My article related to business ethics has been published by Leader's Edge Magazine

Leader's Edge Magazine (published by the Council of Insurance Agents and Brokers), has published my work.

https://www.leadersedge.com/p-c/pivot-point

 

"Can the insurance industry be a force for prevention in the pandemic of child sex abuse?"
Leader's Edge, Sept., 2019

I've been credentialed to cover CHI's Immuno-Oncology Summit in Boston next week

I'm happy to say that I have been registered to attend and cover CHI's Seventh Annual Immuno-Oncology Summit next week in Boston. Immunotherapy was the subject of a fascinating panel at BIO last month. I am available to cover this meeting.

https://www.immuno-oncologysummit.com/programs

ASCO 2019: ASCO Releases First-Ever Guidelines for Multiple Myeloma

Development comes on the heels of new drugs, increased overall survival, and revised diagnostic criteria

By John Otrompke

                Science recently achieved a medical milestone, with the publication of ASCO’s first set of guidelines for the treatment of multiple myeloma on May 10. Four new drugs have been approved since 2015. However, the disease remains incurable, with a median survival of slightly more than five years.

Most patients receive at least four lines of therapy, according to the article, “Treatment of Multiple Myeloma: ASCO and CCO Joint Clinical Practice Guideline” (Mikhael, J; Nofisat, I.; Cheung, M; et al). DOI: 10.1200/JCO.18.02096 Journal of Clinical Oncology 37, no. 14 (May 10 2019) 1228-1263.

“Survival in the last 15 years is substantially better,” said Dr. Catherine Diefenbach, MD, director of the clinical lymphoma program at the NYU Langone Perlmutter Cancer Center in New York City. “A study by Kumar et al. (Blood 2008 111:2516-2520) found a clear improvement in overall survival for multiple myeloma patients with relapsed disease after autologous stem cell transplant, with those relapsing 2000 having a median OS of 23.9,  versus 11.9 months for those who relapsed before 2000,” explained Diefenbach, who is also an ASCO committee member.

 Even with Five Year Survival, Disease Still Incurable

Therefore, the guidelines place an emphasis on newer agents; recommendation 5.2, for example, suggests that those patients ineligible for stem cell transplant should receive, at a minimum, a novel agent, and a steroid, if possible.

The guidelines are the result of an analysis of 124 relevant studies.

“The review began in 2005, because the therapies that proceeded this are not relevant to the therapies in use today,” said Diefenbach. “For example, daratumumab is an IgG1kappa monoclonal antibody directed against the antigen CD38 which is highly expressed by multiple myeloma cells,” she explained.

(Daratumumab was given breakthrough status by the FDA in 2013, which put it on an expedited approval schedule. It was also awarded orphan status by the FDA).

                Another new drug is elotuzumab, which received breakthrough status in 2014. “Dartumumab is approved for both upfront therapy of multiple myeloma and for relapsed disease in combination with other agents. Elotuzumab is approved for relapsed patients that have failed one to three lines of therapy in combination with other agents,” Diefenbach noted.

Diagnostic Criteria Updated, Especially for Smoldering Myeloma

                Along with the approval of new agents, the diagnostic criteria were updated by the International Myeloma Working Group (IMWG) in 2014. (Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26). “Many patients who would have previously been defined as having smoldering myeloma will now be more appropriately defined as active and in need of therapy,” according to the guidelines published in JCO.

Autologous stem cell transplant for patients in first remission remains the standard of care, and age and renal function should not be the sole criteria for determining eligibility, according to recommendation 1.2.

For those who are ineligible for transplant, or in first remission, triplet therapies should be considered. (A triplet is defined as including two novel agents, according to recommendation 7.3). According to recommendation 5.3, a combination of the four agents daratumumab, bortezomib, melphalan and prednisone can also be considered.

However, continuous therapy should be offered preferentially to fixed-duration treatment when initiating certain novel agents, such as an immunomodulatory drug or a proteasome inhibitor, according to recommendation 5.5.

“Acquired mutations are important for the progression from monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma, but have less significance for disease progression in multiple myeloma,” said Diefenbach. (MGUS is also known as smoldering myeloma). However, “most multiple myeloma patients will relapse and become resistant to therapy over time,” she added.

                Genetic markers for high-risk disease include cytogenetic abnormalities such as t(4;14), t(14;16), t(14;20), del17p13.

