1. No category

National Medical Policy
“The Medical Policy Department is no longer maintaining the section of this policy
addressing Biologic Therapies for Psoriasis. Please refer to the HNPS Prior
Authorization Criteria Database which can be found at
http://hnps.healthnet.com/pac/”
Subject:
Phototherapy for Psoriasis
(Click on hyperlink for related policy on
Excimer Laser for Psoriasis
Policy Number:
NMP350
Effective Date*:
June 2007
Updated:
March 2014
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document
For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage
guidelines prior to applying Health Net Medical Policies
The Centers for Medicare & Medicaid Services (CMS)
For Medicare Advantage members please refer to the following for coverage guidelines first:
Use
X
Source
National Coverage Determination
(NCD)
National Coverage Manual Citation
Local Coverage Determination
(LCD)*
Article (Local)*
Other
None
Reference/Website Link
Treatment of Psoriasis:
http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
Use Health Net Policy
Instructions
 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL
regions.
Phototherapy for Psoriasis Mar 14
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


Medicare LCDs and Articles apply to members in specific regions. To access your specific
region, select the link provided under “Reference/Website” and follow the search
instructions. Enter the topic and your specific state to find the coverage determinations
for your region. *Note: Health Net must follow local coverage determinations (LCDs) of
Medicare Administration Contractors (MACs) located outside their service area when
those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4
Section 90.2)
If more than one source is checked, you need to access all sources as, on occasion, an
LCD or article contains additional coverage information than contained in the NCD or
National Coverage Manual.
If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the
Health Net Hierarchy of Medical Resources for guidance.
Current Policy Statement
Health Net, Inc. considers any of the following phototherapy treatments for psoriasis
medically necessary:
1.
Psoralens and ultraviolet A light (PUVA) treatments for severe disabling psoriasis
generally defined as psoriasis affecting more than 10 percent of the body surface
area (BSA)
2.
Psoralens and ultraviolet A light (PUVA) treatments for palmar/plantar psoriasis that
affects less than 10 percent of the body surface area (BSA) but is deemed severe
due to its physically debilitating effect on the quality of life related to painful
exacerbations that impair the use of the hands and/or feet
3.
UVB phototherapy, alone or in combination with another psoriasis therapy, such as
calcipotriene, tazarotene, anthralin or coal tar (also known as the Goeckerman
regimen) for individuals with moderate to severe psoriasis
4.
Narrow-band UVB phototherapy for mild to moderate psoriasis unresponsive to
conservative treatment [Anthralin, coal tar products, topical corticosteroids, topical
tazarotene, topical calcipotriene (Davonex)]
5.
Home phototherapy (UVB) treatment for individuals with severe psoriasis with a
history of frequent flares. Home ultraviolet light booths or ultraviolet lamps, as well
as replacement bulbs sold by prescription only, are considered medically necessary
for patients eligible for home UVB phototherapy when all of the following are met:
a. Documentation of medical necessity of UVB over other treatment by a
dermatologist.
b. The prescribed device must be FDA approved.
c. Demonstrated improvement with in-office UVB light treatments.
d. The patient has the capacity to understand the risks, appropriate dosing, and
the benefits of home UVB light treatments and is reliable and expected to be
compliant with the treatment plan, including periodic office visits for
monitoring.
e. It is a hardship for the patient to attend in-office PUVA/UVB treatments, OR a
home unit is more cost-effective.
Note: On average, up to 25 PUVA treatments may be necessary to achieve clearance.
Phototherapy for Psoriasis Mar 14
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Not Medically Necessary
Health Net, Inc. considers any of the following not medically necessary for treatment of
psoriasis because there is inadequate scientific evidence in the medical literature validating
their effectiveness:
1.
2.
Targeted phototherapy for the first-line treatment of mild psoriasis
Tanning beds for home UVB phototherapy because home UVB devices are designed
solely for the medical treatment of skin diseases and emit a different wavelength of
ultraviolet light than tanning beds.
Abbreviations
PUVA
BSA
UVB
NB-UVB
Psoralens and ultraviolet A light
Body Surface Area
Ultraviolet light B phototherapy
Narrowband ultraviolet B
Codes Related To This Policy
NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in this policy
does not imply that the service described by this code is a covered or non-covered health
service. Coverage is determined by the benefit documents and medical necessity criteria.
This list of codes may not be all inclusive.
On October 1, 2014, the ICD-9 code sets used to report medical diagnoses and inpatient
procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will
now include the preliminary ICD-10 codes in preparation for this transition. Please note
that these may not be the final versions of the codes and that will not be accepted for billing
or payment purposes until the October 1, 2014 implementation date.
ICD-9 Codes
696.1
Plaque psoriasis
ICD-10 Code
L40.0 Psoriasis vulgaris
CPT Codes
96910
96912
96913
Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or
petrolatum and ultraviolet B
Photochemotherapy; psoralens and ultraviolet A (PUVA)
Photochemotherapy (Goeckerman and/or PUVA) for severe
photoresponsive dermatoses requiring at least four to eight hours of
care under direct supervision of the physician (includes application of
medication and dressings) (when specified as PUVA)
HCPCS Codes
E0691
E0692
E0693
Ultraviolet light therapy system, includes bulb/lamps, timer and eye
protection; treatment area 2 sq ft or less
Ultraviolet light therapy system panel, includes bulbs/lamps, timer and
eye protection, 4 foot panel
Ultraviolet light therapy system panel, includes bulbs/lamps, timer and
eye protection, 6 foot panel
Phototherapy for Psoriasis Mar 14
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E0694
Ultraviolet multidirectional light therapy system in 6 foot cabinet,
includes bulbs/lamps, timer and eye protection
Scientific Rationale – Update March 2014
Almutawa et al (2013) reported localized phototherapy including topical psoralen plus
ultraviolet A (PUVA) and targeted ultraviolet B (UVB), and photodynamic therapy (PDT)
have been increasingly used in the treatment of localized psoriasis. Yet, there are no
systematic reviews or meta-analyses that scientifically evaluated the pooled efficacy of
these treatments in psoriasis. The authors searched Medline, Embase, and Cochrane
databases during the period of January 1980 to June 2012. The systematic search resulted
in 765 studies, 23 of them were included in this review. The primary outcome was 75%
reduction in severity score from baseline. A meta-analysis using random effect model found
topical PUVA to be more effective than non-laser targeted UVB [odds ratio: 3.48 (95%
confidence interval 0.56-21.84), P=0.183]. The pooled effect estimate of the efficacy (75%
reduction in severity score) of topical PUVA, targeted UVB, and PDT were as follows: 77%
(topical PUVA), 61% (targeted UVB), and 22% (PDT). The authors concluded topical PUVA
and targeted UVB phototherapy are very effective in the treatment of localized psoriasis.
