OVERVIEW
We spoke with a Gynecologic Oncologist & Surgeon in California on Jan 7 about surgical trends (including robot-assisted surgery), practice dynamics, and the use of liquid biopsy in his practice. We came away from the discussion with a greater appreciation for Natera’s (NTRA) service level, as well as the moat around Signatera and opportunity across additional cancers beyond colorectal (CRC).
HIGHLIGHTS
- Signatera’s platform and technology impress our contact, and he thinks it has the potential applicability across all cancers: “It’s the future of cancer care.” He’s used it for ovarian cases despite the lack of a coverage determination.
- While COVID-19 surged into year’s end and elective procedures have been postponed, doctors’ offices remained open, even in CA. Acuity has been rising due to delayed care, especially in cancer (noticeably more stage 3 and 4 coming in - about 15% of total vs. 5% pre-COVID).
- Intuitive Surgical’s da Vinci likely “holds the wall” for another couple of/few years against any newcomers (MDT or JNJ).
CALL NOTES
Background Information: Our contact is board certified in obstetrics and gynecology and gynecologic oncology and a surgeon + chair of the robotics committee at the local system, which has 4 da Vincis (types not disclosed). He owns a private practice w/ two other partners and has been practicing for over 20 years. He sees about 100 patients per week (~40% of the practice’s total volume, on average). They do all the surgical intervention for GYN cancers and chemo - a “one-stop-shop” for ovarian, uterine, cervical, etc.
Q&A
How are things in California, and how does current practice volume compare to March-April 2020?
- CA went into lockdown at the end of March through June, but cancer-related practices did now shut down. Although still operating, we were down by ~50% and had a huge backlog to work through between mid-June and the end of Sept-early Oct.
- We caught up on the 50% and since then have been super busy, even w/ the latest surge in COVID-19 cases.
- Today is a good example of how things are going. I just finished a few cases at the hospital. The hospitals have stopped doing “elective” procedures (no hernia repairs, no orthopedics, etc.), but there’s been very little impact for most emergencies and cancer patients.
Are you seeing more advanced cases, on average? Asked differently, is average acuity up? If so, why?
- Yes, due to a combination of people’s reluctance to go out and doctors’ offices being closed (especially when primary care was closed). I’d say it’s about 70% patient reluctance.
- The result is about 15% of patients come in at stage 3 or 4, of which about 80% is due to delay in treatment (because of a lack of obtaining care). It has really moved the curve out (i.e., later). That’s a shift of up from ~5%, and about 5% (⅓ of the 15%) are truly inoperable/untreatable because of how advanced the cancer is.
- It seems like it happened quickly, but think about it: patients didn’t want to go out and see a PCP or OB/GYN or had issues w/ access. Maybe a woman had abnormal bleeding in December (‘19) and was scheduled to see her PCP in mid-January. The PCP refers to an OB/GYN and the appointment is in March, but then by the time the patient comes in, it’s June/July because of COVID-19. Maybe we get a diagnosis by early August? Then, by the time she sees me, it’s October and nothing was done [to help] for 10 months.
If you got back to baseline by the end of Sept/beginning of October, do you think there are people still hiding out?
- It’s a good question. The recent COVID-19 surge in CA has spooked a lot of people and we could see a repeat of some of the issues. That said, doctors’ offices have remained open (i.e., it might not be as bad).
We’ve heard a lot of anecdotes around new friction in the system (family members not being able to participate, distancing, etc.) that’s led to lower throughput...
- In general that’s correct, but we’ve developed a good system in our office and it hasn’t impacted the practice. However, throughput in healthcare is slower overall (fewer patients are seen).
- Cancer is high-priority, so we’ll see everyone. Hospitals have essentially shut down true elective procedures and debatable ones to make room for essential care and COVID-19 patients.
Have you seen any, or what do you think about patients that have recovered from COVID-19? Are there lingering effects?
- There are definitely long-haulers. I had a patient (endometrial cancer) that recovered from COVID-19 over the summer (5 days in the hospital), and has had DVT, and has been dealing with atrial fibrillation. I think there’s a long-term risk for patients, not only because it can cause a delay in treatment of serious conditions, but new-onset issues like that.
How are robot-assisted surgeries trending? What’s been the impact there?
- Access is not a problem, generally, for big open [surgical] cases (like a big ovarian case - those patients must be admitted). About 95% of da Vinci procedures are done outpatient now. Those patients are forced to go home for insurance and exposure reasons while hospitals are overwhelmed with COVID. Nobody wants post-operative risk.
- Scheduling on the four robots is not an issue outside of “after hours” procedures - e.g., if a general surgeon is interested in doing a robot-assisted hernia repair - there isn’t staff to support it.
- Prostate procedures (dVPs) peaked and are declining. I’m seeing less of those done every year. Part of it is the lack of proper screening w/ PSA, and another aspect is the technology w/ radiation is so good now that most patients opt for it. Urologists don’t want to do surgical procedures if they don’t have to.
