RE: Reimbursement is critical - RENX vs AGL is a start contrast11 Jun 2022 15:53
Courtesy of Andrew Smith on Telegram:-
My notes on reimbursement:-
From the 29 April 2021 presentation:
Ian Griffiths mentioned "There are existing reimbursement codes that we should be able to utilise, so this is about building the case for higher reimbursement later down the line"
From a Finncap note of 28 October 2020 re ovarian:
"ANGLE will be able to sell to clinicians directly in the first instance for private payers. ANGLE will also be able to generate additional data to facilitate discussions with payers in respect of dedicated reimbursement codes for Parsortix clinical applications. A company cannot apply for a reimbursement code in the US (CPT code) until the test is being offered. Offering the test as an LDT enables a reimbursement code to be secured ahead of subsequent FDA cleared product tests. "
"assuming a c.$1,000 test (similar to Aspira Women’s Health’s OVA-1 and OVERA tests which have weaker performance that Parsortix but CPT reimbursement prices of $897 and $950, respectively)."
From Jefferies note of 19 January 2022:
“Although it will likely take time to build commercial revenues from clinical use, reflecting the need to secure reimbursement and, ideally, inclusion in cancer treatment guidelines, FDA clearance is likely to accelerate all forms of adoption, in our view, driving utilisation in research, plus uptake in pharmaceutical drug trials and by contract research organisations (CROs) as the gold standard means for collecting CTCs for subsequent analysis”
“We assume the Parsortix PMT test is eventually priced at a premium to Aspira Women's Health FDA-approved OVA1 test, which has CMS reimbursement of $897”
“We assume a conservative ramp, reflecting the time taken to build awareness and secure reimbursement codes and coverage, with ANGLE at least initially reliant on private pay, plus the possibility of leveraging OVA1's reimbursement code, until securing its own code after perhaps 2-3 years. Initial referrals are likely to predominate from the Wilmot Cancer Institute as ANGLE builds awareness.”
From the results and webinar of 1 August 2019
the regulatory process is "very long" [now done]. After that there is the need to get reimbursement codes and arrangements with payers. Then to get in the Na
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