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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:
Policy Number:
NMP350
Effective Date*:
June 2007
Updated:
March 2014
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
Instructions
Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL
regions.
Phototherapy for Psoriasis Mar 14
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.
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.
4.
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.
Abbreviations
PUVA
BSA
UVB
NB-UVB
ICD-9 Codes
696.1
Plaque psoriasis
ICD-10 Code
L40.0 Psoriasis vulgaris
CPT Codes
96910
96912
96913
HCPCS Codes
E0691
E0692
E0693
E0694
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.
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.
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 wavelengths 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
7
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
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
Review History
June 2007
June 2008
April 2009
April 2011
March 2012
March 2013
March 2014
6.
7.
8.
3.
10
4.
5.
6.
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Database Syst Rev. 2013 Oct 23;10:CD009481.
Richard EG, Hnigsmann 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.
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12
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19. Luba KM, Stulberg DL. Chronic plaque psoriasis. Am Fam Physician. 2006 Feb 15;
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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
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Important Notice
General Purpose.
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 Nets 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 members 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, new or revised policies
require prior notice or posting on the website before a policy is deemed effective. For information regarding the
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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, new
or revised policies require prior notice or website posting 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: Members Contract Controls Coverage Determinations.
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 members 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 Members contract (also known as the benefit contract, coverage
document, or evidence of coverage) conflicts with the Policies, the Members contract shall govern. Coverage
decisions are the result of the terms and conditions of the Members benefit contract. The Policies do not replace or
amend the Members contract. If there is a discrepancy between the Policies and the Members contract, the
Members contract shall govern.
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.
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.
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Appendix A
To calculate a patients 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%
< 10%
10-29%
30-49%
50-69%
70-89%
90-100%
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
Some
Moderate
Severe
Maximum
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
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