Topical PUVA seems more effective than non-laser targeted UVB phototherapy. On the other
hand, PDT has low efficacy and high percentage of side effects in treating localized
psoriasis.
Scientific Rationale – Update March 2013
Takahashi et al (2013) compared the clinical efficacy of various psoriasis treatments among:
(i) topical application of calcipotriol ointment twice daily (group I); (ii) topical application of
calcipotriol ointment twice daily and narrowband ultraviolet B NB-UVB phototherapy once a
week (group II); (iii) topical application of heparinoid ointment twice daily and NB-UVB
phototherapy more than twice a week (group III); and (iv) topical application of calcipotriol
ointment twice daily and NB-UVB phototherapy more than twice a week (group IV). Ten
patients were randomly selected for each group and treated by the indicated regimens for
12 weeks. All treatments were effective and significantly improved Psoriasis Area and
Severity Index (PASI) scores, self-administered PASI scores and visual analog scale scores
of pruritus. Group IV showed most marked and rapid reduction in PASI and self-PASI scores
among the four regimens. Although the serum levels of interleukin (IL)-17, IL-20 and IL-22
and psoriasis disability index were significantly decreased after the treatments, no
significant difference was detected among the four groups. Our study indicates that
combination of calcipotriol ointment plus NB-UVB more than twice a week is superior to
other treatment regimens, rapidly improving psoriasis lesions.
Archier et al (2012) performed a systematic literature review of the efficacy of Oral 8methoxypsoralen-UV-A (PUVA) and Narrowband UV-B (NB-UVB or UVB TL-01) in the
treatment of chronic plaque psoriasis. The initial literature search identified 773 articles.
The final selection included 29 randomized controlled trials: 18 were about the efficacy of
PUVA, eight about the efficacy of NB-UVB and three directly compared PUVA vs. NB-UVB.
The response rate defined by 75% or more improvement in PASI was 80% with PUVA vs.
70% with NB-UVB. The meta-analysis of the three comparative studies found a higher
probability of remission at 6 months with PUVA than with NB-UVB [OR = 2.73 (95% CI
1.19-6.27), P = 0.02]. The choice of initial dose, according to skin type, the minimal
erythemal dose or minimal phototoxic dose, incremental regimen and periodicity of the
sessions did not appear to be predictive factors of efficacy for PUVA or NB-UVB. Despite
methodological limitations in trials, the number of sessions needed for psoriasis clearance
appeared to be lower with PUVA than with NB-UVB (approx. 17 vs. 25, respectively). The
Phototherapy for Psoriasis Mar 14
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reviewers concluded PUVA and NB-UVB are both effective therapies in treatment of
psoriasis. Our results suggest that compared with NB-UVB, PUVA tends to clear psoriasis
more reliably, with fewer sessions, and provides with longer lasting clearance. However, the
long-term safety of PUVA, especially its cutaneous carcinogenic risk, and the easier
administration procedure often lead dermatologists to prefer NB-UVB as first line
phototherapy treatment in plaque type psoriasis.
Gelfand et al (2012) compared the effectiveness of biologic systemic therapy, nonbiologic
systemic therapy, and phototherapy for treatment of psoriasis in a cross-sectional design.
Ten outpatient dermatology sites across the United States participating in the Dermatology
Clinical Effectiveness Research Network contributed to the study. A total of 713 patients
with plaque psoriasis receiving systemic monotherapy (ie, methotrexate sodium,
adalimumab, etanercept, or ustekinumab) or narrowband UV-B phototherapy were included
in the study. The primary outcome of the study was clear or almost clear skin on the
Physician Global Assessment scale. Secondary outcomes were score on the Psoriasis Area
and Severity Index, affected body surface area, and score on the Dermatology Life Quality
Index. The proportion of patients with clear or almost clear ratings on the Physician Global
Assessment scale differed among treatments: methotrexate (23.8%), adalimumab (47.7%),
etanercept (34.2%), ustekinumab (36.1%), and narrowband UV-B (27.6%) (P < .001). In
adjusted analyses, patients receiving adalimumab (relative response rate, 2.15; 95% CI,
1.60-2.90), etanercept (1.45; 1.06-1.97), and ustekinumab (1.57; 1.06-2.32) were more
likely to have clear or almost clear skin vs patients receiving methotrexate. Patients
receiving phototherapy showed no significant difference (1.35; 95% CI, 0.93-1.96)
compared with those receiving methotrexate. No response difference was observed with
respect to quality of life. Treatment doses were double the recommended doses in 36.1% of
patients taking etanercept and 11.8% of those taking adalimumab;10.6% of patients
undergoing phototherapy received the recommended treatment frequency. Investigators
concluded the effectiveness of psoriasis therapies in clinical practice may be lower than that
reported in previous trials. Although relative differences in objective response rates among
therapies may exist, absolute differences are small and may not be clinically significant.
Dosing of common therapies varied from trial recommendations. These results provide novel
benchmarks emphasizing the critical importance of studying effectiveness in real-world
practice.
Scientific Rationale- Update April 2009
UVB light is categorized as wide-band and narrow-band, which refers to the range of
wavelengths included in the UV light source. The wide-band devices deliver full spectrum
UVB light. The narrow-band devices deliver a very narrow range of the UV light spectrum,
focusing on the specific wavelengths most effective for the treatment of disease. Narrowband UVB light can be delivered with either a light bulb or with a hand held laser device.
UVB treatment is typically offered using a light "booth" or "light box" several times a week
for as long as the condition persists, which may be for the lifetime of the patient.
