By Maria Cheng
Bloomberg Businessweek, October 14, 2011
An independent British medical watchdog says the first treatment proven to help people with the deadliest form of skin cancer is too expensive to be used by the U.K.’s health care system, a recommendation critics called a potential death sentence.
The drug, Bristol-Meyers Squibb’s Yervoy, has offered some hope to people with advanced skin cancers, though a recent study showed it only worked in a small segment of patients studied, and they lived just four months longer than patients given older medications.
The National Institute for Clinical Excellence, or NICE, advised Friday that at a cost of 80,000 pounds ($126,600) Yervoy “could not be considered a cost-effective use” of health funds. A final decision is expected next month after a public consultation.
In the U.K., most medicines are paid for by the government, as long as they’re recommended by the cost-efficiency watchdog. The agency commonly rejects expensive drugs, including recently advising against new treatments for prostate cancer, breast cancer, and multiple sclerosis, though patients and doctors are increasingly protesting the decisions.
The government usually adopts NICE’s recommendations, meaning doctors in the government-funded health service cannot prescribe Yervoy without NICE’s approval.
In its decision, NICE said it was not convinced by the evidence, saying the data for Yervoy, which works by stimulating the immune system to fight cancer, did not compare it to older drugs used to treat melanoma. NICE also said the trial was too short to know how long the drug’s effects would last and raised concerns about the drug’s side effects, including diarrhea, rash, fatigue and nausea, which they said could affect a patient’s quality of life.
“We need to be sure that new treatments provide sufficient benefits to justify the significant cost (the health care system) is being asked to pay,” said Sir Andrew Dillon, NICE’s chief executive, in a statement.
Patient groups and charities slammed the decision, labeling it a “death sentence” for people with advanced skin cancer.
http://www.businessweek.com/ap/financialnews/D9QC77O00.htm
And…
U.K. Agency Rejects Bristol-Myers Skin Cancer Drug
By Jonathan D. Rockoff and Sten Stovall
The Wall Street Journal, October 14, 2011
Yervoy is expected to be a blockbuster for Bristol, with more than $1 billion in yearly sales. The therapy was approved in the U.S. in March and in Europe in July. It had $95 million in sales during the second quarter. Bristol CEO Lamberto Andreotti recently said the company was “very happy with the results so far” from the drug’s uptake.
“The price of Yervoy reflects the value of Yervoy,” Mr. Andreotti added, at the Pharmaceutical Strategic Alliances conference in New York last month.
http://online.wsj.com/article/SB10001424052970204002304576630891235750606.html
And…
Melanoma (stage III or IV) – ipilimumab: appraisal consultation document
National Institute for Health and Clinical Excellence (NICE)
October 12, 2011
Key conclusion
Ipilimumab is not recommended for the treatment of advanced (unresectable or metastatic) malignant melanoma in people who have received prior therapy.
The Committee was satisfied that ipilimumab meets the criteria for being a life-extending, end-of-life treatment and that the trial evidence presented for this consideration was robust.
The Committee acknowledged that few advances had been made in the treatment of advanced melanoma in recent years and ipilimumab could be considered a significant innovation for a disease with a high unmet clinical need.
Despite the combined value of these factors the Committee considered that the magnitude of additional weight that would need to be assigned to the QALY gains (quality-adjusted life years) for people with advanced (unresectable or metastatic) melanoma would be too great for ipilimumab to be considered a cost-effective use of NHS resources.
http://guidance.nice.org.uk/TA/WaveCRS2/48/Consultation/DraftGuidance
Comment:
By Don McCanne, MD
Should a $126,000 drug (Yervoy, ipilimumab) that produced only a very minimal benefit in a small segment of patients studied, yet caused significant side affects, be included in program that we finance? Is there no limit as to what we should add to coverage when our national health expenditures are already challenging individual, business and government budgets?
When the CEO of the manufacturer of this drug says, “The price of Yervoy reflects the value of Yervoy,” we should take a serious look at what constitutes value. That’s precisely what NICE did. Their fairly detailed report should be read before endorsing “anything goes” health care.
There is a limit. When we are picking up the tab, either through taxes for government programs or through premiums for private plans, we should be very concerned about how are funds are being spent.
Additional comment from Merton Bernstein:
Shouldnāt we also question the validity of the price assigned by the manufacturer? The likelihood is that its development was aided by some public funds. If a useful drug is out of reach for those who need it, should not the patent owner modify normal cost calculations to bring it within the reach of more people? It seems to me that pricing drugs should include element reflecting who bore the cost of development and who bears the cost of its unavailability because of cost considerations.