Several conferences I am already scheduled to cover this fall

Hi, here are several conferences I have already made arrangements to cover this fall.

They include the Heart Failure Society, AACAP, ACS, RSNA, and the American Epilepsy Society.

Is anyone else interested in articles from these meetings? If so, I need charge you no expenses.

Many thanks,

~John
John_Otrompke@yahoo.com


1. Heart Failure Society of America
Sept. 13-16, Philadelphia
https://meeting.hfsa.org/<https://meeting.hfsa.org/>

2. American Academy of Child and Adolescent Psychiatry
Oct 14-19, Chicago
https://www.aacap.org/AACAP/CME_and_Meetings/Annual_Meeting/66th_Annual_Meeting/66th_AM_Home.aspx<https://www.aacap.org/AACAP/CME_and_Meetings/Annual_Meeting/66th_Annual_Meeting/66th_AM_Home.aspx>

3. American College of Surgeons
Oct 27-31, San Francisco
https://www.facs.org/clincon2019<https://www.facs.org/clincon2019>

4. Radiological Society of North America
Dec 1-6, Chicago
https://www.rsna.org/annual-meeting<https://www.rsna.org/annual-meeting>

5. American Epilepsy Society
Dec. 6-10, Baltimore
https://meeting.aesnet.org/<https://meeting.aesnet.org/>

Pharma DJ published my article on FDA Commissioner Norman Sharpless from this year's BIO conference

My new client, PharmaDJ (based in Shanghai, China) published my article from the annual BIO conference last month, describing a townhall held by the on FDA Commissioner Dr. Norman Sharpless.

US FDA Must Hire New Staff to Fulfill New Obligations and Review New Technologies

June 12, 2019

http://www.pharmadj.com/cms/detail.htm?item.id=6672f4078cb711e98efdfa163e227c38

Pediatric Phase 1 Dose-Finding Study of Entrectinib Shows Substantial Benefit in Almost Half the Patients

by John Otrompke

A second study in pediatric oncology discussed at the ASCO presscast also was the source of surprisingly good news.

STARTRK-NG was designed as a simple phase I/IB dose-finding study, but objective responses were seen in almost half of the subjects. The study enrolled 29 patients, aged 4 to 20, with rare central nervous system tumors, neuroblastoma, or other solid tumors, of whom 28 were evaluable.

Entrectinib, a novel targeted treatment, was administered for a median of 281 days, and the tumor shrank or disappeared in 12 patients. The median time to response was 57 days, according to abstract 10009, “Phase 1/1B trial to assess the activity of entrectinib in children and adolescents with recurrent or refractory solid tumors including central nervous system (CNS) tumors” (Robinson, Gajjar, Gauvain, et al).

“The medicine was well-tolerated and there appears to be no time frame yet studied in which the medicine stops working or toxicities become limiting,” according to lead author Giles W. Robinson, MD, a pediatric neuro-oncologist at St. Jude Children's Research Hospital in Memphis, who was quoted in the ASCO press release.

No responses were observed among patients lacking the alterations targeted by entrectinib.

Therapies potentially available in the Pediatric MATCH trial, and the mutations they target

• larotrectinib- targeting NTRK

• erdafitinib- targeting FGFR

• tazemetostat- targeting EZH2 and other SWI/SNF complex genes

• LY3023414- targeting the PI3K/MTOR pathway

• selumetinib- targeting the MAPK pathway

• ensartinib- targeting ALK or ROS1

• vemurafenib- targeting BRAF

• olaparib- targeting defects in DNA damage repair

• palbociclib- targeting cell cycle genes

• ulixertinib- targeting the MAPK pathway

Targeted Therapies May Play a Greater Role in Pediatric Oncology

by John Otrompke

                A study attempted to match pediatric cancer patients with genomic treatments has been more successful than predicted, according to a presentation at the pre-meeting press cast of the American Society for Clinical Oncology (ASCO) given on May 15.

                At the outset of the project (the National Cancer Institute-Children’s Oncology Group Pediatric Molecular Analysis for Therapy Choice, or NCI-COG Pediatric MATCH) in 2017, researchers predicted that only 10% of children with refractory cancer would have a mutation-based match to genomic treatment, according to COG study chair Will Parsons, MD, PhD, associate professor of pediatrics-oncology at Baylor College of Medicine in Houston.

But an interim analysis of more than 400 patients screened has revealed a significantly higher match rate, with 24% of participants eligible to receive treatment with at least one drug, according to the ASCO press release.