The majority of patients undergoing UV treatment can be treated in the office. In cases
when patients require frequent treatments or live in remote locations, office visits may not
be practical. An alternative to in office UV treatment is home therapy with UVB light.
Complications of home light therapy includes mild erythema (which is considered a
therapeutic response), howver overexposure can cause serious burns, which could
potentially lead to skin cancer and visible permanent skin damage. Retinal damage may also
occur and members must be instructed to wear protective goggles. The genitalia must also
be protected unless this area is also affected.
Phototherapy for Psoriasis Mar 14
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Concerns about over-exposure to unsafe levels of UV radiation in the home setting have
been addressed with the evolution of integrated security features such as keys, pass codes,
etc. Even so, the patient needs to be assessed by a medical professional on a regular basis
during home therapy to determine the effectiveness of the therapy and to monitor for the
development of side effects, such as “sun burn” and pruritus (itching), as well as skin
cancer, photoaging, and liver or kidney disease.
There are limited studies in which home therapy and in office therapy outcomes are
compared. Most of the studies were small and focused on compliance with the home
treatment itself and indicated high compliance rates (80 – 96%) with no complications
noted. It was determined that this was a very effective treatment method for patients who
meet the criteria as noted in the policy statement.
Scientific Rationale – Update June 2008
Psoriasis is a life long disease that remits and relapses unpredictably. Psoriasis can range
from mild to severe, with the severity of psoriasis usually defined by the percentage of body
surface area (BSA) involved. Mild psoriasis generally affects less than 3% of the BSA while
moderate psoriasis is generally defined as psoriasis that covers 3 - 10% of the BSA. If more
than 10% of the body is affected, the disease is considered severe. When more than 5 to
10 percent body surface area is affected, the individual is generally a candidate for systemic
therapy, since application of topical agents to a large area is not usually practical or
acceptable for most patients. Although severe psoriasis is generally defined as the presence
of lesions over more than 10% of the BSA, psoriasis may also be deemed severe even when
the BSA involved is less than 10%, and phototherapy or systemic therapy should be
considered if the psoriasis proves unresponsive to optimized topical treatments. Individuals
with palmar or plantar psoriasis may have psoriasis that affects only 1% - 2% of the BSA,
however, it can be physically debilitating, impairing the use of the hands or feet, negatively
impacting the quality of life and it therefore may warrant aggressive therapy.
UVB phototherapy and ultraviolet A (UVA) phototherapy (PUVA) have been shown to be
beneficial in the treatment of psoriasis, however, there is a concern of an increased risk of
nonmelanoma skin cancer following PUVA therapy. As a result, PUVA is usually reserved for
severe, recalcitrant, disabling psoriasis.
Sezer et al (2007) evaluated the efficacy and safety of narrowband ultraviolet B (NB-UVB)
phototherapy compared to psoralen plus ultraviolet A (PUVA) in 25 patients with
palmoplantar psoriasis unresponsive to conventional therapies other than phototherapy.
Treatments were administered with NB-UVB on one side and PUVA on the other side three
times a week over 9 weeks. Clinical assessments were performed at baseline and every 3
weeks during the 9-week treatment. The author reported a statistically significant decrease
in the mean clinical scores at the third, sixth and ninth week with both treatments. The
difference in clinical response between the two treatment modalities was statistically
significant at the end of the treatment period, with the percentage reduction in severity
index scores with the PUVA treated side being 85.45% compared with 61.08% for the NBUVB treated side.
Yones et al (2006) also compared the efficacy of PUVA therapy to NB-UVB therapy in
ninety-three patients with chronic plaque psoriasis. Participants were treated twice-weekly
with NB-UVB or PUVA therapy, starting at 70% of the minimum phototoxic or erythema
dose, with 20% incremental increases, until clearance, up to a maximum of 30 sessions;
those with clearance were followed up until relapse or for 12 months. The author reported
that patients with skin types V and VI had a lower rate of clearance than those with skin
Phototherapy for Psoriasis Mar 14
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types I through IV. In patients with skin types I through IV, PUVA was significantly more
effective than NB-UVB at achieving clearance (84% vs 65%). The median number of
treatments to clearance was significantly lower in the PUVA group (17.0 vs 28.5). More
patients treated with PUVA vs NB-UVB were reported to have erythema at some stage
during treatment (49% vs 22%), although this difference may have been due to
ascertainment bias. Six months after the cessation of therapy, 68% of PUVA-treated
patients were still in remission vs 35% of NB-UVB-treated patients.
Scientific Rationale
Psoriasis is a common, genetically determined, inflammatory and proliferative disease of the
skin, the most characteristic lesions consisting of chronic, sharply demarcated, dull-red
scaly plaques, particularly on extensor parts of limbs and in the scalp. Work over the last
decade or so has shown that it is an immunological disease. A chance observation that an
immunosuppressive drug called cyclosporine used to prevent rejection in individuals with
organ transplants cleared psoriasis. Although there are no validated diagnostic criteria, the
diagnosis of psoriasis is clinical and in a majority of cases, histological confirmation is not
necessary. Skin biopsy may be useful in localized pustular psoriasis, in order to exclude
other clinically similar conditions. There are no laboratory findings specific for psoriasis.
Chronic stable plaque psoriasis (psoriasis vulgaris) is the commonest form of the disease,
accounting for 85-90 % of cases. The circumscribed infiltrated skin lesions are scaly and
erythematous and often symmetrically distributed over the body. Psoriasis may become a
disabling disease, and may even be life-threatening on rare occasions.
More recently a huge amount of work has defined many of the immunological events
involved in psoriasis. There is an immune activation of white cells called lymphocytes. The
type of lymphocytes called T-cell lymphocytes are activated and in turn produce chemical
mediators known as cytokines. These cause the cells within the epidermis to grow quickly.
The interaction between the lymphocytes and the cells that introduce the antigen and the
cytokines that are produced is very complicated. Cytokines are chemicals such as interferon,
interleukin or tumor necrosis factors. The discovery of the interactions between these cells
and the specific receptors on the cell surfaces as well as the chemicals that they release has
given the research community an opportunity to develop drugs that block this cascade of
activity at different points.
