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Thursday, November 30, 2006
San Antonio Breast Cancer Symposium Dec. 14 - 17I'll be attending the SABCS again this year as a consumer reviewer with our sister organization, The
Alamo Breast Cancer Coalition. I'm really looking forward to this event. I attended last year and had a fantastic
time reviewing all the latest results of important breast cancer research both here in the U.S. and abroad. The panel discussions
and presentations were amazing and the amount of information was nearly overwhelming. It took me many months of reading
to sort it all out. Later on, I'll give you a view of what the typical day is like at SABCS.
This year, the "hot topic" I've been assigned is prevention and screening research.
I've been given a number of abstracts to review and will report on them at the end of the conference. In addition, the
Alamo group holds a daily "wrap up session" after the conference with various doctors and researchers giving a summary
of the research covered in that day's plenary and poster sessions.
I'm working to make this event accessible to all of you. The Alamo Breast Cancer Coalition will have webcasts
every evening, after the daily "wrap up" session. I'll be posting a link on the web page so you can click on it
and watch each day's web cast.
In addition, I'll present a report on SABCS at the next NOBCCF meeting after the Symposium - on January 25 at
7 pm.
Keep watching this page for more information!
Wednesday, November 29, 2006
News from MAMM MagazineThe latest issue of MAMM Magazine has a number of very interesting stories on breast, ovarian and cervical cancer.
Visit their web site and read their news stories.
Experimental Drug May Fight Off Brain Metastases
A new
experimental cancer drug called Tykerb has been shown to slow the progression of metastatic Her-2 positive breast cancer after
Herceptin treatment has stopped working in patients.
What about Your Father's Side of the Family?
Women who are asked about breast
cancer incidence in their families underreport cases on their father's side, new research suggests.
Another Clue to Recurrence
Link to MAMM
http://www.mamm.com/main.php?optjs=1
Monday, November 27, 2006
A recent note from well-known author and breast cancer research advocate Musa Mayer regarding with some helpful
information about ways to reduce risk of osteonecrosis of the jaw for breast cancer patients living with bone mets.
"A real innovation in the treatment of painful bone metastases from breast cancer, multiple myeloma and prostate
cancer, the three cancers that commonly spread to bone, has been the use of the IV bisphosphonates pamidronate (Aredia) and
zoledronic acide (Zometa), which have greatly reduced the rate of fracture, pain and hypercalcemia, a once common late symptom
of bone mets. As high-potency versions of the bisphosphonates given for osteoporosis, these drugs also slow progression of
the disease in bone by altering the balance of osteoclasts and osteoblasts. It was once thought that women with bone metastases
from breast cancer could simply remain on one or another of these drugs for the remainder of their lives, but in the last
couple of years, a serious side effect of this class of drugs has emerged.
In researching osteonecrosis of the jaw (ONJ), a painful and debilitating side-effect of long-term
use of IV bisphosphonates (and possibly, less commonly, of oral bisphosphonate as well) for the BCMETS mailing list (www.bcmets.org), I came across a very good open access review on the subject in the May 2006 Annals of Medicine that is a position
paper of the American Academy of Oral and Maxillofacial Pathology. You can find it here:
http://www.annals.org/cgi/reprint/144/10/753.pdf
Some women on BCMETS who have been on monthly Zometa or Aredia to slow progression of their bone metastases
have had their oncologists recommend less frequent administration of the bisphosphonates, every two, three or even six months,
which makes some sense (though is not yet supported by evidence), since the condition appears to be related to "oversuppression
of bone turnover."
It is currently unknown whether Denosumab, a RANKL-inhibitor in Phase III trials for bone metastases, will
also cause ONJ.
Musa Mayer
Saturday, November 25, 2006
Medicare & Medicaid Reconsidering Clinical Trial Coverage12/13/2006 - Clinical Trial Policy
Issue
The Centers for Medicare & Medicaid Services is reconsidering its national
coverage decision on the Clinical Trial Policy. On September 19, 2000, the Health Care Financing Administration (now the Centers
for Medicare & Medicaid Services (CMS)) implemented a Clinical Trial
Policy through the NCD process. The Clinical
Trial Policy was developed in response to a June 7, 2000 executive memorandum, issued by President Clinton, directing Medicare
to pay for routine patient costs in certain CLINICAL TRIALS.