“The last 10 years has been an incredible time,” said Parsons, who spoke at the presscast, discussing abstract 10011, “Identification of targetable molecular alterations in the NCI -COG Pediatric MATCH trial” (Parsons, Janeway, Patton, et al).

The median turn-around time was 15 days. But while 24% of enrollees had a match to an eligible treatment, only 10% (39 patients) had actually enrolled in a Pediatric MATCH treatment trial, according to the press release.

Children with cancer sometimes have a better prognosis than adults, yet fewer targeted therapies for cancer are tested in children than adults. (There are more than 150 U.S. approvals for targeted therapies in adult cancers). This situation led ASCO to identify research into precision therapies in pediatric cancers as a priority.

While the abstract presented at the presscast discussed the results of the Pediatric MATCH screening trial, there is also a treatment protocol, Parsons said.

The discussants at New York BIO

Pharmaceutical Finance on the Brink of Epochal Change

by John J. Otrompke, JD

                With pharmaceutical companies entering a bidding process for inclusion onto the formularies of PBMs over the next few months, the drug industry may be entering a historically chaotic time, according to speakers on a May 14 panel at New York BIO, “The Impact of Pricing and Policy on the Next Decade of Therapeutic Intervention.”

That may be especially true if CMS finalizes its proposed rule, “Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees,” which came out in January.

Discussants speculated that the change might come January 1 of 2020.

“Nobody’s quite sure how the rule will shake out, so there’s a dual-bidding process going on for Medicare D contracts, with a deadline in June, with one bid under the old rule, and another bid if the proposed rule passes,” said Jeff Berkowitz, JD, CEO of Real Endpoints.

Inflationary Forces

                Some on the panel opined that the rebate system, in which drug manufacturers compete for PBM formulary access by offering larger rebates, means that competition raises prices, not lowers them.

“The details of the PBM contracts are proprietary, unless there is a lawsuit, like when there were dueling lawsuits in 2017 between Express Scripts and Kaleo, which makes narcan pens,” explained Madelaine Feldman, MD, a rheumatologist and clinical assistant professor of medicine at Tulane University Medical School in New Orleans.

“When attorneys can go in and look at the contract, they found that the PBM was passing back only 7% of the rebate to the plan in the private market, and only 20% to Medicare. The rebate was only 7% of the price concession, 93% of which was held onto by the middleman,” she added.

The proposed regulation would take away the safe harbor under the Anti-Kickback Statute for PBM rebates, and create a safe harbor for a flat, market rate administrative fee. It would also create a safe harbor for patients, noted Feldman, who pointed out that some of her rheumatology patients who take very expensive drugs for incurable diseases rely on rebates for their drugs.

“It would certainly be a change to PBM’s cost structure,” said Berkowitz. “All the PBMs say they could live in a world without rebates, but that they do valuable administrative work, and they would charge an administrative fee for it.”

(Another proposed rule from CMS, “Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses,” was published last November and is still pending. That rule proposes a great many changes, including a new definition of “negotiated price,” but would also allow payors and PBMs to use step therapy for prior authorization for six heretofore protected classes of drugs).

                                Will PBMs Have a Role in Innovation Decisions?

That said, PBMs, too, are an evolving industry. Five large insurers own or intend to own PBMs, such as CIGNA, which recently purchased ExpressScripts, and the Humana-Walmart merger. Last summer, Amazon bought Pillpack, which has pharmacy licenses in 49 states.

In addition to regulatory proposals, other market solutions proliferate.

“In addition to re-aligning financial incentives among supply chain intermediaries so that they do not encourage higher prices, I favor value-based pricing, particularly for treatments that have no branded or unbranded competitors,” said Anna Kaltenboeck, senior health economist at Memorial Sloan Kettering Cancer Center in New York, who also spoke on the panel.

“Value-based reimbursement is one way to get to the answer,” said Berkowitz. “Although it has taken on a negative connotation, it is a term of art in the industry. Now it’s time for pharma to put it on the line. If you don’t get to your outcome, that’s going to have repercussions,” he said.

“In Louisiana, where we have a large prison population, and so a very large hepatitis C problem, the Netflix model was proposed. The state would contract for an unlimited supply of the hepatitis C drug, and the contract also assures the manufacturer of a minimal amount of money,” said Feldman.

