Breast Cancer Drug Blocked By Health Watchdog, Deemed Too Expensive For NHS | HuffPost Life

Breast Cancer Drug Blocked By Health Watchdog, Deemed Too Expensive For NHS

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A new Herceptin-style breast cancer drug, which costs £90,000 but can prolong lives by almost six months is to be turned down from routine NHS access under draft guidance issued by a health watchdog.

Kadcyla is being criticised as "not effective enough" to justify the cost to the NHS, according to the National Institute for Health and Care Excellence (Nice).

The watchdog, responsible for deciding which new medicines are cost effective, said its guidance for Kadcyla, or trastuzumab emtansine, was in draft form and is now up for public consultation.

Meanwhile patients will be able to apply to their local NHS and to the Cancer Drugs Fund (CDF) for the drug, a Nice spokeswoman said.

But the decision, if made final later this year, would mean the drug would not be recommended for routine use in England on the NHS and women would have to rely on their doctors' successful application to the Cancer Drugs Fund.

Sir Andrew Dillon, Nice chief executive, said he hoped Roche would "act in the best interest of patients" and use the consultation period to look again at their evidence and consider if there was "more" they could do.

Story continues below the slideshow:

11 Little Known Breast Cancer Facts

Breast cancer is actually many different types of cancer(01 of10)

Breast cancer, in its simplest definition, is cancer that starts in the cells of the breast. But what we call "breast cancer" actually includes several different types of cancer, all of which require different treatments and have different prognoses. (credit:Shutterstock)

A lump doesn't always (or even usually) mean cancer(02 of10)

Most breast lumps indicate something other than breast cancer—some possible causes for breast lumps include cysts, fibrosis, or benign tumours. And some women are just prone to lumpy breasts, which is stressful but harmless. That said, if you find a lump, get it checked out — know that the odds are good that it's nothing serious, but see your doctor about it for your own peace of mind. (credit:Susan G. Komen)

Breast cancer isn't always a lump(03 of10)

It's helpful to know that breast cancer can appear in forms other than a lump, which means there are other physical signs you should watch for. Other symptoms that you should get checked out include thickening of the skin in the breast or underarm area; swelling, warmth, redness, or darkening of the breasts; a change in your breast size or shape; dimpling or puckering of the breast skin; an itchy, scaly sore or rash on the nipple; a pulling in of your nipple or another part of your breast; sudden nipple discharge; or pain in one spot of the breast that doesn't go away. (credit:Shutterstock)

Breast cancer risk isn't always determined by family history(04 of10)

A family history of breast cancer (on either your mother or father's side) can be an indication that your personal odds of developing it are higher than average, but they don't guarantee that you will. As well, the majority of women who develop breast cancer have no identifiable risk factors, including family history. And the BRCA1 and BRCA2 gene mutations are hereditary, but only account for five to 10 per cent of all breast cancers. (credit:Shutterstock)

BRCA1 or BRCA2 don't always mean cancer is in your future(05 of10)

The news that Angelina Jolie had had a preventative double mastectomy after testing positive for the BRCA1 gene mutation made many women wonder if they had the same mutation--and what it would mean for them if they did. If you do have the BRCA1 or BRCA2 gene mutation, your lifetime risk of developing breast cancer or ovarian cancer is significantly elevated, and women with the mutations who do get cancer tend to develop it at younger ages; one estimate states that 55 to 65 per cent of the women with the BRCA1 mutation and 45 per cent of those with the BRCA2 mutation will develop breast cancer by age 70, versus 12 per cent in the general population. But it does not mean that cancer is definitely in your future, and every person has to make her own individual decision, based on a variety of factors, about how to best mitigate her risk of disease. (credit:Shutterstock)

Not all women have a one-in-eight risk for breast cancer(06 of10)

This often-cited statistic is somewhat misleading. Breast cancer risk varies based on a variety of factors, including age, weight, and ethnic background. Risk increases as you get older (http://www.cdc.gov/cancer/breast/statistics/age.htm): most breast-cancer cases are in women in their 50s and 60s. Also, some ethnic groups appear to be more susceptible to breast cancer; the National Cancer Institute in the U.S. says that white, non-Hispanic women have the highest overall risk of developing breast cancer, while women of Korean descent have the lowest risk, but African-American women have a higher death rate. Finally, being overweight or obese may also up your risk; there is evidence that being obese or overweight after menopause can up your breast-cancer risk, possibly because fat tissue is a source of estrogen. (credit:Shutterstock)