The 2000 Clinical Trial Policy requires trials to be
"qualified" prior to payment of routine costs. The policy provides for certain trials to be deemed qualified;
i.e.,
those that are approved and funded by a Federal agency or have an IND approval from FDA or are IND exempt. An additional option,
the self-certification option, was never implemented. CMS is reconsidering the current Clinical Trial Policy (to be renamed
the
Clinical Research Policy) to address several issues that have surfaced since its implementation including the need
to:
1. Clarify payment criteria for clinical costs in research studies other than CLINICAL TRIALS;
2.
Devise a strategy to ensure that Medicare covered clinical studies are enrolled in the National Institute of Health (NIH)
CLINICAL TRIALS registry website;
3. Develop criteria to assure that any Medicare covered clinical research study
includes a representative sample of Medicare beneficiaries, by demographic and clinical characteristics;
4. Clarify
the definitions of routine clinical care costs and investigational costs in clinical research studies including CLINICAL TRIALS;
5. Remove the self-certification process that was never implemented;
6. Clarify the scientific and technical
roles of Federal agencies in overseeing IND Exempt trials;
7. Determine if coverage of routine clinical care costs
is warranted for studies beyond those covered by the current policy.
8. Clarify how items/services that do not
meet the requirements of 1862(a)(1)(A) but are of potential benefit can be covered in clinical research studies as an outcome
of the National Coverage Determination process;
9. Clarify whether and under what conditions an item/service non-covered
nationally may be covered in the context of clinical research to elucidate the impact of the item or service on health outcomes
in Medicare beneficiaries; and
10. Discuss Medicare policy for payment of humanitarian use device (HUD) costs.
In
CMS' reconsideration of this NCD, we believe there are three overarching goals of the proposed Clinical Research Policy:
1)
to allow Medicare beneficiaries to participate in research studies;
2) to encourage the conduct of research studies that
add to the knowledge base about the efficient, appropriate, effective, and cost-effective use of products and technologies
in the Medicare population, thus improving the
quality of care that Medicare beneficiaries receive; and,
3) to allow
Medicare beneficiaries to receive care that may have a health benefit, but for which evidence for the effectiveness of the
treatment or service is insufficient to allow for full, unrestricted coverage.
Meeting these goals will require some
clarifications to the current Clinical Trial Policy and may require additional regulatory changes. The Clinical Trial Policy
was developed under the authority of section 1862(a)(1)(E) of the Act. This paragraph prohibits payment for items and services
that are not reasonable and necessary to carry out the research purposes of section 1142. In other words, it broadens
the limitations on the scope of permissible Medicare payments (in section 1862(a)(1)(A) of the Act) to include making payments
for what is reasonable and necessary for the Secretary, acting through AHRQ, to carry out research under section 1142. It
permits payment for
clinical care that is being studied under section 1142 for its effectiveness and appropriateness.
Actions
Taken
October 30, 2006
Posted FR notice announcing December 13, 2006 meeting.
November 9, 2006
CMS is extending
the deadline for presentations and written comments for the
December 13, 2006 MCAC meeting. The new deadline is 5PM EST
November 24, 2006.
November 22, 2006
CMS posted the roster and the questions to be discussed at the December 13
MCAC
meeting. The questions may be further refined before the date of the
meeting. Any updates will be posted.
CMS is extending
the deadline for presentations and written comments for the
December 13, 2006 MCAC meeting. The new deadline is 5PM EST
November 30,
2006.
25 nov 06 @ 6:00 pm
Friday, November 17, 2006
OH Prescription Assitance Program Changes To Include More UninsuredOhio's Best Rx, the state's prescription drug discount program for the uninsured, is slated for expansion in lame duck
session over the objections of pharmacists who have absorbed the vast majority of nearly $7 million in savings the cards have
generated since January 2005.
However, with the percentage of enrollees using the card dropping below 14%, and rising concerns that the discounts aren't
reaching enough uninsured Ohioans, supporters have pushed for an eligibility expansion and other changes to beef up participation.
On Wednesday, Rep. John Hagan (R-Alliance) and Sen. Bob Spada (R-N. Royalton) testified to the latest companion versions
of the proposal (HB 468 & SB 251), which was in the House Finance & Appropriations Committee as a substitute bill
(Legislative Service Commission memorandum). Messrs. Hagan and Spada said both chambers have coordinated their efforts to
facilitate passage of the update by the end of the current legislative session on Dec. 31.