The choice of treatment depends on the psoriasis subtype and the extent, severity, and site
of the lesions. Topical agents are often used as a first-line therapy in the treatment of
limited plaque psoriasis. These include salicylic acid, steroids, Vitamin-D analogues (such as
calcipotriol), tazarotene, dithranol, coal tar extracts and combination of any of these agents.
Phototherapy with Ultraviolet B (UVB) light or psoralen plus ultraviolet A (PUVA) is often
used as a first-line treatment of widespread lesions; they are also used as second-line
treatment when topical therapy is insufficient. UVB light waves have wavelength’s ranging
between 290-320 nm. and is the wavelength in sunlight which is responsible for most of the
sunburns. UVB has been used for many years, is highly effective as treatment of plaque
psoriasis, is particularly beneficial in guttate psoriasis, may cause acute phototoxicity, and
has little to no long-term side effects. UVB can be used at home for maintenance therapy.
Sometimes tar, anthralin, calcipotriol/calcipotriene, or tazarotene topical therapy is also
used in conjunction with UVB phototherapy. In 1925, Goeckerman used tar in addition to
UVB, the Ingram method refers to tar baths, topical anthralin, and UVB. UVB is given to the
whole body in a cabinet, or to localized areas with a small portable unit. Most UVB given is
broadband UVB. Narrow band UVB, which has a wavelength of 311 nm, is available in
certain centers. Some patients may do better with narrow band UVB, but the risk of a
sunburn reaction may be greater. The eyes need to be protected with special glasses during
Phototherapy for Psoriasis Mar 14
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UVB treatment in order to prevent eye damage. Although treatment is often limited to 2-4
weeks, long term treatment might be associated with aging of the skin, burning, and
potentially an increase in skin cancer. UVB is usually administered three times a week for
three months for clearing and maintenance can be achieved by using it less frequently. Long
remissions may occur after UVB phototherapy. The mechanism of action is unknown. It
may reduce synthesis of DNA within epidermal cells and alter the immune response in the
skin. It is less effective than PUVA but can be improved by adding other systemic therapies.
The onset of response is slow.
PUVA therapy is an effective but also highly demanding form of phototherapy. The
mechanism of action is unknown but involves the interaction of methoxsalen into DNA
forming cross links. This results in the reduction of DNA synthesis and blocks cell
proliferation. It may also suppress immune response in the skin. The photosensitizing
effects of different psoralens vary ten-fold. During RePUVA therapy the patient receives a
concomitant systemic retinoid (acitretin). The PUVA therapies have fallen out of favor due to
increased risk of skin cancer associated with tablet-PUVA therapy. Despite the associated
risks, PUVA may still be the best choice for some patients in problematic cases. PUVA
therapy is usually given initially 2 to 3 times a week, then less frequently as the skin
improves. It takes about 25 treatments over a 2-3 month period before clearing takes
place. Long remissions may occur after PUVA therapy. Maintenance of improvement can in
some be achieved by much less frequent use. The efficacy is very significant in a large
percentage of patients. The duration of effect is long but the onset of improvement is slow.
Narrow Band UVB is seen to be more effective than UVB. It can cause freckling and changes
of skin aging. It takes longer to administer narrow band versus regular UVB. PUVA stands
for Psoralen (a medication that sensitizes the skin to ultraviolet A light waves) + UVA
(ultraviolet A, with a wavelength range of 320-400 nm). The psoralen may be taken
internally as a pill or applied to the skin (in bath water or as a cream, ointment, or lotion).
After a set time after the psoralen has been taken or applied, the skin is exposed to
ultraviolet A radiation in a cabinet or with a small portable unit.
Systemic therapy with retinoids with or without combination with UV-light, methotrexate
and cyclosporine A are indicated in severe forms of psoriasis, and in patients with
widespread plaque lesions. Systemic therapy may also be indicated in patients with limited
but very disabling lesions (e.g. hand psoriasis). Combined treatment with topical therapies
are common clinical practice to control the disease and to reduce the total dose of the
systemic agent and thereby, at least theoretically, lessen the risk of serious adverse effects.
Laser light treatment has been used for localized resistant patches with some success. The
laser used is the 308nm Eximer laser which gives a quick response. Since the light beam is
relatively small, it is not a practical treatment option for generalized disease. The laser
allows treatment of only involved skin; thus, considerably higher doses of UVB can be
administered to psoriatic plaques at a given treatment compared with traditional
phototherapy. Uncontrolled trials suggest that laser therapy results in faster responses than
conventional phototherapy. As an example, one study of excimer laser therapy involved 124
patients with stable mild to moderate plaque psoriasis, of whom 80 completed the entire
protocol. Treatments were scheduled twice weekly. After 10 or fewer treatments, 84 and 50
percent of patients achieved the outcomes of 75 percent or better and 90 percent or better
clearing of plaques, respectively. This number of treatments was far fewer than that
typically required of phototherapy (25 or more). Side effects of laser therapy included
erythema and blistering; these were generally well tolerated, and no patient discontinued
Phototherapy for Psoriasis Mar 14
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therapy because of adverse effects. Like 311 nm UVB, the excimer laser represents a
therapeutic advance toward specific wavelength therapies for psoriasis.
Previous immune therapy has involved drugs that have a general suppressing effect on the
immune system which consequently prevents high doses being used because of the fear of
side effects. Theoretically the more specific the target to be blocked, the less interference
with other biological functions - making the drug safer.
New drugs, known as biological drugs, are designed to specifically hit immunological targets
that are involved in specific conditions. There are a number of new biologic drugs that are
currently used in psoriasis: alefacept (Amevive), efalizumab (Raptiva), inflixiamab
(Remicade) and etanercept (Enbrel). These drugs can target different steps in the pathway
of producing psoriasis. The following general targets have been identified and can be
blocked: T-cell activation, inhibiting memory or activated T-cells, blocking the migration of
T-cells into the skin, inhibiting the chemicals or cytokines produced (e.g., tumor necrosis
factor) and blocking conversion of one cytokine into another
The results of clinical trials on biological drugs for psoriasis were very similar in terms of
efficacy. The measurement of improvement is measured by the PASI score which takes into
account the surface area of psoriasis involved as well as the severity of the individual
lesions in terms of thickness, redness and scaling. This is a standard measure of
improvement. In a typical study the patients were given 15 mg intramuscularly once a
week. The results showed twenty-four patients with almost total clearing, thirty-three
showed a greater than seventy-five percent reduction in their PASI score and fifty-seven
showed greater than fifty percent reduction. Patients are also asked to evaluate the results
using the Dermatology Life Quality Index (DLQI). This is a questionnaire on the impact of
disease on quality of life. Interestingly, patients with seventy-five percent reduction in PASI
are as happy as those who are completely clear. Those patients with a fifty percent
reduction in their PASI score also showed significant increase in their quality of life
measurement. The improvement in quality of life scores were at least sixty percent, even in
those who showed a fifty percent reduction in their PASI. Most importantly, all aspects of
the improvement persisted well after discontinuing therapy. This is a very strong factor in
favor of these drugs.