There are ways to lower your risk(07 of10)

You can't prevent breast cancer, per se, but there are ways to lower your personal risk. If you are overweight or obese, you could try to lose weight in a healthful way; if you are already in a healthy weight range, try to stay there. Exercise regularly, as as little as 75 to 150 minutes of walking a week has been shown to have a lowering effect on risk. Limit your alcohol consumption — research found that women who have two or more alcoholic drinks each day have an elevated risk of breast cancer. And avoid hormone therapy during menopause, as a combo of estrogen and progestin has been shown to raise breast-cancer risk. (credit:Shutterstock)

Mammograms aren't foolproof(08 of10)

Mammograms are a powerful way to detect breast cancer early on, but they aren't 100 per cent. Mammograms are most effective in women aged 50 and over; they detect about 83 per cent of women who have breast cancer in that age group. For younger women, the sensitivity is 78 per cent. However, that does mean some cancers are missed and that there are false-positive results as well, which could require a biopsy to confirm. Talk to your doctor about when you should start getting mammograms regularly, or if you have symptoms that suggest that you should get one. (credit:Shutterstock)

Fertility treatments don't raise your breast-cancer risk(09 of10)

Some wondered if Giuliana Rancic's fertility treatments were behind her diagnosis of breast cancer in her late 30s, but experts interviewed by WebMD said that there is no strong evidence connecting the disease with the use of fertility drugs. It's true that hormonal treatments can raise the risk for post-menopausal women, but women undergoing fertility treatments are almost never in that age range, and also take the medications for a much shorter period of time. (credit:Getty Images)

Most women survive breast cancer(10 of10)

Cancer is scary, but in most cases, women who are diagnosed with breast cancer survive and lead healthy lives. According to the Breast Cancer Society of Canada, the five-year survival rate is 80 per cent for men and 88 per cent for women. That's up from 79 per cent for women in 1986. (credit:Shutterstock)

"We had hoped that Roche would have recognised the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS," he said.

"This drug is already being funded through the special Cancer Drugs Fund. Our job is to recommend whether it should transfer into the NHS budget.

"We are very aware of the importance that people place on life-extending cancer drugs and a decision not to recommend a cancer treatment for routine NHS funding is never taken lightly.

"We apply as much flexibility as we can in approving new treatments, but the reality is that given its price and what it offers to patients, it will displace more health benefit which the NHS could achieve in other ways, than it will offer to patients with breast cancer."

Professor Paul Ellis, consultant oncologist, at King's College, London and lead triallist for the drug in the UK, described the Nice draft guidance as a "huge blow".

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"Kadcyla represents a significant advance in HER2-positive breast cancer, so for Nice to issue negative preliminary guidance is a huge blow," he said.

"The drug tackles the disease in a different way to any other breast cancer medicine and provides women with valuable extra time with their families and loved ones - time that you cannot put a price on.

"Not only this, Kadcyla is also much better tolerated by women than current standard treatment options, causing much less in the way of traditional chemotherapy associated side effects."

Jayson Dallas, general manager, Roche Products Limited, said: "Roche is extremely disappointed that Nice has failed to safeguard the interests of patients with this advanced stage of aggressive disease.

"The extension to the Cancer Drugs Fund was welcome news for those in England, meaning patients in the UK are some of the first in Europe to be able access medicines like Kadcyla.

"With Nice currently consulting on guidelines for 'value-based assessment', it will be important that they arrive at a sustainable solution that builds upon the success of the CDF, and ensures that patients continue to have rapid access to much needed cancer medicines."

Have a look at 10 of the most recent breast cancer findings:

10 New Breast Cancer Findings

There Are 4 Major Classes Of Breast Cancer(01 of10)

Results of a massive gene analysis, published last month in the journal Nature, shows that there are four major classes of breast cancer, the Associated Press reported. "With this study, we're one giant step closer to understanding the genetic origins of the four major subtypes of breast cancer," study researcher Matthew Ellis, M.B., B.Chir., Ph.D., of the Washington University School of Medicine and the Siteman Cancer Center, said in a statement. "Now, we can investigate which drugs work best for patients based on the genetic profiles of their tumors," he added in the statement. "For basal-like breast tumors, it's clear they are genetically more similar to ovarian tumors than to other breast cancers. Whether they can be treated the same way is an intriguing possibility that needs to be explored."