 “Policy needs to have an effect on solving Alzheimer’s. There’s no capital going into this, and we’re all aging,” he gave as an example.

“In disease areas like COPD, cardiovascular disease and diabetes, there’s not a tremendous amount of continued innovation going on right now,” agreed Berkowitz. “But you’re seeing therapies like CAR-Ts in the pipeline, where you get a one-shot deal. People take it once and get cured. The industry would develop a treatment for a rare disease, and treat seven people for a million dollars each.

“So people in the audience should travel to Louisville, Kentucky, or Minnesota, and sit down with the PBMs, and ask them, ‘What kind of innovation do you want to fund?” he suggested.

© 2019 John Otrompke

The Embargo Has Ended for the ASCO 2019 Presscast

The embargo for the 2019 pre-conference presscast for the American Society of Clinical Oncology (ASCO) has ended.

Discussants described five studies to be presented at this year's meeting.

I have been admitted, and I have made travel arrangements. I will be at the meeting, and I can cover it for you.

https://meetings.asco.org/am/program

Abstract 520: Low-fat dietary pattern and long-term breast cancer incidence and mortality: The Women’s Health Initiative randomized clinical trial (Chlebowski, Aragaki, Anderson, et al)

Abstract 10011: Identification of targetable molecular alterations in the NCI -COG Pediatric MATCH trial. (Parsons, Janeway, Patton, et al).

Abstract 10009: Phase 1/1B trial to assess the activity of entrectinib in children and adolescents with recurrent or refractory solid tumors including central nervous system (CNS) tumors. (Robinson, Gajjar, Gauvain, et al).

Abstract 4006: Optimizing chemotherapy for frail and elderly patients (pts) with advanced gastroesophageal cancer (aGOAC): The GO2 phase III trial. (Hall, Swinson, Waters, et al).

E3A06: Randomized Phase III Trial of Lenalidomide versus Observation Alone in Patients with Asymptomatic High Risk Smoldering Multiple Myeloma (Lonial, Jacobus, Fonseca, et al)

I have received press credentials for Digestive Disease Week

Hello Readers,

I hope you're all preparing for a good and productive weekend.

I have received media credentials for Digestive Disease Week, in San Diego, May 18-21.

This important annual conference presents the timeliest scientific news not only in oncology, but  gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

Would you be interested in freelance coverage from this event?

You may contact me at John_Otrompke@yahoo.com

https://ddw.org/education/scientific-sessions

I am attending ASCO at the end of next month, and available for assignments

I have received media credentials one of my favorite conferences, the annual meeting of ASCO, the American Society for Clinical Oncology.

This year it's in Chicago again.

I am available to cover the meeting, which I have attended around ten times.

Contact me to discuss the voluminous program.

~John

https://meetings.asco.org/am/register-submit-abstracts

Registered for RIMS

Dear readers,

I have been registered for media credentials for the annual meeting of the Risk and Insurance Management Society. This one is in Boston, April 28 through May 1.

It's been a long time. This meeting is often a good place to pick up stories on the insurance market for various undertakings and industries.

I am available to cover the meeting,

https://www.rims.org/rims2019/Pages/Home.aspx

Thanks for your interest,

~John

All contents copyright 2019 John J. Otrompke, JD

Registered for BIO 2019

Dear readers,

I have been credentialed as a journalist for BIO 2019, June 3-6 in Philadelphia.

https://convention.bio.org/2019/

I can cover this conference for you without expenses. Please email me to make arrangements. I'm at John_Otrompke@yahoo.com

This is a conference I have covered before, for Biotechnology Healthcare and other publications.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3571075/

Thanks, and looking forward.

My article has been published in the fourth HIMSS Insights eBook

HIMSS Europe, a repeat client of mine, has published the fourth HIMSS Insights eBook on the topic of Connected Care and Interoperability. 

The e-book contains my article, "iCAN – Finland;s Precision Oncology Toolbox." There is no charge for the download.

 https://pages.healthcareitnews.com/HIMSSInsights4.html

My article on Federal Strategies to Address Health Costs was Published by the Nashville Medical News

Hello readers,

My article, "CMS Utilizes Dartboard Approach to Modernizing the Medicare Drug Benefit
Nashville Medical News," was published by the Nashville Medical News.

https://www.nashvillemedicalnews.com/cms-utilizes-dartboard-approach-to-modernizing-the-medicare-drug-benefit-cms-2888