Cancer Highlights of 2009
1) Biggest Biotech Deal To-Date
After an eight-month battle, Roche finally gained control of its longtime U.S.-biotech partner Genentech in a $46.8 billion takeover deal to reinforce its leading position in cancer medicines. Genentech’s board and shareholders ultimately accepted the Swiss drug maker’s offer of $95 a share for the 44 percent of the company it didn’t already own; the buyout was completed in March and Roche will rebrand its U.S. medicines as Genentech, including non-biotech drugs. In addition, Roche will drop its long-standing membership in the PhRMA (Pharmaceutical Research and Manufacturers of America) trade group in favor of the Biotechnology Industry Organization (BIO).
2) USPSTF Breast Cancer Screening Recommendations Stir Controversy
Controversial new breast cancer screening guidelines issued in November by the U.S. Preventive Services Task Force (USPSTF) dropped widely-held guidance that women get routine annual mammograms starting at age 40. Instead, the guidelines now advise women ages 50 to 74 could be screened every other year, while those in their 40s should make an individual decision after talking with their doctors. The new guidelines shook up the clinical norm on breast cancer screening and ignited a public debate that dominated the news as 2009 came to a close. On the heels of the task force’s announcement, the American College of Obstetricians and Gynecologists (ACOG) announced revised recommendations for Pap tests, saying young women should begin getting the cervical-cancer screening test at a later age and at less frequent intervals than previously recommended.
3) Pricey Cancer Drugs—Here to Stay?
With Allos Therapeutics’ newly approved lymphoma drug Folotyn™ reported to cost $30,000 per month, and GlaxoSmithKline’s new drug Arzerra™, approved for chronic lymphocytic leukemia, reported to cost up to $98,000 for a six-month treatment course, cancer drug costs once again made major headlines. Drug makers have primarily defended the cost of these expensive drugs for rare cancers, and other high-priced cancer treatments, by saying that they fulfill an unmet need for patients who have either few or no treatment options. But critics say that the therapies don’t provide enough benefits to patients to merit the high prices. In the U.K. in November, the National Institute for Health and Clinical Excellence (NICE) issued draft guidance against recommending Nexavar® for advanced liver cancer for reimbursement on the National Health Service (NHS) saying the price being asked by the drug’s manufacturer Bayer was simply too high compared to “better value cancer treatments.” Although NICE indicated it had changed its approach to appraising high cost treatments—with more treatments which could extend life for terminally ill patients being recommended—the advisory body seemed to have held its ground on allowing coverage for a number of the more expensive cancer therapies during 2009. Late in the year, for example, it turned down the use of Avastin® for the treatment of metastatic colorectal cancer, saying that the drug “did not represent a cost-effective use of NHS resources.”
4) Health Care Reform’s Impact on Oncology
The future of the U.S. cancer care delivery system and access to high quality cancer care for patients was increasingly jeopardized in 2009 due to proposed cuts for CY2010 from the Centers for Medicare and Medicaid Services (CMS). But influential cancer groups including ASCO, COA, US Oncology, ASTRO and others voiced their concern with legislators and pulled off several key victories which should impact oncologists and cancer patients more positively than anticipated earlier in the year when a final health care bill is agreed upon by both the House and Senate in early 2010.
Health care reform legislation is estimated to spend between $850 billion and $1 trillion in the industry funded by new taxes, and cuts to insurers, PhRMA, hospitals and other providers, with lessened cuts to core businesses of medical oncology, radiation oncology, office-administered drugs and PET/PET-CT imaging.
The President signed the law that will create a short term patch to Medicare’s Sustainable Growth Rate (SGR) formula, averting the 21 percent cut to Medicare physician payments from taking place for two months. The patch runs through February 28, 2010. It is anticipated that future legislation will permanently eliminate or delay the built up Medicare physician payments cuts currently required by the Sustainable Growth Rate (SGR) formula.
The legislation expands the privately-insured patient population in need of cancer care, eliminating pre-existing condition exclusions and rescissions.
The removal of prompt pay discounts of up to 2 percent from the Average Sales Price (ASP) calculation, not included in either the House or Senate health care bills, is unlikely to be included in final legislation. But oncologists’ felt they had made progress with legislators on the issue.
In the final rule issued in October, CMS eliminated consultation codes entirely, in both the inpatient and outpatient/office setting. According to ASCO, eliminating consultation codes will disadvantage physicians, like most oncologists—a recent analysis suggests that medical oncologists will experience a decrease of 28 percent in Medicare reimbursement as a result. ASCO supported an amendment to the Senate bill which would delay the elimination of consultation codes for one year. The amendment could come up again when the House and Senate bills are reconciled.
It’s likely that a provision requiring insurance companies to cover routine care costs associated with a clinical trial will be a part of the final legislation crafted.
Although the House passed a bill including a new Medicare benefit that will pay physicians to have advance care planning/end-of-life counseling discussions with patients, the Senate’s version of the bill did not. It’s uncertain if the provision will be included in the final bill.
Within health care reform legislation, oncology practices are likely to benefit from the creation of pilot Accountable Care Organization (ACO) programs for Medicare and Medicaid providers. A provision was included in the House bill that will allow oncologists to form ACOs and share in savings that accrue to Medicare through the use of evidence-based pathways, disease management and advance care planning. US Oncology, for one, is working to ensure that the provision remains in the final health care legislation enacted in 2010.
5) Personalized Medicine Makes Strides
In big clinical findings at ASCO, a Phase 3 study of Herceptin® significantly prolonged the lives of patients with HER2-positive advanced stomach cancer when combined with standard chemotherapy. In advanced melanoma patients with a mutated BRAF gene, patients showed significant tumor shrinkage when given an experimental drug being co-developed by Roche and Plexxikon known as PLX4032. Data from a small, early-stage study indicated that the drug prevents progression of the disease for six months. In other news, Genomic Health’s Oncotype DX® colon-cancer test, based on an analysis of seven different genes found in colon-cancer tumors, indicates whether patients are at low, intermediate or high risk of having the disease return after it is surgically removed. And in March of 2009, cancer doctors at Massachusetts General Hospital announced that genetic testing would become a commonplace aspect of treatment for nearly all new cancer patients within a year. Doctors plan to screen for 110 abnormalities, carried o
n 13 major cancer genes, that predict whether drugs on the market or in development might thwart a patient’s tumor.
6) 2009 Clinical Trial Successes & Failures
Some of the more high-profile drugs that were turned down for FDA approval and/or which received a no-go from the Oncologic Drugs Advisory Committee (ODAC) included:
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