Men With Breast Cancer Fare Worse(02 of10)

Men are less likely to get breast cancer than women -- but when they do, it's often deadlier, according to a study presented earlier this year at the American Society of Breast Surgeons meeting. The Associated Press reported that men diagnosed with breast cancer live, on average, two fewer years than women who are diagnosed with breast cancer, and are also more likely to have the breast cancer spread, have larger tumors when the cancer is discovered, and be diagnosed later. (credit:Alamy)

Cadmium Could Raise Breast Cancer Risk(03 of10)

Cadmium -- a toxic metal that can be present in foods like shellfish, root vegetables, offal and cereals -- may raise risk of breast cancer, according to a March 2012 study in the journal Cancer Research. The research included 56,000 women. Researchers were able to analyze about how much cadmium each woman was consuming based on the cadmium-rich foods in her diet. They found that those who consumed the most cadmium had a 21 percent higher breast cancer risk, compared with those who consumed the least cadmium, HuffPost's Catherine Pearson reported. (credit:Alamy)

Sleep May Affect Breast Cancer Risk (04 of10)

Getting six or fewer hours of sleep may raise the risk of recurrent breast cancer among post-menopausal breast cancer patients, according to a study in the journal Breast Cancer Research and Treatment. However, this same link was not observed for pre-menopausal breast cancer patients.The findings suggest "that lack of sufficient sleep may cause more aggressive tumors, but more research will need to be done to verify this finding and understand the causes of this association," study researcher Cheryl Thompson, Ph.D. said in the statement. (credit:Alamy)

A Smallpox Virus Could Be A Promising Treatment(05 of10)

A smallpox virus seems to be promising against a hard-to-treat form of breast cancer, called triple-negative breast cancer, according to a study in mice presented at the 2012 Annual Clinical Congress of the American College of Surgeons."Based upon pathology, we could see that at least 60 percent of the tumors were completely regressed and the other 40 percent had very little areas of tumor cells present with a lot of necrosis, which is a sign that the tumor was responding to therapy," study researcher Dr. Sepideh Gholami, M.D., of Stanford University Medical Center, said in a statement. ABC News pointed out that this kind of breast cancer is notoriously hard to treat because it doesn't respond to other hormonal or immune treatments. (credit:Alamy)

Shift Work May Influence Breast Cancer Risk(06 of10)

Working the night shift is linked to an increased risk of breast cancer, according to two different studies that came out this year.One of them, published in the journal Occupational and Environmental Medicine, showed that breast cancer risk went up among women who worked the night shift more than twice a week, with the risk being the highest among those who said that they are "morning people" instead of "night people." The Toronto Sun reported that the results of this study confirm the findings of the International Agency for Research on Cancer, which has a list of items and habits that may cause cancer. The IARC considers shift work "possibly carcinogenic."The other study, published in the International Journal of Cancer, showed that breast cancer risk is 30 percent higher for women who work the night shift, with the risk being especially clear among those working night-time jobs for four years, or those who worked the night shift for three or fewer nights a week. (credit:Alamy)

Breast Size May Be Linked With Breast Cancer Risk(07 of10)

The genes that help determine a woman's breast size may also be linked with her breast cancer risk, according to a study published earlier this year in the journal BMC Medical Genetics.Researchers examined the genetic data of 16,000 women to find that seven DNA variations, called single nucleotide polymorphisms (SNPs), seem to be linked with breast size -- and three of those SNPs are known to be associated with a person's risk of breast cancer, HuffPost's Catherine Pearson reported. (credit:Alamy)

Exercise Could Help Lower Breast Cancer Risk(08 of10)

Just a little bit of exercise may help to reduce your risk of breast cancer, though the more you move, the better, according to a study in the journal CANCER. Researchers at the University of North Carolina in Chapel Hill found that postmenopausal or reproductive-age women in their study who exercised the most -- from 10 to 19 hours each week -- had a 30 percent lower risk of breast cancer, though exercising less than that was still linked with some protective benefits. "The observation of a reduced risk of breast cancer for women who engaged in exercise after menopause is particularly encouraging given the late age of onset for breast cancer," study researcher Lauren McCullough said in a statement.