Individually, the efficacy of Raptiva is largely based on 7 key studies that included more
than 3,200 patients: 5 placebo controlled studies, plus two extension studies ranging from
12 weeks to 1 year and a long term open label trial for treatment up to 27 months. Patients
randomized to the Raptiva dose group achieved statistically significantly better responses
than placebo on the primary endpoint, i.e., achieving a greater or equal to 75%
improvement in PASI score compared to baseline in all studies. For example, in one study of
339 patients, 41% achieved PASI-75 and 82% achieved PASI-50 at week-12. The
improvement in PASI score in the Raptiva arm relative to the placebo arm was seen as early
as week 2 of treatment and increased over time.
Etanercept (Enbrel) is a fusion protein. This is a TNF-alpha receptor fused onto human IgG.
It acts by inhibiting TNF-alpha activity. In patients with skin psoriasis about one quarter
showed seventy-five percent improvement in their PASI scores. Inflixiamab (Remicade) is a
monoclonal antibody targeted against human tumor necrosis factor-alpha. It is bound to
newly bound surface and soluble circulating TNF. It is a chimeric molecule - meaning a
human-mouse combination. It, too, has a very dramatic effect when given to patients with
psoriasis.
Phototherapy for Psoriasis Mar 14
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Review History
June 2007
June 2008
April 2009
April 2011
March 2012
March 2013
March 2014
Medical Advisory Council, Clinical Pharmacy Advisory
Committee initial approval
Renamed policy to Phototherapy for Psoriasis; removed sections
regarding biological therapies and laser therapy; added PUVA
treatments as medically necessary for palmar/plantar psoriasis when
criteria is met; defined mild, moderate and severe psoriasis
Added section on Home Phototherapy (UBV) Treatment
Update. Added Medicare Table. No revisions.
Update – removed treatments noted under the not medically
necessary list that were not related to phototherapy, but rather other
forms of treatment of psoriasis. Code Updates.
Update – no revisions
Update – no revisions
This policy is based on the following evidence-based guidelines:
1.
2.
3.
4.
5.
6.
7.
8.
British Association of Dermatologists Psoriasis Guideline 2006. Available at:
http://www.bad.org.uk/site/1120/Default.aspx
European Medicines Agency. Guideline On Clinical Investigation Of Medicinal Products
Indicated For The Treatment Of Psoriasis. November 2004.
Pardasani AG, Feldman SR, Clark AR. Treatment of Psoriasis: An Algorithm-Based
Approach for Primary Care Physicians. Am Fam Physician 2000;61:725-33,736.
Available at: http://www.aafp.org/afp/20000201/725.html
National Institute for Health and Clinical Excellence (NICE). Etanercept and efalizumab
for the treatment of adults with psoriasis. London (UK): National Institute for Health
and Clinical Excellence (NICE); 2006 Jul.
Finnish Medical Society Duodecim. Psoriasis. In: EBM Guidelines. Evidence-Based
Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2005 May
25.
American Academy of Dermatology. Guidelines of care for the management of psoriasis
and psoriatic arthritis. May 2008.
American Osteopathic College of Dermatology. Psoriasis. Available at:
http://www.aocd.org/skin/dermatologic_diseases/psoriasis.html
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of
psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of
psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;
62 (1): 114-35. Available at: http://www.aad.org/research/guidelines/index.html
References – Update March 2014
1.
2.
3.
Almutawa F, Alnomair N, Wang Y, et al. Systematic review of UV-based therapy for
psoriasis. Am J Clin Dermatol. 2013 Apr;14(2):87-109
Almutawa F, Thalib L, Hekman D, et al. Efficacy of localized phototherapy and
photodynamic therapy for psoriasis: a systematic review and meta-analysis.
Photodermatol Photoimmunol Photomed. 2013 Nov 28. doi: 10.1111/phpp.12092.
[Epub ahead of print]
Armstrong AW, Robertson AD, Wu J, et al. Undertreatment, treatment trends, and
treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the
United States: findings from the National Psoriasis Foundation surveys, 2003-2011.
JAMA Dermatol. 2013 Oct;149(10):1180-5.
Phototherapy for Psoriasis Mar 14
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4.
5.
6.
Chen X, Yang M, Cheng Y, et al. Narrow-band ultraviolet B phototherapy versus broadband ultraviolet B or psoralen-ultraviolet A photochemotherapy for psoriasis. Cochrane
Database Syst Rev. 2013 Oct 23;10:CD009481.
Richard EG, Hönigsmann H. Phototherapy, psoriasis, and the age of biologics.
Photodermatol Photoimmunol Photomed. 2014 Feb;30(1):3-7.
Sen BB, Rifaioglu EN, Ekiz O, et al. Narrow-band ultraviolet B phototherapy in
childhood. Cutan Ocul Toxicol. 2013 Oct 22.
References – Update March 2013
1.
2.
3.
4.
5.
Archier E, Devaux S, Castela E, et al. 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 May;26 Suppl 3:11-21.
Gustafson CJ, Watkins C, Hix E, Feldman SR. Combination therapy in psoriasis : an
evidence-based review. Am J Clin Dermatol. 2013 Feb;14(1):9-25.
Gelfand JM, Wan J, Callis Duffin K, et al. Comparative effectiveness of commonly used
systemic treatments or phototherapy for moderate to severe plaque psoriasis in the
clinical practice setting. Arch Dermatol. 2012 Apr;148(4):487-94.
