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Shouldn't We Be Improving  AFFORDABLE Access To Life Saving Drugs!  Most Else Is Just  BS (Bogus Spin)!  Part 1 Of A 4 Part Series

12/21/2019

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The major components of the new drug plans in the House focuses on Drug Pricing, and the Senate's bill on pricing really does not even confront the Elephant in the room, which is the lack of negotiation of Medicare Drug Prices.  However, both bills have one thing which will improve ACCESS, which is the cap on out of pocket costs, the House at $2000 and the Senate at $3100.   So what is the Bogus Spin?  There are 3 major categories of BS (Bogus Spin)



- Reducing Negotiated Drug Prices will improve  AFFORDABLE ACCESS to life saving drugs.
- New Drug innovation will be stifled if Medicare negotiates price.
- We have the BEST health care system MONEY CAN BUY.

I had planned to do a three part YouTube broadcast on these three elements, but everyone was focused on other government business(impeachment).  I think it is only logical to start this series after the holidays.  However, I believe I can outline some of the logic beforehand.

Reducing Negotiated Drug Prices will improve AFFORDABLE ACCESS to life saving drugs.

Most private and government insurance (eg. Medicare, Medicaid) base the copay at a percentage of the List Price, not the Negotiated Price.  If the negotiated price goes down by 50% the list remains the same so the copay does not change one bit!  Copay must be changed to a percent of  net  pricing. 

The Insurance companies increase the copay % as the price of the drug goes up.  They call it Tiers, and I think they need to change the spelling to TEARS.  Tier 1 (preferred generic drugs)has a very reasonable copay of $5 to $15 per prescription, but in higher cost drugs in Tier 4 and the Specialty Drug Tier it is 25 to 33%  For cancer drugs this can represent $3000 to $5000 per month. I have myeloma and the one drug which is used in most all treatment regimens is Revlimid, at an out of pocket cost of $14,000 per year.  See the graph below.

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Affordable is a major key to this entire argument.  Is it affordable to all Americans?  I say that is so much BS(Bogus Spin).  It is not affordable to most seniors, nor the middle class, the needy, and minorities.  Let me just talk for a minute about very sick seniors!  The ones with heart disease or cancer.  The number 1 and 2 killer of Americans.  According to the Kaiser Family Foundation the average income of a Medicare Beneficiary was $26,200 in 2016.  To be covered for the 20% copay of Part A & B, they would need to have Part G or F as well, and include Part D for drugs.  Cost for these insurance premiums is $5000 each year and with one drug like Revlimid at a copay of $14000, it comes to a total of $19000.  This is the equivalent to Senior Genocide, but with all cancers a slow agonizing death. Over 600,000 Americans die of Cancer each year!  Just for comparative purposes this contrasts to the costliest war in US history, the Civil War, where 620,000 soldiers died over a period of 4 years. 

New Drug innovation will be stifled if Medicare negotiates price.

If you were provided a free lunch everyday and it was excellent food, why on earth would you pay for your own?   Not having to negotiate price is the "ART OF THE NO DEAL".   Drug companies must negotiate prices with all major industrialized nations, and private insurance companies and PBM's(Pharmacy Benefit Managers), but for everything they lose in these negotiations can be made up by just raising list prices which Medicare will pay by law!

The NIH (National Institute of Health) provides billions of dollar to fund the development of new drugs, and academic institutions provide basic research for drug development.  Frequently, this work is then developed by very small companies which do not have the capital to spend the billions to get FDA approval.  If they have a great idea, they usually are purchased or license  the drug to a large drug company, which has the funding to bring it to market.  The two blockbuster myeloma drugs, Thalidomide/Revlimid(Celgene)and  Velcade(Takeda) were developed by very small companies. Celgene was very small when it licensed the use of Thalidomide from Rockefeller University, and Velcade was first developed by a small biotech ProScript to treat muscle weakness and muscle loss associated with AIDS and muscular dystrophy and ultimately was purchased by Takeda.

