National Medical Policy

Transcription

1 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 Subject: Policy Number: Phototherapy for Psoriasis Please see related policy on Excimer Laser for Psoriasis NMP350 Effective Date*: June 2007 Updated: March 2015 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 Source Reference/Website Link X National Coverage Determination (NCD) Treatment of Psoriasis (250.1): National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. 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 Phototherapy for Psoriasis Mar 15 1

2 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. 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: Phototherapy for Psoriasis Mar 15 2

3 1. Targeted phototherapy for the first-line treatment of mild psoriasis 2. Tanning beds for home UVB phototherapy. (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, 2015, 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, 2015 implementation date. ICD-9 Codes Plaque psoriasis ICD-10 Code L40.0 Psoriasis vulgaris CPT Codes 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 Ultraviolet light therapy system, includes bulb/lamps, timer and eye protection; treatment area 2 sq ft or less E0692 Ultraviolet light therapy system panel, includes bulbs/lamps, timer and eye protection, 4 foot panel E0693 Ultraviolet light therapy system panel, includes bulbs/lamps, timer and eye protection, 6 foot panel E0694 Ultraviolet multidirectional light therapy system in 6 foot cabinet, includes bulbs/lamps, timer and eye protection Scientific Rationale Update March 2015 Phototherapy for Psoriasis Mar 15 3

4 The National Psoriasis Foundation does not support the use of indoor tanning beds as a substitute for phototherapy performed with a prescription and under the supervision of a physician. Only medical professionals should provide and advertise light therapy for the treatment of psoriasis. Per the National Psoriasis Foundation, phototherapy is one of the safest and most cost-effective therapies for psoriasis and is a recommended therapy option for certain subsets of psoriasis patients with limited treatment options, including children, pregnant women, nursing women and immunosuppressed patients. The American Academy of Dermatology, the United States Department of Health and Human Services and the World Health Organization all discourage the use of tanning beds and sun lamps. The ultraviolet radiation from these devices can damage the skin, cause premature aging and increase the risk of skin cancer. 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 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 ), 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 8- methoxypsoralen-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. Phototherapy for Psoriasis Mar 15 4

5 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 ), 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 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, ), etanercept (1.45; ), and ustekinumab (1.57; ) 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, ) 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. Phototherapy for Psoriasis Mar 15 5

6 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. 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 Phototherapy for Psoriasis Mar 15 6

7 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 NB- UVB 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 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 % 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 nm. and is the wavelength in sunlight which is responsible for most of the Phototherapy for Psoriasis Mar 15 7

8 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 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 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 Phototherapy for Psoriasis Mar 15 8

9 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 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. Phototherapy for Psoriasis Mar 15 9

10 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. Review History June 2007 Medical Advisory Council, Clinical Pharmacy Advisory Committee initial approval June 2008 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 April 2009 Added section on Home Phototherapy (UBV) Treatment April 2011 Update. Added Medicare Table. No revisions. March 2012 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. March 2013 Update no revisions. Codes updated March 2014 Update no revisions. Codes updated March 2015 Update no revisions. Codes updated. This policy is based on the following evidence-based guidelines: 1. British Association of Dermatologists Psoriasis Guideline Available at: 2. European Medicines Agency. Guideline On Clinical Investigation Of Medicinal Products Indicated For The Treatment Of Psoriasis. November 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: 4. 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. 5. Finnish Medical Society Duodecim. Psoriasis. In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2005 May American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. May American Osteopathic College of Dermatology. Psoriasis. Available at: 8. 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 Jan; 62 (1): Available at: 9. Hayes. Health Technology Brief. Home Ultraviolet B Phototherapy for Psoriasis. December Updated December 23, References Update March 2015 Phototherapy for Psoriasis Mar 15 10

11 1. Franken SM, Witte B, Pavel S, et al. Psoriasis and daily low-emission phototherapy: effects on disease and vitamin D level. Photodermatol Photoimmunol Photomed Nov 7. doi: /phpp [Epub ahead of print]. 2. Mustonen A, Mattila K, Leino M, et al. Psoriasis causes significant economic burden to patients. Dermatol Ther (Heidelb) Jun;4(1): doi: /s Epub 2014 May Cameron H, Yule S, Dawe RS, et al. Review of an established UK home phototherapy service : improving access to a cost-effective treatment for chronic skin disease. Public Health Apr;128(4): doi: /j.puhe Epub 2014 Apr 13. References Update March Almutawa F, Alnomair N, Wang Y, et al. Systematic review of UV-based therapy for psoriasis. Am J Clin Dermatol Apr;14(2): 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 Nov 28. doi: /phpp [Epub ahead of print] 3. 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, JAMA Dermatol Oct;149(10): 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 Oct 23;10:CD Richard EG, Hönigsmann H. Phototherapy, psoriasis, and the age of biologics. Photodermatol Photoimmunol Photomed Feb;30(1): Sen BB, Rifaioglu EN, Ekiz O, et al. Narrow-band ultraviolet B phototherapy in childhood. Cutan Ocul Toxicol Oct 22. References Update March 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 May;26 Suppl 3: Gustafson CJ, Watkins C, Hix E, Feldman SR. Combination therapy in psoriasis : an evidence-based review. Am J Clin Dermatol Feb;14(1): 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 Apr;148(4): 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 Aug;11(8): 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 Feb 18. References Update March 2012 Phototherapy for Psoriasis Mar 15 11