Senate President Bill Harris (R-Ashland) said the prospects of passing the bill in short order are "very positive."
"We think that we have an agreement that without including the participation by the state retirement (systems), we're
going to be able to put the bill together with agreement of all parties," he said.
In the Senate, the committee held off on accepting a substitute version, Sen. Spada said, because he is still working
on language to merge Best Rx with the Golden Buckeye Card discount program for seniors.
The lawmaker said he views the combination of the programs as a critical component of the package.
"I personally believe the Golden Buckeye and Best Rx don't survive if we don't merge them," he said. That's because of
the lower-than-anticipated participation rates and the fact that startup money for the Best Rx program will run out next year.
In the House, the program merger remains an area of discussion among interested parties that has not been resolved.
Proposed eligibility changes to the Ohio's Best Rx program include:
--An increase in the annual family income limit from 250% to 300% of the federal poverty level, which is $20,000 for
a family of four.
--The elimination of a four-month waiting period for people who have been laid off or released from employment and lose
prescription drug coverage.
--The removal of a prohibition against workers' compensation drug benefits recipients from participation.
--Eligibility for certain recipients of Medicare Part D benefits.
Some aspects of the substitute version of the bill were crafted to resolve a lawsuit over the release of manufacturer
rebate information that pharmacy benefit managers, the middlemen of the prescription drug market, deemed to be proprietary.
Under the original Ohio's Best Rx program setup, the discounts were to be based on those already received by government
employees through state insurance plans, however the PBMs that serve the state and its five pension funds - namely Medco Health
Solutions, Inc. and Caremark - were resistant and legal action ensued in the Franklin County Common Pleas Court.
The substitute version of the bill resolves that issue with language that requires the current PBMs to serve as "consultant
PBMs" to the Best Rx program at no charge to the state. Under the arrangement, the consulting PBM provides "verification services"
in regards to pricing formulas and negotiations with drug manufacturers.
Tom Sherman, government relations officer for the Ohio Public Employees Retirement System, said the state pension funds
will be glad to get out of the middle of the legal battle over the secretly negotiated agreements between PBMs and manufacturers.
"The lawsuit has basically been out there hanging over everybody's head," he said.
Medco and the Pharmaceutical Research and Manufacturers of America, the key group behind the original agreement, were
among the other players who voiced public support Wednesday for the new approach. The Ohio AFL-CIO is also on board, legislative
director Tim Burga said in an interview.
Medco Senior Vice President for Government Affairs Terry Latanich told lawmakers in testimony that the deal resolves
the firm's objections to the program that kept it from participating in the original coalition.
"Our concern was not disclosing this information to our clients. Rather, it was that this information would become readily
available to our competitors and drug manufacturers," he said.
"We recognize, however, that the Best Rx Program needs a mechanism to ensure that the rebate contracts that it negotiates
with drug manufacturers bring significant savings to Best Rx enrollees."
PhRMA attorney Donna Boswell, told House Finance Committee members in proponent testimony that the agreement and bill
as a whole would expand access to the program and make it simpler to enroll.
Representatives of pharmacists and retailers, however, suggested in interviews that it's easy for manufacturer's to buy
into the program because their costs are exponentially smaller than those of pharmacists.
Lora Miller, a lobbyist for the Ohio Council of Retail Merchants, said her group is opposed to the Ohio Best Rx expansion,
in part, because its pharmacy members carry a disproportionate share of the financial burden of the discounts.
State data shows that of the $6.845 million in total savings generated by the program through October 2006, only $520,000
came as a result of manufacturer discounts. Pharmacists essentially ate the rest of the tab, Ms. Miller said.
"When manufacturers begin providing equally meaningful discounts to consumers through the Best Rx. Program, we'll revisit
our position," she said. Kelly Vyzral, director of government affairs for the Ohio Pharmacists Association, said the current
setup is "blatantly unfair."
"It costs an average $8 to fill a prescription. We're getting $3 a prescription through this program," Ms. Vyzral said.
And because of the effects of generic drugs, pharmacists are giving discounts on 100% of the prescriptions that come in while
manufacturers give breaks on only 15%.
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