To me the biggest barrier to new drug development is the lack of protections for small bio tech firms which have become the target of Illegal and criminal stock market manipulation.  Small companies can easily be forced into bankruptcy by Capital Vultures who have found easy prey in small and vulnerable biotech firms.  Many companies have been devalued by as much as 99% in just 5 years.  How many life saving drugs have not made it to market because of these heartless and morally bankrupt animals who feed off the dead and dying?  I explain this in a 3 part series and you can read it if you CLICK HERE.  Two prior blog posts on this major problem are as below, just click on either of the following story headings.


What If The New Cancer Drug Pipeline Runs Dry? No New Cancer Drugs! Patients DIE!
The Proof Capital Vultures Are Destroying Baby Bio Tech Companies Before They Have Time To Create New Drugs!



The USA has the BEST health care system MONEY CAN BUY.

This one is very hard to argue with unless we look at the definition of the word BEST.    If best is the one where you can get the best care in the world only IF you have all the money in the world or have a drug and health plan with affordable co-pays, then it is hard to argue against this statement.  If best is defined by any other measure, best life expectancy, care for all citizens, care for the elderly and needy, most cost effective per citizen, non discriminatory, lowest infant mortality, ad infinitum, then we have a very long way to go. 

Each of these points will be discussed in my 4 part Series titled "The Bogus Spin Report" or in short "The BS Report".
  Good luck and God Bless your Cancer Journey/ [email protected].

For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1
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BIG #MYELOMA NEWS WEEK!  #ASH19 Showed Excellent Progress Towards The CURE, & The House Passed A Drug Cost Control Bill!

12/15/2019

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Myeloma Had An ASH Kicking In Orlando This Year!

I had an opportunity to attend the ASH(American  Society of Hematology) annual conference this year in Orlando from 12/6 to 12/10, and came away with the feeling the future of myeloma treatment is excellent!  These are my top line takeaways.

- Myeloma has a tight knit   community of researchers, myeloma specialists, patient advocates, drug companies, and myeloma organizations like the IMF, MMRF, LLS, and Myeloma Crowd.   They use Twitter and Facebook as communication tools which provides real time information to the myeloma patient community. There are more than 24 major categories of blood diseases represented at ASH, and  myeloma was frequently listed in the top 10 of ASH twittter online influencers.  Given myeloma is one of the the 24 major diseases, you would expect them to have less than one top influencer in the top ten, but they had between 6 to 10 of the top 10.  Just remarkable!

-  Each new class of drug which is approved has resulted in an increase of one year in life expectancy.  We just had one new drug approved, Selinexor.   We also have 7 drugs which have a high probability of approval.  These are the ones with at least two FDA designations like Orphan Drug and Fast Track.  Effectively the ones the FDA finds  fill an unmet need and  have the most potential, kind of like the Teachers Pets of drugs.  CAR T, BiTE's, ADC's, AWC, melflufen, multi target CAR T, CLR131, allogeneic CAR T and many more, are all new classes of drugs which bodes well for current and future patients life expectancy.  I estimate a minimum of 6 new classes of drugs approved for myeloma which, if history repeats itself, would take the current NCI, national average life expectancy, for all patients from 6 years to 12 years.  The 15% who consult or see a myeloma specialist which now have a life expectancy of 10+ would likely to exceed 16+ years.

-  When Daratumumab was approved in RRMM(Relapsed Refractory Myeloma) it had been approved  with an ORR(overall response rate) of 24% and a PFS of  just 1.9 months.  Daratumumab has been moving to early stages of the disease, and in combinations with EVERYTHING!  It seems "Things Go Better With DARA"!  These new combination with Darzalex are exhibiting exceptional resultsl. At this year's ASH we have new drugs which have shown better initial results in heavily pretreated patients who have also failed Darzalex.  The newly approved Selinexor had an ORR of 26% and twice the PFS at 3.7months.  A drug in clinical trial, GSK2857916 has an ORR of 38.5% in  patients who had previously been treated with daratumumab, and a PFS of 7.9 months  This is 4 times more effective than the Darzalex PFS!  The big question is how will these and all the new classes of  drugs perform when moved to earlier in the disease process.  I think the sky is the limit!

