Medicare coverage of Cancer drugs

[michele u]

I was just told that medicare has to pay for on and "off" label cancer drugs. Does anyone know if this is true?

[Lolly]

Apparently it's true, here's an excerpt from NCA's web site:


"...The U.S. Congress passed a law in 1993 requiring Medicare (http://www.medicare.gov/), the federally funded health care program for elderly and disabled people, to cover off-label drugs used in cancer treatment when the use is supported by:

1. A citation in at least one of the following authoritative drug reference books.

2. The American Society of Health-System Pharmacists' American Hospital Formulary Service (AHFS). There is a regularly updated online version.

U.S. Pharmacopeia Drug Information

3. Two or more peer-reviewed articles published in respected medical journals.


Medicare coverage policy is not binding on private health insurance providers, although some insurers have adopted coverage policies consistent with Medicare's. Many states have passed laws or issued regulations requiring state-regulated private health insurers to provide coverage similar to Medicare's for off-label drug use in cancer treatment. However, organizations (usually large companies) funding their own health insurance coverage are exempt from these state laws and regulations, although many comply voluntarily..."



Also, here's a link to an article explaining which off label drugs Medicare/Medicaid will cover under the auspices of a clinical trial.

Medicare's NCD Act
http://www.cancer.gov/clinicaltrials...pments/NCD179N

[sarah]

Dear Michelle and Lolly,
Regarding Medicare coverage: by "off label" do you mean beyond normal protocol i.e. one year for Herceptin or do you mean clinical trials? Wouldn't clinical trials be covered by the drug maker? I'm interested in understanding if longer than normal portocol is covered or not. I'm metatastic and on Herceptin beyond a year.
thanks
sarah

[AlaskaAngel]

Lolly, thanks for that information. I would guess then that medicare might cover those wanting "late" trastuzumab who would otherwise not be able to access it -- as long as they can get the prescription for it -- and that would be very welcome news.

AlaskaAngel

[Lolly]

Hi Sarah,
Herceptin is approved for use in metastatic bc, and is used as either a first-line therapy alone or with chemo, or as a maintenance therapy alone or with chemo. It’s been standard-of-care since trials in the mid-90’s. I myself have been Stage IV since 2001 and have been on Herceptin since then, sometimes with chemo, sometimes with long intervals of just Herceptin maintenance.

And Sarah and AA,
Here’s a excerpt with an explanation of “off-label” that says it more clearly than I could (J), and I believe you may be right in that if a physician thinks Herceptin use is warranted and orders it, it would have to be covered…


"Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label, most often concerning the drug's indication. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drug's safety and efficacy in treating a given disease or condition. If satisfed that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug's label. More detail is included in the drug's package insert. However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine and so the physician makes decisions based on her or his best judgment. It is entirely legal in the United States and in many other countries to use drugs off-label. Exceptions to this are certain controlled substances, such as opiates, which cannot be legally prescribed except for approved purposes (at least in the U.S.). In Australia, amphetamines are included in these drugs which cannot be prescribed off-label.
Some drugs are used more frequently off-label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off label and more than half of cancer patients received at least one drug for an off-label indication. Frequently the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathicpain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain.

Off-Label Use and the Law
In the United States, FDA regulations permit physicians to prescribe approved medications for other than their intended indications. Marketing information for the drug will list one or more indications, i.e., illnesses or medical conditions for which the drug has been shown to be both safe and effective. Pharmaceuticalcompanies are not allowed to promote a drug for any other purpose without formal FDA approval.
However, once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective; they are not limited to its official, FDA-approved indications. This off-label prescribing is most commonly done with older, generic medications that have found new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, there is usually extensive medical literature to support the off-label use..."

Hope this helps.
<3 Lolly

[sarah]

Dear Lolly,
Once again you are a wonderful source of helpful information. Many, many thanks. I now also understand "off label"
Good luck in your fight.
Your posts are so appreciated.
thanks
sarah

[Lolly]

Sarah, you're so welcome, and I didn't mean to leave you out when I addressed AA about off-label; I edited it above

<3 Lolly

[sarah]

Lolly,
don't worry, I never feel left out on this site. I feel I have a group of wonderful, caring friends - may I dare even say a family - and I only hope I can find ways to give something helpful back to this amazing community. Since I am in France it is even more important to me than perhaps others who have more information at hand. I'm so grateful.

One more question: on another post you mentioned "Medicare supplemental" do you mean the new government program or a private outside insurance?
I am currently living in France but may be moving back to the USA. I am on Herceptin here and have been approved for disability with social security. As part of that they gave me Medicare hospitalization. I am trying to find out if I will be covered for Herceptin and exactly what I'll have to do to be covered. You can understand my concern. Hence my question about "medicare supplemental." Thanks.
Sarah

[Lolly]

“…One more question: on another post you mentioned "Medicare supplemental" do you mean the new government program or a private outside insurance?
I am currently living in France but may be moving back to the USA. I am on Herceptin here and have been approved for disability with social security. As part of that they gave me Medicare hospitalization. I am trying to find out if I will be covered for Herceptin and exactly what I'll have to do to be covered. You can understand my concern. Hence my question about "medicare supplemental." Thanks.
Sarah”…


Sarah, it’s gotten kind of complicated, but here’s what I understand of the system; however, you should definitely check things out for yourself by going to Social Security and Medicare’s on-line sites. Links below.


Medicare coverage is a multi-layered program, and the first layer is what you have, Medicare Hospitalization or Part A and which is automatic once you’re on Social Security; there’s no premium for Part A, but it ONLY covers hospitalization, and there are co-pays for that.

Then there’s Part B, which is optional and which I believe costs under $100 a month. The premium is automatically deducted from your monthly disability payment once you’ve signed up. It covers your doctor’s visits and tests, and some prescription meds, but only the one’s administered in your doctor’s office like infused chemo’s(Herceptin included, as far as I know).

Part D is the new prescription plan, and here’s where the medicare supplemental comes in: You can buy into a Medicare Supplemental Insurance Plan, and there are many available, and these plans will pick up a lot of the costs Medicare doesn’t cover. You just have to look at the various ones that offer coverage in the state(s) you’ll be locating to, choose your best option, and sign up. Each supplemental plan usually has additional drug coverage which will cover most prescription meds not covered under Part B. Most of the supplemental plans are quite reasonable. My dad’s total cost for Part B and his supplementals is under $200 a month. Additionally he has a $10 co-pay each time he sees his PCP and a co-pay for his prescriptions, which as I mentioned will vary from one plan to the next; this brings his monthly medical expenses up to around $300 right now.
It helps if you can get some advice from an insurance person; I went to several seminars given by some of the companies offering supplemental programs in our area to help my dad figure out which one would be best for him. You can also call customer service for each plan you’re considering and ask for an information packet to be sent to you.

This is just the basic outline of how the programs work, but you’ll have to do some research to decide what’s going to work best for you. Here are the links to Medicare and Social Security, in case you don’t’ have them:

http://www.medicare.gov/Coverage/Home.asp

http://www.socialsecurity.gov/mediinfo.htm

Hope this helps somewhat J

<3 Lolly

[sarah]

Dear Lolly,
As usual you are so helpful and I greatly appreciate the time you've taken to explain all of this.
Thanks
sarah