2011). Treatment was continued for 4 months or until clearance was achieved. Clearance was defined as disappearance of at least 90% of baseline lesions. All patients in both groups achieved clearance within the 4-month treatment period. Recurrence (defined as a resurgence of at least 50% of the baseline lesions) occurred significantly more often in the topical steroid group (9 of 44, 20.5%) than in the PUVA group (3 of 44, 6.8%), (p=0.007).

In 2009, Sivanesan and colleagues published a double-blind RCT evaluating the efficacy of 8-methoxypsoralen (8-MOP) PUVA treatment in patients 18 years and older with moderate to severe psoriasis affecting at least 10% of their body surface area (Sivanesan, 2009). Individuals with a history of serious side effects from oral PUVA, phototoxic reactions, or cancer; including skin cancer; were excluded. The study included 40 patients, 30 randomly assigned to receive PUVA and 10 to receive UVA plus placebo psoralens. After a washout period of 2 weeks for topical psoriasis medications and 4 weeks for phototherapy and systemic therapies, patients were treated 3 times a week for 12 weeks. A total of 28 patients completed the study, 21 in the PUVA group and 7 in the UVA plus placebo group. The primary outcome was at least a 75% improvement in the Psoriasis Area and Severity Index score (PASI 75). In an intention-to-treat analysis with the last observation carried forward to analysis at 12 weeks, 19 of 30 (63%) in the PUVA group and 0 of 10 (0%) in the UVA with placebo group achieved at least a 75% improvement in the PASI 7 score (p<0.001). In the per protocol analysis, 18 of 21 (86%) in the PUVA group and 0 of 7 (0%) in the placebo group achieved PASI 75. There were no serious adverse effects. The study found a dramatic treatment benefit with PUVA compared to UVA plus placebo; however, there was substantial drop-out and no long-term follow-up.

Two recent RCTs from India compared outcomes after treatment with oral methoxsalen PUVA or narrow-band UVB (NB-UVB). In 2011, Chauhan and colleagues included 51 patients with plaque psoriasis involving greater than 20% of their body surface area (Chauhan, 2011). Patients received treatment with NB-UVB or PUVA 3 times a week. Treatment continued until greater than 75% clearance was attained or for a maximum of 16 weeks. A total of 43 of 51 (84%) patients completed the study. Marked improvement (>75% clearance) was seen in 17 of 21 (90.9%) study completers in the NB-UVB group and 18 of 22 (81.8%) in the PUVA group; p>0.05. The mean time to achieve results was also similar in the 2 groups, a mean of 9.9 weeks with each treatment. A 2010 study by Dayal and colleagues randomly assigned 60 patients with chronic plaque psoriasis to receive twice weekly PUVA (n=30) or twice weekly NB-UVB phototherapy (n=30) (Dayal, 2010). After the 3-month treatment period, all patients in both groups had at least 75% clearance of psoriasis or complete clearance. The PASI score did not differ significantly between groups (mean of 1.39 in the PUVA group and 1.61 in the NB-UVB group). The mean number of treatments to achieve clearance, however, was significantly higher in the NB-UVB group than the PUVA group, 16.4 and 12.7, respectively.

No studies were identified that compared home-based PUVA to office-based PUVA. A 2010 review of various types of home phototherapies for psoriasis did not discuss any studies on PUVA delivered at home (Nolan, 2010).

2013 Update

This update is based on a literature search of the MEDLINE database through February 2012. There was no new literature identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.

Targeted Phototherapy

In 2012, Mudigonda and colleagues published a systematic review of controlled studies comparing the 308-nm UVB excimer laser to non-targeted phototherapy for patients with localized psoriasis (Mudigonda, 2012). The authors identified 3 prospective non-randomized studies comparing the 308-nm excimer laser to narrow-band UVB (NB-UVB); no studies comparing the excimer laser with broad band UVB (BB-UVB) or psoralens with ultraviolet A (PUVA) were identified. Among the 3 studies was one by Goldinger and colleagues that compared the excimer laser to full body NB-UVB in 16 patients. (7) At the end of 20 treatments, the psoriasis area and severity index (PASI) scores were equally reduced on the 2 sides, from a baseline of 11.8 to 6.3 for laser and from 11.8 to 6.9 for non-targeted NB-UVB. Another study, by Kollner and colleagues, included 15 patients with stable plaque psoriasis. (8) The study compared the 308-nm laser, the 308-nm excimer lamp, and standard TL-01 lamps. One psoriatic lesion per patient was treated with each therapy (i.e., each patient received all 3 treatments). The investigators found no significant difference in the efficacy of the 3 treatments after 10 weeks. The mean number of treatments to achieve clearance of lesions was 24.