Lui H, Gulliver W, Tan J, et al. A randomized controlled study of combination therapy
with alefacept and narrow band UVB phototherapy (UVB) for moderate to severe
psoriasis: efficacy, onset, and duration of response. J Drugs Dermatol. 2012
Aug;11(8):929-37.
Takahashi H, Tsuji H, Ishida-Yamamoto A, Iizuka H. Comparison of clinical effects of
psoriasis treatment regimens among calcipotriol alone, narrowband ultraviolet B
phototherapy alone, combination of calcipotriol and narrowband ultraviolet B
phototherapy once a week, and combination of calcipotriol and narrowband ultraviolet B
phototherapy more than twice a week. J Dermatol. 2013 Feb 18.
References – Update March 2012
1.
2.
3.
4.
5.
6.
7.
Al Robaee AA, Alzolibani AA. Narrowband ultraviolet B phototherapy improves the
quality of life in patients with psoriasis. Saudi Med J. 2011 Jun;32(6):603-6.
Benáková N. Phototherapy of psoriasis in the era of biologics: still in. Acta
Dermatovenerol Croat. 2011 Sep;19(3):195-205.
Ehsani AH, Ghaninejad H, Kiani A, et al. Comparison of topical 8-methoxypsoralen and
narrowband ultraviolet B with narrowband ultraviolet B alone in treatment-resistant
sites in plaque-type psoriasis: a placebo-controlled study. Photodermatol
Photoimmunol Photomed. 2011 Dec;27(6):294-6.
Lapolla W, Yentzer BA, Bagel J, et al. A review of phototherapy protocols for psoriasis
treatment. J Am Acad Dermatol. 2011 May;64(5):936-49.
Lynde CW, Gupta AK, Guenther L, et al. A randomized study comparing the
combination of nbUVB and etanercept to etanercept monotherapy in patients with
psoriasis who do not exhibit an excellent response after 12 weeks of etanercept. J
Dermatolog Treat. 2011 Aug 10.
Mudigonda T, Dabade TS, Feldman SR. A review of targeted ultraviolet B phototherapy
for psoriasis. J Am Acad Dermatol. 2011 Oct 13.
Schaarschmidt ML, Umar N, Schmieder A, et al. Patient preferences for psoriasis
treatments: impact of treatment experience. J Eur Acad Dermatol Venereol. 2012 Jan
6. doi: 10.1111/j.1468-3083.2011.04440.x.
References – Update April 2011
1.
Lapolla W, Yentzer BA, Bagel J, et al. A review of phototherapy protocols for psoriasis
treatment. J Am Acad Dermatol. 2011 Mar 21.
Phototherapy for Psoriasis Mar 14
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2.
Beani JC, Jeanmougin M. Narrow-band UVB therapy in psoriasis vulgaris: good practice
guideline and recommendations of the French Society of Photodermatology. Ann
Dermatol Venereol. 2010 Jan;137(1):21-31.
References – Update April 2009 (home phototherapy)
1. Mayke BG et al UVB phototherapy in an outpatient setting or at home: a pragmatic
randomised single-blind trial designed to settle the discussion. The PLUTO study BMC
Med Res Methodol. 2006; 6: 39. Published online 2006 August 1. doi: 10.1186/14712288-6-39.
2. Koek MB, Buskens E, Bruijnzeel-Koomen CA, Sigurdsson V. Home ultraviolet B
phototherapy for psoriasis: Discrepancy between literature, guidelines, general opinions
and actual use. Results of a literature review, a web search, and a questionnaire among
dermatologists. Br J Dermatol. 2006;154(4):701-711
3. 31. S. R. Feldman, A. Clark, D. M. Reboussin, and A. B. Fleischer, Jr. An assessment of
potential problems of home phototherapy treatment of psoriasis. Cutis 58 (1):71-73,
1996.
4. Sarkany RP, A Anstey, BBL Diffey, et al. “Home Phototherapy: Report on a Workshop of
the British Photodermatology Group.” 1999 February;140(2):195- 199.
5. Brad A. Yentzer, MD Adherence to acitretin and home narrowband ultraviolet B
phototherapy in patients with psoriasis Journal of the American Academy of Dermatology
- Volume 59, Issue 4 (October 2008)
References – Update June 2008
1.
El-Mofty M, El Weshahy H, Youssef R, et al. A comparative study of different treatment
frequencies of psoralen and ultraviolet A in psoriatic patients with darker skin types
(randomized-controlled study). Photodermatol Photoimmunol Photomed. 2008 Feb;
24(1): 38-42.
2. Kircik L, Bagel J, Korman N, et al. Utilization of narrow-band ultraviolet light B therapy
and etanercept for the treatment of psoriasis (UNITE): efficacy, safety, and patientreported outcomes. J Drugs Dermatol. 2008 Mar; 7(3): 245-53.
3. Patel V, Horn EJ, Lobosco SJ, et al. Psoriasis treatment patterns: results of a crosssectional survey of dermatologists. J Am Acad Dermatol. 2008 Jun; 58(6):964-9
4. Smith EC, Riddle C, Minter MA, et al. Combining systemic retinoid with biologic agents
for moderate to severe psoriasis. Into J Dermatology. 2008 May; 47(5): 514-8.
5. Trott J, Gerber W, Hammes S, Ockenfels HM. The effectiveness of PUVA treatment in
severe psoriasis is significantly increased by additional UV 308-nm excimer laser
sessions. Eur J Dermatol. 2008 Jan-Feb; 18(1): 55-60.
6. Ceović R, Pasić A, Lipozencić J, et al. Antiproliferative, antiangiogenic and apoptotic
effect of photochemotherapy (PUVA) in psoriasis patients. Coll Antropol. 2007 Jun;
31(2):551-6.
7. Daoud L, Dhaoui MR, Youssef S, et al. Management of severe psoriasis: about 50
cases. Tunis Med. 2007 Oct; 85(10): 849-56.
8. Jones-Caballero M, Unaeze J, Peñas PF, Stern RS. Use of biological agents in patients
with moderate to severe psoriasis: a cohort-based perspective. Arch Dermatol. 2007
Jul; 143(7):846-50.
9. Lapidoth M, Adatto M, David M. Targeted UVB phototherapy for psoriasis: a preliminary
study. Clin Exp Dermatol. 2007 Nov; 32(6): 642-5.