Type 2 Diabetes May Raise Breast Cancer Risk (For Some Women)(09 of10)

For post-menopausal women, having Type 2 diabetes may raise the risk of breast cancer, according to a review conducted by the International Prevention Research Institute. "On the one hand, it's thought that being overweight, often associated with Type 2 diabetes, and the effect this has on hormone activity may be partly responsible for the processes that lead to cancer growth," study researcher Peter Boyle, the president of the International Prevention Research Institute, told The Telegraph. "But it's also impossible to rule out that some factors related to diabetes may be involved in the process." (credit:Alamy)

Being Overweight Tied To Worst Breast Cancer Outcomes(10 of10)

Being overweight could lead to worse outcomes from breast cancer, according to a study published August in the journal Cancer. Specifically, the study showed that overweight women who have been treated for breast cancer have a higher risk of recurrence and death, NBC News reported."Obesity seemed to carry a higher risk of breast cancer recurrence and death -- even in women who were healthy at the time that they were diagnosed, and despite the fact that they received the best available chemotherapy and hormone therapy," study researcher Dr. Joseph Sparano, associate chairman of medical oncology at the Montefiore Einstein Center for Cancer Care, told NBC News. (credit:Alamy)

Kadcyla is currently given to breast cancer patients who have failed on conventional treatment with Herceptin and chemotherapy.

The drug is only suitable for patients with the defective Her2 gene and trial results have shown it can extend life by six months compared with treatment with two other drugs, lapatinib (Tyverb) and capecitabine (a type of chemotherapy).

Kadcyla is designed to penetrate cancer cells and destroy them from within and, because its action is so precise, a normally toxic form of chemotherapy can be used.

Clinical trial results have shown that women on Kadcyla survived 30.9 months compared with 25.1 months for patients treated with lapatinib and capecitabine.

The Cancer Drugs Fund (CDF) was set up for patients in England to access drugs approved by doctors but which have not been given the go-ahead for widespread use on the NHS.

The scheme was set to run until March this year but David Cameron announced last September that the funding programme will run for a further two years to March 2016.

Breakthrough Breast Cancer said currently an estimated 1,500 women in Britain could benefit from Kadcyla every year.

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Senior policy manager, Dr Caitlin Palframan, said: "The drug appraisal process in England, and the cost of drugs, must change if prospects for patients are going to improve.

"This is the third highly-effective breast cancer drug to be rejected by Nice on the basis of cost in the last year and we will be responding to this latest decision, as well as the wider proposed changes to Nice's drug appraisal process, in due course.

"Drug development and research is moving at a pace that the system can't seem to keep up with.

"Kadcyla is a very impressive drug that has been shown to extend life by up to six months in HER2-positive secondary breast cancer patients, and with more manageable side effects than alternative drugs.

"We are now looking to the Department of Health and the pharmaceutical industry to find a way to work together to bring the cost of expensive drugs down and put a sustainable system in place by which new treatments can be made available on the NHS on a routine basis."

Find out what #mamming is and how it helps raise awareness:

#Mamming: Raising Awareness For Breast Cancer

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Emma Pennery, clinical director at Breast Cancer Care said: "It's extremely disappointing news for those living with advanced breast cancer and their families that yet another treatment has not been recommended by Nice.

"Kadcyla can mean those facing limited treatment options live longer and with fewer severe side effects, such as being sick, vastly improving their quality of life.

"We recognise that decisions about approval of cancer drugs are based on many complex factors, but we are concerned by the increasing number of people we support telling us how anxious they are about being able to access treatments when they need them.

"Kadcyla offers people with HER2 positive advanced breast cancer a unique combination of chemotherapy and targeted therapy in one agent.

"We await the results of the consultation period and the final guidance from Nice and hope Kadcyla will become widely available for eligible patients."

A spokeswoman for Roche added that the company would be working closely with Nice as part of the consultation period before final guidance is issued.

She said Kadcyla costs £5,908.16 per month and in the key Phase III study of the drug, patients were treated for an average of 9.6 months at a cost of just under £57,000. But she added that every patient responds differently to treatment.

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