Diskusjon Triggere Porteføljer Aksjonærlister

Photocure fundamentale forhold (PHO)

At kun 1 pasient ble behandlet i mai i år betyr svært lite mhp hvilke potensiale PHO har for markedsandeler.
Ved utløpet av Q2 var det kun utplassert 2 flexiscope i USA. Vi vet ikke eksakt når disse ble utplassert, men deesom de ble utplassert i slutten av mai i år er det naturlige årsaker til at kun et fåtall pasienter ble behandlet, altså kun 1 som det hevdes.

Når man skal se på potensiale til å ta markedsandeler så må man nesten snu ryggen til fortiden og se fremover. Samtidig så kan man legge til grunn hva som har skjedd hittil. Det skjer nå en akselererende utplassering av scope i USA, den ene etter den andre uriologen fremholde BLCC teknologien som det eneste saliggjørende hva angår diagnostisering av blærekreft, og pasintene som er blitt behandlet mener at alle bør få dette tilbudet.

Når man samtidig nå vet at det å la seg diagnostisere med annet enn BLCC teknologi vil være nærmest å sammenligne med russisk rulett, så burde det være rimelig lett å skjønne at BLCC teknologien og PHO blir den nye gullstandarden innen blærekreftdiagnostisering i USA.

Sett i et slikt perspektiv virker 20% noe pinglete, for å si det med Einarsson sine ord. Jeg føler meg rinelig sikker på at BLCC teknologien vil ta 20% av markedet langt raskere enn noen av oss skjønner er mulig og på sikt mener jeg at markedsandelen vil passere 50% med god margin.

Men hvorvidt vi som er aksjonærer i dag får anledning å delta på denne festen fullt ut, ja se det er et helt annet spørsmål. Jeg håper bare at styret og resten av aksjonærene vil vite å sette pris på PHO den dagen en oppkjøper banker på døren.

Desto fortere det går , jo tryggere sitter vi i skuta.

Går det litt tregere kan de komme gjennom med billigere oppkjøp enn ønskelig.

Folkens!

Franzen på HO har funnet gull!

Den amerikanske foreningen for urologer har sendt et brev til myndighetene(medicaid/department of health).

De ber om endringer i refusjonsreglene for cysview.
I praksis ber de om “carte blanche”.

Søk opp denne på google, åpne PDF’en:
https://www.auanet.org/.../AUA-Comment-Letter-2019-Outpatien

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FTFY

Om vi skulle si noe negativt, så er det jo at den beskriver nåsituasjonen i et ikke veldig positivt lys. Men er jo fantastisk å se skryten.

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CMS er Centers for Medicare and Medicaid Services.

Klippet fra teksten:
“CMS’ reimbursement policies should facilitate access to this critical drug.”

Critical drug. Store ord!

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når kan man forvente svar/besluttning fra
Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services

angående The American Urological Association (AUA) sine anbefalinger som kommer frem i brevet.!?

Complexity Adjustment for Blue Light Cystoscopy with Cysview®
CMS proposes to continue to apply a “complexity adjustment” to pay for the Blue Light Cystoscopy with Cysview® procedure when performed in the hospital outpatient setting. Although we are pleased that CMS has recognized that Blue Light Cystoscopy with Cysview® procedures require extra resources beyond traditional “white light” cystoscopy, and therefore, should be assigned additional payment to minimize the harmful effects that the “packaged payment” policy has imposed on utilization of the procedure, CMS’ proposal is incomplete.

The proposed 2019 complexity adjustment increases hospital payment for only 2 of the 7 applicable cystoscopy CPT codes in which Blue Light Cystoscopy with Cysview® is used (52204 and 52224). This means that only a fraction of Blue Light Cystoscopy with Cysview® procedures will be eligible for additional payment through the complexity adjustment. This is because CMS continues to apply technical volume and cost eligibility criteria to its application of complexity adjustments, which in the case of certain Blue Light Cystoscopy with Cysview® procedures, cannot be met because utilization of the procedure has been constrained as a direct result of CMS’ “packaged payment” policy. For the benefit of bladder cancer patients who need this treatment, which is now included in the Guideline for Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer jointly published by the AUA and the Society of Urologic Oncology (SUO), we urge CMS to apply the complexity adjustment to all Blue Light Cystoscopy with Cysview® procedures(CPT codes 52000, 52204, 52214, 52224, 52234, 52235, and 52240).