- General OB/GYN is slow - we haven’t seen much growth there. GYN-Onc has been good/steady and won’t change (it’s consistent YoY).
- General Surgery - I’m seeing increases there in procedure volume. If I strip out the impact from COVID-19, I think it’d be up 10-15% YoY.
What are your thoughts on the competitive threat to ISRG?
- If a competing platform comes along, growth would likely slow for all categories.
- How new platforms will differ from the da Vinci is still the main question. Once a surgeon is used to a system, it’s very hard to change attitude/habits. Also, ISRG’s IP strategy is sound (patents hard to break).
- Medtronic’s Hugo is mobile and supposed to be different, but I’m not sure if it is truly comparable. I haven’t paid attention to what JNJ is doing, but there are rumblings about it (Ottava).
- Until a truly comparable system comes along that is compatible with what we are doing, I think Intuitive Surgical will “hold the wall” for another few years. I’m really not sure what that would look like though. It’s too early.
- Buying a new Xi is not cheap, so if MDT prices its robot in the $500k-$800k range, then a hospital could buy 2-3 systems for one da Vinci and potentially allow for better access. But I do think ISRG has done an amazing job over the past 15 years getting the system perfected to the point where it is used for so many kinds of procedures, and Hugo may not be easily used for all sorts of other procedures.
We can see in our claims data, by lab, that Signatera use is expanding… Can you explain your routine for testing pre-surgical and post-surgical? Which labs do you use, etc.?
- The Signatera platform and tech are absolutely great. The problem is that it’s not validated in GYN/for ovarian cancer, where I’ve used it. I use it with patients that are open to discussing MRD, understand the potential cost, and can pay out of pocket. Coverage is a big issue, but I think it will come.
- Testing starts when the diagnosis and surgical plan are made. Ovarian is a potentially big application - gene profiling on every patient, front-line, makes a ton of sense.
- Whole exome - for ovarian - testing for germline in general and tumor. I’m not routinely using liquid biopsy, as tumor [tissue] is essentially the standard of care in practice (whenever we have access to the tissue, we prefer that).
- Where liquid comes in is recurrence/MRD for me, or where there’s no access to tumor tissue or if it’s a long time since the initial diagnosis (tumor environment changes).
- So with ovarian cancer, if I treated a patient two years ago and she’s disease-free but comes back with elevated CA-125, we’ll order a CT scan and use liquid biopsy. It makes sense to follow up monthly or quarterly.
- I like Caris and Foundation.
- Why?
- I’m most familiar with them. I think they do a better job looking at a higher number of sequences in genes - it’s about 50/50.
- Also on Signatera, we have the biopsy, so why not profile it? Their ability to identify tumor DNA is impressive (i.e., picking the 16 mutations). We really don’t have good surveillance methods for any cancer. It’s tumor markers or CT scans - the ability to identify cfDNA is great. I really believe in the tech and think it’s the future of oncologic care. Just need insurance coverage.
- Signatera turns positive faster than protein markers show up. If we pick up on ovarian recurrence early, we can start a patient on a PARP inhibitor early to give them 2-3-4 years of disease-free interval - that’s huge. What price do you put on that?
What are your thoughts on Grail and screening?
- What’s the cost to find out? The whole point of a screening test is to apply it to the general population. It’s not high-risk germline that must be screened.
What’s the process w/ Signatera again? Can you explain the cost?
- A patient presents w/ ovarian, get a biopsy, then do Signatera (resect then Signatera). Without Signatera, it’s typical to see the patient every 3 months. Screening blood tests and/or CT scans intermittently - just get both things at the same time. CT and PET scans are the go-to, sometimes ultrasound. Depending on the patient, 1-2 CT scans per year. The CA-125 test is cheap - less than $50. The scan costs anywhere from $600-$700 to $1500. One patient we’re using Signatera with paid ~$600, but they’ve helped cover the costs for some patients (have to jump through some hoops).
Ovarian cancer - other types outside of CRC? Uterine?
- I think Signatera is applicable to all cancers. In my world, ovarian, cervical, endometrial, etc. I just started using it over the past 6 months, maybe 10-15% of patients, at most. We’ve had a few instances where it gets covered, but that could have been missed (a mistake by the health plan). My partners are interested in screening w/ it as well. I think the next wave of adopters will be delayed due to COVID-19. It’s usually early adopters and then there’s another wave a year later. It could be 2 years.
Any legitimate competitors?
- I’m not aware of anyone doing fragmented panel analysis like this. It’s a cost issue as well.
- Early diagnosis or treatment selection for immune therapy are heavier use cases for liquid biopsy and there’s more competition. Many of the other genes don't have clinical applicability of treatment. Utilizing for PARPs and Keytruda - more immune-related vs. chemo, but chemo is still standard of care in many areas (like ovarian, it’s first-line).
- Biologic agents are ramping and taking over 25-30% share in second- and third-line recurrent patients.
NIPT Claims Index | January 2020
Please reach out to with any feedback or inquiries, questions for future field checks, or requests for underlying data.
Thomas Tobin
Managing Director
Twitter
LinkedIn
