FDA approves Keytruda for all solid tumors w specific biomarker

TA you may be correct, but I question that. I haven't found any thing that indicates the CMS must reimburse based on FDA approval on label. i am going to do a little more digging before I relent to your contention. What you are saying is that if a pharma presents a comletely tested drug and FDA approves it for an intended use and it costs $10 million per dose, then Medicare, by law, must automatically reimburse for it. That would probably run counter to the reasonable and necessary mandate that CMS is charged with in managing the fiscal aspect of the Medicare funds.

TA

Medicare Part D covers drug reimbursement. Of course it uses private insurance. If Medicare must reimburse for FDA approved drugs how can some of these drugs be denied reimbursement? Silvrtscript, the largest Part D insurer, removed Xtandi from its formulary this year. So no reimbursement under Medicare though it is FDA approved. This is counter to your contention.

I didn't say Medicare Advantage. I said part D traditional Medicare. That is what I am on. I have Part A, Part B and Part D. For Part D I have Silverscript insurance. Silverscript does not reimburse for Xtandi though it is FDA approved. Thus a clear example of an FDA approved drug that is not being reimbursed by Medicare for on label use.

Just reading another NCBI study regarding the very important drug segment called MAbs. Of the 22 approved by the FDA, 82% are approved by CMS for Part B and only 18% are approved for Part D. The article strongly cites the CMS responsibility of using local and regional determinations of reasonable and nessecary assessments in considering whether reimbursement will be granted.

My point is that CMS make a determination separate and distinct from FDA approval. It appears that most FDA approved drugs are eligible for Medicare reimbursement but clearly not all. If the law required all to be automatically reimbursed we would not have all these easily found studies and articles showing specific FDA approved drugs that are not being reimbursed. And not the ones clearly listed for weight loss, etc.

TA

You are missing a very important point. Medicare Part D covers self administered prescription drugs and is mandatory to have. But Medicare is not the payor Private insurance is the payor. So Medicare allows the payor to determine what is reimbursed according to the formulary. So it is completely within the Medicare system to have FDA approved drugs that are not reimbursed by the Medicare system. The only way a Medicare beneficiary gets prescription drugs covered is through a private insurance company. Either one uses traditional Medicare and has Part D coverage or one opts out of traditional Medicare and uses the Part C Medicare Advantage where a private insurance company is the only payor for everything. Medicare then pays nothing under Part C.

Either way it is clear in the law, regulations and practice that there are FDA approved drugs that are not reimbursed through the Medicare system. FDA approval simply does not require or guarantee that a Medicare beneficiary will be reimbursed. That has to be determined by the CMS and the numerous local and regional subcontractors that are charged with making those determinations. The participating insurance companies are part of this group.

Thus Medicare beneficiaries can have different determinations of reimbursement depending on where they live and which Part D company they use. This is true for drugs and treatments covered by Part A and Part B.

TA. This is a friendly debate that needs more factual reporting. You contend that Medicare automatically by law approves for reimbursement any and all drugs upon FDA approval except for the earlier mentioned exclusions for drugs like weight loss. Please cite the applicable portion of the Medicare act that so states that.

I have stated that the charge of FFA and CMS are distinct and that CMS has the charge to determine what drugs or procedures they will reimburse but that they are not required to automatically reimburse just because FDA approves. CMS is charged to reimburse on reasonable and necessary grounds. I will provide some citations to that effect. I have already referenced several studies that clearly show that there are many drugs that Medicare does reimburse for. I will provide more specifics.

Regarding Part D insurance company formularies. I can guarantee you that no company reimburses for absolutely every drug that has ever been approved by the FDA. Nor should they. Regarding the star system you reference have you checked to see how the various companies rank? I have not but I will.

While I enjoy some good hearted sparring I hope others aren't getting bored by us. It evident that you have clearly gained some additional knowledge about the complexities of the Medicare system.

JNF--I for one am anything but bored, only very grateful that you and the Tall One are applying so much diligence and brain power to this terribly complicated situation. Thank you.

I would like to refer to the approval of Keytruda by the FDA again. As Allen pointed out this is indicated for „metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)“.

Prof. de Bono made a presentation at ASCO 2017 on 2nd of June called „Targeting DNA Repair Mutations in Metastatic Castration-Resistant Prostate Cancer“. He mentioned that 5 to 8% of metastatic castration resistant prostate cancer patients have defective MMRs (1). These prostate cancer patients could get Keytruda as specified by the FDA.

He also presented a case where Keytruda provided a very good response (2).

George

(1) VIEW IMAGE

(2) VIEW IMAGE (upper right part after treatment with Keytruda)

TA, et al,

Yes I read the Harvard Blog as well. It's main point was about the rising costs and how they will be paid. Remember that Medicaid is different than Medicare. Medicaid is completely public funded (federal and state). Medicare is a combination of public (federal 80% of parts A&B), commercial insurance (A&B supplemental co-insurance, C Advantage, and D drugs), and patient (premiums, deductibles and co-pays). Kaiser Family Foundation has a running study that breaks all this down and most recently reports that for Medicare beneficiaries the public reimbursement is about 50% of the expenses with the insurance companies and patients paying the other 50%.