We further encourage CMS to improve access to Blue Light Cystoscopy with Cysview® in the ASC setting, particularly given that the procedure is now FDA approved for administration with a flexible scope for surveillance cystoscopy of Non Muscle Invasive Bladder Cancer. CMS should either apply the complexity adjustment to all Blue Light Cystoscopy with Cysview® procedures when performed in the ASC setting, or CMS should unpackage Cysview® from the procedure payment when administered in the ASC—similar to what CMS is proposing for non-opioid pain management drugs in 2019. CMS should encourage, and not disincentivize, medically necessary utilization of Blue Light Cystoscopy with Cysview® for the benefit of bladder cancer patients and the Medicare program.

As noted above, treatment of bladder cancer patients with Blue Light Cystoscopy with Cysview® is supported by the AUA/SUO Guideline. CMS’ reimbursement policies should facilitate access to this critical drug. However, current policies, which package Cysview® with procedure payments and fail to adequately reimburse facilities for the extra costs and resources required to provide this treatment, instead create barriers to recommended care for patients with bladder cancer. CMS should modify its Medicare Hospital Outpatient Proposed Rule to ensure that all Blue Light Cystoscopy with Cysview® procedures are subject to the complexity adjustment or, in the alternative, that Cysview® is unpackaged from the Blue Light Cystoscopy procedure payment.

In November of each year, CMS finalizes the basis of payment for new and substantially revised test codes and the amount of payment through the annual CMS instruction implementing the updated CLFS for the next CY.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html

I fjor kom avgjørelsen 2 november

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Side 7 av 21 på står det at “Medicare (~55% of TURBT)”

“Hospital Outpatient Depts. will
receive an additional $1,000 to cover
the complexity of using Cysview and
Blue Light Cystoscopy procedure for
the following codes: 52204, 52214 &
52224
• Bundled into ambulatory payment
classification (APC – varies by TURBT
type)1
for the higher procedure codes of
52234, 52235 and 52240”

Mens det nå ønskes fra AUA at:

“we urge CMS to apply the complexity adjustment to ALL Blue Light Cystoscopy with Cysview® procedures (CPT codes 52000, 52204, 52214, 52224, 52234, 52235, and 52240)”

Skal ikke si at jeg skjønner alle detaljer rundt dette, men det må da være utrolig positivt at AUA legger hele sin tyngde bak dette.

AUA er den nummer 1 KOL uten sidestykke, ingen over ingen ved siden av. Når de sier noe så er det sånn, punktum.

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Edison lagde en liste over kodebruken:

Det var kode 52234, 52235 og 52240 som ikke kom med under refusjonsordningen fra 1. januar 2018.

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okai så det du sier er at med AUA sin sterke oppfordring angående CMS til å bruke kompleksitetsjusteringen til ALL Blue Light Cystoscopy med Cysview®, så vil the United States Centers for Medicare & Medicaid Services (CMS) godkjenne og implementere dette?

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Det hjalp ingenting i fjor når AUA forsøkte forbedre ordningen til Cysview utover forslaget CMS kom med. En rekke urologer sendte også inn skriv hvor de ba om ytterligere forbedring.

AUA-Comments-2018-OPPS-ASC-Proposed-Rule.pdf (249,0 KB)

Man bør ikke ha forhåpninger om at CMS bryr seg om innspillene i år heller…

Edit: Her ser dere svarene CMS hadde til de forskjellige innspillene i fjor (Søk på Cysview):

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okai sant nok, men etter dette har man jo fått på plass denne:

Oslo, Norway, February 16, 2018 Photocure ASA (OSE: PHO), announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer. This is the only combination of drug and device approved for the detection of bladder cancer.

The approval of this new indication is based on the results from a large Phase 3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This study showed that BLC™ significantly (p<0.0001) improves detection of patients with recurrent bladder cancer.

“This approval is an important milestone for Photocure. With 1.2 million surveillance cystoscopies performed annually in the U.S., this represents a significant opportunity for the company and allows us to bring solutions to current clinical challenges,” said Kjetil Hestdal M.D. Ph.D., President & CEO. “The expanded label now allows repetitive use in the same patient which enables physicians to provide an improved continuum of care to their bladder cancer patients and should lead to reduced cost.”

