CLINICAL INPUT RESPONSES

Transcription

1 CLINICAL INPUT RESPONSES Additional Comments With regard to the 9 indications listed above, there was lower range confidence that there is adequate evidence demonstrating that sutureless fixation human amniotic membrane (also called AMG; eg, Prokera, AmbioDisk) performs as well as or better than sutured or glued AMG. Use of AMG would be expected to improve health outcomes and is considered consistent with generally accepted medical practice for: Original Policy Date: April 2015 Page: 1

2 patients with an epithelial defect that (1) has failed to completely close after 5 days of conservative treatment (2) has failed to demonstrate a decrease in size after 2 days of conservative treatment. Conservative treatment is defined as use of topical lubricants and/or topical antibiotics and/or therapeutic contact lens and/or patching. Failure of multiple modalities should not be required prior to moving to AMG. AMG requires less effort on the part of the patient to adhere to a treatment regimen and has a significant advantage in that regard over treatments that require multiple drops per day. We are in agreement that larger controlled studies are needed to show benefit of AMG in dry eye disease, where the disease is common and such studies should be easy to perform. See Appendices 1 and 2 for details of the clinical input. APPENDI 1: CLINICAL INPUT 2017 Appendix Table 1. Respondent Profile Specialty Society No. Name of Organization Clinical Specialty 1 American Academy of Ophthalmology Ophthalmology Appendix Table 2. Respondent Conflict of Interest Disclosure No. 1. Research support related to the topic where clinical input is being sought Yes/N 2. Positions, paid or unpaid, related to the topic where clinical input is being sought 3. Reportable, more than $1,000, health care related assets or sources of income for myself, my spouse, or my dependent children related to the topic where clinical input is being sought 4. Reportable, more than $350, gifts or travel reimbursements for myself, my spouse, or my dependent children related to the topic where clinical input is being sought Explanation Yes/No Explanation Yes/No Explanation Yes/No Explanation o 1 No No No No Individual physician respondents answered at individual level. Specialty society respondents provided aggregate information that may be relevant to the group of clinicians who provided input to the society-level response. Original Policy Date: April 2015 Page: 2

3 APPENDI 2: CLINICAL INPUT RESPONSES Objective Clinical input is sought to help determine the appropriate use in clinical practice of amniotic membrane graft (AMG) for ophthalmic disorders. Responses 1. With regard to the use of AMG in each of the following ophthalmic disorders: a. Please use the 1 to 5 scale outlined below to indicate your level of confidence that there is adequate evidence demonstrating that this use will improve health outcomes. 1 Neurotrophic keratitis 2. With regard to the use of AMG in each of the following ophthalmic disorders: a. Please use the 1 to 5 scale outlined below to indicate your level of confidence that this clinical use is in accordance with generally accepted medical practice. 1 Neurotrophic keratitis Original Policy Date: April 2015 Page: 3

4 3. With regard to the use of AMG in each of the following ophthalmic disorders: a. Please use the 1 to 5 scale outlined below to indicate your level of confidence that there is adequate evidence demonstrating that sutureless fixation AMG (eg, Prokera) performs as well as or better than sutured or glued AMG. 1 Neurotrophic keratitis 4. For individuals with persistent epithelial defects, what objective condition characteristics (ie, patient selection criteria) and management criteria (ie, regarding prior trial of standard treatment options) would describe use of AMG that improves health outcomes and is considered in accordance with generally accepted medical practice? No. Response 1 Patients with an epithelial defect that 1. has failed to completely close after 5 days of conservative treatment 2. has failed to demonstrate a decrease in size after 2 days of conservative treatment Conservative treatment is defined as use of topical lubricants and/or topical antibiotics and/or therapeutic contact lens and/or patching. Failure of multiple modalities should not be required prior to moving to AMG. AMG requires less effort on the part of the patient to adhere to a treatment regimen and has a significant advantage in that Original Policy Date: April 2015 Page: 4

5 regard over treatments that require multiple drops per day. 5. For individuals with severe dry eye, what objective condition characteristics (ie, patient selection criteria) and management criteria (ie, regarding prior trial of standard treatment options) would describe use of AMG that improves health outcomes and is considered in accordance with generally accepted medical practice? No. Response 1 AMG is a reasonable option when patients demonstrate persistent corneal staining despite conservative therapy. Conservative therapy in this case would include frequent preservative-free tears, hot compresses and efforts to control the environment. At times these may not work because the patient is unable to control the environment or administer drops frequently. Drugs such as cyclosporine or lifitegrast may be helpful in these cases but they may take months to take effect. If the patient's daily activities are significantly affected by dry eye signs and symptoms, AMG may provide rapid relief while waiting for long-term medications to take effect. However, it is unlikely to be of benefit for less-severe disease or disease that responds to conservative therapy. Because it limits acuity it is only viable as a short-term therapy. 6. Additional comments and/or any citations supporting your clinical input on the clinical use of AMG in patients with ophthalmic disorders. No. Additional Comments 1 We are in agreement that larger controlled studies are needed to show benefit of AMG in dry eye disease, where the disease is common and such studies should be easy to perform. It is unlikely that larger RCTs will be possible in less common conditions with multiple different underlying etiologies and severities such as corneal melts or perforations, persistent epithelial defects, or neurotrophic keratitis. The limited clinical literature clearly supports the benefit of AMG in these cases, though sutured AMG is superior to Pro-Kera for the more severe diseases such as perforations and Stevens-Johnson. 7. Is there any evidence missing from the attached draft review of evidence? No. Yes/No Citations of Missing Evidence 1 No Original Policy Date: April 2015 Page: 5