Medical Policy: 07.01.64
Original Effective Date: May 2014
Reviewed: March 2017
Revised: March 2017
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
ACI (Autologous Chondrocyte Implant): ACI is a two-step procedure. New cartilage cells are grown and then implanted in the cartilage defect.
First, healthy cartilage tissue is removed from a non-weight bearing area of the bone. This step is done as an arthroscopic procedure. The tissue which contains healthy cartilage cells, or chondrocytes, is then sent to the laboratory. The cells are cultured and increase in number over a 3 to 5-week period.
An open surgical procedure, or arthrotomy, is then done to implant the newly grown cells. The cartilage defect is prepared. A layer of bone-lining tissue, called periosteum, is sewn over the area. This cover is sealed with fibrin glue. The newly grown cells are then injected into the defect under the periosteal cover.
ACI is most useful for younger patients who have single defects larger than 2 cm in diameter. ACI has the advantage of using the patient's own cells, so there is no danger of a patient rejecting the tissue. It does have the disadvantage of being a two-stage procedure that requires an open incision. It also takes several weeks to complete.
There has been improvement in the two step surgical process with the introduction of Carticel. Carticel® (autologous cultured chondrocytes) is an autologous cellular product indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). Carticel is the only FDA approved product for this indication.
Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown.
The culturing of chondrocytes is considered by the FDA to fall into the category of manipulated autologous structural (MAS) cells, which are subject to a biologic licensing requirement. At the present time, only Carticel™ (Genzyme) has received FDA approval for the culturing of chondrocytes through a biologics license. In 1997, Carticel received FDA approval for the repair of clinically significant, “...symptomatic cartilaginous defects of the femoral condyle (medial lateral or trochlear) caused by acute or repetitive trauma.…” The labeled indication was revised in October 1999 to read as follows:
“Carticel is indicated for the repair of symptomatic cartilaginous defects of the femoral condyle (medial, lateral, or trochlear), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure.” Thus, the revised labeling suggests a more restricted use of autologous chondrocytes, i.e., as a second-line therapy after failure of initial arthroscopic or surgical repair.
The available evidence reports that ACT for the treatment of clinically significant, focal defects of the femoral condyle is associated with improved health outcomes such as diminished pain and improved joint function over the short term. However, the available evidence is not sufficient to determine if the improvements are caused by the use of autologous chondrocytes or how the outcomes compare to the outcomes achievable simply by use of debridement with rehabilitation.
The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. Data regarding functional outcomes beyond 3 years of autologous cultured chondrocyte treatment are limited.
A number of second-generation methods for implanting autologous chondrocytes in a biodegradable matrix are currently in development/testing. These include Atelocollagen (collagen gel, Koken), BioCart II (ProChon Biotech, Phase II trial), Bioseed C (polymer scaffold, BioTissue Technologies) CaReS (collagen gel, Ars Arthro), Cartilix (polymer hydrogel, Cartilix), Cartipatch (solid scaffold with an agarose-alginate matrix, TBF Tissue Engineering, Phase III trial), Chondron (fibrin gel, Sewon Cellontech), Hyalograft C (hyaluronic acid-based scaffold, Fidia Advanced Polymers), MACI® (matrix-induced ACI, Verigen and Genzyme, available outside of the U.S.), NeoCart (ACI with a 3-dimensional chondromatrix, Histogenics. Phase III trial), and Novocart (collagen-chondroitin sulfate scaffold, B. Braun-Tetec). ChondroCelect (characterized chondrocyte implantation, TiGenex, Phase III trial completed) uses a gene marker profile to determine in vivo cartilage-forming potential and thereby optimizes the phenotype (e.g., hyaline cartilage vs. fibrocartilage) of the tissue produced with each ACI implantation cell batch. Each batch of chondrocytes is graded based on the quantitative gene expression of a selection of positive and negative markers for hyaline cartilage formation. Although clinical use of these second-generation ACI products has been reported in Europe and Asia, only MACI is approved for use in the U.S. at this time.
In a 2010 clinical practice guideline on the diagnosis and treatment of osteochondritis dissecans (OCD), the American Academy of Orthopaedic Surgeons (AAOS) was unable to recommend for or against a specific cartilage repair technique in symptomatic skeletally immature or mature patients with an unsalvageable osteochondritis dissecans lesion.
NICE issued an updated Technology Appraisal Guidance (2005 and reviewed in 2008). The NICE guidance cited insufficient evidence to determine the benefits of autologous chondrocyte implantation and indicated this technology “should not be used for the treatment of articular cartilage defects except where the treatment is part of a clinical study.” The guidance noted many limitations in available trial data including length of follow-up, comparison to conservative treatment, assessment of the quality of cartilage produced, and the impact of cartilage produced on functional outcomes and health-related quality of life.
Softening and swelling
Fragmentation and fissures in area less than 0.5 inch in diameter
Fragmentation and fissures in area larger than 0.5 inch in diameter
Exposed subchondral bone
Source: Campbell's Operative Orthopaedics, 2007
Carticel only has FDA approval for narrow indications at this time. Patients must have had an inadequate response to a prior arthroscopic or surgical repair procedure. Therefore, as a first line treatment autologous chondrocyte implantation is investigational.
Carticel is only FDA indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea). Use in any other area including other areas of the knee are considered investigational.
Autologous chondrocyte implantation (also referred to as autologous chondrocyte transplant/ACT), may be considered medically necessary for the treatment of disabling full thickness articular cartilage defects of the femoral condyle (medial, lateral, or trochlear) caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior surgical procedure, when ALL of the following criteria are met:
Adolescent patients should be skeletally mature with documented closure of growth plates in the clinical notes.
Repeat autologous chondrocyte implantation for the same lesion is considered not medically necessary.
If the procedure does not meet all the medical criteria above, the culturing of chondrocytes will not meet medical criteria.
Autologous chondrocyte implantation for treatment of, but not limited to, patellar chondromalacia, osteoarthritis, osteochondral dessicans (OCD), inflammatory disease of the joints, is investigational.
Autologous chondrocyte implants are investigational for patellar or talar lesions or lesions of other joints (e.g., hip and shoulder) and all other indications because the effectiveness of autologous chondrocyte implants for these lesions has not been established or FDA approved.
Matrix-induced chondrocyte implantation including the use of all second-generation methods for implanting autologous chondrocytes in a biodegradable matrix is investigational for the treatment of osteochondral defects/lesions and all other indications because their effectiveness has not been established. This includes all second generation products including, but not limited to: MACI, ChondroCelect, Novocart, NeoCart, Hyalograft C, Chondron, Cartilix and Bioseed. The main deficiency of the existing evidence is that there are no published controlled studies that compare the outcomes of autologous chondrocyte implant with any other treatments or with the natural progression of the disease. The available studies do report the proportions of patients treated with ACT who achieved various levels of outcomes, but there is no way to determine if those outcomes are better than, the same as, or worse than, the outcomes that would have occurred with other treatments.
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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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