10. Menter A, Griffiths CE. Current and future management of psoriasis. Lancet. 2007 Jul
21; 370(9583): 272-84.
Phototherapy for Psoriasis Mar 14
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11. Seer E, Erbil AH, Kurumlu Z, et al. Comparison of the efficacy of local narrowband
ultraviolet B (NB-UVB) phototherapy versus psoralen plus ultraviolet A (PUVA) paint for
palmoplantar psoriasis. J Dermatol. 2007 Jul; 34(7): 435-40.
12. Valbuena MC, Hernández O, Rey M, et al. Twice- vs. thrice-weekly MPD PUVA in
psoriasis: a randomized-controlled efficacy study. Photodermatol Photoimmunol
Photomed. 2007 Aug; 23(4):126-9.
13. Zakarian K, Nguyen A, Letsinger J, Koo J. Excimer laser for psoriasis: a review of
theories regarding enhanced efficacy over traditional UVB phototherapy Drugs
Dermatol. 2007 Aug; 6(8): 794-8.
14. Altiner DD, Ilknur T, Fetil E, et al. Comparison of weekly and daily incremental
protocols of narrowband ultraviolet B phototherapy for psoriasis. J Eur Acad Dermatol
Venereol. 2006 Oct; 20(9): 1076-80.
15. Boztepe G, Akinci H, Sahin S, et al. In search of an optimum dose escalation for
narrowband UVB phototherapy: is it time to quit 20% increments? J Am Acad
Dermatol. 2006 Aug; 55(2): 269-71
16. Boztepe G, Karaduman A, Sahin S, et al. The effect of maintenance narrow-band
ultraviolet B therapy on the duration of remission for psoriasis: a prospective
randomized clinical trial. Int J Dermatol. 2006 Mar; 45(3): 245-50.
17. Goldinger SM, Dummer R, Schmid P, et al. Excimer laser versus narrow-band UVB (311
nm) in the treatment of psoriasis vulgaris. Dermatology. 2006; 213(2): 134-9.
18. Lim C, Brown P. Quality of life in psoriasis improves after standardized administration
of narrowband UVB phototherapy. Australas J Dermatol. 2006 Feb; 47(1): 37-40
19. Luba KM, Stulberg DL. Chronic plaque psoriasis. Am Fam Physician. 2006 Feb 15;
73(4): 636-44.
20. Magliocco MA, Pandya K, Dombrovskiy V, et al. A randomized, double-blind, vehiclecontrolled, bilateral comparison trial of bexarotene gel 1% versus vehicle gel in
combination with narrowband UVB phototherapy for moderate to severe psoriasis
vulgaris. J Am Acad Dermatol. 2006 Jan; 54(1): 115-8.
21. Neumann NJ, Mahnke N, Korpusik D, et al. Treatment of palmoplantar psoriasis with
monochromatic excimer light (308-nm) versus cream PUVA. Acta Derm Venereol.
2006; 86(1): 22-4.
22. Nisticò SP, Saraceno R, Stefanescu S, Chimenti S. A 308-nm monochromatic excimer
light in the treatment of palmoplantar psoriasis. J Eur Acad Dermatol Venereol. 2006
May; 20(5): 523-6.
23. Schleyer V, Radakovic-Fijan S, Karrer S, et al. Disappointing results and low tolerability
of photodynamic therapy with topical 5-aminolaevulinic acid in psoriasis. A randomized,
double-blind phase I/II study. J Eur Acad Dermatol Venereol. 2006 Aug; 20(7): 823-8.
24. Yones SS, Palmer RA, Garibaldinos TT, Hawk JL. Randomized double-blind trial of the
treatment of chronic plaque psoriasis: efficacy of psoralen-UV-A therapy vs narrowband
UV-B therapy. Arch Dermatol. 2006 Jul; 142(7): 836-42.
References
1.
Dhillon S, Lyseng-Williamson KA, Scott LJ. Etanercept: a review of its use in the
management of rheumatoid arthritis. Drugs. 2007;67(8):1211-41.
2. Langley RG, Gupta AK, Cherman AM, Inniss KA. Biologic therapeutics in the treatment
of psoriasis. Part 1: review. J Cutan Med Surg. 2007 May-Jun;11(3):99-122.
3. Romero-Mate A, Garcia-Donoso C, Cordoba-Guijarro S. Efficacy and safety of
etanercept in psoriasis/psoriatic arthritis: an updated review. Am J Clin Dermatol.
2007;8(3):143-55.
4. Pirzada S, Tomi Z, Gulliver W. A review of biologic treatments for psoriasis with
emphasis on infliximab. Skin Therapy Lett. 2007 Apr;12(3):1-4.
5. Jobling R. Psoriasis. BMJ. 2007 May 5;334(7600):953-4.
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6.
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8.
9.
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27.
Price J, Bhosle M, Feldman SR, Balkrishnan R. Outcomes associated with the use of
biologic agents in moderate to severe psoriasis. J Drugs Dermatol. 2007 Mar;6(3):25967.
Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature.
2007 Feb 22;445(7130):866-73.
Nickoloff, BJ, Nestle, FO. Recent insights into the immunopathogenesis of psoriasis
provide new therapeutic opportunities. J Clin Invest 2004; 113:1664.
Bowcock, AM, Barker, JN. Genetics of psoriasis: the potential impact on new therapies.
J Am Acad Dermatol 2003; 49:S51.
Cassell, S, Kavanaugh, AF. Therapies for psoriatic nail disease. A systematic review. J
Rheumatol 2006; 33:1452.
Lebwohl, M, Ali, S. Treatment of psoriasis. Part 1. Topical therapy and phototherapy. J
Am Acad Dermatol 2001; 45:487.
Goodfield, M, Kownacki, S, Berth-Jones, J. Double-blind, randomised, multicentre,
parallel group study comparing a 1% coal tar preparation (Exorex) with a 5% coal tar
preparation (Alphosyl) in chronic plaque psoriasis. J Dermatolog Treat 2004; 15:14.