12 1. Al Robaee AA, Alzolibani AA. Narrowband ultraviolet B phototherapy improves the quality of life in patients with psoriasis. Saudi Med J Jun;32(6): Benáková N. Phototherapy of psoriasis in the era of biologics: still in. Acta Dermatovenerol Croat Sep;19(3): 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 Dec;27(6): Lapolla W, Yentzer BA, Bagel J, et al. A review of phototherapy protocols for psoriasis treatment. J Am Acad Dermatol May;64(5): 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 Aug Mudigonda T, Dabade TS, Feldman SR. A review of targeted ultraviolet B phototherapy for psoriasis. J Am Acad Dermatol Oct Schaarschmidt ML, Umar N, Schmieder A, et al. Patient preferences for psoriasis treatments: impact of treatment experience. J Eur Acad Dermatol Venereol Jan 6. doi: /j x. References Update April Lapolla W, Yentzer BA, Bagel J, et al. A review of phototherapy protocols for psoriasis treatment. J Am Acad Dermatol Mar 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 Jan;137(1): 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: / 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): 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, Sarkany RP, A Anstey, BBL Diffey, et al. Home Phototherapy: Report on a Workshop of the British Photodermatology Group February;140(2): 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 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 Feb; 24(1): Phototherapy for Psoriasis Mar 15 12

13 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 Mar; 7(3): Patel V, Horn EJ, Lobosco SJ, et al. Psoriasis treatment patterns: results of a crosssectional survey of dermatologists. J Am Acad Dermatol Jun; 58(6): Smith EC, Riddle C, Minter MA, et al. Combining systemic retinoid with biologic agents for moderate to severe psoriasis. Into J Dermatology May; 47(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 Jan-Feb; 18(1): Ceović R, Pasić A, Lipozencić J, et al. Antiproliferative, antiangiogenic and apoptotic effect of photochemotherapy (PUVA) in psoriasis patients. Coll Antropol Jun; 31(2): Daoud L, Dhaoui MR, Youssef S, et al. Management of severe psoriasis: about 50 cases. Tunis Med Oct; 85(10): 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 Jul; 143(7): Lapidoth M, Adatto M, David M. Targeted UVB phototherapy for psoriasis: a preliminary study. Clin Exp Dermatol Nov; 32(6): Menter A, Griffiths CE. Current and future management of psoriasis. Lancet Jul 21; 370(9583): 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 Jul; 34(7): Valbuena MC, Hernández O, Rey M, et al. Twice- vs. thrice-weekly MPD PUVA in psoriasis: a randomized-controlled efficacy study. Photodermatol Photoimmunol Photomed Aug; 23(4): 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 Aug; 6(8): 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 Oct; 20(9): 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 Aug; 55(2): 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 Mar; 45(3): 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): Lim C, Brown P. Quality of life in psoriasis improves after standardized administration of narrowband UVB phototherapy. Australas J Dermatol Feb; 47(1): Luba KM, Stulberg DL. Chronic plaque psoriasis. Am Fam Physician Feb 15; 73(4): 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 Jan; 54(1): Phototherapy for Psoriasis Mar 15 13

14 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): 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 May; 20(5): 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 Aug; 20(7): 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 Jul; 142(7): 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): Langley RG, Gupta AK, Cherman AM, Inniss KA. Biologic therapeutics in the treatment of psoriasis. Part 1: review. J Cutan Med Surg May-Jun;11(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): Pirzada S, Tomi Z, Gulliver W. A review of biologic treatments for psoriasis with emphasis on infliximab. Skin Therapy Lett Apr;12(3): Jobling R. Psoriasis. BMJ May 5;334(7600): Price J, Bhosle M, Feldman SR, Balkrishnan R. Outcomes associated with the use of biologic agents in moderate to severe psoriasis. J Drugs Dermatol Mar;6(3): Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature Feb 22;445(7130): Nickoloff, BJ, Nestle, FO. Recent insights into the immunopathogenesis of psoriasis provide new therapeutic opportunities. J Clin Invest 2004; 113: Bowcock, AM, Barker, JN. Genetics of psoriasis: the potential impact on new therapies. J Am Acad Dermatol 2003; 49:S Cassell, S, Kavanaugh, AF. Therapies for psoriatic nail disease. A systematic review. J Rheumatol 2006; 33: Lebwohl, M, Ali, S. Treatment of psoriasis. Part 1. Topical therapy and phototherapy. J Am Acad Dermatol 2001; 45: 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: 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: 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: 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: 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. Phototherapy for Psoriasis Mar 15 14

15 17. 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: 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: 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: Heydendael, VM, Spuls, PI, Opmeer, BC, et al. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med 2003; 349: 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: Strober, BE, Siu, K, Menon, K. Conventional systemic agents for psoriasis. A systematic review. J Rheumatol 2006; 33: Lebwohl, M. Psoriasis. Lancet 2003; 361: Kupper, TS. Immunologic targets in psoriasis. N Engl J Med 2003; 349: Boehncke, WH, Prinz, J, Gottlieb, AB. Biologic therapies for psoriasis. A systematic review. J Rheumatol 2006; 33: Iyer, S, Yamauchi, P, Lowe, NJ. Etanercept for severe psoriasis and psoriatic arthritis: observations on combination therapy. Br J Dermatol 2002; 146: Leonardi, CL, Powers, JL, Matheson, RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003; 349: 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: 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: 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: Lebwohl, M, Tyring, SK, Hamilton, TK, et al. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med 2003; 349: Gordon, KB, Papp, KA, Hamilton, TK, et al. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA 2003; 290: Chaudhari, U, Romano, P, Mulcahy, LD, et al. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet 2001; 357: 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: 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: 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: 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. General Purpose. Important Notice Phototherapy for Psoriasis Mar 15 15

16 Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peerreviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or Phototherapy for Psoriasis Mar 15 16

17 (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Phototherapy for Psoriasis Mar 15 17

18 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% % % % % % 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: Phototherapy for Psoriasis Mar 15 18