Also in 2012, Wollina and colleagues in Germany treated two target lesions of similar size in 21 adult patients with moderate plaque-type psoriasis (Wollina, 2012). One lesion was treated with a new 307-nm excimer laser (which may not be available in the United States) and the other with a topical dithranol ointment. At baseline, the mean psoriasis score index (PSI) was 7.5 in the laser group and 6.9 in the dithranol group. The mean improvement in the PSI score after 3 treatments and a mean of 9 days of follow-up was 3.0 points in each group. The difference in improvement between groups was not statistically significant; this suggests similar efficacy although that conclusion is not definitive due to the small sample size. Treatment tolerance was higher with targeted phototherapy. All dithranol-treated lesions became irritated and had staining. Eleven of 21 targeted phototherapy-treated lesions (52%) had mild-to-moderate erythema and 2 (14%) had temporary blistering.

Psoralens with Ultraviolet A

In 2012, an industry-sponsored systematic review by Archier and colleagues was published on psoralens with ultraviolet A and/or narrow-band UVB for treating psoriasis (Archier, 2012). Three randomized controlled trials (RCTs) were identified that directly compared PUVA to NB-UVB in patients with chronic plaque psoriasis. A pooled analysis of these studies found a significantly higher psoriasis clearance with PUVA compared to NB-UVB (odds ratio [OR]: 2.79; 95% confidence interval [CI]: 1.40 to 5.55). In addition, significantly more patients remained cleared at 6 months with PUVA compared to NB-UVB (OR: 2.73: 95% CI: 1.18 to 6.27).

2016 Update

A literature search conducted through June 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Olsen and colleagues sought to develop separate guidelines for phototherapy for MF/SS for both clinical practice and for clinical trials (Olsen, 2016). This was done through literature review and cutaneous lymphoma expert consensus group recommendations. The paper reviewed the published literature for UVB and UVA/PUVA in MF/SS and suggests practical standardized guidelines for their use. Limitations identified were new standardization of phototherapy

2017 Update

A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.

2018 Update

A literature search was conducted through June 2018. There was no new information identified that would prompt a change in the coverage statement.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement.

2020 Update

A literature search was conducted through June 2020. There was no new information identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

Amirnia M, Khodaeiani E, Fouladi RF et al.(2011) Topical steroids in moderate plaque psoriasis: A clinical trial with cost analysis. J Dermatolog Treat 2011 [Epub ahead of print].

Archier E, Devaux S, Castela E et al.(2012) Efficacy of psoralen UV-A therapy vs. narrowband UV-B therapy in chronic plaque psoriasis: a systematic literature review. J Eur Acad Dermatol Venereol 2012; 26 Suppl 3:11-21.

Chauhan PS, Kaur I, Dogra S et al.(2011) Narrowband ultraviolet B versus psoralen plus ultraviolet A therapy for severe plaque psoriasis: an Indian perspective. Clin Exp Dermatol 36(2):169-73.

Dayal S, Mayanka, Jain VK.(2010) Comparative evaluation of NBUVB phototherapy and PUVA photochemotherapy in chronic plaque psoriasis. Indian J Dermatol Venereol Leprol 2010; 76(5):533-7.

Griffiths CE, Clark CM, Chalmers RJ et al.(2000) A systematic review of treatments for severe psoriasis. Health Technol Assess 2000; 4(40):1-125.

Heald P, Rook A, Perez M, et al.(1992) Treatment of erythrodermic cutaneous T-cell lymphoma with extracorporeal photochemotherapy. J Am Acad Derm 1992; 27:427-433.

Morison WL.(1992) Phototherapy and photochemotherapy. Adv Derm 1992; 7:255-270.

Mudigonda T, Dabade TS, West CE et al.(2012) Therapeutic modalities for localized psoriasis: 308-nm UVB excimer laser versus nontargeted phototherapy. Cutis 2012; 90(3):149-54.

Nolan BV, Yentzer BA, Feldman SR.(2010) A review of home phototherapy for psoriasis. Dermatol Online J 2010; 16(2):1.

Olsen EA, Hodak E, Anderson T, et al.(2016) Guidelines for phototherapy of mycosis fungoides and Sézary syndrome: A consensus statement of the United States Cutaneous Lymphoma Consortium J Am Acad Dermatol. 2016 Jan;74(1):27-58

Orecchia G, Perfetti L.(1992) Photochemotherapy with topical khellin and sunlight in vitiligo. Derm 1992; 184:120-123.

Sivanesan SP, Gattu S, Hong J et al.(2009) Randomized, double-blind, placebo-controlled evaluation of the efficacy of oral psoralen plus ultraviolet A for the treatment of plaque-type psoriasis using the Psoriasis Area Severity Index score (improvement of 75% or greater) at 12 weeks. J Am Acad Dermatol 2009; 61(5):793-8.

Stern RS, Khan HT, et al.(1997) Malignant Melanoma in patients treated for psoriasis, with methoxsalen (Psoralen) and ultraviolet A (PUVA). NEJM 1997; 336:1041-5.

Wolff K.(1997) Should PUVA be abandoned. NEJM 1997; 336:1090-1.

Wollina U, Koch A, Scheibe A et al.(2012) Targeted 307 nm UVB-phototherapy in psoriasis. A pilot study comparing a 307 nm excimer light with topical dithranol. Skin Res Technol 2012; 18(2):212-8.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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