Tzaneva, S, Honigsmann, H, Tanew, A. Observer-blind, randomized, intrapatient
comparison of a novel 1% coal tar preparation (Exorex) and calcipotriol cream in the
treatment of plaque type psoriasis. Br J Dermatol 2003; 149:350.
Kragballe, K, van de, Kerkhof PC. Consistency of data in six phase III clinical studies of
a two-compound product containing calcipotriol and betamethasone dipropionate
ointment for the treatment of psoriasis. J Eur Acad Dermatol Venereol 2006; 20:39.
Koo, J, Blum, RR, Lebwohl, M. A randomized, multicenter study of calcipotriene
ointment and clobetasol propionate foam in the sequential treatment of localized
plaque-type psoriasis: short- and long-term outcomes. J Am Acad Dermatol 2006;
55:637.
Housman, TS, Rohrback, JM, Fleischer, AB Jr, Feldman, SR. Phototherapy utilization for
psoriasis is declining in the United States. J Am Acad Dermatol 2002; 46:557.
Stern, RS, Nichols, KT, Vakeva, LH, et al. Malignant melanoma in patients treated for
psoriasis with methoxsalen (psoralen) and ultraviolet A radiation (PUVA). N Engl J Med
1997; 336:1041.
Feldman, SR, Mellen, BG, Housman, TS, et al. Efficacy of the 308-nm excimer laser for
treatment of psoriasis: results of a multicenter study. J Am Acad Dermatol 2002;
46:900.
Gerber, W, Arheilger, B, Ha, TA, et al. Ultraviolet B 308-nm excimer laser treatment of
psoriasis: a new phototherapeutic approach. Br J Dermatol 2003; 149:1250.
Heydendael, VM, Spuls, PI, Opmeer, BC, et al. Methotrexate versus cyclosporine in
moderate-to-severe chronic plaque psoriasis. N Engl J Med 2003; 349:658.
Lebwohl, M, Drake, L, Menter, A, et al. Consensus conference: acitretin in combination
with UVB or PUVA in the treatment of psoriasis. J Am Acad Dermatol 2001; 45:544.
Strober, BE, Siu, K, Menon, K. Conventional systemic agents for psoriasis. A systematic
review. J Rheumatol 2006; 33:1442.
Lebwohl, M. Psoriasis. Lancet 2003; 361:1197.
Kupper, TS. Immunologic targets in psoriasis. N Engl J Med 2003; 349:1987.
Boehncke, WH, Prinz, J, Gottlieb, AB. Biologic therapies for psoriasis. A systematic
review. J Rheumatol 2006; 33:1447.
Iyer, S, Yamauchi, P, Lowe, NJ. Etanercept for severe psoriasis and psoriatic arthritis:
observations on combination therapy. Br J Dermatol 2002; 146:118.
Leonardi, CL, Powers, JL, Matheson, RT, et al. Etanercept as monotherapy in patients
with psoriasis. N Engl J Med 2003; 349:2014.
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28. Krueger, GG, Papp, KA, Stough, DB, Loven, KH. A randomized, double-blind, placebocontrolled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in
patients with chronic plaque psoriasis. J Am Acad Dermatol 2002; 47:821.
29. Menter, A, Cather, JC, Baker, D, et al. The efficacy of multiple courses of alefacept in
patients with moderate to severe chronic plaque psoriasis. J Am Acad Dermatol 2006;
54:61.
30. Gribetz, CH, Blum, R, Brady, C, et al. An extended 16-week course of alefacept in the
treatment of chronic plaque psoriasis. J Am Acad Dermatol 2005; 53:73.
31. Lebwohl, M, Tyring, SK, Hamilton, TK, et al. A novel targeted T-cell modulator,
efalizumab, for plaque psoriasis. N Engl J Med 2003; 349:2004.
32. Gordon, KB, Papp, KA, Hamilton, TK, et al. Efalizumab for patients with moderate to
severe plaque psoriasis: a randomized controlled trial. JAMA 2003; 290:3073.
33. Chaudhari, U, Romano, P, Mulcahy, LD, et al. Efficacy and safety of infliximab
monotherapy for plaque-type psoriasis: a randomised trial. Lancet 2001; 357:1842.
34. Gottlieb, AB, Masud, S, Ramamurthi, R, et al. Pharmacodynamic and pharmacokinetic
response to anti-tumor necrosis factor-alpha monoclonal antibody (infliximab)
treatment of moderate to severe psoriasis vulgaris. J Am Acad Dermatol 2003; 48:68.
35. Gottlieb, AB, Evans, R, Li, S, et al. Infliximab induction therapy for patients with severe
plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad
Dermatol 2004; 51:534.
36. Reich, K, Nestle, FO, Papp, K, et al. Infliximab induction and maintenance therapy for
moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005;
366:1367.
37. Gordon, KB, Langley, RG, Leonardi, C, et al. Clinical response to adalimumab treatment
in patients with moderate to severe psoriasis: double-blind, randomized controlled trial
and open-label extension study. J Am Acad Dermatol 2006; 55:598.
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Phototherapy for Psoriasis Mar 14
15
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Phototherapy for Psoriasis Mar 14
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Appendix A
To calculate a patient’s PASI score, the body is divided into four sections: legs, body (trunk
area), arms and head. For each skin section, the amount of skin involved is measured as a
percentage, and then assigned a score from 0 to 6:
Coverage Score
0%
0
< 10%
1
10-29%
2
30-49%
3
50-69%
4
70-89%
5
90-100%
6
The severity is measured by four different parameters: itching, erythema (redness), scaling
and thickness, as psoriatic skin is thicker than normal skin. Again, each of these is
measured separately for each skin section. These are measured on a scale of 0 to 4, from
none to 'maximum', according to the following chart:
Severity Score
None
0
Some
1
Moderate
2
Severe
3
Maximum
4
When all 20 of the above scores are figured out, the PASI is ready to be calculated. For each
skin section, add up the four severity scores, multiply the total by the area score, and then
multiply that result by the percentage of skin in that section. The PASI will range from 0 (no
psoriasis) to 96 (covered head-to-toe, with complete itching, redness, scaling, and
thickness).
For an online calculator, go to this site where E = erythema, I = itching and D =
desquamation:
http://irc.projectjj.com/pasicalc.html
Phototherapy for Psoriasis Mar 14
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