The expanded indication includes the combination of Cysview with the KARL STORZ PDD Flexible Blue Light Videoscope System. The approval also expands the indication in the current rigid setting (TURBT) by including the detection of carcinoma in situ (CIS) in bladder cancer patients as well as the repeated use of BLC with Cysview.

“This expanded approval in both rigid and flexible blue light cystoscopy (BLC) means that Cysview can now be used during transurethral resection of bladder cancer surgery for diagnosis and staging, as well as with follow-up surveillance of non-muscle invasive bladder cancer (NMIBC). Patients with NMIBC, especially high grade, require careful and frequent follow-up due to the high rate of recurrence and progression. Blue light cystoscopy with Cysview, will enable physicians to provide appropriate and more accurate treatment earlier, which in my experience results in improved outcomes for my patients. In my high-risk NMIBC clinical practice, I recognize the benefit of using BLC with Cysview to more readily detect carcinoma in-situ, i.e. aggressive high-grade flat lesions. In this study, an additional 35% of CIS patients were found by using BLC with Cysview alone and missed with white light,” says Gary Steinberg, M.D., The Bruce and Beth White Family Professor, Vice Chairman and Director of Urologic Oncology, University of Chicago Medicine.

In collaboration with KARL STORZ Endoscopy-America, Inc., Photocure plans to launch Cysview in combination with blue light enabled flexible video cystoscopy in mid-2018.

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Resultatene fra fase3-studiet kom i mai 2017 og var trolig en stor del av årsaken til at man fikk refusjonsordningen på plass for operasjonsmarkedet fra 1. januar 2018 og tilgang på surveillance. Men det betyr ikke at CMS gjør forbedringer i refusjonsordningen utover utkastet som er på høring for 2019 (noe vi så i fjor da de vedtok forslaget uten hensyn til innspill fra AUA). Utkastet ble sendt ut på høring etter meldingen du her refererer til og CMS er nok godt kjent med den.

Litt reklame fra Karl Storz:

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Takk, zappa🙂 Når er den fra?

Increased Patient Volume at Blue Light Centers
Real-World Example: NCI Designated Comprehensive Cancer Center – A leading NCI Cancer Center
almost doubled its patient volume within two years after purchasing a KARL STORZ Blue Light
Cystoscopy with Cysview® System.

Sykehusene som ikke kan tilby BLC mister pasienter

er ikke sikker, men har ikke sett den før

Har sittet og nerdet med regnearket i helgen for å se på historisk market cap på selskaper, og i den sammenheng må man jo bruke newsweb for å se på kapitaløkninger i aksjer og sånn.

I Photocure sitt tilfelle er jo dette hendelser som nesten aldri skjer, og handelen har stort sett vært lav i aksjen. Er vel mye av grunnen til at norske meglerhus omtrent aldri omtaler denne aksjen regner jeg med?

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Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre :slight_smile:

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

  1. @Savepig (133 likes)
  1. @Snoeffelen (95 likes)
  1. @Londonmannen (61 likes)

Resten av topp 10:

  1. @Inkognito666 (59 likes)

  2. @solvoll (45 likes)

  3. @JAXI (37 likes)

  4. @Longtrader (32 likes)

  5. @zappa66 (25 likes)

  6. @tekdude (22 likes)

  7. @sulzrox (21 likes)

Gratulerer!

Fra Bio Syent sin Q2 rapport (distributør i Canada):
Management was encouraged by the adoption of Cysview® by five additional Canadian hospitals which placed their first orders for the product in 2018. A total of seven hospital sites in Canada are now operational with Cysview®. While H1 2018 sales of Cysview® (units) to Canadian hospitals increased by 80% compared to H1 2017, sales levels and the adoption rate of this product to this point have lagged management’s expectations.

While Cysview® continues to experience a long selling cycle, several Canadian hospitals are in the process of completing or evaluating demonstrations of the
product in an operating room setting with additional sites expected to adopt the product in the second half of 2018. The Company remains committed to the success of this innovative product as part of its portfolio of hospital products.

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