- A big finding for me was a repeated use of the phrase "treatment used as a Bridge".   At end stage myeloma, patients are often too sick to qualify for clinical trials.  If  treated with one of the end stage drugs like  Panobinistat, Selinexor, or many other combinations the disease may be able to be controlled enough to make it into available clinical trials. 

-  Treatments for early stage myeloma have shown excellent results,  For example high risk smoldering myeloma has a 50% chance of progressing to full blown myeloma each year, however an all oral clinical trial of IRd (Ninlaro, Revlimid, dex) had a 0% chance of progressing in the first 30 months or 2 1/2 years.  Many such trials for high risk smoldering myeloma are in process.  Soon the question will be how do we screen the population to catch myeloma in the precursor stages.  This may reduce or eliminate the devastating end organ damage associated with finding myeloma in the later stages of the disease progression.  The future looks bright!

The House Has Passed A Bill Which Should Help Patients To Get Access To Life Saving Drugs!  BUT!

This is great news for the myeloma patient community.  Cost is important, however the critical feature to the patient is ACCESS TO LIFE SAVING DRUGS!

The Congressional Budget Office estimates that the proposal would reduce Medicare drug costs by $500 billion over 10 years in three major ways:

· It would allow Medicare to directly negotiate prices for up to 250 of the mostly costly drugs that have no competition from generics or biosimilar drugs. Companies that don’t negotiate would be subject to an excise tax of up to 95 percent on gross sales.

·  The US prices of those drugs would be tied to a benchmark index of prices in other developed countries.

·  And, for all drugs, manufacturers would have to rebate back to Medicare any price increases that exceed the rate of inflation.

The most significant element of the bill for drug access is the capping of out of pocket and co pay for  Medicare at $2000 per year. Currently there is no out of pocket maximum limit.  Most all newly diagnosed myeloma patients usually have a treatment regimen including Revlimid, and the copay would be $2600 for the first month.  Under the House plan it would be limited to $2000.  Great news, if is was not for the fact 50% of prescriptions with a co pay over $2000 are abandoned at the pharmacy.  I believe Senate bill allows this to be spread across the entire year.  So what is the BUT?

The BUT is the house passed it on Party Lines, and  President Trump, who supported the idea of negotiating drug prices during his presidential campaign, now strongly opposes the House Democrats’ bill for part D.   The measure will likely die in the Senate, where Majority Leader Mitch McConnell (R-KY) may block it from ever coming to a vote. 

The Senate has a bill which the president will likely back BUT is absent one of his initial major objectives to negotiate Medicare, and Medicaid oral drug prices. This bill well likely be rejected if voted on in the House.   The concern in the Senate has to do with the thought this would limit new drug development.   Private insurance companies negotiate prices now, as do all single payer programs throughout the industrialized nations of the world.  It is also the talking point all the drug lobbyists are spinning!   It is known that 8 in 10 American's feel Medicare should be able to negotiate drug prices.   BUT the measure does not address the problem copays are always computed as a percentage of the list price and should include provisions to make copays a percentage of the negotiated price. Under the existing system if the cost of a drug is negotiated down by 50% the copay would remain the same.  Our entire economy is based on negotiating price and trying to get a better deal by leveraging buying power or "The Art Of The Deal".  The USA has 4.3% of the world's population, but is estimated to be 45% of the world's total prescription drug spending by Reuters in 2021.  As President Trump has noted the world gets a free ride or better said the US pays way too much!  Like China's predatory trade practices, this must STOP!


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This is a very complex problem which requires far more of a discussion than I can discuss here. I plan on providing a multi part You Tube broadcast which I will title "The BS(bogus spin) Report". 

Good luck and God Bless your Cancer Journey/ [email protected]
For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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    Gary R. Petersen
    [email protected]
    CLICK HERE for my myeloma journey

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