CMS is tasked by law to provide medical service and drug reimbursement for the Medicare/Medicaid beneficiaries that are " reasonable, necessary, and/or appropriate based on evidence-based clinical standards of care". It is also tasked with managing the trust funds in a prudent manner to insure they stay solvent over the long term. Thus, they have built in discretion to manage appropriately. This includes setting reimbursement levels and rationing of goods and services. They do not have an open checkbook.

Regarding FDA approval, it is stated as a general pre-requisite to make a drug eligible for reimbursement. The drug also has to be available for sale in the USA. These are not absolute as Medicare and their contractors can go outside these requirements in the event of shortages, and such. Note that vaccines are not subject to these rules since the collapse of the vaccine industry in the USA over the past 25 years. Medicare does not automatically require that all FDA approved drugs must be covered. It does follow that most all are covered, but not all.

Good that you found the CMS manual. Note that section 30.15 covers formulary management for Part D, drugs. It requires the insurance company to review FDA approvals within 90 days and make a reimbursement determination within 180 days. It doe not require all FDA approved drugs to be automatically covered. It does spell out minimums that the insurance company must provide. Further the insurance company can impose additional requirements not part of the FDA label including quantity restrictions, time of use restrictions, tier level reimbursement formulas and Step Therapy restrictions that require the use of other drugs first. These are all methods of managing use and reimbursement cost of drugs in order to pursue effective cost management.

Earlier this year Silverscript (the largest Part D insurer) removed Xtandi and Trelestar from their formulary as being unreasonable in cost and un-necessary to reimburse for asSilverscript covered other comparable drugs. In Georgia Medicare gives Silverscript the highest rating of 4 stars. By contrast the AARP Part D plan is a 2 star. I just received an updated Silverscript formulary, effective June 1, 2017, and the two drugs are back in. No news reports can be found unlike the many reports when they were removed. But this tells me that Silverscript negotiated a better price for these drugs.

The rule that Medicare can not directly negotiate drug prices seems to me to be a red herring. For A and B they set the reimbursement rate for a drug. That is not negotiation, that is coercion! For example, my wife gets a monthly injection of Faslodex. Before Medicare it was reimbursed at about $6,500 per shot. Now it is covered by Medicare B and they set the reimbursement at about $2,500 per shot. MC pays 80% of that and our Medicare supplement policy pays the balance. Under Part D prescription drug coverage and Part C Advantage , the insurance companies can and certainly do negotiate dug prices. Remember, Medicare des not and has never reimbursed for self administered prescription drugs. Thus they have no need or reason to negotiate the price.

Also note that the newer classes of biologics like Keytruda (large molecule drugs usually ending in MAB) are considered Part D drugs under the 'Targeted Therapy" definition. Basically a Part D has to be by prescription and self administered. If it has to be administered in a clinic or hospital setting then it is either a Part A or B drug and Medicare bears 80% of the reimbursement. By calling these clinic administered drugs Part D, this shifts the reimbursement costs from the federal government to the insurance company and patient, since Medicare has never paid for self administered prescription drugs (Part D and Part C). The MAB class drugs are injected or infused in a clinic or hospital setting. They can not be ingested due to the large molecule basis which is destroyed by the digestive process. They are extremely expensive to culture and are very vulnerable to time and storage, and require infusion. That is why they cost $12,000 per month or more. Medicare's method of cost control is to not pay for them, but to shift the cost to the private sector and patient.

Back to the Harvard blog and future cost. It is estimated that more than 15,000 people are now on Keytruda at a cost of $150,000 per year. That is $2.25 billion per year. Five years ago it was $0. And the use has just been expanded. While I like that we have such progress, it has to be paid for. The breaking news is no longer the report of the $1 billion drug class, it is now the $100 billion drug class which the MABs are quickly becoming. Count the number of MABS advertised during the nightly news and Jeopardy. Just exactly how many MAB drugs do we really need for psoriasis?

I have a number of great sources that provide much more detail and here are some links for your use. These include the Kaiser Family Foundation, www.kff.org; The Hudson Institute, www.hudson.org; several studies on www.ncbi.hlm.nh.gov/pubmed; National Council on Aging, www.ncos.org; and of course the Medicare site.

I would be happy to start a thread that will address Medicare and the choices, if there is interest. Due to my work, I have to be very familiar with the system and I assist people at least weekly on the considerations and their choices.

Yes you have this correct. Drugs that can not self administered are either covered by A or B depending on the hospitalization status versus out patient.

One exception is with this class of drugs which as you report are administered in a clinical setting. CMS does this by identifying a class of drugs as "targeted therapy" and is an exception to the Part B rule that you reference. I just looked at the Silverscript formulary and found Keytruda as a tier 5 drug.

As to moving more drugs from A&B to D, could CMS do more of this? I am sure they can, but what is the method required? What are they allowed to do within the law and regulations and at what point do they need legislation to make the changes? I don't know. Also remember that there is some federal subsidies in the Part D when in the donut hole and the catastrophic coverage that one will be subjected to when on such an expensive drug.